Background Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs.
Methods An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist.
Results The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies.
Conclusion The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist.
- shared decision making
- patient-centred care
- patient education
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Contributors The writing team was led by KRS and RT and included PA and ASH. All authors were involved in the data acquisition, analysis and interpretation of data, and drafting and critical revision of the manuscript. All but one author (HV) was involved in the study design. Each has provided final approval of the version submitted, and the lead authors KRS and RT are accountable for the accuracy and integrity of the work presented.
Funding The in-person workgroup meetings were supported through grants from the UK’s Health Foundation (grant # 7444, RT) and the Agency for Healthcare Research and Quality’s small conference grant (1R13HS024250-01, KRS). ASH is funded by the shared decision-making collaborative of the Duncan Family Institute for Cancer Prevention and Risk Assessment at the University of Texas MD Anderson Cancer Center.
Competing interests KRS received salary support as a scientific advisory board member for the Informed Medical Decisions Foundation, which was part of Healthwise, a not-for-profit organisation that develops patient decision aids, from April 2014 to April 2017. CAL was employed by Healthwise from April 2014 to November 2016. VAS received personal fees from Merck Pharmaceuticals. During the last 36 months, SLS has received funding from the Agency for Health Services Research and Quality for a scoping review to identify a research agenda on shared decision making and high value care. During this time, she also completed unfunded research or papers on patient decision aid evaluations and developed the reaching for high value care toolkit, a toolkit of evidence briefs and resources on patient-centred high value care for all levels of system leaders. As part of those efforts and efforts on the current manuscripts, SLS has developed a series of research resources on reporting research. She is considering the potential benefits and harms of pursuing intellectual property protection for some of these efforts, but has not initiated these to date.
Provenance and peer review Not commissioned; externally peer reviewed.
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