Using behavioral science to increase core outcome set use in trials

Karen Matvienko-Sikar, Shannen Hussey, Katie Mellor, Molly Byrne, Mike Clarke, Jamie J Kirkham, Jan Kottner, Fiona Quirke, Ian J Saldanha, Valerie Smith, Elaine Toomey, Paula R Williamson

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Abstract

Core outcome sets are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a core outcome set, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of core outcome sets in trials. This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to core outcome set use from four recently published studies examining core outcome set use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques. Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity (APEASE) ratings were used to reach consensus on intervention functions and behavior change techniques. Behavior change techniques were operationalized using examples of tangible potential applications and were categorized based on similarity. Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modelling) and 15 behavior change techniques were identified. Thirty-six behavior change technique examples were developed, including providing information on benefits of core outcome sets for health research, and information choosing core outcome sets. Behavior change technique examples are categorized by approaches related to 'workshops', 'guidance', 'audio/visual resources', and 'other resources'. Study findings represent diverse ways to potentially increase core outcome set use in trials. Future work is needed to examine effects of these behavioral intervention components on core outcome set use. If effective, increased use of core outcome sets can improve outcome reporting and minimize outcome heterogeneity and research waste.
Original languageEnglish
Article number111285
Number of pages10
JournalJournal of Clinical Epidemiology
Volume168
Early online date19 Feb 2024
DOIs
Publication statusPublished - 01 Apr 2024

Keywords

  • trial methodology
  • behavior change
  • Core outcome sets
  • behavioral science

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