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Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies

Author

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  • Matthew J Page
  • Julian P T Higgins
  • Gemma Clayton
  • Jonathan A C Sterne
  • Asbjørn Hróbjartsson
  • Jelena Savović

Abstract

Objective: To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design: Systematic review of meta-epidemiological studies. Methods: We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome (“mortality” versus “other objective” versus “subjective”). Direction of effect was standardised so that ROR

Suggested Citation

  • Matthew J Page & Julian P T Higgins & Gemma Clayton & Jonathan A C Sterne & Asbjørn Hróbjartsson & Jelena Savović, 2016. "Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies," PLOS ONE, Public Library of Science, vol. 11(7), pages 1-26, July.
    • Handle: RePEc:plo:pone00:0159267
    DOI: 10.1371/journal.pone.0159267
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    Cited by:

    1. Nalinee Poolsup & Naeti Suksomboon & Putu Dian Marani Kurnianta & Kulchalee Deawjaroen, 2019. "Effects of curcumin on glycemic control and lipid profile in prediabetes and type 2 diabetes mellitus: A systematic review and meta-analysis," PLOS ONE, Public Library of Science, vol. 14(4), pages 1-18, April.
    2. Lisa Bero, 2018. "Meta-research matters: Meta-spin cycles, the blindness of bias, and rebuilding trust," PLOS Biology, Public Library of Science, vol. 16(4), pages 1-4, April.
    3. Amos Z. B. Flomo & Elissaios Papyrakis & Natascha Wagner, 2023. "Evaluating the economic effects of the Ebola virus disease in Liberia: A synthetic control approach," Journal of International Development, John Wiley & Sons, Ltd., vol. 35(6), pages 1478-1504, August.
    4. Rahman Shiri & Ari Väänänen & Pauliina Mattila-Holappa & Krista Kauppi & Patrik Borg, 2022. "The Effect of Healthy Lifestyle Changes on Work Ability and Mental Health Symptoms: A Randomized Controlled Trial," IJERPH, MDPI, vol. 19(20), pages 1-11, October.
    5. Michael P Hengartner & Janus C Jakobsen & Anders Sørensen & Martin Plöderl, 2020. "Efficacy of new-generation antidepressants assessed with the Montgomery-Asberg Depression Rating Scale, the gold standard clinician rating scale: A meta-analysis of randomised placebo-controlled trial," PLOS ONE, Public Library of Science, vol. 15(2), pages 1-11, February.

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