0384 Assessing the content validity of the IDSIQ through cognitive interviews in individuals with comorbid insomnia and nocturia

Abstract Introduction The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is validated to measure daytime functioning in individuals with insomnia disorder. This study assessed the content validity of the IDSIQ through cognitive interviews in individuals with insomnia and comorbid nocturia. Methods This was a cross-sectional, qualitative observational study. Data were collected from 10 adult subjects from the US suffering from insomnia disorder (DSM-5) and comorbid nocturia (≥2 nocturnal voids). One-on-one, web-based interviews were conducted using semi-structured guides and lasted 60–90 minutes. Based on the stage of the study, all participants examined the content validity of the IDSIQ as part of 1) hybrid concept elicitation and cognitive interviews (n=5; Stage 1), or 2) cognitive interviews (n=5; Stage 2). Institutional review board approval and web-based informed consent were obtained prior to the patient interviews. Results The mean age of participants was 59.5 years (SD=4.3) and 62.2 years (SD=8.5) in the hybrid and cognitive interview groups, respectively. All individuals in the hybrid interviews were female, whereas all individuals in the cognitive interviews were male. Participants’ overall impressions were positive (10/10), describing the IDSIQ as straightforward (5/10), good (1/10), simple (1/10), very precise (1/10), very specific (1/10), clear (1/10), and aligned with their experience (3/10). The items were understood by all participants (10/10) except Item 1, which was understood by almost all participants (9/10). One participant suggested that the responses to questions on the IDSIQ may vary depending on the time the survey is administered, and the amount of sleep obtained the previous night. All 10 participants reported that they could answer all questions. Of the nine participants who were asked, all stated that the IDSIQ was relevant to their experience of their condition. Most participants reported that there were no missing items, whereas two participants stated that an item assessing the impact of insomnia on personal relationships (including family) was missing. Conclusion The content of the IDSIQ was easy to understand by patients that suffer from insomnia and comorbid nocturia. The study provides evidence for the content validity of the IDSIQ and its applicability in this population. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.