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

doi:10.1016/j.jclinepi.2024.111285

Using behavioral science to increase core outcome set use in trials

J Clin Epidemiol. 2024 Apr:168:111285. doi: 10.1016/j.jclinepi.2024.111285. Epub 2024 Feb 19.

Authors

Affiliations

¹ School of Public Health, University College Cork, Cork, Ireland. Electronic address: Karen.msikar@ucc.ie.
² School of Public Health, University College Cork, Cork, Ireland.
³ Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ School of Psychology, National University of Ireland, Galway, Galway, Ireland.
⁵ Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
⁶ Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
⁷ Charité-Universitätsmedizin Berlin, Institute of Clinical Nursing Science, Berlin, Germany.
⁸ College of Medicine, Nursing & Health Sciences, Áras Moyola, National University of Ireland, Galway, Ireland.
⁹ Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, USA.
¹⁰ School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland.
¹¹ School of Nursing and Midwifery/Centre for Health Evaluation, Methodology Research and Evidence Synthesis, University of Galway, Galway, Ireland.
¹² Department of Health Data Science, Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK.

PMID: 38382890
DOI: 10.1016/j.jclinepi.2024.111285

Abstract

Objectives: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, 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 COS in trials.

Methods: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS 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 (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity.

Results: 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 modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources."

Conclusion: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Keywords: Behavior change; Behavioral science; Behaviour change wheel; Core outcome sets; Outcomes; Trial methodology.

MeSH terms

Behavior Therapy*
Behavioral Sciences*
Consensus
Humans
Motivation
Outcome Assessment, Health Care