title: Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process.
abstract: The IPDAS Collaboration has developed a checklist and an instrument (IPDASi v3.0) to assess the quality of patient decision aids (PDAs) in terms of their development process and shared decision-making design components. Certification of PDAs is of growing interest in the US and elsewhere. We report a modified Delphi consensus process to agree on IPDASi (v3.0) items that should be considered as minimum standards for PDA certification, for inclusion in the refined IPDASi (v4.0).
  
  
  
  A 2-stage Delphi voting process considered the inclusion of IPDASi (v3.0) items as minimum standards. Item scores and qualitative comments were analyzed, followed by expert group discussion.
  
  
  
  One hundred and one people voted in round 1; 87 in round 2. Forty-seven items were reduced to 44 items across 3 new categories: 1) qualifying criteria, which are required in order for an intervention to be considered a decision aid (6 items); 2) certification criteria, without which a decision aid is judged to have a high risk of harmful bias (10 items); and 3) quality criteria, believed to strengthen a decision aid but whose omission does not present a high risk of harmful bias (28 items).
  
  
  
  This study provides preliminary certification criteria for PDAs. Scoring and rating processes need to be tested and finalized. However, the process of appraising the quality of the clinical evidence reported by the PDA should be used to complement these criteria; the proposed standards are designed to rate the quality of the development process and shared decision-making design elements, not the quality of the PDA's clinical content.
authors: Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK (NJ-W, RN, AE, GE)
authors: Natalie
authors: N
authors: Joseph-Williams
authors: Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK (NJ-W, RN, AE, GE)
authors: Robert
authors: R
authors: Newcombe
authors: Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, MO (MP)
authors: Mary
authors: M
authors: Politi
authors: Department of Psychology, University of Hertfordshire, Hatfield, UK (M-AD)
authors: Marie-Anne
authors: MA
authors: Durand
authors: Marie Curie Palliative Care Research Centre, Wales Cancer Trials Unit, Cardiff University, Cardiff, UK (SS)
authors: Stephanie
authors: S
authors: Sivell
authors: Faculty of Health Sciences, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada (DS,CB)
authors: Dawn
authors: D
authors: Stacey
authors: Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada (AO)
authors: Annette
authors: A
authors: O'Connor
authors: Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (RJV)
authors: Robert J
authors: RJ
authors: Volk
authors: Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK (NJ-W, RN, AE, GE)
authors: Adrian
authors: A
authors: Edwards
authors: Faculty of Health Sciences, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada (DS,CB)
authors: Carol
authors: C
authors: Bennett
authors: Division of General Internal Medicine, University of North Carolina Department of Medicine, Chapel Hill, NC (MP)
authors: Michael
authors: M
authors: Pignone
authors: Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK (NJ-W, RN, AE, GE)|Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK (RT)
authors: Richard
authors: R
authors: Thomson
authors: Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK (NJ-W, RN, AE, GE)|Dartmouth Center for Health Care Delivery Science, Dartmouth College, Hanover, NH (GE).
authors: Glyn
authors: G
authors: Elwyn
mesh_terms: D002568:Certification / Q000592:standards*; D003657:Decision Making; D003661:Decision Support Techniques; D003697:Delphi Technique; D006801:Humans; D010358:Patient Participation / Q000379:methods*
keywords: decision aid research; outcomes research; patient decision making; shared decision making