Interventions to support patient decision making about taking part in health research: A systematic review

IF 3.1 2区医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Patient Education and Counseling Pub Date : 2025-09-08 DOI:10.1016/j.pec.2025.109339

Jolyn Hersch , Lauren O'Hara , Ilona Juraskova , Rebekah Laidsaar-Powell , Nicci Bartley , Katie Gillies , Mandy Ballinger , Wei Wang , Phyllis Butow

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引用次数: 0

Abstract

Objectives

An important, albeit challenging, aspect of conducting clinical research is achieving informed consent. We systematically reviewed the literature to characterise existing interventions designed to support communication and decision making about participating in health research.

Methods

We searched five databases (1990–2025) for peer-reviewed studies about intervention development and/or evaluation, reporting data on acceptability and/or efficacy. Eligible interventions addressed decisions about research participation and aimed to improve decision quality by enabling adult patients to address their information needs (e.g., question prompt list) and/or incorporate their values into decision making (e.g., decision aid). We conducted a narrative synthesis to describe the interventions, summarising findings on their effects where applicable.

Results

Eighteen studies met inclusion criteria. In seven studies, interventions targeted a specific clinical study; 11 covered clinical trials generally. Eight tools were printed; ten were digital, incorporating various interactive features. Four interventions addressed racial, ethnic, or cultural diversity. Thirteen papers cited relevant theories or frameworks that informed intervention development. Evidence from controlled studies (n = 11) showed that interventions generally increased knowledge, with little effect on participation rates.

Conclusions and practice implications

This review highlights the potential utility of tools for patients considering health research participation, providing an overview of resources available and synthesising key principles for intervention developers. However, most interventions targeted decisions about participation in cancer clinical trials. Future interventions should address other clinical settings and research designs, and emerging areas like genomics and precision medicine. Digital technology can offer opportunities to tailor content, enhance interactivity, and optimise support for diverse communities.

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支持患者参与健康研究决策的干预措施：系统回顾

开展临床研究的一个重要但具有挑战性的方面是获得知情同意。我们系统地回顾了文献，以描述旨在支持参与健康研究的沟通和决策的现有干预措施。方法：我们检索了5个数据库（1990-2025），检索了有关干预措施发展和/或评估的同行评审研究，报告了可接受性和/或疗效的数据。合格的干预措施涉及有关研究参与的决策，旨在通过使成年患者能够解决他们的信息需求（例如，问题提示列表）和/或将他们的价值观纳入决策（例如，决策援助）来提高决策质量。我们进行了叙述综合来描述干预措施，在适用的情况下总结其效果的发现。结果18项研究符合纳入标准。在7项研究中，干预措施针对特定的临床研究；11项涉及一般临床试验。打印了8个工具；其中10个是数字化的，结合了各种互动功能。四项干预措施涉及种族、民族或文化多样性。13篇论文引用了干预措施发展的相关理论或框架。来自对照研究的证据（n = 11）表明，干预措施通常会增加知识，但对参与率影响不大。结论和实践意义本综述强调了工具对考虑参与健康研究的患者的潜在效用，提供了可用资源的概述，并为干预措施的制定者提供了关键原则的综合。然而，大多数干预措施针对的是参与癌症临床试验的决定。未来的干预措施应该针对其他临床环境和研究设计，以及基因组学和精准医学等新兴领域。数字技术可以为定制内容、增强互动性和优化对不同社区的支持提供机会。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Patient Education and Counseling 医学-公共卫生、环境卫生与职业卫生

CiteScore

5.60

自引率

11.40%

发文量

384

审稿时长

46 days

期刊介绍： Patient Education and Counseling is an interdisciplinary, international journal for patient education and health promotion researchers, managers and clinicians. The journal seeks to explore and elucidate the educational, counseling and communication models in health care. Its aim is to provide a forum for fundamental as well as applied research, and to promote the study of organizational issues involved with the delivery of patient education, counseling, health promotion services and training models in improving communication between providers and patients.