Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials: Formative Feedback...

Area of Science:

• Audiology
• Rehabilitation Medicine
• Health Services Research

Background:

• Inconsistent outcome reporting in clinical trials hinders intervention comparison.
• Core outcome sets (COS) are recommended for standardized outcome measurement.
• The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study faced challenges due to pandemic restrictions preventing face-to-face meetings.

Purpose of the Study:

• To evaluate modifications to the CROSSSD study protocol to achieve consensus using exclusively web-based methods.
• To assess the feasibility of adapting a planned face-to-face consensus meeting into a virtual format with minimal deviation from the original protocol.

Main Methods:

• The study team adapted the nominal group technique for a web-based format, involving healthcare users and professionals.
• A follow-up survey collected feedback from 22 participating members on their experience with the virtual consensus process.
• Feedback focused on preparation, facilitated discussions, voting, contribution, and perceived fairness.

Main Results:

• 98% of feedback responses indicated agreement or strong agreement, confirming the web-based meeting achieved its goals of open discussion and voting for a core outcome set.
• Hearing-impaired participants were fully engaged, though methodological challenges were noted.
• Participant challenges included rapport building and task comprehension; study team challenges involved thorough preparation and managing task unpredictability.

Conclusions:

• The adapted web-based consensus exercise successfully established a core outcome set for single-sided deafness.
• Lessons learned from overcoming pandemic-related challenges in delivering a virtual consensus exercise can benefit future COS development.
• Web-based consensus methods can enhance inclusiveness, geographical access, and reduce research costs for future studies.