The Future of PROMIS is NOW David Cella

The Future of PROMIS (is NOW) David Cella and Richard Gershon Northwestern University PHO Annual Meeting October 17, 2017

• Improving the Measures • Growth • Extending distribution • Future changes

Improving the Measures • Expanding the range of PROMIS Physical Function Item Bank • New CAT Algorithm parameters • Shorten tests for patients near the floor or ceiling • Set standard error cutoffs at clinical levels (vs. research levels)

Hockey Stick Growth

PROMIS Publications per Year 981 manuscripts published in 148 different journals [VALUE] Projected 219 128 22 24 39 46 149 65 36 18 4 4 1 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

6 CATDEMO per Year 193701 187206 200000 180000 160000 Volume 140000 103112 120000 100000 61832 80000 75190 75940 36101 41718 60000 40000 2910 215 2805 3355 4443 5626 5713 7461 15077 14446 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 Year Subjects Data points

7 Support tickets per year 5000 4500 4000 3500 2895 3000 318 2000 Assessment Center Phone 228 1000 1994 205 115 500 0 20 176 459 1423 Assessment Center Email 140 261 1500 0 Health. Measures, API and Apps Desk 688 2500 1953 1663 853 2009 2010 2011 2012 2013 2014 2015 2016

Dependent to Independent Source: NIH Reporter search “Patient Reported Outcomes Measurement Information System”

Direct Provider to Master Distributor • Assessment Center API • i. PAD apps

Dedicated PRO Collection University of Rochester, University of Utah, Washington University, Northwestern University, Cleveland Clinic, Stanford, Harvard Partners, UAB, and more!

Electronic Medical Records Coming in 2019:

12 Organizations

In total, PROMIS measures could be made available to üOver half of all US Patients üat hundreds of hospital systems üAnd 1, 100 research institutions üwho last year administered MILLIONS of PROMIS measures

The Future • Clinical Researchers Clinicians • CATs Profiles & Short Forms • Subjects Patients • Outpatients Inpatients • United States International

PROMIS, PHO and Health. Measures • PHO is a 501(c)(3) charitable organization dedicated to advancing PROMIS • PHO was formed by PROMIS Investigators in 2008 • Membership opened to international public in 2014 www. promishealth. org • Health. Measures is the HQ for curation and distribution of PROMIS • Based at Northwestern University • Partner with PHO on standards and strategies www. healthmeasures. net

www. Health. Measures. net • Official distribution center for PROMIS®, Neuro-Qo. L, ASCQ-Me. SM and NIH Toolbox® measures • Access to hundreds of administration-ready measures • Information about: • Measure-related services, including consultation, training, analysis, and translation services • Measure development and validation • How to select measures for specific uses and populations & score/interpret results • Access to updates, expertise and a community of users

PROMIS on Health Measures Today Nearly 2, 000 items • 97 Adult Measure Categories (163 short forms/scales) • • • 3 global 47 physical 30 mental 9 social 6 profiles • 27 Pediatric Measure Categories (35 short forms/scales) • • • 2 global 12 physical 8 mental 2 social 3 profiles

PROMIS languages in priority order • English Spanish Dutch German • Portuguese, French, Chinese, Danish, Swedish, Japanese, Finnish, Hungarian, Italian, Russian, Korean • Most popular: • • Fatigue Pain Interference Physical Function Sleep Depression Global Health PROMIS-29 Social role ability (2. 0) 32 languages 19 languages 18 languages 17 languages 13 languages 9 languages 7 languages • Plan for Globalization: 369 -item expansion into 30+ languages • 7 profile domain banks plus cognitive function and Global-10

PROMIS Regulatory Update • Ruxolitinib (Jakafi®) Approval of PROMIS Fatigue • Physical Function in Oncology (Direct submit) • Fatigue in RA (sub from C-Path PRO Consortium) • Physical Function in Sarcopenia (seeking support) • Fatigue in CFS/ME (Keller)

Health. Measures. net/PROMIS

Can Patient Centered Outcomes be more like Blood Pressure? Many Instruments, but One Metric

PROsetta Stone Allows Comparability for CER Physical Function Change Across Three Conditions Osteoarthritis Baseline Follow-up Cervical Cancer Follow-up Baseline Gestational Diabetes Baseline 25 30 35 40 45 Follow-up 50 Average for General Population 55

Health. Measures. net/PROMIS

CMS and PRO-PMs • Merit-based Incentive Payment System (MIPS) • Performance-based payment adjustment • Orthopedic Surgery: • Percentage of patient visits for patients aged 21 and older with a diagnosis of osteoarthritis with assessment for function and pain. • CMS Comprehensive Care for Joint Replacement • Bundled payment for total hip/knee arthroplasty • Voluntary collection of PROs results is incentivized • PROMIS Global or VR-12, and HOOS (Jr) or KOOS (Jr) Health. Measures. net/PROMIS

PRO Performance Measures (PRO-PMs) • Evaluate clinicians/health systems quality of care • CMS Comprehensive Care for Joint Replacement • Bundled payment for total hip/knee arthroplasty • Voluntary collection of PROs results in reduced discount • Final Nov 2015 – PROMIS Global or VR-12, HOOS or KOOS • Consensus meeting Aug 2015: PROMIS Global or VR-12, HOOSJR, KOOS-JR

PROMIS Population Health Update • CDC and NIH worked closely over the last 10 years to get the NIH PROMIS Global measure added as an HP 2020 objective. Added in 2015! • PROMIS measures have been added to several nationally representative internet panel surveys over the last 8 years. Trend data continues to being actively collected. • However, NCHS does not allow internet panels to be used for HP 2020 purposes. • The NIH has added PROMIS Global to GSS 2018, a nationally representative sample considered appropriate for HP 2030. • This provides a baseline data point for HP 2030 (2018 data is considered the baseline data point for 2030) • NIH is hoping to continue to add the NIH PROMIS Global measure to subsequent administrations of the GSS so that trends in HRQOL can be prospectively monitored by HHS. • As of today, PROMIS Global is the de facto gold standard measure for monitoring HRQOL trends in the US.

PROMIS Research Agenda 2018 and beyond • Ongoing validation studies • Trajectories of scores in specific patient populations • Meaningful (and actionable) individual scores and changes • Expand translations and cross cultural validation • PHO International Committee • Clinical applications / Health care quality

Acknowledgements • Funding for PROMIS was provided by the NIH through U 2 C CA 186878, U 54 AR 057943 , U 54 AR 057951, and U 01 AR 052177. Thank You! Questions? Health. Measures. net/PROMIS