ArticleTrials2019
Investigating causal mechanisms in randomised controlled trials.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- An individual participant data meta-analysis investigating the mediating role of eating behavior traits in Acceptance and Commitment Therapy-based weight management interventions.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2025Pooled it
- Attempting to Separate Placebo Effects from Exercise in Chronic Pain: A Systematic Review and Meta-analysis.Sports medicine (Auckland, N.Z.) · 2022Pooled it
- Mechanisms Underlying an Enhanced Navigation-Based Intervention to Improve Timely Adjuvant Therapy: A Secondary Analysis of the NDURE Randomized Clinical Trial.JAMA otolaryngology-- head & neck surgery · 2026Trial
- Mechanisms of change in a randomized control pilot study of partner-involved financial incentive treatments for dual-smoking couples.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2025Trial
- Early phosphate changes as potential indicator of unreadiness for artificial feeding: a secondary analysis of the EPaNIC RCT.Critical care (London, England) · 2025Trial
- Effect of withholding early parenteral nutrition in PICU on ketogenesis as potential mediator of its outcome benefit.Critical care (London, England) · 2020Trial
- Infants and Mobiles: Developing an Understanding of Cause and Effect.Developmental science · 2026Article
- Feasibility of Recruiting Psychiatrically Hospitalized Adults for a Randomized Controlled Trial of an Animal-Assisted Intervention.Healthcare (Basel, Switzerland) · 2026Article
- Article
- Dietary Temperature's Influence on Energy Balance in Humans: Protocol for a Randomized Controlled Trial and Crossover Design.JMIR research protocols · 2023Article
- Article
- Choosing what works for whom: towards a better use of mechanistic knowledge in clinical practice.Archives of physiotherapy · 2021Article
- Evaluating sources of bias in observational studies of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker use during COVID-19: beyond confounding.Journal of hypertension · 2021Review
- Using Mediation Analysis to Understand How Treatments for Paediatric Pain Work: A Systematic Review and Recommendations for Future Research.Children (Basel, Switzerland) · 2021Review
- Article
- Article
- Development of A Guideline for Reporting Mediation Analyses (AGReMA).BMC medical research methodology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIn some randomised trials, the primary interest is in the mechanisms by which an intervention exerts its effects on health outcomes. That is, clinicians and policy-makers may be interested in how the intervention works (or why it does not work) through hypothesised causal mechanisms. In this article, we highlight the value of understanding causal mechanisms in randomised trials by applying causal mediation analysis to two randomised trials of complex interventions. MAIN BODY: In the first example, we examine a potential mechanism by which an exercise programme for rheumatoid arthritis of the hand could improve hand function. In the second example, we explore why a rehabilitation programme for ankle fractures failed to improve lower-limb function through hypothesised mechanisms. We outline critical assumptions that are required for making valid causal inferences from these analyses, and provide results of sensitivity analyses that are used to assess the degree to which the estimated causal mediation effects could have been biased by residual confounding.
conclusionThis paper demonstrates how the application of causal mediation analyses to randomised trials can identify the mechanisms by which complex interventions exert their effects. We discuss methodological issues and assumptions that should be considered when mediation analyses of randomised trials are used to inform clinical practice and policy decisions.
Indexed as
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What OpenQuestion 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 OpenQuestion graph.