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

Different, but the Same

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

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

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

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

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)

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!)

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

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)

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

It is impractical to use disease specific instruments

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.”

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

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.

Linking Outcomes Measures

Conversion Tables

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

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

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

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

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

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

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

Toolbox Domains Cognition Emotion Motor Sensation

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

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

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

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

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