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Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review

Author

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  • Kerry Dwan
  • Carrol Gamble
  • Paula R Williamson
  • Jamie J Kirkham
  • the Reporting Bias Group

Abstract

Background: The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias and outcome reporting bias have been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Methodology/Principal Findings: In this update, we review and summarise the evidence from cohort studies that have assessed study publication bias or outcome reporting bias in randomised controlled trials. Twenty studies were eligible of which four were newly identified in this update. Only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Fifteen of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions: This update does not change the conclusions of the review in which 16 studies were included. Direct empirical evidence for the existence of study publication bias and outcome reporting bias is shown. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.

Suggested Citation

  • Kerry Dwan & Carrol Gamble & Paula R Williamson & Jamie J Kirkham & the Reporting Bias Group, 2013. "Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review," PLOS ONE, Public Library of Science, vol. 8(7), pages 1-37, July.
    • Handle: RePEc:plo:pone00:0066844
    DOI: 10.1371/journal.pone.0066844
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    Cited by:

    1. Claire Godard-Sebillotte & Mélanie Le Berre & Tibor Schuster & Miguel Trottier & Isabelle Vedel, 2019. "Impact of health service interventions on acute hospital use in community-dwelling persons with dementia: A systematic literature review and meta-analysis," PLOS ONE, Public Library of Science, vol. 14(6), pages 1-18, June.
    2. Kellia Chiu & Quinn Grundy & Lisa Bero, 2017. "‘Spin’ in published biomedical literature: A methodological systematic review," PLOS Biology, Public Library of Science, vol. 15(9), pages 1-16, September.
    3. Arnaud Vaganay, 2016. "Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies," PLOS ONE, Public Library of Science, vol. 11(9), pages 1-21, September.
    4. E. Decullier & P. V. Tang & L. Huot & H. Maisonneuve, 2021. "Why an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysis," Scientometrics, Springer;Akadémiai Kiadó, vol. 126(2), pages 1239-1248, February.
    5. Jamie J Kirkham & Kerry M Dwan & Anette Blümle & Erik von Elm & Paula R Williamson, 2016. "How Much Participant Outcome Data Is Missing from Sight: Findings from a Cohort of Trials Submitted to a German Research Ethics Committee," PLOS ONE, Public Library of Science, vol. 11(6), pages 1-8, June.
    6. Salandra, Rossella & Criscuolo, Paola & Salter, Ammon, 2021. "Directing scientists away from potentially biased publications: the role of systematic reviews in health care," Research Policy, Elsevier, vol. 50(1).
    7. Jaithri Ananthapavan & Gary Sacks & Marj Moodie & Rob Carter, 2014. "Economics of Obesity — Learning from the Past to Contribute to a Better Future," IJERPH, MDPI, vol. 11(4), pages 1-19, April.
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    9. Je-Young Lee & Minkyung Baek, 2023. "Effects of Gamification on Students’ English Language Proficiency: A Meta-Analysis on Research in South Korea," Sustainability, MDPI, vol. 15(14), pages 1-19, July.
    10. Eijgermans, D.G.M. & Fang, Y. & Jansen, D.E.M.C. & Bramer, W.M. & Raat, H. & Jansen, W., 2021. "Individual and contextual determinants of children’s and adolescents’ mental health care use: A systematic review," Children and Youth Services Review, Elsevier, vol. 131(C).
    11. Chuan Hong & Georgia Salanti & Sally C. Morton & Richard D. Riley & Haitao Chu & Stephen E. Kimmel & Yong Chen, 2020. "Testing small study effects in multivariate meta‐analysis," Biometrics, The International Biometric Society, vol. 76(4), pages 1240-1250, December.
    12. Anette Blümle & Tobias Haag & James Balmford & Gerta Rücker & Martin Schumacher & Nadine Binder, 2020. "A multi-state model analysis of the time from ethical approval to publication of clinical research studies," PLOS ONE, Public Library of Science, vol. 15(3), pages 1-15, March.
    13. John Copas, 2022. "Akaike Memorial Lecture 2020: Some of the challenges of statistical applications," Annals of the Institute of Statistical Mathematics, Springer;The Institute of Statistical Mathematics, vol. 74(4), pages 615-637, August.
    14. Zhou-min Yuan & Mingxin Yao, 2022. "Is academic writing becoming more positive? A large-scale diachronic case study of Science research articles across 25 years," Scientometrics, Springer;Akadémiai Kiadó, vol. 127(11), pages 6191-6207, November.
    15. Tinashe Dune & Jacqueline Ullman & Tania Ferfolja & Jack Thepsourinthone & Shirali Garga & Zelalem Mengesha, 2020. "Are Services Inclusive? A Review of the Experiences of Older GSD Women in Accessing Health, Social and Aged Care Services," IJERPH, MDPI, vol. 17(11), pages 1-17, May.
    16. Martin E Héroux & Janet L Taylor & Simon C Gandevia, 2015. "The Use and Abuse of Transcranial Magnetic Stimulation to Modulate Corticospinal Excitability in Humans," PLOS ONE, Public Library of Science, vol. 10(12), pages 1-10, December.

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