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Quality of reporting and risk of bias: a review of randomised trials in occupational health
  1. Christina Tikka1,2,
  2. Jos Verbeek3,
  3. Sharea Ijaz4,
  4. Jan L Hoving3,
  5. Julitta Boschman3,
  6. Carel Hulshof1,
  7. Angela G de Boer1
  1. 1 Department of Public and Occupational Health, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
  2. 2 Occupational health department, Finnish Institute of Occupational Health (FIOH), Kuopio Regional Office, Kuopio, Finland
  3. 3 Department of Public and Occupational Health, Coronel Institute of Occupational Health, Cochrane Work Review Group, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
  4. 4 NIHR ARC West, University of Bristol Medical School, University of Bristol, Bristol, UK
  1. Correspondence to Christina Tikka, University of Amsterdam, Department of Public and Occupational Health, Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC Location AMC, Amsterdam 1012 WX, The Netherlands; c.mischke{at}amsterdamumc.nl

Abstract

Objectives To assess the reporting quality of randomisation and allocation methods in occupational health and safety (OHS) trials in relation to Consolidated Standards of Reporting Trials (CONSORT) requirements of journals, risk of bias (RoB) and publication year.

Methods We systematically searched for randomised controlled trials (RCTs) in PubMed between 2010 and May 2019 in 18 OHS journals. We measured reporting quality as percentage compliance with the CONSORT 2010 checklist (items 8–10) and RoB with the ROB V.2.0 tool (first domain). We tested the mean difference (MD) in % in reporting quality between CONSORT-requiring and non-requiring journals, trials with low, some concern and high RoB and publications before and after 2015.

Results In 135 articles reporting on 129 RCTs, average reporting quality was at 37.4% compliance (95% CI 31.9% to 43.0%), with 10% of articles reaching 100% compliance. Reporting quality was significantly better in CONSORT-requiring journals than non-requiring journals (MD 31.0% (95% CI 21.4% to 40.7%)), for studies at low RoB than high RoB (MD 33.1% (95% CI 16.1% to 50.2%)) and with RoB of some concern (MD 39.8% (95% CI 30.0% to 49.7%)). Reporting quality did not improve over time (MD −5.7% (95% CI −16.8% to 5.4%).

Conclusions Articles in CONSORT-requiring journals and of low RoB studies show better reporting quality. Low reporting quality is linked to unclear RoB judgements (some concern). Reporting quality did not improve over the last 10 years and CONSORT is insufficiently implemented. Concerted efforts by editors and authors are needed to improve CONSORT implementation.

  • clinical trial
  • occupational health
  • public health

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/oemed-2020-107038

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors The research plan and manuscript were written by CT and JV with substantial contributions from all other authors. Reporting quality was assessed by SI, JV and CT. Risk of bias assessments were performed by SI, JV, AGD, CH, JB, JH and CT. Data analysis was performed by CT with substantial contributions from JV, AGD and CH. Caroline Struthers provided comments to the research plan and participated in reporting quality and risk of bias assessment.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.