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Time-dependent bias was common in survival analyses published in leading clinical journals

  • Carl van Walraven
    Correspondence
    Corresponding author. Tel.: 613-761-4903; fax: 613-761-5351.
    Affiliations
    Department of Medicine, University of Ottawa, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, F-660, Ottawa, ON K1Y 4E9, Canada

    Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada

    Clinical Epidemiology Unit, Ottawa Health Research Institute, C405-1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada

    Institute for Clinical Evaluative Sciences, G106-2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada
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  • Darryl Davis
    Affiliations
    Department of Medicine, University of Ottawa, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, F-660, Ottawa, ON K1Y 4E9, Canada
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  • Alan J. Forster
    Affiliations
    Department of Medicine, University of Ottawa, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, F-660, Ottawa, ON K1Y 4E9, Canada

    Clinical Epidemiology Unit, Ottawa Health Research Institute, C405-1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada
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  • George A. Wells
    Affiliations
    Department of Medicine, University of Ottawa, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, F-660, Ottawa, ON K1Y 4E9, Canada

    Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada

    Clinical Epidemiology Unit, Ottawa Health Research Institute, C405-1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada
    Search for articles by this author

      Abstract

      Objective

      In survival analysis, “baseline immeasurable” time-dependent factors cannot be recorded at baseline, and change value after patient observation starts. Time-dependent bias can occur if such variables are not analyzed appropriately. This study sought to determine the prevalence of such time-dependent bias in highly-cited medical journals.

      Study design and setting

      We searched Medline databases to identify all observational studies that used a survival analysis in American Journal of Medicine, Annals of Internal Medicine, Archives of Internal Medicine, British Medical Journal, Chest, Circulation, Journal of the American Medical Association, Lancet, and New England Journal of Medicine between 1998 and 2002. Studies with “baseline immeasurable” time-dependent factors were susceptible to time-dependent bias if a time-dependent covariate analysis was not used.

      Results

      Of 682 eligible studies, 127 (18.6%, 95% CI 15.8–21.8%) contained a “baseline immeasurable” time-dependent factor and 52 (7.6% [5.8–9.9%] of all survival analyses/40.9% [32.3–50.0%] of studies with a time-dependent factor) were susceptible to time-dependent bias. In 35 studies (5.1% [3.7–7.1%]/27.6% [20.5–35.9%]), the bias affected a variable highlighted in the study abstract and correction of the bias could have qualitatively changed the study's conclusion in over half of studies.

      Conclusion

      In medical journals, time-dependent bias is concerningly common and frequently affects key factors and the study's conclusion.

      Keywords

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