Evidence map›Paper›PMID 40350190›Full record

ArticleBMJ open2025

Investigation of trial registration as part of a research integrity assessment of randomised controlled trials in COVID-19 evidence syntheses: a meta-epidemiological study.

Tamara Pscheidl, Florencia Weber, Emma Sydenham, Patrick Meybohm, Stephanie Weibel

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Tamara PscheidlDepartment of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.
Florencia WeberDepartment of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.
Emma SydenhamCochrane Central Editorial Service, Cochrane, London, UK.ORCID http://orcid.org/0000-0002-1471-4237
Patrick MeybohmDepartment of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.ORCID http://orcid.org/0000-0002-2666-8696
Stephanie WeibelDepartment of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany weibel_s@ukw.de.ORCID http://orcid.org/0000-0003-1900-2535

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesProspective registration of randomised controlled trials (RCTs) is an international standard of good clinical practice but is often neglected by evidence synthesis producers. This study aims to assess prospective registration of RCTs included in evidence syntheses as part of a research integrity assessment and examine its impact on the study pool.

designMeta-epidemiological study. DATA SOURCES: COVID-19 Cochrane reviews (CRs) and non-Cochrane systematic reviews (SRs) in MEDLINE via PubMed up to 9 June 2022. ELIGIBILITY CRITERIA: RCTs from CRs and SRs evaluating 13 investigational medicinal products for SARS-CoV-2 and COVID-19. DATA EXTRACTION AND SYNTHESIS: We assessed prospective trial registration in RCTs according to domain 2 of the research integrity assessment tool. Prospective registration is defined as registration before participant enrolment. We extracted the trial registration number, registration date, study start date and inconsistencies in dates between study report and registration. RCTs were categorised as 'no concern', 'awaiting classification' and 'exclude'. We also analysed the relationship between study settings, publishing journals and prospective registration.

resultsWe included 188 RCTs. In the primary study report, 91% reported a trial registration number. In 84 RCTs, either not or retrospectively registered or with missing or inconsistent dates, we searched and/or contacted study authors for prospective registrations, resolving 17 RCTs. Ultimately, 58% of RCTs were prospectively registered and considered 'no concern', 15% were 'awaiting classification' due to inconsistent or missing information and 27% were either not registered or retrospectively registered and categorised as 'exclude'. Prospective registration was higher in larger or international multicentre RCTs and in RCTs conducted in Europe.

conclusionsIf prospective trial registration is required for inclusion in evidence syntheses, only 6 out of 10 COVID-19 RCTs would be eligible. Restricting eligibility to prospectively registered RCTs would include most large and international multicentre RCTs but exclude many smaller and non-European RCTs. PROTOCOL REGISTRATION: The protocol is available on OSF (https://osf.io/3bzeg).

Indexed as

COVID-19Randomized Controlled Trials as TopicRegistriesHumansSARS-CoV-2MethodsSTATISTICS & RESEARCH METHODSSystematic Review

Identifiers

PMID40350190
PMCPMC12067809

What OpenQuestion holds

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Registered trials

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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.