The Standards for UNiversal reporting of patient Decision Aid Evaluation (SUNDAE) Checklist was developed in order to improve the quality of publications evaluating patient decision aids (PDAs). Clear guidelines for reporting PDA evaluation studies will support better study design, will facilitate meta-analyses and systematic reviews to determine the most effective and efficient ways to design and deliver decision aids, and will ensure focused and informed peer review.
The SUNDAE Checklist builds on the work of the International Patient Decision Aid Standards (IPDAS) Collaboration. In 2013, IPDAS updated a series of 12 papers describing the theory and evidence underlying key dimensions of patient decision aids. The findings from these papers along with a 2014 Cochrane Systematic Review identified gaps in published patient decision aid studies including poor or limited reporting of the PDA content, development methods, delivery and evaluation methods.
Members of IPDAS formed a reporting guidelines workgroup (IPDAS-RG) to develop and generate consensus on a set of reporting guidelines that are covered in the 26-item Checklist. The group followed the methods promoted by EQUATOR an international clearinghouse of reporting guidelines and engaged an international group through a two phase Delphi process to generate consensus on the items. The IPDAS-RG also created an Explanation & Elaboration (E&E) document to provide authors with guidance for how to report each of the items and examples from existing literature.
SUNDAE Checklist
Section Item # |
SUNDAE Checklist for evaluation studies of patient decision aids |
Title/Abstract | |
1. | Use the term patient decision aid in the abstract to identify the intervention evaluated and, if possible, in the title. |
2. | In the abstract, identify the main outcomes used to evaluate the patient decision aid. |
Introduction | As part of standard introduction (the problem, gaps, purpose): |
3. | Describe the decision that is the focus of the patient decision aid. |
4. | Describe the intended user(s) of the patient decision aid. |
5. | Summarize the need for the patient decision aid under evaluation. |
6. | Describe the purpose of the evaluation study with respect to the patient decision aid. |
Methods | Studies with a comparator should also address Items 7-13 for the comparator, if possible. |
7. | Briefly describe the development process for the patient decision aid (and any comparator), or cite other documents that describe the process. At a minimum, include the following:
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8. | Identify the patient decision aid evaluated in the study (and any comparator) by including:
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9. | Describe the format(s) of the patient decision aid (and any comparator) (e.g. paper, online, video). |
10. | List the options presented in the patient decision aid (and any comparator). |
11. | Indicate the components in the patient decision aid (and any comparator) including:
*These components are needed to meet the definition of a patient decision aid. |
12. | Briefly describe the components from Item 11 that are included in the patient decision aid (and any comparator) or cite other documents that describe the components. |
13. | Describe the delivery of the patient decision aid (and any comparator) including:
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14. | Describe any methods used to assess the degree to which the patient decision aid was delivered and used as intended (also known as fidelity). |
15. | Describe any methods used to understand how and why the patient decision aid works (also known as process evaluation) or cite other documents that describe the methods. |
16. | Identify theories, models or frameworks used to guide the design of the evaluation and selection of study measures. |
17. | For all study measures used to assess the impact of the patient decision aid on patients, health professionals, organization, and health system:
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18. | For any instruments used:
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Results | In addition to standard reporting of results: |
19. | Describe the characteristics of the patient, family, and carer population(s) (e.g. health literacy, numeracy, prior experience with treatment options) that may affect patient decision aid outcomes. |
20. | Describe any characteristics of the participating health professionals (e.g. relevant training, usual care vs. study professional, role in decision making) that may affect decision aid outcomes. |
21. | Report any results on the use of the patient decision aid:
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22. | Report relevant results of any analyses conducted to understand how and why the patient decision aid works (also known as process evaluation). |
23. | Report any unanticipated positive or negative consequences of the patient decision aid. |
Discussion | As part of the standard discussion section (summary of key findings, interpretation, limitations and conclusion): |
24. | Discuss whether the patient decision aid worked as intended and interpret the results taking into account the specific context of the study including any process evaluation. |
25. | Discuss any implications of the results for patient decision aid development, research, implementation, and theory, frameworks or models. |
Conflict of Interest | |
26. | All study authors should disclose if they have an interest (professional, financial or intellectual) in any of the options in the patient decision aid or a financial interest in the decision aid itself. |
SUNDAE Checklist 2017 Questions or comments? Please email decisions@partners.org |
Download PDFs
SUNDAE Checklist (pdf) this version can be edited to indicate location of each item within a manuscript.
SUNDAE Checklist Glossary contains definitions for key terms and concepts.
SUNDAE Development Paper provides an overview of the development of the checklist.
SUNDAE E&E paper provides examples of how to report each item within a paper.
SUNDAE Checklist Editorial
Acknowledgment of Participants
We had over 100 participants from across the globe participate in the consensus process. The IPDAS-RG Workgroup would like to acknowledge the contributions of all Delphi participants and have listed names below of those who have given us permission to do so.
*IPDAS-RG workgroup member.
Participant Name | Affiliation | Country |
Purva Abhyankar* | Faculty of Health Sciences & Sport, University of Stirling | UK |
Joseph Anthony Anaya | Harvard Medical School | USA |
Patrick Michel Archambault | Université Laval | Canada |
David C. Aron, MD, MS | Case Western Reserve University | USA |
Steven J. Atlas, MD, MPH | Harvard Medical School | USA |
Cristian Baicus | Carol Davila University of Medicine and Pharmacy Bucharest | Romania |
Hilary Bekker* | University of Leeds | UK |
Susan Z. Berg | Dartmouth Hitchcock Medical Center | USA |
J.S. Blumenthal-Barby, PhD | Baylor College of Medicine | USA |
Ana Carvajal de la Torre | Family Medicine, Servicio Galego de Saude | Spain |
Marie-Chantal Loiselle | University of Sherbrooke | Canada |
Catharine Clay | The Dartmouth Institute for Health Policy and Clinical Practice | Costa Rica |
Angela Coulter | Informed Medical Decisions Foundation | UK |
Karina Dahl Steffensen MD, PhD | Department of Clinical Oncology and Director Center for Shared Decision Making, Vejle Hospital | Denmark |
Sandra Dunn | Children’s Hospital of Eastern Ontario Research Institute | Canada |
Karen B. Eden | Oregon Health & Science University | USA |
Susan Edgman-Levitan | Stoeckle Center for Primary CAre Innovation, Massachusetts General Hospital | USA |
Linda Fleisher | Fox Chase Center & Children’s Hospital of Philadelphia | USA |
Richard Fluck | Department of Renal Medicine, Royal Derby Hospital | UK |
Jack Fowler | Informed Medical Decisions Foundation | USA |
Mirjam Marjolein Garvelink | Research Center of the CHU de Quebec-Université Laval | Canada |
Michael R. Gionfriddo | Knowledge and Evaluation Research Unit, Mayo Clinic | USA |
David L. Hahn | University of Wisconsin | USA |
Paul K.J. Han | Maine Medical Center | USA |
Sarah T. Hawley | University of Michigan, Ann Arbor VA | USA |
Berith Hedberg | The Jönköping Academy for Improvement of Health and Welfare, Jönköping Univerity | Sweden |
Dr Jolyn Hersch | The University of Sydney | Australia |
Aubri Hoffman* | Department of Health Services Research, University of Texas MD Anderson Cancer Center | USA |
RIchard M. Hoffman, MD, MPH | University of Iowa Carver College of Medicine | USA |
Margaret Holmes-Rovner | Michigan State University | USA |
Dr Susan Hrisos | Institute of Health & Society, Newcastle upon Tyne | UK |
Jo Jerrome | Thrombosis UK | UK |
Maria L. Jibaja-Weiss | Baylor College of Medicine | USA |
Masahito Jimbo, MD, PhD, MPH | University of Michigan | USA |
Liza-Marie Johnson MD, MPH, MSB | St. Jude Children’s Research Hospital | USA |
Natalie Joseph-Williams | Cardiff University | WALES, UK |
Janet Jull | Ottawa Hospital Research Institute, Bruyere Research Institute, and University of Ottawa | Canada |
Karen Kelly-Blake, PhD | Michigan State University | USA |
Christine E. Kistler, MD, MASc | University of North Carolina at Chapel Hill | USA |
Neil Korsen, MD, MS | Maine Medical Center | USA |
Michel Labrecque | Laval University | Canada |
Lauren Leavitt | Massachusetts General Hospital | USA |
Annie LeBlanc* | Department of Family Medicine and Emergency Medicine, Laval University | Canada |
France Legare | Tier 1 Canada Research Chair in Shared Decision Making and Knowledge Translation | Canada |
Aaron Leppin | Knowledge and Evaluation Unit, Mayo Clinic | USA |
Carrie Levin* | Informed Medical Decisions Foundation, Healthwise, Inc. | USA |
Krystina B. Lewis* | University of Ottawa | Canada |
Dan Matlock | University of Colorado | USA |
Richard M Wexler, MD | USA | |
Ben Moulton | Healthwise, Inc | USA |
Alan Nye | Advancing Quality Alliance | UK |
Rana F. Obeidat RN, CNS, PhD | Faculty of Nursing, Zarqa University | Jordan |
Chad Parmet | Healthwise, Inc | USA |
Monica E. Peek, MD, MPH, MSc | University of Chicago | USA |
Lilisbeth Perestelo-Perez | Canary Islands Health Service | Spain |
Alexander James Pipkin | NHS England | UK |
Dr Tim Rapley | Newcastle University | UK |
Mary Ropka, PhD, RN* | UVA School of Medicine | USA |
Gillian Rowlands | Newcastle University | UK |
Corinna Schaefer | German Agency for Quality in Medicine | Germany |
Mara A. Schonberg MD, MPH | Beth Israel Deaconess Medical Center | USA |
Karen Sepucha* | Massachusetts General Hospital | USA |
Victoria Shaffer* | Health Sciences and Psychological Sciences, University of Missouri | USA |
L. Aubree Shay | University of Texas School of Public Health, San Antonio Regional Campus | USA |
Stacey Sheridan, MD, MPH* | USA | |
Leigh Simmons | Massachusetts General Hospital, Harvard Medical School | USA |
Dawn Stacey* | University of Ottawa | Canada |
Peep Stalmeier* | Health Evidence, Radboud University Nijmegen Medical Center | the Netherlands |
Dr Robert Stenner | Somerset Partnership NHS FT | UK |
Jamie L. Studts, PhD | University of Kentucky College of Medicine | USA |
Richard Thomson* | Institute of Health and Society, Newcastle University | UK |
Karine Toupin April | Children’s Hospital of Eastern Ontario Research Institute and University of Ottawa | Canada |
Lyndal Trevena | University of Sydney | Australia |
Trudy van der weijden | Maastricht University | Netherlands |
Haske van Veenendaal | Institute of Health Policy & Management (iBMG) | The Netherlands |
Floortje Vlemmix | Academisch Medisch Centrum (AMC) | The Netherlands |
Ha Vo | Massachusetts General Hospital | USA |
Robert Volk | The University of Texas MD Anderson Cancer Center | USA |
Prof Bee Wee | University of Oxford | UK |
Celia E. Wills* | Ohio State University | USA |
Holly Witteman | Laval University | Canada |
Brian Zikmund-Fisher | University of Michigan | USA |