Abstract

Objectives
Functional constipation (FC) is common in childhood, significantly impacting quality of life. Since the 2014 international guideline, new evidence has been published, and methods on making guidelines have developed. This treatment guideline for FC in children aged 0–18 years is a collaborative effort of the European and North American Societies for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN and NASPGHAN. The aim was to deliver evidence-based recommendations applicable across all treatment settings worldwide and offer methodological guidance for future research.

Methods
The guideline development followed the “Grading of Recommendations Assessment, Development and Evaluation” (GRADE) approach. The Guideline Development Group (GDG) comprised clinical experts, representing ESPGHAN, NASPGHAN and Cochrane. Prospectively agreed-upon treatments were formatted into “patient, intervention, comparison, outcome” questions. The GDG also determined decision thresholds for efficacy and safety outcomes through a Delphi process to support grading of the literature. Final recommendations were established by consensus voting, and a treatment algorithm was developed.

Results
A total of 102 original randomized controlled trials (RCTs) assessing treatment of FC in children aged 0–18 years were identified. Consensus was reached for 11 GRADE recommendations. Nineteen good practice statements were formulated, and guidance for future research methodology was proposed.

Conclusions
This guideline is the result of a collaborative effort between ESPGHAN and NASPGHAN on treatment options for FC. Systematic review of the evidence has revealed major evidence gaps for commonly used treatments for FC and highlights the need for large pediatric RCTs, particularly on treatment options with no evidence or only very low certainty evidence.