Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle Upon Tyne, NE7 7XA, UK.
Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, NE4 6BE, UK.
Trials. 2024 Mar 25;25(1):215. doi: 10.1186/s13063-024-08073-1.
Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS). However, adult social care and local authorities are relatively uncharted territory for trials. BATH-OUT-2 is one of the first clinical trials currently underway within adult social care and housing adaptations services in six English local authorities. It provides an opportunity to explore how the clinical trial road map fares in these settings.Whilst setting up BATH-OUT-2, we encountered challenges with securing funding for the trial, lack of non-NHS intervention costs, using research and support costs as intended, gaining approvals, identifying additional trial sites, and including people who lack the mental capacity to provide informed consent. Overall, our experience has been like navigating uncharted territory with a borrowed map. In the UK, the clinical trial road map was developed for medical settings. Its key features are integrated within the NHS landscape but have been largely absent, unfamiliar, inaccessible, or irrelevant in social care and wider local authority terrain. Navigating the set-up of a clinical trial outside the NHS has been a complicated and disorientating journey.BATH-OUT-2 highlights how local authorities generally and adult social care specifically are a relatively new and certainly different type of setting for trials. Whilst this poses a challenge for conducting trials, it also presents an opportunity to question longstanding assumptions within trials practices, reimagine the conventional clinical trial road map, and take it in new directions. As the UK research landscape moves forward and becomes better primed for randomised evaluations in local authorities, we propose several suggestions for building on recent progress and advancing trials within adult social care and across health and care systems.
全球人口老龄化速度加快，越来越多的人同时患有多种长期疾病。现在迫切需要高质量、具有成本效益且综合的卫生和社会保健系统的证据。卫生研究资助者现在也将成人社会保健和更广泛的地方当局环境（例如住房服务）的研究作为优先事项。为成人社会保健制定证据基础应包括酌情实施随机对照试验。在英国，临床试验是评估国民保健制度（NHS）中干预措施的既定路线图。然而，成人社会保健和地方当局在试验方面相对来说是未知领域。BATH-OUT-2 是目前在六个英国地方当局的成人社会保健和住房适应服务中进行的首批临床试验之一。它提供了一个机会，可以探索临床试验路线图在这些环境中的表现如何。在设立 BATH-OUT-2 时，我们遇到了为试验提供资金的挑战、缺乏非 NHS 干预成本、按预期使用研究和支持成本、获得批准、确定额外的试验地点以及包括那些缺乏提供知情同意能力的人。总的来说，我们的经验就像使用借来的地图在未知的领域航行。在英国，临床试验路线图是为医疗环境开发的。其主要特点是整合在国民保健制度的景观中，但在社会保健和更广泛的地方当局领域中基本上缺失、不熟悉、难以获得或不相关。在国民保健制度之外设立临床试验的过程非常复杂和令人迷失方向。BATH-OUT-2 强调了地方当局，特别是成人社会保健，是一个相对较新且肯定不同类型的试验环境。虽然这对进行试验构成了挑战，但它也为质疑试验实践中长期存在的假设、重新想象传统的临床试验路线图并开辟新的方向提供了机会。随着英国研究领域的发展，为地方当局的随机评估做好了更好的准备，我们提出了一些建议，以利用最近的进展，在成人社会保健和整个卫生和保健系统中推进试验。
