Evidence map›Paper›PMID 30533597›Full record

ArticleJB & JS open access2018

Registration and Outcome-Reporting Bias in Randomized Controlled Trials of Distal Radial Fracture Treatment.

Shiela Lee, Tanvir Khan, Douglas Grindlay, Alexia Karantana

Abstract read
In one paragraph

Article in JB & JS open access, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Compromising Outcomes.Journal of the American Society of Nephrology : JASN · 2019
    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

4 authors.

Shiela LeeFaculty of Medicine and Health Sciences, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.
Tanvir KhanDepartment of Academic Orthopaedics, Trauma and Sports Medicine, University of Nottingham, Nottingham, United Kingdom.
Douglas GrindlayDepartment of Academic Orthopaedics, Trauma and Sports Medicine, University of Nottingham, Nottingham, United Kingdom.
Alexia KarantanaDepartment of Academic Orthopaedics, Trauma and Sports Medicine, University of Nottingham, Nottingham, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of the present study was to systematically evaluate the completeness of trial registration and the extent of outcome-reporting bias in modern randomized controlled trials (RCTs) relating to the treatment of distal radial fracture.

methodsWith use of 4 databases (PubMed, Cochrane CENTRAL, Embase, and PEDro), this systematic review identified all RCTs of distal radial fracture treatment published from January 1, 2010, to December 31, 2015. We independently determined the registration status of these trials in a public trial registry and compared the characteristics of registered and non-registered trials. We assessed the quality and consistency of primary outcome measure (POM) reporting between the registration data and the final published studies.

resultsNinety studies met the inclusion criteria. Of those, only 28 (31%) were registered, and only 3 (3%) were "appropriately registered" (i.e., prospectively registered and identifying and fully describing the POM). Registered trials had larger sample sizes and were more likely to be multicenter, to report funding sources, and to be published in higher-impact-factor journals. Sixteen (18%) of the 90 registered RCTs named a POM in the registry; 7 (44%) of those 16 registered RCTs stated a different POM, an additional POM, or no POM at all in the final publication than was stated in the registry data. Additionally, 13 (81%) of those 16 registered RCTs had discrepancies in the time point reported for the POM.

conclusionsIn an attempt to address publication and outcome-reporting bias, prospective trial registration in a public registry has been deemed a condition for publication by the International Committee of Medical Journal Editors (ICMJE) since 2005. This study shows poor registration rates as well as inconsistencies in the reporting of POMs of recent trials relating to the treatment of distal radial fracture, one of the most common and most investigated injuries in orthopaedic practice. CLINICAL RELEVANCE: The problems of registration and outcome-reporting bias in RCTs are important to highlight and address, and to find a solution will require the cooperation of researchers, reviewers, and journal editors. Increasing the transparency and consistency of reporting will help to increase the quality of research, which can impact patient care through evidence-based guidelines.

Identifiers

PMID30533597
PMCPMC6242325

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.