University of Helsinki, Department of General Practice and Helsinki University Hospital, Unit of Primary Health Care. PO Box 20, 00014 University of Helsinki, Finland.
University of Helsinki, Department of Medicine, and Helsinki University Hospital, PO Box 340, FI-00029 HUS, Finland.
Age Ageing. 2022 May 1;51(5). doi: 10.1093/ageing/afab282.
Randomised controlled trials (RCTs) usually provide the best evidence for treatments and management. Historically, older people have often been excluded from clinical medication trials due to age, multimorbidity and disabilities. The situation is improving, but still the external validity of many trials may be questioned. Individuals participating in trials are generally less complex than many patients seen in geriatric clinics. Recruitment and retention of older participants are particular challenges in clinical trials. Multiple channels are needed for successful recruitment, and especially individuals experiencing frailty, multimorbidity and disabilities require support to participate. Cognitive decline is common, and often proxies are needed to sign informed consent forms. Older people may fall ill or become tired during the trial, and therefore, special support and empathic study personnel are necessary for the successful retention of participants. Besides the risk of participants dropping out, several other pitfalls may result in underestimating or overestimating the intervention effects. In nonpharmacological trials, imperfect blinding is often unavoidable. Interventions must be designed intensively and be long enough to reveal differences between the intervention and control groups, as control participants must still receive the best normal care available. Outcome measures should be relevant to older people, sensitive to change and targeted to the specific population in the trial. Missing values in measurements are common and should be accounted for when designing the trial. Despite the obstacles, RCTs in geriatrics must be promoted. Reliable evidence is needed for the successful treatment, management and care of older people.
随机对照试验（RCT）通常为治疗和管理提供最佳证据。历史上，由于年龄、多种合并症和残疾，老年人经常被排除在临床药物试验之外。这种情况正在改善，但许多试验的外部有效性仍可能受到质疑。参与试验的个体通常比老年诊所看到的许多患者简单。招募和保留老年参与者是临床试验的特别挑战。需要多种渠道才能成功招募，特别是有脆弱性、多种合并症和残疾的个体需要支持才能参与。认知能力下降很常见，通常需要代理人签署知情同意书。老年人在试验期间可能会生病或感到疲倦，因此，需要特别的支持和富有同情心的研究人员来成功保留参与者。除了参与者退出的风险外，其他几个陷阱可能导致干预效果被低估或高估。在非药物试验中，不完美的盲法通常是不可避免的。干预措施必须精心设计，并且足够长，以揭示干预组和对照组之间的差异，因为对照组的参与者仍必须接受现有最佳的常规护理。结局指标应与老年人相关，对变化敏感，并针对试验中的特定人群。测量中的缺失值很常见，在设计试验时应考虑到这一点。尽管存在障碍，但老年医学中的 RCT 必须得到推广。需要可靠的证据来成功治疗、管理和照顾老年人。
