Castonguay Geneviève, Bédard Sylvain, Dubois Anick, Lessard Émilie, Rivard Léna, Rouly Ghislaine, Boivin Antoine
Canada Research Chair in Partnership with Patients and Communities, Montreal University Hospital Research Center, 850 St-Denis St, Montreal, QC, H2X 0A9, Canada.
Center of Excellence for Partnership with Patients and the Public, Montreal University Hospital Research Center, 850 St-Denis St, Montreal, QC, H2X 0A9, Canada.
Res Involv Engagem. 2025 Feb 26;11(1):15. doi: 10.1186/s40900-025-00689-0.
Patient engagement is attracting considerable interest as a potential strategy to improve the conduct of clinical trials, with evidence of significant improvement in research participant recruitment. However, impact on the retention and adherence of clinical trial participants requires further studies. Embedded studies are specific research designs where a secondary study is "embedded" into a larger host study. We aimed to investigate the feasibility of embedding a study of patient partnership in research, within an ongoing multi-center clinical trial on drug treatment.
We developed and embedded a patient engagement intervention (embedded study) into a phase 3 randomized clinical drug trial (host study). The patient engagement intervention consisted of discussions between host study participants and a patient partner, to improve research participants' experience and retention in the clinical trial. We carried out individual semi-structured interviews with patient partners and other research team members involved in the development and implementation of the embedded study, as well as an analysis of project documents. Data were analyzed using qualitative thematic analysis.
Factors impacting feasibility and lessons learned for future embedded studies on engagement science were identified. Barriers that curtailed the implementation of patient engagement into an ongoing clinical trial included: the late integration of the embedded study into the host clinical trial, different visions of patient partnership and its potential benefits, differences in communication style and preferences, a lack of fit between the specific needs of the host study and the proposed engagement model, and an overall sense of burden. Integrating patient partners into the host clinical trial was seen as potentially beneficial in improving the experience of participants in the host clinical trial through experience sharing, providing support for the consent process, and improving knowledge transfer.
This feasibility study offers insights into how contextual factors and decisions made during the design phase can impact the implementation of patient engagement studies embedded in a clinical trial. Findings suggest that knowledge of the clinical trial context (e.g., organizational, administrative, regulatory, ethics) and early collaboration among embedded study and host study teams before initiation of both studies are key conditions for success.
患者参与作为一种改善临床试验实施的潜在策略正引起广泛关注，有证据表明在研究参与者招募方面有显著改善。然而，对临床试验参与者的留存率和依从性的影响还需要进一步研究。嵌入式研究是一种特殊的研究设计，其中一项次要研究“嵌入”到一项更大的主体研究中。我们旨在调查在一项正在进行的药物治疗多中心临床试验中嵌入一项关于研究中患者伙伴关系的研究的可行性。
我们开发了一项患者参与干预措施（嵌入式研究）并将其嵌入到一项3期随机临床药物试验（主体研究）中。患者参与干预措施包括主体研究参与者与一名患者伙伴之间的讨论，以改善研究参与者在临床试验中的体验和留存率。我们对患者伙伴以及参与嵌入式研究开发和实施的其他研究团队成员进行了个人半结构化访谈，并对项目文件进行了分析。使用定性主题分析对数据进行了分析。
确定了影响可行性的因素以及未来参与科学嵌入式研究的经验教训。阻碍将患者参与纳入正在进行的临床试验的障碍包括：嵌入式研究在主体临床试验中的整合较晚、对患者伙伴关系及其潜在益处的不同看法、沟通风格和偏好的差异、主体研究的特定需求与提议的参与模式之间缺乏契合度以及总体负担感。将患者伙伴纳入主体临床试验被视为可能有助于通过经验分享改善主体临床试验参与者的体验、为知情同意过程提供支持以及改善知识转移。
这项可行性研究提供了关于背景因素以及设计阶段所做决策如何影响嵌入临床试验的患者参与研究实施的见解。研究结果表明，了解临床试验背景（如组织、行政、监管、伦理）以及嵌入式研究和主体研究团队在两项研究启动前的早期合作是成功的关键条件。
