1. 15-minute Introduction to PROMIS Ron D. Hays, Ph.D UCLA Division of General Internal Medicine & Health Services Research Roundtable Meeting on Measuring Burden of Illness November 10, 2010 (1:50-2:05 pm) RTI, Washington, DC

2. What is PROMIS? A nine-year $70 million commitment of NIH to improve and standardize measurement of patient-reported outcomes (PROs) –Self-reported health An answer to the PRO “Tower of Babel”

3. The Tower of Babel (Brueghel, 1563) 3

5. PROMIS-1 Network: 2004-2009 UNC –Chapel Hill ● ● Duke University* ● Stanford ● ● ● University of Pittsburgh ● University of Washington Northwestern ♥ NIH ● NIH ♥Coordinating Center StoneyBrook

7. Psycho- metric Testing Item Bank (IRT-calibrated items) Short Form Instruments CAT Literature Review Item Pool Patient Focus Groups Expert Input and Consensus Existing Items  Questionnaire administered to large representative sample             Secondary Data Analysis Cognitive Testing Translation Expert Review Newly Written Items

8. Physical Functioning Item Bank Item 1 Item 2 Item 3 Item 4 Item 5 Item 6 Item 7 Item 8 Item 9 Item n        50 Are you able to get in and out of bed? Are you able to stand without losing your balance for 1 minute? Are you able to walk from one room to another? Are you able to walk a block on flat ground? Are you able to run or jog for two miles? Are you able to run five miles?

9. LowLow HighHigh                                                       Person Fatigue Score Interpretation                                                     Q Q Q Q Q Q Q Q Q Likely Likely “I get tired when I run a marathon” Likely Likely “I get tired when I run a marathon” Unlikely “I get tired when I get out of a chair”Unlikely “I get tired when I get out of a chair” Item Location Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q    

10. LowLow HighHigh                                                       PRO Bank Person Score Interpretation Aids                                                     3040506070 M = 50, SD = 10 T = (z * 10) + 50    

11. LowLow HighHigh                                                       Example of high fatigue           Fatigue Score=60                                           3040506070     This patient’s fatigue score is 60, significantly worse than average (50). People who score 60 on fatigue tend to answer questions as follows: …”I have been too tired to climb one flight of stairs: VERY MUCH …”I have had enough energy to go out with my family: A LITTLE BIT

12. LowLow HighHigh                                                       Example of low fatigue           Fatigue Score=40                                           3040506070     This patient’s fatigue score is 40, significantly better than average (50). People who score 40 on fatigue tend to answer questions as follows: …”I have been too tired to climb one flight of stairs: SOMEWHAT …”I have had enough energy to go out with my family: VERY MUCH

13. Computerized Adaptive Testing (CAT) Select questions based on a person’s response to previously administered questions. Iteratively estimate a person’s standing on a domain (e.g., fatigue, depressive symptoms) Administer most informative items Desired level of precision can be obtained using the minimal possible number of questions.

14. Beginning of CAT T-Score = 50SE = 10 Best Item- I felt depressed

15. I felt depressed 1.Never 2.Rarely 3.Sometimes 4.Often 5.Always T-Score = 52SE = 4 Next Best Item- I felt like a failure

16. I felt like a failure 1.Never 2.Rarely 3.Sometimes 4.Often 5.Always T-Score = 53SE = 3 Next Best Item- I felt worthless

17. I felt worthless 1.Never 2.Rarely 3.Sometimes 4.Often 5.Always T-Score = 55SE = 2 Next Best Item- I felt helpless

18. I felt helpless 1.Never 2.Rarely 3.Sometimes 4.Often 5.Always T-Score = 55SE = 2

19. CAT assessments can achieve higher precision than fixed forms Rose et al, J Clin Epidemiol 2007 (accepted) SE = 0.32 rel = 0.90 SE = 0.22 rel = 0.95 SF-36 items CAT 10 items Full Item Bank measurement precision (standard error) normed theta values HAQ items SF-12 items representative sample rheumatoid arthritis patients US-Representative Sample 0.4 0.5 0.3 0.2 0.1 -4-3-2-10+1+2

21. Domains # Items Adult Bank # Items Adult Short Forms # Items Peds Bank # Items Peds Short Form Emotional Distress – Anger 2986 Emotional Distress – Anxiety 294, 6, 7, 8158 Emotional Distress – Depression 284, 6, 8a, 8b148 Fatigue954, 6, 7, 82310 Pain – Behavior397 Pain – Interference414, 6a, 6b, 8138 Physical Function1244, 6, 8, 10, 20 -- Mobility238 -- Upper Extremity298 Asthma Impact178 PROMIS Domains in AC, 2010

22. Domains # Items Adult Bank # Items Adult Short Forms # Items Peds Bank # Items Peds Short Forms Satisfaction with Discretionary Social Activities 127 Satisfaction with Social Roles 144, 6, 7, 8 Peer Relationships158 Sleep Disturbance274, 6, 8a, 8b Sleep-Related Impairment 168 Global Health10 PROMIS Domains in AC, 2010

23. DomainsPROMIS-29PROMIS-43PROMIS-57 Emotional Distress – Anxiety 468 Emotional Distress – Depression 468 Fatigue468 Pain – Interference468 Pain – Intensity111 Satisfaction with Social Role 468 Sleep Disturbance468 Physical Function468 2010 PROMIS Profile Instruments

24. Thank you www.nihpromis.org