Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: A consensus report
Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: A consensus report
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DOI：
10.1111/j.1532-5415.2004.52174.x
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发表时间：
2004-04-01
影响因子：
6.3
通讯作者：
Walston, JD
中科院分区：
文献类型：
--
作者：
Ferrucci, L;Guralnik, JM;Walston, JD
寻找有效的干预措施来预防或延迟老年人的残疾是公共卫生的一个优先事项。最有可能从这些干预措施中受益的是尚未残疾的体弱者和那些有进展高风险的早期残疾者。尽管如此，体弱的老年人往往被排除在研究之外，因为他们被假设不能忍受检测或不能从治疗中获益。虚弱干预工作组提出了在临床试验中筛选、招募、评估和保留虚弱老年人的建议。具体建议如下：资格筛选应包括多阶段过程，以快速排除那些身体太好和病情太重的人。纳入标准应针对那些最有可能受益的人，对临床医生有意义，并反映虚弱研究领域的进展。残疾结局指标应包括自我报告、客观和代理指标。提高保留率和依从性并监测其有效性的策略应成为研究设计的一个组成部分。成本和样本量的估计应考虑到高辍学率和竞争结果的干扰。需要进行额外的研究，以完善筛选体弱老年人的标准，确定对体弱老年人可靠有效的残疾客观衡量标准，并改进高风险参与者的知情同意程序，认识到在这一亚组中开展研究对改善其健康结果至关重要。
The discovery of effective interventions to prevent or delay disability in older persons is a public health priority. Most likely to benefit from such interventions are frail individuals who are not yet disabled and those with early disability who are at high risk of progression. In spite of this frail older persons have often been excluded from research on the assumption that they would not tolerate testing or benefit from treatment. The Interventions on Frailty Working Group developed recommendations to screen, recruit, evaluate, and retain frail older persons in clinical trials.Specific recommendations are:Eligibility screening should include a multistage process, to quickly exclude those who are too well and those who are too sick.Inclusion criteria should target those most likely to benefit, be meaningful to clinicians, and reflect advancements in the frailty research area.Disability outcome measures should include self-reported, objective, and proxy measures. Strategies to improve retention and compliance and to monitor their effectiveness should be an integral part of the study design.Estimation of cost and sample size should contemplate high dropout rates and interference bycompeting outcomes.Additional research is needed to refine criteria for screening frail older persons, identify objective measures of disability that are reliable and valid in frail older persons, and improve the informed consent process for high-risk participants, recognizing that research in this subgroup is essential to improving their health outcomes.