A Core Outcome Set for Clinical Trials in Pediatric Functional Abdominal Pain Disorders - 20/05/20
on behalf of the
Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials Working Group
Abstract |
Objective |
To ensure consistency and reduce outcome measure reporting heterogeneity in clinical trials on pediatric functional abdominal pain disorders (FAPDs), a core outcome set (COS) was developed for pediatric FAPD trials.
Study design |
A mixed-method 2-round Delphi technique was used and key stakeholders, including healthcare professionals (HCPs), patients with FAPD, and their parents were invited to participate. In the first round, key stakeholders identified outcomes of importance through an open-ended questionnaire. Outcomes mentioned by ≥10% of the participants were included in a shortlist. In the second round, this shortlist was rated and prioritized. During a consensus meeting with an expert panel, the final COS was defined.
Results |
The first round was completed by 152 of 210 (72%) HCPs, 103 (100%) parents, and 50 of 54 (93%) patients. A total of 104 from 167 (62%) HCPs, 102 (100%) parents, and 53 (100%) patients completed round 2. Pain intensity, pain frequency, quality of life, school attendance, anxiety/depression, adequate relief, defecation pattern (disease specific, irritable bowel syndrome), and adverse events were included in the final COS for FAPDs.
Conclusion |
A set of 8 core outcomes has been identified that should minimally be measured in pediatric FAPD trials. Implementation of the use of this COS will increase comparison between studies and, therefore, improve management of children with FAPDs.
Le texte complet de cet article est disponible en PDF.Keywords : core outcome set, functional abdominal pain disorders, children, Delphi technique, increase comparability, OMERACT, COMET
Abbreviations : COMET, COS, ESPGHAN, FAPD, HCP, IBS, OMERACT, RCT
Plan
| The authors declare no conflicts of interest. |
Vol 221
P. 115 - juin 2020 Retour au numéro
Article précédent
- Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers
- Nina F. Steutel, Judith Zeevenhooven, Elena Scarpato, Yvan Vandenplas, Merit M. Tabbers, Annamaria Staiano, Marc A. Benninga
- Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages
- Peter G. Szilagyi, Christina S. Albertin, Alison W. Saville, Rebecca Valderrama, Abigail Breck, Laura Helmkamp, Xinkai Zhou, Sitaram Vangala, L. Miriam Dickinson, Chi-Hong Tseng, Jonathan D. Campbell, Melanie D. Whittington, Heather Roth, Cynthia M. Rand, Sharon G. Humiston, Dina Hoefer, Allison Kempe
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?