OBJECTIVES

: Gastroesophageal reflux disease (GORD) is a common condition affecting 24% of infants aged 0-23 months. Observer-reported outcome measures (ObsROs) are required to determine the impact of GORD and its treatment on patients given the absence of language in very young paediatric populations. The Infant GORD (Revised version, I-GERQ-R) is one such ObsRO. There is, however, little published evidence regarding effect size (ES) for the I-GERQ-R. The aim of this study was therefore to derive an overall ES for the I-GERQ-R to support the evaluation of clinical changes in GORD symptoms.

METHODS

: A literature review was undertaken (PsycInfo, Embase, MedLine and EconLit databases) for longitudinal studies involving the I-GERQ-R. The articles were limited to English language published in the last 10 years. Standardised ESs were derived from the search results. A random effects model meta-analysis was applied to the ES to calculate an overall ES, along with I and Q statistics.

RESULTS

: The initial search identified 27 potential articles of which 20 were selected for full text review. A final total of 5 articles were identified for full data extraction (5/27, 18.5%). The studies included a total of 552 infants (range: 30 to 313); 424 infants had been diagnosed with GORD (77%). The age range of the infants across the studies was from birth to 7 months. The overall weighted effect size was -5.99 (95% confidence interval: -3.40 to 8.49), Q = 5.07, p=0.88 and I<0 suggesting a homogeneous sample.

CONCLUSIONS

: This is the first study to our knowledge to calculate an ES for the I-GERQ-R based on empirical data. The results suggest that threshold around 6, which is in line with previous studies which also suggested this value to signify a minimal clinically important difference. This may help inform clinical decisions in evaluating change in symptom severity in children affected by GORD.