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

作者：Edward Duncan, Alicia O’Cathain, Nikki S. Rousseau, Liz Croot, Katie Sworn, Katrina M. Turner, Lucy Yardley, Pat Hoddinott · 发表于：BMJ Open · 年份：2020 · DOI：10.1136/bmjopen-2019-033516 · 被引用次数：527 · 研究领域：Delphi Technique in Research、Health Policy Implementation Science、Occupational Therapy Practice and Research

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...