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. 2018 May;27(5):380-388.
doi: 10.1136/bmjqs-2017-006986. Epub 2017 Dec 21.

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist

Karen R Sepucha  1 , Purva Abhyankar  2 , Aubri S Hoffman  3 , Hilary L Bekker  4 , Annie LeBlanc  5 , Carrie A Levin  6 , Mary Ropka  7 , Victoria A Shaffer  8 , Stacey L Sheridan  9 , Dawn Stacey  10   11 , Peep Stalmeier  12 , Ha Vo  13 , Celia E Wills  14 , Richard Thomson  15
Affiliations

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist

Karen R Sepucha et al. BMJ Qual Saf. 2018 May.

Abstract

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.

Keywords: checklists; patient education; patient-centred care; shared decision making.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
SUNDAE guideline development process to date. EQUATOR, Enhancing the QUAlity and Transparency Of health Research; IPDAS, International Patient Decision Aid Standards; SUNDAE, Standards for UNiversal reporting of patient Decision Aid Evaluations.
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