Vervoort J P M, Konijn W S, Jansen D E M C, Boersma C, de Zeeuw J, Ho-Dac-Pannekeet M M, Gansevoort R T, Messchendorp A L, Sanders J S F, de Wildt-Liesveld R
Dutch Kidney Patients Association (NVN), Bussum, The Netherlands.
Department of Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Res Involv Engagem. 2024 Sep 13;10(1):96. doi: 10.1186/s40900-024-00622-x.
The need for patient engagement in health research has been increasingly acknowledged and accepted in recent years. However, implementation is still limited due to lack of evidence on its value and lack of guidance on how to implement patient engagement. This study aims to provide insight into the contribution of patient engagement in the RECOVAC project, which studied COVID-19 vaccination in kidney patients, and formulate concrete practice-based action perspectives for patient engagement.
We used a qualitative participatory mixed methods approach, based on the Patient Engagement Monitoring and Evaluation (PEME) framework. Patient engagement and data collection were based on the Reflexive Monitoring in Action (RMA) approach. Data collection included participant observations, open ended questionnaires and interactive reflection sessions. Qualitative analysis was done via a thematic approach.
We have described the process of patient engagement systematically, provided insight in its value and found that there is a need for clear aims, expectations and preparations from the start of the engagement process. We have shown that reflection throughout the process is of utmost importance and the same applies to clear communication between researchers and patient representatives. By being part of the consortium patient representatives had direct access to information, straight from the source, on for example the vaccination schedule and medication availability and had indirect influence on decisions made by the National Institute for Public Health and the Environment (RIVM) on preventive measures and treatment against COVID-19. Having experienced patient representatives is important, otherwise training needs to be provided. We also found that patient engagement had impact on conduct and outcomes of research activities itself and may have impact on future research and patient engagement activities in general.
Patient engagement has changed the course of the project. Concrete practice-based action perspectives have been formulated, which are already being implemented by the Dutch Kidney Patients Association (NVN). Studying patient engagement in a high pace project with high public interest has resulted in lessons learned and will help prepare and implement patient involvement in future research projects.
The RECOVAC studies in which the patient engagement took place are registered at clinicialtrial.gov (NCT04741386 registration date 2021-02-04, NCT04841785 registration date 2021-03-22 and NCT05030974 registration date 2021-08-20).
近年来，患者参与健康研究的必要性已得到越来越多的认可和接受。然而，由于缺乏关于其价值的证据以及缺乏如何实施患者参与的指导，其实施仍然有限。本研究旨在深入了解患者参与RECOVAC项目的贡献，该项目研究了肾病患者的新冠疫苗接种情况，并为患者参与制定基于实践的具体行动观点。
我们采用了基于患者参与监测与评估（PEME）框架的定性参与式混合方法。患者参与和数据收集基于行动中的反思性监测（RMA）方法。数据收集包括参与观察、开放式问卷调查和互动反思会议。定性分析通过主题方法进行。
我们系统地描述了患者参与的过程，深入了解了其价值，并发现从参与过程开始就需要明确的目标、期望和准备。我们表明，在整个过程中进行反思至关重要，研究人员与患者代表之间的清晰沟通也是如此。作为联盟的一部分，患者代表可以直接从源头获取例如疫苗接种时间表和药物供应等信息，并对国家公共卫生与环境研究所（RIVM）就新冠疫情预防措施和治疗做出的决策产生间接影响。拥有经验丰富的患者代表很重要，否则需要提供培训。我们还发现患者参与对研究活动本身的开展和结果产生了影响，并且可能对未来的研究和一般患者参与活动产生影响。
患者参与改变了项目的进程。已经制定了基于实践的具体行动观点，荷兰肾病患者协会（NVN）已经在实施这些观点。在一个具有高度公众关注度的快节奏项目中研究患者参与，收获了经验教训，并将有助于为未来研究项目中患者参与的准备和实施提供帮助。
进行患者参与的RECOVAC研究已在clinicaltrial.gov上注册（NCT04741386注册日期2021年2月4日，NCT04841785注册日期2021年3月22日，NCT05030974注册日期2021年8月20日）。
