Gastro-oesophageal reflux disease (GERD) is a common disorder in adults and children. The global prevalence of GERD is high and increasing. Non-erosive reflux disease is the most common phenotype of GERD. Heartburn and regurgitation are considered classic symptoms but GERD may present with various atypical and extra-oesophageal manifestations. The pathophysiology of GERD is multifactorial and different mechanisms may result in GERD symptoms, including gastric composition and motility, anti-reflux barrier, refluxate characteristics, clearance mechanisms, mucosal integrity and symptom perception. In clinical practice, the diagnosis of GERD is commonly established on the basis of response to anti-reflux treatment; however, a more accurate diagnosis requires testing that includes upper gastrointestinal tract endoscopy and reflux monitoring. New techniques and new reflux testing parameters help to better phenotype the condition. In children, the diagnosis of GERD is primarily based on history and physical examination and treatment vary with age. Treatment in adults includes a combination of lifestyle modifications with pharmacological, endoscopic or surgical intervention. In refractory GERD, optimization of proton-pump inhibitor treatment should be attempted before a series of diagnostic tests to assess the patient's phenotype.

Gastro-oesophageal reflux disease.

Numerous questionnaires with a wide variety of characteristics have been developed for the assessment of gastroesophageal reflux disease (GERD) Four well-defined dimensions are noticeable in these GERD questionnaires, which are symptoms, response to treatment, diagnosis, and burden on the quality of life of GERD patients The aim of this review is to develop a complete overview of all available questionnaires, categorized per dimension of the assessment of GERD A systematic search of the literature up to January 2013 using the Pubmed database and the Embase database, and search of references and conference abstract books were conducted A total number of 65 questionnaires were extracted and evaluated Thirty-nine questionnaires were found applicable for the assessment of GERD symptoms, three of which are generic gastrointestinal questionnaires For the assessment of response to treatment, 14 questionnaires were considered applicable Seven questionnaires with diagnostic purposes were found In the assessment of quality of life in GERD patients, 18 questionnaires were found and evaluated Twenty questionnaires were found to be used for more than one assessment dimension, and eight questionnaires were found for GERD assessment in infants and/or children A wide variety of GERD questionnaires is available, of which the majority is used for assessment of GERD symptoms Questionnaires differ in aspects such as design, validation and translations Also, numerous multidimensional questionnaires are available, of which the Reflux Disease Questionnaire is widely applicable We provided an overview of GERD questionnaires to aid investigators and clinicians in their search for the most appropriate questionnaire for their specific purposes

Systematic review: questionnaires for assessment of gastroesophageal reflux disease

https://www.cghjournal.org/article/S1542-3565(11)00509-X/pdf

Insights Into Gastroesophageal Reflux Disease–Associated Dyspeptic Symptoms

Summary


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.

International validation of ReQuest in patients with endoscopy-negative gastro-oesophageal reflux disease

Gastroesophageal reflux disease (GERD) symptoms are best assessed using patient-reported outcome (PRO) instruments. Guidance on developing well-defined and reliable instruments that capture optimal information from the patient's perspective was recently published by the US Food and Drug Administration and the European Medicines Agency. The aim of this systematic review was to identify and evaluate existing PRO instruments for GERD symptoms with regard to regulatory requirements. Systematic literature searches were conducted in PubMed and Embase to identify PRO instruments for GERD symptoms that have undergone psychometric evaluation. Content, construct and test-retest reliability, internal consistency, and responsiveness were evaluated in relation to regulatory recommendations. Supplementary searches were conducted to assess whether identified instruments had been used as clinical trial endpoint measures. The systematic literature searches identified 15 PRO instruments for GERD symptoms that have undergone psychometric evaluation. Eight were designed to evaluate GERD symptoms, two were to diagnose GERD, four were designed for both evaluative and diagnostic purposes, and one was designed for screening purposes. Five instruments were developed and reported to include most steps recommended by the Food and Drug Administration and European Medicines Agency, and have also been used as endpoint measures in clinical trials: the GERD Symptom Assessment Scale, the Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire, the Reflux Questionnaire, the Reflux Disease Questionnaire, and the Proton pump inhibitor Acid Suppression Symptom test. Existing PRO instruments for GERD do not meet all the regulatory requirements for an outcome instrument in reflux trials and may need further validation.

Systematic review of patient-reported outcome instruments for gastroesophageal reflux disease symptoms.

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.

Evaluation of GERD symptoms during therapy. Part II. Psychometric evaluation and validation of the new questionnaire ReQuest in erosive GERD.

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Evaluation of GERD symptoms during therapy. Part II. Psychometric evaluation and validation of the new questionnaire ReQuest in erosive GERD.