van der Marck Marjolein A, Olde Rikkert Marcel G M
afdeling Geriatrie, Radboudumc Alzheimer Centrum, Radboud universitair medisch centrum, Nijmegen, Nederland.
Tijdschr Gerontol Geriatr. 2017 Dec;48(6):278-286. doi: 10.1007/s12439-017-0234-4.
This paper describes the development of a guideline on medical research with older subjects. Although our society is aging, evidence on health care for older persons is lacking on many topics, because these subjects are underrepresented in most drug and non-drug trials, while these services are used many older persons, and result in many adverse reactions and unplanned hospitalisation. Part of the reasons for this underrepresentation is the multimorbidity, often leading to exclusion, but also the lack of appropriate research methods plays a major role. Therefore, this paper describes the methods and results of the development of a multidisciplinary, evidence based guideline on how to conduct medical research in older persons. The recent changes in European and Dutch legislation on medical research were another reason to start this guideline project. We conducted two systematic reviews (on informed consent and recruitment) and conducted surveys and focus groups on the other four topics covered by the paper: proportionality, resistance, drop out, and societal relevance. In total we formulated 45 recommendations, all agreed on in consensus meetings, in which older persons' representatives played a major role. This Guideline on medical research in older persons, will be implemented via the ethical review boards, the medical scientific committees, and the Ministry of Health in the Netherlands, who commissioned the guideline work. We hope the guideline stimulates quality and quantity of research on older adults to answer the increasing number of societal and scientific questions with regard to this populations.
本文介绍了一项关于老年受试者医学研究指南的制定情况。尽管我们的社会正在老龄化，但在许多主题上，针对老年人的医疗保健证据仍然匮乏，因为在大多数药物和非药物试验中，这些受试者的代表性不足，而这些服务却被许多老年人使用，并导致了许多不良反应和非计划住院情况。这种代表性不足的部分原因是多种疾病共存，这常常导致受试者被排除在外，但缺乏适当的研究方法也起到了主要作用。因此，本文描述了如何开展针对老年人的医学研究的多学科、循证指南的制定方法和结果。欧洲和荷兰近期关于医学研究的立法变化是启动该指南项目的另一个原因。我们进行了两项系统综述（关于知情同意和招募），并就本文涵盖的其他四个主题进行了调查和焦点小组讨论：相称性、抗拒性、退出率和社会相关性。我们总共制定了45条建议，所有建议都在共识会议上达成一致，其中老年人代表发挥了主要作用。这项关于老年人医学研究的指南将通过荷兰的伦理审查委员会、医学科学委员会以及委托开展指南工作的荷兰卫生部来实施。我们希望该指南能促进针对老年人的研究在质量和数量上的提升，以回答关于这一人群日益增多的社会和科学问题。
