PURPOSE To ensure that research on kidney stones provides meaningful impact for the kidney stone community, patients and caregivers should be engaged as stakeholders in clinical trial design, starting at study inception. This project aimed to elicit, refine, and prioritize research ideas from kidney stone stakeholders to develop a patient-centered research agenda for clinical trials. MATERIALS AND METHODS The Kidney Stone Engagement Core, a group of patients, caregivers, advocates, clinicians, and researchers, executed an iterative process of surveys and focus groups to elicit and refine research themes, which were then translated into research questions. A separate group of patients, caregivers, and clinicians prioritized these questions through parallel modified Delphi and crowd-sourced digital platforms. A research agenda was developed by the Kidney Stone Engagement Core based on the highest rated questions during a hybrid virtual/in-person capstone session. RESULTS A total of 70 individuals (57 patients and caregivers, 13 researchers and clinicians) participated in the elicitation, 20 individuals (15 patients and caregivers, 5 researchers and clinicians) participated in refinement, and an additional 80 individuals (81 patients and caregivers, 9 researchers and clinicians) participated in prioritization. Key novel themes emerged from elicitation and refinement: ureteral stents, genetic evaluation, shared surgical decision-making, key subgroups, cumulative disease burden, genetic evaluation, and psychosocial support. Stakeholders generated 6 proposed trials from these themes focused on surveillance, surgical intervention, and medical prevention. CONCLUSIONS Patients and caregivers valued comparative effectiveness kidney stone research that focused on individualized care, shared decision-making, and improvement of patient-reported experiences. This process provided actionable recommendations for future patient-centered clinical trials within kidney stone disease.

中文翻译：

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肾结石疾病临床试验以患者为优先的研究议程。


目的 为了确保肾结石研究对肾结石社区产生有意义的影响，患者和护理人员应从研究开始时作为利益相关者参与临床试验设计。该项目旨在引出、完善和优先考虑肾结石利益相关者的研究想法，以制定以患者为中心的临床试验研究议程。材料和方法 肾结石参与核心由患者、护理人员、倡导者、临床医生和研究人员组成，执行了调查和焦点小组的迭代过程，以引出和完善研究主题，然后将其转化为研究问题。另一组患者、护理人员和临床医生通过并行修改的德尔福和众包数字平台优先考虑这些问题。肾结石参与核心根据虚拟/面对面混合顶峰会议期间评分最高的问题制定了研究议程。结果 共有 70 人（57 名患者和护理人员、13 名研究人员和临床医生）参与了启发，20 人（15 名患者和护理人员、5 名研究人员和临床医生）参与了细化，另外 80 人（81 名患者和护理人员、 9 位研究人员和临床医生）参与了优先排序。通过启发和完善，出现了关键的新主题：输尿管支架、遗传评估、共享手术决策、关键亚组、累积疾病负担、遗传评估和心理社会支持。利益相关者根据这些主题提出了 6 项拟议试验，重点关注监测、外科干预和医疗预防。 结论 患者和护理人员重视肾结石研究的比较有效性，该研究侧重于个体化护理、共同决策和改善患者报告的体验。这一过程为未来以患者为中心的肾结石疾病临床试验提供了可行的建议。