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Infant gastroesophageal reflux disease score: reproducibility and validity in a developing country
Sandeep Aggarwal1, Santosh K Mittal, Krishan K Kalra
1Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital.
Insights
The infant gastro-oesophageal reflux disease (GERD) score shows good reproducibility in Indian infants but lower diagnostic validity compared to studies in American infants. Further validation is needed for this GERD diagnostic tool in diverse populations.
Area of Science:
- Pediatrics
- Gastroenterology
- Diagnostic Tools
Background:
- Gastro-oesophageal reflux disease (GERD) is a common condition in infants.
- A 25-point GERD score, based on 11 signs and symptoms, has been proposed for infant diagnosis.
- Cross-cultural validation of diagnostic tools is crucial for global applicability.
Purpose of the Study:
- To assess the reproducibility and validity of a 25-point infant GERD score in Indian infants.
- To compare the diagnostic performance of the GERD score with oesophageal pH monitoring and endoscopy.
- To evaluate the adaptability of the infant GER questionnaire in a developing country setting.
Main Methods:
- Administered the Orenstein's infant GER questionnaire to caretakers of 610 infants (1-24 months).
- Assessed reproducibility with independent re-administration of the questionnaire.
- Validated the score against 24-hour oesophageal pH monitoring (95 infants) and endoscopy (35 infants).
Main Results:
- Excellent inter-observer reproducibility was observed (Pearson correlation coefficient = 0.906).
- The mean GERD score did not significantly differ between infants with and without documented GER (p>0.05).
- A GERD score of 5 demonstrated 43% sensitivity and 79% specificity, lower than previously reported.
Conclusions:
- The infant GER questionnaire is reproducible and adaptable for use in developing countries.
- The diagnostic validity of the GERD scoring system in Indian infants is lower than in American populations.
- The study highlights the need for culturally adapted and validated diagnostic tools for infant GERD.
Abstract:
A 25-point infant gastro-oesophageal reflux disease (GERD) score based on 11 signs and symptoms of gastrooesophageal reflux (GER), to diagnose GERD has been suggested in infant. We carried out this study to test the reproducibility and validity of this scoring system in the cross-cultural settings of Indian infants. Caretakers of 610 apparently healthy infants, between the ages of 1 month and 24 months were administered the Orenstein's infant GER questionnaire and assigned a GERD score. Of these, 95 infants were taken up for a 24-hours oesophageal pH monitoring study. Before the pH study, each subject was again tested by the infant GER questionnaire by another independent observer and assigned an infant GERD score. The 24-hours oesophageal pH study was done using the Synectics Digitrapper MK III portable pH recording device. Reflux index (RI) >10% in infants up to 1 year of age and >5% in children more than 1 year of age was taken as pathological. Upper gastrointestinal endoscopy and oesophageal biopsies were performed in 35 cases, after taking informed consent. A good correlation was seen between the scores evaluated independently by the two workers, with a Pearson correlation coefficient of 0.906. The mean GERD score in infants with GER (as diagnosed by pH-metry) was 4.64 +/- 3.99 compared to 3.54 +/- 3.96 in those with no documented GER (p>0.05). A GERD score of 5 had a sensitivity of 43% and specificity of 79%, compared to 86% and 85% observed by Orenstein et al. in their series. The infant GER Questionnaire is easily adaptable and reproducible in the settings of developing countries. However, its diagnostic validity appears to be much less than that obtained by Orenstein et al. in their study on American infants.
