Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Importance: Immune dysregulation contributes to poorer outcomes in COVID-19. Objective: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. Design, Setting, and Participants: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021. Interventions: Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day). Main Outcomes and Measures: The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale. Results: Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28]; P = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; P = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; P = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies. Conclusions and Relevance: Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo. Trial Registration: ClinicalTrials.gov Identifier: NCT04593940.

Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Background: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19. Methods: We conducted a master protocol to investigate immunomodulators for potential benefit treating patients hospitalized with Covid-19 and report results for abatacept. Intravenous abatacept (one-time dose 10 mg/kg, maximum dose 1000 mg) plus standard of care (SOC) was compared with shared placebo plus SOC. Primary outcome was time-to-recovery by day 28. Key secondary endpoints included 28-day mortality. Results: Between October 16, 2020 and December 31, 2021, a total of 1019 participants received study treatment (509 abatacept; 510 shared placebo), constituting the modified intention-to-treat cohort. Participants had a mean age 54.8 (SD 14.6) years, 60.5% were male, 44.2% Hispanic/Latino and 13.7% Black. No statistically significant difference for the primary endpoint of time-to-recovery was found with a recovery-rate-ratio of 1.14 (95% CI 1.00-1.29; p=0.057) compared with placebo. We observed a substantial improvement in 28-day all-cause mortality with abatacept versus placebo (11.0% vs. 15.1%; odds ratio [OR] 0.62 [95% CI 0.41- 0.94]), leading to 38% lower odds of dying. Improvement in mortality occurred for participants requiring oxygen/noninvasive ventilation at randomization. Subgroup analysis identified the strongest effect in those with baseline C-reactive protein >75mg/L. We found no statistically significant differences in adverse events, with safety composite index slightly favoring abatacept. Rates of secondary infections were similar (16.1% for abatacept; 14.3% for placebo). Conclusions: Addition of single-dose intravenous abatacept to standard-of-care demonstrated no statistically significant change in time-to-recovery, but improved 28-day mortality. Trial registration: ClinicalTrials.gov ( NCT04593940 ).

Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Background: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care. Methods: We conducted a master protocol investigating immunomodulators for potential benefit in treatment of participants hospitalized with Covid-19 pneumonia. We report results for infliximab (single dose infusion) versus shared placebo both with standard of care. Primary outcome was time to recovery by day 29 (28 days after randomization). Key secondary endpoints included 14-day clinical status and 28-day mortality. Results: A total of 1033 participants received study drug (517 infliximab, 516 placebo). Mean age was 54.8 years, 60.3% were male, 48.6% Hispanic or Latino, and 14% Black. No statistically significant difference in the primary endpoint was seen with infliximab compared with placebo (recovery rate ratio 1.13, 95% CI 0.99-1.29; p=0.063). Median (IQR) time to recovery was 8 days (7, 9) for infliximab and 9 days (8, 10) for placebo. Participants assigned to infliximab were more likely to have an improved clinical status at day 14 (OR 1.32, 95% CI 1.05-1.66). Twenty-eight-day mortality was 10.1% with infliximab versus 14.5% with placebo, with 41% lower odds of dying in those receiving infliximab (OR 0.59, 95% CI 0.39-0.90). No differences in risk of serious adverse events including secondary infections. Conclusions: Infliximab did not demonstrate statistically significant improvement in time to recovery. It was associated with improved 14-day clinical status and substantial reduction in 28- day mortality compared with standard of care. Trial registration: ClinicalTrials.gov ( NCT04593940 ).

"It helps me find balance": older adult perspectives on the intersection of caregiving and volunteering.

Caregiving is an increasingly prevalent experience that can negatively impact health and well-being. Volunteerism, long associated with positive benefits for older adults, is one potential strategy that can be used to counteract caregiver stress. A national cohort of existing older adult volunteers was engaged to explore the intersection of volunteering and caregiving through qualitative analysis of respondent comments using the lens of role theory. Survey responses from 533 older volunteers were analyzed. Role conflict and role enhancement themes were examined, with time constraints and reduced energy emerging as the perceived causes of conflict between the caregiver and volunteer roles. Caregivers discussed benefits to their caregiving role, including respite, learning, access to information and resources relevant to caregiving, increased socialization and improved physical and cognitive health. Findings indicate that volunteering can be framed as a health and well-being intervention for caregivers.

Profiles of women who help us to age in place.

As our population ages and people overwhelmingly prefer to age in place, the need for home care workers is steadily increasing. Unfortunately, due to the low value society places on caring work, filling these positions and retaining workers is a challenge. Drawing on a pilot study involving in-depth interviews with eight female home care aides, this brief report profiles three categories of worker perceptions of their jobs: "satisfied" (n = 3), "need more support" (n = 3), and "on my way out" (n = 2). Study participants liked their work but believed their jobs needed to be improved. Policy implications based on study findings are explored.

Maine's Bold Initiative: Homecare for All.

A 2018 ballot initiative in Maine proposed universal home care and improved work conditions for home care workers.Although ultimately defeated, the innovative proposal received considerable support and laid the groundwork for an upcoming legislative campaign.It offers a framework for increasing access to home care and creating quality jobs for home care aides. This commentary reviews the problems addressed by the Homecare for All initiative, what was proposed, the campaign process and anticipated next steps, and implications for gerontological social workers.

Exploring Relationships Among Occupational Safety, Job Turnover, and Age Among Home Care Aides in Maine.

As the U.S. population ages, the number of people needing personal assistance in the home care setting is increasing dramatically. Personal care aides and home health workers are currently adding more jobs to the economy than any other single occupation. Home health workers face physically and emotionally challenging, and at times unsafe, work conditions, with turnover rates ranging from 44 percent to 65 percent annually. As part of a mixed-method, longitudinal study in Maine examining turnover, interviews with 252 home care aides were analyzed thematically. Responses to interview questions regarding the job's impact on health and safety, the adequacy of training, and the level of agency responsiveness were examined. Emergent themes, indicating some contradictory perspectives on workplace safety, quality of training, and agency support, were compared across three variables: job termination, occupational injury, and age. Implications for increasing occupational safety and job retention are discussed.

Older lesbians receiving home care: formal and informal dimensions of caregiving.

Older lesbians face the triple jeopardy of ageism, sexism, and heterosexism, and their experiences are largely invisible. This qualitative, exploratory study examines the formal and informal caregiving experiences of 20 lesbians, 65 and older, who had utilized home care services due to acute illness or chronic disabilities. Half of those not partnered reported some level of isolation from support networks. Nearly all study participants eventually found home care workers with whom they were satisfied and even quite connected. Practice implications are discussed in context of study participants' views of how being lesbian affects their aging process and day-to-day lives.

Association of School-Based Influenza Vaccination Clinics and School Absenteeism--Arkansas, 2012-2013.

BACKGROUND: Influenza is a major cause of seasonal viral respiratory illness among school-aged children. Accordingly, the Arkansas Department of Health (ADH) coordinates >800 school-based influenza immunization clinics before each influenza season. We quantified the relationship between student influenza vaccination in Arkansas public schools and school absenteeism during the 2012-2013 influenza season. METHODS: The relationship between the percent of students vaccinated in Arkansas public schools during ADH-facilitated clinics and the average daily percent of students absent from school during the 2012-2013 influenza season was quantified using linear regression modeling. The effect of increasing vaccination coverage among students on absentee days in the Arkansas public school system was estimated. RESULTS: For every 1% higher vaccination coverage, 0.027% fewer absenteeism days were predicted. Larger school size was associated with higher absenteeism and predicted decreases in absenteeism were larger in magnitude for larger schools compared with smaller schools. Extrapolation of the model showed that a 10% higher vaccination level was associated with a reduction of 16-163 student absentee days per school over a 12-week influenza season. CONCLUSIONS: Influenza vaccination is an effective tool to reduce school absenteeism. School-based clinics are a feasible way to target influenza vaccinations to school-aged children.

Resilience in attaining and sustaining sobriety among older lesbians with alcoholism.

This phenomenological study illuminates coping among older lesbians with alcoholism. Twenty study participants were recruited through purposive and snowball sampling; each completed 3 interviews structured to gain a deeper understanding of participants' lived experiences. This article focuses on the key situations and people that helped study participants obtain sobriety and stay sober. Five major themes emerged from the data: wake-up calls, impact of formal treatment, impact of 12-step recovery groups, consequences from other sources, and resiliency. Findings support the need for culturally sensitive approaches to practice with this subpopulation of older adults.

Determinants of longer job tenure among home care aides: what makes some stay on the job while others leave?

An inadequate supply of direct care workers and a high turnover rate in the workforce has resulted in a "care gap" in our long-term care system. As people are increasingly choosing community-based care, retention of home care workers is particularly important. The mixed-method study described herein explored determinants of longer job tenure for home care aides (n = 261). Study participants were followed for 18 months, completing two mail surveys and one telephone interview each. Predictors of longer job tenure included older age, living rurally, lower physical function, higher wages, a greater sense of autonomy on the job, and less frequent feelings of personal accomplishment. Thematic analysis of telephone interviews revealed long-term stayers to be less concerned about low wages and inconsistent hours than those who left their jobs within a year; both groups of workers reported high levels of job satisfaction. Policy implications of study findings are discussed.

Supporting home care aides: what employers can do to assist their workers.

The demand for personal care workers in home-based care is expected to double with the aging of the baby boomer population at the same time that home care agencies struggle with high rates of turnover. This article examines the job experience of 171 home care aides who remained on the job over 18 months of data collection in the longitudinal home care worker retention study. The three groups of themes that emerged from the analysis of telephone interviews with study participants-challenges of the job, compensating strategies, and potential employer interventions-provide insight on how to offer support to these valuable workers.

Older women doing home care: exploitation or ideal job?

The increased need for both personal assistance workers and meaningful employment opportunities for older workers results in growing numbers of older home care aides. This study examined lifetime financial security and perceived advantages of older age in this field through interviews with 31 older home care aides. Study participants experienced high levels of financial insecurity and perceived older workers as particularly well suited to the home care job. The consequences of this low-wage, low-status work are explored along with implications for social workers to advocate for improved conditions for these workers providing essential care to frail elders.

Prevalence and characteristics of rib fractures in ex-preterm infants.

OBJECTIVES: This study aimed to identify the prevalence and characteristics of rib fractures in ex-preterm infants. METHODS: Infants born at <37 weeks' gestation and admitted before 2011 to 3 regional neonatal units were identified from admission registers. For 2 centers, these data were available from 2000 onward and, for another center, from 2005. Electronic records were searched to identify chest radiographs performed up to age 1 year. Chest radiograph reports were then reviewed for evidence of rib fractures, and the case notes of all affected individuals were scrutinized. RESULTS: Of the 3318 eligible preterm infants, 1446 had a total of 9386 chest radiographs. Of these infants, 26 (1.8%) were identified as having a total of 62 rib fractures. Their median (range) gestation at birth was 26 weeks (23-34). The median chronological age of these infants at the time of the radiograph was 14 weeks (5 weeks to 8 months). The median corrected gestational age at the time of the radiograph was 39 weeks (34 weeks to 4 months). Of the 62 fractures, 27 (36%) were sited posteriorly, and 15 (53%) of the infants with posterior rib fractures were diagnosed with osteopathy of prematurity. Classic risk including conjugated hyperbilirubinemia and diuretics, were present in 23 of 26 (88%) infants. A full skeletal survey was performed in 8 of 26 (31%). Investigations for nonaccidental injury occurred in 4 of 26 (15%) cases. CONCLUSIONS: Evidence of rib fractures is present in ~2% of ex-preterm infants. The evaluation of these fractures in infancy requires a detailed neonatal history irrespective of the site of rib fracture.

Older women caring for older women: the rewards and challenges of the home care aide job.

As our population ages, the need for personal assistance services increases. Paid personal care is predominantly provided by women, often older women, and has been considered low-status, low-wage work. This article reports on a mixed-method, longitudinal study of 261 home care aides; study participants were 46 years old, on average. Predictors of termination included younger age and lack of health insurance. Study participants reported more rewarding than challenging aspects to the job, though low and inconsistent compensation often forced them to leave the work they loved. Implications of the study with regard to older women caring for older women are explored.

Clinical features and respiratory complications in Myhre syndrome.

We describe the clinical characteristics of 4 singleton cases, 3 males and 1 female, with Myhre Syndrome (OMIM 139210), who were born to non-consanguineous parents. Three cases had no family history of similarly affected individuals but 1 male's mother had short stature, some facial features suggestive of Myhre syndrome and evidence of skewed X-chromosome inactivation in her blood DNA. Short stature, deafness, learning difficulties, skeletal anomalies and facial dysmorphisms were evident in all cases. Arthralgia and stiff joints with limited movement were also present. The facial appearance, thickened skin, a 'muscular' habitus are memorable features. The female patient was least affected: this patient and one affected male displayed streaky skin with areas of patchy thickening, suggestive of genetic mosaicism. One patient developed sleep apnoea, a restrictive ventilatory defect and died following a choking episode. Another affected male developed recurrent, progressive, proximal, tracheal stenosis requiring partial tracheal resection, laser treatment and eventually tracheotomy. Review of Myhre syndrome patients in the literature and syndromes in the differential diagnosis, suggests heterogeneity in Myhre syndrome and clinical overlap with Laryngotracheal stenosis, Arthropathy, Prognathism and Short stature syndrome.

Why do they leave? Factors associated with job termination among personal assistant workers in home care.

Recruiting and retaining an adequate number of personal support workers in home care is both challenging and essential to allowing elders to age in place. A mixed-method, longitudinal study examined turnover in a sample of 261 personal support workers in Maine; 70 workers (26.8%) left their employment in the first year of the study. Logistic regression analysis indicated that younger age and lack of health insurance were significant predictors of turnover. Analysis of telephone interviews revealed three overarching themes related to termination: job not worthwhile, personal reasons, and burnout. Implications of study findings for gerontological social workers are outlined.

Home care aides' voices from the field: job experiences of personal support specialists.

In response to a rapidly aging population that is living longer with more chronic health needs, increased recruitment and successful retention of home care aides is essential. Insight into the job experiences of Personal Support Specialists is provided through the qualitative findings from a mixed-method mail survey (n = 131). Workers described reasons why they do their jobs (feeling rewarded, valuing helping, and being energized by home care work) as well as the challenges they face providing home care (low wages, along with a lack of benefits, respect, and recognition). Both short- and long-term recommendations are formulated based on workers' narrative responses.