Redesigning a web-based stakeholder consensus meeting about core outcomes for clinical trials: Formative feedback study

Abstract

Background:Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes makes it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK-government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study.Objective:An observational study evaluated the modifications taken by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol.Methods:The study team worked with healthcare users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experience of the 22 participating members. Feedback covered (i) pre-meeting preparation, (ii) process of facilitated discussions and voting, (iii) ability to contribute, and (iv) perceived fairness of the outcome.Results:Overall, 53 out of 54 feedback responses agreed or strongly agreed with the statements given, indicating the web-based meeting achieved its original goals of open discussion, debate, and voting to agree a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and managing the unpredictability of tasks on the day.Conclusions:Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximise inclusiveness, enhance geographical access, as well as to reduce research costs