Abstract
Introduction. Patient self-evaluation is an important aspect in the assessment of dysphagia and comprises both Functional Health Status (FHS) and Health-Related Quality of Life (HR-QoL). As many measures combine both FHS and HR-QoL, disease-related functioning cannot be distinguished from disease-related quality of life as experienced by the patient. Moreover, current patient self-reported measures are limited by poor and incomplete data on psychometric properties. Objective. This study aimed to establish content validity for the development of two new self-reported measures on FHS and HR-QoL in adults with oropharyngeal dysphagia (OD), in line with the psychometric taxonomy and guidelines from the COSMIN group (COnsensus-based Standards for the selection of health Measurement INstruments). Methods. Using the Delphi technique, international expert consensus was achieved; participants and patients with dysphagia evaluated relevance, comprehensiveness, and comprehensibility of definitions of relevant constructs (i.e., dysphagia, FHS and HR-QoL) and potential items. Results. A total of 66 Delphi participants from 45 countries achieved consensus across two rounds. The Delphi study resulted in two prototype measures, the Functional health status measure of Oropharyngeal Dysphagia (FOD) and the health-related Quality of life measure of Oropharyngeal Dysphagia (QOD), consisting of 37 and 25 items, respectively. Minimal revisions were required based on feedback by patients. Conclusions. This study provides evidence of good content validity for both newly developed prototype measures FOD and QOD. Future studies will continue the process of refining the measures, and evaluate the remaining psychometric properties using both Classic Test Theory (CTT) and Item Response Theory (IRT) models.
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