title: The suitability of the GERDyzer instrument in pH-test-proven laryngopharyngeal reflux patients.
abstract: The use of validated patient-reported outcome (PRO) instruments for the treatment outcome measure of laryngopharyngeal reflux (LPR) is crucial given the lack of objective markers. However, current symptom-based PRO instruments can only partially capture the impact of LPR. The GERD Analyzer (GERDyzer), an existing disease-specific PRO instrument, which measures multidimensional health-related quality of life (HRQL) affected by the illness rather than by any specific symptoms, has been validated in patients with erosive gastroesophageal reflux disease (GERD). Following the U.S. Food and Drug Administration PRO guidance, we cross-culturally adapted the GERDyzer instrument into Chinese, and examined the qualitative and quantitative psychometric properties of the Chinese version GERDyzer in pH-test-proven LPR patients.The GERDyzer comprises 10 dimensions of HRQL, including general well-being, pain/discomfort, physical health, diet, energy, activities, leisure activities, social life, mood, and sleep. To examine the content validity, we recruited 26 pH-test-proven LPR participants to conduct 4 focus group meetings for direct patient input on clinical manifestations and HRQL impacts. We also tested the quantitative psychometric properties, including reliability, validity, and responsiveness in 100 pH-test-proven LPR patients.Saturation of concept elicitation was achieved from the 4 focus groups, and a strong conceptual match was evident between the GERDyzer contents and responses from the focus group participants. Cognitive debriefing assessment showed that the Chinese version GERDyzer was adequate for use by patients as it demonstrated linguistic validation and cultural harmonization. Quantitative psychometric properties showed evidence of high internal consistency (Cronbach α: 0.96), good to excellent test-retest reliability (intraclass correlation coefficient: 0.84-0.98). Confirmatory factor analysis supported a 2-factor structure. Convergent validity was confirmed by moderate correlation assessments referencing the Reflux Symptoms Index and the Reflux Questionnaire. The discriminant validity was supported by the ability to discriminate moderate-to-severe disease from mild disease. The responsiveness was also high in participants with and without typical GERD symptoms (effect sizes 1.20 and 1.21, respectively).In conclusion, the Chinese version GERDyzer instrument is a reliable, valid, and responsive instrument for assessing HRQL in Taiwanese patients with LPR.
authors: Health Examination Center, China Medical University Hospital, Taichung, Taiwan Preventive Medicine Center, China Medical University Hospital, Taichung, Taiwan Graduate Institute of Biostatistics, China Medical University, Taichung, Taiwan Department of Otolaryngology, Taichung Veterans General Hospital, Taichung, Taiwan School of Medicine, National Yang-Ming University, Taipei, Taiwan School of Speech Language Pathology & Audiology, Chung Shan Medical University, Taichung, Taiwan Division of Gastroenterology, Taichung Veterans General Hospital, Taichung, Taiwan Department of Internal Medicine, Chung Shan Medical University, Taichung, Taiwan Department of Internal Medicine, National Yang-Ming University, Taipei, Taiwan Division of Chest Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan Management Office for Health Data, China Medical University and Hospital, Taichung, Taiwan Institute of Clinical Medical Science, China Medical University College of Medicine, Taichung, Taiwan.
authors: Cheng-Pin
authors: CP
authors: Wu
authors: Wen-Miin
authors: WM
authors: Liang
authors: Chen-Chi
authors: CC
authors: Wang
authors: Chi-Sen
authors: CS
authors: Chang
authors: Hong-Zen
authors: HZ
authors: Yeh
authors: Jeng-Yuan
authors: JY
authors: Hsu
authors: Chung-Wang
authors: CW
authors: Ko
authors: Shou-Wu
authors: SW
authors: Lee
authors: Shu-Chuan
authors: SC
authors: Chang
authors: Fung-Chang
authors: FC
authors: Sung
authors: Han-Chung
authors: HC
authors: Lien
mesh_terms: D000328:Adult; D015331:Cohort Studies; D065246:Culturally Competent Care; D003938:Diagnostic Techniques, Digestive System / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D017144:Focus Groups; D005764:Gastroesophageal Reflux / Q000175:diagnosis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D057045:Laryngopharyngeal Reflux / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013624:Taiwan