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The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument.
Clin Gastroenterol Hepatol. 2006 May; 4(5):588-96.CG

Abstract

BACKGROUND & AIMS

Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation.

METHODS

A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms.

RESULTS

Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001).

CONCLUSION

This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms.

Authors+Show Affiliations

Center for Health Outcomes Research, United BioSource Corporation, Seattle, Washington 98121, USA. leah.kleinman@unitedbiosource.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

16678075

Citation

Kleinman, Leah, et al. "The Infant Gastroesophageal Reflux Questionnaire Revised: Development and Validation as an Evaluative Instrument." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 4, no. 5, 2006, pp. 588-96.
Kleinman L, Rothman M, Strauss R, et al. The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument. Clin Gastroenterol Hepatol. 2006;4(5):588-96.
Kleinman, L., Rothman, M., Strauss, R., Orenstein, S. R., Nelson, S., Vandenplas, Y., Cucchiara, S., & Revicki, D. A. (2006). The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 4(5), 588-96.
Kleinman L, et al. The Infant Gastroesophageal Reflux Questionnaire Revised: Development and Validation as an Evaluative Instrument. Clin Gastroenterol Hepatol. 2006;4(5):588-96. PubMed PMID: 16678075.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument. AU - Kleinman,Leah, AU - Rothman,Margaret, AU - Strauss,Richard, AU - Orenstein,Susan R, AU - Nelson,Suzanne, AU - Vandenplas,Yvan, AU - Cucchiara,Salvatore, AU - Revicki,Dennis A, PY - 2006/5/9/pubmed PY - 2006/7/11/medline PY - 2006/5/9/entrez SP - 588 EP - 96 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin Gastroenterol Hepatol VL - 4 IS - 5 N2 - BACKGROUND & AIMS: Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation. METHODS: A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms. RESULTS: Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001). CONCLUSION: This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms. SN - 1542-3565 UR - https://www.unboundmedicine.com/medline/citation/16678075/The_infant_gastroesophageal_reflux_questionnaire_revised:_development_and_validation_as_an_evaluative_instrument_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(06)00177-7 DB - PRIME DP - Unbound Medicine ER -