健康研究中报告干预发展研究的指南 (GUIDED):一项基于证据的共识研究。

Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

机构信息

Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK

School of Health and Related Research, University of Sheffield, Sheffield, UK.

出版信息

BMJ Open. 2020 Apr 8;10(4):e033516. doi: 10.1136/bmjopen-2019-033516.

Abstract

OBJECTIVE

To improve the quality and consistency of intervention development reporting in health research.

DESIGN

This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.

PARTICIPANTS

Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.

RESULTS

e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.

CONCLUSIONS

Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

摘要

目的

提高健康研究中干预措施制定报告的质量和一致性。

设计

这是一项共识性工作,包括两项同时进行且内容完全相同的三轮电子德尔菲研究(一轮面向干预措施制定专家,一轮面向更广泛的利益相关者,包括资助者、期刊编辑和公众参与成员),之后是一次共识会议。德尔菲项目是从两项先前的系统评价和一项定性访谈研究中系统得出的。

参与者

来自英国、北美和欧洲的干预措施制定者(n=26)和更广泛的利益相关者(n=18)分别参加了电子德尔菲研究。干预措施制定者(n=13)和更广泛的利益相关者(n=13)参加了为期一天的共识会议。

结果

电子德尔菲参与者就 15 项报告项目达成共识。在共识会议反馈后,最终确定了 14 项包含描述和解释的项目,并达成了一致意见。这些项目重点关注背景、目的、目标人群、方法、证据、理论、指导原则、利益相关者的贡献、在发展过程中内容或格式的变化、针对亚组的必要更改、持续存在的不确定性以及开放获取出版。它们构成了 GUIDED(干预措施制定报告指南)清单,其中包含每个项目的描述和解释,以及良好报告的示例。

结论

现在为出版商和研究人员提供了用于健康研究中干预措施制定的基于共识的报告指南。GUIDED 有可能提高透明度,提高干预措施制定研究和实践的质量和学习效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7c/7245409/88c05617e49d/bmjopen-2019-033516f01.jpg

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