PROMIS: Collaborative Approach to Defining and Improving Outcomes in Orthopaedics
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1 PROMIS: Collaborative Approach to Defining and Improving Outcomes in Orthopaedics Kenneth J. Hunt, M.D. Stanford University Department of Orthopaedic Surgery
2 Disclosures No financial relationships to disclose Chair of the OFAR Managerial Board
3 Patient Reported Outcomes Outline Outcomes in Orthopaedics NIH PROMIS System Goals for The Future
4 Patient Reported Outcomes Patient Reported Outcomes (PROs) Health status perceived by patients
5 Patient Reported Outcomes Patient Reported Outcomes (PROs) Health status perceived by patients Outcomes
6 Clinical Findings Patient Reported Outcomes Patient Reported Outcomes (PROs) Health status perceived by patients Outcomes
7 Patient Reported Outcomes Patient Reported Outcomes (PROs) Health status perceived by patients X-rays Clinical Findings Outcomes
8 Patient Reported Outcomes Patient Reported Patient Reported Outcomes (PROs) Health status perceived by patients X-rays Clinical Findings Outcomes
9 Patient Reported Outcomes Patient Reported Outcomes (PROs) Health status perceived by patients Patient improvement X-rays Patient Reported Clinical Findings Reimbursement (CMS) ABOS Recertification Outcomes
10 Patient Reported Outcomes Measuring, reporting and comparing outcomes are perhaps the most important steps toward improving outcomes and reducing costs Porter ME, NEJM Dec, 2010
11 Patient Reported Outcomes Value = Outcome Cost Porter ME, NEJM Dec, 2010
12 Patient Reported Outcomes Value = Outcome Cost $ $ $ $ $ $ $ Porter ME, NEJM Dec, 2010
13 Patient Reported Outcomes Value = Outcome Cost $ $ $ $ $ $ $ Porter ME, NEJM Dec, 2010
14 Outcome Instruments Global Health Scales SF-36 SF-12 EQ-5D HAQ SMFA UCLA Activity Score 36 items 12 items 5 items 20 items 46 items 10 items
15 Outcome Instruments Disease or Region Specific Scales Shoulder/Elbow ASES Constant DASH Spine SRS-22 NDI & ODI CSOQ Hand/Wrist DASH BCTQ MHQ Arthroplasty Harris hip score WOMAC AKSS Oxford Scales Knee/ACL KOOS Lysholm IKDC
16 Outcome Instruments Disease or Region Specific Scales Foot/ankle lacks such an instrument Current foot/ankle PROs 139 unique PRO scales 55 scales used more than once 28 scales used five times or more Most common: AOFAS scales Hunt and Hurwit, 2013 JBJS Am
17 Outcome Instruments AOFAS scales The not so good with AOFAS scales Have not been shown to be valid or reliable Small number of response categories Absolute descriptors ( No pain, No limitations ) Limits precision Score clustering Physician-entered variables No standard measuring technique Poor inter-observer variability and reliability No clear guidelines for data interpretation
18 Outcome Instruments AOFAS scales AOFAS position statement (2011): Scores from the AOFAS Clinical Scoring Systems have not been found to be valid or reliable, and therefore their continued use is not recommended Pinsker and Daniels, 2011 FAI
19 Outcomes in Foot and Ankle OFAR Network Part of OFAR mission is to help providers define outcome metrics for QI and research
20 Foot and Ankle Outcomes Domains Physical Health Pain ADL Function Sports Activities Self Reported Health Mental Health Affect/Depression Cognition Social Health Relationships Function
21 Patient Reported Outcomes Outline Outcomes in Orthopaedics NIH PROMIS System Goals for The Future
22 Foot and Ankle Outcomes Data Collection Patient Reported Outcomes Measurement Information System Web-based PRO data collection system Efficient, Precise, Valid measures No Cost (currently sponsored by NIH) Adds Computer Adaptive Testing (CAT)
23 Foot and Ankle Outcomes Data Collection Computer Adaptive Testing (CAT) based on Item Response Theory
24 Computer Adaptive Testing Example of Classical Test Theory: Foot Function Index How much difficulty did you have: Walking around the house? No difficulty Unable to do Walking on uneven ground? No difficulty Unable to do Walking four or more blocks? No difficulty Unable to do Climbing stairs? No difficulty Unable to do Descending stairs? No difficulty Unable to do Standing on tip toe? No difficulty Unable to do Getting out of a chair? No difficulty Unable to do Climbing up or down curbs? No difficulty Unable to do Walking fast or running? No difficulty Unable to do 23 questions total Score calculated on a scale of 100
25 Computer Adaptive Testing Example of Item Response Theory: CAT Uses a Bank of Validated Questions Questions selected based on patient s response to previously administered questions Asks only the most pertinent and informative items Produces score with high level of precision using the minimal possible number of questions
26 Computer Adaptive Testing 1. Unable to do 2. With much difficulty 3. With some difficulty 4. With a little difficulty 5. Without any difficulty Physical Function CAT Same score with good precision in 4 questions
27 Computer Adaptive Testing CAT Scoring Physical Function CAT 50-3 SD -2SD -1SD th 1 SD 2 SD 3 SD %ile T score is reported (50 = average) Each SD = 10
28 NIH PROMIS A New Paradigm? Domain-specific Not Disease-specific Applies to different diseases, not only orthopaedic
29 PROMIS Physical Health Banks Pain Behavior Pain Interference Fatigue Physical Health Physical Function Sleep Disturbance Sleep Impairment Sexual Function
30 NIH PROMIS A New Paradigm? OFAR Pilot Study
31 OFAR Network The Pilot Project Baylor/UTSW Campbell Clinic HSS Orthocarolina Stanford University University of Arizona University of Iowa UCLA Univ. of Rochester University of Utah 10 Pilot Sites
32 OFAR Network The Pilot Project Hunt et al FAI
33 Each site: OFAR Network The Pilot Project Enrolled 30 patients undergoing surgery for: Ankle/Hindfoot Ankle Arthritis Ankle Instability Flatfoot Deformity Forefoot Bunions Hammer toe(s) Hallux rigidus
34 OFAR Network The Pilot Project PROMIS system used for patient surveys Demographic and comorbidity data PRO data Computer Adaptive Tests Physical Function CAT Pain Interference CAT Legacy Instruments Foot and Ankle Ability Measure (FAAM) Foot Function Index (FFI)
35 OFAR Network The Pilot Project PROMIS system used for patient surveys Demographic and comorbidity data PRO data Computer Adaptive Tests Physical Function CAT Pain Interference CAT Legacy Instruments Foot and Ankle Ability Measure (FAAM) Foot Function Index (FFI) 3 month enrollment period Data collected Pre-op 6 months post-op
36 OFAR Pilot Project Total Enrollment 328 total patients enrolled
37 OFAR Pilot Project Total Enrollment 328 total patients enrolled Ankle Instability 38 Ankle Arthritis 36 Hallux Valgus 79 Hammertoe 24 Hallux Rigidus 36 Flatfoot 27 Other/Missing
38 Item Counts OFAR Pilot Project Efficiency CAT vs. Legacy Scales Physical Function CAT Pain Interference CAT FAAM FFI 4.3 questions 4.3 question 28.0 questions 23.0 questions
39 # of Patients OFAR Pilot Project Efficiency Time to Complete Instrument PF CAT 0:46 seconds Time to complete
40 # of Patients PF CAT OFAR Pilot Project Efficiency Time to Complete Instrument 0:46 seconds Pain CAT 0:33 seconds Time to complete
41 # of Patients OFAR Pilot Project Efficiency Time to Complete Instrument PF CAT 0:46 seconds Pain CAT 0:33 seconds FFI 3:16 Time to complete
42 # of Patients OFAR Pilot Project Efficiency Time to Complete Instrument PF CAT 0:46 seconds Pain CAT 0:33 seconds FFI 3:16 FAAM 2:54 ¼ the time to complete CATs Time to complete
43 OFAR Pilot Project Psychometric properties of PROMIS instruments Hung et al CORR Hung et al FAI
44 OFAR Pilot Project Psychometric Properties Responsiveness: * Physical Function CAT Average Function * * * Pre-op Post-op * Ankle Instability Ankle Arthritis Hallux Valgus Hammertoe Hallux Rigidus Flatfoot
45 OFAR Pilot Project Psychometric Properties Responsiveness: * * Pain CAT * Pre-op Post-op * * Average Pain 45 Ankle Instability Ankle Arthritis Hallux Valgus Hammertoe Hallux Rigidus Flatfoot
46 OFAR Pilot Project Psychometric Properties Responsiveness: * * FAAM * * Pre-op Post-op * Ankle Instability Ankle Arthritis Hallux Valgus Hammertoe Hallux Rigidus Flatfoot
47 OFAR Pilot Project Psychometric Properties Responsiveness: Foot Function Index Pre-op Post-op Ankle Instability Ankle Arthritis Hallux Valgus Hammertoe Hallux Rigidus Flatfoot
48 OFAR Pilot Project Construct validity: Rasch model High for all instruments Convergent validity Pearson correlation Psychometric Properties PF CAT FAAM FFI PF CAT FAAM FFI We are measuring what intended to measure
49 OFAR Pilot Project Psychometric Properties Reliability: High for all instruments Person Reliability Item Reliability PF CAT FAAM FFI
50 Instrument coverage: Minimal ceiling effect (SEM %) No floor effect Precision: OFAR Pilot Project Psychometric Evaluation of PF CAT Physical Function CAT High across a broad range of physical function Hung et al., CORR in press
51 CAT scales vs. Legacy Scales All PROMIS CAT items valid, reliable Lower test burden* CAT surveys completed much faster 3-8 questions on average Eliminates unnecessary questions Better Precision NIH PROMIS A New Paradigm? Floor/Ceiling effects can be eliminated *Does not interfere with clinical productivity Hunt et al., 2014 FAI Hung et al., 2013 CORR
52 NIH PROMIS A New Paradigm? PROMIS CATs in Orthopaedics Tyser et al., 2014 JHSA Hung et al., 2014 Spine Hung et al., 2014 JOT Papuga et al JOR
53 Patient Reported Outcomes Outline Outcomes in Orthopaedics NIH PROMIS System Goals for The Future
54 NIH PROMIS Moving Forward PROMIS NIH Roadmap Initiative NIH committed to improve and standardize measurement of PRO More than $90 million invested since 2004 Goal is widespread adoption by all specialties Across the entire US population PROMIS CATs are open source AssessmentCenter.net RedCAP, EPIC, Ipad App
55 Outcomes in Foot and Ankle Moving Forward Measuring Outcomes Physical Function is an important domain But it is not the only domain Health Domains Physical Health Mental Health Social Health Physical Function Pain Interference Pain Intensity Fatigue Depression Anxiety Cognitive Function Relationships Function Social Support
56 Outcomes in Foot and Ankle Moving Forward Measuring Outcomes Physical Function is an important domain But it is not the only domain Establish Normative data for populations
57 Outcomes in Foot and Ankle Moving Forward Where we are heading: Patients complete questionnaire
58 Outcomes in Foot and Ankle Moving Forward Where we are heading: Patients complete questionnaire Instantly scored and uploaded to EMR Upon entering room Know PRO scores Population norms Historical values Will intervention help?
59 Outcomes in Foot and Ankle Moving Forward Where we are heading: Patients complete questionnaire Instantly scored and uploaded to EMR Upon entering room PRO scores part of clinic note
60 Outcomes in Foot and Ankle Moving Forward Where we are heading: Response to treatment can be monitored Comparison to internal and national standards
61 Outcomes in Foot and Ankle Our Ultimate Goal: Moving Forward Enhance our ability to assess patient outcomes Improve quality and generalizability of outcomes assessment Direct the conversation on quality assessment and appropriate allocation of HC resources
62 Thank You OFAR Network AOFAS/OEF
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