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Using behavioral science to increase core outcome set use in trials.

Karen Matvienko-Sikar1, Shannen Hussey1, Katie Mellor2

  • 1School of Public Health, University College Cork, Cork, Ireland.

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|February 21, 2024
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Summary

This study identified behavioral strategies to increase the use of core outcome sets (COS) in clinical trials. These strategies include education, training, and persuasion to improve research standardization and reduce waste.

Keywords:
Behavior changeBehavioral scienceBehaviour change wheelCore outcome setsOutcomesTrial methodology

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Area of Science:

  • Clinical trials methodology
  • Behavioral science in research

Background:

  • Core outcome sets (COS) enhance clinical trial standardization and reduce outcome heterogeneity.
  • The adoption of COS is a behavior that can be influenced by targeted interventions.

Purpose of the Study:

  • To identify behavioral intervention components that can increase the utilization of COS in clinical trials.
  • To apply the Behavior Change Wheel framework to understand and influence COS adoption.

Main Methods:

  • Utilized the Behavior Change Wheel framework and the COM-B model to analyze barriers and facilitators to COS use.
  • Two reviewers extracted and coded data from four studies on COS use.
  • Intervention functions and behavior change techniques (BCTs) were identified and mapped.

Main Results:

  • Barriers and facilitators were identified across capability, opportunity, and motivation domains of the COM-B model.
  • Five intervention functions and 15 BCTs were identified, with 36 tangible examples developed.
  • BCT examples included providing information on COS benefits and selection guidance, categorized by delivery method.

Conclusions:

  • The study provides diverse behavioral intervention components to promote COS use in clinical trials.
  • Further research is required to evaluate the effectiveness of these identified components.
  • Successful implementation of COS can lead to improved outcome reporting and reduced research waste.