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
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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®
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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
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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
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Mental
Physical
Social
(29-43-57 items)
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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
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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
