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Multidimensional measure for gastroesophageal reflux disease (MM-GERD) symptoms in children: a population-based study
Hoda M Malaty1, Kimberly J O'Malley, Suhaib Abudayyeh
1Department of Medicine, University of Texas, Health Science Center, Houston, TX, USA. Hmalaty@bcm.tmc.edu
Insights
A new multidimensional measure effectively assesses gastroesophageal reflux disease (GERD) symptoms in children, improving quality of life evaluations. This validated tool is reliable for pediatric gastroenterology clinical trials.
Area of Science:
- Pediatric Gastroenterology
- Clinical Outcomes Measurement
- Health-Related Quality of Life
Background:
- Gastroesophageal reflux disease (GERD) is common in children, causing symptoms like abdominal pain and heartburn.
- GERD significantly impairs quality of life for affected children and their families.
- Physicians face challenges in evaluating pediatric GERD due to a lack of validated symptom measures.
Purpose of the Study:
- To develop and validate a multidimensional measure for GERD symptoms in children.
- To assess the measure's responsiveness in children attending pediatric gastroenterology clinics.
Main Methods:
- A cross-sectional study enrolled 133 children with GERD symptoms from a pediatric GI clinic.
- A standardized questionnaire and physician interviews were used to gather data on symptoms, pain, disability, and satisfaction.
- The multidimensional measure comprised four scales: symptoms (10 items), pain intensity (3 items), disability (3 items), and satisfaction (2 items).
Main Results:
- The study included 133 children (59% girls, ages 4-18, mean age 10).
- Excellent correlations were found between the measure's scales in children aged 7 and younger (R=0.70) and older (R=0.74).
- Reliability was demonstrated by Cronbach's alpha coefficients ranging from 0.60 to 0.78 for the different scales.
Conclusions:
- The developed multidimensional measure demonstrated good responsiveness and reliability in assessing GERD symptoms in children.
- The measure performed well across different pediatric populations.
- This validated tool is suitable for use in clinical trials evaluating GERD symptoms in children.
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.
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