ArticleTrials2025
A scoping review of how behavioural theories, models and frameworks have been applied to the design, conduct, analysis or reporting of clinical trials.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundClinical 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.
methodsA 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.
resultsA 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%).
conclusionA 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.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.