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Measurement issues in trials of pediatric acute diarrheal diseases: a systematic review

Bradley C Johnston1, Larissa Shamseer, Bruno R da Costa

  • 1Department of Clinical Epidemiology and Biostatistics, McMaster University, Health Sciences Centre, Hamilton, Ontario, Canada. bjohnst@mcmaster.ca

Pediatrics
|June 23, 2010
PubMed

Insights

Pediatric acute diarrhea research lacks standardized definitions and outcome measures. Clinical trials show varied approaches, with instruments lacking reported validity, despite good methodology.

Area of Science:

  • Pediatric gastroenterology
  • Clinical trial methodology
  • Evidence-based medicine

Background:

  • Diarrheal diseases are a leading cause of childhood illness globally.
  • Current research on pediatric acute diarrhea lacks standardized definitions and measurement tools for clinical trials.

Purpose of the Study:

  • To analyze definitions of acute diarrhea and its resolution in pediatric randomized controlled trials (RCTs).
  • To document primary outcomes, measurement instruments, and methodological quality in pediatric acute diarrhea RCTs.

Main Methods:

  • Systematic search of CENTRAL, Embase, Global Health, and Medline databases up to February 2009.
  • Inclusion of English-language RCTs in children (<19 years) with acute diarrhea as a primary outcome.

Main Results:

  • 138 RCTs were identified, exhibiting significant heterogeneity in 64 diarrhea definitions, 69 resolution definitions, and 46 primary outcomes.
  • While 32 trials used assessment instruments, only 3 claimed validity, with no reported evidence.
  • The methodological quality of the included trials was generally good.

Conclusions:

  • Heterogeneity in definitions, outcomes, and instruments persists in pediatric acute diarrhea RCTs, even those with sound methodology.
  • Instruments used for assessing pediatric acute diarrhea lack reported evidence of validity.
  • Current trial endpoints may not reflect outcomes most meaningful to patients.
Abstract

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