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Clinically Meaningful Difference for the Infant Gastroesophageal Questionnaire Revised Version (I-GERQ-R): A Quantitative Synthesis

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Specialty Health Services
Date 2020 Mar 20
PMID 32189972
Citations 2
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Abstract

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 I 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 I=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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PMID: 38183243 PMC: 10771753. DOI: 10.1177/17534666231220817.


Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux.

Sultana Z, Hasenstab K, Moore R, Osborn E, Yildiz V, Wei L Gastro Hep Adv. 2022; 1(5):869-881.

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References
1.
Baldassarre M, Di Mauro A, Pignatelli M, Fanelli M, Salvatore S, Di Nardo G . Magnesium Alginate in Gastro-Esophageal Reflux: A Randomized Multicenter Cross-Over Study in Infants. Int J Environ Res Public Health. 2019; 17(1). PMC: 6981691. DOI: 10.3390/ijerph17010083. View

2.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J . Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998; 16(1):139-44. DOI: 10.1200/JCO.1998.16.1.139. View

3.
Brown P . Medical management of gastroesophageal reflux. Curr Opin Pediatr. 2000; 12(3):247-50. DOI: 10.1097/00008480-200006000-00012. View

4.
Kleinman L, Rothman M, Strauss R, Orenstein S, Nelson S, Vandenplas Y . The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument. Clin Gastroenterol Hepatol. 2006; 4(5):588-96. DOI: 10.1016/j.cgh.2006.02.016. View

5.
Deshpande P, Rajan S, Sudeepthi B, Abdul Nazir C . Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011; 2(4):137-44. PMC: 3227331. DOI: 10.4103/2229-3485.86879. View