Patient and public involvement (PPI) has become an essential part of the design, conduct, and dissemination of research. While researchers who employed PPI mainly report on the positive aspects, in practice PPI is still an exception in clinical trials in Germany. There are specific challenges in the process of involvement that can jeopardize the conduct of involvement. The aim of our study was to analyze the experience of patients and researchers with PPI in a clinical trial in Germany, so we could learn more about potential challenges and how they could be addressed. We established a patient board for a randomized controlled trial on urinary tract infections, where patients and researchers regularly met to discuss relevant aspects of the trial. Minutes were taken for each meeting and the moderator also noted her observations in a postscript. After four meetings, we conducted two focus groups, one each with the patients and researchers. We analyzed and categorized the minutes, postscripts, and focus group transcripts using thematic qualitative text analysis. Patients and researchers felt comfortable with the composition of the patient board and its’ atmosphere. In terms of challenges, patients and researchers needed time to get familiar with PPI. Both parties saw a need for training in PPI but differed in their views on the relevant topics. Patients wished to learn more about their role and tasks within the board at the onset of the PPI. They also preferred to meet more frequently and get more intensely involved in the trial. In contrast, researchers perceived that they were already highly involved. They further felt that the involvement was of benefit to them, the trial and future research. Patients described benefits for themselves, but also wondered if their involvement had had an impact on the trial. To facilitate effective PPI, resources, adequate structures, and training are needed. Patients and researchers need to agree on their respective roles, training needs, and the mode of cooperation right at the beginning. The parties involved should continuously reflect on the actual benefits of PPI, describe them explicitly and make them transparent for all.

中文翻译：

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患者和研究人员与患者委员会一起进行尿路感染临床试验的经验

患者和公众参与 (PPI) 已成为研究设计、实施和传播的重要组成部分。虽然使用 PPI 的研究人员主要报告了积极方面，但实际上 PPI 在德国的临床试验中仍然是一个例外。参与过程中存在可能危及参与行为的具体挑战。我们研究的目的是分析 PPI 患者和研究人员在德国进行的临床试验中的经验，以便我们更多地了解潜在挑战以及如何解决这些挑战。我们为尿路感染的随机对照试验建立了一个患者委员会，患者和研究人员定期会面讨论试验的相关方面。每次会议都有记录，主持人还在后记中记录了她的观察结果。在四次会议之后，我们进行了两个焦点小组，每个小组与患者和研究人员一起参加。我们使用主题定性文本分析对会议记录、后记和焦点小组成绩单进行了分析和分类。患者和研究人员对患者委员会的组成及其氛围感到满意。在挑战方面，患者和研究人员需要时间来熟悉 PPI。双方都认为有必要进行 PPI 培训，但对相关主题的看法不同。患者希望在 PPI 开始时更多地了解他们在董事会中的角色和任务。他们还喜欢更频繁地见面并更积极地参与试验。相比之下，研究人员认为他们已经高度参与。他们进一步认为参与对他们有益，试验和未来的研究。患者描述了自己的益处，但也想知道他们的参与是否对试验产生了影响。为了促进有效的 PPI，需要资源、适当的结构和培训。患者和研究人员需要在开始时就各自的角色、培训需求和合作模式达成一致。相关各方应不断反思 PPI 的实际好处，明确描述它们并使其对所有人透明。