title: Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden. Anna.Ryden@astrazeneca.com
authors.forename: Anna
authors.initials: A
authors.lastname: Rydén
authors.forename: Hans
authors.initials: H
authors.lastname: Denison
authors.forename: Maria
authors.initials: M
authors.lastname: Karlsson
authors.forename: Nimish
authors.initials: N
authors.lastname: Vakil
mesh_terms: D000328:Adult; D003371:Cough / Q000209:etiology; D003680:Deglutition Disorders / Q000209:etiology; D004884:Eructation / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006356:Heartburn / Q000209:etiology; D006685:Hoarseness / Q000209:etiology; D006801:Humans; D057045:Laryngopharyngeal Reflux / Q000209:etiology; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011594:Psychometrics; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors