Ethical Challenges in the Middle Tier of Covid-19 Vaccine Allocation: Guidance for Organizational Decision-Making

This supplement to The Hastings Center’s “Ethical Framework” aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health authorities, health care institutions, or other groups involved in vaccine allocation. The document’s scope is limited to the ethics of vaccine distribution within the United States; it does not address the ethics of international cooperation and sharing vaccines versus focusing solely on ensuring vaccine access in one’s own nation (“vaccine nationalism”). The focus of this document is the middle tier of vaccine allocation and the ethical challenges arising in the U.S. in the first half of 2021. This focus reflects general consensus and ongoing implementation concerning highest-priority vaccination of two populations: frontline health care workers and residents of long-term care facilities (the groups constituting “Phase 1a in recommendations from the Advisory Committee on Immunization Practices [ACIP]).The ethical justification for prioritizing these populations was their high risk of contracting the virus, of passing it to others at high risk of severe disease, and, in the case of long-term care residents, of dying of severe Covid-19. Additional justifications include the relatively small size of these initial cohorts, the relative ease of locating them and providing the vaccine, and the value of public trust created by witnessing health professionals receiving the vaccine. There is also broad consensus that vaccine allocation to the general public—people without major risk factors and who can reasonably protect themselves through masking and physical distancing—should occur only after the vaccination of groups at high risk of infection or at high risk of severe illness or death if infected. This document therefore does not address the final stages of vaccine distribution to lower-risk members of the public

Collaborative Family Healthcare Association commentary on the joint principles: Integrating behavioral health care into the patient-centered medical home

The Collaborative Family Healthcare Association (CFHA) welcomes the opportunity to comment on the complementary set of Joint Principles underscoring the Integration of Behavioral Health Care Into the Patient-Centered Medical Home (The Working Party Group on Integrated Behavioral Healthcare et al., 2014). CFHA is an organization that promotes comprehensive and cost-effective models of health care delivery that integrate mind and body, individual and family, patients, providers, and communities. CFHA appreciates that the Joint Principles do not explicitly endorse any single model of collaboration between behavioral health and medical practice. Rather, they broadly emphasize integration, affirming the only way to have a whole person orientation is to adopt a biopsychosocial-spiritual perspective. This commentary will highlight areas of notable strength within the Joint Principles, as well as challenge the language, if not perspective, on a few critical elements

Reach of a low-intensity, multicomponent childhood overweight and obesity intervention delivered in an integrated primary care setting

Reach (i.e., proportion and representativeness of participants) of low-intensity, multicomponent childhood overweight/obesity interventions delivered in primary care settings with low-income and/or minority families is unknown. The purpose of this research is to describe the reach of a lowintensity, multicomponent childhood overweight/obesity intervention delivered in an integrated primary care setting in a federally qualified health center (FQHC). Eligibility criteria included children aged 4-10 years with a body mass index (BMI) ≥85th percentile, with a female caregiver. Using the electronic health record (EHR) and release forms, families were broadly categorized into groupings from recruitment flow, with differing proportions calculated from these groupings. Representativeness was determined using EHR data from families who were informed about the program (n = 963). Three calculated reach rates ranged from 54.9% to 3.9%. Lower reach rates were calculated using the number of families randomized (n = 73) as the numerator and the children from families who were informed about the program (n = 963) or all eligible children in the FQHC attending appointments (n = 1,864) as denominators. The first two steps in recruitment, informing families about the program and families initiating participation, were where the largest decreases in reach occurred. Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic. Reach of the intervention was low. Strategies that assist with reducing time for informing families of treatment and increasing families\u27 awareness of their child\u27s weight status should assist with enhancing reach

Implementing Prevention Plus with Underserved Families in an Integrated Primary Care Setting

This proof-of-concept trial examined a 6-month Prevention Plus (PP) intervention implemented in a federally qualified health center on child standardized BMI (ZBMI), using a planned clinical effect threshold of -0.16 ZBMI. The relationship between food security status and PP delivered with caregiver goals (PP+) and without caregiver goals (PP-) on energy balance behaviors (, fruits and vegetables, physical activity) and child ZBMI was explored. Seventy-three, underserved children, 4-10 years of age with a BMI ≥85th percentile, were randomized to one of two interventions, PP+ and PP-, both providing 2.5 hours of contact time, implemented in five clinics by behavioral health consultants (BHCs). Outcomes were child anthropometrics (included 9-month follow-up), implementation data collected from electronic health records, and caregiver and BHC evaluations. Children were 57.5% female and 78.1% Hispanic, with 32.9% from food-insecure households and 58.9% from households with an annual income of less than $20,000. Child ZBMI significantly ( \u3c 0.05) decreased at 6 and 9 months (-0.08 ± 0.24 and -0.12 ± 0.43), with only PP+ reaching the clinical threshold at 9 months (PP+: -0.20 ± 0.42 vs. PP-: -0.05 ± 0.42). Sixty-four percent of families attended ≥50% of the sessions, and BHCs delivered 78.5% ± 23.5% of components at attended sessions. Caregivers were satisfied with the intervention and BHCs found the intervention helpful/useful. No relationship with food insecurity status and outcomes was found. PP+ when delivered by a primary care provider to underserved families showed promise for producing a clinically meaningful effect. Families and providers felt the intervention was a viable treatment option

Ethical Challenges in the Middle Tier of Covid-19 Vaccine Allocation: Guidance for Organizational Decision-Making

This supplement to The Hastings Center’s “Ethical Framework” aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health authorities, health care institutions, or other groups involved in vaccine allocation. The document’s scope is limited to the ethics of vaccine distribution within the United States; it does not address the ethics of international cooperation and sharing vaccines versus focusing solely on ensuring vaccine access in one’s own nation (“vaccine nationalism”). The focus of this document is the middle tier of vaccine allocation and the ethical challenges arising in the U.S. in the first half of 2021. This focus reflects general consensus and ongoing implementation concerning highest-priority vaccination of two populations: frontline health care workers and residents of long-term care facilities (the groups constituting “Phase 1a in recommendations from the Advisory Committee on Immunization Practices [ACIP]).The ethical justification for prioritizing these populations was their high risk of contracting the virus, of passing it to others at high risk of severe disease, and, in the case of long-term care residents, of dying of severe Covid-19. Additional justifications include the relatively small size of these initial cohorts, the relative ease of locating them and providing the vaccine, and the value of public trust created by witnessing health professionals receiving the vaccine. There is also broad consensus that vaccine allocation to the general public—people without major risk factors and who can reasonably protect themselves through masking and physical distancing—should occur only after the vaccination of groups at high risk of infection or at high risk of severe illness or death if infected. This document therefore does not address the final stages of vaccine distribution to lower-risk members of the public

Exercise Treatment for Major Depression: Maintenance of Therapeutic Benefit at 10 Months

Objective: The purpose of this study was to assess the status of 156 adult volunteers with major depressive disorder (MDD) 6 months after completion of a study in which they were randomly assigned to a 4-month course of aerobic e-ercise, sertraline therapy, or a combination of e-ercise and sertraline. Methods: The presence and severity of depression were assessed by clinical interview using the Diagnostic Interview Schedule and the Hamilton Rating Scale for Depression (HRSD) and by self-report using the Beck Depression Inventory. Assessments were performed at baseline, after 4 months of treatment, and 6 months after treatment was concluded (ie, after 10 months). Results: After 4 months patients in all three groups e-hibited significant improvement; the proportion of remitted participants (ie, those who no longer met diagnostic criteria for MDD and had an HRSD score \u3c8) was comparable across the three treatment conditions. After 10 months, however, remitted subjects in the e-ercise group had significantly lower relapse rates (p = .01) than subjects in the medication group. Exercising on one’s own during the follow-up period was associated with a reduced probability of depression diagnosis at the end of that period (odds ratio = 0.49, p = .0009). Conclusions: Among individuals with MDD, e-ercise therapy is feasible and is associated with significant therapeutic benefit, especially if e-ercise is continued over time

Exercise Treatment for Major Depression: Maintenance of Therapeutic Benefit at 10 Months

Objective: The purpose of this study was to assess the status of 156 adult volunteers with major depressive disorder (MDD) 6 months after completion of a study in which they were randomly assigned to a 4-month course of aerobic exercise, sertraline therapy, or a combination of exercise and sertraline. Methods: The presence and severity of depression were assessed by clinical interview using the Diagnostic Interview Schedule and the Hamilton Rating Scale for Depression (HRSD) and by self-report using the Beck Depression Inventory. Assessments were performed at baseline, after 4 months of treatment, and 6 months after treatment was concluded (ie, after 10 months). Results: After 4 months patients in all three groups exhibited significant improvement; the proportion of remitted participants (ie, those who no longer met diagnostic criteria for MDD and had an HRSD score ,8) was comparable across the three treatment conditions. After 10 months, however, remitted subjects in the exercise group had significantly lower relapse rates (p 5 .01) than subjects in the medication group. Exercising on one’s own during the follow-up period was associated with a reduced probability of depression diagnosis at the end of that period (odds ratio 5 0.49, p 5 .0009). Conclusions: Among individuals with MDD, exercise therapy is feasible and is associated with significant therapeutic benefit, especially if exercise is continued over time

The Association between Physical Activity and Depression in Older Depressed Adults

Previous studies of younger, healthy individuals have demonstrated an inverse relationship between physical activity and depression. The present study addressed the relation between self-reported physical activity and symptoms of depression in 146 men and women aged 50 years and older with major depressive disorder (MDD). Patients who met clinical criteria for MDD completed the Beck Depression Inventory (BDI) and the Minnesota Leisure-Time Activity Questionnaire (MQ). Multiple regression analysis indicated that lower levels of physical activity were associated with more severe depressive symptoms (p = .04), after adjusting for age and gender. The implications of these findings for the treatment and prevention of depression are discussed

Effects of Exercise Training on Older Patients With Major Depression

Background: Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression. However, the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder (MDD) has not been systematically evaluated. Objective: To assess the effectiveness of an aerobic exercise program compared with standard medication (ie, antidepressants) for treatment of MDD in older patients, we conducted a 16-week randomized controlled trial. Methods: One hundred fifty-six men and women with MDD (age, ≥50 years) were assigned randomly to a program of aerobic exercise, antidepressants (sertraline hydrochloride), or combined exercise and medication. Subjects underwent comprehensive evaluations of depression, including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and Hamilton Rating Scale for Depression (HAM-D) and Beck Depression Inventory (BDI) scores before and after treatment. Secondary outcome measures included aerobic capacity, life satisfaction, self-esteem, anxiety, and dysfunctional cognitions. Results: After 16 weeks of treatment, the groups did not differ statistically on HAM-D or BDI scores (P = .67); adjustment for baseline levels of depression yielded an essentially identical result. Growth curve models revealed that all groups exhibited statistically and clinically significant reductions on HAM-D and BDI scores. However, patients receiving medication alone exhibited the fastest initial response; among patients receiving combination therapy, those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms. Conclusions: An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons. Although antidepressants may facilitate a more rapid initial therapeutic response than exercise, after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD