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Infant gastroesophageal reflux disease score: reproducibility and validity in a developing country.

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.