Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease

Abstract

OBJECTIVES: Brief, reliable, and valid self-administered questionnaires could facilitate the diagnosis of gastroesophageal reflux disease in primary care. We report the development and validation of such an instrument. METHODS: Content validity was informed by literature review, expert opinion, and cognitive interviewing of 50 patients resulting in a 22-item survey. For psychometric analyses, primary care patients completed the new questionnaire at enrollment and at intervals ranging from 3 days to 3 wk. Multitrait scaling, test-retest reliability, and responsiveness were assessed. Predictive validity analyses of all scales and items used specialty physician diagnosis as the "gold standard." RESULTS: Iterative factor analyses yielded three scales of four items each including heartburn, acid regurgitation, and dyspepsia. Multitrait scaling criteria including internal consistency, item interval consistency, and item discrimination were 100% satisfied. Test-retest reliability was high in those reporting stable symptoms. Scale scores significantly changed in those reporting a global change. Regressing specialty physician diagnosis on the three scales revealed significant effects for two scales (heartburn and regurgitation). Combining the two significant scales enhanced the strength of the model. Symptom response to selfdirected treatment with nonprescription antisecretory medications was highly predictive of the diagnosis also, although the item demonstrated poor validity and reliability. CONCLUSIONS: A brief, simple 12-item questionnaire demonstrated validity and reliability and seemed to be responsive to change for reflux and dyspeptic symptoms.

Randomised clinical trial: addition of alginate‐antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms

“…At the screening visit, eligible patients were enrolled in a 7‐day run‐in period during which they continued their once‐daily PPI and completed the HRDQ to assess reflux symptoms and a diary card to record compliance with PPI treatment and satisfaction, every day (Figure ). Following the 7‐day run‐in, patients were re‐assessed for eligibility to enter the treatment phase of the trial and completed the Reflux Disease Questionnaire (RDQ) to determine (baseline) satisfaction with medication over the previous 7 days. Patients, who met the symptom threshold for eligibility (Exploratory study: patients with at least one reflux symptom of at least moderate intensity during run‐in and a summarised 7‐day HRDQ score for heartburn and/or regurgitation of at least 18, e.g.…”

“…Primary efficacy data were based on the HRDQ, a measure designed specifically to capture symptoms that are most relevant for patients with uncontrolled GERD symptoms while taking daily PPIs. The HRDQ was adapted from the two most extensively tested patient‐reported outcome measures, the RDQ and ReQuest questionnaires which, while well‐validated, are not designed for patients with residual GERD symptoms while on therapy. The RDQ is a 12‐item questionnaire designed to retrospectively assess (1‐week re‐call) the frequency and severity of heartburn, regurgitation and dyspeptic symptoms of GERD in primary care .…”

“…The HRDQ was adapted from the two most extensively tested patient‐reported outcome measures, the RDQ and ReQuest questionnaires which, while well‐validated, are not designed for patients with residual GERD symptoms while on therapy. The RDQ is a 12‐item questionnaire designed to retrospectively assess (1‐week re‐call) the frequency and severity of heartburn, regurgitation and dyspeptic symptoms of GERD in primary care . The HRDQ differs from the RDQ in that the questionnaire is shorter, completed daily and also assesses night‐time events and total duration of symptoms .…”

Prevalence of Gastroesophageal Reflux Disease in Type II Diabetes Mellitus

“…The highest score for one patient was 40. Symptom-based diagnosis of GERD was made when a patient had a score more than 12 [8]. …”

Helicobacter pylori infection and gastritis: The Systematic Investigation of gastrointestinaL diseases in China (SILC)

“…Reflux esophagitis was diagnosed using the Los Angeles classification 12 . All participants were also asked to complete a general information questionnaire and a Chinese version of the Reflux Disease Questionnaire (RDQ) 13 . The RDQ was used to assess the frequency and severity of heartburn (“burning behind the breastbone” and/or “pain behind the breastbone”), regurgitation (“acid taste in the mouth” and/or “unpleasant movement of materials upwards from the stomach”) and epigastric pain (“pain in the centre of the upper stomach” and/or “burning in the centre of the upper stomach”) during a 1‐month recall period.…”