Evidence map›Paper›PMID 33179875›Full record

Observational studyBJS open2020

Transparency in surgical randomized clinical trials: cross-sectional observational study.

J A Helliwell, B Shelton, H Mahmood, R Blanco-Colino, J E Fitzgerald, E M Harrison, A Bhangu, S J Chapman

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BJS open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 22% of its field
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

8 authors at 7 institutions in 2 countries.

J A HelliwellLeeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.ORCID 0000-0002-3579-0183
B SheltonDepartment of Anaesthetics, Guy's and St Thomas' Hospital, London, UK.
H MahmoodChelsea and Westminster Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-1301-8942
R Blanco-ColinoGeneral Surgery Department, Vall d'Hebron University Hospital, Barcelona, Spain.
J E FitzgeraldDepartment of Surgery, Royal Free Hospital NHS Trust, London, UK.
E M HarrisonCentre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK.ORCID 0000-0002-5018-3066
A BhanguDepartment of Academic Surgery, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
S J ChapmanLeeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.ORCID 0000-0003-2413-5690
University of Leeds · GBChelsea and Westminster Hospital NHS Foundation Trust · GBSt Thomas' Hospital · GBThe Royal Free Hospital · GBUniversity of Birmingham · GBUniversity of Edinburgh · GBVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRCTs provide the scientific basis upon which treatment decisions are made. To facilitate critical review, it is important that methods and results are reported transparently. The aim of this study was to explore transparency in surgical RCTs with respect to trial registration, disclosure of funding sources, declarations of investigator conflicts and data-sharing.

methodsThis was a cross-sectional review of published surgical RCTs. Ten high-impact journals were searched systematically for RCTs published in years 2009, 2012, 2015 and 2018. Four domains of transparency were explored: trial registration, disclosure of funding, disclosure of investigator conflicts, and a statement relating to data-sharing.

resultsOf 611 RCTs, 475 were eligible for analysis. Some 397 RCTs (83.6 per cent) were registered on a trial database, of which 190 (47·9 per cent) had been registered prospectively. Prospective registration increased over time (26 per cent in 2009, 33·0 per cent in 2012, 54 per cent in 2015, and 72·7 per cent in 2018). Funding disclosure was present in 55·0, 65·0, 69·4 and 75·4 per cent of manuscripts respectively. Conflict of interest disclosure was present in 49·5, 89·1, 94·6 and 98·3 per cent of manuscripts across the same time periods. Data-sharing statements were present in only 15 RCTs (3·2 per cent), 11 of which were published in 2018.

conclusionTrial registration, disclosure of funding and disclosure of investigator conflicts in surgical RCTs have improved markedly over the past 10 years. Disclosure of data-sharing plans is exceptionally low. This may contribute to research waste and represents a target for improvement.

Indexed as

Conflict of InterestDisclosureGeneral SurgeryCross-Sectional StudiesEditorial PoliciesHumansJournal Impact FactorPeriodicals as TopicRandomized Controlled Trials as TopicResearch Support as Topic

Identifiers

PMID33179875
PMCPMC7528514
OpenAlexW3049210363

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.