Validation of a Quality-of-Life Instrument for Laryngopharyngeal Reflux

Abstract

To establish the reliability, validity, and responsiveness of a new, disease-specific assessment tool, the LPR-HRQL, which assesses patient-reported outcomes (PRO) with regard to health-related quality of life (HRQL) of patients with laryngopharyngeal reflux (LPR). A prospective, open-label, repeated-measures study. Six centers in 4 states in the eastern United States. Patients with LPR. Open-label treatment with 20 mg of omeprazole twice daily. Clinical and PRO HRQL data were collected. Several PRO instruments were administered to patients at each of several time points; these instruments included the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), a general HRQL tool; the Voice Handicap Index (VHI), a symptom-specific tool for assessing voice problems; and the QOLRAD instrument (Quality of Life in Reflux and Dyspepsia), used to assess the impact of gastroesophageal reflux disease. Factor analyses of the LPR-HRQL scales confirmed single dimensions for each. All LPR-HRQL items contributed to internal consistency of scales and had substantial variability permitting useful information. Substantial evidence of convergent and divergent validity with SF-36, VHI, and QOLRAD items was observed. Test-retest validity was adequate for the time interval tested. Changes in domain scores of the LPR-HRQL at 4 and 6 months documented its responsiveness. The LPR-HRQL displays reliability, validity, and responsiveness, has face validity, and is simple and not burdensome to administer, score, and analyze. Accordingly, it may be used to assist physicians and patients in understanding the HRQL burden of LPR and the impact of therapy.