Prospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 16, 2025; 13(23): 105022
Published online Aug 16, 2025. doi: 10.12998/wjcc.v13.i23.105022
Validity and reliability of the Thai “Rome IV diagnostic questionnaires” for functional gastrointestinal disorders in neonates and toddlers
Kanticha Chatpermporn, Yuda Chongpison, Thitima Ngoenmak, Suporn Treepongkaruna, Palittiya Sintusek
Kanticha Chatpermporn, Department of Pediatrics, Police General Hospital, Bangkok 10330, Thailand
Yuda Chongpison, Research Affairs, Chulalongkorn University, Bangkok 10330, Thailand
Thitima Ngoenmak, Department of Pediatrics, Naresuan University Hospital, Naresuan University, Phitsanulok 65000, Thailand
Suporn Treepongkaruna, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand
Palittiya Sintusek, Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology, Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330, Thailand
Author contributions: Chatpermporn K designed and conducted the research, took part in testing the validity, and wrote the manuscript; Ngoenmak T took part in backward translation of the questionnaire; Treepongkaruna S was appointed as Rome Foundation-designated clinician monitor, merged the two Thai version of translation into a single translation and validated the final Thai version; Sintusek P conceived, designed, conducted, and coordinated the research, contacted Rome Foundation, took part in testing the validity, and made critical revisions related to the intellectual content of the manuscript; Chatpermporn K, Chongpison Y and Sintusek P conducted basic statistical analysis, and checked data; and all authors read and approved the final manuscript.
Supported by Ratchadapiseksompotch Fund, Graduate Affairs, Faculty of Medicines, Chulalongkorn University, No. 2566-077, No. 2566-078, and No. 2566-079; and The Royal College of Pediatricians of Thailand, No. 2566.2.2.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Faculty of Medicine, Chulalongkorn University, approval No. 0649/2023.
Clinical trial registration statement: This study does not have clinical trial registration statement because it is not a clinical trial study.
Informed consent statement: All participants voluntarily agreed to participate in this study and provided written informed consent prior to enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Statistical summaries are presented in the published article. The dataset and statistical code are available from the corresponding author at (palittiya.s@chula.ac.th). Participants gave informed consent for data sharing. No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Palittiya Sintusek, MD, PhD, Associate Professor, Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology, Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Chulalongkorn University, 1873 Rama IV, Pathumwan, Bangkok 10330, Thailand. palittiya.s@chula.ac.th
Received: January 9, 2025
Revised: April 4, 2025
Accepted: April 25, 2025
Published online: August 16, 2025
Processing time: 146 Days and 16.6 Hours
Abstract
BACKGROUND

The Rome Foundation’s questionnaires, including the latest version, Rome IV diagnostic criteria since 2016, are widely used globally for diagnosing functional gastrointestinal disorders (FGIDs). However, a tailored Thai version for diagnosing FGIDs in neonates and toddlers is yet to be developed.

AIM

To develop and validate the Thai version of the Rome IV diagnostic questionnaire for FGIDs in neonates and toddlers.

METHODS

This study was conducted at a tertiary hospital in Bangkok. The Rome IV diagnostic questionnaire for neonates and toddlers was translated into Thai following Rome Foundation guidelines. Validity was assessed using item-objective congruence. The final version was administered to 65 caregivers of children under 4 years. Reliability was evaluated using Cronbach’s alpha and intraclass correlation coefficient based on test-retest responses collected over a 4-15 day interval.

RESULTS

A total of 58 complete questionnaires were returned. The median interval between the first and second time was 7 days (range: 4 days to 15 days). The item-objective congruence index for the Thai-adapted Rome IV diagnostic questionnaire was 0.74. Internal consistency, as indicated by Cronbach’s alpha, was 0.753, 0.712, and 0.750 for the three respective sections. The intraclass correlation coefficients for test-retest reliability were 0.782, 0.782, and 0.807.

CONCLUSION

The Thai Rome IV diagnostic questionnaire for FGIDs in neonates and toddlers demonstrates acceptable validity and reliability, supporting its use in future clinical and research applications.

Keywords: Functional constipation; Infant regurgitation; Functional diarrhea; Infant constipation; Colic

Core Tip: The Thai version of the Rome IV diagnostic questionnaire demonstrates acceptable validity and reliability as a diagnostic tool for functional gastrointestinal disorders in young Thai children. It achieved an item-objective congruence of 0.74, with Cronbach’s alpha and intra-class correlation coefficients ranging from 0.712 to 0.807. This validated questionnaire has the potential to significantly improve the accuracy of diagnoses and treatment, thereby enhancing the quality of care for affected children. The findings highlight its value as a crucial resource for clinical practice, future research, and advancing the study of pediatric gastrointestinal health in Thailand.