SUNDAE Checklist

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:

  • Participation of stakeholders in its development
  • The process for gathering, selecting and appraising evidence to inform its content
  • Any testing that was done
8. Identify the patient decision aid evaluated in the study (and any comparator) by including:

  • Name or information that enables it to be identified
  • Date and/or version number
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:

  • Explicit description of the decision*
  • Description of health problem*
  • Information on options and their benefits, harms, and consequences*
  • Values clarification (implicit or explicit)*
  • Numerical probabilities
  • Tailoring of information or probabilities
  • Guidance in deliberation
  • Guidance in communication
  • Personal stories
  • Reading level or other strategies to help understanding
  • Other components

*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:

  • How it was delivered (e.g. by whom and/or by what method)
  • To whom it was delivered
  • Where it was used
  • When it was used in the pathway of care
  • Any training to support delivery
  • Setting characteristics and system factors influencing its delivery
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:

  • Identify the measures
  • Indicate the timing of administration in relation to exposure to the patient decision aid and health care interventions
18. For any instruments used:

  • Name the instrument and the version (if applicable)
  • Briefly describe the psychometric properties, or cite other documents
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:

  • How much and which components were used
  • Degree to which it was delivered and used as intended (also known as fidelity)
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