Optimal thresholds, sensitivity, and specificity of long-term pH-metry for the detection of gastroesophageal reflux disease

Abstract

Long-term esophageal pH-metry has become the preferred test to quantify acid gastroesophageal reflux, but its accuracy in separating physiologic from pathological reflux is not well defined. To establish optimal thresholds of 24-h pH-metry, we studied 45 patients with clinically proven gastroesophageal reflux disease and 42 healthy volunteers. Twenty-four-hour esophageal pH was measured while the subject was ambulatory, using a combined glass electrode connected to a portable recorder. Percentage of time with esophageal pH < 4, the number and mean duration of reflux episodes, the number of episodes lasting longer than 5 min, and the duration of the longest episode were calculated for periods of upright and supine body position, respectively. Discriminant analysis and receiver-operating-characteristic analysis were used to define optimal thresholds. A maximum of sensitivity (93.3%) and specificity (92.9%) was obtained using receiver-operating-characteristic analysis with the following criteria. (a) Only percentage of time with esophageal pH < 4 is considered, (b) A subject is classified as “normal” if both values for the upright and supine body position are below the thresholds, otherwise the subject is classified as “pathological.” (c) The thresholds are 10.5% of time with esophageal pH < 4 for the upright position and 6.0% for the supine position. Within the limits of this retrospective study, it is concluded that rather simple criteria yield a high diagnostic accuracy in the evaluation of long-term esophageal pH-metry. Nevertheless, a prospective and independent confirmation of these criteria is needed.