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BACKGROUND/AIMS: Evaluation of the response of gastroesophageal reflux disease (GERD) symptoms to treatment would be facilitated by a brief, valid, reliable and responsive, self-assessed GERD-sensitive scale. We therefore developed the Reflux Questionnaire (ReQuest). This publication describes the psychometric evaluation and validation of ReQuest. METHODS: This second phase of development was based on data from a clinical trial of patients with erosive GERD who received pantoprazole 20 or 40 mg daily for 28 days and completed weekly the long, and daily the short version of ReQuest. The psychometric analyses of ReQuest included internal consistency, test-retest reliability and responsiveness. Construct validity was evaluated by comparison with the Gastrointestinal Symptom Rating Scale (GSRS) and the Psychological General Well-Being (PGWB) scale. RESULTS: Validation of ReQuest indicated very high internal consistency (Cronbach's alpha = 0.90) and test-retest reliability (intraclass correlation coefficient 0.94 (long-long) and 0.86 (short-short)). This was also the case for the two subscales ReQuest-GI and ReQuest-WSO with Cronbach's alpha coefficients of 0.84 and 0.81. Responsiveness was high with a responsiveness index of >0.8 at day 28. Construct validity was good. CONCLUSION: ReQuest is a highly reliable, valid and responsive self-assessment tool for evaluating treatment response in patients with erosive GERD, and can be applied daily.

Background : Many dual and triple therapy treatment regimens have been proposed for the eradication of Helicobacter pylori. However, assessing the relative efficacy of these regimens is complicated by differences in study design, and few well-controlled comparative studies have been reported. Methods : This multicentre, randomized, double-blind study involved 530 duodenal ulcer patients, of whom 520 had confirmed H. pylori infection. Patients received 14 days b.d. dual therapy of either ranitidine bismuth citrate (RBC) 400 mg or omeprazole 20 mg, both with clarithromycin 500 mg to eradicate H. pylori, followed by a further 14 days of treatment with RBC 400 mg b.d. or omeprazole 20 mg o.d. to facilitate ulcer healing. H. pylori eradication and ulcer healing were assessed at least 26 days after the end of treatment. Adverse events were recorded throughout the study. Results : H. pylori was eradicated in 90% of patients who received RBC with clarithromycin and in 66% of patients who received omeprazole with clarithromycin (per protocol; P

Pantoprazole, the third proton pump inhibitor (PPI) to become available, has been extensively investigated. Pantoprazole inhibits acid more powerfully than histamine H(2) receptor antagonists (H(2)RAs) and omperazole 20 mg and raises median 24-h gastric pH from about 1.5 to 3-4 in healthy volunteers and in duodenal ulcer patients to above 5. Results from studies have confirmed that pantoprazole is superior to H(2)RAs in speed of healing and symptom relief in patients with peptic ulcer. In patients with duodenal ulcer pantoprazole was as effective as omperazole 20 mg and in patients with gastric ulcer pantoprazole was statistically superior to omeprazole 20 mg after 4 weeks. In triple combination therapy of peptic ulcer disease, the mean eradication rate of Helicobacter pylori in data pooled from 32 pantoprazole-based studies was 86% and compliance with treatment was about 90%. Results pooled from 5 large clinical trials of gastroesophageal reflux disease showed healing rates significantly superior to those achieved with H(2)RAs and similar to those of other PPIs at 4 and 8 weeks. Symptom relief was more rapid with pantoprazole and maintenance treatment kept the majority of patients in remission; relapse rates at 1 year were 25-28% on 20 mg daily and 6-22% on 40 mg daily. Maintenance treatment with pantoprazole 40 mg has been shown to keep most patients with aggressive or refractory ulcer and reflux disease in remission for up to 3 years. Pantoprazole was also effective in the management of patients with Zollinger-Ellison syndrome. In volunteers given aspirin, pantoprazole 40 mg proved significantly superior to ranitidine and placebo in preventing the development of mucosal damage and was significantly better than placebo in preventing gastric ulcer and duodenal ulcer in arthritic patients on nonsteroidal antiinflammatory drugs. Clinical trials, postmarketing surveillance and long-term studies have confirmed that pantoprazole is effective and safe for the short- and long-term management of peptic ulcer and reflux disease, with side effects similar in incidence and type to those of H(2)RAs.

In about 5-10% of duodenal ulcer patients, ulcer healing is difficult or impossible to achieve with H2-receptor antagonists. Such patients are considered to have a refractory ulcer. The cause of refractoriness remains unknown. Some patients have high acid secretion or inadequate acid suppression on treatment, but this has not been confirmed by all investigators or in all patients. Abnormalities in mucosal defence presumably exist, but none have as yet been identified. The principal medical therapeutic approach has been to continue suppressing acid or to use mucosal protective agents. Increasing the duration of H2-receptor antagonist treatment at the same dose had little effect, but doubling or trebling the dose improved healing rates in open studies. Markedly higher healing rates occurred when treatment was changed from cimetidine to ranitidine (which is more potent) in open studies, but this was not always confirmed in controlled studies. Adding the anti-muscarinic, pirenzepine, to cimetidine to achieve better acid inhibition, improved healing rates in some controlled studies but not in others. The mucosal protectant, colloidal bismuth subcitrate, proved significantly more effective than H2-receptor antagonist treatment, but the drug is suitable only for short-term therapy. Controlled studies with omeprazole confirmed the results of open studies and proved the product to be superior to continued H2-receptor antagonist treatment in healing refractory duodenal ulcer. Open studies using maintenance treatment with low-dose omeprazole suggest that such therapy is effective in keeping refractory duodenal ulcer healed.

Gastroesophageal reflux disease (GERD) is one of the most prevalent diseases worldwide, and it is becoming increasingly important to monitor the effect of various interventions on GERD symptoms. There can be rapid temporal changes in the severity and frequency of patients’ symptoms as well as their health status and well-being, all of which could, theoretically, be monitored using diaries or questionnaires. However, current GERD monitoring instruments are not appropriate because they do not assess symptoms daily, they are not sufficiently responsive to short-term changes in health status or they are not adequately validated. To address these problems, the conceptual and psychometric requirements for a GERD symptom assessment questionnaire were identified. A dimension-based scale was designed to reduce the number of symptoms monitored on a daily basis, and the validation process was defined to produce parallel long and short forms of a scale for patients’ self-assessment of their GERD symptom response to therapy. These basic principles which underlie the successful development of a new, self-assessed symptomatic reflux questionnaire (ReQuestTM) are also applicable to the development of validated questionnaires for daily symptom self-assessment in other disease areas.

Background/Aims: The growing importance of symptom assessment is evident from the numerous clinical studies on gastroesophageal reflux disease (GERD) assessing treatment-induced symptom relief. However, to date, the a priori selection of criteria defining symptom relief has been arbitrary. The present study was designed to prospectively identify GERD symptom thresholds for the broad spectrum of GERD-related symptoms assessed by the validated reflux questionnaire (ReQuest™) and its subscales, ReQuest™-GI (gastrointestinal symptoms) and ReQuest™-WSO (general well-being, sleep disturbances, other complaints), in individuals without evidence of GERD. Methods: In this 4-day evaluation in Germany, 385 individuals without evidence of GERD were included. On the first day, participants completed the ReQuest™, the Gastrointestinal Symptom Rating Scale, and the Psychological General Well-Being scale. On the other days, participants filled in the ReQuest™ only. GERD symptom thresholds were calculated for ReQuest™ and its subscales, based on the respective 90th percentiles. Results: GERD symptom thresholds were 3.37 for ReQuest™, 0.95 for ReQuest™-GI, and 2.46 for ReQuest™-WSO. Conclusion: Even individuals without evidence of GERD may experience some mild symptoms that are commonly ascribed to GERD. GERD symptom thresholds derived in this study can be used to define the global symptom relief in patients with GERD.

Background: Reflux Questionnaire (ReQuest™), a newly developed gastro-oesophageal reflux disease-sensitive scale, can be used to reliably evaluate the effect of treatment on gastro-oesophageal reflux disease symptoms. Aim: International validation of this scale, in patients suffering from endoscopy-negative gastro-oesophageal reflux disease. Methods: In this open, multicentre and multinational clinical trial 840 endoscopy-negative gastro-oesophageal reflux disease patients received pantoprazole 20 mg daily for 28 days. The long and short versions of ReQuest™ were completed both in the pre-treatment and treatment phases. For scale development an item reduction analysis was performed. Internal consistency, test–retest reliability and responsiveness were calculated for psychometric analysis. Construct validity was evaluated by comparison with the Gastrointestinal Symptom Rating Scale and the Psychological General Well-being questionnaire by means of correlation coefficients. Results: Factor analyses confirmed the content validity of both long and short version of ReQuest™. Psychometric calculations proved high internal consistency (Cronbach’s alpha: 0.9), test–retest reliability [Intraclass Correlation Coefficient: 0.9 (long vs. long) and 0.8 (short vs. short)], and responsiveness (Responsiveness Index 320.3) of the scale, for which also good construct validity was achieved (correlation coefficient: Gastrointestinal Symptom Rating Scale 0.6; Psychological General Well-being –0.4). Conclusion: ReQuest™ proved valid, reliable, and responsive in this multinational clinical trial to evaluate treatment response in endoscopy-negative gastro-oesophageal reflux disease patients.

Background: Gastro-oesophageal reflux disease (GERD) is highly prevalent in Western countries. Because the majority of patients do not present with endoscopic abnormalities, the assessment of the symptom severity and quality of life, and their response to treatment, has become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinical trials. Aim: To evaluate the validity of available GERD measurement tools. Methods: An ideal GERD symptom assessment instrument, suitable as a primary end-point for clinical trials, should possess the following characteristics: (i) be sensitive in patients with GERD; (ii) cover the frequency and intensity of typical and atypical GERD symptoms; (iii) be multidimensional (cover all symptom dimensions); (iv) have proven psychometric properties (validity, reliability and responsiveness); (v) be practical and economical; (vi) be self-assessed; (vii) use ‘word pictures’ which are easy to understand for patients; (viii) respond rapidly to changes (responsiveness over short time intervals); (ix) be used daily to assess changes during and after therapy; and (x) be valid in different languages for international use. Results: A literature review revealed five scales that met some of the above characteristics, but did not fulfil all criteria. Conclusion: There is a need for a new evaluative tool for the assessment of GERD symptoms and their response to therapy.