ArticleBMJ open2022
From registration, protocol to report: are COVID-19-related RCTs in mainland China consistent? A systematic review of clinical trial registry and literature.
Article in BMJ open, 2022. 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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo provide a comprehensive review of registered COVID-19-related randomised controlled trials (RCTs) in mainland China and evaluate the transparency of reporting through comparison of registrations, protocols and full reports.
designSystematic review of trial registrations and publications. DATA SOURCES: International Clinical Trials Registry Platform, Chinese Clinical Trial Registry, ClinicalTrials.gov, the ISRCTN registry and EU Clinical Trial Register were accessed on 1 February 2022. Publications were searched in PubMed, Embase, Cochrane Library, Google Scholar, CNKI.net and Wanfangdata from 10 February 2022 to 12 February 2022. ELIGIBILITY CRITERIA: Eligible trials were COVID-19 related RCTs carried out in mainland China. Observational studies, non-randomised trials and single-arm trials were excluded. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data from registrations, publications and performed risk of bias assessment for trial reports. Information provided by registrations and publications was compared. The findings were summarised with descriptive statistics.
resultsThe number of eligible studies was 415. From these studies 20 protocols and 77 RCT reports were published. Seven trials published both protocol and RCT full report. Between registrations and publications, discrepancy or omission was found in sample size (7, 35.0% for protocols and 47, 61.0% for reports, same below), trial setting (13, 65.0% and 43, 55.8%), inclusion criteria (12, 60.0% and 57, 74.0%), exclusion criteria (10, 50.0% and 54, 70.1%), masking method (9, 45.0% and 35, 45.5%) and primary outcome or time frame of primary outcome measurement (14, 70.0% and 51, 66.2%). Between protocols and full reports, 5 (71.4%) reports had discrepancy in primary outcome or time frame of primary outcome measurement.
conclusionsDiscrepancy among registrations, protocols and reports revealed compromised transparency in reporting of COVID-19-related RCTs in mainland China. The importance of trial registration should be further emphasised to enhance transparent RCT reporting.
Indexed as
Identifiers
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.