1. Patient-reported outcome measures for sleep-wake function Daniel J. Buysse, M.D. Jean Miewald, B.A. University of Pittsburgh School of Medicine PMBC Sleep Workshop April 11, 2008 Pittsburgh, PA

2. PROs for sleep-wake function  Why PROs?  Dimensions of sleep-wake function measured with PROs  Common examples of PROs  Measurement interfaces  Demonstration

4. Patient-reported outcomes (PRO): Definition   A patient-reported outcome (PRO) is a measurement of any aspect of a patient's health status that comes directly from the patient, without the interpretation of the patient's responses by a physician or anyone else.   How a patient feels or functions with respect to his or her health or condition -FDA Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Draft, January 2006

6. Why use PROs for sleep-wake function?   Some aspects of sleep are not measurable with objective means   Quantitative sleep measures not necessarily most salient to patient experience   Treatments may have different effects on objective and self-report measures   Ease of administration   Multiple formats, methods of administration

7. Potential problems with PROs for sleep- wake function   Variability of sleep-wake function   Choosing a reasonable time frame   One major sleep episode per day   Recall biased by extreme examples   Not all behaviors/events occur daily   Self-report biased by other aspects of mental state   Inherent limitations in recall of a state with reduced awareness   Some aspects of sleep not accurately measurable with self-report   Compliance with diary-type measures

8. Variability in sleep diary data Buysse et al., SLEEP 2008 (Abstract) Time in Bed Sleep Quality No insomnia n=31 Chronic insomnia n=61

9. Self-report sleep questionnaires  “Quantitative” questionnaires and diaries  Sleep amount  Time to fall asleep, # awakenings, etc.  Sleep timing  Sleep quality (e.g. Pittsburgh Sleep Quality Index, MOS Sleep Scale)  Daytime sleepiness (e.g. Epworth Sleepiness Scale)  Specific disorder-oriented  Women’s Health Initiative Insomnia Scale  IRLSSG Questionnaire (Restless Legs Syndrome)  Berlin (apnea)

10. Sleep quality  Depth  Soundness  Restfulness Quantitative and timing measures  Sleep onset  Sleep duration  Sleep continuity  Sleep offset  Rhythms and timing Behaviors and beliefs  Sleep habits and behaviors  Causes of sleep disturbance  Sleep-related beliefs Sleep disorder symptoms  Dreams and nightmares  Breathing-related sleep problems (apnea)  Movement disorders  Parasomnias  Insomnia Waking symptoms  Sleepiness and alertness  Fatigue and energy  Other waking consequences of poor sleep Dimension of sleep for PROs

11. PROs for sleep-wake function   General and quantitative aspects of sleep   Pittsburgh Sleep Quality Index   Epworth Sleepiness Scale   Sleep Timing Questionnaire   PROMIS Sleep Quality and Wake Quality instruments   MOS Sleep Scale   Circadian preference   Smith Morningness-Eveningness   Circadian Type Questionnaire   Social Rhythm Metric and SRM-5 (see below)

12. PROs for sleep-wake function   Sleep disorders   IRLSSG Questionnaire   Berlin Sleep Apnea Questionnaire   Functional Outcomes of Sleep Questionnaire   Insomnia Severity Index   Pittsburgh Insomnia Rating Scale   Sleep diaries   Text, chart, and graphic versions   Social Rhythm Metric and SRM-5

13. PROMIS Sleep-Wake Function Item Bank Development CategoriesBinsItems 17532529 1753310 1746128 5  4  2 Factors 70 2 Factors 2716

14. Final calibrated items: Sleep Quality

15. Final calibrated items: Wake Quality

16. PROMIS Sleep-Wake Function Item Bank Development