CVD192 • COVID-19 Special Offer for MHPs

Table of Contents

CVD192 • COVID-19 Special Offer for MHPs

How to Receive Credit

NetCE 10 Hour Course #91693 • Families of Patients with Chronic Illness

91693 • Families of Patients with Chronic Illness

1. INTRODUCTION

2. KEY TERMS, CONCEPTS, AND THEORIES

3. IMPACT OF CHRONIC ILLNESS ON THE PATIENT

4. IMPACT OF CHRONIC ILLNESS ON FAMILIES

5. ROLE OF CULTURE, RACE, AND ETHNICITY IN CAREGIVING AND CAREGIVING BURDEN

6. ASSESSMENTS FOR FAMILIES OF PATIENTS WITH CHRONIC ILLNESS

7. INTERVENTIONS FOR FAMILIES

8. INTERPROFESSIONAL PRACTICE AND COLLABORATION

9. CONCLUSION

10. RESOURCES

Works Cited

NetCE 2 Hour Course #94151 • The Coronavirus Disease (COVID-19) Pandemic

94151 • The Coronavirus Disease (COVID-19) Pandemic

1. BACKGROUND

2. THE 2019–2020 NOVEL CORONAVIRUS OUTBREAK: A GLOBAL THREAT

3. CLINICAL MANIFESTATIONS OF COVID-19

4. COVID-19 IN CHILDREN

5. DIAGNOSTIC TESTING FOR SARS-COV-2

6. COVID-19 TREATMENT OPTIONS

7. COVID-19 VACCINES

8. TRANSMISSION DYNAMICS AND MITIGATION MEASURES

9. GLOBAL PUBLIC HEALTH CONCERNS AND WHO RESPONSE

10. OTHER AVAILABLE RESOURCES

Works Cited

NetCE 3 Hour Course #97664 • Online Professionalism and Ethics

97664 • Online Professionalism and Ethics

1. INTRODUCTION

2. INTERNET AND DIGITAL TECHNOLOGY TRENDS

3. REVIEW OF INTERNET COMMUNICATION TOOLS

4. USE OF INTERNET TOOLS IN CLINICAL PRACTICE

5. OVERVIEW OF PROFESSIONALISM AND ETHICS

6. INTERNET TECHNOLOGIES AND PROFESSIONALISM AND ETHICS

7. ONLINE SELF-DISCLOSURES

8. ONLINE SEARCHES FOR INFORMATION ON PATIENTS OR CLIENTS

9. BEST PRACTICE GUIDELINES

10. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

CVD192 • COVID-19 Special Offer for MHPs

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

CVD192 • COVID-19 Special Offer for MHPs

Expiration Date: 05/31/2024

How to Receive Credit

To complete this Special Offer for continuing education credit please go to http://www.netce.com/specials in your browser.

For assistance with receiving continuing education credit, please contact us at help@netce.com.

91693 • Families of Patients with Chronic Illness

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2021 NetCE, All rights reserved.

This course will review crisis theory and family systems theory as they apply to families of chronically ill patients. In addition, this course will review areas of family life that chronic illness impacts, how families respond to various stressors, caregiver stress, and the role of gender, culture, race, and ethnicity. By understanding the social impact chronic physical illness has on the family system, nurses, social workers, marriage and family therapists and other service providers will be in a better position to provide effective services and to empower families to increase their resources, coping behaviors, and problem-solving skills to deal with the stressors involved in having a family member with chronic illness.

Table of Contents

91693 • Families of Patients with Chronic Illness

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Individual State Nursing Approvals

Individual State Behavioral Health Approvals

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. KEY TERMS, CONCEPTS, AND THEORIES

ILLNESS AND DISEASE

ACUTE AND CHRONIC

HOW MANY ARE AFFECTED BY CHRONIC ILLNESS?

WHY THEORIES?

CRISIS THEORY

CASE STUDY 1

FAMILY SYSTEMS PERSPECTIVE

CASE STUDY 2

THE BEST OF BOTH WORLDS: FAMILY ADJUSTMENT AND ADAPTATION RESPONSE (FAAR) MODEL

3. IMPACT OF CHRONIC ILLNESS ON THE PATIENT

DOMAINS OF THE PATIENT'S LIFE AND CHRONIC ILLNESS

THE DEVELOPMENTAL LIFE CYCLE

4. IMPACT OF CHRONIC ILLNESS ON FAMILIES

STRESSORS AND STRAINS ON FAMILY LIFE

TYPES OF COPING RESPONSES

FACTORS INFLUENCING HOW FAMILIES WILL RESPOND TO CHRONIC ILLNESS

CAREGIVER STRESS AND BURDEN

5. ROLE OF CULTURE, RACE, AND ETHNICITY IN CAREGIVING AND CAREGIVING BURDEN

HISPANICS/LATINOS AND THE CAREGIVING EXPERIENCE

AFRICAN AMERICANS AND THE CAREGIVING EXPERIENCE

ASIAN AMERICANS AND THE CAREGIVING EXPERIENCE

6. ASSESSMENTS FOR FAMILIES OF PATIENTS WITH CHRONIC ILLNESS

QUALEY'S THREE-STAGE ASSESSMENT

GENOGRAMS

SOCIAL NETWORK GRID (OR MAP)

STANDARDIZED INSTRUMENTS

7. INTERVENTIONS FOR FAMILIES

PROVIDING INFORMATION

EXPLORING THE MEANING OF CHRONIC ILLNESS AND AMBIGUOUS LOSS

SELF-CARE FOR FAMILY MEMBERS

FAMILY THERAPY

PSYCHOEDUCATIONAL GROUPS

SELF-HELP GROUPS

MACRO-ORIENTED INTERVENTIONS

8. INTERPROFESSIONAL PRACTICE AND COLLABORATION

9. CONCLUSION

10. RESOURCES

Works Cited

91693 • Families of Patients with Chronic Illness

Education Category. Community Health

Release Date. 06/01/2021

Expiration Date. 05/31/2024

Course Overview

This course will review crisis theory and family systems theory as they apply to families of chronically ill patients. In addition, this course will review areas of family life that chronic illness impacts, how families respond to various stressors, caregiver stress, and the role of gender, culture, race, and ethnicity. By understanding the social impact chronic physical illness has on the family system, nurses, social workers, marriage and family therapists and other service providers will be in a better position to provide effective services and to empower families to increase their resources, coping behaviors, and problem-solving skills to deal with the stressors involved in having a family member with chronic illness.

Audience

This course is designed for physicians, nurses, social workers, marriage and family therapists, and any healthcare professionals involved in the care of patients with chronic illness.

Accreditations & Approvals

In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NetCE has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 6361. Programs that do not qualify for NBCC credit are clearly identified. NetCE is solely responsible for all aspects of the programs. NetCE is approved by the California Nursing Home Administrator Program as a provider of continuing education. Provider number 1622. NetCE is approved to offer continuing education through the Florida Board of Nursing Home Administrators, Provider #50-2405. As a Jointly Accredited Organization, NetCE is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU. NetCE is approved as a provider of online continuing education for certified nursing assistants through the California Department of Public Health Licensing and Certification Division. Nurse Aide Certification (NAC) Provider #7005. NetCE is recognized by the New York State Education Department's State Board for Social Work as an approved provider of continuing education for licensed social workers #SW-0033. This course is considered self-study, as defined by the New York State Board for Social Work. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed mental health counselors #MHC-0021. This course is considered self-study by the New York State Board of Mental Health Counseling. Materials that are included in this course may include interventions and modalities that are beyond the authorized practice of licensed master social work and licensed clinical social work in New York. As a licensed professional, you are responsible for reviewing the scope of practice, including activities that are defined in law as beyond the boundaries of practice for an LMSW and LCSW. A licensee who practices beyond the authorized scope of practice could be charged with unprofessional conduct under the Education Law and Regents Rules. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed marriage and family therapists. #MFT-0015.This course is considered self-study by the New York State Board of Marriage and Family Therapy.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 10 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this enduring material for a maximum of 10 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. NetCE designates this continuing education activity for 10 ANCC contact hour(s). NetCE designates this continuing education activity for 12 hours for Alabama nurses. NetCE designates this continuing education activity for 3.5 NBCC clock hour(s). Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 10 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Social workers participating in this intermediate to advanced course will receive 10 Clinical continuing education clock hours. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery's Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 10 MOC points in the American Board of Pediatrics' (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME's "CME in Support of MOC" program in Section 3 of the Royal College's MOC Program. This home study course is approved by the Florida Board of Nursing Home Administrators for 10 credit hour(s). This course is approved by the California Nursing Home Administrator Program for 10 hour(s) of continuing education credit - NHAP#1622010-9415/P. California NHAs may only obtain a maximum of 10 hours per course. AACN Synergy CERP Category B. NetCE is authorized by IACET to offer 1 CEU(s) for this program.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through July 29,2025); Alabama, Provider #ABNP0353, (valid through July 29, 2025); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2025; South Carolina, Provider #50-2405; South Carolina, Provider #50-2405. West Virginia RN and APRN, Provider #50-2405.

Individual State Behavioral Health Approvals

In addition to states that accept ASWB, NetCE is approved as a provider of continuing education by the following state boards: Alabama State Board of Social Work Examiners, Provider #0515; Florida Board of Clinical Social Work, Marriage and Family Therapy and Mental Health Counseling, CE Broker Provider #50-2405; Illinois Division of Professional Regulation for Social Workers, License #159.001094; Illinois Division of Professional Regulation for Licensed Professional and Clinical Counselors, License #197.000185; Illinois Division of Professional Regulation for Marriage and Family Therapists, License #168.000190;

Special Approvals

This activity is designed to comply with the requirements of California Assembly Bill 1195, Cultural and Linguistic Competency.

Course Objective

The purpose of this course is to increase the knowledge base of social workers, physicians, nurses, marriage and family therapists, and other allied healthcare professionals who work with patients with chronic illness and their families, in order to effectively address the impact of chronic illness on the entire family system.

Learning Objectives

Upon completion of this course, you should be able to:

1. Differentiate between the key terms involved in discussions of chronic illness.

2. Discuss the major assumptions of crisis theory and their application for families with patients experiencing chronic illness.

3. Discuss the major assumptions of family systems theory and their applications for families with patients experiencing chronic illness.

4. Explain the Family Adjustment and Adaptation Response (FAAR) Model and its application for families with members who are chronically ill.

5. Describe the impact of chronic illness on the patient and the role of the patient's developmental stage in affecting the meaning and impact of chronic illness.

6. Describe the types of demands experienced by the family system when a family member is diagnosed with chronic illness.

7. Describe the variations of coping responses.

8. Identify and explain factors that influence how families respond to the diagnosis of chronic illness.

9. Articulate the role of gender in family adaptation to chronic illness.

10. Discuss the role of spirituality and religiosity in family adaptation to chronic illness.

11. Distinguish between the terms "caregiving" and "caregiver," and define the concept of caregiver stress.

12. Discuss the role of culture, race, and ethnicity in family caregiving.

13. Utilize various types of assessments and interventions for the families of patients with chronic illness.

Faculty

Alice Yick Flanagan, PhD, MSW, received her Master’s in Social Work from Columbia University, School of Social Work. She has clinical experience in mental health in correctional settings, psychiatric hospitals, and community health centers. In 1997, she received her PhD from UCLA, School of Public Policy and Social Research. Dr. Yick Flanagan completed a year-long post-doctoral fellowship at Hunter College, School of Social Work in 1999. In that year she taught the course Research Methods and Violence Against Women to Masters degree students, as well as conducting qualitative research studies on death and dying in Chinese American families.

Previously acting as a faculty member at Capella University and Northcentral University, Dr. Yick Flanagan is currently a contributing faculty member at Walden University, School of Social Work, and a dissertation chair at Grand Canyon University, College of Doctoral Studies, working with Industrial Organizational Psychology doctoral students. She also serves as a consultant/subject matter expert for the New York City Board of Education and publishing companies for online curriculum development, developing practice MCAT questions in the area of psychology and sociology. Her research focus is on the area of culture and mental health in ethnic minority communities.

Faculty Disclosure

Contributing faculty, Alice Yick Flanagan, PhD, MSW, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Chronic physical illness impacts both the patient and the entire family system. The patient with the illness is profoundly affected in the biologic, psychologic, and social functioning arenas. Those persons in the immediate social context of the patient, such as family members, are also affected in multiple ways. Family members are affected emotionally, cognitively, and behaviorally and are often faced with changing their day-to-day routines, plans for the future, and feelings and meanings about self, others, and life. Meyerstein described the impact of chronic illness in the following way [1]:

Patient and family members wander in unfamiliar territory, facing strange hospital environments, foreign "medicalese," and confusing procedures. Family members are thrown off their familiar path and have difficulty finding their way back. While the detour has different meanings for individual family members, sustaining one's spirits and preserving identity in the face of illness is a challenge.

This course focuses on chronic physical illness in general and does not cover mental illness. It is possible to take a noncategorical approach because the impact psychologic, social, financial, and emotional of chronic illness can be generalized to families experience all types of chronic illnesses [48]. The unique characteristics and features of mental illness evoke a different set of reactions from family members, friends, and society than physical illness. In addition, the mental health system is different from the general health system and warrants separate attention.

The first section of the course reviews key terms and concepts and highlights three theoretical perspectives: crisis theory, family systems theory, and the Family Adjustment and Adaptation Response (FAAR) Model as they apply to families who have patients with chronic illness. The second section describes how chronic illness impacts the patient. It is important to have an overview of the patient's subjective world as it is affected by chronic illness because it will ultimately impact the patient's family. Each member responds to chronic illness differently, and, therefore, the social realities of mothers, fathers, and siblings in coping with chronic illness will be described. Gender and spirituality/religiosity will be discussed as variables that affect family coping with chronic illness. The third section examines the areas of family life that chronic illness impacts, the concept of caregiver stress, and how variables such as gender, culture, race, and ethnicity color family perceptions and responses to chronic illness. The fourth section focuses on assessments for nurses, social workers, marriage and family therapists, and other service providers when working with patients with chronic illness and their families. The final sections cover interventions for families and the role of interprofessional collaboration and practice.

The premise and goal of this course is to arm nurses, social workers, healthcare professionals, and other service providers with knowledge and skills to help educate patients and families about the social and familial dynamics of chronic illness. Chronic illness is not just about symptom management; it is about the journey that families and patients undertake when they first learn about the diagnosis, cope with the symptoms, and ultimately, make life meaningful despite the illness.

2. KEY TERMS, CONCEPTS, AND THEORIES

ILLNESS AND DISEASE

The terms "illness" and "disease" are frequently employed interchangeably; however, there is a distinction, particularly in relation to the life experiences of families of patients with chronic illness. The terms actually tap into a potential gap between the view of the service provider and that of the patient [2]. "Disease" refers to the problem as viewed by the practitioner or service provider in terms of symptoms and, ultimately, the diagnosis [3]. Diseases are conceptualizations or constructs based upon a culture within the practitioner's community and discipline (e.g., medicine, social work, physical rehabilitation). "Illness" refers to the human experience and the lived social reality of the symptoms, suffering, and process of adaptation that patients and family members make in light of the disease [3,4]. Individuals and families have illness beliefs, which are cognitions or explanations that help make sense and meaning of the reality of their illness and the existential questioning of death, vulnerability, and mortality [125,132]. Similarly, when service providers refer to "disease course," they are talking about the progression of the disease and the characteristics and phases of the symptoms. Meanwhile, an "illness trajectory" encompasses psychosocial issues, such as managing the medical regimen, adapting to potential restrictions due to the disease, altering one's lifestyle, learning to live with the stigma associated with the disease, and adjusting to the social and financial impact of the disease [5]. It is the illness experience of family members that this course will attempt to capture.

ACUTE AND CHRONIC

What is the distinction between an acute illness and a chronic illness? Acute illnesses involve a sudden onset of symptoms that are related to the disease process itself. Patients with acute illnesses require short-term care and usually improve upon receiving care [141]. The symptoms usually end shortly with almost complete recovery, resumption of prior activities, or death [3].

In the past, many types of conditions would have rapidly killed patients, but because of technologic and pharmacologic advances, patients with chronic illnesses, such as intellectual disability, multiple sclerosis, cerebral palsy, paralysis of extremities, cancer, diabetes, dementia, respiratory illnesses, acquired immune deficiency syndrome (AIDS), and stroke, live longer. However, because chronic illness tremendously affects patients' functioning and daily activities of life, and because of increased life expectancies, chronic illnesses may be viewed as long-term visitors who do not inform their hosts how long they plan to stay [3,6]. With many families, chronic illness becomes part of the patient's and family's identity.

The definition of chronic illness has always been nebulous. Miller offers one definition: a state caused by a nonreversible pathologic condition, which cannot be corrected by medical intervention and ultimately results in an altered health state with a lingering disability that cannot be easily treated [7]. Other researchers have defined chronic illness as a condition that last for more than one year, resulting in functional impairment and requiring additional health care and treatment [157]. The World Health Organization categorizes chronic illnesses as either communicable (e.g., human immunodeficiency virus [HIV]) and noncommunicable (e.g., diabetes, heart disease) [87].

The National Center for Health Statistics highlights four dimensions of chronic illness [6,8]:

- Time period: An illness is chronic if it is prolonged (i.e., generally more than 12 months in duration).

- Lifestyle: An illness is chronic if it is long-term and affects and interferes with the patient's functioning in the physical, psychologic, or social arena.

- Quality of life: An illness is chronic if the symptoms of the illness do not resolve spontaneously and begin to affect the normal activities, roles, and routines of the patient and the patient's family.

- Symptom management: An illness is chronic if it involves symptom management. Due to the incurable nature of the chronic illness, symptoms are persistent and long-term, and the patient will be left with residual effects of the condition. Ultimately, the goal is to manage the symptoms on a daily basis.

The Australian Institute for Health and Welfare has identified the following common attributes of chronic conditions [142]:

- Development of the condition may be long with no visible signs of symptoms

- Complex factors contributing to causality

- Functional impairment

- Possible other health conditions that result

In general, chronic illnesses are slow in progression and lengthy in duration [143]. Given the nature of the illness, there is usually variability and fluctuation in symptom severity over time, profoundly affecting the family and the course of the patient's life [193]. Because so many different types of conditions fall under the heading of chronic illness, and the nature and social perception of each individual condition varies, it is important not to make sweeping generalizations. For example, the family of an AIDS patient will experience tremendous negative social stigma compared to a family who has a patient diagnosed with multiple sclerosis. This course attempts to provide an overview of how chronic illness, as a long-term visitor, affects family life and to provide a foundation for nurses, social workers, and other healthcare professionals to intervene.

HOW MANY ARE AFFECTED BY CHRONIC ILLNESS?

It is estimated that 60% of adult Americans suffer from a form of chronic illness [2,8,194]. An estimated 150 million Americans have been diagnosed with a chronic condition, and of these individuals, an estimated 100 million have more than one chronic condition [156]. Those with five or more chronic conditions comprise approximately 12% of the adult population in the United States. Given the developmental life cycle, elders will inevitably have to confront illness. Of older Americans, it is estimated that 80% have a chronic condition [195]. However, chronic illness is not merely associated with the elderly. Approximately one-third of persons in the United States 18 to 44 years of age experience chronic illness [2]. It is estimated that more than two-thirds of all deaths are caused by one or more of the following chronic diseases: heart disease, cancer, stroke, chronic obstructive pulmonary disease, and diabetes [196].

Approximately 18 million children have some form of chronic illness. The majority of these children are not cared for within institutional settings but live with parents or guardians, which means that caregiving is provided within the home [9]. More than 75% of healthcare costs in the United States may be attributed to chronic illness [8]. For heart disease and stroke alone, total costs were estimated at $329.7 billion in 2014 [126]. The Centers for Disease Control and Prevention estimates that chronic conditions are responsible for a total annual cost of $3.8 trillion in healthcare costs in the United States [194]. It is projected that by 2030, healthcare costs associated with chronic illness will grow to $42 trillion [197].

WHY THEORIES?

Theories are logical systems of concepts that provide a framework for organizing and understanding observations. They are intended to offer comprehensive, simple, and dependable principles for the explanation and prediction of observable phenomena. Theories provide explanations and direction for how the service provider will proceed during various phases of the change process. They define the problem, the etiology of the problem, and, ultimately, guide assessments and interventions. All families experience a crisis at the onset of chronic illness; therefore, the first theoretical perspective to review is crisis theory.

CRISIS THEORY

There are two types of family crises: maturational (i.e., transitional or developmental) and situational. Maturational crises refer to universal crises that are associated with the normal developmental stages of the individual or the family, which occur at major life transitions. These life transitions include adolescence to adulthood, middle-age to old-age, birth of a child, school entry, children leaving home, and retirement [10]. These are predictable and universal life-stage events that can be anticipated and for which families can prepare accordingly.

Situational crises, on the other hand, are unpredictable. They are typically major sudden interruptions for the individual or the entire family system. They originate from three different sources: (1) material or environmental (e.g., fires, natural disasters); (2) personal or physical (e.g., loss of limb due to accident, diagnosis of an illness); and (3) interpersonal or social (e.g., death of a loved one) [11]. Inevitably, the crisis causes anxiety and disequilibrium, which can trigger anxiety and feelings of helplessness and despondency, and the individual or the family must learn to cope [158]. The crisis situation is short-term or time-limited.

A crisis can be viewed in one of two ways: as a threat or as an opportunity [12]. It can be viewed as a threat because the crisis could have negative ramifications or consequences on psychologic health and social well-being. It can also affect quality of life. Self-esteem and problem solving are correlated with quality of life; yet, when a crisis hits, problem solving may be temporarily hampered, which then leads to a sense that one's quality of life has been disrupted [13]. However, from an opportunity perspective, an individual or a family who is in crisis is more vulnerable and, consequently, may be more receptive to interventions, which can then lead to growth [12]. Family crisis interventions are often successful because the growth and opportunity that may occur during crisis can break the normally rigid boundaries of the family system, making the family and its members more open to change [127].

A closer look at the major tenets of crisis theory and a brief case study will illustrate this theoretical perspective. This course provides only a basic overview of crisis theory.

Major Assumptions and Tenets of Crisis Theory

The major assumptions of crisis theory are [14,159]:

- Crisis situations are normal. They are not an illness and are not pathologic. They occur throughout the normal life spans of individuals, families, groups, communities, and nations.

- Crises are initiated by some sort of hazardous event. This is defined as a finite, stressful blow. It may be either a single catastrophic event (e.g., earthquake) or a series of stressful events that build up a cumulative effect.

- The impact of the hazardous event disturbs the individual's homeostatic balance or equilibrium (i.e., state of stability). This hazardous event then places the individual in a vulnerable state. In an attempt to regain equilibrium, the individual will use his/her existing repertoire of coping and problem-solving strategies. If these strategies are not successful, his/her upset or stress increases. The individual may seek new strategies to deal with the crisis.

- If the problem continues and cannot be resolved, the tension peaks, and a precipitating factor can bring about a turning point. The individual's repertoire of problem-solving skills is not adequate to take care of the stress. This is the state of active crisis.

- During the course of the developing crisis situation, the individual may perceive the initial and subsequent events as a threat, a loss, or a positive challenge.

- Each of these perceptions regarding the crisis elicits an emotional reaction. A threat elicits anxiety. A loss may evoke feelings of depression and grief. A challenge may bring forth some anxiety, but there will also be an undercurrent of hope and expectation.

- A crisis may reactivate some earlier unresolved conflict, which will exacerbate the crisis situation.

- All crises follow a series of predictable stages, which can be mapped out.

- Crisis situations are temporary in nature. The total length of time between the initial blow and the final resolution of the crisis may vary. Crisis situations, by definition, are time-limited, usually lasting up to four to six weeks.

- During the resolution of the crisis, the individual tends to be open to help. Therefore, minimal interventions can yield maximum results.

- During the reintegration phase, new coping and adaptive styles are learned which helps the individual to cope more effectively with other situations at other times. However, if help is not available, maladaptive patterns may be adopted.

The tenets of the theory should then flow into the intervention. Therefore, the ultimate goal of crisis intervention is to help individuals return to their level of functioning in the precrisis state [15]. Roberts developed a seven-stage crisis intervention model, which encompasses the following [16]:

- Stage 1: Assess the client's level of danger to himself/herself

- Stage 2: Establish rapport

- Stage 3: Identify the major problems to work on

- Stage 4: Explore feelings

- Stage 5: Explore alternatives

- Stage 6: Develop a concrete, solutions-focused action plan

- Stage 7: Follow up with the client

Crisis intervention is based on a problem-solving orientation, where the situation is immediately assessed. The type of assistance is decided upon and a concrete plan of action is implemented. When the client's equilibrium appears to be achieved, the practitioner should reinforce those techniques used by the individual or family unit that helped promote adaptation and coping [17].

CASE STUDY 1

Patient Y is a married woman, 76 years of age. She emigrated from China to the United States with her husband 53 years ago. They have three children: a daughter who lives near them; a son who lives in the same city; and a son who lives out of state. They also have eight grandchildren. Patient Y is a homemaker. She and her husband have lived in the same neighborhood, in the same house for more than 40 years. Patient Y speaks little English and depends on family members to translate for her when the need arises. Recently, she became ill, complaining of dizziness, shortness of breath, being tired all the time, and loss of appetite. During a visit, her daughter noticed that she looked pale and had lost strength in her left arm. She convinced her mother to go to the hospital and accompanied her; Patient Y was diagnosed as having had a mild heart attack and was admitted to the hospital for tests and observation. On the second day following hospitalization, Patient Y suffered a second, more serious heart attack and was admitted to the intensive care unit (ICU). Her condition was guarded and other family members were notified, including the son who lived out of state.

The hazardous event in this case scenario is the onset of the illness and the symptoms. It usually occurs when the family receives news of the diagnosis. Rolland's trajectory phases of illness chronicle the natural history of chronic diseases [18]. Rolland's first phase is the crisis stage, which includes the onset of symptoms, learning about the diagnosis, and the initial adjustment period. During this stage, the patient and family assimilate the news of the diagnosis, attempt to comprehend the meaning of the disease, and begin grieving the loss that the disease will bring. Eventually, there is a movement toward acceptance and gradual equilibrium in the family system. In crisis theory jargon, the hazardous events in this case study are the initial diagnosis of the first attack, and later, the diagnosis of chronic heart disease and Patient Y slipping into a coma. Patient Y's family will learn of the diagnosis and begin to comprehend the enormity and gravity of the situation.

Although visiting in the ICU was strictly limited, a family member was allowed to stay with Patient Y most of the time due to her anxiety about hospitals and the staff's limited ability to converse with her. Patient Y continued to refuse to eat, and IVs were maintained. Her condition was guarded, although she insisted through her husband and children that she was fine and just wanted to go home to prepare for Thanksgiving.

The younger son was contacted due to the seriousness of his mother's condition and arrived the night after her second heart attack. The daughter organized the family to take turns being with Patient Y, and the grandchildren and other extended family members provided transportation, cooked, cleaned the home, and met her basic needs.

After three days in the ICU, Patient Y was transferred to the telemetry unit. The crisis situation began taking its toll on the family. The younger son argued with his sister that his mother should be allowed to go home to familiar surroundings, familiar foods, and family care. He was angry about his mother's condition and blamed his father and siblings for not taking better care of her. Patient Y's husband ignored him and refused to discuss any future plans with him or the other children. The long days and nights and his worry about his wife were obviously affecting this quiet man whose wife had always looked after him and dealt with the children.

The daughter took over and met with physicians and the hospital social worker and organized family resources to assure her father's care. She arranged for a family member to always be present with Patient Y and arranged with the hospital to allow the family to bring more familiar foods to her mother. She quietly and competently mobilized family resources to meet new and different demands and began gathering information about available resources for when (and if) her mother was able to leave the hospital, in spite of her father's denial and her brother's unrealistic optimism.

Crisis theory is helpful in normalizing the crisis event and the responses evoked by Patient Y's illness. In this case study, the son's anger and the calm, methodical, and systematic responses of the daughter are not viewed in a pathologic perspective. Instead, they are viewed in light of the crisis and from the perspective that a range of emotions and reactions are normal. The range of responses on the part of the patient and/or family members may include: (1) a biophysical response (e.g., the patient's experience of pain and discomfort); (2) the range of emotional responses (e.g., anger, sorrow, shock, loss, helplessness, anxiety about welfare of children, spouse), fear of death, and other emotions; (3) the cognitive response (e.g., fears, belief systems about how illness will affect the future); and (4) the behavioral response (e.g., the patient and the family's adjustment to medical regimen, hospital rules if hospitalized, assimilation of diagnosis) [10]. Because of the crisis event, the family system freezes, requiring an altering of family functions and roles. In this case scenario, the daughter's role was redefined as she mobilized the family to meet the various demands of her mother's illness. The grandchildren assumed various caretaking roles including cooking, cleaning, and transporting Patient Y's husband to and from the hospital. Because the stress was a threat to the ongoing functions of the family, its members mobilized its energy to establish new equilibrium.

FAMILY SYSTEMS PERSPECTIVE

Practitioners should not view "families as mere adjuncts to the patient, [as] it will perpetuate the tendency for healthcare professionals to identify families as generally dysfunctional, to marginalize the family's role in care" [160]. Therefore, family systems theory helps to understand the course of the illness within the context of the whole family's beliefs and dynamics. Family systems theory is based on von Bertalanffy's theory [19]. von Bertalanffy argued that systems are a set of interrelated elements but that each of the elements is distinct from the environment in which it is embedded. Energy from the environment will inevitably permeate the boundaries of the system. The family is then viewed as in a continual state of change given that the family will always be interacting with the environment [19]. Family systems theory is quite detailed and this course provides only an overview of the theoretical perspective.

Basic Assumptions of Family Systems Theory

A system refers to a set of elements in a patterned relationship to each other. Therefore, a family system consists of a group of individuals who are characterized by marked transactional patterns and dynamics of relationships between them [20,21,161]. These transactional patterns are the focal points as they influence which members act and how they behave [21]. The family is a dynamic system of interdependent parts, and the family system is constantly characterized by change [22]. Change impacts both the individual and the entire family system. For example, family members' emotional states are interdependent, and the overall family emotional climate will affect the ill member's health and well-being [193,198].

Within this family system there exists family structure and family functioning. Family structure is defined as the organizational patterns or characteristics of the family [21]. Boundaries mark who is in and who is out. The boundaries are semipermeable, so the family system can change and adapt to normative transitional forces (e.g., births, marriages, deaths, divorce). Boundaries also ensure differentiation of the subsystem [21]. Boundaries in families are also marked by generations; that is, all family systems have generational boundaries. Generational boundaries refer to the differences in communication, roles, privileges, and responsibilities between members within different family generations [23]. It is important to remember that culture, race, and ethnicity influence these boundaries. For example, some ethnic groups, such as Latino families, incorporate nonfamily members into the family structure [24]. Some family structures are more highly organized (e.g., the structures of Asian families) where there are clearly defined generational boundaries and roles [25,161].

Subsystems include those members who are part of the larger family system on either a temporary or permanent basis, all with specific roles [21]. Subsystems may be organized by gender, power, past history, or interests [21]. Family subsystems might include marital dyad, parental unit, the parent-child unit, and grandparents.

Family functioning refers to the connections of the members within the family system. Level of cohesion and flexibility, problem-solving styles, behavioral controls, and affective expressions are elements that characterize family functioning [20]. The family seeks homeostasis or stability given the dynamic and changing nature of the family system. However, disequilibrium is normal, and a family can grow as a result of it, but homeostasis restores equilibrium [22].

All families have rules and roles. Family rules are the expectations for behavior that shape and direct how families function. These rules can be either implicit or explicit. Rules may be manifested in the routines and daily activities of family life. Family roles refer to the beliefs that define how each member should behave and the specific function that each individual plays [23,161]. For example, a mother may assume the primary responsibility of caretaker and nurturer [22]. It is important to remember that the family roles are not only defined by needs or family origin, but also by culture, race, and ethnicity.

The family is indeed a unique system. On one hand, the system strives for togetherness, which helps maintain closeness, harmony, and a sense of responsibility for each other [26]. Yet, simultaneously, each member of the family strives for individuality by attempting to achieve personal goals and responsibilities [26]. Family systems theory argues that when there are changes in the environment, there will inevitably be changes (not necessarily negative) within the family structure [23]. Therefore, healthy family systems have clear boundaries between the subsystems as well as flexible rules and roles to promote individuality, but still maintain healthy generational hierarchies and promote growth and adaptability [25].

When families experience stress, such as when a family member is diagnosed with chronic illness, the homeostasis of the system is interrupted as the forces of togetherness and individuality may come in conflict. For example, the mother may have to forfeit her personal goal of returning to a career, or she may find that most of the emotional and logistic work of caregiving falls on her—working to maintain the patient's medical regimen, care for the patient, and navigate between continual hospitalizations and home life [160]. The goal of togetherness is achieved, but at times to the detriment of personal individuality [22]. Chronic illness can also affect family roles. The eldest child may assume the role of a coparent, helping his/her siblings, while the parents deal with the patient's regimen and care. In addition, chronic illness often affects boundaries. Boss coined the term boundary ambiguity for a chronically ill family member who may be physically present but psychologically absent [27]. A parent diagnosed with dementia, for example, may not be available either emotionally or psychologically for the family. The family system must deal with the ambiguity of the role of the ill parent. This is further exacerbated by feelings of loss and mourning, with no closure, since the physical presence of the ill family member will continually activate these feelings.

Family coping behaviors as they relate to family boundaries can also be understood by two concepts—engulfment and balancing/boundary setting [28]. These two concepts can be viewed along a continuum, with engulfment on one end and balancing/boundary setting on the other end. They are not meant to be viewed as absolute, distinct entities whereby an individual's behavior can be clearly classified in one of the two categories. Rather, caregivers often exhibit mixed responses and at times, shift from one end of the continuum to the other [28]. Engulfment occurs when the caregiver subordinates his/her needs and activities to that of the patient with chronic illness [28]. The caregiver is so involved that the physical and psychologic suffering of the patient becomes entwined with the caregiver's. On the other end of the spectrum are balancing/boundary setting, where there is psychologic distance or separation between the caregiver and the patient. In addition, some families also find that they come together to meet the challenges by dividing up the tasks that need to be completed and finding resources and learning new caregiving skills [160].

CASE STUDY 2

The family in this case consists of a mother, a father, and three children: a daughter 39 years of age; a son, Patient J, 38 years of age; and a daughter 32 years of age. Patient J has recently made contact with his family after an absence of 16 years. During this time, he has lived in another state and has had no contact with his father and older sister. He has been in touch sporadically with his mother and younger sister, although without the knowledge of his father and older sister. Nine years ago, Patient J was diagnosed with HIV and 11 months ago was diagnosed with AIDS. His health is deteriorating, and he will most likely be unable to care for himself within a few months. Patient J has been in a stable relationship for about seven years, and his partner is both willing and able to care for him throughout the course of his illness. Patient J would like to reconcile with his father and older sister and move back to his hometown. His partner, a successful writer who works from their home, is willing to accompany him. They have purchased a home approximately six miles from Patient J's family home and have arranged to transfer his medical treatment to a local physician. All of this has been accomplished with the assistance of Patient J's younger sister and mother, both of whom are eager to have the patient near them but are apprehensive about the reception he will receive from his father and older sister.

In this scenario, we see how the diagnosis of HIV and AIDS has estranged Patient J from both his father and older sister. Although Patient J has made repeated attempts to bridge the gap, his attempts have been rebuffed. The patient's mother and younger sister have worked to bring him home, with much disapproval from his father and older sister. We can imagine the conflict that must have transpired within the marital dyad and perhaps between the two sisters. We can also see how AIDS has affected the lives of Patient J and his partner. Patient J's partner, who is committed to him, has taken on the responsibility of providing the day-to-day care for the patient. He is also willing to sacrifice his professional writing career, deciding to relocate with Patient J to their new home.

THE BEST OF BOTH WORLDS: FAMILY ADJUSTMENT AND ADAPTATION RESPONSE (FAAR) MODEL

Derived from the family systems perspective, the FAAR Model has been developed specifically for understanding family response and coping with stressful life events [29,199]. It encapsulates elements of both crisis and family systems theory.

The FAAR Model argues that all families experience a pileup of demands, stressors, and strains. Stressors are acute and isolated events that cause changes in the family system, while strains are ongoing tensions [162]. Families attempt to maintain equilibrium or homeostasis by employing their resources and coping behaviors to deal with the demands and stressors of the illness [29,30]. The resources and coping behaviors may be viewed as the family's protective factors [30]. Tangible resources might include finances, while intangible resources are the psychologic inner strengths. Stressors might include daily minor disruptions of the day, unresolved family strains, and normative and non-normative events [30].

How families accomplish a sense of equilibrium is a function of how they perceive and ascribe meaning to the stressors they experience and the resources they have available to cope with the stressors [20,30,162]. There are three levels of meanings. First, situational meanings refer to the family's appraisal of its resources and coping behaviors and its appraisal of the stressor [30]. The second level of meaning involves the family's identity; that is, how the family views itself as a family unit [30]. The third level of meaning consists of the family's worldview, which refers to how it sees its family system in relation to the larger system (i.e., community, society) [30]. Overall, how a family recovers from the crisis will be a function of the number of demands, appraisal and meaning-making of the crisis, and the resources used [162]. This model is strength-oriented and is consistent with the person-in-environment perspective [163].

In summary, how families engage their repertoires of tangible and intangible resources and coping skills to deal with the stressors and the meanings they ascribe to illness event will influence family adaptation [30]. The goal of practitioners who utilize the FAAR model is to facilitate the family's resources and coping behaviors in order to restore balance within the family system. It assumes that practitioners will take a proactive approach in working with families and that families have the strengths to deal with the stressors [30].

According to the FAAR Model, there are three phases that families travel through when the news of chronic illness hits [199].

Adjustment Phase

This is a relatively stable period of time during which families attempt to meet the normal demands and minor stressors of life with their existing resources and coping behaviors. Resources are either tangible (e.g., money) or intangible (e.g., self-esteem) and may come from the individual, the family, or the community. Coping behaviors are the specific things that families do to deal with stress and restore family equilibrium [29].

Family identity and its worldview remain intact during this phase. A family identity is its sense of oneness that makes it feel distinct and separate from other families [29]. A family identity formulates through the routines, rituals, and values that are maintained and reinforced [29]. A worldview is a family's perception of and orientation toward the world [29]. It encompasses religious and cultural beliefs and other belief systems that serve as a guide for how to deal with and understand the changes around them [29]. Family identity and worldview are influenced by the meanings that families attribute to life's demands and stressors and affected by the family's existing resources and coping behaviors.

Crisis Phase

A hazardous event (e.g., news of the chronic illness) threatens the existing equilibrium of the family system [162]. This is not necessarily a pathologic phase since crisis can bring growth to families. It is a time when families are most open to help.

Adaptation Phase

As the crisis besets a family, it feels vulnerable, stressed, and uncomfortable. Consequently, the family will attempt to restore stability or homeostasis by obtaining new resources, coping skills, and problem-solving skills to handle the stressors evoked by the family member who is diagnosed with chronic illness [162]. The family must ascribe new meanings to the event. Family identity may change as routines, rituals, and roles change to deal with the crisis. In addition, a family's worldview might also change. For example, in cases of chronic illness, Patterson maintains that families who may have had a high internal locus of control may move towards a balance of external and internal loci of control. The family realizes that it cannot control all aspects of the world around it [29].

It is important to remember that this phase may not necessarily be a one-time phase: instead, a family may cycle in and out of the crisis and adaptation phases, depending upon the nature of the crisis [29].

3. IMPACT OF CHRONIC ILLNESS ON THE PATIENT

The problems associated with chronic illness will ultimately color the various domains of the patient's life, including the physical, psychologic, economic, and social dimensions. Although these domains overlap and are not necessarily discrete entities, they will be presented as such in this course. Impact of chronic illness is never static; it is an ever-changing process that influences how the patient accepts the disease, copes, manages, and integrates and adjusts to the illness [200].

DOMAINS OF THE PATIENT'S LIFE AND CHRONIC ILLNESS

Physical Domain

Functional Status

This refers to the patient's ability to continue functioning in his/her daily activities, such as self-care, going to work or school, participating in recreational activities, and continuing with activities that the patient enjoyed prior to the chronic condition [31].

Physical Symptoms

Because of the nature of chronic illness and its long-term symptoms, the patient is continually reminded of his/her condition [3]. The symptoms include both the symptoms related to the chronic illness and the side effects from the treatment that is prescribed [31].

Schirm argues that symptoms are continual symbols for the patient [31]. They may serve as a reminder of the patient's eventual death, and on a more abstract level, symptoms symbolize psychosocial loss, such as helplessness, grief, and powerlessness [31]. Ultimately, how a patient perceives the symptoms will affect the course of the illness. Patients who are resigned to their symptoms will passively accept them, while those who view their symptoms as challenges will engage forcefully and actively to combat them [31].

Psychologic Domain

Grief and Sorrow

Loss, sorrow, and the ensuing grief are characteristic in patients coping with chronic illness [6]. There is grief of the loss of a body part and of physical functioning [32]. Variables such as age, gender, health before the diagnosis of the illness, and the patient's existing social support influence what types of losses will be experienced [6]. Both the patient and family members grieve and mourn over the loss of the person who once was and the personality and traits associated with that person [33]. Olshansky termed this chronic sorrow because, although the patient may have accepted the diagnosis, the feelings of grief and loss continue to wax and wane throughout the course of the illness [34].

Fears

Patients with chronic illness experience a variety of fears due to the uncertainty of the prognosis of their illness, difficulties understanding medical jargon, having to adapt to medical regimens and new schedules, and feeling a loss of control over their lives. Pollin highlighted eight fears that a patient with chronic illness experiences [6,35]:

- Loss of control

- Loss of self-image

- Loss of independence

- Stigma

- Abandonment

- Expression of anger

- Isolation

- Death

Other patients may experience fears and anxiety about their own future, that of their children's future, and the effect of the illness on relationships [36]. Concerns about their own sense of attractiveness may also affect their outlook, sense of self-esteem, and body image [32,36]. Body image, for example, is an unconscious mental representation of one's body and is influenced by a host of factors including attitudes, sensory and physical sensations, and interpersonal interactions, all of which are affected by chronic illness [32].

Stigma

Stigma is the devaluation of a person due to an attribute, such as chronic illness [128]. In general, people seek to enter a social relationship in which both partners are perceived to bring a benefit and not a social cost. Because patients with illnesses of any kind may be stigmatized as not credible and abnormal, it may be difficult to maintain or obtain friendships and other relationships [128].

Interpreting and Reinterpreting Meaning

When patients learn of the diagnosis, their worldview collapses. They wrestle to answer questions, such as: "Why did this happen?" "Why me?" and "Who or what is responsible for this?" [31]. Foley asserted that, generally, individuals ascribe various meanings to illness or suffering, including [37]:

- Punishment (i.e., having done something to deserve punishment)

- Testing (i.e., testing one's faith or character)

- Bad luck

- Nature merely taking its course

- Resignation to the will of God

- Acceptance of human condition (e.g., pain, suffering)

- Personal growth (i.e., suffering helps one grow, makes them a better person)

- Denial

- Minimizing (i.e., downplaying the severity of the illness or prognosis)

- Divine perspective

- Redemption (i.e., finding peace in suffering)

Economic Domain

Chronic illness is not only an emotional drain but is also a financial drain on patients and family members. Because of the debilitating effects of the illness, patients may find themselves giving up their jobs. Some may find it necessary to give up their home and return home to their parents [36]. Even if the patient has health insurance, there are often out-of-pocket expenses that are not covered by insurance. Finally, the patient's family may also experience loss of income, particularly those family members who have to forfeit their jobs to assist with caregiving activities [31]. The sense of economic instability may rise given looming medical bills and, at times, substantial out-of-pocket expenses [201].

Social Domain

Because of their limited functional abilities, some patients with chronic illness may decrease their level of participation in social activities, thereby altering their social network relationships [38]. Developmental tasks, such as attending school, developing and maintaining friendships, finding a mate, having children, or moving to the next phase of their career, may also be affected [36,202]. With certain illnesses, such as AIDS, family and friends may withdraw from the patient. Because the issue of mortality is inevitably linked with chronic illness, not only do patients confront this issue, but their friends and social network systems become uncomfortable with the idea of their own mortality [38]. Consequently, they may withdraw. This is particularly important because loneliness has been shown to be a precursor of depression, particularly among older women [164].

THE DEVELOPMENTAL LIFE CYCLE

Developmental transitions are normal aspects of life, and accomplishing developmental tasks may bring about stress. However, the uncertainty of chronic illness compounds these difficulties; it influences how the patient views his/her chronic condition and ultimately affects the family system [6,20]. Chronic illness inevitably sets a different tone for the individual and the family.

Childhood

During childhood years, particularly around 6 to 11 years of age, school becomes a primary context for developmental acquisitions, including both formal knowledge and social skills. Success in the school environment aids in the development of self-mastery, which is a crucial developmental task of this life cycle [39]. A child who is chronically ill may not be able to attend school to learn and to play with peers. The child may have frequent hospitalizations, adhere to strict medical regimens, and/or comply with rules that restrict his/her movement [40,202]. The child feels isolated, knowing that he/she is different from others in the peer group, which can in turn affect the child's self-esteem. In one meta-analysis, researchers found that children with chronic illness tended to have lower self-esteem scores, particularly girls compared to boys [129]. The child's adjustment to illness is highly dependent on the coping skills and adjustment of those around him/her, such as parents, sibling, and friends [39]. Indeed, one of the most vital tasks of a chronically ill child is to effectively handle and cope with other's responses.

Adolescence

Adolescence is characterized as a period of confusion and turmoil. Boice noted that one of the main developmental tasks for the adolescent is the search for identity, and those adolescents who achieve a sense of identity will experience well-being—a sense of knowing where they are going and feeling a comfort level with their body. In their search for identity, adolescents wrestle with the perception that they are different from their peers [41]. Social acceptance is one of the major concerns for adolescents. However, often the chronically ill adolescent is isolated from other teenagers and spends a large amount of time with adult caregivers and healthcare professionals. This is one reason adolescents with chronic illness often welcome returning to school. In a study of adolescents with cancer, participants reported that returning to school represented "being on the right track" to recovery, rebuilding friendships, and regaining their sense of identity [165]. Rejection by and isolation from peers may contribute to even greater stress [41]. Indeed, studies have found that when chronically ill adolescents have frequent peer contacts during their illness, psychosocial outcomes are improved [42,43,44]. And when their healthy counterparts have increased interactions with adolescents who are chronically ill, prejudicial attitudes held by the healthy peers decrease [42].

Adolescence is also a period marked by tremendous biologic changes. Chronic illness may impair biologic processes or affect the timing of the process of puberty [41]. It has been documented that adolescents who are chronically ill express more anxiety about their height and weight [41]. Chronic illness diagnoses at this age may have change patients' body image, which can impact their sense of identity, sense of belonging, and future plans [203]. Providers should discuss with patients how their chronic illness affects their current and future biographies [203].

Adolescents typically want more freedom, and this is no exception for those with chronic illness. Parents may give adolescents increasing responsibility for managing their illness, depending on his or her level of self-efficacy [130]. Research indicates that children who are expected to do household chores despite their illness exhibit higher levels of health self-efficacy and self-management [130].

Early Adulthood

The emphasis during the early adulthood years is on finding a place in a vocational niche, finding their personal identity, establishing intimacy with others, and selecting goals for life. In one study, patients who had a chronic illness reported struggling with establishing their identity [131]. Participants tended to feel threatened by how others might respond to them and that they had limited social status as a result of their chronic illness [131]. Others may struggle with a changed body image or loss of physical function that they have to adjust to or struggle with being less independent [166].

Intimacy with others entails interactions with others, which in turn are affected by one's own perceptions of oneself as competent and valuable [6]. Chronic illness may interrupt this process of achieving intimacy and the life one had envisioned [166]. Again, the illness may force patients to isolate themselves. Patients in early adulthood who have achieved relationships prior to the diagnosis of the illness now struggle with maintaining levels of intimacy with spouses and children. Some wrestle with whether they should have children or additional children [6]. For those who have to give up jobs or careers, they may feel unproductive and unsuccessful [45].

Middle Age

According to Erikson, one of the major developmental tasks during the middle-age years is generativity versus stagnation. The tasks of generativity involve productivity and giving back to society [46]. However, patients with chronic illness who are navigating this developmental stage may feel unanchored, grieve over missed opportunities, and feel anxious about impending death [6,45].

Older Adulthood

In older age, the major developmental task as defined by Erikson is achieving integrity versus despair. This involves a review of life accomplishments and acceptance of one's life [46]. Major issues include dealing with loss and developing a point of view regarding death. In this stage of life, chronic illness can be especially debilitating, both physically and psychologically. However, elders with chronic illnesses also are very resilient. They view resilience as a unique skill in managing physical and emotional challenges [167].

This section provides only a snapshot of the many variables that affect the coping and adjustment processes of patients with chronic illness. It does not do justice to their courage or to the pain, frustration, and unique challenges that they experience. The reader is encouraged to listen to patients' stories in order to provide more effective psychosocial interventions.

4. IMPACT OF CHRONIC ILLNESS ON FAMILIES

All families go through normal challenges that are related to life cycles and situational stressors. However, families living with chronic illness confront a new set of demands related to that illness [20]. The effects and meanings of the illness have an dynamic interplay on the patient and all family members [204]. This section focuses on the various demands that challenge families with chronic illness and explains the factors that influence how families react to chronic illness. This includes caregiver stress, gender, culture, race, and how ethnicity affects caregiving and caregiver stress.

STRESSORS AND STRAINS ON FAMILY LIFE

Patterson and Garwick argue for systemic analysis and the need for longitudinal studies on families experiencing chronic illness. They maintain that it is difficult to disentangle the stressors and demands that existed prior to the diagnosis of the chronic condition from the stressors and demands that emerged as a result of the chronic illness. However, it is the multiple demands that these families experience that nurses, social workers, and other healthcare professionals should address. Patterson and Garwick coined the term "pileup of demands" to describe these cumulative stressors and demands [20]. Parents of children and youths with chronic illness often assume the responsibility of managing their children's medication regimen, dealing with any emergencies that might arise, and supervising educational, social, and recreational activities [205]. These responsibilities are in addition to typical day-to-day responsibilities of family life.

In a study with 17 families affected by chronic illness, participants described how stressors varied at different phases of the illness and healing [168]. The first phase of chronic illness is described as the "fight" or adversarial stage, during which the family member learns of the illness. This stage involves acknowledging the illness and the stressors that emerge as a result of dealing with the illness. The second phase involves family members coming to terms with the illness and redefining family life. The third phase involves the day-to-day living of the illness. Often, families have to re-invent routines in order to minimize the impact of the illness on the family system. Phase four focuses on maintaining the social relationships within the family so everyone feels supported. The final phase is figuring out how to move the illness to the background of family life [168]. A qualitative study found that families initially felt that their family life fell into disarray because routines were disrupted and, often, controlled by the patient's needs [206].

Financial Stressors and Strains

Patients with chronic illness and their families often experience financial strains due to frequent physicians' visits, hospitalizations, and medical and therapeutic treatments. For those families who are uninsured and without access to proper medical care, there are tremendous ramifications in terms of the disease course and the quality of life [47]. Approximately 26.1 million Americans did not have health insurance coverage for the entirety of 2019 [169]. This particularly affects ethnic minority families and those from lower socioeconomic brackets. In 2017, 10.6% of African Americans, 16.1% of Hispanics, and 7.3% of Asians did not have insurance coverage at any time during the year, compared with 5.9% of white Americans [170]. For those families who may be adequately covered, a family member may have to leave his/her employment in order to care for the patient, as full-time nursing care is often not economically feasible [20]. Family demands related to care may either preclude a family member from receiving a promotion or result in the loss of a job [49]. Medical visits, therapy, special equipment, medicines, and other specialized services are part of the financial demands associated with chronic illness [49]. For those families who are already financially stressed, chronic illness may place them at additional risk of draining their resources [49]. It has been shown that financial resources are a crucial predictor to family coping and adjustment to chronic illness [50]. The amount of financial resources has implications for access to and quality of health services.

Day-to-Day Demands

The effects of chronic illness on families may be examined from a "task perspective" [51]. This perspective involves listing the activities and tasks of the primary caregiver in order to understand the demands of caregiving. The list usually includes an exhaustive array of tasks that must be accomplished on a daily basis. Some of the activities are intimate, such as assisting with the patient's personal care and hygiene. Other tasks are more practical, such as shopping, making meals, running errands, doing laundry, housekeeping, and helping with the patient's paper work [51]. In a national survey, all types of carers reported on average 2.1 hours a week in providing some type of care related to the health of the family member [171]. An estimated 21% attended their family member's appointments. In total, 32% indicated they had trouble paying for medications, and 41% felt they did not have adequate information about the family member's illness or maintenance regimen. Caregivers often talk about experiencing role strain, which is influenced by feeling "in the middle" when making decisions about the care of the chronically ill family member; a "burden of responsibility" in assuming a multitude of tasks; and a "changed identity" due to new roles related to caregiving [52]. Family routinization has been found to be the main coping strategy for family members who provide caregiving [133,134]. Non-caregiving family members (e.g., siblings) will also assume new responsibilities and may feel partially responsible for keeping the family together [207].

In addition to assisting with the patient's activities of daily living, Coffey found that caregivers also assume an advocacy role, which entails three elements: vigilance and taking over; negotiating and taking a halt; and tenacious information seeking [9]. While fighting for services and care for the patient was found to be a large part of the advocacy role, taking a halt was equally important. This meant that the caregiver was firm about calling a halt to care when he or she felt that the patient had had enough of a certain medical treatment or intervention. Also important was the need to be assertive in obtaining health information so as to make the best and most informed choices for the patient. Caregivers struggled to balance the fine line between worrying that they might alienate healthcare providers and wanting to ensure the best care for the patient [9].

Social Demands

When families have a family member with chronic illness, their social spheres will inevitably be affected. Particularly for those families who provide care for the ill family member, there is a loss of family privacy, reduced spontaneity of life, time taken away from other family members, such as children, and potential loss of work opportunities [20].

The responsibility for caring for a patient with chronic illness, particularly a child, can strain marital relationships. Marital satisfaction can be compromised because the communication process between the spouses may be hampered, and there is less "down time" together [53; 205]. Lower marital satisfaction was related to increased treatment compliance and less maternal contact, indicating that parents find themselves in a difficult situation, in which they must sacrifice either their relationship or the care of the chronically ill child [53]. Parents are often involved aspects of the patient's life they usually would not be, often feeling responsible for protecting the normalcy of the patient's social development [202].

The level of marital satisfaction is ultimately affected by the wife's perceived support from her spouse. Mothers of young children who are chronically ill, for example, expend a lot of time and energy in caring for and coordinating the regimen of the sick child. Assistance from the spouse has been identified as a major predictor of marital satisfaction [49].

Siblings in a family system are also affected. Studies have shown that siblings of a chronically ill family member are vulnerable to adjustment problems, low self-esteem, poor peer relations, anxiety, depression, and lower health-related quality of life [54]. In some cases, parents may underestimate the overall functioning of the healthy sibling(s) in part because they use the frame of reference of the unhealthy child [135]. Siblings may feel caught by being a caregiver and defender of the ill family member, and may feel jealous, frustrated, resentful, and neglected [53; 207]. They may perceive injustices as a result of different expectations, rules, and parental attention and indulgences for the ill sibling [136]. Parents may have less physical and emotional time to spend with siblings to help them adjust to the effects of chronic illness on the family system. In addition, the degree to which the siblings are affected is also influenced by the severity of the condition [54]. They also miss out on a normal sibling relationship and companionship [136].

Healthy siblings will either internalize or externalize their emotional experiences in response to their chronically ill sibling. Examples of internalizing their emotions include withdrawing, becoming "invisible" to alleviate their parents' burden, loneliness, and separation anxiety. Separation anxiety most likely stems from frequent separations from parents who are caring for the sick sibling. Examples of externalizing emotions include intense anger, restlessness, hyperactivity, academic problems, and aggressive behaviors [136].

There is research that indicates that healthy siblings may not be as socially competent as their peers without ill family members. However, a variety of factors play a role in social adjustment, including gender, age, social support, and contact with other children [208].

Psychologic Demands

Both the patient and family mourn over the loss of what could have been—the hopes, dreams, and possibilities of the ill family member. It has been argued that living with and caring for a patient with chronic illness requires a continual navigation of emotionally charged routes for families [6]. The family continues to experience a loss of "what could have been," as Olshansky described in the concept of chronic sorrow [34]. Boss and Couden also term this as ambiguous loss that results because the ill family member is still physically present but perhaps psychologically absent [55]. With illnesses where the diagnosis has yet to be confirmed or the prognosis is unclear, both the patient and family members may feel as if they are riding an emotional roller coaster [55]. There may also be ambiguity about the roles, rules, and boundaries in the family system as a result of the patient's illness [55]. This ambiguity may be particularly true in the early stages, when family members are in denial and physicians express optimism [6]. Then there are the concerns and anxieties about the future and the pressures of constant decision making [20]. Chronic sorrow may be triggered by many factors, including missed developmental milestones, chronicity of the illness, uncertainties related to the future, missing school, hospital readmissions, and the realization that the family member will need a guardian in the event a parent passes away [172,209].

Another emotion that is ever pervasive is worry, or, as Coffey terms it, "living worried" [9]. It is a type of worry that is characterized as being present focused, but also projected in the future. For example, families worry about who will care for the patient if they are no longer able to provide care. However, this worry is not a passive emotion; rather, it is tinged with hypervigilance, where families are continually on guard observing for: changes in symptoms and health status; how the illness is affecting siblings; and how the illness is affecting the patient's social functioning in other areas, such as school [9].

These demands are further colored by what Rolland terms the "psychosocial typology of illness" [47]. Instead of purely biologic criteria in categorizing illness, Rolland argues that the nature of the chronic illness has certain psychosocial demands on families. Rolland conceptualized the typology along five points [47,125]:

- Onset: This can be categorized as either acute or chronic illnesses. For acute illnesses, families experience the emotional and day-to-day demands in a more compressed fashion. However, with chronic illness, the period of coping, adjustment, and family reorganization is extended.

- Course: A chronic illness can be progressive, constant, or episodic. An example of a progressive chronic illness is Alzheimer disease. Families who have a patient with a progressive chronic condition continually refine and organize their roles to adapt to the illness. Family caregivers continually juggle the demands of life with negotiating the care of the patient. A chronic illness that is constant means that the occurrence of the initial event (i.e., illness) is followed by a relatively stable biologic course. An example of a constant chronic illness is a heart attack. The initial illness and diagnosis are followed by shock and crisis. However, families adjust and equilibrium is restored. A chronic condition that is episodic is characterized by periods of crisis that occur whenever the symptoms flare up followed by equilibrium, which is restored when the crisis abates. An example of an episodic condition is asthma. Families live with a ghost that periodically comes back to haunt them. Families require flexibility to navigate between two forms of family roles and organization-one when the symptoms exacerbate and one when the symptoms diminish.

- Outcome: Outcomes for chronic illnesses can be fatal (e.g., terminal cancer), can shorten the patient's life span (e.g., heart conditions), or may not necessarily affect the patient's life span (e.g., arthritis). The outcome of the illness affects how families grieve or mourn. When death is imminent, families may emotionally detach themselves from the patient. They may also experience a range of emotions (e.g., anger, sadness) that are at times consuming and distract the family system from engaging in the practical tasks that are integral to family functioning and organization. When loss is not necessarily at the forefront, families have to work on bringing normalcy back to the family system. Rolland notes that family members could take on an "it could happen" mentality, which breeds overprotection on the part of healthy family members and powerful secondary gains for the patient.

- Incapacitation: The degree of disability affects role reallocation in families. A patient who is diagnosed with Alzheimer disease impairment will be cognition-oriented. Family members may find that they have to provide more caregiving activities compared to a condition that leaves a patient disfigured but with cognition and movement intact.

- Uncertainty: The level of unpredictability of the course of the illness will affect family coping and adaptation.

Although families with a member who has a chronic illness will experience stress, challenges, and loss, it is important to remember that post-traumatic growth may occur. The concept of post-traumatic growth comes from positive psychology, which acknowledges the resiliency of the human spirit and that positive change that can follow negative events [137]. Meaning making and available social supports are predictors of post-traumatic growth for those with chronic illness [210]. Researchers observe that positive and negative affective states do not occur in a linear fashion. Instead, growth and loss operate independently and affect the well-being of the individual members and the entire family system [137]. Most families do function and adapt well despite the stressors. Positive functioning is often contingent upon available support and family connection [211].

TYPES OF COPING RESPONSES

Freud first talked about the unconscious mechanisms of coping. His discussion of defense mechanisms, such as denial, repression, rationalization, and projection, were unconscious ways in which individuals managed stress and anxiety. By the 1970s, the research moved into examining conscious coping strategies [56]. Lazarus was one of the first to develop a theoretical perspective about coping as a conscious process [57]. He first defined stress as consisting of three components: (1) primary appraisal, the process of perceiving the stress as a threat to oneself; (2) secondary appraisal, the process whereby one brings to mind the potential response to the threat; and (3) coping, which is the process of carrying out the response(s) to deal with the stress. This is not necessarily a process whereby each stage is experienced in an unbroken, linear manner. For example, if a family initially learns of a child's diagnosis of a serious illness, family members may initially be in shock, but may realize that they have a full array of coping resources, allowing them to reappraise the situation and perceive the threat as less threatening [58].

Lazarus identified two types of coping. Problem-solving coping is concrete and task-oriented [57]. It involves doing something to alter the source of stress [58]. Emotion-focused coping is targeted at reducing or managing the emotional distress that is triggered by the stressful event [58]. Both types of coping are utilized in stressful situations. However, Folkman and Lazarus found that problem-solving coping is used when individuals feel that something constructive can be done, while emotion-focused coping is used primarily when individuals perceive the stressful situation as something that must be endured or persevered [59]. Folkman and Lazarus later highlighted eight different coping styles that again fell into two major headings: problem-focused coping and emotion-focused coping. Problem-focused coping consists of problem-focused strategies and the seeking of social support. Emotion-focused strategies consist of eight subdimensions [59]:

- Wishful thinking

- Distancing

- Emphasizing the positive

- Self-blame

- Tension reduction

- Self-isolation

- Seeking social support

- Self-control

Individuals who are self-compassionate are able to view stressors in a less threatening manner and ultimately are more likely to use cognitive reframing strategies and less likely to employ avoidance coping strategies [173]. In a study in which parents of children with chronic illness were interviewed, many parents reported using cognitive strategies (e.g., reframing, passive appraisal) [211].

Cultural variations in coping have been discussed in the literature. Culturally-based worldviews and values affect how individuals respond to stress. Collectivistic values emphasize interpersonal relationships (i.e., family or other social support networks) and whether these relationships affect coping. For example, in one study, Chinese caregivers relied primarily on family-related coping strategies. These strategies focused on obtaining help and support from immediate family members rather than assistance from outsiders [212]. This type of coping should not be labeled as pathologic, as it fits within cultural norms of collectivism, filial piety, and familialism. Values that focus on independence might dictate that individuals from Western cultures use coping strategies such as being assertive, disclosing vocalizing feelings and thoughts, confronting others, and actively problem-solving [60]. Western frameworks, however, do not capture the full nuances of the coping strategies of individuals from communal and collectivistic cultures (i.e., Asia, Latin America, and Africa). For example, forbearance, perseverance, and sacrifice are characteristics that are highly valued in collectivistic cultures. Consequently, individuals from these cultures may cope by not disclosing their problems to others because they do not want to burden others [60]. Helping professionals should therefore not immediately label these strategies as resistance to or denial of the problem and attribute pathology. Helping professionals should be alert to the possibility that more serious psychologic, social, and mental health problems might be being masked [60].

Religious coping among ethnic minorities (particularly African Americans) has also been discussed in the literature [61]. Culver et al. found that African Americans and Hispanics used greater levels of religious coping and humor than whites [62]. Furthermore, they were less likely to use venting compared to their white counterparts [62]. In a comprehensive review of the literature, Latino caregivers who had children with a chronic illness tended to use religion/spirituality, support from their family network, alternative healing practices, and information about the illness to cope [174].

Hill's model of coping specifically addresses families' adaptation to a family member's illness [63]. The model was initially developed to understand how mothers coped with their children's diagnoses of sickle cell disorders; however, it is also useful in understanding the coping styles used to adapt to a family member's chronic illness. Hill proposed five different coping strategies [63]:

- Embracing the medical model: This strategy focuses on acquiring information about the illness.

- Achieving mastery: This mechanism emphasizes managing the symptoms. It is characterized by day-to-day survival rather than trying to understand the situation.

- Normalization: This strategy focuses on reducing stigma and establishing a sense of control.

- Positive reframing: This coping style emphasizes reframing the loss to acknowledge the ill family member's other positive strengths or attributes.

- Religion: This strategy focuses on how the stressful situation is part of spiritual growth.

These different types of coping styles overlap with Lazarus' and Folkman's initial conceptualization of coping styles.

FACTORS INFLUENCING HOW FAMILIES WILL RESPOND TO CHRONIC ILLNESS

Variations exist in how families respond to the consequences of chronic illness. These variations are influenced by nature and characteristics of the condition, resources, illness phases, family life stage, and gender [20].

Nature and Characteristics of the Illness

Some research indicates that how a family adapts depends more on the characteristics of the illness than on the initial diagnosis. These characteristics include:

- Degree and type of incapacitation (e.g., sensory, motor, cognitive)

- Extent of visibility of the condition

- Prognosis or life expectancy (e.g., is the outlook negative or positive; is it a terminal illness)

- Course of the illness (e.g., constant, relapsing, or progressive)

- Amount of home treatment, outpatient, and inpatient medical treatment and the expertise needed for the patient

- Amount of pain or other symptoms experienced

Resources

Families possess three types of resources [20; 64;213]:

- Personal Resources: This refers to the family's inherent resources for dealing with the challenge of chronic illness. These resources include their socioeconomic status, level of coping skills, self-efficacy, positive emotions, courage, being kind to oneself, sense of mastery, and their own physical health.

- Social/Familial Resources: This refers to the availability of social support networks in families, including confidantes, friends, and extended family members. Social support is an important moderating variable. The extent of an individual's or family's social support system can buffer stress. How a family responds to chronic illness will be impacted by its social support system, which includes family, friends, neighbors, and community resources. Familial resources refer to the organization of the family, such as clarity of rules and expectations, routines for daily family tasks, clear generational boundaries, and good communication.

- Community Resources: This refers to the quality of relationships that families have with professionals who are providing care and other services to the ill family member. Families who are familiar with navigating the medical and social service delivery system and have interactions with professionals who are well-trained, professional, reliable in scheduling, and sensitive to family dynamics are better able to mitigate the strain of chronic illness.

Illness Phases

Neither illness nor family coping is static; rather, it is dynamic. How a family responds to chronic illness is also a function of the phase of the illness as each phase of the illness has specific demands and transitions, and families will require different strengths, resources, and reorganization to meet these psychosocial demands [47]. Illness phases, as conceptualized by Rolland, can be delineated into three periods: crisis, chronic, and terminal phases [47].

- Crisis Phase: This time period includes the symptomatic period prior to the diagnosis and the initial period of coping and adjustment after the diagnosis. Families in this phase must learn to cope with the symptoms related to the condition, navigate the medical and healthcare system, and manage the day-to-day responsibilities of caring for the patient. In addition, patients and family members begin to make meaning of the illness.

- Chronic Phase: This phase is characterized as the "long haul," which includes the day-to-day activities and tasks related to caring for the patient and the family's attempt to maintain a semblance of normalcy. Family members reallocate roles and work on maintaining individual autonomy in the family system and not letting the illness define them.

- Terminal Phase: This period is marked by the imminence of death, and family members struggle to deal with issues of separation, mourning, and resuming family life after the loss.

Family Life Stage

Rolland as well as Carter and McGoldrick assert that there are distinct family roles, goals, functions, and transitional points at various stages of the family life cycle [47,65]. Carter and McGoldrick highlighted eight phases of the family life cycle, where each phase heralds a distinct marker with its associated inherent stressors [65]. Chronic physical illness adds a new dimension and hue to these normal developmental stressors. At times, chronic illness will propel the family system into a new stage: a family anticipating the birth of a new child with new hopes and dreams that hears about an ill family member will be forced to deal with loss [47].

Families who have a family member with a chronic illness have different needs, strengths, and resources at various points in the family life cycle. In a family with young children, for example, when one of the parental figures is diagnosed with a debilitating disease, the impact on child-rearing tasks can be affected in several ways. In many ways, one parent is lost to the chronic illness; the other parent is also "lost" because his/her presence may be diminished by new caregiving roles [47]. In some cases, an older child may take on a caregiver role or assume more adult responsibilities. Spousal relationships can change as one inevitably has to become the carer and the reciprocal relationship can no longer be maintained [175]. In addition, a "new" family member (i.e., chronic illness) becomes part of the family system [47,175]. During later stages, a chronic illness may have less impact on the parent dyad, but new anxieties emerge about the future welfare of their ill child [175].

Absent a chronic illness, parents who have raised their children and are ready to launch them into the world will renegotiate their roles and dreams in order to accommodate the exits [65]. Spouses will plan how they will be using their free time since they no longer have child-care responsibilities. However, if a family member is diagnosed with a serious chronic illness, parents may need to revise their "launching plans." For example, parents may have to re-examine the issues of autonomy and individuation and revisit the notion of caretaking as the patient becomes more dependent [47]. The case of Mr. and Mrs. P below illustrates this situation.

Case Study 3

Mr. and Mrs. P have long anticipated their retirement years. They have plans to travel the country in the RV they purchased last year and have spent many evenings studying maps and brochures about campgrounds. With their two children grown and relatively stable, they look forward to having time to devote to each other and to their shared interest in travel. Their friends tease them about their pending "second honeymoon" and are planning a surprise retirement party for Mrs. P, who will retire from her career as an elementary school teacher in one week, at the end of the school year. Mr. P has been retired for two years. Both are eagerly anticipating the freedom that Mrs. P's retirement will allow and have been caught giggling together on more than one occasion. Future plans include taking their two grandchildren to the Grand Canyon and Disneyland, but they first plan to spend six months alone just going wherever they please and getting used to the RV lifestyle.

Neither has anticipated the total disruption to their lives that the telephone call from the hospital brings. Their daughter has been involved in an auto accident and has suffered severe brain damage. She is currently in a coma in intensive care and the prognosis is not good. Their son-in-law asks if one of them can pick up their 7-year-old grandson from school and take him to a neighbor who sometimes babysits for the parents. They decide that Mr. P will do this and then meet Mrs. P at the hospital.

Later in the evening Mr. and Mrs. P, their son-in-law, and their other daughter meet with the neurologist who is attending their injured daughter. The neurologist reports that the damage is extensive and, at best, they can expect several weeks of hospitalization followed by months of rehabilitation. Suddenly, everyone's plans have changed and the future no longer seems so carefree.

Role of Gender

Gender is another important variable that influences how a family responds to chronic illness. The term "feminization of care" refers to the notion that most women are caregivers and expected to provide caregiving duties [66,176]. Women who work full-time are more than four times as likely as men who work full-time to be primary caregivers to elderly parents [67]. The typical caregiver is an employed woman 46 years of age who spends 18 hours per week on caregiving activities [68]. The competing demands of balancing full-time work, caring and nurturing their own children, and maintaining their own homes contribute to the caregiving stress and burden on women. According to Short, adult daughters are more likely to care for their frail elderly parents, and they provide 33% of the long-term care; 75% reside with the frail elderly parent to provide the care, and on average, the majority provide some sort of care and assistance every day for at least four hours [69]. The caregiver burden may also threaten women's financial security as a result of their having to leave the workforce [138]. Women typically do more hands-on caregiving tasks and spend more hours providing caregiving compared with men [139].

Because of the prevailing belief that women are more involved as caretakers when a family member is chronically ill, fathers have received less empirical attention. However, men are assuming more caregiving responsibilities. A study conducted using three national datasets of young adult caregivers found that over half of the caregivers were men [70]. Furthermore, there do not appear to be gender differences in the amount of caregiver burden experienced [214]. Katz and Krulik found that fathers had more difficulty than mothers adjusting to their child's physical limitations due to a chronic illness [71]. Fathers also disclosed experiencing tremendous stress in having to assume greater financial responsibility due to the costs of medical treatment, physicians' visits, and hospitalizations, particularly if the mother had to give up her job to assume caregiving responsibilities. Goble's qualitative study of fathers who had a chronically ill child indicated that finances were a continual stress [72]. Some fathers had to work overtime and some stated that they lived from paycheck to paycheck and were lucky to make ends meet.

Fathers have also reported feeling like the forgotten parent because they are frequently not as involved as the mothers [73]. However, they also felt conflicted by the desire to spend more time with their chronically ill child and the need to work because of the additional medical expenses. Work also helped the fathers to forget about the stresses and bring some normalcy back to their lives [74].

The fathers also disclosed that they felt closer to their wives and experienced a lot of support from them [72]. However, there was no down time to merely relax and have fun with their wives. One of the fathers in the study stated that he missed being in a husband-wife relationship and that having a chronically ill child was like running a business. Everything was scheduled down to the minute, except relaxation time as husband and wife [72].

In a 2016 qualitative study, some instances of caring were identified as more "masculine" (e.g., lifting the patient). Men in this study also described how the illness provided an opportunity to emotionally express themselves and seek emotional support [176].

Role of Beliefs: Religiosity and Spirituality

Shaw and Halliday observed that belief systems are central to understanding how families respond to crises and adversity [75]. Belief systems are defined as strongly adhered-to ideas that have been either learned through socialization or shared through time to connect people in a meaningful manner [75]. Families have belief systems (whether secular or religious/spiritual) about health and illness, the healthcare system and practitioners, and the meaning of adversity [75]. During a crisis, these belief systems will be triggered, which will then influence family responses.

Religion and spirituality influence adjustment and coping for chronic illness and can enhance existing pathways of coping, adjustment, and health, while also giving meaning and purpose to the caregiver and the patient [177]. Religiousness or religiosity is defined as personal belief in God or a higher being, often times encapsulated in organizational and institutional practices, such as church attendance, church membership, or an organized religion [76]. It is an external expression of faith [77]. Spirituality is broader and defined as a personal philosophy, which could include religion as well as culture, where a person strives to search for meaning and believes that power extends beyond himself/herself [76,77].

Religion can assist with coping with stressful situations (i.e. chronic illness) in a multitude of ways [77]:

- How the illness is interpreted: Is the illness part of God's plan? Is God to blame?

- How the coping process is shaped: For example, religion could provide fortitude.

- How and whether the coping process can influence religion: A highly stressful situation can lead a person to religion.

Pargament identified three types of religious coping [78]:

- Self-Directing Style: The individual who uses this coping style does not involve God in the process at all.

- Collaborative Religious Coping Style: The individual and God work together to solve the problem.

- Deferring Style: The individual waits passively for God to intervene.

In later studies, Pargament et al. hypothesized that there might be an additional religious coping style, called "Plead," in which the individual petitions to God for a miraculous intervention to bring about the identified outcome(s) [79]. The individual refuses to accept the status quo. Other studies have indicated that pleading may not be adaptive since it has been associated with greater levels of psychologic distress [80].

One qualitative study found that Chinese family caregivers pray and rely on the belief in a higher power to give them inner strength [212]. Children may also demonstrate these religious coping styles. Pendleton argued that children display declarative religious/spiritual coping whereby they command God to intervene [140]. They may also demonstrate petitionary religious/spiritual coping (i.e., asking or pleading with God to help) or collaborate religious/spiritual coping (i.e., offering to do something in exchange for God helping and intervening).

CAREGIVER STRESS AND BURDEN

The terms "caregiving" and "caregiver" have been employed in this course rather ubiquitously. At what point do we define a person as a caregiver? After all, family members provide both concrete assistance and mutual support to each other as a part of normal family interactions [81]. Biegal et al. maintain that caregiving in the context of chronic illness extends beyond the traditional tasks and services offered by family members [81]. Caregiving in these situations is "the increment of extraordinary care that goes beyond the bounds of normal or usual care" [81]. Because it extends beyond what is normally provided, one of the emotional consequences that a family may experience is stress or burden.

There are two types of family caregivers. A care provider is one who performs and carries out practical tasks such as shopping, doing housework, cooking, and caring for the patient's hygiene [82]. A care manager refers to family members who arrange for and/or coordinate the caregiving services of other professionals or lay people [82]. Socioeconomic status and the extent of the patient's illness will play a role in determining whether a family caregiver is primarily a care provider or a care manager [82].

Others define caregiving as the behavioral expression of the commitment to caring, which is the affective component of an individual's commitment to the welfare of another [83]. Yet in a study conducted by Ayalong, caregivers distinguished between the terms "care" and "caregiving" [84]. Care was a reciprocal activity, while caregiving was something one had to do (i.e., an obligation), although it could be viewed in a positive manner. Whatever definition is used, the literature converges on a single point-families experience caregiving stress, which might ultimately lead to caregiving burden when a family member has a chronic illness.

Caregiver stress results when the demands of providing care for an ill family member are perceived as exceeding the resources available [82]. These resources may include what was discussed earlier-personal, family/social, and community resources. Caregiver stress can result in depression, anxiety, feelings of helplessness, and burden.

The concept of caregiver burden received much empirical attention in the 1980s, and most of the research has focused on impaired elderly patients. Recently, however, the literature has used this concept with other populations as well. Caregiver burden has been defined as the range of physical, psychologic, social, and financial strains or problems experienced by a family in which a family member has a disability [85]. It is perceived negatively by the caregiver [82]. The concept has been broken down into two categories: objective burden and subjective burden. Objective burdens refer to the emotions stemming from providing specific caregiving tasks and the time spent on these tasks [86]. Subjective burdens encompass the emotional, psychologic, and social impact involved in providing care [86]. Not surprisingly, caregivers who provide more activities of daily living and perform more tasks related to the management of the patient's health tend to experience more anxiety symptoms and poorer health [215].

5. ROLE OF CULTURE, RACE, AND ETHNICITY IN CAREGIVING AND CAREGIVING BURDEN

More recently, there has been a concerted effort in research literature to examine the role of culture, race, and ethnicity in caregiving and caregiving burden. In part, three factors or trends have contributed to a more systematic cross-cultural examination in this area. First, the United States is becoming increasingly multicultural. Demographic trends indicate that ethnic minorities are rapidly growing. By 2060, it is estimated that the African American population will increase to 74.5 million and the Hispanic population will increase to 119 million [144].

Second, the gerontologic literature shows that the number of minority older adults is increasing at a faster rate compared with the non-Hispanic white population [88]. Chronic illness is often associated with older adults. In addition, certain chronic illnesses, such as heart disease and hypertension, are found in exceedingly higher rates in African American populations [89]. Consequently, it is crucial to examine the role of culture, race, and ethnicity and its impact on caregiving.

Finally, caregiving burden is a highly subjective experience. Meanings of experiences are inextricably embedded in cultural values and belief systems, and therefore, it is safe to surmise that perceptions and patterns of caregiving, as well as the outcomes of caregiving (e.g., burden or stress) might be mediated by culture. The hypotheses about the role of culture, race, and ethnicity can go in either direction. One can postulate that certain cultural values and beliefs, such as familism and collective versus individualistic orientation, as expressed in Asian and Hispanic communities, the extended family structure, as expressed in African American families, and the role of filial piety, may promote a higher level of caregiving concern. Therefore, these cultural values and characteristics might provide a buffer against caregiving stress [82,90,91]. A recurrent theme in research with ethnic/racial minority participants was that caregiving is perceived to be embedded in the fabric of life [146]. However, one could also argue that the additive force of traditional cultural norms as well as the adoption of new Western norms may result in internal conflict in the area of caregiving [91]. For example, many Asian immigrants in the United States may have been socialized and influenced by traditions such as filial piety. However, as they acculturate to Western values and belief systems, their expectations about gender roles may alter. In traditional Korean families, for example, it is expected that the elder son's wife will provide care for her parents-in-law when they become frail. However, because of acculturation, these daughters-in-law may find caregiving burdensome [91]. While they have been taught the importance of filial piety, they may be influenced by the more egalitarian gender roles in the United States. Role blurring and confusion are even more pronounced in multicultural families. Families from collectivistic cultures tend to provide caregiving because interdependence is inextricably woven into their cultures; individualistic cultures tend to provide caregiving out of necessity [147]. It is also plausible that when immigrants from collectivistic cultures acculturate, they will adopt views about caregiving that are more similar to those from individualistic cultures.

HISPANICS/LATINOS AND THE CAREGIVING EXPERIENCE

Lim and Luna identified four potential cultural values in the Mexican culture that may help us to understand how Mexican cultural values and belief systems color the caregiving experience [92]. These four cultural values include: emphasis on the family unit; emphasis on the family over the individual; specific gender role expectations; and emphasis on existential suffering.

The family is very important in Mexican culture. It is the basic source of emotional support, and interdependence is valued [92,93]. Children are socialized early on to carry out family responsibilities and esteem family unity [93]. Because interdependence is emphasized, the extended family structure is relied on for support [93]. Therefore, one could postulate that Mexican American families view caregiving in a positive light as it is an extension of family life, with individual needs relegated to the needs of the family. Elderly family members are highly revered for their wisdom and often live with their family [148]. However, one could also argue that the emphasis on interdependence could lead to high levels of caregiver stress and burden because caregivers ignore their needs in favor of the ill family member [92]. This was confirmed in a study by Cox and Monk [94]. Yet, despite the high levels of reported caregiving stress and familiarity with formal services, the caregivers opted not to use formal services. They rarely even disclosed to friends or close family members about any stress [94]. Hispanics tend to have higher family systems-related resources [216]. Although this is a cultural strength, external resources have been found more beneficial in alleviating stress.

Other studies have indicated that caregivers of Hispanic descent are more likely to decrease their work hours or quit their job entirely in order to provide care for an ill family member [178]. Similar patterns have been noted in third-generation Asian Americans, who, along with Hispanic caregivers, exhibit the greatest number of caregiving hours [178,179].

The focus on the collective over the individual is related to the cultural value of family orientation [92]. In this orientation, the individuals' well-being and identity are intricately linked to the collective reference group (i.e., family unit). Caregiving tasks are distributed among family members, and therefore, the social support network acts as a buffer against the caregiving burden [92,148,217]. However, Tirrito and Nathanson found that female caregivers in Hispanic, Asian, and African American families with an extended family network were experiencing comparable levels of role strain and stress as caregivers from nuclear white families [67]. Similarly, other findings have shown that, although the extensive social network system provided support to Hispanic families, the actual instrumental assistance (i.e., running errands, cooking) provided by relatives was minimal [92]. It is important to remember that Hispanic families are heterogenous, and it is important for providers not to assume that Hispanic caregivers have extensive family support [216].

Gender role expectations are highly demarcated in Mexican American families. Men perform tasks and duties related to the outside world, while women perform tasks related to the family. Therefore, there is an expectation that women will provide the caregiving duties, and daughters appear to be the first choice of caregiver across racial/ethnic groups [92,178]. When men perform caregiving tasks, they are most likely to help with transportation [148]. There is some indication that Latina daughters assume caregiving responsibilities earlier compared to their white counterparts [95].

Finally, the cultural characteristic of enduring suffering is another value associated with Mexican American culture. In part, existential suffering is rooted in Catholicism [92]. This cultural trait may influence the caregiving experience both positively and negatively. The caregiving process may be perceived as self-sacrificing and a source of pride, even as the caregiver may be reluctant to seek help from community services or assistance from family and friends [92]. In addition, the caregiver may keep silent about any stress or sense of isolation experienced. A study conducted by Calderon and Tennstedt found that Puerto Rican caregivers were more likely to cope with the stressors associated with caregiving by employing strategies such as resignation, denial, and respect. They turned to their Catholic faith and asked God to give them strength [96].

In a study conducted with Latina and white female caregivers, cultural values and acculturation appeared to play a role among Latinos in their decisions to institutionalize elder family members [95]. Those Latina caregivers who had positive views toward caregiving and were less acculturated were more likely to play a role in the decision to delay institutionalization. Cultural values of familismo, where the family is emphasized over the individual, respecto, where respect for older persons is emphasized, and dignidad, which is the value of maintaining dignity and not asking for help, may all contribute to caregiving decisions, such as not wanting to institutionalize a family member [95]. However, practitioners should not assume that all Hispanic/Latino families will be willing to care for their elders. Those Latino caregivers who had less positive views of caregiving institutionalized their elderly family members more quickly than either their white counterparts or those who had more positive views of caregiving [95].

AFRICAN AMERICANS AND THE CAREGIVING EXPERIENCE

African Americans are more likely than other ethnicities to extend caregiving to relatives outside their immediate families [97]. Caregiving in African American families tends to be wider in scope and assumed by adult children, friends, and members of an extended family network [84,218]. Given this, there is a stereotype that African Americans are less likely to use nursing homes for their elders. Yet, African American elders age 85 years and older are more likely to reside in nursing homes compared to whites [98].

Groger and Mayberry examined African Americans' attitudes about filial obligations toward elder [98]. African American college age students and young adults had the most stringent expectations about filial obligations. They rejected the idea of nursing homes. In particular, they declared that they were willing to put their careers on hold to care for their family members. The young adults were similarly passionate, yet they qualified this by noting the role of the elders' needs versus the family's ability to meet those needs. African Americans from the middle-age group were the ones who actually experienced the demands of providing caregiving to elderly family members while balancing raising their own children. Nursing home placement was considered the last resort. Other intermediate options such as homecare services were weighed. African American elders understood the realities of caregiving as they had experienced it. They also understood firsthand the burden of caregiving, yet they asked for small things, such as not being ignored and being visited. They wanted to be independent and valued their children's help, but they did not want to be a burden [98]. In a 2017 study, African American caregivers averaged 11 hours more per week in caregiving activities post-stroke compared with their white counterparts [180].

Studies have found that African American caregivers reported less caregiving burden compared to their white counterparts [98,99]. Some have postulated that the lower levels of burden can be explained by the African American family structure. One pattern among African Americans is that extended family members share households for both economic and cultural reasons, such as beliefs about connectedness [100]. Studies indicate that African American families often have an extended network of family members, relatives, friends, and other individuals who assist in providing care [218]. These norms may reduce the stress and strain associated with caregiving [100]. Indeed, Dilworth-Anderson et al. found that the majority (74%) of the structures were collectivist in that they were formed by two or more caregivers [100]. It is plausible, however, that the expression of burden is expressed differently in African American caregivers than in white caregivers, and it is important to note that much of the measurement employed in research includes standardized scales that may not adequately capture differing expressions of burden [96]. Calderon and Tennstedt found that African American caregivers described the caregiving experience through somatic complaints and feelings of frustration and anger [96]. As with Puerto Rican caregivers, resignation was the most frequently expressed mode of coping among African American caregivers. They viewed caregiving as part of their fate and part of God's will [96]. African American caregivers may use the church for their emotional support, as religion and their church family are often central to their lives [149]. White caregivers employed more active and hands-on techniques, such as relying on formal services to mitigate the day-to-day logistics of caregiving, and found other outlets, such as gardening or other hobbies [96].

ASIAN AMERICANS AND THE CAREGIVING EXPERIENCE

Traditional Asian beliefs and values are centered around Confucian thought, which focuses on harmony, unity, and family [101]. In traditional Chinese culture, for example, one way to maintain harmony is to adhere to the hierarchical structure of the family. Therefore, there are specific prescribed roles for men and women; men have more authority than women. Women's roles are primarily circumscribed in the home and in child-rearing activities [101]. Children are expected to obey their parents and demonstrate filial piety and to repay their parents for all the sacrifices they have made for them [102]. Filial piety is defined as a set of obligatory behaviors and expectations closely tied to family relationships; it is characterized by children respecting and obeying their parents and families honoring ancestors [219]. This belief system extends to providing physical, emotional, and material/financial care to parents and elders [212]. In families who adhere to Confucian principles, caregiving is allocated to daughters-in-law. If there is no daughter-in-law, the role goes to unmarried daughters, then to married daughters, and finally extended female family members [146]. Filial piety is believed to act as a buffer against caregiver stress and to improve the perception of caregiving [181,182].

The concept of filial piety also applies to Korean culture. As noted, the eldest son and his wife typically assume caregiving tasks when the eldest son's parents become old and frail. The son is to fulfill his financial obligations to his parents; however, it is the daughter-in-law who is to execute the day-to-day caregiving activities because caregiving is congruent with the cultural gender role expectations of Asian women performing domestic and nurturing tasks [90,103]. Given this cultural expectation, Lee and Sung hypothesized that Korean caregivers (primarily daughters-in-law) of frail elderly parents would display greater filial obligations, and white caregivers (primarily daughters) would have access to more formal services. Therefore, these variations of norms and values would produce differential responses toward caregiving [90]. They found that the white caregivers reported closer relationships with the care recipient and higher gratification from the caregiving compared to their Korean caregiver counterparts. Korean caregivers showed higher levels of filial responsibility and utilized greater extended family support, while white caregivers displayed lower levels of filial obligation and employed more extensive formal services. The level of overall caregiving burden was lower for Korean caregivers, which was associated with higher levels of filial responsibility and the use of extended family support. However, the level of emotional burden was much higher compared to white caregivers, and this may be because Korean caregivers are primarily daughters-in-law, who ultimately experience less gratification with caregiving [90]. Studies also show that when elderly parents perceive their children are exhibiting filial piety, their well-being increases along with their health status [150].

Chao and Roth found somewhat similar results in a qualitative study of 31 Taiwanese women, 23 to 58 years of age, who were primary caregivers to their parents-in-law [104]. A major theme that emerged was the "just doing," which encapsulated the caregiver's sense of duty, sense of dealing with trials, and sense of filial piety, which was viewed as a lifelong commitment [104]. Therefore, the amount or degree of caregiving was not the issue, but rather, how the caregiver interpreted the nature of her role. In cultures characterized by filial piety, caregiving is seen as a reciprocal expression of love [212]. Clearly, cultural norms influenced perceptions of caregiving.

One might hypothesize that as the individuals become more acculturated, they demonstrate less filial piety. However, research indicates that highly acculturated individuals continue to exhibit high levels of filial piety [183]. Consequently, the family system, may serve as a barrier to seeking formal and community assistance [102]. This may further be compounded by the Japanese cultural value of shikata ga nai, which refers to the view that the situation cannot be helped and nothing else can be done [102]. Asai and Kameoka further argue that it may not necessarily be filial piety that influences the Japanese to provide caregiving, but rather the cultural value of sekentei[105]. Sekentei refers to social dignity, reputation, and social appearance in public [105]. It taps into the notion of individuals behaving in a certain way because of one's concern about the public eye on behavior. In terms of caregiving, sekentei comes into play because individuals are concerned about what others may think of them if they do not provide caregiving [105]. The notion of saving face (i.e., avoiding public or community criticism) surfaced in a study conducted with Korean caregivers [103]. Coupled with the desire for family harmony and saving face, these cultural values impede caregivers from seeking formal services for chronically ill family members; instead, they opt to provide care within the home [103].

In Filipino culture, which is highly influenced by Catholicism, caregivers may view the caregiving experience as a part of God's plan [102]. Again, as mentioned earlier, the reliance on God and the emphasis on quiet endurance may color caregiving both positively and negatively. Filipino caregivers look towards God for support and do not view caregiving as a burden. However, this silent perseverance may impede Filipino caregivers from seeking formal and community assistance.

The counterpart to filial piety as exemplified in Filipino culture is the concept of utang na loob, which refers to a debt of gratitude within relationships [102]. Children are indebted to their parents because their parents raised them. Therefore, children are expected and socialized early on to care for their parents until their parents' deaths [102]. Again, it is plausible that these cultural values may provide a buffer against caregiving burden and stress.

The perceptions of the caregiving experience are colored by cultural factors and the social environment. As the United States becomes increasingly multicultural, it is important for nurses, social workers, marriage and family therapists, and other healthcare professionals to explore and identify specific cultural factors that influence the caregiving experience and help-seeking behaviors, as well as potential outcomes, such as caregiving stress and burden. It is also important to remember that there is tremendous diversity within groups, and therefore, the themes presented above should not be generalized to every individual and family with which the helping professional comes into contact. Factors such as level of acculturation, age-of-immigration, educational level, and socioeconomic status contribute to the heterogeneity among groups.

6. ASSESSMENTS FOR FAMILIES OF PATIENTS WITH CHRONIC ILLNESS

Catching a glimpse of human response and experience is the essence of the assessment process. Nurses, social workers, marriage and family therapists, and other allied healthcare professionals need ways of recognizing and organizing cues in order to effectively assist patients with chronic illness and their families [106]. Assessing the impact of chronic illness is vital for two reasons. First, caregivers can prove to be valuable allies when working with the patient. Consequently, the assessment phase provides an opportunity for healthcare professionals to build rapport with families and patients. Second, caregivers experience specific demands, which have been highlighted throughout this course. The literature shows that continued feelings of caregiver strain or burden lead to greater risk of serious health and mental health outcomes [106]. Therefore, it is important for healthcare professionals to know how to intervene.

QUALEY'S THREE-STAGE ASSESSMENT

A general framework of the assessment process is highlighted below, using Qualey's three-stage assessment process when working with family caregivers [107]. Within this framework, basic problem-solving skills are identified [108].

Pre-Problem Assessment Phase

During this phase, the helping professional tries to empathize with and truly understand what the caregiver is experiencing. This phase builds on the therapeutic relationship between the helping professional and the family caregiver. During this time, the caregiver is asked about resources that are required, such as Medicare, home care, or social services.

Problem Assessment Phase

To define a problem accurately, it is important to help caregivers express their problems or needs as specifically as possible. Often, problems are expressed in global terms [108]. In addition, it is important to focus on the present, as opposed to the past. It is not beneficial to dredge up numerous examples of problematic behavior. Clients often have a tendency to bring up a host of problems, shifting from one problem to another. Therefore, the helping professional should help the caregiver identify and focus on a single problem.

The Family Caregiver Alliance National Center on Caregiving recommends that practitioners explore the following domains [151]:

- Background of the patient and caregiver

- Caregiver's perception of the patient's daily functional abilities

- Caregiver's beliefs and values

- Physiologic, psychologic, financial, and social effects of caregiving on the caregiver

- Care needs of the patient

- Resources available

Although it is beyond the scope of this course to review religion and spirituality assessments, practitioners should also evaluate the family caregiver(s) use of religion and spirituality as a pathway for coping as well as if the chronic illness as a stressor has facilitated a religious/spiritual crisis [184].

Solution/Evaluation Assessment Phase

Healthcare professionals can educate caregivers in how to problem-solve. Hepworth et al. delineated the following steps [108]:

1. Acknowledge the problem

2. Analyze the problem and identify needs

3. Employ brainstorming to generate possible solutions

4. Evaluate each option realistically

5. Implement the option selected

6. Evaluate the outcome of the problem-solving efforts

The next section discusses the various tools and instruments that can be utilized during the assessment process to identify how chronic illness affects families. In addition, several standardized instruments for measuring caregiving strain, burden, and related mental health outcomes such as depression and anxiety will be discussed.

GENOGRAMS

Genograms are excellent assessment tools that visually represent family chronology and family patterns. They provide healthcare professionals the ability to map the family structure and to note and update the family picture as it forms and alters [109,125]. Genograms give both the clinician and the family member(s) a sense of the relationships among family members by highlighting the roles of family members. This can be extremely helpful in identifying the caregiver(s) of the ill family member and the specific tasks they assume. If the caregiver is experiencing strain, then identifying the roles and tasks of the caregiver in the presence of other family members may help them to realize the extent of caregiving provided and offer to take on some of the responsibilities. Healthcare professionals may ask the following types of questions [109]:

- Who helps out when needed?

- To whom do family members turn for assistance?

- Who would you say is the caregiver or caregivers for the patient? What types of tasks and activities are provided by the caregiver(s)?

- Who in the family can take on and adapt to new roles easily?

- Who in the family is seen as the strong one? The dominant one? The submissive one?

- Who is close to the patient?

Life events and crises, both maturational (e.g., births, deaths, a family member leaving for college) and situational (e.g., job loss, chronic illness) may be tracked on a genogram. It is also important to take into account the family's developmental life cycle [125,151]. This provides a sense of historical continuity and gives a picture of the effect that changes have on the family system [109]. In terms of chronic illness, the clinician can explore these issues with family members by asking the following types of questions [109]:

- How did the family react when symptoms emerged? When a diagnosis was given?

- Who took it the hardest? The easiest? How did personality styles correlate with this?

- How did each family member react and respond to the patient?

- What types of stressors and demands were experienced by each family member?

SOCIAL NETWORK GRID (OR MAP)

Another visual tool employed to assess a family's degree of social support network is the Social Support Network Map [110]. This assessment tool can be utilized with the primary caregiver of a patient with chronic illness. To conduct this assessment, the helping professional assists the caregiver in identifying family members in the immediate and extended family system, friends and neighbors, formal organizations, and other community services whom the caregiver perceives as supportive, particularly in his/her role as a caregiver. When working with children who have assumed caregiving tasks, a social network map can provide a useful, visual tool for articulating challenging concepts, such as the complexity of family dynamics, nuclear and extended family relationships, and other social supports [185]. This tool may be used to launch discussion with caregivers about their needs and the resources available to them for help. Social network mapping assesses the following types of issues [110]:

- Who provides social support

- The types of support provided and available

- Gaps in relationship resources

- Opportunities for reciprocal exchanges

- Presence of negativism and stress that produces criticism

- Barriers to using available resources

- Priority of social support in relation to other challenges

STANDARDIZED INSTRUMENTS

Standardized instruments or measures are also viable assessment tools for healthcare professionals. Standardization refers to the process whereby the same procedures are applied across a set of situations so that the results from administering an instrument can be compared and interpreted [111]. Standardization yields findings where one knows that the differences in responses are a reflection of the respondents versus the process of administering the instrument [111]. Standardized instruments have established psychometric properties, which indicate the degree of an instrument's validity and reliability. Such instruments can be useful in clinical practice because they provide a quick means to identify needs that help guide individualized care and interventions [200].

Table 1 lists and describes some standardized instruments that tap into variables related to families and chronic illness.

Table 1: COMPILATION OF STANDARDIZED INSTRUMENTS FOR FAMILIES WITH PATIENTS WITH CHRONIC ILLNESS

Instrument/Measure

Description

Caregiving Issues

Caregiver Strain Index (CSI)

A 13-item instrument used to measure strain among caregivers of physically ill and functionally impaired older adults. Good internal consistency with Cronbach's alpha of 0.86.

Caregiver's Burden Scale (CBS)

A 29-item scale designed to assess feelings of burden experienced by caregivers of elderly persons with senile dementia.

Caregiver Well-Being Scale

The Caregiver Well-Being Scale measures caregiver well-being from a strengths-based perspective by assessing caregivers' basic human needs and satisfaction with activities of daily living.

Caregiver Reaction Assessment

A 24-item instrument employed to measure a caregiver's reactions to caregiving for elderly family members with a variety of chronic illness. Measures both positive and negative reactions.

Revised Scale for Caregiver Self-Efficacy

A 15-item instrument used to measure confidence in one's ability to carry out issues related to caregiving. It measures three specific areas: self-efficacy for obtaining rest and help, dealing with disruptive patient behaviors, and handling upsetting thoughts related to caregiving. Reliable, with Cronbach's alpha greater than 0.80 for all three subscales.

Caregiver Burden Inventory

A 24-item instrument that asks the caregiver to respond to various demands of care and how it affects one's time, physical health, and social and emotional development.

Mental Health Outcomes

Center for Epidemiologic Studies—Depressed Mood (CES-D)

A 20-item scale to measure depression in the general population. Very good internal consistency with Cronbach's alpha of 0.85 with the general population.

Self-Rating Anxiety Scale

This is a 20-item instrument comprising elements found in anxiety disorders.

Perceived Stress Scale

This is a 10-item instrument utilized to measure the degree to which one appraises situations in one's life as stressful. Cronbach's alpha is 0.78, indicating respectable reliability.

Social Support

Multidimensional Scale of Perceived Social Support (MSPSS)

This is a 12-item instrument designed to measure perceived social support from three sources: family, friends, and a significant other. It has excellent reliability with Cronbach's alpha of 0.91.

Social Support Questionnaire

This scale asks about people in the individual's environment who provide help or support. The scale first asks the individual to list people who provide the support, and then to indicate his/her level of satisfaction.

Social Support Behavior Scale

This is a 45-item instrument used to access five types of social support: emotional, socializing, practical assistance, financial assistance, and advice/guidance.

Financial Burden

The Economic Hardship Questionnaire

This is a 12-item instrument that measures how the household has been affected by financial challenges.

The Family Burden Interview Schedule

This instrument does not solely measure financial burden; it also measures how an illness affects family routines, interactions, leisure, and health and mental health. This is a 24-item instrument that has been demonstrated to be valid and reliable.

Source: [115,116,117,118,119,120,121,122,123,124,152,186,220,221]

7. INTERVENTIONS FOR FAMILIES

Because chronic illness can vary over time, the medical regimen prescribed to the patient, the prognosis, and the functional capability of the patient will inevitably vary as well. This unpredictability undoubtedly causes stress for every member of the family system. Chronic illness involves a life-long commitment from all parties—patients, their caregiver(s), and their family members. Consequently, it is imperative that physicians, nurses, social workers, marriage and family therapists, and other healthcare professionals have an understanding of the various types of interventions that can help families and caregivers mitigate the stress brought on by chronic illness. This section is meant to provide some general guidelines for healthcare professionals who work with families that include a member with chronic illness.

PROVIDING INFORMATION

Families who have members with chronic illness require information. This sounds simple, but it is crucial for healthcare professionals to realize that chronic illness is a new and unanticipated event to the family. Therefore, families need concrete information targeted to various timelines [222]. At the initial diagnosis, the family may be overwhelmed and struggling to come to terms with the illness. It may also be grappling to understand new medical jargon and trying to assimilate a tremendous amount of information in order to make decisions about medical care plans. Over time, some family members may be required to take on more responsibilities related to the medical care. This requires practitioners to teach family members necessary skills and to provide support when they feel uncertain about these new responsibilities [153]. At this juncture, the helping professional should assist in enhancing communication between the primary physician and the family [112]. Technical information about the illness, prognosis, and care regimen should be conveyed. Healthcare professionals should be sensitive to the fact that this information may need to be relayed on several occasions. Information and education should be communicated in a lay-friendly and non-hurried manner [222]. During this time, the helping professional may want to begin to coordinate a list of resources and referrals [112].

Over the course of the illness, caregivers and family members continue to need information about how to efficiently care for the patient. The types of information may range widely. Lubkin and Larsen, for example, note that healthcare professionals can provide general information about human development to family members. It is beneficial for caregivers and family members to understand normal changes that are part of human development and the life cycle, changes that are specifically related to the illness, or possibly, an interaction of both [82]. Egocentrism, for example, is a part of adolescence. Chronic illness can magnify this as the adolescent receives a great deal of medical and parental attention, and the adolescent can become overbearing [41]. Yet, simultaneously, an adolescent may believe that he/she is the only one with these problems and feel that no one can empathize [41]. Social isolation may occur. Therefore, it becomes a complicated issue to determine whether a particular behavioral change is the result of normal human development or illness-related.

Technical information related to the daily care of the patient should also be relayed. Family members may have to be taught how to lift and move patients around without hurting themselves or the patient and how to administer medications [82]. Family members should be reminded and educated about the physical consequences of the illness. Patients, for example, may experience fatigue as a result of the medications and/or the illness; however, some family members may become frustrated with the patient and interpret the patient as being lazy and taking advantage of the sick role [82]. Healthcare professionals should be fully knowledgeable about resources on both the local and national level to assist families in coordinating care for both the patient and themselves. Resources and services include places to access special equipment, legal and financial information, respite care, counseling, and support groups [82].

EXPLORING THE MEANING OF CHRONIC ILLNESS AND AMBIGUOUS LOSS

The emphasis is to provide an opportunity for family members to explore their feelings of loss, sorrow, mourning, and grief. Interventions also focus on helping families to accept the ill family member's lost physical functioning and capabilities [32].

Boss and Couden argue for the importance of helping families deal with ambiguous loss [55]. The goal is not necessarily to eliminate this sense of loss, but rather, to increase family tolerance and coping. Interventions are both structural/short-term and solutions-focused as well as psychodynamic [55]. After identifying the loss, the family would work collaboratively to make decisions regarding day-to-day care and activities. Operating from this lens, depression, which is commonly experienced among caregivers, may also be viewed as symptomatic of ambiguous loss. Therefore, practitioners can help encourage caregivers to not assume all the burden of responsibility, but rather to delegate and distribute the work. This may mean obtaining respite assistance [55].

One of the more difficult tasks is for family members to understand and make sense of the ambiguous loss [55]. They can begin by looking at their own family's socialization, spiritual and religious values, and mentality of thinking and viewing the world optimistically, and by evaluating the family's beliefs about mastery [55].

SELF-CARE FOR FAMILY MEMBERS

In order to prevent burnout, family members and caregivers should learn to take care of themselves. Caregivers often experience a host of conflicting emotions, including guilt, sadness, anxiety, and exhaustion. They often feel that they should not express negative feelings, believing that it will adversely affect the patient [82]. Healthcare professionals should routinely ask caregivers how they are feeling and coping, and then validate their experiences and feelings.

Caregivers should also be encouraged to obtain respite care. Respite refers to any type of service, either informal or formal, that offers relief and assistance for family members to cope with the challenges of chronic illness [113]. Informal respite assistance may include extended family members, neighbors, and friends who might periodically help with meal preparations, transportation, or housekeeping. Formal respite consists of in-home respite or out-of-home respite. In-home respite care involves a paid companion who spends time with the patient and helps with the patient's care, while out-of-home respite care includes adult day-care centers and community recreational services [113].

Mindfulness interventions may also be beneficial for caregivers. These approaches teach caregivers to be aware of what is occurring at the moment without any judgement and to focus on regulating emotions. In a study to evaluate the effectiveness of an online mindfulness intervention, the level of caregiver burden was decreased after eight weeks of weekly, one-hour mindfulness practice and self-compassion training [187].

In collectivist cultures, one's identity is intertwined with the ill family member, and how the ill family member fares also affects the caregiver [188]. As such, interventions may target the patient and caregiver simultaneously [188].

FAMILY THERAPY

Based on family systems theory, family therapy can be a useful intervention to assist families in acknowledging and accepting the patient's illness as well as the treatment plan and prognosis [112]. It can help the patient and family understand the illness narratives created by the patient and how this story has affected the family system. The goal is to help each member co- and re-author the illness narrative(s) [223]. It can help families develop coping skills to manage the challenges of the continual stressors related to chronic illness and identify maladaptive family patterns, such as enmeshment, triangulation, overprotectiveness, and rigidity [112,125]. Role expectations can be clarified among family members, and lines of communication can be opened, and at times, restored, if certain family members feel overloaded with caregiving responsibilities [82]. Furthermore, assuming a caregiving role for an elderly parent may resurrect previous developmental issues [154].

PSYCHOEDUCATIONAL GROUPS

Psychoeducational groups were first used in families with members who had schizophrenia; however, they have been adapted for use with other clinical populations. Psychoeducational groups typically involve a didactic and support component, whereby family members (i.e., caregivers) convene for 10 to 12 structured sessions, on a biweekly basis [114]. It assumes that the caregivers are experts and each member can help each other [155]. The didactic component focuses on both cognitive information and behavioral change. Caregivers, for example, listen to a series of mini-lectures that focus on disease etiology, treatment, and management [114]. Problem-solving skills and coping strategies are often discussed. Caregivers are encouraged to use these newly learned skills and apply them at home. The support component of the psychoeducational groups provides a forum for family members to talk about various issues that may come up in the caregiving situation. Facilitators and other family members provide validation and recognition of feelings. Ultimately, when family members feel confident about providing care, their quality of life improves [153]. In terms of the research evaluating the effectiveness of psychoeducational groups for caregivers, the findings are mixed. In one study, nurse-facilitated psychoeducational groups for caregivers resulted in no improvements in perceived caregiver burden [189]. But a separate study found participation in distance or in-person psychoeducational groups was associated with improved caregiver distress and burden [190].

SELF-HELP GROUPS

Support and self-help groups focus on a specific client population (e.g., patients diagnosed with cancer) and related caregiver needs. These groups are facilitated either by volunteers or healthcare professionals. They may vary, but will provide information regarding the illness and disease process and symptom management, normalize members' experiences, provide emotional support around caregiving, encourage advocacy, or a combination of these services [82,191]. Trust is a key element for these types of groups [192]. Such groups can also help to improve members' outlook on life, feelings of optimism, and self-esteem [224].

MACRO-ORIENTED INTERVENTIONS

Findley argues that part of their social justice advocacy role for social workers and other service providers is to challenge issues of marginalization when working with families and family members who have been diagnosed with a chronic illness [145]. It is important to advocate reducing or eliminating barriers that prevent families and patients from receiving the care and support that they need. Practitioners can also work to promote evidence-based interventions and guidelines to ensure greater collaboration between patients and their family members at the various levels of care [145].

8. INTERPROFESSIONAL PRACTICE AND COLLABORATION

Chronic illness is a multifaceted and complex issue for the patient and the patient's family. It is estimated that patients with chronic illness consistently visit an average of four to nine different healthcare professionals [225]. To facilitate more efficient and greater quality care, it is vital that care plans be synchronized and carefully coordinated among practitioners. This requires that practitioners have broad knowledge informed by a biopsychosocial perspective, with competence in the medical facts of the illness condition, family systems, spirituality/religiosity, marriage and couple therapy, developmental theories, and social work and case management skills. Because it is impossible for a single practitioner to be highly competent in all of these areas, interprofessional collaboration (IPC) is key.

IPC is characterized as a process whereby multiple service providers representing different professional fields work together to provide comprehensive services to clients/patients in order to coordinate high-quality services across settings. The World Health Organization defines interprofessional collaboration as occurring "when multiple health workers from different professional backgrounds work together with patients, families, carers and communities to deliver the highest quality of care across settings" [226]. It requires professionals to alter the way they practice—moving from working in a silo to working in a collaborative and trusting manner. Efficiency, cost containment, and measurable outcomes are key to IPC.

The core features of IPC include sharing, interdependency, communication, and mutual trust and respect [227]. Because of the complexity of chronic illness, the ideal is to have one shared care plan and document that is easily accessible by all providers [225].

A systematic review of clinical trials studies on the role of interprofessional collaboration on chronic illness found that interprofessional collaboration improved the quality of coordinated care and ensure that care provided was patient-centered [228]. However, there is not sufficient evidence that interprofessional collaborations improved medication adherence or decreased mortality.

9. CONCLUSION

Education is an empowering form of intervention. Often, families are overwhelmed and need guidance in pointing them in the direction where they can obtain information and resources. Nurses, practitioners, and other healthcare professionals are encouraged to review and look into these resources as a means of continuing their own education as well as a place to direct families for additional resources.

10. RESOURCES

Families have a range of resources to tap when attempting to gather information. This section highlights some national organizations as well as material and resources that may be found on the Internet. Service providers can use these as a starting point when working with families.

Alzheimer's Association

https://www.alz.org

The Alzheimer's Association, a national network of chapters, is the largest national voluntary health organization committed to finding a cure for Alzheimer's and helping those affected by the disease.

American Cancer Society

https://www.cancer.org

The American Cancer Society is the nationwide community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service.

American Diabetes Association

https://www.diabetes.org

The American Diabetes Association is a nonprofit health organization providing diabetes research, information, and advocacy.

American Society on Aging

https://www.asaging.org

Brings together researchers, practitioners, educators, business people and policymakers concerned with the physical, emotional, social, economic, and spiritual aspects of aging.

Caregiver Media Group

https://caregiver.com

Caregiver Media Group is a leading provider of information, support, and guidance for family and professional caregivers. They publish Today's Caregiver Magazine, the first national magazine dedicated to caregivers. They also sponsor caregivers.com, a website that includes topic specific newsletters, online discussion lists, back issue articles of Today's Caregiver Magazine, and chat rooms.

Center for the Study of Chronic Illness and Disability

https://chhs.gmu.edu/research/research-centers/CCID

The CCID is an interdisciplinary research center at George Mason University. Founded in 2007, it works to promote research to improve the lives of people with chronic illness and disability.

Eldercare Locator

https://eldercare.acl.gov

The Eldercare Locator is a public service of the Administration on Aging, a division of the U.S. Department of Health and Human Services, and is administered by the National Association of Area Agencies on Aging and the National Association of State Units on Aging.

Family Caregiver Alliance

https://www.caregiver.org

Founded in 1977, the Family Caregiver Alliance was the first community-based nonprofit organization in the country to address the needs of families and friends providing long-term care at home. It is now a nationally recognized information center on long-term care.

Genograms

https://www.therapistaid.com/therapy-guide/genograms

This site provides information about communication patterns and the basics of genograms.

Juvenile Diabetes Research Foundation International

https://www.jdrf.org

Juvenile Diabetes Research Foundation International is the world's leading nonprofit, nongovernmental funder of diabetes research. JDRF was founded in 1970 by the parents of children with juvenile diabetes-a disease that strikes children suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications.

KidsHealth

https://kidshealth.org

KidsHealth is a doctor-approved health information site providing information about children from before birth through adolescence.

National Association for Home Care and Hospice

https://www.nahc.org

NAHC is the nation's largest trade association representing the interests and concerns of home care agencies, hospices, home care aide organizations, and medical equipment suppliers.

National Caregivers Library

http://www.caregiverslibrary.org

The National Caregivers Library is dedicated to improving the lives of caregivers of the elderly, disabled, and chronically ill by creating a highly accessible resource where caregivers can better learn the process of caregiving, receive help in managing their fears and concerns, and obtain resources for help with all aspects of caregiving.

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94151 • The Coronavirus Disease (COVID-19) Pandemic

John M. Leonard, MD

www.netce.com

Copyright © 2023 NetCE, All rights reserved.

Widespread outbreaks of novel (new) coronavirus infection have occurred in each of the past two decades, and the current outbreak poses the third threat of a severe novel coronavirus epidemic on a global scale. In response to a 13-fold increase in the number of reported cases within the span of two weeks and active cases in more than 100 countries, the WHO reached a decision that the COVID-19 outbreak should be characterized as a pandemic. After three years, the global COVID-19 disease burden totaled more than 659 million confirmed cases and more than 6.6 million deaths, of which 100 million cases and 1 million deaths were in the United States. COVID-19 continues to affect the public and patient populations in all settings.

Table of Contents

94151 • The Coronavirus Disease (COVID-19) Pandemic

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Individual State Nursing Approvals

Individual State Behavioral Health Approvals

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. BACKGROUND

CORONAVIRUS

HUMAN CORONAVIRUS INFECTION

2. THE 2019–2020 NOVEL CORONAVIRUS OUTBREAK: A GLOBAL THREAT

3. CLINICAL MANIFESTATIONS OF COVID-19

SEVERITY AND PROGRESSION OF ILLNESS

SYSTEMIC COMPLICATIONS OF COVID-19

PREGNANCY AND COVID-19

RECOVERY FROM COVID-19

LATE SEQUELAE OF COVID-19

4. COVID-19 IN CHILDREN

PEDIATRIC MULTISYSTEM INFLAMMATORY SYNDROME

5. DIAGNOSTIC TESTING FOR SARS-COV-2

ANTIBODY TESTING

6. COVID-19 TREATMENT OPTIONS

RACIAL/ETHNIC MINORITIES AND MARGINALIZED GROUPS

COVID-19 THERAPEUTICS

MANAGEMENT OF COVID-19 IN THE AMBULATORY CARE SETTING

7. COVID-19 VACCINES

COVID-19 mRNA VACCINES

COVID-19 ADENOVIRUS VECTOR VACCINE

COVID-19 VACCINES AND PREGNANCY, LACTATION, AND FERTILITY

COVID-19 VACCINE SAFETY

DURABILITY OF IMMUNITY AND REINFECTION

COVID-19 VACCINATION STRATEGY AND VEXATIONS OF AN ONGOING PANDEMIC

8. TRANSMISSION DYNAMICS AND MITIGATION MEASURES

9. GLOBAL PUBLIC HEALTH CONCERNS AND WHO RESPONSE

ADVICE TO THE PUBLIC

CDC MONITORING AND GUIDANCE FOR HEALTHCARE PROFESSIONALS

10. OTHER AVAILABLE RESOURCES

Works Cited

94151 • The Coronavirus Disease (COVID-19) Pandemic

Education Category. Infection Control / Internal Medicine

Release Date. 03/01/2023

Expiration Date. 02/28/2026

Course Overview

Widespread outbreaks of novel (new) coronavirus infection have occurred in each of the past two decades, and the current outbreak poses the third threat of a severe novel coronavirus epidemic on a global scale. In response to a 13-fold increase in the number of reported cases within the span of two weeks and active cases in more than 100 countries, the WHO reached a decision that the COVID-19 outbreak should be characterized as a pandemic. After three years, the global COVID-19 disease burden totaled more than 659 million confirmed cases and more than 6.6 million deaths, of which 100 million cases and 1 million deaths were in the United States. COVID-19 continues to affect the public and patient populations in all settings.

Audience

This course is designed for physicians, nurses, and other healthcare professionals who may identify or educate patients regarding coronavirus infection.

Accreditations & Approvals

In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NetCE is approved by the California Nursing Home Administrator Program as a provider of continuing education. Provider number 1622. NetCE is approved to offer continuing education through the Florida Board of Nursing Home Administrators, Provider #50-2405. As a Jointly Accredited Organization, NetCE is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. This course, The Coronavirus Disease (COVID-19) Pandemic, Approval #07012022-42, provided by NetCE is approved for continuing education by the New Jersey Social Work Continuing Education Approval Collaborative, which is administered by NASW-NJ. CE Approval Collaborative Approval Period: Friday, July 15, 2022 through August 31, 2024. New Jersey social workers will receive 2 Non-Clinical CE credits for participating in this course. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU. NetCE is approved as a provider of online continuing education for certified nursing assistants through the California Department of Public Health Licensing and Certification Division. Nurse Aide Certification (NAC) Provider #7005.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 2 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this enduring material for a maximum of 2 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. NetCE designates this continuing education activity for 2 ANCC contact hour(s). NetCE designates this continuing education activity for 2 pharmacotherapeutic/pharmacology contact hour(s). NetCE designates this continuing education activity for 2.4 hours for Alabama nurses. Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 2 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Social workers participating in this intermediate to advanced course will receive 2 Clinical continuing education clock hours. NetCE designates this activity for 2 ACPE credit(s). ACPE Universal Activity Number: JA4008164-0000-23-004-H01-P. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery's Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. This activity has been approved for the American Board of Anesthesiology’s® (ABA) requirements for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology’s (ABA) redesigned Maintenance of Certification in Anesthesiology Program® (MOCA®), known as MOCA 2.0®. Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements. Maintenance of Certification in Anesthesiology Program® and MOCA® are registered certification marks of the American Board of Anesthesiology®. MOCA 2.0® is a trademark of the American Board of Anesthesiology®. Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 2 MOC points in the American Board of Pediatrics' (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit. This activity has been designated for 2 Lifelong Learning (Part II) credits for the American Board of Pathology Continuing Certification Program. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME's "CME in Support of MOC" program in Section 3 of the Royal College's MOC Program. This home study course is approved by the Florida Board of Nursing Home Administrators for 2 credit hour(s). This course is approved by the California Nursing Home Administrator Program for 2 hour(s) of continuing education credit - NHAP#1622002-9403/P. California NHAs may only obtain a maximum of 10 hours per course. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program. AACN Synergy CERP Category A.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through July 29,2025); Alabama, Provider #ABNP0353, (valid through July 29, 2025); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2025; South Carolina, Provider #50-2405; South Carolina, Provider #50-2405. West Virginia RN and APRN, Provider #50-2405.

Individual State Behavioral Health Approvals

In addition to states that accept ASWB, NetCE is approved as a provider of continuing education by the following state boards: Alabama State Board of Social Work Examiners, Provider #0515; Florida Board of Clinical Social Work, Marriage and Family Therapy and Mental Health Counseling, CE Broker Provider #50-2405; Illinois Division of Professional Regulation for Social Workers, License #159.001094; Illinois Division of Professional Regulation for Licensed Professional and Clinical Counselors, License #197.000185; Illinois Division of Professional Regulation for Marriage and Family Therapists, License #168.000190;

Special Approvals

This activity is designed to comply with the requirements of California Assembly Bill 1195, Cultural and Linguistic Competency.

Course Objective

The purpose of this course is to provide physicians, nurses, and other healthcare professionals an overview of the 2019–2020 global outbreak of novel human coronavirus (SARS-CoV-2) infection, including background epidemiology, clinical features, mode of transmission, epidemic potential, and the clinical and public health measures recommended to limit spread of infection and control the outbreak.

Learning Objectives

Upon completion of this course, you should be able to:

1. Differentiate between the common, ubiquitous strains of human coronavirus and novel (outbreak) strains with respect to epidemiology, modes of transmission, spectrum of illness, and public health implications.

2. Recognize clinical manifestations of acute COVID-19 and the "long COVID" syndrome, and anticipate systemic complications of severe disease in those with known risk factors.

3. Implement guideline recommendations for diagnostic testing and management of patients with recent exposure, newly diagnosed, or suspected COVID-19.

4. Discuss the dynamics of SARS-CoV-2 transmission and advise patients as to preventive measures (e.g., social distancing, masking) and the role of COVID-19 vaccines, giving special attention to those at risk for severe disease.

5. Explain public health implications of emerging SARS-CoV-2 variants, including benefits and limitations of natural, vaccine, and hybrid immunity.

Faculty

John M. Leonard, MD, Professor of Medicine Emeritus, Vanderbilt University School of Medicine, completed his post-graduate clinical training at the Yale and Vanderbilt University Medical Centers before joining the Vanderbilt faculty in 1974. He is a clinician-educator and for many years served as director of residency training and student educational programs for the Vanderbilt University Department of Medicine. Over a career span of 40 years, Dr. Leonard conducted an active practice of general internal medicine and an inpatient consulting practice of infectious diseases.

Faculty Disclosure

Contributing faculty, John M. Leonard, MD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John V. Jurica, MD, MPH

Sharon Cannon, RN, EdD, ANEF

Alice Yick Flanagan, PhD, MSW

Randall L. Allen, PharmD

Shannon E. Smith, MHSC, CST, CSFA

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. BACKGROUND

CORONAVIRUS

Coronaviruses (a subfamily of Coronaviridae) are enveloped, single-stranded RNA viruses that are broadly distributed among humans, other mammals, and birds. Under electron microscopy, the outer envelope of the virion shows club-like surface projections that confer a crown-like appearance to the virus, which accounts for the name given to this family of viruses. The nucleocapsid is a long, folded strand that tends to spontaneous mutations and recombination of genomic material. When virus circulation (and replication) is high, the opportunity for random mutations within the genome grows, increasing the likelihood that such changes may impact transmissibility and pathogenicity.

In addition to four specific subtypes of coronavirus commonly found in humans, other strains are specific to many different species of animals, including bats, cats, camels, and cattle. On rare occasions, an animal coronavirus causes zoonotic infection in humans, meaning that a new (novel) coronavirus is transmitted from an animal host to one or more humans, resulting in clinical illness and the risk of secondary spread to close personal contacts. The wide distribution, genetic diversity, and frequent shifts in the genome, combined with unique human-animal interface activities, are considered important factors for novel coronavirus outbreaks in human populations [1,2].

HUMAN CORONAVIRUS INFECTION

Common Strains

Human coronavirus (HCoV) was first identified in 1965, isolated from a patient with what was described as the common cold [3]. Subsequently, four types of HCoV have been detected frequently in respiratory secretions from children and adults in scattered regions of the globe, labeled HCoV-229E, -NL63, -OC43, and -HKU1. These agents are a common cause of mild-to-moderate upper respiratory illness, including common cold, bronchitis, bronchiolitis in infants and children, and asthma exacerbation. Rarely, HCoVs have been implicated in lower respiratory tract infection (viral pneumonia), a complication more common to persons with underlying cardiopulmonary disease or weakened immune systems.

Novel Coronavirus Outbreaks

In addition to the seasonal infections caused by the ambient, adaptive HCoVs described, widespread outbreaks of novel coronavirus infection have occurred in each of the past two decades, and the 2019–2020 Wuhan, China, outbreak poses the third threat of a severe novel coronavirus epidemic on a global scale [1,4]. The epidemiologic feature common to these outbreaks is an initial point source cluster of zoonotic infection followed by secondary spread of the virus via human-to-human transmission. Among the factors thought to be conducive to the emergence of such outbreaks are the following: genomic recombination in an animal CoV capsid that renders the virus better adapted to human infection (and perhaps more virulent); and dietary practices and cultural determinants that bring humans into close contact with livestock or raw meat and carcasses of wild animals and birds, thereby facilitating transmission from an infected animal host to humans. After infection is established, secondary viral transmission occurs through close person-to-person contact by way of droplet nuclei propelled into the air during coughing and sneezing. The first two known novel coronavirus outbreaks, severe acute respiratory syndrome coronavirus (SARS-CoV) in 2003 and Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, are considered to be zoonotic in origin and were associated with serious, sometimes fatal illness.

Severe Acute Respiratory Syndrome (SARS-CoV)

Infection with SARS-CoV was first recognized in China in November 2002, and signs of an outbreak in Asia were evident by February 2003 [3]. Epidemiologic investigation found that early cases of SARS-CoV were zoonotic infection involving transmission from civet cats to humans. Over the next several months, SARS-CoV spread to countries in North America, South America, Europe, and other parts of Asia before the global outbreak was contained later in the same year.

SARS-CoV infection began with fever, headache, malaise, and arthralgia/myalgia followed in two to seven days by cough, shortness of breath, and signs of pneumonia [3].

According to the World Health Organization (WHO), the 2002–2003 outbreak caused 8,098 probable cases of SARS worldwide and 774 deaths. Just eight cases were identified in the United States. Since 2004, no additional known cases of SARS-CoV infection have been reported anywhere in the world [3].

In response to the 2003 global SARS outbreak, the Centers for Disease Control and Prevention (CDC), working in concert with the WHO, developed a strategy for controlling the epidemic that included the following elements [3]:

- Activated the Emergency Operations Center to provide around-the-clock coordination and response.

- Committed more than 800 medical experts and support staff to work on the SARS response and to assist with ongoing investigations around the world.

- Provided assistance to state and local health departments in investigating possible cases of SARS in the United States.

- Conducted extensive laboratory testing of clinical specimens from patients with SARS to identify the cause of the disease.

- Initiated a system for distributing health alert notices to travelers who may have been exposed to cases of SARS.

This experience informed the rapid public health response to the 2019–2020 coronavirus outbreak in China.

Middle East Respiratory Syndrome (MERS-CoV)

MERS-CoV was first reported in Saudi Arabia in 2012, and all cases to date have been linked to countries in or near the Arabian Peninsula. Travel-associated cases of MERS-CoV infection have been reported in many countries, including two imported cases diagnosed in the United States in 2014 involving unlinked healthcare providers recently returned from Saudi Arabia. Two modes of transmission have been identified: zoonotic infection from an animal reservoir to humans (with camels acting as the intermediate host), and person-to-person transmission via close contact with an index case, as described in association with a family case cluster and a nosocomial outbreak [5,6,7].

Most persons with confirmed MERS-CoV infection have had moderately severe respiratory illness manifest by fever, cough, and shortness of breath, often complicated by pneumonia and respiratory failure. The case-fatality rate approaches 40%. Most deaths have been in patients with pre-existing chronic conditions such as diabetes, cancer, or heart, lung, or renal disease. Sporadic cases of MERS-CoV continue to appear in various parts of the Middle East [3].

2. THE 2019–2020 NOVEL CORONAVIRUS OUTBREAK: A GLOBAL THREAT

In December 2019, Chinese physicians in Hubei Province, China, began an investigation of a cluster of cases of severe viral pneumonia in area hospitals. In the weeks following, it became evident that a large outbreak of respiratory illness was rapidly emerging within Wuhan City and nearby communities, reaching the thousands by mid-January.

On January 24, scientists in Wuhan City, China, reported clinical and diagnostic findings of viral studies conducted on bronchoalveolar lavage specimens from three patients with severe bilateral interstitial, alveolar pneumonia [2]. The investigation identified a viral genome matched to lineage B of the genus betacoronavirus, showing more than 85% match with a SARS-like CoV genome previously described in bats. Ultrathin sections of infected human airway epithelial cells showed inclusion bodies filled with virus particles in membrane-bound vesicles in the cytoplasm. The morphology of the virion on electron microscopy is consistent with the Coronaviridae family. This newly identified coronavirus was responsible for a widespread outbreak of severe respiratory illness in Wuhan City, beginning December 2019.

The novel Wuhan coronavirus was named severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is referred to as coronavirus infectious disease-2019 (COVID-19). Like SARS-CoV and MERS-CoV, SARS-CoV-2 is a betacoronavirus that likely had its origin in bats, with one or more animals serving as the intermediate host. The actual source and timing of initial human infection is unclear. Evidence appears to support origin from either a large wet market that deals in exotic animals or a local, state-sponsored virology laboratory that conducts basic research on animal coronaviruses; however, this does not definitively exclude other hypotheses [120]. CDC investigation of initial SARS-CoV-2 cases imported into the United States found that virus sequences were similar to the one posted by China, indicating emergence of this virus from a point-source in Wuhan, China [12].

The rapid spread of COVID-19 in Wuhan City, followed by cases in nearby provinces of central China and acute infection in healthcare workers, indicated that facile human-to-human transmission of SARS-CoV-2 was the key factor responsible for propagation of the outbreak. Within weeks, cases of confirmed COVID-19 were identified in multiple countries outside China, associated with travel to or from Wuhan City and other parts of central China. The role of person-to-person transmission unrelated to travel became increasingly evident from the pace of community spread and from results of contact investigations. By mid-March 2020, SARS-CoV-2 had spread to Europe, the United States, and other areas of the world, prompting the WHO Director General to declare the COVID-19 outbreak a global pandemic. After three years, the global COVID-19 disease burden totaled more than 659 million confirmed cases and more than 6.6 million deaths, of which 100 million cases and 1 million deaths were in the United States [8,137].

Despite the availability of effective COVID-19 vaccines beginning in December 2020, the pandemic remained undiminished in Europe and the United States throughout the summer and fall of 2021, in part because of a slow rollout and limited acceptance of COVID-19 vaccines and the emergence of new SARS-CoV-2 strains (variants) more infectious than the original. By July 2021, SARS-CoV-2 Delta variant accounted for 99% of all COVID-19 cases reported in the United States; in December 2021, Delta was rapidly supplanted by the less severe but highly infectious Omicron variant [132].

The scope of the ongoing pandemic creates an enormous pool of replicating virus, greatly magnifying the number of spontaneous genomic mutations and increasing the likelihood new variants of SARS-CoV-2 will emerge. Many variants emerge and disappear; variants having a transmission advantage gradually replace the SARS-CoV-2 strains in circulation. Because of concerns that emerging SARS-CoV-2 variants could circumvent COVID-19 countermeasures, the SARS-CoV-2 Interagency Group (SIG) was established to monitor the transmission, disease severity, and potential of variants to evade vaccine-induced immunity [123]. Using genetic sequencing of SARS-CoV-2 isolates, the CDC's national genomic surveillance program identifies SARS-CoV-2 variants and tracks the geographic distribution and proportion of COVID-19 cases caused by variants. Closely genetically related variants derived from a common ancestor are designated a lineage.

Throughout most of 2022, an estimated 100% of new COVID-19 cases in the United States were caused by subvariants of SARS-CoV-2 Omicron lineage [123,124]. As of January 2023, a new, more highly transmissible Omicron derivative (XBB.1.5) has emerged, threatening yet another surge of COVID-19 in the first quarter of 2023. CDC projection estimates show that XBB.1.5 accounted for approximately 66% of COVID-19 for the week ending February 3, 2023 [124]. Omicron XBB.1.5 is less sensitive to neutralizing antibody acquired from previous infection and vaccination, raising concern for higher risk of SARS-CoV-2 reinfection than in the past. Although Omicron XBB.1.5 is outpacing other subvariants in circulation, there is no apparent change in clinical profile or risk of adverse outcomes; weekly reported cases, hospitalization, and deaths from COVID-19 declined in mid-January 2023 [124].

3. CLINICAL MANIFESTATIONS OF COVID-19

The incubation period of SARS-CoV-2 infection is 5 to 7 days, with a range of 2 to 14 days. It is estimated that 97.5% of persons with COVID-19 who develop symptoms will do so within 11.5 days of infection [15,18]. The onset and progression of illness is variable; most patients experience some combination of fever, cough, fatigue, anorexia, myalgias, and shortness of breath. Less common presenting symptoms include rhinorrhea, sudden loss of smell (anosmia) and/or taste (ageusia), and sore throat. Numerous atypical presentations of COVID-19 have been reported. Elderly adults and persons with comorbidities may have delayed presentation of fever and respiratory symptoms [15]. Headache, confusion, rhinorrhea, sore throat, hemoptysis, vomiting, and diarrhea have been reported but are less common (<10%). Some with COVID-19 have experienced gastrointestinal symptoms, such as diarrhea and nausea, prior to developing fever or lower respiratory tract symptoms. Anosmia or ageusia preceding the onset of respiratory symptoms was frequently reported during the original and Delta COVID-19 periods, a clinical feature that differentiates SARS-CoV-2 from other viral upper respiratory infections.

In order to better characterize the symptom profiles of patients with COVID-19 in the United States, especially among nonhospitalized patients, the CDC used an optional questionnaire to collect detailed information from a sample of confirmed COVID-19 cases reported from 16 participating states [60]. Among 164 symptomatic patients with onset of illness between January 14 and April 4, 2020, a total 158 (96%) reported fever, cough, or shortness of breath. Of 57 hospitalized adult patients, 39 (68%) reported all three of these symptoms, compared with 25 (31%) of the 81 nonhospitalized adult patients. Each of the following symptoms was reported by more than half of patients: cough (84%), fever (80%), myalgia (63%), chills (63%), fatigue (62%), headache (59%), and shortness of breath (57%). Gastrointestinal symptoms were relatively common, most frequently diarrhea (38%) and least frequently vomiting (13%). Shortness of breath was more common in hospitalized patients (82%) than nonhospitalized patients (38%). Anosmia and ageusia were reported by a higher percentage of nonhospitalized patients (22%) than hospitalized patients (7%) [60].

An array of cutaneous symptoms and signs has been described in patients with COVID-19. Although the exact frequency remains unknown, reports have ranged from 0.2%, early in the pandemic, to as high as 20.4% [15]. In addition to the exanthems common to many viral infections, pernio-like lesions have been described [105]. Pernio (chilblains) is a superficial inflammatory vascular response that occurs on acral skin, usually after cold exposure. In patients with COVID-19, these lesions appear as discolored edematous plaques on the toes and fingers. An international registry was organized early in the pandemic to characterize the diversity of dermatologic manifestations. In a study of 171 registry patients with confirmed COVID-19, the most common morphologies were morbilliform (22%), pernio-like (18%), urticarial (16%), macular erythema (13%), vesicular (11%), papulosquamous (9.9%), and retiform purpura (6.4%) [106]. Morbilliform rashes were often pruritic and involved the trunk. Pernio morphologies were often painful/burning and involved the hands/feet. Pernio-like lesions were generally observed in patients with mild disease, whereas retiform purpura was seen exclusively in critically ill patients. Cutaneous manifestations usually appeared at the onset of or after other COVID-19 symptoms. However, in 12% of cases skin lesions occurred before other COVID-19 symptoms or signs [106]. Images of cutaneous findings are available from the American Academy of Dermatology at https://www.aad.org/public/diseases/coronavirus/covid-toes.

Although most symptomatic patients with COVID-19 experience a mild-to-moderate illness with slow convalescence, there is substantial risk of progression to bilateral pneumonia complicated by respiratory failure and death. In February 2020, the overall case fatality rate for confirmed cases of COVID-19 reported from China was approximately 3%. As the pandemic progressed, reported case fatality rates varied considerably among countries and regions, ranging from 3% to as high as 14%. Multiple factors account for this variance, including available health resources and access to care, differences in public health mitigation strategies, lack of uniformity in the way deaths are attributed to COVID, and the extent to which testing and contact tracing identifies asymptomatic infections. Based on reported cases and attributable deaths through mid-July 2020, the COVID-19 case fatality rate during the first six months of the pandemic was 3.6% in the United States [8]. It is more useful to consider age-adjusted case fatality rates, which range from less than 1% in persons younger than 20 years of age to more than 15% for those older than 75 years of age.

SEVERITY AND PROGRESSION OF ILLNESS

The first description of clinical features in hospitalized patients with COVID-19-related pneumonia in Wuhan City was published online January 24, 2020 [9]. Of 41 patients with laboratory-confirmed SARS-CoV-2 infection; 30 (73%) were men and 27 (66%) had been exposed to the open-air Huanan Seafood Market. The median age was 49 years, and fewer than half of the patients had a history of underlying chronic disease. Common symptoms at onset of illness were fever (98%), cough (76%), and myalgia or fatigue (44%). Dyspnea developed in 22 patients (55%), at a median time of eight days after onset of illness. Common laboratory abnormalities included leukopenia, lymphopenia, and mild hepatic enzyme elevations. All 41 patients were reported to have pneumonia, and in all save one case there was radiographic evidence of bilateral involvement. The typical findings on chest computed tomography (CT) images of intensive care unit (ICU) patients were bilateral multilobar and segmental areas of consolidation. Acute respiratory distress syndrome developed in 12 (32%) patients, 13 (32%) were admitted to an ICU, and 6 died (15%).

A larger retrospective study examined the clinical characteristics of COVID-19 in a cohort of 1,099 hospitalized patients in China during the first two months of the outbreak [17]. The most common symptoms were fever (43.8% on admission, 88.7% during hospitalization), cough (67.8%), and fatigue (38.1%) [17]. The most common patterns on chest CT were ground-glass opacification (36.4%) and bilateral patchy shadowing (51.8%). Some degree of radiographic or CT abnormality was evident in 82% of patients with non-severe disease and 97% of patients with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Sixty-seven patients (6.1%) were admitted or transferred to the ICU, 2.3% required mechanical ventilation, and 1.4% died [17].

In a summary of 72,314 cases reported to the Chinese Center for Disease Control and Prevention, the severity of illness ranged from mild to critical with approximately the following distribution [15,23]:

- Mild to moderate (mild symptoms up to mild pneumonia): 81%

- Severe (dyspnea, hypoxia or >50% lung involvement on imaging): 14%

- Critical (respiratory failure, shock, or multiorgan dysfunction): 5%

The majority of cases (81%) were characterized as mild, with no or mild pneumonia [23]. The overall case-fatality rate was 2.3%, with higher rates among patient subgroups. Specifically, the case-fatality rate was 49% among critical patients, and all reported deaths occurred in critical patients [23].

Classification of COVID-19 Severity

For purposes of risk stratification and prioritization of care, adults with COVID-19 can be grouped into the following severity of illness categories:

- Asymptomatic or presymptomatic infection: Individuals who test positive for SARS-CoV-2 using a virologic test but who have no symptoms consistent with COVID-19.

- Mild illness: Individuals who have any of the signs or symptoms of COVID-19 but who do not have shortness of breath, dyspnea, or abnormal chest imaging.

- Moderate illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation measured by pulse oximetry (SpO_2) ≤94% on room air at sea level.

- Severe illness: Individuals who have SpO_2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO_2/FiO_2) <300 mm Hg, a respiratory rate >30 breaths/minute, or lung infiltrates.

- Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.

Risk Factors for Severe Disease

Persons of all ages are at risk for SARS-CoV-2 infection and severe COVID-19. The likelihood of severe disease is greater for children younger than 4 years and adults older than 65 years of age, those living in nursing home or long-term care facilities, those with multiple comorbidities, and those unvaccinated against COVID-19. Individual risk factors for severe disease include advanced age, obesity (body mass index ≥30), cardiovascular disease, diabetes, cancer, and chronic obstructive pulmonary disease (COPD). Of more than 70,000 cases reported in China the first two months of the pandemic, 87% occurred in persons 30 to 79 years of age [23]. The proportion of case fatalities among patients 70 to 79 years of age was 8%, among those 80 years of age or older, the rate was 14.8%. The case fatality rate for patients with comorbidities was elevated as well, specifically those with cardiovascular disease (10.5%), diabetes (7.3%), chronic respiratory disease (6.3%), hypertension (6%), and cancer (5.6%). Only 2% of cases in persons younger than 20 years of age were fatal, and no deaths were reported in those younger than 10 years of age.

In June 2020, the CDC issued an epidemiologic report on 1,320,488 laboratory-confirmed COVID-19 cases in the United States and territories, reported to CDC between January 22 and May 30, 2020 [55]. Cumulative incidence (403.6 cases per 100,000 persons) was similar among males (401.1) and females (406.0), highest among persons 80 years of age or older (902.0), and lowest among children younger than 9 years of age (51.1). Among 599,636 cases with known information on both race and ethnicity, 36% were non-Hispanic White, 33% were Hispanic, 22% were Black, 4% were Asian, and 1.3% were American Indian or Alaska Native. Among 287,320 cases with sufficient data on underlying health conditions, the most frequently reported comorbidities were cardiovascular disease (32%), diabetes (30%), and chronic lung disease (18%). Overall, 14% were hospitalized, 2% admitted to an ICU, and 5% died. The rate of hospitalization was six times higher among patients with underlying health conditions (45.4%) than among those without reported underlying comorbidities (7.6%). The mortality rate was 12 times higher among patients with reported underlying conditions (19.5%) compared with those reporting none (1.6%). Approximately 4% of reported cases were asymptomatic. Among 373,833 cases with data on individual symptoms, 70% noted fever, cough, or shortness of breath; 35% experienced muscle aches and/or headache; 8% reported loss of taste or smell [55].

During the course of the pandemic in the United States, obesity has been identified as an important independent risk factor for severe COVID-19, especially among adult patients younger than 60 years of age. Multiple reports, ranging from single-center studies to analyses of records from large patient care networks, have found that severe obesity (body mass index >35) is associated with higher rates of hospitalization, respiratory failure, and mortality from COVID-19 [77,78]. The risk varies directly with degree of obesity and is independent of obesity-associated comorbidities. The impact is more striking among men than women. There are multiple mechanisms by which obesity may contribute to adverse outcomes in patients with COVID-19. In addition to obstructive pulmonary physiology, severe obesity is associated with immune dysfunction (depression of anti-inflammatory signaling and increased pro-inflammatory signaling), alterations in vascular endothelium, and renin-angiotensin stimulation, which together may worsen lung inflammation and alveolar damage [78].

SYSTEMIC COMPLICATIONS OF COVID-19

At the cellular level, susceptibility to virus infection requires some affinity of the virion for the host cell combined with mechanisms that facilitate attachment and entry into the cell. Cell entry of SARS-CoV-2 depends on binding of the surface spike protein to angiotensin-converting enzyme (ACE2) receptors, followed by activation of the spike protein by host cell transmembrane protease serine 2 [30]. ACE2 is highly expressed by epithelial cells in the nasopharynx and type II alveolar cells in the lung. ACE2 is also expressed in the heart, kidney, vascular endothelium, and intestinal epithelium, which may explain, in part, the propensity for multiorgan dysfunction and vascular complications in patients with severe COVID-19. An autopsy series of 27 patients with COVID-19 reported detectable SARS-CoV-2 in multiple organs, including the lungs, pharynx, kidney, heart, liver, and brain [31]. Measurable SARS-CoV-2 viral load, with preferential targeting of glomerular cells, was present in all kidney compartments examined.

Renal and cardiac complications are common in severe COVID-19. In a retrospective study from China, 251 of 333 (75%) hospitalized patients with COVID-19 pneumonia exhibited some degree of renal involvement, as evidenced by proteinuria or hematuria, and 35 (10%) met criteria for acute kidney injury [32]. In another case series of 138 hospitalized COVID-19 patients, 7% overall and 22% of those admitted to the ICU developed elevated troponin levels or electrocardiogram abnormalities indicative of myocarditis or cardiac injury at some point during hospitalization [33]. A review of cardiac complications found that myocardial injury affects more than one-quarter of COVID-19 cases classified as critical, with two patterns: acute myocardial injury and dysfunction on presentation, and myocardial injury developing as illness severity intensifies [34]. While headache and confusion are seen in some patients presenting with severe COVID-19, there is no indication that SARS-CoV-2 causes primary infection of the central nervous system (e.g., encephalitis). In an autopsy series of 18 consecutive patients who died 0 to 32 days after onset of COVID-19, histopathologic examination of brain specimens did not show encephalitis or other specific brain changes referable to the virus [56].

Coagulopathy

Hospitalized patients with advanced COVID-19 may have laboratory signs of a coagulopathy and increased risk for arterial and venous thromboembolic complications [15,39,40]. The pathogenesis is unknown but likely involves some combination of systemic inflammation, endothelial dysfunction, platelet activation, immobility, and stasis of blood flow [40]. The earliest abnormalities are elevated D-dimer levels and mild thrombocytopenia; with disease progression, fibrin degradation products are elevated and prothrombin time becomes prolonged. Laboratory measure of coagulation factors in a patient hospitalized with COVID-19 provides a way to track disease severity. The presence of an elevated D-dimer on admission carries a poor prognosis and has been associated with increased risk of requiring mechanical ventilation, ICU admission, and mortality [40,41]. The most frequently reported complications of COVID-19 coagulopathy are deep venous thrombosis (DVT) and pulmonary emboli (PE). In a prospective study of 150 critically ill patients from two centers in France, 25 patients developed PE and 3 developed DVT despite prophylactic anticoagulation [42]. In a report of 184 patients with severe COVID-19 from three centers in the Netherlands, the cumulative incidence of venous thromboembolism was 27%, including PE in 80% of the cases affected [43]. Other centers have reported lower rates. Among 393 patients from New York, venous thromboembolism was diagnosed in only 13 patients (3.3%), 10 of whom were on mechanical ventilation [44]. These differences point to the need for studies that control for clinical severity, underlying comorbidities, prophylactic regimen, and COVID-19-related therapies. At present, there are limited data available to inform clinical management around prophylaxis or treatment of venous thromboembolic complications in patients with COVID-19 [15]. One source of interim guidance recommends regularly monitoring hemostatic markers—namely D-dimer, prothrombin time, and platelet count—in all patients presenting with COVID-19 and prophylactic use of low-molecular-weight heparin in all hospitalized patients, unless there are contraindications [40]. Clinical guidance on use of antithrombotic therapy for patients with COVID-19 is provided by the National Institutes of Health (NIH) at https://www.covid19treatmentguidelines.nih.gov/therapies/antithrombotic-therapy.

In summary, the clinical features of COVID-19 range from self-limited upper respiratory syndrome to pneumonia and rapid-onset respiratory insufficiency to vascular complications and critical organ dysfunction. Older patients and those with comorbidities are at significant risk for severe disease. Among patients with COVID-19 who progress to pneumonia, the median time from initial symptoms to onset of dyspnea is 5 to 8 days, to ARDS is 8 to 12 days, and to ICU admission is 10 to 12 days. Therefore, in monitoring at-risk patients, clinicians should bear in mind the anticipated period of rapid clinical deterioration is 7 to 8 days after onset of symptoms. Data from clinical series show that in patients hospitalized for COVID-19, 26% to 42% require ICU admission; in those admitted to ICU, 65% to 85% develop ARDS [15]. Reported mortality rates among patients requiring ICU admission range from 39% to 72%. The median length of hospitalization for survivors is 10 to 13 days.

PREGNANCY AND COVID-19

Although the absolute risk of severe COVID-19 is low among people of child-bearing age, the risk of severe illness and complications is substantial when infection is acquired during pregnancy. Evidence for this comes from an analysis of 409,462 women (15 to 44 years of age) with symptomatic COVID-19 reported to the CDC between January 22 and October 3, 2020 [107]. Of the total, 23,434 women (5.7%) were pregnant at the time of infection. Pregnant patients were admitted to an ICU more frequently than nonpregnant patients (10.5 versus 3.9 per 1,000 cases) and were more likely to receive invasive ventilation (2.9 versus 1.1 per 1,000 cases) or extracorporeal membrane oxygenation (ECMO) (0.7 versus 0.3 per 1,000 cases). The mortality rate was 1.5 per 1,000 cases for pregnant women compared with 1.2 per 1,000 cases for nonpregnant women. Older pregnant patients (35 to 44 years of age) with symptomatic COVID-19 were nearly four times more likely to require invasive ventilation and twice as likely to die than were nonpregnant patients of the same age [107].

Following the emergence of the Delta variant and 2021 summer surge of COVID-19, the risk for unvaccinated pregnant individuals infected with SARS-CoV-2 became more serious. A retrospective cohort study comparing COVID-19 outcomes among unvaccinated pregnant patients infected in the pre-Delta period with those infected during the Delta surge found that proportions of severe-critical illness and ICU admissions were three-fold higher among patients in the Delta cohort than those in the pre-Delta cohort [149]. Rates of intubation and mechanical ventilation were higher among those with Delta variant infection. Maternal COVID-19 from SARS-CoV-2 Delta infection also had an adverse effect on perinatal outcomes; rates of cesarean delivery, stillbirth, preterm birth, and neonatal intensive care unit admission were all higher during the period of Delta predominance [149].

Vertical Transmission and Neonatal COVID-19

Multiple cohort studies and meta-analyses have found that vertical transmission of SARS-CoV-2 is rare, though severe maternal COVID-19 has been associated with SARS-CoV-2 infection in newborn infants. The majority of SARS-CoV-2 infections reported in newborns result from exposure to maternal COVID-19 at the time of birth or shortly after. One systemic review and meta-analysis found that 1.8% of newborn infants from mothers with SARS-CoV-2 infection tested positive for the virus [177]. In a subset of 592 SARS-CoV-2-positive infants with data on time of exposure and testing, 7 had evidence of confirmed mother-to-child transmission in utero. Risk factors associated with neonatal SARS-CoV0-2 infection in offspring included severe maternal COVID-19, maternal admission to ICU, maternal death, and postnatal maternal COVID-19 [177].

Several small clinical series have reported fetal demise or stillbirth following maternal COVID-19, resulting from placental SARS-CoV-2 infection without evidence of intrauterine transmission to fetus. Data from a prospective clinicopathologic study of placentas from unvaccinated pregnant individuals affected by COVID-19 were used to examine the placental pathology associated with autopsy findings in six stillbirth cases [178]. In all six stillbirths, the maternal placentas showed extensive inflammation and massive perivillous fibrinoid deposition with trophoblast damage, associated with the presence of virions on electron microscopy and positive immunostaining for SARS-CoV-2 spike protein. Thus, severe "placentitis," with near 75% obliteration of the maternal intervillous space, accounted for intrauterine fetal death. Complete fetal autopsy examination found signs of tissue asphyxia as mode of death and no evidence of viral transmission to the fetus [178]. The interval between maternal COVID-19 diagnosis and fetal death ranged from 3 to 15 days.

RECOVERY FROM COVID-19

Convalescence following SARS-CoV-2 infection follows a variable course, and symptomatic recovery from severe COVID-19 may take weeks to months. In a cohort study of 146 patients with moderate-to-severe COVID-19 hospitalized a median of two weeks with interstitial viral pneumonia, 87% had persistent symptoms two months or more after discharge from hospital [68]. On follow-up clinical assessment 60 days after onset of the first COVID-19 symptom, 18 (13%) were symptom free; of the remaining participants, 32% had one or two symptoms and 55% had three or more symptoms. The most common persistent symptoms were fatigue (53%), dyspnea (43%), joint pain (27%), and chest pain (22%). None had fever or signs of acute illness. Of the total, 44% reported persisting decline in quality of life imposed by COVID-19.

"Long COVID" is the term applied to the syndrome of persistent symptoms four weeks or later after recovery from acute COVID-19. The majority of reported cases are adults in the 35-to-69-year age group, and women are 30% more likely to get long COVID than men [133]. The range of complaints includes residual cough, fatigue, loss of smell or taste, shortness of breath, headache, and "brain fog." The prevalence of post-COVID-19 cognitive impairment and association with disease severity was investigated in 740 adult patients with no prior history of dementia. Study participants were 38 to 59 years of age, prior COVID severity ranged mild to severe, and evaluations were performed an average of 7.6 months after diagnosis. Deficits were found in processing speed (18%), executive functioning (16%), phonetic fluency (15%) and category fluency (20%), memory encoding (24%), and memory recall (23%) [134]. Executive functioning, processing speed, and memory encoding and recall impairments were predominant among hospitalized patients.

A multistate survey conducted by the CDC found that persistent symptoms three weeks after diagnosis of SARS-CoV-2 infection was common among outpatients with milder illness [69]. Of 270 respondents who were symptomatic at diagnosis, 95 (35%) had not returned to their usual state of health 14 to 21 days from the test date, including 26% of those 18 to 34 years of age and 47% of those older than 50 years of age. Among respondents reporting cough, fatigue, or shortness of breath at the time of COVID-19 diagnosis, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview [69].

A cohort study of long-term symptoms in healthcare professionals found that after mild COVID-19, 26% of participants reported at least one moderate-to-severe symptom lasting two months and 15% reported at least one moderate-to-severe symptom lasting eight months [108]. The most common symptoms were anosmia, fatigue, ageusia, and dyspnea. These studies show that low-risk adults with mild COVID-19 commonly experience a slow convalescence with diverse long-term symptoms that may disrupt work and social activity.

LATE SEQUELAE OF COVID-19

In addition to the lingering functional impairments represented by long COVID syndrome, there is growing evidence that beyond acute infection, SARS-CoV-2 may have late adverse effects on critical organ function that impacts the subsequent incidence of cardiovascular disease and diabetes. The lung/vascular/heart involvement of acute-phase moderate-to-severe COVID-19 reflects the trophism of SARS-CoV-2 augmented by a dysregulated (hyperimmune) inflammatory response to infection, resulting in multiple potential complications. Microvascular dysfunction and endothelial injury may precipitate thromboembolic events. Myocarditis is usually transient but may lead to cardiomyopathy. Acute coronary syndromes from vasculitis and plaque instability may cause myocardial ischemic injury, resulting in heart failure. Parenchymal lung injury and microvascular thrombosis may lead to interstitial fibrosis and hypoxemia, adding to the cardiac workload and subsequent risk of clinical or subclinical heart failure [159].

The cardiovascular sequelae of post-acute COVID-19 were analyzed using the databases of the U.S. Department of Veterans Affairs to build a cohort of 153,769 individuals with COVID-19, as well as cohorts of contemporary and historical controls. The study was designed to estimate risks and one-year burdens of a set of prespecified incident cardiovascular outcomes. The analysis showed that beyond 30 days after diagnosis, individuals with COVID-19 were at increased risk of subsequent cardiovascular diseases in several categories, including dysrhythmias, ischemic and non-ischemic heart disease, pericarditis, myocarditis, heart failure, and thromboembolic disease [160]. Increased risk and additional disease burden were evident among hospitalized and nonhospitalized patients. Overall, the impact increased in graded fashion according to the clinical care setting. In a separate report, using the same database and study protocol, investigators also found that the risks and 12-month burdens of incident diabetes and antihyperglycemic use were increased among people who survived COVID-19, compared to a contemporary control group that had not contracted SARS-CoV-2 infection [161]. The post-acute diabetes risks and disease burdens increased in graded fashion according to severity of the acute phase of COVID-19.

Chronic, persistent SARS-CoV-2 infection following COVID-19 has been reported in patients with hematologic malignancies and immunodeficiency disorders. The common features are protracted virus shedding, fluctuating symptoms, and failure of humeral immunity many months after acute infection. In addition to the burden of ongoing symptoms and added cost of care, these patients often have to endure prolonged self-isolation and inability to resume productive lives. COVID-19 vaccines may be beneficial in such cases; in a reported case study, mRNA COVID-19 vaccination elicited humoral and cellular immune responses to SARS-CoV-2, which had failed in response to ongoing infection itself, followed by viral clearance [162].

4. COVID-19 IN CHILDREN

The CDC and NIH websites provide updated clinical guidance for pediatric healthcare providers on the evaluation and management of childhood COVID-19 and neonates at risk for COVID-19 [45,57]. Acute SARS-CoV-2 infection in childhood tends to be asymptomatic or mild, consisting of transient fever, cough, and other signs common to an upper respiratory viral syndrome. Severe manifestations of COVID-19 have been reported in children of all ages, though the incidence is far less common than in adults and fatalities following acute childhood infection are rare. Among more than 2,000 pediatric cases in China, 4% were asymptomatic, 51% had mild symptoms, 39% were moderately ill with some evidence of pneumonia, and 5% were severely ill with dyspnea, hypoxia, and central cyanosis [45]. Only 0.6% developed respiratory failure, shock, or multi-organ dysfunction.

Children younger than 18 years of age account for 22% of the U.S. population and represent 18% of cumulative COVID-19 cases reported since the onset of the pandemic [136]. As of January 2023, more than 15.2 million children have tested positive for COVID-19, including 172,000 child cases added in the month of December 2022. Reported cases are likely a substantial undercount of COVID-19 cases among children [136]. Severe illness from SARS-CoV-2 infection is uncommon. Among states reporting, pediatric cases account for 1.2% to 4.6% of COVID-19-related hospitalizations. Less than 1.5% of all child COVID-19 cases result in hospitalization. The childhood COVID-19 case fatality rate is 0.03% [46,136]. Although the childhood COVID-19 mortality rate is low (about 1 death per 100,000 population), the mortality burden in children is best understood in the context of all causes of death. An epidemiological analysis for the years 2019 to 2022 found that among children and young people 0 to 19 years of age, COVID-19 ranked eighth among all causes of death, fifth among disease-related causes of death, and first in deaths caused by infectious or respiratory diseases [155]. COVID-19 was the underlying cause in at least 821 childhood and adolescent deaths occurring in theone-year period from August 1, 2021, to July 31, 2022. As among adults with COVID-19, children with underlying medical conditions and special healthcare needs, including genetic, neurologic, and metabolic disorders or congenital heart disease, are at increased risk of severe illness and adverse outcomes.

Following emergence of the highly infectious SARS-CoV-2 Omicron variant in December 2021, COVID-19-associated hospitalization rates increased rapidly among children 0 to 4 years of age, a group at that time not yet eligible for vaccination. During the period December 2021 to February 2022, weekly hospitalizations among children 0 to 4 years of age peaked at 14.5 per 100,000, a level fivefold higher than during the previous six months (Delta predominance) [163]. During the period of Omicron predominance, 63% of hospitalized children had no underlying medical conditions. Monthly pediatric COVID-19 ICU admission rates were approximately 3.5 times higher during peak Omicron predominance in January 2022, than during peak Delta predominance in September 2021 [163].

Although most SARS-CoV-2 infections in childhood are asymptomatic or mild, the percentage of ICU admissions among hospitalized children with COVID-19 is comparable to that for hospitalized adults. Clinical studies have identified multiple risk factors for severe disease and adverse outcomes in childhood COVID-19. These risk factors include prematurity in young infants, obesity, diabetes, chronic lung disease, cardiac disease, neurologic disorders, and immunocompromising conditions [57]. Certain age groups (infants younger than 1 year of age, children 10 to 14 years of age) and non-White race/ethnicity also are associated with increased risk of severe disease and adverse outcomes among hospitalized children with COVID-19.

Long COVID has also been described in children, though to a lesser degree than in adults. Adolescents and teenagers account for the majority (70%) of reported cases [133]. In a study of 151 children with documented SARS-CoV-2 infection, 8% had post-acute COVID-19 symptoms lasting three to eight weeks [135]. The most common symptoms were residual cough and/or fatigue. On follow-up survey at six months, all 151 children had fully recovered.

PEDIATRIC MULTISYSTEM INFLAMMATORY SYNDROME

During the first year of the pandemic, reports from United Kingdom, Italy, and New York described a serious inflammatory disorder in children linked to COVID-19, with many features common to Kawasaki disease and toxic shock syndrome [46,47,48]. The term applied to this condition is multisystem inflammatory syndrome in children (MIS-C). Kawasaki disease is an acute vasculitis of unknown cause that affects infants and young children, first described in Japan and thought to involve an aberrant immune response to an unidentified pathogen in certain persons with genetic predisposition [47]. COVID-related MIS-C is an acute, rapidly progressive inflammatory disorder with signs of intravascular volume depletion and critical organ failure. Symptoms and signs include persistent fever, abdominal complaints, rash, leukocytosis, elevated C-reactive protein, and evidence of single- or multiple-organ dysfunction [49]. Hypotension on presentation is common; myocarditis and other cardiovascular changes (e.g., mitral regurgitation, coronary artery dilatation) may be seen. The majority of patients have tested positive for recent SARS-CoV-2 infection by molecular diagnostic and/or antibody testing. The onset of MIS-C may come days or weeks after what appears to have been an asymptomatic or mild case of COVID-19.

During a 10-day period in mid-April 2020, pediatricians at an intensive care hospital in England noted an unprecedented cluster of eight children with hyperinflammatory shock and other clinical features similar to atypical Kawasaki disease [47]. All had previously been healthy; five of the children were boys. Four of the children had known family exposure to SARS-CoV-2. Clinical presentations were similar, with unrelenting fever, variable rash, conjunctivitis, peripheral edema, and warm shock refractory to intravenous fluids, eventually requiring vasopressors. No clinical or virologic evidence of lower respiratory involvement was observed. All patients were treated with IV immunoglobulin (IVIG); seven recovered and one died following arrhythmia, shock, and cerebral infarction. During the course of the COVID-19 epidemic in northern Italy, physicians in Bergamo observed 10 children (median age: 7.5 years) in the span of two months with a severe form of Kawasaki-like disease, a 30-fold increase in incidence when compared to the previous five years [48]. All were positive for recent SARS-CoV-2 infection. In June 2020, the New York State Department of Health investigated 195 reported cases of MIS-C and 3 deaths in children. Of these patients, 28% were younger than 5 years of age and 69% were between 5 and 19 years of age, and 93% have tested positive for COVID-19 [46]. A targeted surveillance for MIS-C in pediatric health centers across the United States identified 186 cases in 26 states during a five-week period between March and May 2020 [61]. The median age was 8.3 years, 165 (62%) were male, and 131 (70%) tested positive for SARS-CoV-2 infection by rT-PCR or serologic antibody test.

The clinical features in the MIS-C cases investigated by the New York Department of Health have been reported [62]. Of 191 patients in the study, all presented with fever and tachycardia, 80% were admitted to the ICU, and 62% required vasopressor support. Abdominal complaints and gastrointestinal symptoms were common (62%), as was rash (60%), conjunctival injection (56%), and mucosal changes (27%). Laboratory markers of inflammation included elevated levels of C-reactive protein in all patients, positive D-dimer (91%), and elevated troponin (71%). Evidence of myocarditis was present in 53% of patients. At least one echocardiogram was obtained for 93 patients (94%); 51 (52%) had some degree of ventricular dysfunction, 32 (32%) had pericardial effusion, and 9 (9%) had a documented coronary artery aneurysm. The majority of patients were treated with IVIG and/or glucocorticoids in addition to vasopressors. The median duration of hospitalization was six days. Two patients died. As observed in cases reported from Italy, MIS-C cases in New York followed the peak of the COVID-19 epidemic in that state and nearly all patients tested seropositive for recent SARS-CoV-2 infection [62].

The onset of MIS-C after SARS-CoV-2 infection is two to four weeks and presents with fever, multisystem organ involvement, and elevated markers of inflammation. Early recognition of MIS-C and prompt referral (hospitalization) is essential. Approximately 50% to 60% of children and adolescents with MIS-C present with cardiovascular signs, hypotension, and warm shock requiring vasopressor support, compared with about 5% of children with Kawasaki disease [61,62]. Cardiac abnormalities include a 9% incidence of coronary artery aneurysm. Echocardiography is recommended in all patients presenting with MIS-C, and until more is known about long-term cardiac sequelae of MIS-C, providers should consider follow-up imaging one to two weeks and four to six weeks after treatment [61]. Clinical evaluation should include inquiry as to recent COVID-19 illness and known exposure to COVID-19. Clinical management of children with MIS-C includes close observation, correction of hemodynamic instability, diagnostic evaluation for bacterial infection (e.g., streptococcal or staphylococcal sepsis, toxic shock syndrome), and consideration of treating with IVIG. The CDC recommends that patients younger than 21 years of age meeting MIS-C criteria be reported to local, state, and territorial health departments. The CDC case definition for MIS-C is [49]:

- An individual younger than 21 years of age presenting with fever (>38.0°C for at least 24 hours), laboratory evidence of inflammation (including, but not limited to, one or more of the following: an elevated C-reactive protein, erythrocyte sedimentation rate, fibrinogen, procalcitonin, D-dimer, ferritin, lactic acid dehydrogenase, or interleukin-6, elevated neutrophils, reduced lymphocytes, and low albumin), and evidence of clinically severe illness requiring hospitalization, with multisystem (at least two) organ involvement; AND

- No alternative plausible diagnoses; AND

- Positive for current or recent SARS-CoV-2 infection or exposure to a suspected or confirmed COVID-19 case within the four weeks prior to the onset of symptoms

All individuals should be reported if they meet the case definition for MIS-C, regardless of whether they fulfill criteria for Kawasaki disease. In addition, MIS-C should be considered in any pediatric death with evidence of SARS-CoV-2 infection.

The CDC tracks case reports of MIS-C associated with COVID-19. As of January 2023, the number of patients meeting the case definition of MIS-C in the United States totaled 9,333, with 76 deaths [137]. The median age of reported cases was 9 years, and half of children with MIS-C are 5 to 13 years of age. Of the total MIS-C cases reported, 56% are Hispanic/Latino or non-Hispanic Black, 60% are male, and 98% had a positive test for recent SARS-CoV-2 infection [137].

Vaccination of children 12 to 18 years of age with mRNA vaccine is highly effective in preventing COVID-19-associated MIS-C. A multi-state, case-control study comparing 124 patients with MIS-C with 181 hospitalized controls across 24 pediatric hospitals found that the estimated effectiveness against MIS-C following two doses of Pfizer-BioNTech vaccine was 91% [164]. Ninety-five percent of patients hospitalized with MIS-C were unvaccinated, and of 38 MIS-C patients requiring life support, all were unvaccinated.

Information for healthcare providers about MIS-C, including clinical evaluation, diagnostic testing, treatment, and a compendium of additional resources for clinicians (e.g., links American Academy of Pediatrics and American College of Rheumatology clinical guidance) and parents is available on the CDC website at https://www.cdc.gov/mis/mis-c/hcp.

5. DIAGNOSTIC TESTING FOR SARS-COV-2

There are two types of diagnostic tests for determining active SARS-CoV-2 infection: molecular tests that use the real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect viral RNA, and antigen immunoassays that detect the presence of specific proteins on the surface of the virion. For clinical assessment of a symptomatic patient, the most widely used and reliable of these is RT-PCR, which can be applied to mucus specimens from the upper or lower respiratory tracts and to serum samples. SARS-CoV-2 viral RNA can be detected more readily in secretions taken by swab from the nasopharynx than in samples obtained by throat swab [15]. RT-PCR testing of deep nasopharyngeal swab specimens has become the standard procedure for the laboratory diagnosis of active SARS-CoV-2 infection [79,80]. This test is highly accurate and results can be obtained within one or two days.

Antigen tests for the diagnosis of active SARS-CoV-2 infection are performed on nasopharyngeal, nasal swab, or saliva specimens placed directly into the assay's extraction buffer or reagent. Currently authorized antigen tests include point-of-care, laboratory-based, and self-tests. Although antigen tests for SARS-C0V-2 are generally less sensitive than RT-PCR, antigen test results are produced quickly (within approximately 15 to 20 minutes) [80]. Clinicians should bear in mind that unlike molecular detection of viral DNA, which may persist for weeks, the sample concentration of antigen required for detection by assay decreases rapidly as the duration of illness increases. Specimens collected more than seven days after onset of illness are considered more likely to be negative compared to a RT-PCR assay [80]. Thus, a positive antigen test result is highly reliable, but a negative test may need to be confirmed with RT-PCR. Updated CDC guidance for healthcare providers for SARS-C0V-2 antigen testing, including case management (isolation) strategies according to clinical status and test results, is available at https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html.

The availability of safe, reliable, and timely SARS-CoV-2 diagnostic testing is essential for effective public health measures to control the COVID-19 pandemic. The nasopharyngeal swab specimen collection method involves close interaction between healthcare workers and patients, requires personal protective equipment, and entails a measure of discomfort for the test subject—all disadvantages to community drive-through diagnostic testing and contact tracing. Self-collected saliva could prove to be a simple, less expensive alternative that alleviates the need for personal protective equipment. Studies show that the molecular test detection rate for saliva specimens from individuals with symptomatic and asymptomatic SARS-CoV-2 is comparable to deep nasopharyngeal swab specimens. Yale investigators found that among 70 inpatients with confirmed COVID-19 and 495 asymptomatic healthcare workers, the use of self-collected saliva specimens for SARS-CoV-2 molecular diagnostic testing compared favorably with nasopharyngeal swab specimens collected by personnel [81]. In another study of 354 patients presenting to a drive-through testing center with at least one symptom consistent with COVID-19, the SARS-CoV-2 positivity rate was 22.6% for nasopharyngeal swab specimens compared with 22.9% for salivary specimens [82]. Between nasopharyngeal swab specimens and salivary specimens, the positive percent agreement was 93.8% and the negative percent agreement 97.8%.

COVID-19 diagnostic testing in the United States is available at all state and local public health laboratories and at commercial laboratories authorized by the U. S. Food and Drug Administration (FDA) [16,80]. Although in some cases viral nucleic acid can be detected in nasopharyngeal specimens for weeks after infection, studies show that SARS-CoV-2 viral cultures are usually negative within 8 to 10 days after onset of infection. Shedding of live virus may persist longer in severely ill, hospitalized patients (median range of viral shedding: 12 to 20 days) [15]. Information on specimen collection, handling, and storage is available online at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html.

ANTIBODY TESTING

SARS-CoV-2 antibody assays are useful for epidemiologic investigation of prevalence in the general population and to identify groups at risk for infection. Unlike RT-PCR and antigen detection tests that identify acute infection, antibody tests determine whether there is evidence of prior infection, even if the person being tested never developed symptoms. The FDA has not authorized the use of serology to detect active SARS-CoV-2 infection, and the CDC does not recommend antibody testing for routine diagnosis of acute infection [79]. However, antibody testing in conjunction with viral RT-PCR may be used to support clinical assessment of persons who present late in the course of COVID-19, or a patient suspected of having a post-infectious syndrome caused by recent SARS-CoV-2 infection (e.g., MIS-C).

Following SARS-CoV-2 infection, IgM and IgG antibodies appear almost simultaneously in the serum within two to three weeks after symptom onset, at which time infectiousness likely is greatly decreased and some degree of immunity from future infection has developed [83]. Thus, early IgM assay without IgG testing is of little value. The duration of detectable antibody is unknown, and the absence of detectable IgM or IgG antibodies does not necessarily rule out previous infection. Several commercially marketed serologic assays for SARS-CoV-2 have emergency use authorization (EUA) by the FDA, which has independently reviewed their performance. A list of all tests authorized for emergency use under EUA is maintained on the FDA website [84]. All currently authorized tests are qualitative (providing a result that is positive, negative, or indeterminate) rather than quantitative (providing a quantitative assessment of antibody levels). It is important to minimize false-positive test results by choosing an assay with high specificity and by testing individuals with an elevated likelihood of previous exposure to SARS-CoV-2 [83].

6. COVID-19 TREATMENT OPTIONS

After the SARS-CoV-2 viral genome was mapped in mid-January 2020, NIH-sponsored efforts were initiated to improve diagnostics, identify effective treatments, and develop vaccines against SARS-CoV-2 [10]. In addition to repurposed antiviral agents with activity against coronavirus, other modes of therapy for COVID-19 included passive enhancement of immunity (e.g., convalescent plasma, monoclonal antibody) early after onset and anti-inflammatory corticosteroids (dexamethasone) at a later stage and severity of illness. Effective COVID-19 vaccines for prevention of SARS-CoV-2 and protection against severe disease have been in distribution since December 2020.

The majority of patients with mild-to-moderate COVID-19 do not progress to more severe illness. Management of nonhospitalized, low-risk patients with acute COVID-19 should include supportive care under Isolation Precautions, steps to reduce the risk of SARS-CoV-2 transmission, and advising patients on when to seek further evaluation. Those at high risk of progression to severe illness should be triaged for pharmacologic therapy. Patients with persistent or progressive dyspnea, especially those with an oxygen saturation measured by pulse oximetry (SpO_2) <94% on room air or have symptoms suggestive of high acuity illness (e.g., chest discomfort, weakness, confusion), should be referred to a healthcare provider for in-person evaluation [57].

RACIAL/ETHNIC MINORITIES AND MARGINALIZED GROUPS

Communities that have been historically marginalized or made socially vulnerable through lack of access to health care or inability to socially isolate are at increased risk of SARS-CoV-2 acquisition, COVID-19-related hospitalization, and death. This includes racial and ethnic minorities, essential non-healthcare workers, and some people with disabilities. Clinicians, healthcare systems, and public health agencies should work to ensure equitable access to high-quality care and treatment for all patients, regardless of race, ethnic, or social status [57].

COVID-19 THERAPEUTICS

Two main processes are thought to drive the pathogenesis of COVID-19 [57]. Early in the clinical course, disease activity is driven by the replication of SARS-CoV-2; later in the clinical course, the disease is primarily driven by a dysregulated immune/inflammatory response to the virus that leads to tissue damage. Antiviral therapies that directly target SARS-CoV-2 are anticipated to have the greatest effect early in the course of disease, while immunosuppressive/anti-inflammatory therapies are likely to be more beneficial in the later stages of COVID-19. As noted, the NIH Treatment Guidelines Panel provides updated clinical information and guidance on the treatment COVID-19, including recommendations for risk assessment, patient prioritization, and selection of therapeutic regimens in hospitalized and nonhospitalized patients [57].

Antiviral Therapy

As of January 2023, there is no highly effective, safe, and easily administered antiviral therapy for routine treatment of COVID-19. Remdesivir, which must be administered intravenously, is the only drug approved by FDA for treatment of COVID-19. Two oral antiviral drugs, ritonavir-boosted nirmatrelvir (Paxlovid) and molnupiravir, have received EUA from the FDA for early treatment in nonhospitalized patients with mild-to-moderate COVID-19 who are at risk of progressing to severe illness. Recommendations for use of antiviral therapies apply to adults and children (of certain age and weight limitations). The NIH Panel guidelines recommend selecting from the following antiviral agents, in order of preference [57]:

- Ritonavir-boosted nirmatrelvir (Paxlovid): Adults and children at least 12 years of age

- Remdesivir: Adults and children older than 28 days of age and weighing at least 3 kg

- Molnupiravir as alternative therapy when ritonavir-boosted nirmatrelvir and remdesivir are not available

Remdesivir

Remdesivir is a nucleotide analog RNA polymerase inhibitor having in-vitro activity against SARS-CoV-2 [15]. A multinational study at the onset of the pandemic described favorable outcomes when hospitalized patients were given a 10-day course of intravenous remdesivir as part of a compassionate use program [26]. The study enrolled patients from the United States, Canada, Europe, and Japan with confirmed SARS-CoV-2 infection and signs of lower respiratory tract disease severe enough to require oxygen supplementation and/or ventilatory support. Of 53 patients in the data analysis, 32 (68%) showed significant improvement in oxygenation with use of remdesivir. Mortality at 18 days follow-up was 13% overall, 18% among patients who required invasive ventilation, and 5% among those who had received noninvasive ventilation. The authors observed that although this was not a randomized study and patients were not directly comparable, observed mortality was considerably less than that reported contemporaneously in other COVID-19 case series and reports [26].

Remdesivir is approved by the FDA for treatment of adults and pediatric patients with COVID-19. The approval was supported by three randomized, controlled clinical trials showing that remdesivir reduces risk of disease progression and shortens the time to recovery in adult patients hospitalized with moderate-to-severe COVID-19 [90]. The analysis included data from a double-blind, placebo-controlled trial that enrolled 1,062 patients, randomized to receive either intravenous remdesivir or placebo. The primary outcome was time to recovery, defined by discharge from hospital or resolution of need for clinical care (hospitalization for infection-control purposes only). The median time to recovery was 10 days for the remdesivir group, compared with 15 days for the placebo group [35]. In an analysis of secondary outcomes, patients who received remdesivir were more likely than those who received placebo to have clinical improvement at day 15. The proportion of serious adverse events related to respiratory failure and the need for higher levels of ventilatory support were lower among patients in the remdesivir group. Kaplan-Meier estimates of mortality showed a trend in favor of the treatment group: 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% versus 15.2% by day 29 [35].

The NIH Panel recommends remdesivir for treatment of COVID-19 in hospitalized patients with SpO_2 <94% on ambient air, or require supplemental oxygen, and for those who require noninvasive or mechanical ventilation [57]. The duration of treatment recommendation, including advisability of combining remdesivir with a glucocorticoid such as dexamethasone, depends on severity of illness and level of ventilatory support. For patients who require supplemental oxygen but have no need for delivery of oxygen through a high-flow device, the recommended regimen is remdesivir 200 mg IV for one day, followed by 100 mg daily for four days or until hospital discharge, whichever comes first. The duration of remdesivir therapy may be extended up to 10 days when there is no substantial clinical improvement by day 5 (57).

The FDA has approved the use of remdesivir (three-day regimen) in nonhospitalized patients with COVID-19 who are at risk of severe disease in settings where intravenous therapy and close patient monitoring are feasible. In a randomized, placebo-controlled clinical trial among nonhospitalized adults (mean age: 50 years) with symptomatic COVID-19 and at least one risk factor for disease progression, a three-day course of remdesivir resulted in an 87% lower risk of hospitalization or death than placebo [165]. COVID-19-related hospitalizations and deaths from any cause occurred in 2 patients (0.7%) in the remdesivir group and 15 patients (5.3%) in the placebo group.

Remdesivir is indicated for treatment of mild-to-moderate COVID-19 in adults and children (28 days of age and older and weighing at least 3 kg), whether hospitalized or not hospitalized, who are at risk for progression to severe disease, hospitalization, or death [57]. The recommended dosage for adults and pediatric patients weighing at least 40 kg is a single loading dose of 200 mg, followed by once-daily doses of 100 mg, administered by intravenous infusion. For younger/smaller pediatric patients weighing 3 kg to less than 40 kg, the initial dosage is 5 mg/kg, followed by 2.5 mg/kg daily. For nonhospitalized patients, the total duration of therapy is 3 days; for hospitalized patients, duration of therapy is 5 or 10 days, determined by severity of respiratory insufficiency (need for mechanical ventilation) and clinical response.

Oral Anti-SARS-CoV-2 Agents

Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Nirmatrelvir is a protease inhibitor active against a constitutive protein (protease) essential for virus replication. It has demonstrated antiviral activity against all human coronaviruses [57]. Nirmatrelvir is used in combination with ritonavir, a pharmacokinetic booster required to increase nirmetrelvir concentration into therapeutic range. A randomized, placebo-controlled clinical trial of nirmatrelvir-riyonavir (Paxlovid) was conducted among unvaccinated, nonhospitalized high-risk adults with symptomatic COVID-19. The incidence of disease progression to hospitalization or death was 89% lower in the treatment group than in the placebo group [166]. The incidence was 0.77% (3 of 389 patients) in the nirmatrelvir group, with 0 deaths, compared with 7.01% (27 of 385 patients) in the placebo group, with 7 deaths.

The available formulation uses nirmatrelvir 300 mg plus ritonavir 100 mg administered orally twice daily for five days in patients older than 12 years of age and weighing more than 40 kg. Treatment should be initiated as soon as possible and within five days of symptom onset. The NIH Panel recommends nirmatrelvir-riyonavir for high-risk, nonhospitalized patients with mild-to-moderate COVID-19 [57]. Because ritonavir is a potent P450 3A4 inhibitor, it may increase blood concentrations of certain concomitant medications and the potential for serious drug toxicities. Many potential drug-drug interactions can be safely managed (e.g., with certain statins, calcium channel blockers, or direct oral anticoagulants) [57]. Before using nirmatrelvir-ritonavir, clinicians should review the patient's concomitant medications and consider consulting with a pharmacist. The following online resources are available to assist in identifying and managing drug-drug interactions:

- The FDA ritonavir-boosted nirmatrelvir EUA Fact Sheet: https://www.fda.gov/media/155050/download

- NIH ritonavir-boosted nirmatrelvir (Paxlovid) factsheet: https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions

There are reports of SARS-CoV-2 viral rebound and clinical relapse of COVID-19 in some patients who have completed treatment with nirmatrelvir-ritonavir [57,176]. These patients reportedly have had mild, self-limited symptoms without illness progression or need of additional treatment. Viral rebound and recurrence of COVID-19 symptoms also occurs in patients who have not been treated with nirmatrelvir-ritonavir. Patients with suspected COVID-19 rebound following treatment should be advised to re-isolate for at least five days to prevent further transmission of the virus.

Molnupiravir

Molnupiravir is the prodrug of a ribonucleoside that exhibits antiviral activity against RNA viruses, including SARS-CoV-2. Uptake by viral RNA-dependent RNA polymerases causes mutations that are lethal to the virus. In clinical trials, 800-mg molnupiravir twice daily for five days reduced the rate of hospitalization or death among patients with COVID-19 by 30% compared with placebo [57]. Molnupiravir is not recommended for use in pregnant patients due to concerns about potential fetal toxicity. The NIH Panel recommends using molnupiravir as an alternative when nirmatrelvir-ritonavir and remdesivir are not available, not feasible to use, or clinically inappropriate [57]. Molnupiravir appears to have lower clinical efficacy than the other treatment options.

Other Potential Therapeutic Antiviral Drugs

Several other approaches to antiviral therapy have been explored for the treatment of COVID-19, with poor results. Hydroxychloroquine and ivermectin are of historical interest, have been evaluated in multiple clinical trials, and therefore are discussed in detail below. The NIH guidelines for the treatment of COVID-19 recommend against the use of nitazoxanide, lopinavir/ritonavir, and other HIV protease inhibitors to manage or prevent COVID-19 outside of clinical trials [57].

Hydroxychloroquine

In-vitro studies show that chloroquine phosphate and hydroxychloroquine sulphate (commonly used to treat malaria) interfere with the replication cycle of coronaviruses, including SARS-CoV-2, and thus may offer some therapeutic efficacy for treatment of COVID-19 [21]. Randomized controlled clinical trials of hydroxychloroquine are underway in the United States. Based on small case studies and anecdotal reports of possible efficacy, many clinicians have been inclined to administer hydroxychloroquine to patients with COVID-19 who are so ill as to require hospitalization and having risk factors for severe disease (i.e., age older than 65 years, underlying medical conditions, and/or signs of viral pneumonia). On March 28, 2020, the FDA issued an EUA that allowed chloroquine phosphate or hydroxychloroquine sulphate to be used for the treatment of patients hospitalized with COVID-19 when clinical trials are not available or participation is not feasible [36]. However, this letter was revoked in June 2020 [58]. If used, hydroxychloroquine is generally preferred as it is better tolerated. The suggested dosage regimen is hydroxychloroquine sulphate administered orally in a loading dose of 400 mg twice daily (for one day) then 200 mg twice daily for four days [22]. Potential adverse effects include cardiac conduction QT-prolongation and a number of drug-drug interactions.

An observational study examined the association between hydroxychloroquine use and clinical outcomes, analyzing data from 1,376 consecutive patients with COVID-19 admitted to a clinical center in New York City between March 7 and April 8, 2020 [37]. To assess potential benefit or detrimental effect, the primary end point selected was a composite of intubation or death in a time-to-event analysis, comparing outcomes in patients who received hydroxychloroquine with those who did not. A total of 811 patients (59%) were treated with hydroxychloroquine for a median of five days, 60% of whom also received azithromycin. After adjusting for severity of illness, the investigators found no significant difference in the rate of the composite end point of intubation or death over a median follow-up of 22.5 days. Thus, the risk of intubation or death was not significantly different among hospitalized patients with COVID-19 who received hydroxychloroquine than among those who did not [37].

Randomized, controlled clinical trials to assess efficacy of hydroxychloroquine in patients hospitalized with COVID-19 have not shown a benefit. A multicenter study of hospitalized patients with mild-to-moderate COVID-19 found that hydroxychloroquine, alone or in combination with azithromycin, was no more effective than standard care in improving clinical status at 15 days [70]. Preliminary analysis of data from a multicenter, randomized trial in the United Kingdom found no reduction in 28-day mortality among those treated with hydroxychloroquine when compared with the control group [71]. Hydroxychloroquine use was associated with increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation. An NIH-sponsored, controlled clinical trial was halted (after the fourth interim analysis) because hydroxychloroquine was found unlikely to be beneficial to hospitalized patients with COVID-19 [72]. As of November 2021, multiple randomized, controlled trials have failed to demonstrate any significant benefit for hydroxychloroquine in outpatient treatment of mild COVID-19 or as primary or secondary prophylaxis against SARS-CoV-2 infection.

On June 15, 2020, the FDA revoked the EUA that allowed for chloroquine and hydroxychloroquine donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was not available or feasible [58]. This decision was based on an ongoing analysis of emerging data indicating that these drugs are unlikely to be effective for patients hospitalized with COVID-19. As of December 28, 2022, the NIH Panel continues to recommend against the use of hydroxychloroquine or chloroquine with or without azithromycin [57].

Ivermectin

Ivermectin is an antiparasitic drug approved by the FDA for the treatment of several tropical diseases (e.g., onchocerciasis, helminthiases, scabies) and under investigation for the prevention of malaria transmission. Ivermectin is poorly absorbed from the intestinal tract, which enhances its effectiveness against parasitic infections confined largely to the intestinal tracts of humans and large mammals (e.g., sheep, cattle, horses). Reports from in vitro studies suggest that ivermectin acts by inhibiting the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host's antiviral response. In addition, ivermectin docking may interfere with the attachment of the SARS-CoV-2 spike protein to the human cell membrane. Although ivermectin inhibits SARS-CoV-2 replication in vitro (cell culture), the effect is dose-dependent, meaning that inhibition is observed when the concentration of ivermectin is raised to a certain level. Furthermore, the ivermectin concentration required for in vitro inhibition of SARS-CoV-2 is 50 to 60 times higher than can be achieved in humans by standard oral doses of the drug. Pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.

In 2021, ivermectin dispensing by retail pharmacies increased dramatically, as did the use of available over-the-counter veterinary formulations not intended for human consumption. The number of ivermectin prescriptions dispensed in the United States increased from 3,600 per week at the pre-pandemic baseline to more than 88,000 per week in August 2021 [167]. During the same period, state poison control centers across the country reported a fivefold increase in consultations for human exposures to ivermectin [167,168]. Misuse of prescription ivermectin by excess dosage or duration can have adverse effects. Veterinary formulations intended for use in horses and cattle are often highly concentrated and unsafe for ingestion by humans. Clinical signs of ivermectin toxicity include gastrointestinal upset, confusion, ataxia, hypotension, disturbances of vision, hallucinations, seizures, and coma.

Ivermectin is neither authorized nor approved by FDA for prevention or treatment of COVID-19. Clinical studies regarding the use of ivermectin to treat or prevent COVID-19 have been conflicting, and many studies had incomplete information and significant methodological limitations. Among 400 patients with mild COVID-19, a double-blind, randomized, placebo-controlled trial of ivermectin 300 mg/kg twice daily for five days found that ivermectin had no significant effect on time to resolution of symptoms compared with placebo [169]. A larger, double-blind, randomized, placebo-controlled trial of early ivermectin treatment for COVID-19 (679 patients in each comparator group) found that ivermectin did not lower the rate of hospitalization (progression of disease) or duration of time required for emergency department observation [170]. In a randomized, placebo-controlled trial among patients hospitalized with mild-to-moderate COVID-19, treatment with ivermectin on admission had no beneficial effect on the rate of disease progression (21.6%) compared with standard care (17.3%) [171]. The rates of COVID-19-associated ICU admission, mechanical ventilation, and mortality were not significantly different for the ivermectin group than the control group. Due to the lack of reliable and accurate data, the NIH Panel does not recommend either for or against the use of ivermectin for the treatment of COVID-19 [57].

Approaches to Disease Modification

Severe SARS-Cov-2 infection results in progressive interstitial-alveolar pneumonia and respiratory failure. Disease pathogenesis is linked to activation of the innate immune system and dysregulation of adaptive immune responses, with release of proinflammatory cytokines and chemokines. Death from COVID-19 is often preceded by signs of a hyperimmune inflammatory response ("cytokine storm") that leads to ARDS, multi-organ dysfunction, and circulatory collapse. Laboratory markers of heightened inflammation include elevated C-reactive protein, ferritin, and interleukin-6. Novel approaches to clinical treatment attempt to modify disease progression and prevent or ameliorate pulmonary and systemic complications of cytokine storm, thereby reducing mortality from COVID-19.

COVID-19 Convalescent Plasma

In the past, passive immunization with plasma obtained from surviving patients has been used to treat life-threatening infections absent specific therapy. Early in the COVID-19 pandemic, before emergence of SARS-CoV-2 variants that evade neutralizing antibody, studies demonstrated that intravenous transfusion of convalescent plasma with high-titer antibody directed against SARS-CoV-2 was effective in reducing mortality in hospitalized patients with COVID-19 pneumonia. In a preliminary, uncontrolled case series of five critically ill Chinese patients with COVID-19 and ARDS, administration of convalescent plasma containing neutralizing antibody was followed by improvement in clinical status, including resolution of ARDS in four patients at 12 days after transfusion [27].

A study from the Mayo Clinic Expanded Access Protocol (EAP) involving 35,322 registered patients found that plasma infusion was safe and reduced COVID-19 mortality if administered early after hospitalization [76]. A subset analysis showed a gradient of mortality in relation to IgG antibody levels in transfused plasma. The risk of dying from COVID-19 was lower among patients who had received convalescent plasma units containing high titer anti-SARS-CoV-2 antibody than among those who received plasma containing low antibody levels. The pooled relative risk reduction among patients transfused with high antibody level plasma units versus low-level antibody plasma was 35% at 7 days and 23% at 30 days. The Mayo EAP report is an analysis of registry data and not a randomized controlled study.

On August 23, 2020, the FDA granted an EUA to COVID-19 convalescent plasma for treatment of patients hospitalized with COVID-19 [73]. This decision was based on historical evidence derived from the use of plasma in prior outbreaks of respiratory virus infection, small case series, and non-randomized clinical trials conducted during the current outbreak. The only double-blind, placebo-controlled clinical trial of convalescent plasma failed to demonstrate a reduction in mortality or improvement in other clinical outcomes [93]. This study enrolled 333 patients with severe COVID-19 pneumonia, randomized in a 2:1 ratio to receive convalescent plasma (228 subjects) or placebo (105 subjects). Of the total, 68% were men and 65% had a coexisting condition at entry into the trial. The median time from onset of COVID-19 symptoms to enrollment was eight days. More than 90% were receiving oxygen and glucocorticoids at the time of entry into the trial. The infused convalescent plasma had a median titer of 1:3,200 of total SARS-CoV-2 antibodies. At 30 days, the clinical status of patients in the convalescent plasma group did not differ significantly from that of patients in the placebo group. The proportion of ICU admissions and invasive ventilatory support requirements were similar in both groups. Overall mortality was 11.43% in the placebo group and 10.96% in the convalescent plasma group. In a subset analysis, no differences favoring convalescent plasma were noted in a group of 39 patients who received the intervention within 72 hours of symptom onset [93]. Of note, all patients in this study had signs of severe pneumonia; thus, no firm conclusion can be drawn as to the potential efficacy of COVID-19 convalescent plasma initiated at an earlier stage of illness.

Convalescent plasma therapy is not beneficial for hospitalized patients with COVID-19 pneumonia; however, high-titer convalescent plasma administered within three to five days of symptom onset was shown to reduce the risk of disease progression caused by strains of SARS-CoV-2 circulating early in the pandemic. Evidence for this comes from a randomized, placebo-controlled trial of convalescent plasma with high IgG titers against SARS-CoV-2 administered to older adults within 72 hours after onset of mild COVID-19 symptoms. In a subset of patients who received high-titer plasma therapy, 13 of 80 (16%) patients progressed to severe respiratory disease, compared with 25 of 80 patients (31%) who received placebo [109]. This corresponds to a relative risk reduction of 48%. The study population consisted of adults 75 years of age or older, or between 65 and 74 years of age with at least one coexisting condition.

The FDA has subsequently revised the EUA to limit authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for treatment of COVID-19 in patients with immunosuppressive disease or immunosuppressive treatment [179]. The FDA also issued new guidance for healthcare providers and investigators, with recommendations on pathways for use of investigational convalescent plasma, collection of convalescent plasma, and record keeping [179].

Monoclonal Antibody to SARS-CoV-2

Modern immunologic techniques enable the identification of pathogen-specific memory B cells and recovery of immunoglobulin genes that can be expressed to produce monoclonal antibodies [85]. FDA-approved monoclonal antibody products are available to treat or prevent respiratory-syncytial virus, anthrax, and Clostridioides difficile. Memory B cells harvested from patients recovering from COVID-19 have been used to produce anti-SARS-CoV-2 monoclonal antibodies directed against the surface spike glycoprotein, preventing entry of virus into host cells. Monoclonal antibody infusions have potential for preventing COVID-19 in vulnerable people and for blocking disease progression in patients at risk for severe illness. Given the long half-life of immunoglobulin (approximately three weeks), a single monoclonal antibody infusion should suffice for either prevention or treatment of COVID-19 [85]. A phase 2 randomized study among outpatients with mild or moderate COVID-19, during circulation of the original strain SARS-CoV-2, found that infusion of bamlanivimab (a monoclonal neutralizing antibody) was followed by a rapid decline in viral load and reduced need for further medical attention [94]. Subsequent COVID-related hospitalization or emergency department care was required in 1.6% of patients in the monoclonal antibody group, compared with 6.3% in the placebo group.

Four monoclonal antibody products (bamlanivimab plus etexevemab, casirivimab plus imdevimab, sotrovimab, and bebtelovimab) have received EUAs from the FDA for treatment of outpatients with mild-to-moderate COVID-19. Placebo-controlled clinical trials performed during the first year of the pandemic found that treatment with anti-SARS-CoV-2 monoclonal antibodies reduced the risk of hospitalization or death 70% to 85% [57]. Following emergence of the Omicron variant in early 2022, soltrovimab was recommended over other products when studies demonstrated that only sotrovimab exhibited acceptable activity against the Omicron subvariants in circulation at that time.

Outpatient monoclonal antibody therapy is useful during periods when the dominant SARS-CoV-2 variant in circulation shows little evidence of immune evasion. This mode of therapy is reserved for at-risk symptomatic patients and should be administered soon after confirmation of SARS-CoV-2 infection, within 7 to 10 days of symptom onset. Patients with symptomatic COVID-19 who meet one of the following criteria are eligible for treatment:

- Body mass index >35

- Diabetes

- Chronic kidney disease

- Immunosuppressive disease or current immunosuppressive treatment

- Age 65 years or older or 55 years or older with underlying cardiovascular disease, hypertension, or chronic lung disease

The NIH guidelines provide updated guidance on current efficacy, patient selection criteria, authorized dosage, and treatment precautions. As of February 2023, the NIH Panel recommends against using anti-SARS-CoV-2 monoclonal antibody for the treatment of COVD-19 because current Omicron subvariants in circulation are not expected to be susceptible to these products [57].

Anti-Inflammatory/Immunomodulatory Drugs

Dexamethasone

A large multicenter therapeutic trial demonstrated that dexamethasone (a glucocorticoid) improves survival in patients hospitalized with COVID-19 who require supplemental oxygen and/or some degree of ventilatory support [63]. In this study platform, patients were randomly assigned to a group of different therapies and efficacy was assessed using a single endpoint: mortality within 28 days after randomization. In total, 2,104 patients were assigned to receive dexamethasone at a dose of 6 mg daily, and 4,321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1,110 patients (25.7%) in the usual care group died within 28 days after randomization. The observed differences in mortality varied in relation to the level of respiratory support patients required upon entry to the study. Among patients receiving mechanical ventilation, the 28-day mortality was significantly lower in the dexamethasone group (29.3%) than that in the usual care group (41.4%). Among patients receiving supplemental oxygen without mechanical ventilation, the observed benefit was less pronounced but also significant, 23.3% in the dexamethasone group and 26.2% in the usual care group. There was no demonstrable benefit from dexamethasone treatment in patients who did not require oxygen.

The NIH Panel recommends using dexamethasone (at a dose of 6 mg per day for up to 10 days) for the treatment of COVID-19 in patients who are mechanically ventilated and in patients who only require supplemental oxygen (not mechanical ventilation) [57]. If dexamethasone is not available, equivalent doses of another glucocorticoid may be used, such as prednisone 40 mg/day or methylprednisolone 32 mg/day. Dexamethasone is the preferred glucocorticoid to use in pregnant women with COVID-19 who require respiratory support, because of the potential benefit of decreased maternal mortality and the known low risk of fetal adverse effects associated with short-course maternal dexamethasone therapy [57]. Patients receiving dexamethasone at the time of hospital discharge should be given a prescription to complete the specified 10-day course. The NIH Panel recommends against the use of dexamethasone in patients with COVID-19 who do not require supplemental oxygen.

Potential adverse effects of glucocorticoid use include hyperglycemia and opportunistic infection. Clinicians should be mindful of Strongyloides hyperinfection syndrome as a complication of modest-dose and short-duration dexamethasone regimens [75]. Patients at risk are those who have previously resided in South America, the Caribbean, the Middle East, Africa, or Asia. Clinical indicators of possible subclinical or unrecognized Strongyloides infection include peripheral eosinophilia and unexplained gram-negative bacteremia [75].

Tocilizumab and Baricitinib

Patients hospitalized with COVID-19 and worsening hypoxemia despite high-flow supplemental oxygen and/or ventilatory support plus dexamethasone often have signs of ongoing systemic inflammation. Clinical trials have demonstrated that these patients benefit from combining dexamethasone with an additional immunomodulator, such as an interleukin (IL)-6 inhibitor (e.g., tocilizumab) or Janus kinase (JAK) inhibitor (e.g., baricitinib, tofacitinib) [57]. The NIH Panel recommends baricitinib or tofacitinib in addition to dexamethasone in hospitalized COVID-19 patients on high-flow oxygen or noninvasive/mechanical ventilation, who have evidence of systemic inflammation and increasing oxygen needs [57].

Tocilizumab, a monoclonal antibody directed against the interleukin-6 receptor, can be effective in mitigating the cytokine storm associated with COVID-19 hyperinflammatory states. A retrospective cohort study of hospitalized patients requiring ICU support found that treatment with tocilizumab was associated with reduced mortality [74]. Of 630 patients selected for analysis, 358 (57%) died—102 (49%) who received tocilizumab and 256 (61%) who did not receive tocilizumab. The primary multivariable Cox regression analysis showed an association between receipt of tocilizumab and reduction in hospital-related mortality. This association was also noted among subgroups requiring mechanical ventilation and with baseline C-reactive protein of 15 mg/dL or higher. In contrast to findings from this and other observational studies of COVID-19 pneumonia, randomized clinical trials have not demonstrated a mortality benefit with tocilizumab therapy [91]. Tocilizumab has been reported to reduce the requirement for mechanical ventilation in some patient populations, thereby alleviating the burden on ICU-level care for management of severe COVID-19. A published editorial assessment concluded that newly released randomized trials suggest a potential role for tocilizumab in COVID-19 but do not show clear evidence of efficacy [91].

JAK inhibitors interfere with phosphorylation of key proteins required for signal transduction that promotes immune activation and inflammation (e.g., the cellular response to proinflammatory cytokines such as IL-6) [57]. The FDA has issued an EUA for baricitinib to treat COVID-19 in hospitalized adults and in pediatric patients 2 to 17 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO [175]. The recommended dosage of baricitinib under the EUA is 4 mg once daily for patients 9 years of age and older or 2 mg once daily for patients 2 to 8 years of age. Treatment should continue for 14 days or until hospital discharge, whichever occurs first [175].

Before initiating therapy, baseline glomerular filtration rate, liver enzyme level, and complete blood count should be assessed, as modifications in approach are necessary with abnormalities in any of these values. Baricitinib is not recommended for patients with active tuberculosis, who are on dialysis, have end-stage renal disease, or have acute kidney injury [175].

MANAGEMENT OF COVID-19 IN THE AMBULATORY CARE SETTING

Approximately 80% of patients presenting with COVID-19 have mild symptoms (having no signs of viral pneumonia or hypoxemia) and do not need medical intervention [57]. Most patients with mild COVID-19 can be managed as outpatients, with supportive care and counseling on when to seek in-person evaluation. As noted, clinical signs of progression to lower respiratory tract disease tend to become manifest toward the second week of illness. Patients 65 years of age and older and all others with risk factors for progression to severe illness should be monitored closely, including those who are obese, pregnant, or have comorbidities such as COPD, cardiovascular disease, diabetes, cancer, and immunosuppressive disorders. Patients with mild COVID-19 and risk factors for disease progression may be candidates for early antiviral therapy. All patients, regardless of risk profile, who present with moderate COVID-19 (i.e., having signs of viral pneumonia but without hypoxemia) require in-person evaluation and follow-up for signs of respiratory insufficiency. Patients with severe COVID-19 (i.e., having dyspnea, hypoxemia, or lung infiltrates) require immediate hospitalization.

Several therapeutic options are now available for treatment of nonhospitalized patients with mild COVID-19 who are at risk of progressing to severe illness, including anti-SARS-CoV-2 monoclonal antibody, parenteral remdesivir, and oral anti-SARS-CoV-2 agents. Factors to consider in selecting the best treatment option for a given patient are clinical efficacy and availability of the treatment option, feasibility of parenteral administration (for remdesivir or monoclonal antibody), potential drug-drug interactions (particularly those associated with use of nirmatrelvir-ritonavir), and the local prevalence of SARS-CoV-2 variants of concern [57]. As of February 2023, the predominant SARS-CoV-2 Omicron subvariants in circulation are not considered susceptible to available monoclonal antibody products. Administration of remdesivir requires three consecutive days of intravenous infusion. Nirmatrelvir-ritonavir is the preferred choice for most patients, but necessitates reviewing concurrent medications and supplements for potential drug-drug interactions. Molnupiravir, which has a lower efficacy than the other treatment options, should only be used when other options are not available [57].

Isolation and Transmission Precautions

The CDC advises that the decision to monitor a patient in the outpatient or inpatient setting should be made on a case-by-case basis. Important considerations are the patient's clinical status, reliability, need of clinical monitoring, and options for home isolation to reduce risk of secondary transmission. General guidance on patient isolation and transmission precautions for people with COVID-19 is available at https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html.

The CDC recommends that for most patients with confirmed SARS-CoV-2 infection, the decision to discontinue transmission-based precautions should be made using a symptom-based strategy [88]. Patients with mild-to-moderate COVID-19 may discontinue isolation five days after onset of illness if respiratory symptoms have improved and at least 24 hours have passed since resolution of fever (without the use of fever-reducing medications). For patients who were asymptomatic throughout their infection, precautions may be discontinued when at least five days have passed since the date of the first positive viral diagnostic test. A well-fitted face mask should be worn by symptomatic and asymptomatic persons during the period of isolation and for five additional days when around others and in public. Additional considerations, including extending the period of isolation precautions to 10 days or more, apply to patients who have sustained severe or critical illness and to those who are significantly immunocompromised [88].

7. COVID-19 VACCINES

Development of vaccines against coronavirus began in response to the 2002–2004 SARS outbreak, but was halted because propagation of SARS-CoV disappeared rapidly. These earlier preclinical studies identified the optimal coronavirus target antigen and laid the groundwork for current SARS-CoV-2 vaccine development. Coronaviruses encode for a single large surface glycoprotein, the spike protein, which is responsible for host receptor binding and membrane fusion [97]. As noted, SARS-CoV-2 spike protein binds to ACE2 receptors on host cells and facilitates release of the viral genome into the cytoplasm where replication of new virions begins. Antibodies that bind to the spike protein prevent attachment and neutralize virus spread [97]. On the basis of these observations, the spike protein became the principal antigenic target for development of vaccines against SARS-CoV-2.

By December 2020, more than 180 candidate vaccines were in preclinical studies worldwide, and several had entered clinical trials. The range of vaccine platforms included inactivated-virus and live-virus vaccines, recombinant protein vaccines, vectored vaccines, and novel RNA and DNA vaccines [97]. Three vaccines showed promising early results, confirmed by phase 3 clinical trials. Two vaccine candidates were messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna, and the third candidate vaccine was an adenovirus-vectored vaccine developed by Astra-Zeneca and University of Oxford. Pfizer and the German company BioNTech reported preliminary results of an ongoing phase 1 mRNA vaccine trial in 45 healthy adults 18 to 55 years of age [64]. All participants developed an immune response. Following the second dose, antibody titers and serum neutralizing antibody activity were comparable to levels measured in a control panel of SARS-CoV-2 convalescent serum. Adverse events such as fatigue, myalgia, feverishness, and pain at injection site were common after the second injection. In a follow-up report of 40 older adults (50% 56 to 70 years of age and 50% older than 70 years of age) administered the mRNA vaccine, the safety profile and immunogenicity were comparable to results in the younger cohort of participants [86]. Enrollment in a phase 3 trial began in late July 2020.

A report from the University of Oxford described early results of a clinical trial using a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCov-19) that expresses a full-length version of the SARS-CoV-2 spike protein [65]. In a phase 1/2 randomized controlled trial, 1,077 healthy adults received either the candidate vaccine or a meningococcal conjugate vaccine as control. After one dose, ChAdOx1 nCoV-19 elicited spike-specific T-cell responses that peaked on day 14 and measurable anti-spike IgG antibody by day 28. Strong humoral and cellular immune responses persisted at day 56 of the ongoing trial. Neutralizing antibody was detected in 32 (91%) of 35 participants after a single dose, and in 10 (100%) of 10 participants who received a booster dose. Adverse events such as discomfort at injection site, fever, malaise, and headache were common but mild or moderate and self-limiting. There were no serious adverse reactions. Progression to phase 2/3 trials began in the summer of 2020, recruiting older age groups with comorbidities, healthcare workers, and those at higher risk for SARS-CoV-2 exposure [65].

COVID-19 mRNA VACCINES

COVID-19 mRNA vaccine is the product of a new vaccine technology with important public health advantages. An mRNA vaccine can be produced completely in vitro, which facilitates purification and allows for rapid production of individual vaccine doses. The COVID-19 mRNA vaccine consists of a nucleoside-modified messenger RNA wrapped in a lipid-laden nanoparticle. The vaccine mRNA encodes for SARS-CoV-2 surface spike protein. The lipid envelope facilitates vaccine delivery into host cells, enhances stability, and may also augment the immune response. Following intramuscular inoculation, host myocytes utilize vaccine mRNA to express SARS-CoV-2 antigen on cell surfaces, which in turn elicits neutralizing antibody and cellular immune responses to SARS-CoV-2. Vaccine mRNA does not enter the host cell nucleus and cannot become part of the host's own DNA.

Phase 3 clinical trials demonstrated the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines to be safe and 94% to 95% effective against the original strain of SARS-CoV-2 [98,99]. In the Pfizer-BioNTech vaccine trial, 43,448 adults were randomized to receive vaccine (21,720 participants) or placebo (21,728 participants) in two doses 21 days apart [98]. The primary outcomes were safety and the incidence of symptomatic COVID-19 at least seven days after the second vaccine dose. The interim analysis included the first 170 cases of symptomatic COVID-19 diagnosed in the study population and covered a median of two months of safety data. Of the total, eight cases of COVID-19 were observed in the vaccine group and 162 cases in the placebo group. This corresponds to a vaccine efficacy of 95.0%. Vaccine efficacy was similar across subgroups defined by age, sex, race, body mass index, and coexisting medical conditions. Ten cases of severe COVID-19 occurred with onset after the first dose, of which nine were in placebo recipients. Post-vaccination reactions included mild-to-moderate localized pain at the injection site and transient systemic reactions such as fatigue, fever, and headache. Systemic reactions occurred more commonly in younger vaccine recipients (16 to 55 years of age) and after the second dose [98]. The Moderna phase 3 vaccine trial results were equally favorable [99]. In this trial, 30,420 adult participants were randomly assigned to receive either two doses of vaccine or placebo 28 days apart. Of 196 confirmed cases of symptomatic COVID-19 with onset at least 14 days after the second inoculation, 185 cases were in the placebo group and 11 in the vaccine group, a vaccine efficacy of 94.1%. Severe COVID-19, including one fatality, occurred in 30 participants, all of whom were in the placebo group. Transient local and systemic post-vaccination reactions occurred commonly; no safety concerns were identified [99].

In mid-December 2020, following independent verification of safety and efficacy data, the FDA issued an EUA to the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines for use in adults and older adolescents. After reviewing efficacy and safety data in spring 2021, Pfizer mRNA COVID-19 vaccine received FDA EUA for use in adolescents 12 to 18 years of age. In November 2021, the FDA issued an EUA and the CDC/ACIP recommended Pfizer COVID-19 vaccine use, at reduced dosage, in children 5 to 11 years of age. Providers should advise mRNA COVID-19 vaccine recipients to expect local reactions (e.g., injection site pain, swelling, erythema, localized axillary lymphadenopathy) and systemic symptoms such as fever, fatigue, headache, or myalgias. Most post-vaccination side effects are mild and resolve within one to three days of onset.

COVID-19 ADENOVIRUS VECTOR VACCINE

In February 2021, Johnson and Johnson (Janssen Pharmaceuticals) received an EUA for Janssen COVID-19 vaccine use in adults [110]. This is a recombinant, replication-incompetent adenovirus vector vaccine encoded for the SARS-CoV-2 prefusion spike glycoprotein. Interim data from an international phase 3 clinical trial demonstrated that a single dose of Janssen COVID-19 vaccine was highly effective in preventing COVID-19-associated hospitalization and death [110]. The phase 3 study enrolled 43,783 participants across three regions: 44% from United States, 41% from Latin America, and 15% from South Africa. One-third of the participants were older than 60 years of age and 41% had underlying chronic health conditions. At 14 days following vaccination, the Janssen vaccine was 66% effective in preventing symptomatic COVID-19. After 28 days, vaccine efficacy was 85% against severe disease and 93% effective in preventing hospitalization. Among participants in South Africa, where 95% of COVID-19 cases were caused by the B.1.351 variant, vaccine efficacy against severe disease was 89%. No COVID-19 deaths were reported in the vaccine group, compared with seven deaths in the placebo group. Vaccine administration side effects were mild-to-moderate, and adverse events were rare and manageable; no anaphylaxis was encountered [110].

As of January 2023, four COVID-19 vaccines are approved or authorized in the United States: Pfizer-BioNTech, Moderna, Johnson & Johnson/Janssen (J&J/Janssen), and Novavax [101]. The J&J/Janssen COVID-19 vaccine is authorized only for certain situations because of safety concerns. The CDC/ACIP recommend COVID-19 vaccination for everyone 6 months and older for prevention of COVID-19; updated guidance is available at the CDC website, including recommended schedules for primary and bivalent booster, contraindications, anticipated side effects, and COVID-19 vaccination in pregnancy and certain other underlying medical conditions [101]. While protection against Omicron subvariant infection is not as strong as for earlier SARS-CoV-2 strains, COVID-19 vaccines (bivalent booster) remain highly protective against severe illness, hospitalization, and death.

Data from clinical trials indicate that it is safe to offer vaccination to persons with evidence of a prior SARS-CoV-2 infection, and the CDC recommends doing so after 90 days have passed since diagnosis [101]. Studies show natural immunity following SARS-CoV-2 infection is enhanced by COVID-19 vaccination. Anti-spike antibody titers increased more than 140-fold from peak pre-vaccine levels following a single dose of mRNA vaccine [111]. A small cohort study in persons previously infected found that a single dose of vaccine substantially increased neutralizing activity against the important SARS-CoV-2 variants circulating in the United States [112]. Data from virologic investigations and epidemiologic studies have demonstrated that immunity derived from natural infection combined with vaccination (hybrid immunity) provides the most effective, durable level of protection against COVID-19.

COVID-19 VACCINES AND PREGNANCY, LACTATION, AND FERTILITY

As noted, observational data demonstrate that pregnant persons are at increased risk of severe illness and complications from COVID-19, and higher rates of ICU admission and mechanical ventilation [107]. Related concerns include the possibility that COVID-19 during pregnancy may increase the risk for adverse pregnancy outcomes (e.g., pre-eclampsia, coagulopathy, preterm birth) [101]. Any currently authorized COVID-19 vaccine can be administered to pregnant or lactating people; the ACIP does not state a product preference [101,149].

Vaccination reduces the risk of getting COVID-19 and protects patient and fetus from severe consequences. Vaccination while pregnant has the added benefit of providing transplacental maternal antibody protection to the newborn for some months after delivery. Studies show that maternal neutralizing antibodies directed against SARS-CoV-2 are present in umbilical cord blood of newborn infants and in breast milk [138].

There is no expectation that COVID-19 vaccines would pose a risk to pregnant persons or the fetus based on current knowledge of human coronaviruses and the science of COVID-19 vaccine development. The authorized COVID-19 vaccines in use are non-replicating vaccines; they do not contain intact virus and cannot cause infection in either the mother or fetus [101]. No reproductive, fetal developmental, or safety concerns were demonstrated in preclinical vaccine studies in animals, nor were any adverse pregnancy-related outcomes, including fetal outcomes, determined to be related to previous use of an adenovirus vector platform in a large-scale Ebola virus vaccine trial [101].

The CDC has three national surveillance programs in place to monitor the safety and efficacy of COVID-19 vaccination in pregnant persons [139]. As of October 25, 2021, more than 169,000 participants had enrolled in the CDC v-safe Health Checker, indicating they were pregnant when vaccinated against COVID-19. The COVID-19 Vaccination Registry, a subset of 5,100 participants enrolled within 30 days of vaccination, provided direct contact and detailed surveillance, including access to medical records. To date, there has been no indication of increased risk of pregnancy loss or adverse effects on fetal growth and development, or other safety concerns among pregnant or lactating individuals. An analysis of outcomes among registry participants vaccinated before 20 weeks' gestation found no increased risk of miscarriage in association with COVID-19 vaccine use early in pregnancy [140]. A case-control analysis of outcomes from Norwegian registries on first-trimester pregnancies also found no evidence of an increased risk for early pregnancy loss after COVID-19 vaccination [141]. In general, there is no difference in the incidence of pregnancy loss, preterm birth, delayed gestational growth, congenital abnormalities, and neonatal death among pregnant persons who have received mRNA vaccine compared with the known background incidence of these events in unvaccinated pregnant persons.

The Academy of Breastfeeding Medicine has not advised cessation of breastfeeding for individuals who are vaccinated against COVID-19 [142]. The Academy considers it unlikely that vaccine lipid would enter the blood stream and reach breast tissue, and if it did, even less likely that either the intact nanoparticle or mRNA would transfer into milk. In the unlikely event mRNA is present in milk, it would be digested by the child and be unlikely to have any biological effects. In a study of seven breastfeeding mothers who received either Pfizer or Moderna COVID-19 vaccine, analysis of 13 samples of breast milk obtained 4 to 48 hours after vaccination found no detectable mRNA or any other vaccine-related particles in any of the samples tested [143].

On September 14, 2021, the Society for Maternal and Fetal Health and the American College of Obstetrics and Gynecology, along with 18 other professional organizations representing nurse practitioners, nurse-midwives, pediatricians, infectious disease specialists, and public health professionals, issued a joint Statement of Strong Medical Consensus for Vaccination of Pregnant Individuals Against COVID-19 [144]:

As the leading organizations representing experts in maternal care and public health professionals that advocate and educate about vaccination, we strongly urge all pregnant individuals—along with recently pregnant, planning to become pregnant, lactating, and other eligible individuals—to be vaccinated against COVID-19.

A conversation between the patient and clinical team may assist with decisions about the selection and timing of a COVID-19 vaccine during pregnancy, though a discussion with a healthcare provider is not required before vaccination [101]. In making a decision, patient and provider should consider the level of SARS-CoV-2 community transmission, the patient's risk of contracting COVID-19, the risks of COVID-19 to the patient and potential risks to the fetus, the efficacy and side effects of the vaccine, and data about COVID-19 vaccine use in pregnancy [101]. Pregnant persons who choose to receive COVID-19 vaccine are encouraged to enroll in the CDC's v-safe registry, established to follow outcomes among people who are vaccinated [113].

Concerning infertility, there is no scientific basis for COVID-19 vaccines having any impact on fertility, and no scientific evidence that these vaccines cause sterility in either women or men. Claims that vaccine-derived antibodies directed against SARS-CoV-2 spike protein cross-react with uterine syncytin-1 protein, causing damage to the developing trophoblast and preventing implantation of the embryo, are unfounded. A study comparing implantation and sustained pregnancy success rates among individuals receiving frozen embryo transfer found no significant difference in outcomes among vaccine seropositive, infection seropositive, and seronegative participants. Rates of sustained embryo implantation for seronegative, vaccine seropositive, and infection seropositive patients were 52.3%, 65.7%, and 47.4%, respectively [150]. These success rates were comparable to those achieved pre-COVID-19. The investigators concluded that seropositivity to the SARS-CoV-2 spike protein derived from either vaccination or infection, had no adverse effect on embryo implantation or early pregnancy development.

There are no studies showing COVID vaccination reduces sperm concentration or motility. Among 45 male volunteers for baseline and post-vaccination measure of sperm parameters, no significant differences in semen volume, sperm counts, or sperm motility were found after two doses of mRNA COVID-19 vaccine [151]. On the other hand, male sexual dysfunction and related fertility issues have been reported as potential late complications of symptomatic COVID-19 [152].

COVID-19 VACCINE SAFETY

Adverse Reactions to COVID-19 mRNA Vaccines

Early side effects, such as soreness at injection site, fatigue, and headache, occur in about 50% of vaccine recipients; feverishness is less common, and all side effects usually resolve in 12 to 36 hours. Immediate, severe allergic reactions (anaphylaxis) do occur rarely within 15 minutes after injection, as with influenza vaccine. Anaphylaxis was not observed during clinical trials, in part because potential participants who had experienced reactions to vaccines were excluded. However, according to a review of SARS-CoV-2 vaccine safety, several cases of anaphylaxis associated with the Pfizer mRNA vaccine were reported following vaccination of 2 million healthcare workers in the United States [102]. For most vaccines in common use, vaccine-associated anaphylaxis has been a rare event, at about one case per million injections. The estimated risk of anaphylaxis associated with use of the Pfizer mRNA vaccine is 1 in 100,000 inoculations—10 times higher [102]. The explanation for this is unclear. One component unique to mRNA vaccines is a polyethylene glycol (PEG) 200 lipid conjugate used to stabilize the nanoparticle carrier system. PEG is a stabilizing compound commonly used in medications and other products and has been implicated in IgE-mediated reactions and recurrent anaphylaxis [102]. This has raised concern that individuals sensitized by past exposure to PEG (or its polysorbate derivative) in commercial products may be at risk of anaphylactic reactions from mRNA vaccination. Anaphylaxis is an acute allergic reaction that can lead to upper airway obstruction, bronchospasm, and circulatory collapse. Prompt recognition and treatment with epinephrine is necessary to prevent life-threatening complications.

A detailed discussion of contraindications and precautions to be observed with mRNA vaccine administration is included in the guidance provided by the CDC [101]. The history of any one of the following reactions is considered a contraindication to vaccination with either the Pfizer-BioNTech or Moderna COVID-19 vaccines [101]:

- Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA vaccine or any of its components

- Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including PEG)

- Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)

Persons with an immediate allergic reaction to the first dose of an mRNA vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines [101]. Healthcare providers who participate in mRNA vaccine administration should be familiar with signs and symptoms of hypersensitivity reactions and have access to medications and supplies needed for assessing and managing anaphylaxis. The CDC has provided interim guidance on preparation for the potential management of anaphylaxis after COVID-19 vaccination [103].

Delayed-onset local reactions have been reported after mRNA vaccination in some individuals beginning a few days through the second week after the first dose [101,114]. The suspected cause is delayed-type or T-cell-mediated hypersensitivity, and reactions resolve within a few days. In a small series report, the recurrence rate following the second dose was less than 50% [114]. Vaccinees with only a delayed-onset local reaction (e.g., erythema, induration, pruritis) around the injection site do not have a contraindication or precaution to the second dose of vaccine. The CDC recommends these individuals receive the second dose using the same vaccine product as the first dose at the recommended interval, preferably in the opposite arm [101].

Immune Thrombotic Thrombocytopenia and Adenovirus-Vectored Vaccines

On April 13, 2021, after more than 6.8 million doses of the Janssen COVID-19 vaccine had been administered in the United States. the FDA placed a pause on use of this vaccine while the CDC investigated reports of severe intravascular clotting events in six vaccine recipients within two weeks following vaccination [127]. A rare form of blood clot (cerebral venous sinus thrombosis) combined with thrombocytopenia was observed between the 6th and 13th day after vaccination. All cases were women 18 to 48 years of age, one of whom died. The pause was for purposes of further analysis and so health professionals could become familiar with the diagnostic and management implications. Treatment of this clotting disorder is different from heparin anticoagulant typically administered for treatment of blood clots. Administration of heparin may be dangerous, and alternative therapies are needed for management of COVID-19 vaccine-associated thrombotic complications [127]. The risk of cerebral venous thrombosis following Jenssen COVID-19 vaccination was approximately 1 in 1,000,000 vaccinees.

AstraZenica COVID-19 vaccine, the other primate adenovirus-vectored vaccine used in Europe, has also been linked to thrombotic events in vaccinees. In two separate reviews (11 cases from Germany and Austria, and 5 cases from Norway), patients presented 5 to 16 days after vaccination with thrombocytopenia and signs of vascular thrombosis at unusual sites [128,129]. In patients with one or more thrombotic events, there were 13 instances of cerebral venous thrombosis, 4 of splanchnic-vein thrombosis, 2 of pulmonary embolism, and 4 involving other sites. The patient age range was 22 to 54 years, and 13 of 16 cases were women. The timing of events and character of clinical features were similar to that observed in cases of severe autoimmune heparin-induced thrombocytopenia, suggesting an antibody-mediated thrombotic thrombocytopenia triggered by the vaccine. All patients in each series had high levels of antibodies directed against antigenic complexes of platelet factor 4 (PF4). None of the patients had previously received heparin. This disorder is thought to represent vaccine-induced immune thrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4 [128,129].

These reports, and the action taken by the FDA and the CDC, have important implications for health professionals. Surveillance data from millions of vaccine doses administered indicate that the risk of thrombotic events is extremely low. The risk may be highest in women younger than 50 years of age. Vaccinees who are beyond three weeks from date of vaccination are not considered at risk of thrombotic complications. Individuals who develop any of the following new-onset symptoms within three weeks of vaccination should be evaluated for possible thrombotic complications: severe headache, abdominal pain, swelling or pain in the leg, chest pain, or shortness of breath. The evaluation should include a platelet count and imaging studies appropriate to clinical exam findings. A screening immunoassay for antibodies against PF4-heparin, or an enzyme-linked immunosorbent assay for antibodies against PF4-polyanion should be ordered. Hematology consultation is advisable. Patients with thrombocytopenia and suspicion of a thrombotic event should not be treated initially with a heparin product. Potential treatment options include high-dose immunoglobulins and non-heparin anticoagulants [128,130].

Guillain-Barré syndrome (GBS) has also been reported after Janssen COVID-19 vaccination. As of June 2021, approximately 12.6 million doses of Janssen COVID-19 vaccine had been administered in the United States, with 100 reports of GBS with disease onset 3 to 42 days after vaccination [145]. The median age of reported cases was 57 years, and 61 were male. The GBS reporting rate for all recipients was 7.8 cases per million doses administered; among men 50 to 64 years of age, the rate is 15.6 cases per million doses [145].

Myocarditis/Pericarditis and mRNA COVID-19 Vaccines

Myocarditis and pericarditis have been reported more frequently than expected following receipt of either the Pfizer or Moderna mRNA COVID-19 vaccine, usually within seven days after the second dose of vaccine. The majority were male adolescents or young adult, and most cases were mild, responded well to treatment, and improved rapidly without evident long-term effects. Because a background level of seasonal myocarditis/pericarditis is associated with several common viral infections, at issue is whether and how many additional (excess) cases are precipitated by COVID vaccination. Following a nationwide vaccination program, a one-to-one comparison study with 800,000 subjects each in the vaccinated and control groups found that mRNA COVID-19 vaccine was associated with an excess risk of myocarditis (2.7 events per 100,000 persons) [146]. SARS-CoV-2 infection in the same time period was associated with a higher incidence of myocarditis (11 events per 100,000 persons). The estimated incidence of vaccine-associated myocarditis among males 16 to 29 years of age was 10 events per 100,000 vaccinees; among females 16 to 29 years of age, 0.3 events per 100,000 vaccinees; and among men 30 years of age or older, 2 events per 100,000 [153].

Data from a network of 40 healthcare systems (subserving 15 million people) found the risk of cardiac complications (myocarditis/pericarditis) was significantly higher after SARS-CoV-2 infection than after mRNA COVID-19 vaccination in all age groups evaluated. For example, among males 12 to 17 years of age, the incidence rate of myocarditis/pericarditis was 50 to 65 cases per 100,000 after infection, 2 to 3 cases per 100,000 after the first dose of vaccine, and 22 to 36 after the second dose; among males 18 to 29 years of age, the corresponding incidence rates (cases per 100,000) were 55 to 100 after infection, to -8 after the first and 7 to 15 after the second dose of vaccine. Among young children 5 to 11 years of age, the incidence of myocarditis/pericarditis was considerably lower. After infection, the rate was 13 to 18 cases per 100,000 among males and 5 to 11 cases per 100,000 among females; after COVID-19 vaccination, the rate was 0 to 4 cases per 100,000 among males and 0 cases among females [173]. These findings show that the risk of myocarditis/pericarditis in adolescent and young adult males is 5 to 8 times higher after SARS-CoV-2 infection than after mRNA COVID-19 vaccination.

On July 22, 2021, the ACIP reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits of COVID-19 vaccination outweigh the risks for rare serious adverse events after COVID-19 vaccination [145]. In reaching this conclusion, the ACIP reviewed population-level considerations, including that COVID-19 cases were rising in the United States, the predominance of the highly transmissible Delta variant, and the importance of providing options for the type of COVID-19 vaccines offered in relation to epidemiologic considerations. The Department of Health and Human Services, American Academy of Pediatrics, American Heart Association, and other health professional organizations issued a joint statement concurring with the ACIP findings and recommended COVID-19 vaccination of all eligible persons [147].

DURABILITY OF IMMUNITY AND REINFECTION

Three years into the COVID-19 pandemic, there is limited information on durability of immunity following SARS-CoV-2 infection and COVID-19 vaccination. Despite the scope of the pandemic and burgeoning number of COVID-19 cases, reports of reinfection were uncommon before the emergence of SARS-CoV-2 variants. Natural and vaccine immunity to SARS-CoV-2 appeared to be quite durable for protection against reinfection by the original infecting strain, but less robust or predictable for protection against reinfection by variant strains of the virus.

As with most viral infections, pathogen-specific IgG antibody assays in the weeks following onset of COVID-19 are useful for diagnostic purposes but not for measuring the durability of immunity provided by (unmeasured) neutralizing antibody and memory B- and T-cell immune responses, which often persist for months to years. In a population-based study designed to assess durability of humoral immune responses to SARS-CoV-2, serum samples from 1,107 seropositive persons were collected up to four months after diagnosis of COVID-19. Antiviral Ig-antibody titers increased during the first two months and had not declined four months after infection [116]. In a longitudinal study of healthcare workers at the University of Oxford Hospitals undergoing periodic SARS-CoV-2 testing, the presence of antibodies in persons with previous asymptomatic or symptomatic COVID-19 substantially reduced the risk of reinfection [117]. Workers were offered nasopharyngeal SARS-CoV-2 PCR testing every two weeks and antibody testing at two-month intervals. Of 11,364 workers who were initially seronegative, 223 subsequently acquired SARS-CoV-2 infection. Among 1,265 workers who were seropositive, 2 subsequently developed asymptomatic reinfection, evidenced by a positive PCR. During eight months surveillance, no symptomatic SARS-CoV-2 reinfections were detected among workers who had serologic evidence of prior SARS-CoV-2 infection [117].

Population-based studies conducted early in the pandemic found that reinfection with SARS-CoV-2 was uncommon, occurring in less than 1% of individuals who had previously tested positive by SARS-CoV-2 PCR. Using a PCR-test data set from 4 million inhabitants of Denmark, researchers analyzed infection rates across separate surges of COVID-19 to estimate the degree of protection afforded by natural immunity against SARS-CoV-2 reinfection more than seven months later [118]. Among 11,068 persons who tested PCR-positive during the first COVID-19 surge (March to May 2020), 72 (0.65%) tested positive again during the second surge (September to December 2020). By comparison, the rate of infection among uninfected persons who became PCR-positive during the second surge was 3.27%. Thus, the estimate of protection against SARS-CoV-2 reinfection was 80.5%. However, protection against reinfection among persons older than 65 years of age was lower (47%). Limitations of the study included absence of information about severity of infection and the possibility individuals infected during the first COVID-19 surge may have altered their subsequent behavior, affecting risk of exposure. These findings highlight the importance of administering SARS-CoV-2 vaccines to previously infected individuals, especially the elderly [118].

Durable protective immunity after SARS-CoV-2 infection or COVID-19 vaccination consists of a repertoire of immune responses, often referred to as "immunological memory" [119]. Components of immunologic memory include pathogen-specific antibodies and cellular immune responses (memory B cells, CD4+ T cells, and/or memory CD8+ T cells). Cellular immune responses play a crucial role in clearance of viruses by eliminating virus-infected cells. Immunologic memory provides protection against SARS-CoV-2 reinfection and severity of disease in the event of reinfection, and thus determines the quality and durability of vaccine efficacy. Cellular immune responses induced by COVID-19 vaccines have shown greater durability than serum neutralizing antibody activity. Because CD8+ T cell responses control viral replication after infection, anti-SARS-CoV-2 vaccines will likely continue to provide substantial protection against severe disease even after measurable antibody wanes [29,121].

An analysis of 254 blood samples from 188 COVID-19 cases, including some samples up to eight months after infection, found that substantial immune memory involving all four types of immune response was retained in 95% of subjects over the six- to eight-month period of observation [119]. Antibodies to SARS-CoV-2 spike and receptor binding domains declined over eight months, and memory B cell activity increased between one month and eight months after infection. Circulating antibody titers were not predictive of memory T-cell activity. The authors concluded that simple serologic tests for SARS-CoV-2 antibodies do not reflect the quality and durability of immune memory to the virus [119]. Another study demonstrated that memory B cells and strong CD4+ T cell immune responses persisted up to eight months after mRNA COVID-19 vaccination [156]. Furthermore, vaccine-induced cellular immune responses impacting cell binding to SARS-CoV-2 variants were found to be superior to infection-induced natural immunity. This may account in part for epidemiologic study results showing COVID-19 vaccination provided greater protection against subsequent Delta COVID-19 than did prior SARS-CoV-2 infection. An analysis of hospitalizations for COVID-19-like illness during January–September 2021 found that the adjusted odds of having laboratory-confirmed COVID-19 were five-fold higher in unvaccinated patients with documented previous SARS-CoV-2 infection than in previously vaccinated (mRNA COVID-19 vaccine) patients with no prior SARS-CoV-2 infection [157].

These findings suggest that the primary function of neutralizing antibodies is to block acquisition of SARS-CoV-2 infection; both antibody and cellular immune responses (immunological memory) are necessary for durable protection against severe disease. Current COVID-19 vaccines provide limited, short-term protection against Omicron subvariant infection. In contrast to neutralizing antibodies, vaccine-induced memory CD8+ T cell responses are highly cross-reactive against Omicron and likely contributes substantially to protection against severe disease [121].

Natural immunity to SARS-CoV-2 augmented by COVID-19 vaccination against SARS-CoV-2 may provide the most effective and durable protection against subsequent COVID-19. In a retrospective cohort study, using data from national health registries subserving the entire population of Sweden, investigators analyzed the impact of postinfectious natural immunity on risk of SARS-CoV-2 reinfection and COVID-19 hospitalization and further benefit from COVID-19 vaccination (hybrid immunity). Natural immunity from SARS-CoV-2 infection was associated with a 95% lower risk of reinfection and 87% lower risk of COVID-19 hospitalization up to 20 months follow-up. One- and two-dose hybrid immunity was associated with a lower risk of SARS-CoV-2 reinfection than natural immunity up to nine months follow-up. One-dose hybrid immunity conferred a 94% lower risk of subsequent COVID-19 hospitalization than natural immunity alone, though differences in absolute numbers were small [174].

SARS-CoV-2 Variants of Concern and Evasion of Immunity

In late 2020, variant strains of SARS-CoV-2 began to appear in countries with high COVID-19 case rates. Widespread circulation of SARS-CoV-2 combined with spontaneous mutations in the genome increases the probability that mutations affecting transmissibility will lead to emergence of a variant strain. The CDC's national genomic surveillance program identifies SARS-CoV-2 variants and tracks the proportion and distribution of COVID-19 cases attributable to variants [123,124]. SARS-CoV-2 variants circulating in the United States are characterized as variants of concern (VOC) or variants of interest (VOI). In spring 2021, three VOCs accounted for 40% of COVID-19 cases in the United States: B.1.1.7, B.1.351, P.1, and California (B.1.351, 427/429) [123]. The defining characteristics of VOC include increased transmission (B.1.1.7), increased disease severity (B.1.1.7), and decreased neutralization by monoclonal antibody therapeutics (evasion of immunity) (P.1, B.1.351, 427/429). By June/July 2021, these variants had been superseded by a single highly transmissible VOC: B.1.617.2 (Delta) variant [132].

Delta Variant

Compared with the original SARS-CoV-2 strain, Delta variant was more infectious, spread faster, and caused more severe illness in unvaccinated people than previous variants [132]. First detected in December 2020, the Delta variant spread rapidly to 43 countries across six continents. In spring 2021, the COVID-19 surge in the United States had receded to the lowest point of the pandemic; the seven-day moving average of daily new cases was 12,000. By mid-July, the daily average of new cases had again surged to more than 60,000, of which 98% were caused by the SARS-CoV-2 Delta variant [132].

During the period of Delta predominance, breakthrough infection (usually asymptomatic or mild) occurred in vaccinated persons, but the majority of hospitalizations and deaths caused by Delta variant COVID-19 were in unvaccinated people. During the summer COVID-19 surge in Los Angeles County, unvaccinated individuals were five times more likely to acquire Delta variant infection and 29 times more likely to be hospitalized than persons who had been fully vaccinated [158]. The principal risk of secondary household and community transmission was also attributable to unvaccinated people, who were much more likely to become infected and thus shed the virus. Fully vaccinated individuals with breakthrough Delta infection did spread virus to others, but to a lesser degree and for a shorter period of time [132]. An investigation of virologic characteristics among healthcare workers with Delta variant breakthrough COVID-19 found that illness was uniformly mild; shedding of virus from the nose and throat was either unmeasurable or rapidly dissipated within one to three days [115].

Omicron Variant and Subvariants

In mid-November 2021, a new SARS-CoV-2 strain (the Omicron variant) emerged in South Africa among children, college students, and international travelers. By December, Omicron COVID-19 cases were identified in 50 countries, indicating a high level of transmission. Initial cases of SARS-CoV-2 Omicron in the United States were reported in December 2021; by end of month, Omicron replaced Delta as the predominant variant and principal cause of COVID-19 in the United States [123,124]. Omicron SARS-CoV-2 was unique because for the number of genomic mutations and substitutions identified—50 overall, with more than 30 in the spike protein, some associated with reduced susceptibility to monoclonal antibody therapeutics and reduced neutralization by convalescent and vaccinee sera [123]. Epidemiologic studies demonstrated the Omicron variant had a 13-fold increase in infectivity and was three times more infectious than Delta variant [29]. Clinical reports indicated Omicron-associated COVID was mild (e.g., nasal congestion, cough, and fatigue); rates of hospitalization were less than half than with Delta variant. Apparent moderation in disease severity and lower rates of hospitalization for COVID-19 could be misleading, as many early Omicron patients were children and vaccinated adults, in whom illness would is expected to be mild. However, in vitro studies have found that, in hamsters, the Omicron variant was less likely to infect the lungs, and in human alveolar cells, the replication rate was lower, compared with the Delta variant [29].

It was expected that the Omicron variant might evade immune protection gained from prior SARS-CoV-2 infection or COVID-19 vaccination. Studies showed that two-dose mRNA vaccine (Pfizer, Moderna) efficacy in prevention of Omicron COVID-19 waned after four to six months, though protection against severe illness and hospitalization was preserved. Evasion of vaccine immunity was reversed following receipt of a booster dose in persons who previously received the primary COVID-19 vaccine series; an interval-appropriate third (booster) dose increased neutralizing antibody levels 25- to 60-fold, reducing the risk of breakthrough infection by 75% and providing >90% protection against severe illness and hospitalization.

Continued, wide-spread circulation of SARS-CoV-2 has led to new lineages of the Omicron variant and subvariants more transmissible than the previous strain. The BA.5 and BA.4.6 lineages emerged in mid-2022, replaced by XBB subvariant and XBB.1.5 in January 2023. XBB.1.5 is a combination of two earlier Omicron lineages and became the predominant Omicron lineage in the United States, accounting for an estimated 66.4% of cases the week ending February 3, 2023 [124]. Apart from heightened transmissibility and risk of reinfection, the severity of COVID-19 caused by current subvariants is unchanged and the degree of protection against hospitalization and serious outcomes derived from natural and boosted vaccine immunity appears similar to that with prior SARS-CoV-2 strains.

The emergence and subsequent surges of Delta and Omicron COVID-19 demonstrate that SARS-CoV-2 variants can impact transmission, disease severity, risk of reinfection, and vaccine efficacy. At issue is whether and to what extent adaptive immunity (CD4+ and CD8+ T cell responses) acquired from prior infection and/or vaccination recognizes conserved epitopes on new SARS-CoV-2 variants of concern. Fortunately, studies to date have demonstrated that SARS-CoV-2 T cell epitopes are not appreciably affected by mutations found in newly described variants [125,126]. Overall, CD4+ and CD8+ T cell responses in convalescing COVID-19 patients and COVID-19 mRNA vaccinees remain active against VOC circulating in the United States in 2023, including Delta and Omicron variants.

Emerging SARS-CoV-2 Variants, Vaccine Efficacy, and Booster Doses

Following initial rollout in December 2020, COVID-19 vaccines were 94% effective in preventing SARS-CoV-2 infection and nearly 100% effective against severe disease, hospitalization, and death. Six months later, after emergence of the Delta variant in May/June 2021, vaccine protection against severe outcomes remained high (92% to 95%) while efficacy against infection (70%) had declined. From January to May 2021, 100 million adults were vaccinated against SARS-CoV-2; an analysis of COVID-19 hospitalizations for the same period found that 600 previously vaccinated adults had been hospitalized for breakthrough COVID-19. Of this group, 74% were older than 65 years of age and 130 died (all patients 71 to 89 years of age) [154].

By mid-2021, vaccine effectiveness against SARS-CoV-2 infection was gradually diminishing among healthcare and other frontline workers, most likely because of decreased immune protection and greater infectiousness of the Delta variant. Clinical trials demonstrated that administration of a COVID-19 vaccine booster dose enhanced significantly the anti-SARS-CoV-2 immune response in previously immunized participants [131]. In response, CDC/ACIP recommended that all persons 5 years of age and older receive an interval-appropriate COVID-19 vaccine booster dose; specifically, six months after having received either a Pfizer or Moderna mRNA primary series, or two months after receiving Johnson & Johnson vaccine. Choice of vaccine booster was left open, meaning that one may "mix and match" vaccine selected for the booster dose; however, selecting one of the mRNA vaccines was preferred. In April 2022, a second interval-appropriate COVID-19 vaccine booster dose was recommended for vaccinees 50 years of age and older, and for others at risk of severe illness because of underlying medical conditions.

Efficacy of COVID-19 vaccine booster against SARS-CoV-2 variants was demonstrated in an analysis of data from a multistate hospital network comprising 7,544 patients enrolled between March 11, 2021, and January 24, 2022. This study found that two or three doses of COVID-19 mRNA vaccine conferred 90% protection against COVID-19-related invasive mechanical ventilation or in-hospital death [172]. Vaccine effectiveness against adverse outcomes was consistent throughout the periods of Delta and Omicron predominance; protection against mechanical ventilation and death (94%) in the Omicron period was higher in patients with COVID-19 who had received a third (booster) dose. In a large cohort study of nursing home residents, receipt of a second mRNA COVID-19 booster dose during circulation of Omicron subvariants was 74% effective at 60 days against severe COVID-19-related outcomes (including hospitalization and death) and 90% against death alone compared with receipt of a single booster [180].

Bivalent Vaccine Booster

Following emergence in November 2021, Omicron SARS-CoV-2 has evolved into multiple sublineages, accumulating additional mutations that facilitate evasion of neutralizing antibody activity elicited by both natural infection and COVID-19 vaccination. SARS-CoV-2 circulation persisted in the general population, new cases of COVID-19 continued, and reports of reinfection increased among persons previously infected or vaccinated. In order to bring the pandemic under better control, the CDC/ACIP recommended replacing monovalent mRNA vaccine boosters with a newly developed Pfizer bivalent mRNA vaccine composed of Omicron BA.4/BA.5 spike and ancestral SARS-CoV-2 spike protein. Beginning September 2022, bivalent mRNA vaccine replaced the monovalent vaccine for COVID-19 booster dose vaccination in the United States and other countries.

During the intervening period, September 2022 to January 2023, studies of bivalent mRNA COVID-19 vaccine effectiveness demonstrated greater immunogenicity and additional benefit against Omicron subvariants when compared with monovalent COVID-19 vaccine. A comparison study found that neutralizing antibody titers elicited against all Omicron sublineages (including XBB.1) were several times higher with bivalent vaccine compared to monovalent vaccine when administered as a fourth booster dose [181]. Participants with a history of prior SARS-CoV-2 infection exhibited higher titers to bivalent vaccination than those without prior history of infection. CDC surveillance data from a healthcare network demonstrated that bivalent boosters provided significant additional protection against symptomatic SARS-CoV-2 infection in participants who had received at least two prior monovalent vaccines. Relative benefits increased with time since receipt of the most recent monovalent vaccine dose [182]. In another report, bivalent boosters provided substantial additional protection against Omicron COVID-19 disease severity and hospitalization, higher (59%) than monovalent boosters (25%) [183]. An observational cohort study in Great Britain found that people 65 years of age and older who received the bivalent vaccine had lower COVID-19 hospitalization and mortality rates than non-recipients up to 70 days after vaccination. Of the 622,700 participants in the study, 85,300 (14%) received a bivalent booster during the 70-day study period. Hospitalization due to COVID-19 occurred in 6 bivalent vaccine recipients and 297 non-recipients, corresponding to 80% effectiveness against hospitalization for bivalent vaccine. Death from COVID-19 occurred in 1 bivalent booster dose recipient and 73 non-recipients of bivalent vaccine booster [184]. In a January 2023 early release, CDC investigators reported that receipt of bivalent mRNA booster dose provided additional protection against symptomatic XBB/XBB.1.5 subvariant infection for at least three months after vaccination in persons who had previously received two to four monovalent vaccine doses [185]. These finding indicate the importance of continued monitoring of vaccine effectiveness and the value of staying up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when eligible.

The CDC uses public health surveillance data from participating health departments, hospitals, and long-term care facilities to monitor rates of COVID-19 cases, hospitalizations, and deaths by vaccination status. Participating jurisdictions represent a large proportion of the United States population and all regions of the country. Age-standardized weekly rates of COVID-19 cases and deaths are displayed by vaccination status, including receipt of an updated booster (bivalent) dose [124]. As of December 2022, all age-matched vaccinated groups had lower rates of dying from COVID-19 and lower rates of testing positive for SARS-CoV-2 compared with those who were unvaccinated. People who were vaccinated with an updated (bivalent) booster dose had lower rates of dying and testing positive compared with those vaccinated but who had not received an updated (bivalent) booster dose. People 5 years of age and older who were vaccinated with an updated (bivalent) booster had 3.1 times decreased risk of testing positive for SARS-CoV-2 and 12.7 times decreased risk of dying from COVID-19. In people 65 to 79 years of age, the death rate from COVID-19 was 24 times lower among those vaccinated and (bivalent) boosted (0.3 per 100,000 population) compared with those unvaccinated (8 per 100,000) [124].

As of January 2023, COVID-19 vaccines have been in use in the United States for two years; more than 665 million COVID-19 vaccine doses have been administered and 229.5 million people have completed a primary series, comprising 69% of the total population [124]. In people 65 years of age and older, 71.4% have completed a primary series and received at least one booster dose. Approximately 52% of the eligible general population have received a primary COVID-19 series and an interval-appropriate booster dose. The efficacy of COVID-19 vaccines in reducing the incidence of symptomatic SARS-CoV-2 infection and protecting against severe outcomes (hospitalization and death) has been demonstrated in clinical trials and confirmed by real-world observational studies.

COVID-19 VACCINATION STRATEGY AND VEXATIONS OF AN ONGOING PANDEMIC

The development in 10 months' time of vaccines 90% effective in preventing SARS-CoV-2 infection and 95% effective against severe COVID-19 was a remarkable achievement. Rapid deployment of vaccines on a worldwide scale was expected to hasten population "herd immunity" and quickly end the pandemic. In reality, the task proved to be too enormous, cumbersome, and slow to outpace the adaptive advantages gained by spontaneous mutations within the SARS-CoV-2 genome. New, more highly transmissible variants were emerging even as the vaccine roll-out began. Continued propagation of SARS-CoV-2 infection begets continued spontaneous virus mutations, increasing the probability that subsequent variants or subvariants will emerge better able to evade both natural and vaccine immunity. The moderating effect of population immunity will continue to increase through a combination of widespread vaccination and infection [121].

Immunologists have pointed to another potential vexation, the possibility that repeated dosing with modified COVID-19 vaccines fail to achieve the expected antigen-specific, robust immune response because of a phenomenon within the primed immune system referred to as "immune imprinting." Experience with yearly influenza vaccination has shown that after primary exposure to an antigen, B call memory tends to "lock in" on the original antigenic epitope; re-exposure to a modified (vaccine) viral epitope quickens immune memory and antibody production in the direction of the original antigen, thereby preventing the immune system from mounting a robust antibody response specific for the newly modeled vaccine. In effect, antibody titers elicited to ancestral virus epitopes in a prior vaccine may be robust, while antibody titers specific to a new vaccine epitope modeled after a circulating variant is lower than expected. Vaccine-derived imprinting has been shown to affect subsequent antibody responses stimulated by COVID-19 vaccination as well as SARS-CoV-2 infection [28]. Immune imprinting might blunt efficacy and durability of vaccine-elicited antibody protection against SARS-CoV-2 infection, while cellular immune protection against severe illness is preserved and possibly enhanced. At the three-year point of the COVID-19 pandemic, there is something of a stalemate. SARS-CoV-2 infection remains endemic, but ambient population immunity augmented by interval-appropriate vaccine boosters does blunt transmission, shelter the vulnerable, and provide significant protection against severe illness and death from COVID-19.

8. TRANSMISSION DYNAMICS AND MITIGATION MEASURES

Epidemiologic investigation of the COVID-19 outbreak provided early evidence that human-to-human transmission, including close contact with persons having mild, nonspecific symptoms, is the principal means of SARS-CoV-2 spread within the community. Studies indicate that infected droplet nuclei expelled during coughing, sneezing, loud talking, or singing is the primary mode of transmission. Sustained close personal contact (being within 6 feet for at least 15 minutes) with an infected person increases the risk of transmission. Limiting exposure time and lengthening distance reduce the risk [87]. Upper respiratory virus sheading begins to decline three days after onset of COVID-19; recovery of replication-competent SARS-CoV-2 from secretions obtained more than10 days after onset is rare [88]. Recovery of replication-competent virus between 10 and 20 days after symptom onset has been documented in patients with severe COVID-19.

Unlike the 2003 SARS-CoV, whereby replication occurred mostly in the lower respiratory tract and virus shedding was temporally associated with symptom onset, SARS-CoV-2 is characterized by high-level viral replication and shedding in the upper respiratory tract, even during the pre-symptomatic phase of infection [38]. Newly infected individuals are infectious 1 or 2 days before and for 7 to 10 days after the onset of symptoms. This means that asymptomatic and pre-symptomatic SARS-CoV-2 infection may produce a high viral load in nasopharyngeal secretions, rendering the individual an efficient vector of transmission. Therefore, a strategy for prevention that relies solely on symptom-based detection and isolation of COVID-19 cases is likely to have limited effectiveness. In a study of skilled nursing facility residents who acquired SARS-CoV-2 infection from a healthcare worker, half were asymptomatic or pre-symptomatic at the time of contact tracing evaluation and testing [15].

These considerations have important public health implications. Close personal contact implies touching and the sharing of common utensils; it is also defined by a proximity of 6–8 feet—the distance respiratory droplets travel after coughing or sneezing. As noted, the risk of infection is greatest for persons who have prolonged, unprotected close contact (i.e., within 6 feet for 15 minutes or longer) with someone recently diagnosed with SARS-CoV-2 infection, regardless of whether the patient has symptoms [89]. A CDC contact investigation demonstrated that even brief periods of unprotected close contact, if repeated and cumulative (exceeding 15 minutes) over the course of a day, significantly increases the risk [92]. This highlights the importance of avoiding congregate settings (e.g., assisted living facilities, college dormitories, family gatherings, indoor dining and bars) because of the increased likelihood of repetitive or sustained close contact. People can reduce the community spread of SARS-CoV-2 by practicing social distancing, wearing face coverings in public, and washing their hands.

For purposes of contact investigation and public health guidance, the CDC defines "close contact" as someone who was within 6 feet of an infected person for a cumulative total of 15 minutes within any 24-hour period starting from two days before symptom onset (or, for asymptomatic patients, two days prior to test specimen collection) until the person begins isolation precautions [59]. The cumulative 15-minute exposure refers to any combination of individual exposures (e.g., three 5-minute exposures) over a 24-hour period. Factors to consider when assessing close contact include proximity, duration of exposure, whether the individual has symptoms (as the period around onset of symptoms is associated with highest levels of viral shedding), whether the infected person was likely to generate aerosols (e.g., was coughing, shouting, singing), and other environmental factors (e.g., crowding, adequacy of ventilation, whether exposure was indoors or out of doors) [59].

Several emerging reports and epidemiologic studies indicate that children younger than 10 years of age may play only a small role in transmission of SARS-CoV-2. An investigation of 36 childhood COVID-19 cases in China found that 89% acquired the infection from exposure to an older household family member [50]. A population-based surveillance study in Iceland, drawing from a nationwide random sample, found that of 848 children younger than 10 years of age, none tested positive for SARS-CoV-2, whereas 100 of 12,232 (0.8%) adolescents and adults tested positive [51]. Contact tracing in relation to a cluster of COVID-19 among family and friends in France revealed that despite several days of potential exposure to a symptomatic pediatric case, there was no evidence of secondary transmission among 172 school contacts [52]. One possible explanation for these observations is the finding that gene expression of ACE2 in nasal epithelium is age-dependent; it is significantly lower in young children and increases as one develops into adulthood [53]. Lower ACE2 expression in children relative to adults could impact transmission dynamics and may help explain why COVID-19 is less prevalent in children.

Assumptions about childhood transmission of COVID-19 have been tempered somewhat since emergence of the highly transmissible SARS-CoV-2 Delta in 2021and Omicron subvariants in 2022. Compared with original strain infection, nasal and pharyngeal virus shedding is significantly higher; persons with Delta or Omicron infection are two and four times more infectious, respectively. Consequently, transmission now occurs more readily among children and from child to adult. Because most children were unvaccinated, symptomatic childhood infection has increased and with it the need for hospitalization. COVID-19-associated hospitalization rates among children and adolescents in the United States increased five-fold from June 2021 to mid-August 2021 [148]. Hospitalization rates were 10 times higher among unvaccinated than among vaccinated adolescents.

The stability of SARS-CoV-2 on environmental surfaces has been studied in order to assess whether surface contamination (fomites) could play a role in virus transmission. After application of aerosols containing a standard dose of SARS-CoV-2, viable virus was detected up to 72 hours on plastic and stainless steel, though the virus titer was greatly reduced; on cardboard, no viable SARS-CoV-2 was measured after 24 hours [19]. These data should be interpreted with caution, as it is unclear to what extent environmental detection of virus in much reduced titer at a given interval, experimentally, can be equated with actual risk of transmission from common environmental surfaces. In an April 2021 scientific brief, a CDC analysis of quantitative microbial risk assessment studies concluded the risk of SARS-CoV-2 infection via the fomite transmission route is less than 1 in 10,000, which means that each contact with a contaminated surface has less than a 1 in 10,000 chance of causing an infection [122].

When population immunity from natural infection is low and effective vaccines are unavailable, public health control of an infectious disease outbreak must rely on mitigation strategies to reduce exposure and limit transmission. These measures may include the following: suspension or cancellation of common public events such as cinema, theatre, concerts, and collegiate and professional sports competition; closure of schools and cancellation of classes at colleges and universities; observing social distancing in smaller venues such as restaurants and churches; the wearing of masks or cloth face coverings at indoor commercial venues and social gatherings. By slowing the degree and pace of virus transmission, effective mitigation helps to protect those most vulnerable and to ensure that the clinical case load does not overwhelm local hospital and critical care resources.

9. GLOBAL PUBLIC HEALTH CONCERNS AND WHO RESPONSE

The WHO monitors developments and tracks progress of the pandemic, providing weekly situation reports on its website [8]. In an effort to curb the spread of infection, The WHO and national agencies have developed public health measures and clinical criteria to guide the evaluation and management of persons with significant exposure and/or compatible illness.

ADVICE TO THE PUBLIC

Both the WHO and the CDC have published guidance designed to protect the general public and mitigate transmission of SARS-CoV-2 [11]. CDC recommendations on how to best protect oneself and others include the following [24]:

- Get vaccinated and stay up to date with recommended COVID-19 vaccine boosters.

- Wash hands often with soap and water for at least 20 seconds, especially after having been in a public place or after coughing, sneezing, or blowing your nose. If soap and water are not readily available, a hand sanitizer that contains at least 60% alcohol may be used.

- Avoid touching eyes, nose, and mouth with unwashed hands.

- Avoid crowds and close contact with people who are sick

- Put distance (3 to 6 feet) between yourself and other people.

- When community level of COVID-19 activity is medium or high, cover the mouth and nose with a high-quality face mask when in public places or using public modes of transportation. Note: This recommendation does not apply to children younger than 2 years of age, persons with breathing difficulties, or those who are unable to remove the mask unassisted.

- Cover coughs and sneezes.

WHO and CDC guidance on the use of a face covering, whether by prefabricated mask or fashioned from cloth, was predicated on evidence that asymptomatic and presymptomatic individuals infected with SARS-CoV-2 can transmit the virus to others in close proximity [54]. Therefore, anyone out in public should consider that he or she could, unwittingly, be an agent of transmission to others. The simple act of coughing, sneezing, talking, singing, or forceful breathing can release virus-laden droplets and respiratory particles into the air and onto nearby environmental surfaces. Multi-layered cloth masks block 50% to 70% of fine droplets and particles and limit the forward spread of those not captured [104]. Although the primary function of a face covering is prevention of inadvertent transmission of virus to others ("source control"), it may also provide a degree of barrier protection to the one wearing it. The CDC recommends wearing a face mask in settings where social distancing measures are difficult to maintain (e.g., grocery stores, pharmacies), especially in areas experiencing significant community-based transmission. Detailed guidance on the construction, proper usage, and cleaning of cloth face coverings is provided on the CDC website [12].

As public health restrictions have lifted, professional and social interactions in the community present more opportunities for spread of SARS-CoV-2. The risk of transmission varies in proportion to how closely a person interacts with an infected individual and for how long. In a scientific brief updated November 20, 2020, the CDC summarized the experimental and epidemiologic data supporting community masking to reduce the spread of SARS-CoV-2 and concluded that the prevention benefit of masking is derived from the combination of source control and personal protection for the mask wearer [104]. Studies confirm that wearing face masks or double-layer cloth face coverings reduces the risk of transmission for medical personnel, patients, and the general public when in social and community settings, especially when social distancing is not possible [66,67]. A CDC report of a contact investigation involving a hair salon where universal face covering was practiced is illustrative. Two stylists with COVID-19 symptoms had worked closely with 139 clients over an eight-day period before learning of their COVID-19 diagnosis, yet there was no evidence of secondary transmission [67]. None of the clients developed COVID-19 symptoms and of 67 individuals tested for SARS-CoV-2, all were negative. Both stylists and 98% of clients interviewed had followed posted company policy and city ordinance requiring face coverings by employees and clients in businesses providing personal care services.

As noted, COVID-19 vaccination is not 100% effective at preventing SARS-CoV-2 breakthrough infection, especially since the advent of variant strains. Most breakthrough infections in immunized individuals are asymptomatic or mild and have little public health import when community COVID-19 activity is low. In order to mitigate risk during periods of heightened SARS-CoV-2 transmission, the CDC website provides updated public health recommendations for vaccinated people [131]. The CDC recommends that fully vaccinated persons wear a face mask in public, when indoors, if local SARS-CoV-2 transmission is sustained or high, and get tested for COVID-19 if experiencing symptoms or within five to seven days after exposure to someone with known or suspected COVID-19.

CDC MONITORING AND GUIDANCE FOR HEALTHCARE PROFESSIONALS

COVID-19 Data Tracker

The CDC's surveillance program maintains a COVID-19 Data Tracker and Weekly Review of reported COVID-19 cases, hospitalizations, and deaths in the United States [124]. This website also provides updated information on COVID-19 vaccination rates, prevalence of SARS-CoV-2 variant strains in circulation, and the current community levels of COVID-19 by county, district, and territory. As of February 1, 2023, the seven-day average of weekly new cases (40,130) decreased 6.7% compared with the previous week, and the Omicron lineage (e.g., XBB.1.5, BQ.1, XBB) accounted for 100% of new cases. The seven-day daily average of new hospital admissions was 3,319, a decrease of 8.4% from the prior week. The seven-day average of new COVID-19 deaths (493) decreased 9% compared with the previous seven-day average. Overall, about 229.7 million people (69.2% of the population) have completed a primary COVID-19 vaccine series. Approximately 71% of people >65 years of age have completed a primary COVID-19 vaccine series followed by at least one interval-appropriate booster. About 111 million people (49% of the eligible population) have completed a primary series plus one additional booster dose of COVID-19 vaccine. More than 42.1 million people, or 20% of the eligible population 5 years of age and older, have received an updated (bivalent) booster dose [124].

The CDC recommends use of their COVID-19 Community Levels site to determine the impact of COVID-19 on communities, the local risk of exposure, and advisable precautions. As of February 3, 2023, 4% of counties, districts, or territories had a high COVID-19 Community Level, 25% had a medium Community Level, and 71% had a Low Community Level [124]. Compared with the prior week, the number of counties in the high and medium levels increased by 1.5%.

The CDC website also provides updated COVID-19 clinical guidance for providers, laboratories and health facilities, and public health officials [124]. Included are recommendations for the evaluation of persons/patients under investigation, laboratory specimen transport, and protection of healthcare workers and transmission precautions in clinical settings. Recommendations for patient assessment and care in hospitals, clinics, and other healthcare facilities emphasize the importance of adherence to isolation and barrier precautions, including proper use of personal protective equipment (PPE). Selected materials from the CDC website, including recommendations for travelers, are reproduced in the following sections. Please note that language and/or cultural barriers may impede assessment of risk and patient education on the topics pertaining to transmission of infection and public safety; using interpreters and translated materials are recommended, when appropriate.

CDC Guidance on Travel During COVID-19

The CDC provides updated information and guidance on domestic and international travel precautions [13]. The CDC recommends being up to date with COVID-19 vaccines before travel and checking COVID-19 community level at destination. Vaccinated and unvaccinated individuals who travel should observe the following precautions [13]:

- Avoid contact with sick people.

- Avoid touching your eyes, nose, or mouth with unwashed hands.

- Wash hands often with soap and water for at least 20 seconds or use an alcohol-based hand sanitizer that contains at least 60% to 85% alcohol.

- Avoid traveling if you are sick.

- Wear a high-quality mask over the nose and mouth in terminals and other public venues.

- Cover coughs and sneezes.

- Pick up food at drive-throughs, curbside restaurant service, or stores.

Unvaccinated persons should consider obtaining a SARS-CoV-2 nasopharyngeal swab test one to three days before the trip, and repeat the viral test three to five days after return from destinations with medium or high COVID-19 activity. Returning travelers from any destination are encouraged to observe standard precautions, monitor health, and follow state, territorial, tribal, and local recommendations or requirements after travel [13].

As of May 2022, the CDC recommends that persons who are up to date with COVID-19 vaccination can travel with low risk to themselves and others [13]. Up-to-date COVID-19 vaccination status is defined as having received the initial primary series and an interval-appropriate booster dose. Such persons can travel safely within the United States without the need for pre-travel testing or post-travel self-quarantine if they continue to take COVID-19 precautions while traveling.

Recommended Criteria to Guide Evaluation of Patients Under Investigation for COVID-19

CDC guidance specifies who should be tested for COVID-19 and encourages clinicians to use clinical judgment in determining whether a patient with signs and symptoms compatible with COVID-19 should be tested [14]. Symptoms to be considered include fever, chills, cough, sore throat, muscle aches, shortness of breath, new loss of taste or smell, and vomiting or diarrhea. As noted, SARS-CoV-2 can cause asymptomatic, pre-symptomatic, and minimally symptomatic infection, leading to virus shedding that may result in transmission to others who are particularly vulnerable to severe disease and death. Special attention should be paid to older adults and to patients with underlying conditions or immunosuppressed states. Even mild signs and symptoms of COVID-19 should be evaluated among potentially exposed healthcare personnel because of their extensive contact with vulnerable patients in healthcare settings.

The CDC has established priorities for COVID-19 diagnostic testing [14]. High priority for testing applies to hospitalized patients with compatible clinical features, healthcare facility workers and those who work in congregate living settings with symptoms, and residents in long-term care facilities (including prisons and shelters) with symptoms. Priority designation for testing applies to any person in the community with symptoms of potential COVID-19. In addition, persons without symptoms may be prioritized by health departments or clinicians for reasons such as public health monitoring, sentinel surveillance, or screening purposes.

Clinicians should work with their local and state health departments to coordinate testing through public health laboratories or work with commercial or clinical laboratories using SARS-CoV-2 diagnostic tests granted an Emergency Use Authorization by the FDA. Patients should be evaluated and discussed with public health departments on a case-by-case basis if their clinical presentation or exposure history is equivocal.

Other considerations that may guide testing include epidemiologic factors (e.g., close contact with an individual who in the past 14 days has tested positive for SARS-CoV-2) and the occurrence of local transmission or a cluster of COVID-19 within a specific community setting (e.g., nursing home, manufacturing facility) [14]. Close contact is defined as one of the following:

- Being within approximately 6 feet (2 meters), or within the room or care area, of a novel coronavirus case for a prolonged period of time while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, certified disposable N95 respirator, eye protection); close contact can include caring for, living with, visiting, or sharing a healthcare waiting area or room with a novel coronavirus case.

- Having direct contact with infectious secretions of a novel coronavirus case (e.g., being coughed on) while not wearing recommended personal protective equipment.

Any patient with fever and severe acute lower respiratory illness (e.g., pneumonia, ARDS) requiring hospitalization and without alternative explanatory diagnosis (e.g., influenza) should be evaluated for COVID-19, even if no source of exposure has been identified [14].

Symptomatic patients should be provided a surgical mask and placed on respiratory isolation, preferably in an airborne isolation negative pressure room. Caregivers should observe enhanced precautions (i.e., wear gloves, gown, eye protection device [other than prescription eye glasses], and N95 respirator). For information on the management of patients with COVID-19, see https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/clinical-considerations-index.html.

Diagnostic Testing

The CDC recommends that healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department in the event of a newly diagnosed or suspected case of COVID-19.

Confirmation of COVID-19 is performed using the RT-PCR assay for SARS-CoV-2 on respiratory specimens (which can include nasopharyngeal or oropharyngeal aspirates or washes, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage, tracheal aspirates, or sputum) and serum. The FDA has worked to expedite the availability of tests through emergency authorization of commercial laboratories that have developed SARS-CoV-2 testing capability. Information on specimen collection, handling, and storage is available at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html. After initial confirmation of COVID-19, additional testing of clinical specimens can help inform clinical management, including discharge planning. Additional guidance for collection, handling, and testing of clinical specimens is available at the CDC website [12].

Infection with both SARS-CoV-2 and with other respiratory viruses has been reported, and detection of another respiratory pathogen does not rule out COVID-19 [15].

Interim Clinical Guidance for Management of Patients with Confirmed COVID-19

The CDC and NIH websites provide updated clinical guidance and additional resources for clinicians caring for patients with COVID-19 [15,57]. Clinical management entails prompt implementation of recommended infection prevention and control measures, and resources to support patients with complications, including advanced organ support if indicated [15]. Healthcare personnel should care for patients in an airborne infection isolation room. Isolation Precautions should be used when caring for the patient. For detailed recommendations, see the CDC's Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. The NIH and the Infectious Diseases Society of America provide updated COVID-19 management guidelines, including specific recommendations for the use of remdesivir and dexamethasone in hospitalized patients [10,57].

10. OTHER AVAILABLE RESOURCES

CDC Information for Healthcare Professionals about Coronavirus (COVID-19)

https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html

CDC Information for Healthcare Professionals about COVID-19 Vaccination

https://www.cdc.gov/vaccines/covid-19/index.html

CDC Coronavirus Disease 2019 (COVID-19) Resources for Health Departments

https://www.cdc.gov/coronavirus/2019-ncov/php/index.html

World Health Organization Coronavirus Disease 2019 (COVID-19) Pandemic

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Johns Hopkins University and Medicine Coronavirus Resource Center

https://coronavirus.jhu.edu

NIH Coronavirus Disease 2019 (COVID-19) Treatment Guidelines

https://www.covid19treatmentguidelines.nih.gov

Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19

https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management

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97664 • Online Professionalism and Ethics

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

Internet technology has become an integral part of American life, and it is crucial for practitioners to determine how technology impacts their professional lives. The course will review the different forms of Internet technologies that are commonly employed in both the professional and personal arenas and how these various online vehicles can have both positive and negative influences on professionalism and clinical practice. The concept of professionalism and how practitioners' online identity can impact boundaries, self-disclosure, privacy/confidentiality, and client/practitioner relationships will be reviewed.

Table of Contents

97664 • Online Professionalism and Ethics

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Individual State Nursing Approvals

Individual State Behavioral Health Approvals

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. INTERNET AND DIGITAL TECHNOLOGY TRENDS

SOCIAL NETWORKING

3. REVIEW OF INTERNET COMMUNICATION TOOLS

ELECTRONIC MAIL (E-MAIL)

CHATROOMS

BLOGS OR MICROBLOGS

INSTANT AND TEXT OR PHOTO MESSAGING

SOCIAL NETWORKING WEBSITES

PHOTO OR VIDEO SHARING

WIKIS

4. USE OF INTERNET TOOLS IN CLINICAL PRACTICE

5. OVERVIEW OF PROFESSIONALISM AND ETHICS

DEFINING PROFESSIONALISM

ETHICS AND CODES OF ETHICS

6. INTERNET TECHNOLOGIES AND PROFESSIONALISM AND ETHICS

SOCIAL NETWORKING SITES

E-MAIL DISTRIBUTION LISTS

CELL PHONES/SMARTPHONES

BLOGS AND ONLINE DISCUSSION GROUPS

7. ONLINE SELF-DISCLOSURES

8. ONLINE SEARCHES FOR INFORMATION ON PATIENTS OR CLIENTS

9. BEST PRACTICE GUIDELINES

USE PRIVACY FILTERS

POST CAUTIOUSLY

THE "FRIEND" DILEMMA

SEARCH WISELY

SOCIAL MEDIA AND TECHNOLOGY IN INFORMED CONSENT

10. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

97664 • Online Professionalism and Ethics

Education Category. Ethics - Human Rights

Release Date. 05/01/2024

Expiration Date. 04/30/2027

Course Overview

Internet technology has become an integral part of American life, and it is crucial for practitioners to determine how technology impacts their professional lives. The course will review the different forms of Internet technologies that are commonly employed in both the professional and personal arenas and how these various online vehicles can have both positive and negative influences on professionalism and clinical practice. The concept of professionalism and how practitioners' online identity can impact boundaries, self-disclosure, privacy/confidentiality, and client/practitioner relationships will be reviewed.

Audience

This course is designed for physicians, nurses, social workers, psychologists, therapists, and mental health counselors who wish to increase their knowledge of how their online presence can affect their professional practice in terms of professionalism, ethics, and professional identity.

Accreditations & Approvals

In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NetCE has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 6361. Programs that do not qualify for NBCC credit are clearly identified. NetCE is solely responsible for all aspects of the programs. As a Jointly Accredited Organization, NetCE is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibility for the content of the programs. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU. NetCE is recognized by the New York State Education Department's State Board for Social Work as an approved provider of continuing education for licensed social workers #SW-0033. This course is considered self-study, as defined by the New York State Board for Social Work. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed mental health counselors #MHC-0021. This course is considered self-study by the New York State Board of Mental Health Counseling. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed marriage and family therapists. #MFT-0015.This course is considered self-study by the New York State Board of Marriage and Family Therapy. Materials that are included in this course may include interventions and modalities that are beyond the authorized practice of licensed master social work and licensed clinical social work in New York. As a licensed professional, you are responsible for reviewing the scope of practice, including activities that are defined in law as beyond the boundaries of practice for an LMSW and LCSW. A licensee who practices beyond the authorized scope of practice could be charged with unprofessional conduct under the Education Law and Regents Rules.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 3 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this enduring material for a maximum of 3 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. NetCE designates this continuing education activity for 3 ANCC contact hour(s). NetCE designates this continuing education activity for 3.6 hours for Alabama nurses. NetCE designates this continuing education activity for 2 NBCC clock hour(s). NetCE designates this activity for 3 ACPE credit(s). ACPE Universal Activity Number: JA4008164-0000-24-014-H04-P. Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 3 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Social workers participating in this intermediate to advanced course will receive 3 Clinical continuing education clock hours. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery's Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. This activity has been approved for the American Board of Anesthesiology’s® (ABA) requirements for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology’s (ABA) redesigned Maintenance of Certification in Anesthesiology Program® (MOCA®), known as MOCA 2.0®. Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements. Maintenance of Certification in Anesthesiology Program® and MOCA® are registered certification marks of the American Board of Anesthesiology®. MOCA 2.0® is a trademark of the American Board of Anesthesiology®. Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 3 MOC points in the American Board of Pediatrics' (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit. This activity has been designated for 3 Lifelong Learning (Part II) credits for the American Board of Pathology Continuing Certification Program. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME's "CME in Support of MOC" program in Section 3 of the Royal College's MOC Program. AACN Synergy CERP Category B. NetCE designates this continuing education activity for 3 credit(s). NetCE is authorized by IACET to offer 0.3 CEU(s) for this program.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through July 29, 2025); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2025; South Carolina, Provider #50-2405; West Virginia RN and APRN, Provider #50-2405.

Individual State Behavioral Health Approvals

In addition to states that accept ASWB, NetCE is approved as a provider of continuing education by the following state boards: Alabama State Board of Social Work Examiners, Provider #0515; Florida Board of Clinical Social Work, Marriage and Family Therapy and Mental Health Counseling, CE Broker Provider #50-2405; Illinois Division of Professional Regulation for Social Workers, License #159.001094; Illinois Division of Professional Regulation for Licensed Professional and Clinical Counselors, License #197.000185; Illinois Division of Professional Regulation for Marriage and Family Therapists, License #168.000190;

Special Approvals

This course fulfills the Florida requirement for 3 hours of Professional Ethics and Boundaries education. This course meets the requirement for 3 hours of Ethics continuing education as required by the Pennsylvania State Board of Social Worker, Marriage and Family Therapists and Professional Counselors. This activity is designed to comply with the requirements of California Assembly Bill 1195, Cultural and Linguistic Competency.

Course Objective

As Internet technologies increasingly become ingrained in our professional and personal lives, the issues of professionalism and ethics should be considered carefully. The purpose of this course is to increase practitioners' level of awareness and knowledge of how Internet tools impact professionalism and ethics in clinical practice.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define Internet usage patterns and common Internet technologies.

2. Analyze how various Internet technologies are utilized in clinical practice.

3. Define professionalism.

4. Evaluate how the use of specific Internet technologies can affect professionalism and ethics.

5. Discuss how the use of Internet technologies can impact issues of boundaries, self-disclosure, privacy/ confidentiality, and professional relationships.

6. Identify best practices for using Internet technologies as a clinical practitioner.

Faculty

Alice Yick Flanagan, PhD, MSW, received her Master’s in Social Work from Columbia University, School of Social Work. She has clinical experience in mental health in correctional settings, psychiatric hospitals, and community health centers. In 1997, she received her PhD from UCLA, School of Public Policy and Social Research. Dr. Yick Flanagan completed a year-long post-doctoral fellowship at Hunter College, School of Social Work in 1999. In that year she taught the course Research Methods and Violence Against Women to Masters degree students, as well as conducting qualitative research studies on death and dying in Chinese American families.

Previously acting as a faculty member at Capella University and Northcentral University, Dr. Yick Flanagan is currently a contributing faculty member at Walden University, School of Social Work, and a dissertation chair at Grand Canyon University, College of Doctoral Studies, working with Industrial Organizational Psychology doctoral students. She also serves as a consultant/subject matter expert for the New York City Board of Education and publishing companies for online curriculum development, developing practice MCAT questions in the area of psychology and sociology. Her research focus is on the area of culture and mental health in ethnic minority communities.

Faculty Disclosure

Contributing faculty, Alice Yick Flanagan, PhD, MSW, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Mary Franks, MSN, APRN, FNP-C

Margaret Donohue, PhD

Randall L. Allen, PharmD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Professionals are increasingly entering the digital world to network both socially and professionally. Internet technology can be a powerful tool when job searching and developing and expanding professional networks; however, it is important for individuals to use discretion and judgment in the types of information they post, as the casual and informal nature of social networking sites can make it easy to inadvertently cross professional boundaries. The term "digital footprint" has been used to refer to the digital content and evidence left behind as a result of posting on discussion boards, social networking sites, blogs, and other Internet platforms[1]. These digital footprints can affect how the public, colleagues, supervisors, and employers will perceive an individual in the future. In fact, it is becoming increasingly commonplace for individuals to search online for information about another individual, particularly for professional reasons. For example, 19% of online adults in one study had searched the Internet for information about an individual with whom they had a professional relationship [1]. Some universities and colleges will look up their applicants on social media as part of the admission process [7]. What might a photo of an applicant partying, drinking, or using substances convey to the admissions panel [79]?

One of the hallmarks of curricula in graduate professional degree programs is to socialize novice professionals about the profession's identity, ethical practice within the field, and sense of professionalism. However, with the advent of technology and the era of online venues, the notion of professional identity and boundaries can become blurred. In 2000, there was little written on e-professionalism; since then, recommendations have been formulated to help professionals ensure their professional and personal identities are appropriately presented online [100]. The vestiges of digital footprints might be unintended, but they can have negative professional consequences in the future [13]. Today, 70% of future employers screen their applicants on social media [13]. A review found that 63% of employers decided to reject potential employees after finding inappropriate or unprofessional content in their profiles on social networking sites [2,79]. A nurse in Sweden was dismissed after she posted a photo of herself holding a piece of flesh during a brain operation [3]. Agencies and organizations have to weigh the risks and benefits of these online behaviors, including perceived professionalism and potential legal risks of compromising confidentiality [100].

In professions such as medicine, psychology, social work, mental health counseling, family therapy, and nursing, unprofessional online identities can have negative repercussions for both the client and practitioner. This is because practitioners are viewed not merely as individuals but also as trusted representatives of their profession and their employers [65]. In addition, practitioners searching for information about clients on the Internet can result in damaged relationships and impact care. The Internet can be a powerful tool, but it is important to consider how appropriate it is to access information about a client who has not disclosed the information within the therapeutic setting. For example, what is the practitioner's ethical obligation if a client posts depressive thoughts that might be indicative of suicidal risk on a social networking site [5]? In one scenario, a clinician conducted an Internet search of a young client because the grandfather refused to elaborate about the trauma experienced as a result of the client's parents' plane crash [4]. When the clinician utilized the information during the search in the therapeutic process, the grandfather terminated the sessions. The grandfather perceived this as a violation of privacy, and ultimately the working alliance was adversely affected. Even something as seemingly innocuous as sending out an e-mail correspondence from an Internet hotspot or public terminal to a client or a clinical supervisor with the client's name could potentially violate issues of privacy [6].

The goal of this course is to raise awareness and build the knowledge base of psychologists, social workers, mental health counselors, family therapists, physicians, and nurses regarding the impact of Internet technology on professionalism and ethics [14]. Technology has become an integral part of the American lifestyle, and it is crucial for practitioners to determine how it impacts their professional lives. Of course, having an online presence is not necessarily negative. Instead of fear and abstinence from Internet and social media, practitioners should be thoughtful and fully evaluate the risks and benefits of developing and maintaining an online presence.

2. INTERNET AND DIGITAL TECHNOLOGY TRENDS

In order to understand the pervasive social, psychological, and cultural impact of the Internet on the lives of individuals, it is important to obtain a brief glimpse of Internet and digital technology usage and consumption. In 2018 in the United States, it was estimated that 85.3% of households had an Internet subscription [78]. In a 2018 study conducted by the Pew Research Center with adults 18 years of age and older, 89% reported Internet use, compared with 52% in 2000 and 76% in 2010 [8]. However, as of 2021, an estimated 77% of households in the U.S. had broadband Internet [8]. Individuals 18 to 29 years of age are the most likely to utilize the Internet (98%), while adults 65 years of age and older are the least likely (75%) [8]. There is no doubt that Internet technology has become a ubiquitous part of the American landscape. Although data published in the last several years is among the most current, the Internet landscape changes so rapidly that obtaining accurate data is nearly impossible.

SOCIAL NETWORKING

A huge number of individuals are using online social networking sites like Facebook and Instagram. As of 2010, the average American spends 6 hours and 35 minutes on blogs and social networking sites every month [9]. As of 2021, an estimated 69% of Americans 18 years of age and older used Facebook, 81% used YouTube, 40% had an Instagram profile, 31% used Pinterest, 28% reported using LinkedIn, 25% used Snapchat, and 23% used X (formerly Twitter) [76]. TikTok, YouTube, and Reddit were the only two platforms measured that saw statistically significant growth since 2019. As of March 2022, TikTok videos with the hashtag #mentalhealth have been viewed more than 29 billion times [101].

Women and girls tend to use Facebook and Instagram at a slightly higher rate than men and boys, while men and boys are more like to report use of Reddit [76]. Instagram, Snapchat, and TikTok are more commonly used by younger individuals, while Facebook and WhatsApp appear to be more evenly used among all age groups [76].

The general belief is that social networking users are adolescents and young adults. While the percentage of adolescents and young adults using online social networking sites like Facebook and TikTok is higher compared to older adults, this is beginning to change. In 2021, 50% of adults 65 years of age and older used Facebook [76]. Older adults report using social networking technology to connect with people by sharing photos, personal news and updates, and links.

3. REVIEW OF INTERNET COMMUNICATION TOOLS

Before discussing how Internet technologies may impact professional ethics and conduct, it is important to have a clear understanding of the tools and terminology used. Each of the following applications presents unique benefits and challenges.

ELECTRONIC MAIL (E-MAIL)

E-mail is a form of electronic communication that involves sending messages over the Internet. It is one of the most commonly used Internet applications. It allows for the delivery of a message to another person or to a group of individuals rapidly, conveniently, and without incurring any per message charges (as with text messaging) [12].

CHATROOMS

A chatroom or chat group is a virtual community or venue in which a group of individuals can "dialogue" and share information about a common interest asynchronously (non-real time) or synchronously (real time). Chatrooms are often organized by specific topics or interests, such as a hobby, an illness, mental health disorders, or personal interests. For example, it is possible to find an online chatroom devoted to the discussion of depression.

BLOGS OR MICROBLOGS

Blogs are analogous to a website journal and generally consist of a log of entries displayed in chronologic order. Entries might include commentary, information about events, graphics, or videos posted by an individual or group. Globally, it is estimated that there are more than 600 million blogs, and in the United States, there are an estimated 32.7 million bloggers [102].

There are many free services to develop and search for blogs, including Blogger, Google, Tumblr, WordPress, Wix, Weebly, Blogspot, SquareSpace, and LiveJournal [77]. Microblogging is similar to blogging, but with a limit on the number of characters that may be used. Twitter, for example, is limited to 140 characters [5]. According to Nielsen, women are more likely than men to blog, and one in three bloggers is a mother [10]. The largest blogging platforms for 2024 were Wordpress, Wix, and Weebly [116].

INSTANT AND TEXT OR PHOTO MESSAGING

Instant messaging and text messaging are forms of synchronous communication whereby individuals communicate through text and/or photos using computers, cellular phones, or other devices. Text messaging has become one of the most popular forms of electronic communication, especially among adolescents and young adults. In 2020, 97% of Americans owned a cellphone of some kind, and 85% owned a smartphone [117]. For adults 65 years of age and older, 61% own a smartphone [117]. In a 2019 survey conducted by the Pew Research Center, 78% of cell phone owners in emerging countries use their phone for texting or messaging [58]. On average, more than two-thirds Americans check their texts at least 160 times per day [103]. Some estimate that they receive more than 2,000 texts monthly [104].

Applications that allow users to send photos or videos (usually modified with text and/or drawings) have also gained popularity since 2010. One popular example of this platform is Snapchat, which allows users to send images or videos and limit the amount of time they are available; after the set time, the file can no longer be accessed. Since 2019, the video-sharing platform TikTok has gained popularity. Teens are also likely to use apps such as Snapchat to send messages to friends (in lieu of or in addition to texting). Among cell phone owners 18 to 24 years of age, 65% were using this application as of 2021 [76].

SOCIAL NETWORKING WEBSITES

Social networking is a form of online communication that is comprised of "web-based services that allow individuals to construct a public or semi-public profile within a bounded system, articulate a list of other users with whom they share a connection, and view and traverse their list of connections and those made by others within the system" [15]. Examples of social networking sites include YouTube, Facebook, TikTok, LinkedIn, Pinterest, Twitter, Instagram, Snapchat, Tumblr, and Gab [76].

PHOTO OR VIDEO SHARING

Posting original photos and videos online is a common Internet activity, and there are a variety of ways that users may upload their images online. Most social media users include personal photos and videos on their online profiles; it is estimated that half of all persons using the Internet post original photos online [76]. A variety of photo- and video-based applications have been adopted by users, including Instagram, YouTube, TikTok, and Flickr.

WIKIS

Wikis, derived from the Hawaiian word for quick, are collaborative websites on which anyone with access can add, revise, or remove the content published [16]. The most popular wiki is Wikipedia, which is similar to a collaborative encyclopedia, but there are many specific wikis focusing on a single topic, such as suicide prevention or a video game. Often, access is not restricted, but in some cases, editing may be password restricted [16]. Wikis have grown tremendously popular, as they can be a vehicle to quickly access and share information [17]. Wikis have been developed in healthcare communities to promote continuing education and professional development [16].

4. USE OF INTERNET TOOLS IN CLINICAL PRACTICE

In addition to affecting personal life, recreation, and the dissemination of information, Internet technologies have also impacted the provision of health and mental health care. E-mail is one of the most commonly utilized web-based interventions in clinical practice [18]. E-mail-based counseling consists of asynchronous interactions between a counselor and client using text-based communications sent electronically. E-mail communications allow the client to provide brief narratives, and the counselor can structure the communication for exploration of the described symptoms with a problem-solving focus [19]. Some practitioners will use e-mail as a mechanism to provide support. The premise is that the opportunity to interact with another individual, even in writing, can help to mitigate maladaptive responses to stressors [20]. This may be the most useful for clients who cannot easily see a practitioner due to transportation issues or residing in remote areas. In addition, e-mail counseling or any type of counseling involving text-based communication may be cathartic for the client and allow him or her to control how much information to disclose and when to disclose it [80]. E-mail counseling has been likened to a journal, allowing clients to revisit conversations with counselors. E-mail counseling was also perceived as flexible and accessible [105]. Even with high risk and sensitive topics (e.g., suicide), e-mail counseling may be preferred to phone counseling if the client feels better able to express him/herself through writing [106].

In one study of abuse survivor care, nurse practitioners reported that e-mail technology allowed for immediate referrals, education, support, information, and guidance, improving their practice and level of care [20]. E-mails have also been used as a supplement for supervision, and they can serve as a journal of thoughts and questions between an intern and a supervisor to stimulate reflection [21]. Due to the convenience of e-mails and the ability to aggregate lists of e-mail addresses (e-mail distribution lists), forming groups in which participants interact through e-mail has proliferated [12]. A single individual can physically set-up distribution lists and send mass e-mails, or the distribution of the e-mails can be moderated through special software. E-mail software application systems are available to handle the task of subscribing or unsubscribing persons from the e-mail distribution list (LISTSERV) [12]. Such applications are often developed for the purpose of disseminating information or providing support for a specific issue [22]. They can be particularly helpful in keeping practitioners abreast of current information and connected with colleagues. These distribution lists may also be beneficial for training and continuing professional development [23]. In a study conducted by Cook and Doyle about the motivations of using e-mail-based counseling, many of the participants indicated that they preferred it to face-to-face counseling because it was less embarrassing and they had the ability to read and reread e-mails and reflect on the counseling sessions [59]. Furthermore, it offers flexibility for both the client and counselor, as they do not need to be communicating synchronously [118].

As of 2024, there are an estimated 10,000 to 20,000 mental health-oriented apps, focused on helping individuals with issues such as stress, anxiety, sleep, and depression [119]. While it is not clear how many mental health- and wellness-related type of apps are on smartphones, there are more than 80 apps on individuals' smartphones on average, and 92% of time spent on a smartphone is on an app [120]. It is estimated that only 3% to 5% of mental health apps have been empirically tested. Therefore, practitioners should be cautious about the apps they recommend or how they are used in conjunction with interventions [120].

Online chatting, texting, and instant messaging refers to the exchange of brief written messages in quasi-real time (i.e., quasi-synchronously) between two phones or computers [80]. Common platforms for online counseling may include MSN, WhatsApp, SMS, or IMessage [81]. While online chatting is slower than talking, clients appear to disclose the problem more quickly, which may be attributable to characteristics of chatting that promote disinhibition [82]. In a qualitative study examining counselor/client e-mails and online chats, clients tended to get to the point of the problem more quickly in chats, while in e-mail counseling, clients wrote longer narratives with greater detail [82]. In e-mail counseling, there was more interactional space, while in online chat, there was more real-time interaction. Texting may also be used as an adjunct to traditional psychotherapy, particularly as a means of providing appointment reminders to increase treatment compliance [107]. Text messages can also increase rapport between the client and the counselor [107]. Others feel more open and disinhibited using text, and to some extent, they perceive there is more anonymity to texting. This promotes a greater sense of confidentiality [122]. Despite all the benefits of text-based counseling, the nuances of face-to-face interactions can get lost, and if the content is too long in the text, clients may be less likely to fully read and process the content [122]. Best practice is to use 160 characters of less in a single message [123].

Chatrooms or discussion groups may be established to address specific topics or interests (e.g., surviving cancer, coping with depression). Ideally, these websites will have experienced practitioners acting as facilitators who may observe and guide the "conversations" [24,25]. Benefits of discussion groups include lasting documentation of discussions (in the form of archived transcripts), the creation of a supportive environment, and a minimization of isolation. Online discussion boards offer an opportunity for members to be heard and to relate to others, reducing feelings of isolation [108]. In a study of a real-time chatroom offering peer counseling on a variety of emotional issues, the online peer counseling was found to be person-centered [60]. The youths who participated were satisfied with their counselor's ability to provide support. However, the counselors had difficulty providing solutions and assisting participants to think critically and generate solutions.

Blogs have traditionally been used in clinical practice in one of two ways [26]. First, they may be used as an online journal of life events, feelings or emotions, and personal views or belief systems. A community of readers and fellow bloggers may comment and share their life experiences with each other. These responses can be empathic and sincere, giving the blogger a sense of community, understanding, and support [109]. In this way, the blog can act as a record of symptoms and triggers and also as a support group of sorts. Second, blogs may be used by professionals to discuss a particular topic, with readers or other bloggers providing recommendations and feedback [26,109]. In a 2005 study, researchers found that half of all evaluated blog posts were written with the purpose of self-help or self-therapy [27]. Third, blogs may be used as a form of social justice activism, encouraging people into social action and change [83].

A 2010 study analyzing 951 blogs related to health during a two-year period found that women wrote more than half of blogs, and almost half of the blogs were written by those in the health professions [28]. Typically, the blogs included links, archives, and comments sections, and most of the topics revolved around mental health. For example, more than one-quarter focused on autism, while another quarter concentrated on bipolar disorders. The blogs were informational but also contained personal experiences. They obtain support and help patients and caregivers cope. However, it could also be a cathartic mechanism for health professionals dealing with workplace stress to share challenges experienced in the healthcare sector.

Social networking sites are being used in the health and mental health fields to build and connect members within a community. These sites often collect information about their members by having them create profiles. Members then connect with each other based on information from their profiles [29]. In a survey study of 658 nurses, 85% indicated that social media was beneficial for work-related activities. Many received work-related messages online, and more than 50% subscribed to a medical-related social media site [110]. Furthermore, the content on social media sites can be used for public education. TikTok, for example, has been widely adopted, and many videos have gone viral. Dr. Julie Smith, a psychologist who has successfully used TikTok for bite-sized public education on a range of mental health topics, has an estimated 2.9 million followers on the platform [124]. A content analysis of 100 TikTok therapy-related videos found that the videos were primarily used for psychoeducation, and it also offered a vehicle to validate and affirm viewers and their concerns [125]. Therapists also employed TikTok to normalize therapy and mental health support and to humanize the therapist.

Because social support is an essential factor in helping people cope with medical conditions, social networking may be an important tool. The U.S. Department of Health and Human Services and the National Suicide Prevention Lifeline partnered with Facebook in an initiative to prevent suicide. As part of this program, if a Facebook user notices that a "friend" posted a suicidal comment or a post that alluded to suicidal intent, the comment could be reported to the National Suicide Prevention Lifeline, with the "friend" then contacted via e-mail or an instant chat [61]. The Italian Service for Online Psychology (SIPO) also employs Facebook as a means to provide free online psychological consultations [84]. Between November 2011 and June 2014, 284 individuals used Facebook for 30-minute consultations with an SIPO clinician. Depression was the most common reported presenting problem. In this example, Facebook chat offers a convenient and non-stigmatizing way to access mental health assistance, thereby eliminating barriers to access to traditional mental health care [84].

The use of video-based counseling/therapy increased during the COVID-19 pandemic. Video technology may be used to facilitate long-distance therapeutic interventions as well as to share repetitive therapeutic information. Real-time video conferencing, using secure networks or online technology like Zoom, Skype, Google Hangouts, Microsoft Teams, or FaceTime, can allow practitioners to provide care in underserved areas or to persons who are unable to travel even small distances to receive therapy [81]. Counseling via video conferencing is generally less expensive than face-to-face therapy, and consequently, clients may have the opportunity to attend more frequently [126]. It also increases continuity of care due to increased access, flexibility, and reduced cost [126].

Using technology, people can more easily provide both emotional and informational support to each other regardless of geographic or other barriers. One example of a social networking site for patients focusing on health and medical conditions is PatientsLikeMe (https://www.patientslikeme.com). There are also social networking sites specifically developed to allow healthcare professionals to connect with each other and share information. Examples include AllNurses (https://allnurses.com), Sermo (https://app.sermo.com), and Doximity (https://www.doximity.com).

These are tools that can help facilitate communication, education, awareness, advocacy, and patient/client care. On the individual or micro level, professionals can more easily communicate with colleagues and other professionals from different disciplines, fostering interprofessional collaboration and communication [13]. Social networking tools can also be used to convey immediate health and mental health information to clients/patients and family members as well as to provide emotional and psychological support [127]. On the mezzo and community levels, Internet tools can help organize stakeholders, and on the macro level, it can influence legislators and policy makers [13].

5. OVERVIEW OF PROFESSIONALISM AND ETHICS

DEFINING PROFESSIONALISM

As noted, one of the hallmarks of curricula in graduate professional degree programs is to acquaint novice professionals about the profession's identity, ethical practice within the field, and sense of professionalism. Professional identity has been defined as a "frame of reference for carrying out work roles, making significant decisions, and developing as a professional" [30]. The developmental process of a practitioner's professional identity is a continual process involving attitudinal, behavioral, and structural changes that result in an understanding and acceptance of what is involved in being a professional. The development of a practitioner's professional identity begins in graduate school, and the process continues to affect future professional behaviors [30]. This dynamic process includes teaching knowledge, development of a professional identity, and socialization into the group or profession's norms and values [62].

To be even more exact, it is important to have a clear definition of what constitutes a profession. A profession is defined as involving, "the application of general principles to specific problems, and it is a feature of modern societies that such general principles are abundant and growing" [31]. Professions are characterized by two major dimensions: the substantive field of knowledge that the specialist professes to command, and the technique of production or application of knowledge over which the specialist claims mastery [31]. Therefore, professionals have or claim to have knowledge and apply this knowledge to specific problems.

Professionalism is defined as a set of norms endorsed by a collective community and is characterized by "a personal high standard of competence," including "the means by which a person promotes or maintains the image" of a profession [32]. Professionalism involves a set of qualities, including not only knowledge and clinical skills but commitment, integrity, altruism, individual responsibility, compassion, and accountability [33]. In health care, professionalism often involves employing and applying a unique set of clinical skills and scientific knowledge base [85]. In the helping professions, professionalism is designed to promote patient/client autonomy, protect the public, improve access to care, distribute constrained resources in a just and equitable manner, and ensure professional accountability to the public [34,35]. Ultimately, the public has to trust the profession and its professionals [128].

In the past, and to some degree today, professional organizations defined specific behaviors and characteristics that conformed to the standards of a particular profession. Consequently, many graduate programs selected and screened students determined to be the "right kind" of person, one who met a set list of characteristics and behaviors that conformed to the standards of competence, ethics, and professionalism within the field [36]. In addition, there are codes of conduct to regulate behavior and supervisory processes to ensure appropriate use of autonomy [86]. Therefore, many argue that merely compiling a list of behaviors and characteristics does not allow for the fact that professionalism is field- and context-independent. The standards of professionalism, ethics, and competence are influenced by a range of external factors, such as the social, political, economic, and cultural goals of the professional institutions and organizations, social norms, and the experiences of clients/patients and their families [36]. There are also factors in the presentation of professionalism that can be more easily controlled. First impressions can be extremely influential in how a professional is perceived [37]. Professional appearance (e.g., clothing, hygiene, presentation) and behavior (e.g., language use, nonverbal cues, etiquette) are vital components of a positive first impression [37,85]. Ultimately, professionalism forms the foundation of trust between the client/patient and practitioner [63].

E-professionalism is a set of online attitudinal and behavioral standards that conforms to the expectations and values of a profession (e.g., integrity, competence, confidentiality, beneficence) [111]. It is not simply etiquette in the Internet space, such as demonstrating respect in an email or in a social media post. Rather, it involves constructing and projecting an online persona and identity that embodies the traits of professionalism [129,130]. Unfortunately, it is not clear if one can simply apply traditional professional principles directly in the online environment [111]. Breaches of privacy and confidentiality on social media, blurring of personal and professional relationships, online civility, and violations of agency/organizational policies are common issues that should be addressed in e-professionalism guidelines [112].

ETHICS AND CODES OF ETHICS

It is not possible to talk about professionalism without a discussion of ethics. The code of ethics in a profession has been said to be the "hallmark of professionalism" [64]. Codes of ethics provide guidance to the public and professionals regarding the responsibilities of professionals. They also serve as vehicles for accountability in the profession and as a means for practitioners to self-monitor and enhance practice [87].

Ethics are beliefs about what constitutes correct or proper behavior, the principles of right conduct and how to live as a good person [38]. Ethical principles are statements that reflect one's obligations or duties [39]. General ethical principles common to the helping profession include [39]:

- Autonomy: An individual's right to make his or her own decisions

- Beneficence: The duty to do good

- Confidentiality: The duty to respect privacy and trust and to protect information

- Fidelity: The duty to keep one's promise or word

- Gratitude: The duty to make up for (or repay) a good

- Justice: The duty to treat all fairly, distributing risks and benefits equitably

- Nonmaleficence: The duty to cause no harm

- Ordering: The duty to rank the ethical principles that one follows in order of priority and to follow that ranking in resolving ethical issues

- Publicity: The duty to take actions based on ethical standards that must be known and recognized by all who are involved

- Reparation: The duty to make up for a wrong

- Respect for persons: The duty to honor others their rights and their responsibilities

- Universality: The duty to take actions that hold for everyone, regardless of time, place, or people involved

- Utility: The duty to provide the greatest good or least harm for the greatest number of people

- Veracity: The duty to tell the truth

Based on these ethical principles, professions develop ethical codes that embody the values of the profession and guide behaviors of members. In an analysis of the codes of ethics of diverse professions, researchers were able to classify the codes into four domains [40]:

- The professional's qualities and characteristics

- Behaviors toward other professionals and colleagues

- Behaviors of professionals in a range of situations

- The responsibility of the profession and the professional to society and the common good

These same principles and values apply online. For example, if a practitioner posts unprofessional content on social media (e.g., a photo of him/herself surrounded by alcohol), how could this potentially affect his/her work with patients with alcohol use disorder? Could it harm the therapeutic goals? If so, this would violate the ethical principle of beneficence [79].

Although ethics and professionalism are different, there is considerable overlap. Acting professionally entails adhering to accepted codes of conduct and ethics within a given field, and acting in an ethical manner in online interactions is a good first step in ensuring online professionalism.

The International Society for Mental Health Online (ISMHO), established in 1997, formulated the Suggested Principles for the Online Provision of Mental Health Services in 2000 [88]. Many professional organizations have attempted to keep abreast advances in digital technology and its impact, and many have begun to revise their ethical standards to reflect the ubiquitous nature of technology in modern society. The American Counseling Association (ACA) added an addendum to their code of ethics in 1999 and, in 2005, finalized comprehensive guidelines for Internet counseling [88]. In the field of psychology, Guidelines for the Practice of Technology were developed by the American Psychological Association (APA), the Association of State and Provincial Psychology Boards, and the APA Insurance Trust [89]. In 2017, the National Association of Social Workers (NASW) Delegate Assembly approved updates to the NASW Code of Ethics, including new guidance regarding the role of technology in informed consent, privacy, confidentiality, competency, supervision, and client records [90]. In addition, in 2017 the NASW, in conjunction with the Association of Social Work Boards, the Council on Social Work Education, and the Clinical Social Work Association, published specific guidance in its publication Standards on Technology and Social Work Practice [91]. The American Nurses Association and the American Medical Association have developed opinion statements and toolkits for the appropriate use of technologies such as social media in their respective professions [92,93].

A content analysis of nine different Codes of Ethics in social work found that among three codes that were published between 20025 and 2014 there was no mention of the development and inclusion of Internet technologies in social work [131]. Although Codes of Ethics are living documents, it is time-consuming to revise them to keep up with the changing environment. Codes of Ethics should be viewed as not necessarily prescriptive; instead, they offer general guidelines or principles and cannot account for every possible scenario and outcome [131].

6. INTERNET TECHNOLOGIES AND PROFESSIONALISM AND ETHICS

Internet technologies can be powerful tools when job-searching, developing and growing professional networks, promoting health and mental health, and providing support to clients. As a result, e-professionalism, or professionalism in the Internet world, should be instilled in practitioners [3,94]. Some maintain that e-professionalism, the application of ethics online, and digital literacy should be essential components of the knowledge and skill of practitioners [83]. In terms of the applications of ethical principles to the online world, some are concerned with the anonymity associated with the Internet and how it might affect the principle of beneficence and the duty of care. How does a practitioner deal with an individual who has disappeared virtually after having disclosed that they may be a danger to themselves? How can appropriate referrals be made [131]? Beneficence may be more easily maintained in the physical world and more easily compromised in the virtual world [127]. For example, details of client's history might be inadvertently posted, thereby infringing on principles of confidentiality. It is also important, for example, to use discretion and judgment in the types of information made public online. The casual and informal nature of social networking sites, for example, can cause practitioners to inadvertently cross professional boundaries, which can negatively affect their professional identity and may breach ethical standards. This is referred to as digital boundary crossing [132]. If practitioners discuss work-related problems (e.g., difficult clients, conflicts with colleagues) on social media, it could disclose confidential information or qualify as abuse [95]. Not everyone considers how the image or persona portrayed online may be perceived in the future. Because the Internet can be a public forum, viewers do not necessarily avoid viewing personal, intimate, and/or embarrassing behaviors [41]. The issue may not be the ever-growing presence of Internet communications, but rather the seeming mindlessness or carelessness with which information is shared; this has been referred to as the diminishing of intentionality of online communication [42]. Misinformation can be highly detrimental and potentially dangerous, again compromising the duty of care [127]. Practitioners may adhere to strict guidelines for self-disclosure in "real" life, but the Internet may defy practitioners' best intentions. Some have likened the Internet to a clinical practice in a rural area, where practitioners inevitably have unplanned encounters with their clients/patients due to the size of the community [42]. In some cases, individuals may inaccurately believe that the privacy settings will ensure confidentiality [95,110]. With the Internet, practitioners have minimal control over when and how clients encounter information about them online [42]. The Internet has no expiration date, and anything posted online should be assumed to be permanent [66]. Unfortunately, many codes of ethics in fields such as medicine, psychology, social work, nursing, and counseling have struggled to keep up with these technologic changes [41]. In some cases, standards have been established for the provision of technology-assisted services (such as online counseling), but not for online professional conduct [43].

SOCIAL NETWORKING SITES

The use of social networking platforms can affect professional relationships and boundaries. In a 2013 survey of psychologists, social workers, and physicians, 59% of the practitioners indicated they maintained a Facebook account and 75% of users reported using a privacy setting [67]. Similarly, in a survey study with 695 psychology students and psychologists, 77% indicated they had an account on a social networking site, and of these users, 85% used privacy settings [42]. In a 2018 study with nursing students, 96.6% reported having a Facebook account [96]. However, practitioners were ambivalent about what to do when clients contacted them through a social networking site. It may appear to be an innocuous request, but it can bring up many ethical issues. If the practitioner accepts the client as a friend, the client may have access to personal information, blurring professional boundaries. If the practitioner does not accept the request, the client might misconstrue this as rejection, potentially harming the therapeutic relationship. This is made more complicated with platforms like TikTok, because practitioners may not have any control over who "follows" them [101]. Similar issues may arise if information about a client is gleaned from a social networking site. In a study of 302 graduate psychology students, 27% had reported actively seeking out client information on the Internet; most stated they wanted to verify the clients' claims [41]. In a study with 346 undergraduates, participants were asked to evaluate their likelihood of posting different types of "problematic" information in their Facebook profiles and their perceptions of how others would view their image after seeing their profiles [44]. Gender differences were found; specifically, undergraduate men were more likely to report that their Facebook profile contained an image that was sexually appealing, wild, or offensive. Men were also more likely to post "problematic" content in their profiles compared to their female counterparts. In a survey of nurses and midwives, 18.4% of the participants reported having accepted a request from a patient and/or family member to be a social media contact [65]. Younger participants were more likely to receive a request from a patient or family member of a patient to add them and were more likely to accept a request. In a qualitative study of 813 medical students and residents, 44% were found to have an account and only 33% of these profiles were made private [45]. Of the profiles that were not private, the researchers found that more than half included overt mentions of personal and/or ideologic views, such as political affiliation (50%), sexual orientation (52%), and relationship status (58%). In some cases, the medical students and residents had uploaded photos that could be interpreted negatively (e.g., photos with alcohol, excess drinking, drug use). In the study of graduate psychology students, 81% confirmed having some sort of online profile, with 37% reporting having a social networking page [46]. Of the students who used social networking, more than 65% used their real names and 13% stated they posted photos they would not want their faculty members to see. Nearly 30% stated they posted photos they would not want their clients to see, and 37% posted information they would not want to their clients to read. A study of first-year nursing students, participants reported ambivalence regarding patients seeing their posts in Facebook, perhaps because they lack clinical experiences [96]. In a content analysis of Facebook profiles of nurses in the United Kingdom and Italy, the researcher looked at photos posted and classified them according to the content [68]. Approximately 18.5% of the profiles included photos of the nurse engaged in unhealthy behavior, including smoking and drinking alcohol [68]. The representations of professionals' behaviors on social networking sites could inadvertently have a negative effect on the integrity of the profession [69].

Therapeutic boundaries are established to promote client beneficence and define the client/practitioner relationship. Informed consent, single-role relationship, and confidentiality support these boundaries [70]. The boundaries of the client-practitioner relationship will get blurred as online friendship interactions can lead to sharing of private information on the part of both parties, which may negatively impact the professional relationship [47,79,125]. If practitioners find sensitive or embarrassing information about clients, they may be conflicted regarding the appropriate way to use this information. For example, a practitioner may be working with a client on abstaining alcohol, and in the session, the client denies having used alcohol in the past 24 hours. However, if the client and practitioner are linked on a social networking site, the practitioner may stumble onto a photo of the client at a party holding a beer bottle. There is no clear correct course of action. Should the practitioner utilize this information in the next clinical session? If the practitioner does bring it up, does it violate privacy issues? Will it affect the clinical rapport and relationship?

In some cases, social media profiles have been used by law enforcement or social service providers to guide their interactions with clients. For example, there have been reports of social workers "friending" a youth in foster care in order to keep track of them, using a client's social media post to demonstrate his/her lack of progress or faulty character, or using an online profile picture to search for someone [94].

A good first step is to consider the ethical ramifications of each action utilizing the ethical principles identified in many of the professional codes of ethics [41]:

- Beneficence (the duty to do good): How would the information obtained from a social networking site promote the well-being and welfare of the client?

- Fidelity (the duty to keep one's promises): How would the information gleaned about a client on a social networking site help promote trust?

- Nonmaleficence (the duty to do no harm): What harm might emerge from using social networking sites to find information about the client? How might this unintentionally harm the client?

- Autonomy (the individual's right to make his or her own decisions): How does the information found on a social networking site help to promote the client's ability to make his or her own choices about what to share or not in the clinical sessions? Will seeking information on the Internet without the client's consent violate autonomy and respect for the client?

- Justice (the duty to treat everyone fairly): How will the practitioner's being able to find information (or not) on a social networking site provide clues to the client's gender, race, sexual orientation, socioeconomic status, religion, ability, etc.? How might this information affect how the practitioner treats the client?

The same questions can be asked when practitioners use social networking sites to create profiles and post information. How might this information harm the client or jeopardize trust, credibility, and the working the relationship? If a practitioner is a supervisor, what issues of subtle coercion may arise [5]? Of course, each practitioner's behavior on social networking sites must be in accordance with the profession's ethical codes. Befriending a client or patient on a social networking site could potentially violate standards regarding multiple relationships or dual relationships [48].

Practitioners should use their self-reflective skills to ask themselves the following questions in order to guide the information they post on social networking sites [71,95]:

- What information do you want to share? Is this information important, harmful, protected?

- Why do you want to share this information? What are the benefits and consequences of sharing the information?

- Who needs to see this information? Why?

- Where do I want to share this information?

- What professional boundary issues might "friending" someone pose?

- How might any "off-duty" conduct be perceived?

- How might a photo or post be taken out of context?

- How does my professional code of ethics or other organizational policies guide sharing this information?

E-MAIL DISTRIBUTION LISTS

The main ethical issues associated with e-mail distribution lists concern risks to confidentiality and privacy. Mass e-mail communications can be intercepted at four different points: prior to being e-mailed from the originating computer, during transmission, upon receipt, and when subpoenaed [24]. In one study, 10% of social workers reported having e-mailed something to the wrong person [97]. Some practitioners may utilize this technology to solicit professional consultation from their colleagues. If this is the case, they may describe a case in detail. Even if the client's name and specific identifying information are excluded, the details provided could increase the risk to violating confidentiality. This risk is further increased with the advent of data mining software, which can analyze and search e-mails for certain content or key words [23].

In addition, there is no insurance that the sender or receiver is the person whom they claim to be. A best practice to reduce these risks is to encrypt the e-mail, to alert the client that an e-mail will be sent, or to ask for a phone confirmation that the e-mail has been received [97].

One of the main applications of the ethical principle of respect for persons is informed consent. When seeking consultation from another colleague on the phone or face-to-face, practitioners obtain informed consent from their clients; the same is true when using e-mail distribution lists for this purpose. Practitioners should inform clients they plan to use e-mail for the purpose of consultation and that certain details of the case will be provided. The potential for violations of privacy and confidentiality using this technology should be outlined [23].

CELL PHONES/SMARTPHONES

Cell phones and smartphones are commonplace, and it is important to carefully consider the possible benefits and consequences before providing a personal cell phone number to a patient or client. First, conversations on cell phones cannot be guaranteed confidentiality, as it possible that the conversation will be intercepted by another device (e.g., baby monitor) [70]. Perhaps more importantly, cell phones can imply some level of personal familiarity that goes beyond the client/practitioner relationship [70]. Finally, giving a cell phone number may imply that the practitioner will be available at any time, including after professional hours. To create boundaries, practitioners may inform the client that messages will only be checked during work hours [97].

It is important to be upfront with clients regarding the use of a cell phone in order to clarify the policies and to obtain informed consent form [70]. Practitioners should explicitly discuss the circumstances under which a client may call the practitioner on his/her cell phone, when he/she would not be available, any additional fees involved, and the amount of time he/she will spend on the cell phone with the client.

If practitioners recommend or use mental health apps as part of their interventions, they should keep in mind that many of these apps have not been empirically tested. Therefore, client safety should be considered. Disclaimers should be provided about calling 911 or seeking help from mental health professionals in emergency situations [120]. Clients should also be informed or reminded that any personal information that is collected by the installation of the app can be given/sold to third parties. Clients should read any privacy disclaimers (if provided) [120].

BLOGS AND ONLINE DISCUSSION GROUPS

Concerns about privacy and confidentiality also apply to blogs and online discussions. Practitioners who write or comment on blogs must be sensitive to revealing personal identifiers of clients, which could violate practitioner/client confidentiality and privacy. Practitioners in the health fields should keep the Health Insurance Portability and Accountability Act (HIPAA) in the forefront of their minds when blogging or posting in online discussion groups. HIPAA privacy rules protect any identifiable health data, including any past, present, or future health information that can be used to identify an individual [49]. For example, a practitioner might blog about a difficult client who was treated at his or her workplace at a particular time and date [50]. Even if the client's name is not provided in the blog, if the blog author is not anonymous, it is possible that the workplace could be traced and the identity of the client linked back to the appointment book. Or a practitioner could post a message to his or her friends on a discussion board describing clinical experiences, but in doing so, express enough information about a client to be identifiable [49,72]. It is also important to be careful of how clients or patients are depicted, including the tone and content of postings, so as not to threaten or damage the integrity of the professional field or discipline [51].

Conflict of interest is another ethical issue that may arise when using blogs or discussion boards. A practitioner should be cautious of openly endorsing any products or services. Some blogging software platforms, particularly free ones, automatically display advertisements along with the platform. It is vital to avoid dual relationships or have the appearance of having a conflict of interest with service providers. Some experts recommend limiting blog content to announcements about conferences, events, and professional organizations that represent the practitioner's field [26].

In a 2008 study involving 271 medical blogs, individual patients were described in 42% of the blogs, and 16.6% of these had sufficient identifiers, revealing the identity of physicians or patients [51]. The researchers found that 17.7% of the blogs depicted patients in a negative manner (by tone or content), and 11.4% contained product promotions, either by images or direct content. There is a definite need for practitioners to practice self-regulation and self-monitoring, carefully considering ethics and professionalism while blogging, so the ethical principles of respect for persons and beneficence are not compromised.

7. ONLINE SELF-DISCLOSURES

Much of science and medicine in Western culture is premised on the tenets of logical positivism, advocating for quantification and objectivity [52]. The psychology, counseling, mental health, and social work fields have followed suit, and as a result, paternalism has become the backbone of the patient/client and practitioner relationship. For example, the physician/patient relationship is typically characterized as hierarchical, with the physician viewed as the "expert." Many counseling and social work models, with the exception of feminist and humanistic orientations, similarly espouse this hierarchical relationship. Traditionally, practitioners are positioned as the "objective" experts, disclosing very little about themselves. In the Freudian tradition, therapists are supposed to present as a blank slate to reflect the client's image [79]. However, the extent to which practitioners self-disclose has changed with the growth of the Internet. With the prevalent use of Internet technologies, the client/patient is now an active consumer of health and mental health services, and they are more likely to use the Internet to research or share information about practitioners, services, and facilities [53]. Therefore, the question is not to what extent practitioners should disclose private information to their clients, but rather how to manage the Internet-driven self-disclosure that has become almost inevitable [54,125]. It is ultimately the practitioner's responsibility to develop the tone of the professional relationship [66]. Therefore, when disclosing information on social networking sites, the practitioner should take time to reflect on how it may affect the client and the therapeutic relationship.

There are three main types of self-disclosures, and the Internet can affect each of these types [53]:

- Deliberate self-disclosure: The practitioner intentionally discloses certain information, verbally or nonverbally. Internet examples include uploading a photo on LinkedIn, a professional social networking site, or posting information on a commercial website about one's professional background, training, and experiences.

- Accidental self-disclosure: Personal information about the practitioner is inadvertently revealed to the client. For example, a client sees his or her therapist at a boutique, which may reveal information that the practitioner had no plan of sharing. On the Internet, accidental self-disclosures can occur when clients inadvertently come across photographs of their practitioner in a non-professional setting or personal blog posts on a social networking site.

- Unavoidable self-disclosure: These types of revelations are not deliberate but are related to information conveyed by conducting the normal affairs of life. For example, wearing a wedding ring indicates one's marital status. Of course, one can argue whether this is deliberate or unavoidable. Again, photos uploaded on a website or a professional social networking account can reveal information that the practitioner has no control over.

There are two types of anonymity: visual anonymity and discursive anonymity [113]. Visual anonymity refers to a lack of physical or visual cues (e.g., a photo in an online profile) to provide the other party a sense of who is being represented online. Discursive anonymity refers to a lack of textual cues (e.g., use of an online pseudonym) to give a sense of who is being represented. It does not appear that type of anonymity affects the extent of online disclosure.

The most typical disclosures via Facebook profiles are of one's age, gender, education, and relationship status [98]. In the past, if a client asked about a practitioner's background, this could be used as an opportunity to understand the underlying dynamics of the client's interest. Ultimately, practitioners must be diligent in managing their images in both the face-to-face and Internet worlds. Issues of self-disclosure and transparency have moved outside the therapeutic encounter and onto the Internet, and online posts, blogs, threads in discussion forums, and mass e-mails will for the most part stay "alive" in the virtual world [54,125]. The psychotherapy environment is relational and intimate, and the Internet has reduced the physical dimensions between the client and professional, all of which makes it easier for therapists to accidentally reveal their non-therapist self to their clients [125].

8. ONLINE SEARCHES FOR INFORMATION ON PATIENTS OR CLIENTS

Conducting online searches, commonly referred to as "Googling," is a common part of modern Internet use. Some practitioners engage in patient-targeted Googling, searching for a specific patient or client on the Internet [73]. In a 2014 study involving counseling graduate students, 75% reported using the Internet to search for information about a client, with 29.2% using Google and 19.5% using a social networking site. Of those who searched, more than 80% stated that they did not obtain informed consent from the client, did not document the search in the client's file, and did not consider this to be a confidentiality issue [73]. In a study with mental health professionals, almost half indicated they had purposively searched for information on the Internet regarding their clients or prospective clients, and in another 2016 survey study, 39.4% of psychotherapists reported having looked online for additional information about their clients; 75% had not obtained client consent to do an online search [99,133]. In a survey of psychotherapists, 10% of the participants were uncertain about the ethicalness of Googling a client [132]. Almost one-third stated that Googling a client was "unquestionably unethical," and almost a half (48%) believed it was "ethical under rare circumstances." There are cases in which patient-targeted Googling may have yielded fruitful clinical outcomes, such as locating family members of a patient with dementia after all other venues have been exhausted [73].

There is empirical evidence that practitioners are ambivalent about garnering online information about their clients to use for assessment and interventions. It appears that their decisions to do so are dictated by pragmatism, with the risks and the benefits weighed [134]. A 15-month ethnographic study used observations and interviews to explore how social workers in child protection services used Facebook to obtain information about service users [134]. Some of the participants were adamantly against using Facebook to obtain information about their clients. However, there were some who did use Facebook information, especially if supervisors or colleagues were open about using Facebook for the monitoring and surveillance of clients' and families' activities and behaviors. Some argued that if the information was employed in the best interest of the child, they did not view it as unethical. There were some who were drawn into it regardless of how they felt when managers or supervisors gave them the information from Facebook to act on it. Due to the lack of guidance in many organizations and agencies, there continues to be confusion about social media usage to inform practice.

Searching online to obtain information about an individual's home has become a common Internet activity, but there are some who argue it may not be a place for such activity in the clinical encounter. It is vital for practitioners to draw a line between voyeurism and a clinical constructive goal [11,73]. Although the Internet is considered public, for practitioners to make an active decision to search for additional information not given by the client may be a violation of his or her rights [74]. This continues to be an issue when considering what to do with information obtained online. If search results are documented in the client's record, it may impact their future care or insurance coverage [73]. In addition, it can undermine the therapeutic relationship and the client's trust in the practitioner and cause boundary issues [114]. Some experts assert that it may be inappropriate to search for online information about a client unless there is a clinical emergency [114].

The following questions may be useful when considering searching for client information on the Internet [94,114]:

- Why do I want to conduct this search?

- How will the information obtained from the search affect engagement and treatment?

- Is an informed consent needed from the client before searching?

9. BEST PRACTICE GUIDELINES

Evidence Based Practice Recommendation

The American College of Physicians and the Federation of State Medical Boards assert that standards for professional interactions should be consistent across all forms of communication, and care should be taken to preserve the relationship and maintain confidentiality, privacy and respect.

https://www.acpjournals.org/doi/10.7326/0003-4819-158-8-201304160-00100

Last Accessed: April 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

In today's environment of technology and information proliferation, it is important to balance the amount of information available to clients and to carefully consider one's online persona as an extension of one's professional identity [55]. Practitioners must now actively manage their virtual identities and reputations. In order to do so, the following best practice guidelines have been established for practitioners when using Internet technologies for both personal and professional reasons.

USE PRIVACY FILTERS

When using social networking sites and/or blogs, practitioners should use a pseudonym, check their privacy filters, block certain personal information (e.g., birthdates, marital status, hometown), and research the restrictions in place for their online profiles in order to exercise control over who can access the information [79,135]. Most social networking sites and blog platforms have some kind of privacy filter available, but even when in use, clients may be able to view limited information (e.g., a profile picture). Practitioners should remember that privacy controls are subject to change at the discretion of the social media company [66]. Some experts recommend checking privacy settings every three to six months or with every software update [112].

POST CAUTIOUSLY

Practitioners should be cautious regarding posting client/patient information. The Internet has made the world smaller, and it is not difficult to trace the identity of the author of online postings. Furthermore, it is easy to inadvertently post information online that may violate a client's/patient's confidentiality and privacy [5]. Along these same lines, think twice about sharing personal information or photos online. The concept of digital footprints should be at the forefront of practitioners' minds. If any uploaded photos can be professionally compromising, they should not be posted. Consider the underlying message any information might convey [56,112]. Certainly, photos that could endanger the privacy of clients or violate HIPAA rules should not be uploaded. Carefully weigh the costs and benefits of posting various information [46]. It is wise to assume that online forums are public, even if it says it is closed and private [100].

Clinicians should also refrain from posting clinical advice or comments regarding people's mental health situation or personal problems social media [101]. It is also important for practitioners not to use online platforms as mechanisms to vent about professional issues. Venting feelings of frustrations with clients, employers, supervisors, salaries, or an agency/organization are likely to be perceived negatively by colleagues and conveys a message of unprofessionalism [50,115]. Reflect on how information posted on the Internet could undermine one's professional credibility as well as the legitimacy of the professional field [46].

Practitioners might consider having a separate professional email, social media account, and any other digital accounts [135]. This helps mitigate the blurring of boundaries, although practitioners will still need to exercise caution about how their professional online persona and identities are conveyed.

THE "FRIEND" DILEMMA

As discussed, the issue of dual relationships is at the heart of deciding whether or not to accept patients/clients as "friends" on social networking sites [66]. The risks and the benefits should be weighed. If a patient or client invites a practitioner to be an online "friend," the practitioner can discuss dual relationships and the reasons why this is unprofessional and unethical; this request could become part of the clinical work [46,47,125]. If the client becomes angry that the practitioner has "rejected" him or her or ignored the invitation, this could be discussed within the context of the client's previous experiences with loss, rejection, and self-esteem [97].

Consider crafting a professional statement about why accepting patients/clients as online friends is inappropriate. If this is an issue affecting your practice, spend time writing a standard statement to send to clients/patients regarding the professional policy not to accept clients as online friends [50]. This statement can be friendly but firm and should indicate the reasons it is not wise to establish this online relationship due to privacy and confidentiality issues. However, clients should be encouraged to discuss any issues with the practitioner during a scheduled session within the context of the therapeutic setting.

SEARCH WISELY

Practitioners should reflect on the underlying motivations for searching for client information on the Internet and how this information could be used positively. Therefore, searching for information about a client or patient is not necessarily unethical. Rather, consider how clients or the therapeutic relationship could ultimately be negatively affected by any information found and how the information can help the client [11,46,114,132]. In general, it is best to avoid searching for client information online.

However, practitioners should search for themselves on the Internet. Many professionals believe that everyone experiences some level of privacy through online obscurity, and in general, individuals take the path of least resistance in monitoring their online presence [57,79]. This can be detrimental and may limit the practitioner's ability to control disclosures. Practitioners should conduct Internet searches regularly to monitor the information available about themselves and to have better control of the content [42]. Furthermore, if clients raise information they found on the Internet in a clinical session, this will prevent practitioners from being caught unaware.

SOCIAL MEDIA AND TECHNOLOGY IN INFORMED CONSENT

The content of informed consent forms should reflect the changing technologic times. The following points should be incorporated into informed consent forms [70,72,75,79,107]:

- How cell phones, e-mails, and social media will be used with the patient/client

- Whether the practitioner will search for information about the patient/client on the Internet

- How the practitioner will respond if contact is made by the patient/client on a social media site

- If the practitioner will follow, respond, or block clients, and how clients will be advised that they have permission to block practitioners

- If the practitioner will take cell phone calls and, if so, parameters for use

- Whether there will be additional fees if the client makes contact with the practitioner via phone, e-mail, and/or social networking site

- Whether therapeutic issues will be discussed via e-mail

- If the practitioner does respond via e-mail, expected response turnaround time

- Risks and benefits of clients using social media within the therapeutic context

Some practitioners recommend openly discussing social media with their clients. For example, if a practitioner is active on social media, it may be good practice to ask clients if they have viewed their online postings and how they feel about the content [101,124]. If practitioners are active on social media for professional reasons, a disclaimer is recommended. A weblink for referral to mental health resources can be provided in the profile area and/or other areas in the social media profile [101]. Any content developed for psychoeducation should have a disclaimer that the information is not directed to any specific individual and that the individual should always seek formal mental health services [124].

10. CONCLUSION

The landscape of professional practice has changed with the increasing use of Internet technology by both practitioners and clients/patients. The opportunities that the Internet affords are endless, and practitioners should reflect on how information posted online can have implications on their professional practice and their relationships with clients/patients. The codes of ethics and professional standards may not have necessarily kept up with the technologic changes, and therefore, there may not be clear guidelines on how to behave online. Ultimately, more education is needed for professionals entering the fields to prepare to make the complex ethical decisions they will face using new technologies. Clinical supervisors should initiate conversations with their supervisees regarding how online personas and identities can affect professional identities, credibility, and roles. Finally, psychologists, social workers, counselors, therapists, physicians, and nurses must take an active role in shaping the development of professional standards for the provision of services in the new online environment, conforming to the ethical and professional best practices in their respective fields.

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Evidence-Based Practice Recommendations Citations

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