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患者和公众参与临床试验的方法学研究重点：改良 Delphi 法。

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

机构信息

Clinical Trials Research Centre (CTRC), North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.

Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.

出版信息

Health Expect. 2017 Dec;20(6):1401-1410. doi: 10.1111/hex.12583. Epub 2017 Jun 15.

DOI:10.1111/hex.12583
PMID:28618076
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5689224/
Abstract

BACKGROUND

Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.

OBJECTIVE

To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.

DESIGN

A modified Delphi process including a two round online survey and a stakeholder consensus meeting.

PARTICIPANTS

In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.

RESULTS

Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.

CONCLUSIONS

The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

摘要

背景

尽管国际上对此兴趣日益浓厚，但在实施临床试验中的患者和公众参与（PPI）方面，缺乏关于最有效、最有效和最可接受的方法的证据。

目的

确定英国 PPI 利益相关者对方法学研究的优先事项，以帮助解决临床试验中 PPI 的不确定性。

设计

一项改良的 Delphi 过程，包括两轮在线调查和一次利益相关者共识会议。

参与者

共有 237 人注册，其中 219 人（92%）完成了第一轮。219 人中的 187 人（85%）完成了第二轮；25 名利益相关者参加了共识会议。

结果

第一轮调查包括 36 个主题；第二轮和共识会议考虑了 42 个主题。大约 96%的会议参与者将前三个主题评为同等重要。这些主题如下：在研究人员和 PPI 贡献者之间建立强大和富有成效的工作关系；探索在选择对患者重要的试验结果方面的 PPI 实践；以及对 PPI 活动进行系统审查，以提高试验信息（例如参与者信息表）对参与者的可及性和有用性。

结论

优先考虑的方法学研究主题表明了试验中 PPI 的重要不确定性领域。解决这些不确定性对于增强 PPI 至关重要。我们的发现应在临床试验中 PPI 的规划和资助中使用，以帮助集中研究工作并最大限度地减少浪费。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8be2/5689224/6ec1352df2ad/HEX-20-1401-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8be2/5689224/6ec1352df2ad/HEX-20-1401-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8be2/5689224/6ec1352df2ad/HEX-20-1401-g001.jpg

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