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Related Experiment Video

Updated: Apr 29, 2026

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
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Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

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Gender differences in randomised, controlled trials in intensive care units.

M L Kristensen1, T R Vestergaard, H-H Bülow

  • 1The Department of Anaesthesiology and Intensive Care, Holbaek Hospital, Region Zealand, University of Copenhagen, Holbaek, Denmark.

Acta Anaesthesiologica Scandinavica
|May 16, 2014
PubMed
Summary

Intensive care unit (ICU) randomized controlled trials (RCTs) show significant male dominance. Researchers must consider gender distribution to ensure unbiased results and appropriate application of findings across diverse patient populations.

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Area of Science:

  • Critical Care Medicine
  • Clinical Trial Design
  • Medical Research Methodology

Background:

  • Intensive care units (ICUs) typically have a higher proportion of male patients.
  • This demographic imbalance may lead to skewed gender representation in clinical research conducted within ICUs.

Purpose of the Study:

  • To evaluate the gender distribution in randomized controlled trials (RCTs) conducted in intensive care units.
  • To assess whether researchers are aware of and address potential gender biases in their trial populations.

Main Methods:

  • Systematic literature search on PubMed for RCTs in ICUs published between January 2011 and May 2012.
  • Inclusion criteria focused on RCTs within ICUs, yielding 25 studies with 12,788 patients.
  • Analysis of gender distribution in the overall trial population and within randomized groups.

Related Experiment Videos

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Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
10:38

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Published on: January 16, 2019

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Main Results:

  • A significant overall male dominance (63.6%) was observed across the 25 RCTs (P < 0.0001).
  • Eighteen trials showed a statistically significant gender difference in their total population, yet none reported a P-value for this difference.
  • Only five trials reported a significant gender difference within the randomized groups; three did not specify gender in randomized groups.

Conclusions:

  • Marked male predominance exists in ICU-based RCTs, potentially limiting the generalizability of findings.
  • Future RCT planning should consider potential gender influences on outcomes and data.
  • Methods like proportional allocation or stratification may be necessary to mitigate gender bias in skewed populations.