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Reporting on Outcome Measures of Functional Constipation in Children-A Systematic Review
Sophie Kuizenga-Wessel1, Sascha L Heckert, Willemijn Tros
1*Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center †Medical library, Academic Medical Centre, Amsterdam, The Netherlands.
Insights
Inconsistent definitions and outcome measures in pediatric functional constipation (FC) trials hinder treatment comparisons. Standardized definitions and validated instruments are crucial for reliable research in childhood FC.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Standardized outcome measures are essential for comparing clinical trial results.
- This facilitates the identification of the most effective therapeutic interventions.
- Functional constipation (FC) is a common condition in children requiring effective treatments.
Purpose of the Study:
- To systematically assess definitions and outcome measures in therapeutic randomized controlled trials (RCTs) for childhood functional constipation (FC).
- To identify inconsistencies and heterogeneity in current research practices.
- To provide recommendations for improving future research in this field.
Main Methods:
- Searched PubMed, EMBASE, and Cochrane databases for therapeutic RCTs on childhood FC.
- Included studies involving children aged 1-18 with FC, providing an FC definition, and published in English.
- Utilized the Delphi list for quality assessment of included studies.
Main Results:
- Analyzed 45 studies, revealing 22 different definitions of FC and 29 definitions of treatment success.
- Seventeen studies used Rome III criteria for FC definition; 27 interventions were investigated.
- Most trials (80%) used parental diaries, with only 2 validating their instruments; 53% were of good methodological quality.
Conclusions:
- Significant inconsistency and heterogeneity exist in FC definitions and outcome measures in pediatric RCTs.
- There is a need for standardized definitions, outcome measures, and validated instruments.
- A minimum core outcome set is recommended for pediatric FC research to enable cross-study comparisons.
Objective:
Standardized outcome measures provide a basis for comparing outcomes of different clinical trials. Consequently, they can serve as the foundation for determining which therapeutic interventions are most effective. The aim of the present study is to systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of children with functional constipation (FC).
Methods:
PubMed, EMBASE, and Cochrane databases were searched. Studies were included if it was a (systematic review of) therapeutic RCT, concerning children from 1 to 18 years old with FC, a definition of FC was provided, and if they were written in English. The Delphi list was used for quality assessment.
Results:
A total of 4092 articles were found but only 45 studies fulfilled our inclusion criteria. In these 45 trials, 22 different definitions of FC were used (17 studies used the Rome III-criteria), 27 different interventions were investigated, and 29 different definitions of treatment success were used. Thirty RCTs (57%) reported primary outcomes of which treatment success was the most frequently used. Most trials (80%) used parental diaries of which only 2 RCTs stated that their instrument was validated. Twenty-four trials (53%) were of good methodological quality.
Conclusions:
Inconsistency and heterogeneity exist in definitions and outcome measures used in RCTs on childhood FC. Standard definitions, outcome measures, and also validated instruments are needed. We recommend the development of a minimum core outcome set for clinical research in children with FC to make comparison possible between the effects of different therapeutic interventions across studies.
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