Abstract
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 I2 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 I2=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.
Acknowledgment
A previous version of the abstract was presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe Conference 2018: Smith AB, Hodgkinson V, Kotze H, Coyle C. The infant gastroesophageal reflux disease questionnaire (I-GERQ-R): A meta-analysis. Value in Health 2018: 21(S3): S389-S390.
Disclosure
All authors are employees of Reckitt Benckiser. The authors report no other conflicts of interest in this work.