DEVELOPMENT OF THE OBSTRUCTIVE SLEEP APNEA QUESTIONNAIRE FOR USE IN CLINICAL PRACTICE

Abstract Introduction An American Academy of Sleep Medicine (AASM) task force identified a need for a valid, reliable, patient-reported outcome measure (PROM) to monitor obstructive sleep apnea (OSA) in adults in clinical practice. Ideally, the PROM should be easy and quick to complete (<5 minutes), available electronically, and accepted by clinicians treating OSA. Development of the Obstructive Sleep Apnea Questionnaire (OSA-Q) was undertaken to meet this need and was guided by the 2009 Food and Drug Administration (FDA) Guidance for Industry on developing PROMs. Methods Development of the OSA-Q included interviews with patients with OSA (n=14) to identify important concepts to them, conceptual model and draft questionnaire formulation, and cognitive interviews (n=14) to assess content validity and guide revisions to wording, item comprehension and redundancies, recall period, and response options. Usability of the electronic version of the OSA-Q was then assessed in patients with OSA. Finally, acceptability and utility of the OSA-Q in clinical practice was evaluated by surveying clinicians in ten geographically-dispersed US sleep clinics. Results Patient interviews were used to construct a conceptual model for the draft OSA-Q which served as a basis for generating 44 items about daytime/night-time symptoms and OSA impacts. Cognitive interviews identified poorly worded, ambiguous, and redundant items to inform revisions, resulting in a revised draft OSA-Q (3 domains, 28 items). Subsequently, clinicians (n=13) administered the draft OSA-Q to five patients each, obtained patients’ feedback on the OSA-Q, and completed a survey regarding its comprehensiveness, format/content, utility, and acceptability in clinical practice. These clinicians endorsed the OSA-Q for ease of use, language simplicity, convenience of electronic platform, and speed of completion (3-5 min). They also indicated that the OSA-Q would be useful in clinical practice and enhance patient communications (69% and 77%, respectively). The OSA-Q was revised and finalized for psychometric testing, based on clinician comments. Conclusion A new AASM-supported PROM to monitor OSA in clinical practice has been developed, including the patients’ perspective according to FDA guidance. This OSA-Q shows content validity and is positively perceived by clinicians. Psychometric testing of the OSA-Q is underway to establish its measurement properties and demonstrate its validity, reliability, and sensitivity to change in patients with OSA. Support (If Any) This work was funded by the American Academy of Sleep Medicine.