Article
Using mixed methods to explore the content validity and importance of various sleep parameters in a sleep diary questionnaire
Search Medline for
Authors
-
Andrea Phillips-Beyer
- Innovus Consulting, Ltd, London, United Kingdom
-
Sally Mannix
- Evidera, Bethesda, MD, USA
-
Leah Kleinman
- Evidera, Seattle, WA, USA
-
Peter Kaskel
- Idorsia Pharmaceuticals Germany GmbH, Market Access, München, Deutschland
| Published: | September 30, 2022 |
|---|
Outline
Text
Background and status of (inter)national research: 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).
Research question and objective: Content validity of the SDQ and the relative importance of several sleep parameters was evaluated.
Method: 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.
Discussion: 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.
Funding: Sonstige Förderung; Idorsia Pharmaceuticals Ltd., Allschwil, Schweiz
