1. PROMIS ® : Advancing the Science of PRO measurement Common Data Elements NIH CDE Webinar September 8, 2015 Ashley Wilder Smith, PhD, MPH Chief, Outcomes Research Branch Healthcare Delivery Research Program National Cancer Institute / National Institutes of Health

2. 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 ®

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5. 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)

6. Adaptability: Addresses need for high precision, broad range 0 1 2 3 - 1 - 2 - 3 Questionnaire with a wide range but low precision 1 2 Questionnaire with high precision but small range high physical function low physical function

7. Computerized Adaptive Tests (CAT) 0 1 2 3 - 1 - 2 - 3 high physical function 0 1 2 Question #2 1 2 Question #3 Questionnaire with high precision AND a wide range low physical function Question #1

8. Flexibility: PROMIS® Short forms and Profiles (v1) Anxiety29 Depression28 Fatigue 95 Pain Interference 41 Sleep Disturbance 27 Physical Function 124 Satisfaction with Roles 14 4 6 8 Mental Physical Social (29-43-57 items)

9. 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)PROMISSF-36Brief Pain InventoryCES-DMASQFACIT-Fatigue  Expands range of assessment options within a common, standardized metric  Provides equivalent scores for different scales measuring the same health outcome

10. 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

11. Questions? Ashley.Smith@nih.gov Coming soon! www.healthmeasures.net