Digestion

doi: 10.1159/000102566pmid: N/A

Beglinger, Christoph

doi: 10.1159/000101019pmid: N/A

Stanghellini, V.; Armstrong, D.; Mönnikes, H.; Bardhan, K.D.

doi: 10.1159/000101077pmid: 17489027

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.

Armstrong, David; Mönnikes, Hubert; Bardhan, Karna Dev; Stanghellini, Vincenzo

doi: 10.1159/000101078pmid: 17489028

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 (ReQuest™) are also applicable to the development of validated questionnaires for daily symptom self- assessment in other disease areas.

Beckerling, Andree; Braun, Waldemar; Sommer, Michael

doi: 10.1159/000101079pmid: 17489029

Often, the decision whether a patient can be considered as healthy or ill is very difficult and depends on measurements and the interpretation of the results. Therefore, it is necessary to build and establish devices that base on certain pre-considerations (who should assess the data, when and how should be measured). Additionally, these devices have to be valid, reliable and responsive. According to the literature we came to the conclusion that no uniform definition of what is ‘healthy’ exists. Referring to mathematical considerations we show an approach to solve this problem especially when the device is a scale. Based on the quality of the scale and of certain pre-considerations, normal ranges can be established that will help to distinguish whether patients are ‘healthy‘ or ‘ill’. In this short review we discuss the problem of the establishment of a cut-off level on the basis of devices and we try to point out a solution to solve the arising problems.

Bardhan, K.D.; Stanghellini, V.; Armstrong, D.; Berghöfer, P.; Gatz, G.; Mönnikes, H.

doi: 10.1159/000101080pmid: 17489030

Background/Aims: The changes in gastroesophageal reflux disease (GERD)-related symptoms on treatment are variously described, but currently available questionnaires have shortcomings. We therefore developed a self-assessment reflux questionnaire (ReQuest™). This article describes the process of development and testing. Materials and Methods: For the first version of ReQuest™the symptom spectrum of GERD and the various symptom descriptions were investigated. The 67 identified symptom descriptions were condensed empirically into 6 dimensions, to which a 7th dimension on general well-being was added. The symptom burden of the dimensions was measured by frequency and/or intensity. ReQuest™ was translated into different languages and then tested in focus groups. The initial validation was based on data from a clinical trial of patients with erosive GERD, treated with pantoprazole 20 or 40 mg daily for 28 days. Factor analyses determined the contribution of each symptom to the different dimensions. Additionally, correlation analyses between the identified factors and the dimensions were performed. Results: On the basis of factor analyses, ReQuest™ was reduced to a 60-item scale. The factors generated correlated strongly with the dimensions and confirmed the empirical process mathematically. Conclusion:ReQuest™ provides a valuable, self-assessment tool for evaluating the daily treatment response in patients with erosive GERD.

Mönnikes, H.; Bardhan, K.D.; Stanghellini, V.; Berghöfer, P.; Bethke, T.D.; Armstrong, D.

doi: 10.1159/000101081pmid: 17489031

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 α = 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 α 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.

Bardhan, K.D.; Stanghellini, V.; Armstrong, D.; Berghöfer, P.; Gatz, G.; Mönnikes, H.

doi: 10.1159/000101082pmid: 17489032

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.

Stanghellini, Vincenzo; Armstrong, David; Mönnikes, Hubert; Berghöfer, Peter; Gatz, Gudrun; Bardhan, Karna Dev

doi: 10.1159/000101083pmid: 17489033

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 (ReQuestTM) and its subscales, ReQuestTM-GI (gastrointestinal symptoms) and ReQuestTM-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 ReQuestTM, the Gastrointestinal Symptom Rating Scale, and the Psychological General Well-Being scale. On the other days, participants filled in the ReQuestTM only. GERD symptom thresholds were calculated for ReQuestTM and its subscales, based on the respective 90th percentiles. Results: GERD symptom thresholds were 3.37 for ReQuestTM, 0.95 for ReQuestTM-GI, and 2.46 for ReQuestTM-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.

Mönnikes, Hubert; Pfaffenberger, Bernd; Gatz, Gudrun; Hein, Jasper; Bardhan, Karna Dev

doi: 10.1159/000101084pmid: 17489034

Background/Aims: A prime concern for gastroesophageal reflux disease (GERD) patients is fast symptom control. Sparse valid information is available on the rapidity of the effect of proton pump inhibitors in providing symptom relief. The new reflux questionnaire ReQuest^TM is validated for daily assessment of changes in GERD symptoms. Therefore, this study investigated the efficacy of 20 mg pantoprazole and 20 mg esomeprazole with regard to the time to symptom relief in patients with endoscopy-negative GERD (enGERD) using ReQuest^TM. Methods: 529 patients were treated with pantoprazole or esomeprazole over 4 weeks. ReQuest^TM symptom scores were assessed daily. The mean and median times to first and sustained symptom relief were determined. Results: Median time to first symptom relief was 2 days for both drugs (intention-to-treat population). The median time to sustained symptom relief was 3 days shorter with pantoprazole (10.0 vs. 13.0 days). The Hodges-Lehmann estimator for the difference in time to reach first and sustained symptom relief between both groups was 0.00 days. For both variables the one-sided 95% CI (Moses) was [0.00; ∞[, documenting no significant differences between the treatment groups. Conclusions: The rapidity of symptom control can be evaluated by clinically significant parameters using ReQuest^TM. Pantoprazole and esomeprazole are equally effective in the time to first and sustained symptom relief.