A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials

Taylor Coffey; Naomi Young; Katie Gillies

doi:10.1186/s13063-025-08808-8

A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials

Taylor Coffey^* (Corresponding Author)
, Naomi Young
, Katie Gillies

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

5 Downloads (Pure)

Abstract

Background
Clinical trials provide much of the evidence that guides decision making about treatment and care but are often complicated to deliver. Trials can be thought of as complex systems with interacting individuals, as such behavioural science is a useful lens to investigate how trial processes may be improved. To guide selection of an appropriate behavioural theory, model, or framework to further enhance trial processes, we sought to map their past application within the design, conduct, analysis and reporting of clinical trials.

Methods
A scoping review to investigate the breadth of trials methods research that has utilised a behavioural theory, model, or framework was conducted through a database search and citation analysis. Publications investigating any part of the trial lifecycle (from design to reporting) through a behavioural lens were included. Data were extracted from each study and organised thematically to summarise trends in behavioural approach application within different trial-related behaviours and contexts.

Results
A total of 96 studies were included. A majority of these (n = 93, 97%) investigated trial conduct processes, such as recruitment and retention. A total of 23 unique theories, models or frameworks were identified. Three behavioural theories, models or frameworks, the Theory of Planned Behaviour (n = 23, 24%), Social Cognitive Theory (n = 12, 13%) and the Theoretical Domains Framework (n = 30, 31%), accounted for more than two-thirds of those utilised. When compared to key stages of the Knowledge to Action cycle, approaches reported in included studies were most often utilised to “Identify a problem” within trials (n = 40, 42%).

Conclusion
A wide variety of behavioural approaches to investigate trial conduct were identified. However, the trial processes studied were focused within trial recruitment and largely used a select number approaches. Future research should assess whether these approaches are fit for purpose, as well as prioritising other trial areas for methods research.

Original language	English
Article number	104
Number of pages	13
Journal	Trials
Volume	26
DOIs	https://doi.org/10.1186/s13063-025-08808-8
Publication status	Published - 25 Mar 2025

Data Availability Statement

An abbreviated, live version of the included studies in the review, along with PDF copies of those included studies, are available on the Open Science Framework (https://osf.io/zkpv4/?view_only=01faeffd2c904496945c46c33f26d841). All other datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Funding

This project was funded as part of a Medical Research Council non-clinical fellowship awarded to KG (MR/X007464/1). The funder had no specific role in the conceptualization, design, data collection, analysis, decision to publish or preparation of the manuscript.

Funders	Funder number
Medical Research Council	MR/X007464/1

Keywords

behavioural science
clinical trials
trials methodology
scoping review

Access to Document

10.1186/s13063-025-08808-8Licence: CC BY

Coffey_etal_BMCT_A_scoping_review_VOR
© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Final published version, 2.35 MBLicence: CC BY

https://osf.io/zkpv4/?view_only=01faeffd2c904496945c46c33f26d841

Cite this

@article{41340b9c68cf4da3bd32665f419881d0,

title = "A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials",

abstract = "Background Clinical trials provide much of the evidence that guides decision making about treatment and care but are often complicated to deliver. Trials can be thought of as complex systems with interacting individuals, as such behavioural science is a useful lens to investigate how trial processes may be improved. To guide selection of an appropriate behavioural theory, model, or framework to further enhance trial processes, we sought to map their past application within the design, conduct, analysis and reporting of clinical trials. Methods A scoping review to investigate the breadth of trials methods research that has utilised a behavioural theory, model, or framework was conducted through a database search and citation analysis. Publications investigating any part of the trial lifecycle (from design to reporting) through a behavioural lens were included. Data were extracted from each study and organised thematically to summarise trends in behavioural approach application within different trial-related behaviours and contexts. Results A total of 96 studies were included. A majority of these (n = 93, 97\%) investigated trial conduct processes, such as recruitment and retention. A total of 23 unique theories, models or frameworks were identified. Three behavioural theories, models or frameworks, the Theory of Planned Behaviour (n = 23, 24\%), Social Cognitive Theory (n = 12, 13\%) and the Theoretical Domains Framework (n = 30, 31\%), accounted for more than two-thirds of those utilised. When compared to key stages of the Knowledge to Action cycle, approaches reported in included studies were most often utilised to “Identify a problem” within trials (n = 40, 42\%). Conclusion A wide variety of behavioural approaches to investigate trial conduct were identified. However, the trial processes studied were focused within trial recruitment and largely used a select number approaches. Future research should assess whether these approaches are fit for purpose, as well as prioritising other trial areas for methods research.",

keywords = "behavioural science, clinical trials, trials methodology, scoping review",

author = "Taylor Coffey and Naomi Young and Katie Gillies",

year = "2025",

month = mar,

day = "25",

doi = "10.1186/s13063-025-08808-8",

language = "English",

volume = "26",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

}

TY - JOUR

T1 - A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials

AU - Coffey, Taylor

AU - Young, Naomi

AU - Gillies, Katie

PY - 2025/3/25

Y1 - 2025/3/25

N2 - Background Clinical trials provide much of the evidence that guides decision making about treatment and care but are often complicated to deliver. Trials can be thought of as complex systems with interacting individuals, as such behavioural science is a useful lens to investigate how trial processes may be improved. To guide selection of an appropriate behavioural theory, model, or framework to further enhance trial processes, we sought to map their past application within the design, conduct, analysis and reporting of clinical trials. Methods A scoping review to investigate the breadth of trials methods research that has utilised a behavioural theory, model, or framework was conducted through a database search and citation analysis. Publications investigating any part of the trial lifecycle (from design to reporting) through a behavioural lens were included. Data were extracted from each study and organised thematically to summarise trends in behavioural approach application within different trial-related behaviours and contexts. Results A total of 96 studies were included. A majority of these (n = 93, 97%) investigated trial conduct processes, such as recruitment and retention. A total of 23 unique theories, models or frameworks were identified. Three behavioural theories, models or frameworks, the Theory of Planned Behaviour (n = 23, 24%), Social Cognitive Theory (n = 12, 13%) and the Theoretical Domains Framework (n = 30, 31%), accounted for more than two-thirds of those utilised. When compared to key stages of the Knowledge to Action cycle, approaches reported in included studies were most often utilised to “Identify a problem” within trials (n = 40, 42%). Conclusion A wide variety of behavioural approaches to investigate trial conduct were identified. However, the trial processes studied were focused within trial recruitment and largely used a select number approaches. Future research should assess whether these approaches are fit for purpose, as well as prioritising other trial areas for methods research.

AB - Background Clinical trials provide much of the evidence that guides decision making about treatment and care but are often complicated to deliver. Trials can be thought of as complex systems with interacting individuals, as such behavioural science is a useful lens to investigate how trial processes may be improved. To guide selection of an appropriate behavioural theory, model, or framework to further enhance trial processes, we sought to map their past application within the design, conduct, analysis and reporting of clinical trials. Methods A scoping review to investigate the breadth of trials methods research that has utilised a behavioural theory, model, or framework was conducted through a database search and citation analysis. Publications investigating any part of the trial lifecycle (from design to reporting) through a behavioural lens were included. Data were extracted from each study and organised thematically to summarise trends in behavioural approach application within different trial-related behaviours and contexts. Results A total of 96 studies were included. A majority of these (n = 93, 97%) investigated trial conduct processes, such as recruitment and retention. A total of 23 unique theories, models or frameworks were identified. Three behavioural theories, models or frameworks, the Theory of Planned Behaviour (n = 23, 24%), Social Cognitive Theory (n = 12, 13%) and the Theoretical Domains Framework (n = 30, 31%), accounted for more than two-thirds of those utilised. When compared to key stages of the Knowledge to Action cycle, approaches reported in included studies were most often utilised to “Identify a problem” within trials (n = 40, 42%). Conclusion A wide variety of behavioural approaches to investigate trial conduct were identified. However, the trial processes studied were focused within trial recruitment and largely used a select number approaches. Future research should assess whether these approaches are fit for purpose, as well as prioritising other trial areas for methods research.

KW - behavioural science

KW - clinical trials

KW - trials methodology

KW - scoping review

U2 - 10.1186/s13063-025-08808-8

DO - 10.1186/s13063-025-08808-8

M3 - Article

C2 - 40134006

SN - 1745-6215

VL - 26

JO - Trials

JF - Trials

M1 - 104

ER -

A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials

Abstract

Data Availability Statement

Funding

Keywords

Access to Document

Fingerprint

Cite this