Using MIXED Methods to Explore the Content Validity and Importance of Various SLEEP Parameters in a SLEEP Diary Questionnaire
Author(s)
Beyer A1, Mannix S2, Kleinman L3
1Innovus Consulting Limited, London, LON, UK, 2Evidera, Bethesda, MD, USA, 3Evidera, Seattle, WA, USA
OBJECTIVES: Use of a sleep diary is common when assessing insomnia. The Sleep Diary Questionnaire (SDQ) is a patient-reported outcome measure developed from the Consensus Sleep Diary (Carney, 2012). Content validity of the SDQ and the relative importance of several sleep parameters was evaluated. METHODS: Content validity was assessed by a web-survey of subjects self-reporting insomnia disorder symptoms per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (Phase I). Subjects rated their comprehension of the SDQ questions on a scale from 1 “very difficult to understand” to 5 “very easy to understand”. In Phase II, follow-up qualitative interviews were conducted collecting in-depth cognitive debriefing of the SDQ questions and assessing importance of the sleep parameters (on a scale 1-10) and meaningful change. RESULTS : Phase I subjects (N=100): white (88%), female (82%), mean age 51.9 (±12.7) years. Mean ratings per question were generally ≥4.0. Phase II (N=17): white (N=15), female (N=12), mean age: 53.4 (± 11.9) years. Fourteen (82%) gave the highest ranking of 10 (extremely important) when rating the importance of improving subjective total time asleep (sTST). Most subjects (N=10) reported typically sleeping three to five hours, with 14 subjects indicating that sTST ≥6 hours would be meaningful. Thirteen subjects also indicated that having enough sleep at least five nights per week would be a meaningful improvement. In comparison, fewer subjects reported improvement in subjective latency to sleep onset, subjective wake after sleep onset, or early awakenings to be important. CONCLUSIONS: The results support the content validity of the SDQ in individuals with insomnia. Subjects indicated that achieving at least six hours of sleep per night was extremely important. Despite the small sample size, these findings support the relevance of improving total time asleep in order to positively impact the lives of patients with insomnia.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PNS229
Topic
Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods, Stated Preference & Patient Satisfaction
Disease
Neurological Disorders, No Specific Disease