Clinical Reader in Ageing and Health, School of Medicine, University of Dundee, Dundee DD1 9SY, UK.
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Age Ageing. 2017 Nov 1;46(6):889-894. doi: 10.1093/ageing/afx153.
Randomised controlled trials provide the most rigorous test of efficacy and effectiveness for interventions used in healthcare. They underpin much of clinical practice, yet older people are often excluded from studies, resulting in uncertainty about risks and benefits of new treatments. Encouraging inclusion of older people in randomised controlled trials and reporting of trial results in a rigorous manner is a key function of clinical geriatrics journals such as Age and Ageing. This article provides practical advice on how to report randomised controlled trials that are targeted at older people. Some of these issues are generic, but there are specific requirements which apply to most studies of older people. Recording and reporting basic characteristics of recruits in terms of physical function, cognition, comorbidity and/or frailty is vital to allow proper interpretation of the external validity of the trial. Adverse effects should include consideration of common geriatric problems including falls. Authors should follow the CONSORT reporting guidelines (CONsolidated Standards Of Reporting Trials) to enhance the transparency and quality of their manuscript.
随机对照试验为医疗保健中使用的干预措施提供了最严格的疗效和有效性测试。它们是临床实践的基础,但老年人往往被排除在研究之外,导致对新治疗方法的风险和益处存在不确定性。鼓励将老年人纳入随机对照试验,并以严格的方式报告试验结果,这是 Age and Ageing 等临床老年学杂志的主要功能之一。本文提供了关于如何报告针对老年人的随机对照试验的实用建议。其中一些问题是通用的,但对于大多数老年人研究都有具体的要求。记录和报告参与者的身体功能、认知、合并症和/或虚弱等基本特征对于正确解释试验的外部有效性至关重要。不良反应应包括考虑常见的老年问题,如跌倒。作者应遵循 CONSORT 报告指南(CONsolidated Standards Of Reporting Trials),以提高手稿的透明度和质量。