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A Core Outcome Set for Clinical Trials in Pediatric Functional Abdominal Pain Disorders

Judith Zeevenhooven1, Robyn Rexwinkel1, Vera W A Van Berge Henegouwen1

  • 1Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Pediatric Gastroenterology, Hepatology and Nutrition, Amsterdam, The Netherlands.

The Journal of Pediatrics
|April 22, 2020
PubMed

Insights

A core outcome set (COS) was developed for pediatric functional abdominal pain disorders (FAPDs) trials. This standardized set of 8 outcomes will improve consistency and comparison in research for better FAPD management.

Area of Science:

  • Pediatric gastroenterology
  • Clinical trial methodology
  • Core outcome sets

Background:

  • Functional abdominal pain disorders (FAPDs) in children lack consistent outcome reporting in clinical trials.
  • Heterogeneity in outcome measures hinders study comparison and evidence synthesis.
  • A standardized approach is needed to improve the reliability and applicability of FAPD research.

Purpose of the Study:

  • To develop a core outcome set (COS) for clinical trials involving pediatric functional abdominal pain disorders (FAPDs).
  • To ensure consistency and reduce heterogeneity in outcome measure reporting for pediatric FAPD trials.

Main Methods:

  • A mixed-method, two-round Delphi technique involving healthcare professionals, patients, and parents.
  • Round 1: Open-ended questionnaire to identify important outcomes.
  • Round 2: Prioritization of shortlisted outcomes, followed by a consensus meeting to finalize the COS.

Main Results:

  • High participation rates were achieved across all stakeholder groups in both Delphi rounds.
  • Eight core outcomes were identified for pediatric FAPD trials: pain intensity, pain frequency, quality of life, school attendance, anxiety/depression, adequate relief, defecation pattern, and adverse events.
  • The identified outcomes cover key aspects of symptom burden, functional impact, and treatment response.

Conclusions:

  • A consensus-based core outcome set of 8 essential outcomes for pediatric FAPD trials has been established.
  • Implementation of this COS is expected to enhance comparability across studies.
  • This will ultimately contribute to improved clinical management strategies for children with FAPDs.
Abstract

Keywords:
COMETDelphi techniqueOMERACTchildrencore outcome setfunctional abdominal pain disordersincrease comparability

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