ArticleTrials2025
Process evaluations nested in randomised controlled trials of complex interventions: a scoping review of approaches and reporting.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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
5 citing papers in PubMed.
- Trial
- Process-evaluation alongside a cluster-randomized trial examining the effectiveness of the 'SELF-program' on nurses' activity encouragement behavior.International journal of nursing studies advances · 2026Article
- Methodological considerations in interpreting a process evaluation of antimicrobial stewardship for community-acquired pneumonia.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2026Article
- Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe United Kingdom Medical Research Council (MRC) guidance for complex interventions recommends the nesting of process evaluations in randomised controlled trials (RCTs) of complex interventions. To date, there has been limited review of how the MRC guidance has been operationalised in RCTs of complex interventions.
objectivesThis scoping review aimed to identify how process evaluations nested in RCTs on complex interventions have been conducted and reported since the 2015 publication of MRC guidance.
methodsWe identified articles in PubMed and Scopus that cited the 2015 main journal article on the MRC guidance and applied an RCT filter to these articles. Studies reporting on RCT nested process evaluations in any field of health or social care were included. Data was extracted about study details, process evaluation study design, including methods used for data collection, data analyses, integration with RCT data and use of theory in process evaluation design.
resultsWe identified 160 RCTs and 53 pilot/feasibility RCTs. Most process evaluations included a combination of qualitative and quantitative data collection methods, either triangulated (mixed method studies) or not (multi-method studies). Most studies did not report the use of theory in shaping how the process evaluation was designed. Common methods for data analysis included descriptive statistics and thematic analysis for quantitative and qualitative studies respectively. There was limited triangulation of process evaluation data with RCT outcomes.
conclusionsWhilst process evaluations can be helpful in explaining outcomes of RCT interventions and subsequent implementation of these intentions, information gathered from process evaluations is often not fully reported in papers. There are currently no suitable reporting guidelines for process evaluations linked to RCTs; work to develop such guidelines, potentially as a StaRI checklist extension, would be valuable.
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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.