ReviewTrials2026
Methodological changes made to NIHR-funded randomised controlled trials: review of 100 trials.
Review in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
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
backgroundPrevious studies have reviewed protocol amendments to trial methods in commercial studies and single centres. These studies identified that many were avoidable changes. This study aimed to assess the types of changes and rationale for changes in publicly funded randomised controlled trials undertaken in the UK.
methodsThe most recent 100 published randomised controlled trials, on 23rd June 2024, in two NIHR Journals (Health Technology Assessment and Efficacy and Mechanism Evaluation), were selected for review. Data was collected on trial characteristics and the changes reported in the protocol, published reports, and trial registry entry.
resultsOf the 100 included trials, 90 reported changes to the methods. A total of 846 methodological changes were recorded; 45.49% of the recorded changes occurred within the first year of study conduct. A rationale was provided for 204 of the changes with 39 unique reasons given. Frequent reasons for the changes were oversight committee recommendations, site feedback, COVID, and alignment with clinical guidance. The changes were not universally reported across the report, protocol, and registry entry and less than half were reported on the trial registry.
conclusionsThe majority of NIHR-funded trials make methodological changes throughout the duration of the trial, with a large proportion being made within the first year. Consideration should be given to whether a change in the way trials are designed and planned could reduce the need for changes early on. The reporting of methodological changes also needs improvement to ensure trial documentation is consistent and up to date.
trial registrationThis project was registered on the OSF registry, the details of the registration are available here: https://doi.org/10.17605/OSF.IO/WV2GX . Registered on July 22 2024.
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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.