Measures for Social and Behavioral Determinants of HealthThe view provided by two large National Institutes of Health sponsored development effortsRichard 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 PROsCreate a computerized adaptive testing system that will allow for efficient, psychometrically robust assessment of PROs

NIH Roadmap, 2003$100 million invested to date

NIH Neuroscience Blueprint, 2006 $40 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

Psychometrically soundBrief, easy to useIntellectual Property “Free”Applicable in variety of settings

and with different subgroupsAvailable in multiple languages

Clinician/researchers wanted measures which were:

Cover the full range of a traitNo Floor EffectNo Ceiling Effect

Available for use across the age span

As well as measures which:

The same instrument used for many diseasesThe same “scale” applicable to all instruments/diseasesThe same scale regardless of instrument format:

Single itemShort FormLong FormComputerized Adaptive Test (CAT)

Further, all of the NIH Systems Drive to Utilize a

Common Metric

Psychometrically sound NOT ALWAYSBrief, easy to use RARELYIntellectual Property “Free” NOT ALWAYSApplicable in variety of settings SOMETIMES

and with different subgroups RARELY

Available in multiple languages SOMETIMES,

(and if so, rarely with the same meaning!)

BUT most legacy measures failed to make the grade:

Cover the full range of a trait ALMOST NEVER

No Floor Effect SOMETIMESNo Ceiling Effect NEVER?

Available for use across the age span RARELY

Neither can most legacy measures:

The same instrument used for many diseases RARELYThe same “scale” applicable to all instruments/diseases NEVERThe same scale regardless of instrument format: NOPE!

Single itemShort FormLong FormComputerized Adaptive Test (CAT)

Nor do legacy instruments have:

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More on the ceiling issueLegacy 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% ileAthletes and others in physically active roles need to accurately differentiate very high levels of functioningA 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 TypesCAT Short

Form Scale

ModeComputer Computer and

paperComputer and paper

PrecisionHigh for all trait levels

Varies by length and how well the form is targeted to the specific subject

Varies by length and how well the form is targeted to the specific subject

BrevityVariable 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 ReportedOutcomes Measurement Information System

Advancing Knowledge>100 Peer-Reviewed

Publications

Tools40 Adult Measures; 20 Pediatric Measures

TranslationsAll item banks

SpanishIndividual Banks and

Instruments in Many

Languages

Cooperative Group12 Research Sites

3 Centers150+ Scientists

DiseasesNon-Disease

SpecificValidated in

Many Diseases

Domain Framework

Self-Reported

Health

Social Health

Mental Health

Physical Health

Symptoms

Function

Affect

Behavior

Cognition

Relationships

Function

Global Health

Physical Health

Mental Health

Social Health

Pediatrics

The NIH Toolbox for theAssessment of Neurologicaland Behavioral Function

Advancing Knowledge54 Peer-Reviewed

Publications

TranslationsAll instruments

Spanish

Contract Mechanism80 Institutions

256 Scientists & Staff20,000 Subjects

DiseasesNon-Disease SpecificValidated for use in growing number of

diseases

ToolsFour 30-minute domain-level batteries

fully normed for ages 3-85108 Instruments in total

Sensation

Motor

Cognition

Emotion

Toolbox Domains

Expert Survey of selection criteria (N=152; NIH top epidemiologists/researchers)

Focus group interviews with patientsExpert Interviews (44 interviews)Surveys to nominate and rank sub-domains and constructs

Instrument Selection

Emotion Domain Framework

+ Pain Interference

Many of these measures already ARE being used in

EHR’s2012 – EPIC enables PROMIS short forms2014 – EPIC in the process of enabling PROMIS CATs2014 – The Department of Defense EHR using CATs

Now: Walter ReedSpring: 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 patientsCleveland ClinicAO 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 HealthThe view provided by two large National Institutes of Health sponsored development effortsRichard C. Gershon, PhD.Northwestern University