Use of the Montreal global definition as an assessment of quality of life in reflux disease.

According to the Montreal Consensus Group's classification, gastroesophageal reflux disease develops when the reflux of stomach contents causes troublesome symptoms and/or complications such as esophagitis. The characteristic gastroesophageal reflux disease symptoms included in this statement are retrosternal burning and regurgitation. Troublesome is meant to imply that these symptoms impact on the well-being of affected individuals; in essence, quality of life (QOL). Whether heartburn and regurgitation symptoms would be characterized as more troublesome in those with confirmed pathologic acid reflux was determined. A second purpose was to assess how well troublesome scores correlated with the results of a validated, disease-specific QOL instrument. Subjects who underwent esophagogastroduodenoscopy (EGD) with 48-hour wireless esophageal pH testing off proton pump inhibitor therapy were interviewed. Esophagitis on EGD or pH < 4.0 for ≥4.5% of time over the 2-day period was considered positive for acid reflux. Assessment of how troublesome their symptoms of heartburn and regurgitation were made using separate 0-100 visual analog scales (VAS). Subjects were then asked to complete the Quality of Life in Reflux and Dyspepsia (QOLRAD) 25-item questionnaire. Sixty-seven patients (21 males, 46 females) with mean age 47.8 ± 15.6 years were identified. Forty (59.7%) had an EGD or pH study positive for acid reflux. Overall 35/40 (87.5%) complained of either heartburn or regurgitation. There was no difference (P= 0.80) in heartburn VAS troublesome ratings for those with (54.0 ± 43.9) and without (56.7 ± 37.6) confirmed acid reflux. The same was true for regurgitation VAS troublesome ratings (P= 0.62). Likewise, mean QOLRAD scores did not differ between those with and without confirmed acid reflux by pH or EGD (4.5 ± 1.7 vs. 4.3 ± 1.7; P= 0.61). There was a moderately strong inverse correlation between patient self-rated VAS troublesome scores for both heartburn and regurgitation with each dimension (emotional distress, sleep disturbance, eating problems, physical/social functioning, and vitality) of the QOLRAD (P < 0.05 for all comparisons). In regression analysis, both heartburn and regurgitation troublesome ratings were associated with the overall QOLRAD score independent of pH data, frequency of reflux episodes, age, and gender. Use of the term troublesome in the Montreal Consensus Group classification is supported by our findings. It correlates well with the results of a validated disease-specific QOL instrument. Use of heartburn and regurgitation VAS may serve as accurate measures of the burden of reflux disease on patients. It is likely that these scales will not have sufficient discriminate value to identify individuals with pathologic acid reflux from those with negative studies.