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Reproducibility of 24 hour oesophageal pH studies in infants
F J Hampton1, U M MacFadyen, H Simpson
1Department of Child Health, Leicester Royal Infirmary.
Insights
Reproducibility of gastro-oesophageal reflux diagnosis is low in infants. Two 24-hour pH monitoring tests showed significant variability, primarily due to biological factors, impacting treatment assessment.
Area of Science:
- Pediatrics
- Gastroenterology
- Medical Diagnostics
Background:
- Gastro-oesophageal reflux (GER) is a common condition in infants.
- Accurate diagnosis of GER is crucial for appropriate management and treatment.
- Twenty-four hour oesophageal pH monitoring is a standard diagnostic tool for GER.
Purpose of the Study:
- To assess the reproducibility of 24-hour oesophageal pH monitoring in infants.
- To determine the extent of variability in GER diagnosis between repeated tests.
- To evaluate the impact of variability on assessing treatment effectiveness.
Main Methods:
- Thirteen infants diagnosed with GER underwent two separate 24-hour oesophageal pH monitoring studies.
- Infants' activities were not restricted during the monitoring periods.
- Data analysis focused on the percentage of time oesophageal pH was less than 4.
Main Results:
- Significant variability was observed between the two pH monitoring tests in the same infants.
- The percentage of time with pH < 4 varied up to 3.7-fold between tests.
- Variability was attributed mainly to biological factors rather than technical issues.
Conclusions:
- Single 24-hour oesophageal pH monitoring studies in infants may have limited reliability for GER diagnosis.
- Substantial changes in pH monitoring results are needed to confidently demonstrate treatment effects.
- Findings impact the interpretation of GER diagnosis and treatment response assessment.
Abstract:
Thirteen infants who had undergone 24 hour oesophageal pH monitoring to diagnose gastro-oesophageal reflux had a second study carried out to see if the results were reproducible. The studies were done without restricting the babies' activities. Appreciable differences were found, the percentage of the total time during which the pH was less than 4 varying by up to 3.7-fold between the two tests. The differences were largely the result of biological rather than technical variability. From these results estimates were made of the reliability of a single diagnostic study and the size of changes that would be necessary to show the effect of treatment. These findings have a considerable impact on the diagnosis of abnormal gastro-oesophageal reflux and its response to treatment whether using 24 hour pH monitoring or any other method of measurement.