PROMIS®: Advancing the Science of PRO measurement

Common Data Elements

NIH CDE WebinarSeptember 8, 2015

Ashley Wilder Smith, PhD, MPHChief, Outcomes Research Branch

Healthcare Delivery Research Program National Cancer Institute / National Institutes of Health

2

Patient Reported Outcomes Measurement Information System®

PROMIS®: brief, precise, valid, reliable fixed or tailored measures of patient-reported health status in physical, mental, and social well-being for adult & pediatric populations

Advantages: Disease-agnostic, Flexible, Adaptable, Low burden, Comparable, Accessible

Development: Item Response Theory (IRT) for measure construction

Standardized: One metric (T-score, Mean=50, SD=10; ref US pop)

Progress, Progress, Progress! >40 Research Protocols; >60,000 people have provided data >400 publications to date; >100 NIH grants using PROMIS®

3

4

5

Innovation: Domains, Item Banks, CDE

State of the Science of Health Outcome Measurement• Domain-based measures: valid, reliable, clinically relevant• Developed across the lifecourse, in many populations, can be applied

in many research and clinical settings

Item Response Theory (IRT) Methodology Used for Construction:• Develop and evaluate groups of questions called “item banks”• Evaluate properties and refine items • Scoring individuals• Linking multiple measures onto a common scale

Common Data Elements• The CDE for PROMIS are item banks• There are currently >75 adult or child health domains represented • Most commonly used banks have LOINC codes available• Items are HL7 compatible (important for integration in EHR systems)

Adaptability: Addresses need for high precision, broad range

01

23

- 1

- 2

- 3

Questionnairewith a wide rangebut low precision

12

Questionnairewith high precisionbut small range

high physicalfunction

lowphysicalfunction

Computerized Adaptive Tests (CAT)

01

23

- 1

- 2

- 3

high physicalfunction

01

2

Question #2

12

Question #3

Questionnairewith high precisionAND a wide range

lowphysicalfunction

Question #1

Flexibility: PROMIS® Short forms and Profiles (v1)

Anxiety29

Depression28

Fatigue95

Pain Interference41

Sleep Disturbance27

Physical Function124

Satisfaction with Roles14

46

8

Mental

Physical

Social

(29-43-57 items)

9

Comparability: Instrument Linking

A common problem when using a variety of PRO measures is comparability of scales

Linking establishes relationships between scores on two different measures

http://www.prosettastone.org/

PROsetta Stone® developed and applied methods to link the PROMIS with other instruments (e.g., SF-36, Brief Pain Inventory, CES-D, MASQ, FACIT-Fatigue)

Expands range of assessment options within a common, standardized metric

Provides equivalent scores for different scales measuring the same health outcome

10

Availability:PROMIS ® Funding and Future

History: NIH Roadmap/Common Fund Initiative PROMIS® I: (‘04-’09) 6 Research Sites, 1 Coordinating Center PROMIS® II: (’09-’14) 12 Research Sites, 3 Centers

Moving toward Sustainability: HealthMeasures Trans-NIH cooperative agreement with Northwestern University Research resource supporting PROMIS ® and other systems Same methodology used to develop NIH Toolbox, NeuroQOL, and

ASCQ-Me, all now managed under HealthMeasures

Current/Future Focus Implementation in clinical research and practice Availability: API, web (e.g., REDCap), mobile, IVRS, EHR, more… Examining use in drug labeling, clinical quality performance Long-term availability via public/private partnerships

Questions?

Ashley.Smith@nih.gov

Coming soon!

 www.healthmeasures.net