Person-Centered Outcome Instruments: PROMIS, Neuro-QOL, and NIH Toolbox
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1 Person-Centered Outcome Instruments: PROMIS, Neuro-QOL, and NIH Toolbox Nan Rothrock, PhD Feinberg School of Medicine Northwestern University June 10, 2014
2 Patient-Reported Outcomes (PROs) Quantification of symptoms, functional status, perceptions of health Subjective and multi-dimensional
3 Why ask patients? Best source of information Symptoms or health-related quality of life (HRQL): pain, fatigue, distress Impact of symptoms on continuing meaningful activities Knowledge, attitudes, behavior Satisfaction Same biological value in 2 pts same impact Variability in correlation b/w clinician and pt reports HRQL scores (espphysical fx) predicts survival in many conditions 1 1 Hahn EA et al (2007) Mayo ClinProc, 82,
4 Carrots and Sticks for PROs Era of patient-centeredness 3 rd level health IT meaningful use incentive program CMS gathering info on PRO-based performance measures PCORI
5 Problems with PRO Measures Ceilings and floors Being John Malkovich 1999
6 Measurement Ceiling Effect Size
7 Problems with PRO Measures Ceilings and floors Patient burden Royalties/costs Psychometric limitations Being John Malkovich 1999 Scores w/o interpretation guidelines
8 WOMAC SMFA
9 It is impractical to use disease-/conditionspecific instruments
10 New Measurement Initiatives Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life in Neurological Disorders (Neuro-QOL) NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox)
11 Approach to Measurement Non-disease/condition specific (universal) Domains of self-reported health NIH Toolbox also performance measures Item Response Theory State of the science mixed methods Desired Aims More widely applicable More sensitive More efficient
12 PROMIS Item banks self report physical, mental, social health Use across chronic conditions Ages 8 adult (self report). Age 5 proxy. CAT, short forms Link scores between measures
13 PROMIS Domain Framework Physical Health Symptoms Function Self-Reported Health Mental Health Affect Behavior Cognition Social Health Relationships Function
14 PROMIS Physical Health Item Banks Adult Pain Behavior Pediatric Pain Interference Pain Interference Fatigue Physical Health Fatigue Sleep Disturbance Sleep-related Impairment Physical Function Upper Extremity Mobility Asthma Impact Sexual Function Pain Intensity *Also in Spanish & other languages
15 PROMIS Mental Health Item Banks Adult Anxiety Pediatric Anxiety Depression Depression Mental Health Anger Psychosocial Illness Impact Cognitive Function Alcohol Use, Consequences, Expectancies Anger *Also in Spanish & other languages
16 PROMIS Social Health Item Banks Adult Ability to Participate in Roles & Activities Satisfaction with Roles & Activities Pediatric Peer Relationships Social Health Companionship Emotional Support Informational Support Instrumental Support Social Isolation *Also in Spanish & other languages
17 In Progress Adult GI Symptoms Self-efficacy for management of chronic disease v2.0 Sexual Function Pediatric Pain Behavior, Quality, Intensity Physical Activity Experience of Stress Subjective Well-being Impact of Child Illness on Family Family Belongingness Global Health
18 PROMIS Pain Interference Short Form Reprinted with permission from the PROMIS Health Organization and PROMIS Cooperative Group 2012
19 PROMIS T-score Mean = 50 Standard Deviation = 10 Referenced to the US General Population High scores = more of domain MIDs = 4-6 points (physical function) 1 1 Yost et al 2011
20 Neuro-QOL Item banks self report physical, mental, social health Supplemental domains specific to targeted diseases (e.g., stigma) Use in chronic neurologic conditions CAT, short forms Link scores
21 Neuro-QOL Domain Framework Physical Health Symptoms Function Self-Reported Health Mental Health Emotional Health Cognitive Health Social Health *Also in Spanish
22 Neuro-QOL Physical Health Banks Adult Pediatric Fatigue Fatigue Sleep Disturbance Pain Physical Health Upper Extremity Mobility Upper Extremity Mobility *Also in Spanish
23 Neuro-QOL Mental Health Banks Mental Health Adult Anxiety Depression PosAffect & Wellbeing Emotional & Beh Dyscontrol Stigma Cognitive Function Pediatric Anxiety Depression Anger Stigma Cognitive Function Communication *Also in Spanish
24 Neuro-QOL Social Health Banks Adult Ability to Participate in Roles & Activities Pediatric Interactions w Peers Social Health Satisfaction with Roles & Activities *Also in Spanish
25 Neuro-QOL T-score Mean = 50 Standard Deviation = 10 Referenced to the US General Population or Clinical Population High scores = more of domain
26 NIH Toolbox Assessment of neurological and behavioral function Use across diverse populations Ages 3-85 Batteries (CATs, short forms) Cognition, Motor, Sensation, Emotion Objective tests and survey measures English and Spanish
27 Cognition Domains Executive Function Working Memory Attention Processing Speed Episodic Memory Language
28 Motor Domains Motor Dexterity Endurance Strength Locomotion Balance
29 Sensation Domains
30 Emotion Domains Emotion Psychological Well-Being Social Relationships Stress & Self- Efficacy Negative Affect Positive Affect Social Support Perceived Stress Fear Life Satisfaction Companionship Self-Efficacy Sadness Meaning & Purpose Social Distress Anger Positive Social Development
31 NIH Toolbox Scores PRO and Performance Measures Mean = 100 (SD=15) Unadjusted Scale Score Age-adjusted scale score Fully adjusted scale score PRO Raw scores also available to match PROMIS T-score mean = 50 (SD=10)
32 Advantages to Newer Instruments Improved measurement Increased power reduced sample size Adaptability Low patient burden Comparability Royalty-free
33 Physical Function Measurement Precision and Range PROMIS Short Form 10 items SF items PROMIS Short Form 20 items SE = 3.3 rel = 0.90 Error CAT 10 items SE = 2.3 rel = HAQ 20 items 0.00 rheumatoid arthritis patients US general population Fries et al 2009
34 NeuroQOL Adult Item Bank Information Functions Positive Affect and Well-Being Depression Anxiety Applied Cog General Concerns rel.=.95 rel.= rel.=.95 rel.= rel.=.95 rel.= rel.=.95 rel.= T-score T-score T-score T-score Applied Cog - Executive Function Stigma Lower Extremity Function - Mobility Upper Extremity Fxn Fine Motor, ADL rel.=.95 rel.= rel.=.95 rel.= rel.=.95 rel.= rel.=.95 rel.= T-score T-score T-score T-score Ability to Participate in Social Roles/Activities Satisfaction with Social Roles/Activities rel.=.95 rel.= rel.=.95 rel.=.90 The shaded The shaded areas areas represent represent the effective the effective measurement measurement ranges ranges where where a reliability a reliability of roughly of.95 roughly is attainable..95 is attainable T-score T-score
35 Measures of Responsiveness Effect size (ES) = Standardized response mean (SRM)= Responsiveness statistic (RS) =
36 Physical Function Responsiveness Effect Sizes PROMIS-Cancer Physical Functioning SF (10 items) SF-36 Physical Functioning (10 items) Better (N=75) Same (N=114) Worse (N=55) Yost et al 2011
37 Advantages to Newer Instruments Improved measurement Increased power reduced sample size Adaptability Low patient burden Comparability Royalty-free
38 Adaptability Patients High PF Items New Item New Item New Item New Item New Item New Item New Item New Item New Item New Item New Item New Item Low PF Hung et al 2011
39 Advantages to Newer Instruments Improved measurement Increased power reduced sample size Adaptability Low patient burden Comparability Royalty-free
40 Fast Completion Times 66 seconds Lower Extremity CAT Patients scheduled for foot and ankle surgery 1 98 seconds Physical Function CAT Proximal humerus fractures in patients > 60 years old 2 1 Hung et al Vrahas under review
41 Advantages to Newer Instruments Improved measurement Increased power reduced sample size Adaptability Low patient burden Comparability Royalty-free
42 PROMIS Fatigue Across Five Clinical Conditions Cancer N = 310 Cancer w/ benefit (2 mos) Cancer Chemo (B) Back Pain N = 229 Back Pain (3 mos) Back Pain (1 mo) Back Pain (B) Depression N = 114 Depression (3 mos) Depression (1 mo) Depression (B) Heart Failure N = 64 HF Post-transplant HF Pre-transplant Exacerbation to Stable COPD N = 125 COPD Stable (B) COPD Exacerbation (B) Average for General Population
43 PROsettaStone Linking tables Legacy instruments to PROMIS metric BPI, CES-D, FACIT, HAQ, SF-36, PHQ-9, etc
44 Advantages to Newer Instruments Improved measurement Increased power reduced sample size Adaptability Low patient burden Comparability Royalty-free
45 How Do I Choose a Measure? Population Age Domains See definitions, review items PROMIS Scoring Manuals Aims of measurement (e.g., screening, primary outcome) Precision Completion time
46 To Learn More Video tutorials Publications Manuals
47 Acknowledgements This work was supported by funding from the NIH (U54 AR , U54 AR , U01 AR ) and AO Foundation
48 Thank you!
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