Academic Unit of Elderly Care & Rehabilitation, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Temple Bank House, Duckworth Lane, Bradford, West Yorkshire, UK.
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Age Ageing. 2015 Jul;44(4):547-50. doi: 10.1093/ageing/afv044. Epub 2015 Apr 8.
There is widespread evidence of under-recruitment of older people to research studies, notably randomised controlled trials of interventions. Study exclusion criteria, ethical dilemmas, patient preference, risk of bias and challenges for treatment comparisons are particular problems faced by researchers. This article describes how more widespread use of the cohort multiple randomised controlled trial (cmRCT) design in ageing research may help address many of these problems. The original key features of the cmRCT design are a large observational cohort of people with the condition of interest (e.g. frailty) with regular measurement of outcomes for the whole cohort. For each RCT eligible patients are identified and a random selection offered the trial intervention; their outcomes are compared with those eligible patients not offered the intervention. Relevant assents are obtained at baseline to enable future involvement in a range of potential trials. Where possible, the follow-up schedule is aligned with the key time points for assessment in future trials and includes the key baseline descriptors, and primary and secondary outcomes. The cmRCT approach also enables detailed observational and qualitative research for the chosen condition of interest, and might include the establishment of research biobanks to better align basic science, epidemiological, qualitative and clinical trial research.
有广泛的证据表明，老年人在研究中的参与率较低，特别是在干预措施的随机对照试验中。研究排除标准、伦理困境、患者偏好、偏倚风险以及治疗比较的挑战是研究人员面临的特殊问题。本文描述了在老年研究中更广泛地使用队列多随机对照试验（cmRCT）设计如何有助于解决许多这些问题。cmRCT 设计的最初主要特点是对感兴趣的疾病（如虚弱）的大量观察性队列人群进行定期测量，对整个队列进行评估。对于每个 RCT，确定符合条件的患者，并为他们提供随机选择的试验干预措施；将他们的结果与未接受干预的符合条件的患者进行比较。在基线时获得相关同意，以使其能够在未来参与一系列潜在试验。在可能的情况下，随访计划与未来试验的关键评估时间点对齐，并包括关键的基线描述符、主要和次要结局。cmRCT 方法还可以为选定的感兴趣疾病进行详细的观察性和定性研究，并且可能包括建立研究生物库，以更好地将基础科学、流行病学、定性和临床试验研究联系起来。
