Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...
This article reports on the process and outcomes of a systematic integrative literature review, designed to enhance understanding of the factors influencing bereaved families' decisions to agree or decline the donation of their deceased relative's organs for transplantation. Research originating from eight Western countries (N = 20 studies) provided an international perspective to the review. Thematic analysis and synthesis of textual data culminated in the development of three global themes (past, present, and future) that captured the temporal dimensions of family decision making. The review findings provide valuable insight into ways of increasing the rate of consent to organ donation through the development family-centered care interventions that reflect the needs of the bereaved. Further research to explore the pathway of donation after circulatory death and the experiences of bereaved families who decline organ donation is essential to providing a more complete understanding of the factors affecting donation decisions.
BackgroundUS health care providers are increasingly demanding patient engagement with digital health technologies to enroll in care, access personal health information, communicate with providers, and monitor their own health. Such engagement may be difficult for disadvantaged populations who may have limited health literacy, time constraints, or competing priorities.ObjectiveWe aimed to understand the extent of adoption and use of digital health tools and to identify key perceived psychological motivators of technology use among disadvantaged first-time pregnant women and mothers of young children.MethodsWe recruited women from health organizations serving low-income communities in the Midwest and on the East and West coasts. A total of 92 women participated in 14 focus groups. During each session, we administered worksheets that measured 3 utilization outcomes: the number of recent Web-based health-seeking activities, current use of digital health-management practices (eg, accessing personal health information, communicating with providers, and scheduling appointments), and potential adoption of digital health-management tools among low users or nonusers. Responses to the worksheets and to a pre-focus group survey on demographics, technology access, and motivators of use were examined to create user profiles. Separate regression models identified the motivators (eHealth literacy, internal health orientation, and trust in digital information) associated with these outcomes. Qualitative data were incorporated to illustrate the worksheet responses. ResultsWhereas 97% of the participants reported that they had searched for health information on the Internet in the past year, 42% did not engage in digital health-management practices. Among the low users and nonusers, 49% expressed interest in future adoption of digital health tools. Web-based health information-seeking activities were associated with digital health-management practices (P<.001). When controlling for covariates, eHealth literacy was positively correlated with the number of Web-based health-seeking activities (beta=.03, 95% CI 0.00-0.07). However, an internal health orientation was a much stronger correlate of digital health-management practices (beta=.13, 95% CI 0.02-0.24), whereas trust in digital information increased the odds of potential adoption (vs no adoption) in adjusted models (OR 5.21, 95% CI 0.84-32.53). Demographic characteristics were not important drivers of digital health use and few differences distinguished use among mothers and pregnant women.ConclusionsSeeking health information on the Internet may be an important gateway toward engaging in digital health-management practices. Notably, different consumer motivators influence digital health tool use. The relative contributions of each must be explored to design tools and interventions that enhance competencies for the management of self and child health among disadvantaged mothers and pregnant women. Unless we address disparities in digital health tool use, benefits from their use w...
We have an innovation that is showing tremendous gains in improving health, especially among vulnerable populations. It has produced a return on investment of 4:1 when applied to children with asthma and a return on investment of 3:1 for Medicaid enrollees with unmet longterm care needs (Felix et al., 2011). Among participating patients with HIV, 60 percent achieve undetectable viral loads (Behforouz, 2014). In fact, examples keep emerging from around the country about its effectiveness in improving health outcomes and reducing emergency room visits and hospitalizations (CHWA, 2013; CDC, 2011; ICER, 2013). If these were the results of a clinical trial for a drug, we would likely see pressure for fast tracking through the FDA; if it was a medical device or a new technology, there would be intense jockeying from a range of start-ups to bring it to market. Instead, despite the promise this innovation has shown for years-and recognition from the Institute of Medicine (IOM, 2010), the Affordable Care Act, and the Department of Laborit still has not been widely replicated or brought into the mainstream of U.S. health care delivery. It is still not supported by most health care financing mechanisms, which causes some organizations that successfully deploy the innovation-and show better health outcomes-to actually lose money (Paquette, 2014). The innovation is the use of community health workers (CHWs), and, more specifically, their integration into team-based primary care. Scaling up the use of CHWs presents a unique set of obstacles, but it is also possible to chart a roadmap forward. The potential to improve care for vulnerable populations, help achieve the Triple Aim of better care, better health and lower costs, and advance population health is too promising to be deterred.
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