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Clinically Meaningful Difference for the Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R): A
Adam B Smith1, Neil Fawkes2, Helen Kotze3
1Health Outcomes, Medical Affairs & Evidence Generation, Reckitt Benckiser, Hull, UK.
Insights
This study determined a clinically important difference (CID) for the Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R). A threshold of approximately 6 indicates a significant change in infant gastroesophageal reflux disease symptoms.
Area of Science:
- Pediatrics
- Gastroenterology
- Clinical Outcomes Research
Background:
- Gastroesophageal reflux disease (GORD) is prevalent in 30% of infants.
- The Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R) assesses GORD impact in infants.
- Limited data exists on the clinically important difference (CID) for the I-GERQ-R.
Purpose of the Study:
- To determine the clinically important difference (CID) for the I-GERQ-R in infants.
- To establish a threshold for meaningful change in GORD symptom severity.
Main Methods:
- A systematic literature review of longitudinal studies using the I-GERQ-R was conducted.
- Data from 7 selected articles, including 661 infants, were analyzed.
- A random effects model was employed to calculate the overall CID.
Main Results:
- The overall CID for the I-GERQ-R was calculated as -6.54.
- A threshold of approximately 6 suggests a clinically important difference.
- A minimally important difference may be indicated by a threshold of 3 to 4.
Conclusions:
- A CID for the I-GERQ-R was successfully derived.
- The findings provide guidance for interpreting I-GERQ-R scores in clinical practice.
- This research aids in evaluating meaningful symptom changes in infants with GORD.
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.
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