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Definitions of Pediatric Functional Abdominal Pain Disorders and Outcome Measures: A Systematic Review

Judith Zeevenhooven1, Merel L Timp1, Maartje M J Singendonk1

  • 1Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Pediatric Gastroenterology, Amsterdam, the Netherlands.

The Journal of Pediatrics
|July 7, 2019
PubMed

Insights

This review found inconsistent definitions and outcome measures in pediatric functional abdominal pain disorders (FAPDs) trials. A core outcome set is needed for better comparison of FAPDs interventions.

Area of Science:

  • Pediatric Gastroenterology
  • Clinical Trial Methodology
  • Pain Management

Background:

  • Functional abdominal pain disorders (FAPDs) are common in children.
  • Therapeutic randomized controlled trials (RCTs) in pediatric FAPDs lack standardized definitions and outcome measures.
  • Adherence to Outcome Measures in Rheumatology (OMERACT) recommendations is crucial for consistent trial reporting.

Purpose of the Study:

  • To systematically review FAPDs definitions and outcome measures in pediatric therapeutic RCTs.
  • To assess adherence to OMERACT recommendations in existing literature.
  • To identify gaps and inconsistencies in current research practices.

Main Methods:

  • Systematic literature search of Cochrane, MEDLINE, Embase, and Cinahl databases (up to April 2018).
  • Inclusion of English-written therapeutic RCTs for pediatric FAPDs (ages 4-18).
  • Descriptive tabulation of FAPDs definitions, interventions, outcome measures, instruments, and assessors; quality assessment using the Delphi List.

Main Results:

  • 64 articles were included, with 39% of high methodologic quality.
  • FAPDs definitions varied, using Rome III (50%), Rome II (17%), Apley (16%), and author-defined (17%) criteria.
  • Diverse interventions (pharmacologic, dietary, psychosocial) and 211 unique outcome measures across 23 domains were reported, predominantly patient-reported (61%).

Conclusions:

  • Pediatric FAPDs studies exhibit limited methodologic quality and significant heterogeneity.
  • Inconsistent definitions and outcome measures hinder the comparison of intervention studies.
  • Development of a core outcome set is essential for advancing research in pediatric FAPDs.
Abstract

Keywords:
OMERACTchildrencore outcome set (COS)definitionsfunctional abdominal pain disorders (FAPDs)measurement instrumentsoutcome measures

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