公众和患者参与（PPI）知情参与者信息单张（PIL）可以改善试验招募、保留和决策质量吗？一项随机对照双盲试验（SWAT）结果

IF 3.2 3区医学 Q2 HEALTH CARE SCIENCES & SERVICES

Health Expectations Pub Date : 2025-06-08 DOI:10.1111/hex.70321

Linda O'Neill, Peter Knapp, Suzanne L. Doyle, Sanela Begic, Emily Smyth, Neil Kearney, Sophie Grehan, Adwoa Parker, Peter Browne, Ricardo Segurado, Deirdre Connolly, Jacintha O'Sullivan, John V. Reynolds, Emer Guinan, Juliette Hussey

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引用次数: 0

摘要

公众和患者参与（PPI）可用于改进试验行为的各个方面。本研究是在一项试验（SWAT）中进行的，目的是检查一份知情的参与者信息传单（PIL）是否可以改善上胃肠道（UGI）癌症幸存者基于运动的康复试验（RESTORE II）的招募、保留和决策质量。方法SWAT分两期进行。第一阶段应用定性方法来开发和完善一个基于ppi的PIL。第二阶段在RESTORE II试验中嵌入了一个随机对照双盲SWAT，比较了标准PIL （PIL a）和ppi通知PIL （PIL B）在招聘、保留和决策质量（决策问卷[DMQ]）方面的差异。结果一期招募了16名PPI成员（平均年龄67.01[9.28]岁，主要为男性[81.25%]，全部为UGI癌症幸存者）。与会者审阅了标准的PIL - A，并提出了改进建议，包括修改布局、标题、文本、在第一页提供关键信息，以及更加强调参与的潜在好处。这个反馈被用来起草可选的PIL B，第一阶段的参与者通过对外观、文本和布局的微小更改来审查和完善它。在第二阶段，307名潜在的RESTORE II试验参与者被随机分配接受PIL A （n = 154）或PIL B （n = 153）。总体录取率为28.7%。（PIL A 26.6% vs. PIL B 30.7%, OR 1.22 [95% CI 0.74 ~ 2.01, p = 0.43]），保留率为84.1% （PIL A 85.4% vs. PIL B 83.0%, OR 0.84 [95% CI 0.26 ~ 2.65, p = 0.760]）。平均（SD） DMQ评分无显著差异：PIL A: 29.1 (4.4) vs. PIL B: 29.1(5.1)（平均差异0.03,95% CI - 1.64 ~ 1.69, p = 0.49）。结论：在RESTORE II试验中，ppi通知的PIL并没有改善招募、保留或决策。患有UGI癌症的患者为介入性PIL b的发展提供了信息。作者P.B.作为试验指导委员会的成员，在整个SWAT中从患者的角度提供了意见，为SWAT管理提供监督，并对本文的分析和制作做出了贡献。SWAT注册：北爱尔兰试验方法研究中心，SWAT商店，SWAT 100 https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,914713,en.pdf。宿主试验注册临床试验。gov https://clinicaltrials.gov/study/NCT03958019。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Can a Public and Patient Involvement (PPI) Informed Participant Information Leaflet (PIL) Improve Trial Recruitment, Retention, and Quality of Decision Making? Results of a Randomised Controlled Double-Blind Study Within a Trial (SWAT)

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Introduction

Public and patient involvement (PPI) may be utilised to improve aspects of trial conduct. This study within a trial (SWAT) aimed to examine if a PPI-informed participant information leaflet (PIL) could improve recruitment, retention, and quality of decision-making of an exercise-based rehabilitation trial (RESTORE II) for upper gastrointestinal (UGI) cancer survivors.

Methods

This SWAT was conducted over two phases. Phase 1 applied qualitative methods to develop and refine a PPI-informed PIL. Phase 2 embedded a randomised controlled double-blind SWAT within the RESTORE II trial, comparing a standard PIL (PIL A) to the PPI-informed PIL (PIL B) in terms of recruitment, retention, and quality of decision-making (Decision Making Questionnaire [DMQ]).

Results

Phase 1 recruited 16 PPI members (mean age 67.01 [9.28] years, mostly male [81.25%] and all UGI cancer survivors). Participants reviewed the standard PIL A and made suggestions for improvement, including revisions to the layout, title, text, provision of key information on the first page, and greater emphasis on the potential benefits of participation. This feedback was used to draft the alternative PIL B, which the Phase 1 participants reviewed and refined through minor changes to the appearance, text, and layout. In Phase 2, 307 potential RESTORE II trial participants were randomised to receive either PIL A (n = 154) or PIL B (n = 153). The overall recruitment rate was 28.7%. (PIL A 26.6% vs. PIL B 30.7%, OR 1.22 [95% CI 0.74 to 2.01, p = 0.43]), retention was 84.1% (PIL A 85.4% vs. PIL B 83.0%, OR 0.84 [95% CI 0.26 to 2.65, p = 0.760]). No significant difference in mean (SD) DMQ scores was observed: PIL A: 29.1 (4.4) vs. PIL B: 29.1 (5.1) (mean difference 0.03, 95% CI −1.64 to 1.69, p = 0.49).

Conclusions

A PPI-informed PIL did not improve recruitment, retention, or decision-making for the RESTORE II trial.

Patient or Public Contribution

Patients with UGI cancer informed the development of the interventional PIL B. Author P.B. provided input from the patient's perspective throughout the SWAT as a member of the Trial Steering Committee, providing oversight to the SWAT management, and contributed to analysis and the production of this manuscript.

Trial Registration

SWAT Registration: The Northern Ireland Hub for Trials Methodology Research, SWAT Store, SWAT 100 https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,914713,en.pdf. Host Trial Registration Clinical Trials. gov https://clinicaltrials.gov/study/NCT03958019.

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来源期刊

Health Expectations 医学-公共卫生、环境卫生与职业卫生

CiteScore

5.20

自引率

9.40%

发文量

251

审稿时长

>12 weeks

期刊介绍： Health Expectations promotes critical thinking and informed debate about all aspects of patient and public involvement and engagement (PPIE) in health and social care, health policy and health services research including: • Person-centred care and quality improvement • Patients'' participation in decisions about disease prevention and management • Public perceptions of health services • Citizen involvement in health care policy making and priority-setting • Methods for monitoring and evaluating participation • Empowerment and consumerism • Patients'' role in safety and quality • Patient and public role in health services research • Co-production (researchers working with patients and the public) of research, health care and policy Health Expectations is a quarterly, peer-reviewed journal publishing original research, review articles and critical commentaries. It includes papers which clarify concepts, develop theories, and critically analyse and evaluate specific policies and practices. The Journal provides an inter-disciplinary and international forum in which researchers (including PPIE researchers) from a range of backgrounds and expertise can present their work to other researchers, policy-makers, health care professionals, managers, patients and consumer advocates.