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Related Experiment Videos

Randomized, controlled clinical trials in sepsis: has methodological quality improved over time?

Jürgen Graf1, Gordon S Doig, Deborah J Cook

  • 1Medical Clinic I, Department of Cardiology, University Hospital Aachen, Aachen, Germany. jgraf@gmx.de

Critical Care Medicine
|March 13, 2002
PubMed
Summary

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Methodological quality of randomized clinical trials for sepsis improved over time, particularly for trials focusing on mortality outcomes. This analysis aids future sepsis trial design for enhanced validity.

Area of Science:

  • Critical Care Medicine
  • Clinical Trial Methodology
  • Sepsis Research

Background:

  • Randomized clinical trials (RCTs) are crucial for advancing sepsis treatment strategies.
  • Evaluating the methodological rigor of sepsis RCTs is essential for interpreting their findings.
  • Understanding trends in sepsis trial quality over time can inform future research design.

Purpose of the Study:

  • To systematically assess the methodological quality of published randomized clinical trials concerning sepsis.
  • To determine if the methodological quality of sepsis RCTs has improved from 1966 to 1998.
  • To compare the quality of trials with mortality as the primary endpoint versus those using surrogate outcomes.

Main Methods:

  • A comprehensive search of MEDLINE and bibliographies identified RCTs on sepsis, severe sepsis, and septic shock in adults.

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  • Articles were categorized based on primary outcome: mortality or surrogate measures.
  • Methodological quality was graded using a specific objective scheme, with data extraction performed independently by two reviewers.

    • Main Results:

    • Seventy-four RCTs met inclusion criteria (40 mortality-focused, 34 surrogate-outcome focused).
    • Trials prioritizing mortality outcomes demonstrated significantly higher methodological quality scores than those using surrogate outcomes.
    • Overall trial methodology improved significantly between 1976 and 1998 (0.36 points/year), driven by improvements in mortality outcome trials.

    Conclusions:

    • Randomized clinical trials for sepsis have shown improvements in methodological quality over time, especially those measuring mortality.
    • Identifying current methodological limitations can guide enhancements in future sepsis trial design.
    • Improving trial design will increase the validity and reliability of findings in sepsis research.