SynthesisTrials2025
The reporting of health systems data use in primary results publications of clinical trials: a systematic review.
Synthesis 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
6 authors.
Funding
Abstract
backgroundData collected within clinical trials often overlaps with routinely collected Health Systems Data (HSD). There is potential for HSD to reduce burdens for trials and understanding HSD use can help triallists make decisions about using HSD in future trials. However, it is unknown to what extent HSD use has been reported in trial publications, despite the development of guidelines such as ESMO-GROW and CONSORT-ROUTINE extension for reporting HSD use in trials. This study expands on work previously conducted by Lensen and colleagues (Trials 21(1):398, 2020). It aims to provide insights into how HSD use is reported in main result publications that present main trial results, before and after the release of the CONSORT-ROUTINE extension.
methodsThis was a systematic review of the reporting of HSD use in primary results publications of trials that accessed HSD between 2017 and 2018. Of 90 trials identified by Lensen and colleagues, those that had published primary outcome results were included in the review. Trials were excluded if (1) primary results were not yet due to be reported; (2) not yet published; (3) they were published prior to June 2017; (4) they were published in 2017, but HSD was accessed in 2018 and (5) the primary publication only reported HSD use in secondary, interim or Study Within a Trial (SWAT) analysis. Eligible publications were identified using ISRCTN, ClinicalTrials.gov, EU Clinical Trials Registries, PubMed and Embase. The reporting of HSD use was compared against expectations for reporting outlined in the CONSORT-ROUTINE extension.
resultsForty-nine primary publications from 46 trials were included in the review. Overall, none of the included publications reported all the information suggested in the CONSORT-ROUTINE. However, there has been an improvement in the reporting of HSD use, since the publication of the CONSORT-ROUTINE guidelines.
conclusionsReporting of HSD use has improved over time. However, it still does not meet the expectations set out in the CONSORT-ROUTINE extension. Triallists should be encouraged to provide further information in publications about the use of HSD as per the CONSORT-ROUTINE extension guidelines. This would allow greater transparency in reporting, facilitating effective HSD use in future trials.
Indexed as
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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.