1. Measures for Social and Behavioral Determinants of Health
The view provided by two large National Institutes of Health sponsored development efforts
Richard C. Gershon, PhD.
Northwestern University

2. Different, but the Same

3. The NIH seeks proposals for innovative approaches to measuring patient-reported outcomes (PROs). . . across a wide variety of chronic disorders and diseases.
Develop and test a large bank of items measuring PROs
Create a computerized adaptive testing system that will allow for efficient, psychometrically robust assessment of PROs
NIH Roadmap, 2003
$100 million invested to date

4. Develop unified/integrated of multiple indicators (cognitive, emotional, motor, sensory) of neural and behavioral health functioning for use in large cohort studies and clinical trials
Could be used as a form of “common currency” across diverse study designs and populations
Would maximize yield from large, expensive studies with minimal increment in subject burden and cost
NIH Neuroscience Blueprint, 2006
$40 million invested to date

5. Clinician/researchers wanted measures which were:
Psychometrically sound
Brief, easy to use
Intellectual Property “Free”
Applicable in variety of settings
and with different subgroups
Available in multiple languages

6. As well as measures which:
Cover the full range of a trait
No Floor Effect
No Ceiling Effect
Available for use across the age span

7. Further, all of the NIH Systems Drive to Utilize a Common Metric
The same instrument used for many diseases
The same “scale” applicable to all instruments/diseases
The same scale regardless of instrument format:
Single item
Short Form
Long Form
Computerized Adaptive Test (CAT)

8. BUT most legacy measures failed to make the grade:
Psychometrically sound NOT ALWAYS
Brief, easy to use RARELY
Intellectual Property “Free” NOT ALWAYS
Applicable in variety of settings SOMETIMES
and with different subgroups RARELY
Available in multiple languages SOMETIMES,
(and if so, rarely with the same meaning!)

9. Neither can most legacy measures:
Cover the full range of a trait ALMOST NEVER
No Floor Effect SOMETIMES
No Ceiling Effect NEVER?
Available for use across the age span RARELY

10. Nor do legacy instruments have:
The same instrument used for many diseases RARELY
The same “scale” applicable to all instruments/diseases NEVER
The same scale regardless of instrument format: NOPE!
Single item
Short Form
Long Form
Computerized Adaptive Test (CAT)

11. More on the ceiling issue
Legacy measures can fail to identify treatment success, nor do they typically accurately assess anyone above the mean!

12. It is impractical to use disease specific instruments

13. And often patients don’t want to settle for “average”function
Previously physically active patients, who are now recovering from an accident, don’t want to be considered “cured” because the instrument used to assess their physical functioning “ceilings” at the 50% ile
Athletes and others in physically active roles need to accurately differentiate very high levels of functioning
A cancer patient whose fatigue instrument shows them to be “above” the clinically relevant range assessed by a typical instrument– may be far away from from feeling “normal.”

14. Many Instrument Types CAT Short Form Scale Mode Precision Brevity
Computer
Computer and paper
Precision
High for all trait levels
Varies by length and how well the form is targeted to the specific subject
Brevity
Variable length (4 – 12 items)
Range of lengths available
Instrument Dependent

15. NIH Measures can also be compared to legacy measures
A common problem when using a variety of patient-reported outcome measures is the comparability of scales on which the outcomes are reported. Linking establishes relationships between scores on two different measures.
The PRO Rosetta Stone (PROsetta Stone®) developed and applied methods to PROMIS and other PCORR instruments with other related instruments (e.g., SF-36, Brief Pain Inventory, CES-D, MASQ, FACIT-Fatigue) to expand the range of PRO assessment options within a common, standardized metric. It provides equivalent scores for different scales that measure the same health outcome.

16. Linking Outcomes Measures

17. Conversion Tables

18. The Patient Reported Outcomes Measurement Information System
Tools
40 Adult Measures; 20 Pediatric Measures
Diseases
Non-Disease Specific
Validated in Many Diseases
Advancing Knowledge
>100 Peer-Reviewed
Publications
Cooperative Group
12 Research Sites
3 Centers
150+ Scientists
Translations
All item banks  Spanish
Individual Banks and Instruments in Many Languages

19. Domain Framework Symptoms Physical Health Function Affect
Self-Reported Health
Mental Health
Behavior
Cognition
Global Health
Relationships
Social
Health
Function

20. PROMIS Basic (Profile Banks)
Physical Health
PROMIS Basic (Profile Banks)
Physical Function
Pain Intensity
Pain Interference
Fatigue
Sleep Disturbance
PROMIS Plus
Pain Behavior
Sleep-related impairment
Sexual Function
Extras
Upper Extremity
Mobility
Asthma Impact
GI Symptoms

21. PROMIS Basic (Profile Banks)
Mental Health
PROMIS Basic (Profile Banks)
Depression
Anxiety
PROMIS Plus
Anger
Applied Cognition
Alcohol Use, Consequences & Expectancies
Psychosocial Illness Impact
Extras
Experience of Stress
Subjective Well-being

22. PROMIS Basic (Profile Banks)
Social Health
PROMIS Basic (Profile Banks)
Satisfaction with Participation in Social Roles
PROMIS Plus
Satisfaction with Social Roles & Activities
Ability to Participate in Social Roles & Activities
Social Support
Social Isolation
Companionship
Extras
Peer Relationships
Emotional Support
Informational Support

23. Pediatrics Physical Health Pain Behavior, Quality, Intensity
Physical Activity
Mental Health
Experience of Stress
Subjective Well-being
Social Health
Impact of Child Illness on Family
Family Belongingness
Global Health

24. The NIH Toolbox for the Assessment of Neurological and Behavioral Function
Tools
Four 30-minute domain-level batteries
fully normed for ages 3-85
108 Instruments in total
Advancing Knowledge
54 Peer-Reviewed
Publications
Diseases
Non-Disease Specific
Validated for use in growing number of diseases
Contract Mechanism
80 Institutions
256 Scientists & Staff
20,000 Subjects
Translations
All instruments Spanish

25. Toolbox Domains
Cognition
Emotion
Motor
Sensation

26. Instrument Selection Expert Survey of selection criteria
(N=152; NIH top epidemiologists/researchers)
Focus group interviews with patients
Expert Interviews (44 interviews)
Surveys to nominate and rank sub-domains and constructs

27. Emotion Domain Framework
Psychological Well-Being
Positive Affect
Life Satisfaction
Meaning & Purpose
Social Relationships
Social Support
Companionship
Social Distress
Positive Social Development
Stress & Self-Efficacy
Perceived Stress
Self-Efficacy
Negative Affect
Fear
Sadness
Anger
+ Pain Interference

28. Many of these measures already ARE being used in EHR’s
2012 – EPIC enables PROMIS short forms
2014 – EPIC in the process of enabling PROMIS CATs
2014 – The Department of Defense EHR using CATs
Now: Walter Reed
Spring: Balboa and Madigan

29. Do we have time for more examples?
The Department of Defense – this week made PROMIS the priority outcome system for choice for 13,000,000 patients
Cleveland Clinic
AO Foundation (3,000 Orthopedic Trauma Surgeons)
The National Children’s Study (N=105,000, 25 years+)
Selected a wide range of PROMIS and NIH Toolbox instruments – for Parents, for Parents as Proxies for their Children, and for the Children themselves

30. Measures for Social and Behavioral Determinants of Health
The view provided by two large National Institutes of Health sponsored development efforts
Richard C. Gershon, PhD.
Northwestern University