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BMJ Qual Saf. 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.

Author information

1
Division of General Internal Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
2
Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.
3
Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
4
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
5
Department of Family Medicine and Emergency Medicine, Universite Laval Faculte de medecine, Quebec, Canada.
6
Department of Research, Healthwise Inc, Boise, Idaho, USA.
7
Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
8
Health Sciences and Psychological Sciences, University of Missouri, Columbia, Missouri, USA.
9
The Reaching for High Value Care Team, Chapel Hill, North Carolina, USA.
10
Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
11
School of Nursing, University of Ottawa, Ottawa, Ontario, Canada.
12
Health Evidence, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
13
Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
14
College of Nursing, Ohio State University, Columbus, Ohio, USA.
15
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.

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

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.

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