Rathjen Kim Isabel, Herbon Carolin, Jilani Hannah, Scharpenberg Martin, Schilling Imke, Schmiemann Guido, Brannath Werner, Gerhardus Ansgar
Universität Bremen, Institut für Public Health und Pflegeforschung (IPP), Abteilung 1: Versorgungsforschung, Bremen, Deutschland; Health Sciences Bremen, Bremen, Deutschland.
Universität Bremen, Kompetenzzentrum für Klinische Studien Bremen (KKSB), Bremen, Deutschland; Health Sciences Bremen, Bremen, Deutschland.
Z Evid Fortbild Qual Gesundhwes. 2020 Nov;156-157:82-88. doi: 10.1016/j.zefq.2020.07.009. Epub 2020 Aug 27.
Patient involvement in health research is an integral part of health care in many countries. It promotes the relevance and quality of research and increases the meaningfulness of research results. Meanwhile, the value of patient involvement has also been recognised in Germany. The lack of a common understanding of patient involvement and appropriate methods make implementation difficult. In Germany, patients are still rarely involved in the planning and conduct of health research. Vulnerable patient groups such as the elderly and the very old are considered particularly challenging for researchers in active patient involvement due to their special needs, which is why they are often neglected. Especially nursing home residents suffer from a variety of health impairments which are accompanied by a high number of prescription drugs and adverse events and can therefore make patient involvement more difficult. The present project aims to test the method of patient advisory boards for the involvement of nursing home residents. Using the design of a clinical trial to optimise medication for nursing home residents as a case study, we will assess the feasibility of the method for this target group. We will also install a patient advocate as moderator of the advisory board. The study plan is described in the present study protocol.
Two patient advisory boards with nursing home residents will be established. With a patient advocate acting as moderator, the essential elements of a clinical trial to optimise medication will be discussed and passed on to the study planning team via the patient advocate. The overall topic of the clinical trial is the optimisation of medication in cardiovascular disease. The nursing home residents are informed about the contents and ideas of the study to be planned and the interests of the researchers, respectively, and will discuss the proposals of the study planning team. Nursing home residents', the patient advocate's and the researchers' expectations and experiences will be examined in individual interviews.
The study will provide a potentially suitable method to involve nursing home residents in the research process. The jointly developed study design will be incorporated into a new project proposal. The results will be used to inform the development of a German handbook on active public and patient involvement.
患者参与健康研究在许多国家都是医疗保健的一个组成部分。它促进了研究的相关性和质量，并增加了研究结果的意义。与此同时，患者参与的价值在德国也得到了认可。对患者参与缺乏共同的理解和适当的方法使得实施变得困难。在德国，患者仍然很少参与健康研究的规划和实施。由于特殊需求，老年人等弱势群体被认为在积极让患者参与方面对研究人员特别具有挑战性，这就是为什么他们经常被忽视。特别是养老院居民患有各种健康损害，伴随着大量处方药和不良事件，因此可能使患者参与更加困难。本项目旨在测试患者咨询委员会让养老院居民参与的方法。以优化养老院居民用药的临床试验设计作为案例研究，我们将评估该方法对这一目标群体的可行性。我们还将任命一名患者权益倡导者作为咨询委员会的主持人。本研究方案中描述了研究计划。
将成立两个由养老院居民组成的患者咨询委员会。由一名患者权益倡导者担任主持人，讨论优化用药的临床试验的基本要素，并通过患者权益倡导者传达给研究规划团队。该临床试验的总体主题是心血管疾病用药的优化。分别向养老院居民介绍拟计划研究的内容和想法以及研究人员的利益，并将讨论研究规划团队的提议。将通过个人访谈来考察养老院居民、患者权益倡导者和研究人员的期望和经验。
该研究将提供一种可能适合让养老院居民参与研究过程的方法。共同制定的研究设计将纳入一个新的项目提案。研究结果将用于为编写一本关于公众和患者积极参与的德国手册提供信息。
