Unit of Injury, Recovery and Inflammation Sciences (IRIS), School of Medicine, University of Nottingham, Derby DE22 3NE, UK.
NIHR Applied Research Collaboration-East Midlands (ARC-EM), Nottingham, UK.
Age Ageing. 2022 Mar 1;51(3). doi: 10.1093/ageing/afac052.
The COVID-19 pandemic resulted in catastrophic levels of morbidity and mortality for care home residents. Despite this, research platforms for COVID-19 in care homes arrived late in the pandemic compared with other care settings. The Prophylactic Therapy in Care Homes Trial (PROTECT-CH) was established to provide a platform to deliver multi-centre cluster-randomized clinical trials of investigational medicinal products for COVID-19 prophylaxis in UK care homes. Commencing set-up in January 2021, this involved the design and development of novel infrastructure for contracting and recruitment, remote consent, staff training, research insurance, eligibility screening, prescribing, dispensing and adverse event reporting; such infrastructure being previously absent. By the time this infrastructure was in place, the widespread uptake of vaccination in care homes had changed the epidemiology of COVID-19 rendering the trial unfeasible. While some of the resources developed through PROTECT-CH will enable the future establishment of care home platform research, the near absence of care home trial infrastructure and nationally linked databases involving the care home sector will continue to significantly hamper progress. These issues are replicated in most other countries. Beyond COVID-19, there are many other research questions that require addressing to provide better care to people living in care homes. PROTECT-CH has exposed a clear need for research funders to invest in, and legislate for, an effective care home research infrastructure as part of national pandemic preparedness planning. Doing so would also invigorate care home research in the interim, leading to improved healthcare delivery specific to those living in this sector.
COVID-19 大流行导致疗养院居民发病率和死亡率达到灾难性水平。尽管如此,与其他护理环境相比,疗养院的 COVID-19 研究平台在大流行后期才出现。预防疗法在疗养院试验(PROTECT-CH)的建立旨在为英国疗养院的 COVID-19 预防研究提供一个平台,以进行多中心集群随机临床试验,以提供研究性药物。该试验于 2021 年 1 月开始建立,涉及为合同和招聘、远程同意、员工培训、研究保险、资格筛选、处方、配药和不良事件报告设计和开发新的基础设施;以前不存在这种基础设施。当这种基础设施到位时,疫苗在疗养院的广泛使用已经改变了 COVID-19 的流行病学,使得试验变得不可行。虽然通过 PROTECT-CH 开发的一些资源将能够为未来建立疗养院平台研究提供支持,但疗养院试验基础设施的缺乏以及涉及疗养院部门的全国性相关数据库将继续严重阻碍进展。这些问题在大多数其他国家也存在。除了 COVID-19 之外,还有许多其他研究问题需要解决,以为居住在疗养院的人提供更好的护理。PROTECT-CH 清楚地表明,研究资助者需要投资并立法建立有效的疗养院研究基础设施,作为国家大流行准备计划的一部分。这样做也将在过渡期间振兴疗养院研究,从而提高特定于居住在这一领域的人的医疗保健服务。