Clinically Meaningful Difference for the Infant Gastroesophageal Questionnaire Revised Version (I-GERQ-R): A Quantitative Synthesis
Overview
Affiliations
Background: Gastroesophageal reflux disease (GORD) is a common condition affecting 30% of infants aged 0-23 months. The Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R) is an observer-reported outcome measures (ObsRO) developed to evaluate the impact of GORD on young infants. However, evidence regarding the clinically important difference (CID) for the I-GERQ-R is limited. The aim of this study was to determine a CID for the I-GERQ-R.
Methods: A literature review was undertaken (PsycInfo, Embase, MedLine and EconLit databases) for longitudinal studies involving the I-GERQ-R. Articles were not limited by language or publication date. A random effects model was applied to calculate an overall CID, along with I and Q statistics. Publication bias was also assessed.
Results: The search identified 42 articles; 11 were selected for full-text review and 7 articles were identified for full data extraction. The studies included a total of 661 infants (range: 30 to 313); 424 infants had been diagnosed with GORD (64%). The age range of the infants across the studies was from birth to 7 months. The overall CID was -6.54 (95% confidence interval: -4.35 to -8.74), Q = 17.96, p=0.08 and I=22.04.
Conclusion: This study derived a CID for the I-GERQ-R and indicated a threshold around 6 could signify a clinically important difference for this instrument. The lower limit of the 95% confidence interval suggested a threshold of 3 to 4 could represent a minimally important difference. These results may help inform clinical decisions in evaluating meaningful change in symptom severity in children affected by GORD.
Li W, Zhang T, Gu W, Shi W, Wang S, Zhu Y Ther Adv Respir Dis. 2024; 18:17534666231220817.
PMID: 38183243 PMC: 10771753. DOI: 10.1177/17534666231220817.
Sultana Z, Hasenstab K, Moore R, Osborn E, Yildiz V, Wei L Gastro Hep Adv. 2022; 1(5):869-881.
PMID: 36310566 PMC: 9615096. DOI: 10.1016/j.gastha.2022.06.004.