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Inadequate reporting of trials compromises the applicability of systematic reviews

Gerald Gartlehner1, Patricia Thieda, Richard A Hansen

  • 1Department for Evidence-based Medicine and Clinical Epidemiology, Danube University, Krems, Austria. gerald.gartlehner@donau-uni.ac.at

International Journal of Technology Assessment in Health Care
|July 22, 2009
PubMed
Abstract

Insights

Most clinical trials lack sufficient reporting to determine if findings apply to real-world patient populations. Key reporting gaps include study setting, adverse event assessment, and sample size for patient-important differences.

Area of Science:

  • Clinical research methodology
  • Evidence-based medicine
  • Health services research

Background:

  • Clinicians and policymakers face challenges in applying controlled trial results due to uncertainty.
  • Assessing the applicability of study findings to specific patient groups is crucial for effective healthcare.

Purpose of the Study:

  • To evaluate the adequacy of reporting in clinical studies for assessing applicability.
  • To determine if study designs reported in systematic reviews are sufficiently detailed to distinguish explanatory from pragmatic approaches.

Main Methods:

  • Analysis of 137 studies from four systematic reviews on second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and immune modulators.
  • Development and application of a questionnaire assessing seven criteria for distinguishing explanatory from pragmatic study designs.
  • Independent assessment of reporting adequacy by two reviewers for each included study.

Main Results:

  • Only 12% of studies provided adequate information to differentiate between explanatory and pragmatic designs.
  • Significant reporting deficiencies were identified in study setting, adverse event assessment methods, and sample size justification for patient-important differences.
  • These shortcomings hinder the ability to determine the applicability of trial findings.

Conclusions:

  • Clinical trials exhibit substantial reporting gaps in study design elements critical for applicability assessment.
  • Improved reporting standards are necessary to enhance the clinical utility and real-world application of research findings.

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