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Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist
  1. Karen R Sepucha1,
  2. Purva Abhyankar2,
  3. Aubri S Hoffman3,
  4. Hilary L Bekker4,
  5. Annie LeBlanc5,
  6. Carrie A Levin6,
  7. Mary Ropka7,
  8. Victoria A Shaffer8,
  9. Stacey L Sheridan9,
  10. Dawn Stacey10,11,
  11. Peep Stalmeier12,
  12. Ha Vo13,
  13. Celia E Wills14,
  14. Richard Thomson15
  1. 1 Division of General Internal Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
  2. 2 Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK
  3. 3 Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  4. 4 Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
  5. 5 Department of Family Medicine and Emergency Medicine, Universite Laval Faculte de medecine, Quebec, Canada
  6. 6 Department of Research, Healthwise Inc, Boise, Idaho, USA
  7. 7 Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA
  8. 8 Health Sciences and Psychological Sciences, University of Missouri, Columbia, Missouri, USA
  9. 9 The Reaching for High Value Care Team, Chapel Hill, North Carolina, USA
  10. 10 Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
  11. 11 School of Nursing, University of Ottawa, Ottawa, Ontario, Canada
  12. 12 Health Evidence, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
  13. 13 Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
  14. 14 College of Nursing, Ohio State University, Columbus, Ohio, USA
  15. 15 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
  1. Correspondence to Dr Karen R Sepucha, Department of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA 02114, USA; ksepucha{at}


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
  • checklists
  • 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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