Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors.

Scand J Gastroenterol 2013 Sep 6;48(9):1018-26. Epub 2013 Aug 6.

AstraZeneca R&D, Mölndal, Sweden.

Objective: The Reflux Symptom Questionnaire 7-day recall (RESQ-7) was developed, in line with the US Food and Drug Administration (FDA) guidelines, to address the need for a patient-reported outcome (PRO) instrument assessing symptoms specifically in patients with gastroesophageal reflux disease (GERD) who are only partially responsive to proton pump inhibitor (PPI) therapy.

Materials And Methods: The RESQ-7 was constructed using patient interviews and expert consensus. The instrument was psychometrically validated in a clinical trial setting in patients with persistent GERD symptoms despite PPI therapy.

Results: Evaluation of content validity yielded a 13-item structure for the RESQ-7, incorporating symptoms overlooked by existing GERD questionnaires, such as hoarseness, cough, difficulty swallowing and burping. Principal component analysis suggested a four-domain structure. All domains had a high inter-item correlation (Cronbach's α lower 95% confidence limits: 0.77-0.87 for intensity; 0.72-0.82 for frequency). Test-retest reliability was fair-to-good or excellent (intraclass correlation coefficient lower 95% confidence limits: 0.70-0.78 for intensity; 0.65-0.75 for frequency). Convergent and discriminant validity were confirmed by correlation comparisons with the Gastrointestinal Symptom Rating Scale.

Discussion: The RESQ-7 demonstrated good content validity and psychometric properties in patients with GERD and a partial response to PPIs. The weekly recall makes the RESQ-7 appropriate for use in routine clinical care. The authors believe that it is the first instrument to be developed specifically for patients with a partial response to PPI therapy in line with FDA guidelines on PROs (ClinicalTrials.gov identifier: NCT00703534).

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http://dx.doi.org/10.3109/00365521.2013.822544DOI Listing
September 2013
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