In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators' use of core outcome sets in randomised controlled trials

Abstract

Objective: This study aimed to investigate barriers and facilitators to core outcome set (COS) uptake in randomized controlled trials to inform the first steps in developing interventions to improve the uptake of COS.

Study design and setting: Semi-structured qualitative interviews with a purposive sample of United Kingdom chief investigators were audio-recorded, transcribed and analyzed thematically. Where appropriate, barriers and facilitators were mapped to components of behavior informed by the COM-B model of behavior.

Results: Thirteen chief investigators were interviewed. Facilitators to uptake included: the behavior of investigators, for example, their awareness and understanding of COS; and the wider research system, for example, recommendations to use COS from funders and journals. Barriers to uptake included: the perceived characteristics of COS, for example, increasing patient burden and recommendations becoming outdated; and the COS development process, for example, not including all specialties who will use the COS.

Conclusion: Based on the barriers and facilitators identified, recommendations to improve COS uptake include ensuring engagement with the research community who will use the COS, involving patients in the development of COS and ensuring COS remain up to date.

Keywords: Clinical trials; Core outcome set; Interview; Qualitative research; Research waste; Uptake.