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“给我们工具!”:根据 SPIRIT-PRO 扩展,开发知识转移工具以支持患者伙伴参与具有患者报告结局(PROs)的临床试验方案的制定。

'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension.

机构信息

Institute of Applied Health Research, Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.

Stakeholder Group, BBMRI-ERIC, Graz, Austria.

出版信息

BMJ Open. 2021 Jun 30;11(6):e046450. doi: 10.1136/bmjopen-2020-046450.


DOI:10.1136/bmjopen-2020-046450
PMID:34193492
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8246365/
Abstract

OBJECTIVES: (a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners. DESIGN: A 1-day patient and public involvement session. PARTICIPANTS: Seven patient partners. METHODS: A patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist. RESULTS: Two user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram. CONCLUSIONS: These tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

摘要

目的:(a) 将标准方案条目:干预试验推荐(SPIRIT)-患者报告结局(PRO)扩展指南改编为便于患者伙伴使用的格式,以及(b) 共同设计一个基于网络的工具,以支持患者伙伴传播和采用 SPIRIT-PRO 扩展。 设计:为期一天的患者和公众参与会议。 参与者:7 名患者伙伴。 方法:一名患者伙伴制作了 SPIRIT-PRO 指南的初步通俗摘要和词汇表。我们于 2019 年 11 月在伯明翰大学举行了为期一天的 PPI 会议。五名患者伙伴讨论了草案通俗摘要,商定了最终措辞,共同设计并同意了这两个工具的最终内容。另外两名患者伙伴参与了手稿的撰写。该研究符合 INVOLVE 指南,并根据参与患者和公众报告指南 2 清单进行了报告。 结果:开发了两个用户友好的工具来帮助患者和公众参与临床试验中 PRO 收集的共同设计。第一个工具呈现了 SPIRIT-PRO 扩展指南的通俗版本。第二个工具通过交互流程图展示了患者伙伴确定的最相关要点。 结论:这些工具有可能根据 SPIRIT-PRO 扩展指南,支持患者伙伴在制定临床试验协议的 PRO 方面做出知情贡献。患者伙伴的参与确保了这些工具专注于他们最关注的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee96/8246365/a7c96e3c3acd/bmjopen-2020-046450f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee96/8246365/1f9e7bb88811/bmjopen-2020-046450f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee96/8246365/a7c96e3c3acd/bmjopen-2020-046450f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee96/8246365/1f9e7bb88811/bmjopen-2020-046450f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee96/8246365/a7c96e3c3acd/bmjopen-2020-046450f02.jpg

相似文献

[1]
'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension.

BMJ Open. 2021-6-30

[2]
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[3]
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[4]
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[5]
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[6]
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BMC Med. 2023-7-5

[7]
Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols.

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[8]
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[9]
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[10]
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Engagement of patients and the public in personalised prevention in Europe using genomic information: a scoping review.

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[2]
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[3]
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[4]
Recruitment of patients, carers and members of the public to advisory boards, groups and panels in public and patient involved health research: a scoping review.

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[5]
Patient-centred clinical trial design.

Nat Rev Nephrol. 2022-8

[6]
Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.

PLoS Med. 2022-2

[7]
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

BMJ Open. 2021-6-30

本文引用的文献

[1]
Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials.

J Natl Cancer Inst. 2019-11-1

[2]
Taking patient reported outcomes centre stage in cancer research - why has it taken so long?

Res Involv Engagem. 2018-7-19

[3]
A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice.

J Patient Rep Outcomes. 2017

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Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

Lancet Oncol. 2018-5

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BMJ Open. 2018-2-3

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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

JAMA. 2018-2-6

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