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Incomplete Reporting of Baseline Characteristics in Clinical Trials: An Analysis of Randomized Controlled Trials and Systematic Reviews Involving Patients with Chronic Low Back Pain

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  • Maria M Wertli
  • Manuela Schöb
  • Florian Brunner
  • Johann Steurer

Abstract

Objective: The aim of this study was to evaluate the reporting of relevant prognostic information in a sample of randomized controlled trials (RCTs) that investigated treatments for patients with chronic low back pain (LBP). We also analysed how researchers conducting the meta-analyses and systematic reviews addressed the reporting of relevant prognostic information in RCTs. Methods: We searched the Cochrane Database to identify systematic reviews that investigated non-surgical treatments for patients with chronic LBP. The reported prognostic information was then extracted from the RCTs included in the reviews. We used a purpose-defined score to assess the quantity of information reported in the RCTs. We also determined how the authors of systematic reviews addressed the question of comparability of patient populations between RCTs. Results: Six systematic reviews met our inclusion criteria, and we analysed 84 RCTs. Based on the scores, the reporting of important prognostic variables was incomplete in almost half of the 84 RCTs. Information regarding patients’ general health, social support, and work-related conditions was rarely reported. Almost half of the studies included in one of the meta-analyses provided insufficient information that did not allow us to determine whether patients in the primary trials were comparable. Conclusions: Missing prognostic information potentially threatens the external validity (i.e. the generalizability or applicability) not only of primary studies but also of systematic reviews that investigate treatments for LBP. A detailed description of baseline patient characteristics that includes prognostic information is needed in all RCTs to ensure that clinicians can determine the applicability of the study or review results to their patients.

Suggested Citation

  • Maria M Wertli & Manuela Schöb & Florian Brunner & Johann Steurer, 2013. "Incomplete Reporting of Baseline Characteristics in Clinical Trials: An Analysis of Randomized Controlled Trials and Systematic Reviews Involving Patients with Chronic Low Back Pain," PLOS ONE, Public Library of Science, vol. 8(3), pages 1-9, March.
    • Handle: RePEc:plo:pone00:0058512
    DOI: 10.1371/journal.pone.0058512
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    References listed on IDEAS

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    1. Alessandro Liberati & Douglas G Altman & Jennifer Tetzlaff & Cynthia Mulrow & Peter C Gøtzsche & John P A Ioannidis & Mike Clarke & P J Devereaux & Jos Kleijnen & David Moher, 2009. "The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-28, July.
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