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

1 4 422 18 24

39 4636

65

128149

219

290 Projected

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

981 manuscripts published in 148 different journals

CATDEMO per Year

6

0

20000

40000

60000

80000

100000

120000

140000

160000

180000

200000

2008 2009 2010 2011 2012 2013 2014 2015 2016

215 2805 3355 4443 5626 5713 746115077 14446

2910

36101 41718

6183275190 75940

103112

193701 187206

Vo

lum

e

Year

Subjects Data points

Support tickets per year7

0176

459853

1423

1994 19531663

020

115

205

261

318228

140

688

2895

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2009 2010 2011 2012 2013 2014 2015 2016

HealthMeasures, API and Apps Desk

Assessment Center Phone

Assessment Center Email

Dependent to Independent

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

Direct Provider to Master Distributor

•Assessment Center API

• iPAD apps

Dedicated PRO Collection

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

Coming in 2019:

Electronic Medical Records

12

Organizations

In total, PROMIS measures could be made available to

Over half of all US Patients

at hundreds of hospital systems

And 1,100 research institutions

who 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 HealthMeasures

• 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

• HealthMeasures is the HQ for curation and distribution of PROMIS• Based at Northwestern University• Partner with PHO on standards and strategies

www.healthmeasures.net

www.HealthMeasures.net

• Official distribution center for PROMIS®, Neuro-QoL, ASCQ-MeSM 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 TodayNearly 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 32 languages• Pain Interference 19 languages• Physical Function 18 languages• Sleep 17 languages• Depression 13 languages• Global Health 9 languages• PROMIS-29 9 languages• Social role ability (2.0) 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)

HealthMeasures.net/PROMIS

Can Patient Centered Outcomes be more like Blood Pressure?

Many Instruments, but One Metric

4025 30 35 45 50 55

Average for General Population

Baseline Follow-up

Follow-upBaseline

Follow-upBaseline

Cervical Cancer

Osteoarthritis

Gestational Diabetes

PROsetta Stone Allows Comparability for CER Physical Function Change Across Three Conditions

HealthMeasures.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)

HealthMeasures.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, HOOS-

JR, 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 HP2020 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 HP2020

purposes.

• The NIH has added PROMIS Global to GSS 2018, a nationally representative sample considered appropriate for HP2030. • This provides a baseline data point for HP2030 (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 Agenda2018 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 U2C CA186878, U54 AR 057943 , U54 AR 057951, and U01 AR 052177.

Thank You!Questions?

HealthMeasures.net/PROMIS