TY - JOUR
T1 - A Core Outcome Set for Clinical Trials in Pediatric Functional Abdominal Pain Disorders
AU - Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials Working Group
AU - Zeevenhooven, Judith
AU - Rexwinkel, Robyn
AU - van Berge Henegouwen, Vera W. A.
AU - Krishnan, Usha
AU - Vandenplas, Yvan
AU - Strisciuglio, Caterina
AU - Staiano, Annamaria
AU - Devanarayana, Niranga M.
AU - Rajindrajith, Shaman
AU - Benninga, Marc A.
AU - Tabbers, Merit M.
PY - 2020/6
Y1 - 2020/6
N2 - 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.
AB - 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.
KW - COMET
KW - Delphi technique
KW - OMERACT
KW - children
KW - core outcome set
KW - functional abdominal pain disorders
KW - increase comparability
UR - http://www.scopus.com/inward/record.url?scp=85083338987&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jpeds.2020.02.032
DO - https://doi.org/10.1016/j.jpeds.2020.02.032
M3 - Article
C2 - 32312551
SN - 0022-3476
VL - 221
SP - 115-122.e5
JO - Journal of pediatrics
JF - Journal of pediatrics
ER -