Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process.

Area of Science:

• Health Services Research
• Medical Informatics
• Patient Engagement

Background:

• Patient decision aids (PDAs) are crucial tools for shared decision-making.
• Assessing PDA quality is increasingly important for certification in the US and globally.
• The IPDAS Collaboration developed the IPDASi v3.0 instrument to evaluate PDAs.

Purpose of the Study:

• To establish minimum standards for patient decision aid (PDA) certification using a modified Delphi consensus process.
• To refine the IPDASi instrument (v4.0) by identifying essential criteria for PDA quality and certification.

Main Methods:

• A two-stage modified Delphi consensus process was employed.
• Expert voting and qualitative analysis were used to evaluate IPDASi v3.0 items for inclusion as minimum standards.
• Item scores and expert feedback informed the selection and categorization of criteria.

Main Results:

• The process reduced 47 items to 44 essential criteria for PDA certification.
• Criteria were categorized into qualifying (6 items), certification (10 items), and quality (28 items).
• Qualifying criteria are necessary for an intervention to be considered a decision aid; certification criteria identify high risk of bias.

Conclusions:

• Preliminary certification criteria for PDAs have been established.
• The proposed standards focus on the PDA development process and shared decision-making design, not clinical content quality.
• Further testing and finalization of scoring processes are needed; clinical evidence appraisal should complement these criteria.