Post on 22-Aug-2019
PROMIS®
Patient Reported Outcomes
Measurement Information System:
The Case for an International PROMIS initiative
Jordi Alonso, MD, PhD, on behalf of PROMIS International
Director, Program Epidemiology & Public HealthIMIM-Hospital del Mar Medical Research Institute
Pompeu Fabra UniversityBarcelona, Spain
King’s Fund. PROMS Research Conference
November18, 2014. London.
Content of presentation
• PROMIS
• Measures, Tools & Metric
• Assessment Centre
• PROMIS International
• Translation & Requirements for Release
• Any questions…
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Vision-Mission:
• Vision– The Patient-Reported Outcomes Measurement
Information System (PROMIS®), funded by the National Institutes of Health, aims to provide clinicians and researchers access to efficient, precise, valid, and responsive adult- and child-reported measures of health.
• Mission
– PROMIS uses measurement science to create an efficient state-of-the-art assessment system for self-reported health.
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DOMAINS
A domain is the specific feeling, function, or perception you want to measure.
Cuts across different diseases
PROMIS Measures
• Adult Health Measures• More than 1,000 individual items (questions)
• 51 distinct item banks or scales
• 12-124 items per bank
• Pediatric Health Measures• More than 150 items (questions)
• 18 distinct banks or scales
• 22 more on the way
PROMIS Basic Tools
Derived from Item Banks
• Computerized Adaptive Testing (CAT) Dynamic testing averaging 4-5 items per domain
• Fixed Length (“Short”) Forms By individual domain (4-10 items)
7-domain health profiles (-29, -43, -57)
Global Health Index
• Global-10
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ITEM BANKS
An item bank is a large collection of items measuring a single domain.
Therefore…..Any and all items can be used to provide a score for that domain.
Fatigue Item Bank
Chemotherapy trial
Same metric, same meaning
Osteoarthritis trial
Diabetes trial
Heart Failure trial
Epilepsy trial
Items 1-10 CAT Items 6-12
Items 1-5Items 2, 4, 9, 13
The PROMIS Metric
• T Score Mean = 50
SD = 10
• Referenced to the US General Population
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CAT demo results
5035 40 45 55 60 65
PROMIS Fatigue Across Five Clinical Conditions
Average for General Population
COPD Stable (B) COPD Exacerbation (B)
HF Pre-transplantHF Post-transplant
Exacerbation to Stable
Depression
(B)
Depression
(1 mo)
Depression
(3 mos)
Cancer
Chemo
(B)
Cancer
w/ benefit
(2 mos)
Back Pain
(B)
Back Pain
(1 mo)
Back Pain
(3 mos)
N = 64
N = 310
N = 114
N = 229
N = 125
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What is Assessment Center?
• Web-based research management tool
– Primary mechanism for distribution of PROMIS instruments
– Display of item- and instrument-level statistics
• Allows creation of study-specific URLs for data collection
– Enabled to administer CATs
• Administration of PROMIS and other instruments
• FREE!!
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Select CATs
PROMIS: Potential for International Community
• Solid, comprehensive, new generation PRO measurement initiative
• Oriented to clinical research and practice
• International research (RCTs, Cumulative Data, Meta-analyses, CER)
• International comparisons
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PROMIS International (non-US)
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1st Name Surname Country
Susan Bartlett Canada
Alain Leplège France
Matthias Rose Germany
Sandra Nolte Germany
Ulrike Ravens-Sieberer Germany
Aiping Lu Hong Kong
Fabio Efficace Italy
Agnieszka Żukowska Poland
Wojciech Glinkowski Poland
Gemma Vilagut Spain
Jordi Alonso Spain
John Chaplin Sweden
Caroline Terwee The Netherlands
Hein Raat The Netherlands
Neil Aaronson The Netherlands
Chema Valderas UK
John Brazier UK
PROMIS International: Steps
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• Translation
• DIF assessment
• Calibration
• Country-specific reference scores
• Further validation
• Other issues
PROMIS Translation & Cultural Adaptation
• Harmonization & Universal Approach
Harmonization across languages –
o Not an exact replica, unavoidable variation, harmonization determines acceptable variation.
Universal approach to translation –
o Goal: one language version for multiple countries
(vs country-specific versions)
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PRISM - PROMIS International Standards and Measures
Objective is to increase the availability of:
o full item banks (9) to a total of 12 languages, and of
o selected short forms (14) to 26 languages
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Minimum Requirements for Release
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Thank you!
jalonso@imim.es
PROMIS: http://www.nihpromis.org/
Asmnt. Center: https://www.assessmentcenter.net/
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Recommendations for further Evaluation
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Instrument Recommendations for further psychometric evaluation AFTER release
Sample size
Item bank Calibration of item banks in relevant patient groups and the general population;
Minimum 500 Optimal 1000-2000
Short form / item bank The collection of language- or country-specific reference scores in the general population;
At least 300-400
Short form / item bank An evaluation of the relevance and comprehensiveness of the items (content validity) of the item bank and cultural adaptation;
4-6 focus groups or 12 interviews
Short form / CAT Further psychometric evaluation (construct validity, internal consistency, test-retest reliability, measurement error, DIF among different patient groups) of PROMIS instruments in specific patient populations;
200 subjects per group for DIF 50-100 for other measurement properties
Short form / CAT Responsiveness and Minimal Important Change of PROMIS instruments in relevant patient populations.
50-100
PROMIS Translation & Cultural Adaptation
Universal approach to translation –
o Goal: one language version for multiple countries (vs country-specific versions)
Strategies:
1. Translators from various countries or dialectscontribute to the translation process;
2. Avoiding colloquial and idiomatic expressions;
3. Pretesting and debriefing items with samples from relevant countries.
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PROMIS Instrument Maturity Model
Stages
1.Developmental• Conceptualization & Item Pool Development
2.Developmental• Calibration Phase – DIF impact
3.Public Release • Calibrated & Preliminary Validation Completed
4.Maturing• Responsiveness & Expansion
5.Fully Mature • Interpretation & User Support
PROMIS Psychometrics & Calibration
1. Traditional Descriptive Statistics• Items analysis, Scale analysis
2. Evaluation of IRT Assumptions• Unidimensionality, Local independence &
Monotonicity3. Evaluation of IRT Model Fit
• IRT parameters, Model fit, Item & Scale properties4. Evaluation of DIF
• Hypotheses, IRT-based & non-IRT-based models5. Item Calibration for Item Banks
• Full/Incomplete blocks, Standardization, CAT algorithms
PROMIS Item Development
1. Identification of Extant Items
2. Binning & Winnowing
3. Item Revision Process
4. Response Options
5. Recall Time Frame
6. Focus Groups
7. Cognitive interviews
8. Final Item Reviews
PROMIS Int’l: The Netherlands
Website: www.dutchflemihspromis.nl
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PROMIS Int’l: Spain
o Translation: not needed. Cognitive debriefings of
Pain SFs. PI: Dr. Rafael Gálvez
o 3 Mental Health Item Banks:
o Cognitive Debriefings
o Clinical Validation
o Calibration: Gen population (internet panel= 2,000)
PI: Gemma Vilagut. Funded: ISIII, M. Economy & Competitivity
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PROMIS Int’l: Canada• National stakeholder meeting: needs, priorities, infrastructure
to support and sustain Canada PRO Initiative and create a Canada PRO website
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www.mcgill.ca/can-pro-network
• to include PROMIS-Canada CAT platform and French versions
• Publish Canada PRO Initiative workshop reports in a special edition of the Journal of Clinical Epidemiology