Patient-Reported Outcomes in Gastroenterology: Clinical and Research Applications
- Brennan M R Spiegel
- Journal of neurogastroenterology and motility
BACKGROUND Gastroesophageal reflux disease (GERD) symptoms are very common in children with major presenting symptoms of abdominal pain, heartburn and regurgitation. The presence of GERD symptoms often result in an impaired health-related quality of life for both the patients and their parents. Evaluation of children with GERD symptoms continues to challenge physicians due to the lack of a validated measure for GERD symptoms. AIMS To develop and test a multidimensional measure for GERD symptoms in children and to evaluate the responses of the measure among children attending pediatric gastroenterology (GI) clinics. METHODS We conducted a cross-sectional study that enrolled children with GERD symptoms from pediatric GI clinic. All children and parents received a standardized questionnaire concerning socio-economic parameters, GERD symptoms, duration, frequency, intensity and missed activities due to GERD symptoms. Each child and parent pair was interviewed by a physician to complete baseline information for the multidimensional measure that consisted of four scales: symptoms scale (10 items), pain intensity scale (3 items); disability scale (3 items) and satisfaction scale (2 items). RESULTS One hundred and thirty-three children participated in the study; 59% girls, ages 4 to 18 years, mean age = 10 +/- 3, 50%, 10 years and younger. There was an excellent correlation between the four-scales measure among children 7 years and younger (R = 0.70, p = 0.0001) and children >7 years (R = 0.74, p = 0.0001). The inter-item consistency (Cronbach's co-efficient alpha) for the symptoms items, pain intensity items, disability items and satisfaction items were 0.71, 0.74, 0.78 and 0.60, respectively, demonstrating adequate reliability of the measure. CONCLUSION Children with GERD symptoms have good responses to the multidimensional measure for GERD symptoms, showing that the measure performed well across populations. The measure is reliable and specific for assessing the symptoms of GERD in children and is an appropriate outcomes measure for clinical trials involving GERD symptoms in children.