Background: Treatment of uncomplicated gastroesophageal reflux disease (GERD) is primarily to improve the symptoms of the patient. However, measurement of symptomatic outcome is difficult because it is as the patient perceives it to be and not "objective." This creates a need to develop a simple and understandable instrument to measure symptomatic outcome.
Study design: All patients referred for evaluation of GERD were eligible for this prospective study. During the initial visit, patients were asked to complete the Gastroesophageal Reflux Data Sheet. This ten-item questionnaire included an overall assessment of satisfaction; the best possible score was 0, and the worst was 45. The evaluation included history, physical examination, and additional studies, including upper gastrointestinal series, esophagogastroduodenoscopy, esophageal manometry, and 24-hour esophageal pH monitoring as indicated. Initial treatment was medical with histamine2-blockers, omeprazole, cisapride, or both. If a patient was dissatisfied with medical treatment and had both a hypotensive lower esophageal sphincter and abnormal results of the 24-hour pH monitoring, then operative treatment with either laparoscopic or open Nissen or Toupet fundoplication was offered. After approximately three months of medical treatment or one month after operative treatment, patients were asked to complete the questionnaire again. Data were analyzed using nonparametric tests and linear regression analysis.
Results: A total of 72 patients were assessed, and 100 percent of them completed the questionnaire. Patients who were satisfied with their condition had a median health-related quality of life (HRQL) score of five, and those who were dissatisfied had a median score of 26 (p < 0.000001). Patients who ultimately chose surgical therapy had a median preoperative score of 28, compared with 15 for patients who chose to continue medical therapy (p = 0.0001). The change in HRQL score from before treatment to after treatment for surgical patients was 27 compared with 11 for medically treated patients (p < 0.002). Items 1 through 6 of the questionnaire were individually sensitive to the effects of treatment. However, there was no correlation between HRQL and the composite pH score or with the lower esophageal sphincter pressure.
Conclusions: This HRQL score has advantages over standard health status instruments for GERD including simplicity for patients (and therefore a high compliance rate), ease of understanding for physicians, and sensitivity to the effects of treatment. In addition, it may help determine, early in the course of treatment, patients who may ultimately require surgical therapy, thereby avoiding prolonged, but futile, medical therapy.