The Gift of the The Gift of the OMERACT Filter OMERACT Filter Jasvinder Singh, MD, MPH Jasvinder Singh, MD, MPH Jasvinder Singh, MD, MPH Jasvinder Singh, MD, MPH University of Alabama at Birmingham University of Alabama at Birmingham Birmingham Veterans Affairs Medical Center Birmingham Veterans Affairs Medical Center Mayo Clinic College of Medicine Mayo Clinic College of Medicine On Behalf of the OMERACT Steering Committee On Behalf of the OMERACT Steering Committee Sincere thanks to Maarten Boers, MSC, MD, PhD at Sincere thanks to Maarten Boers, MSC, MD, PhD at VU VU University Medical Center Amsterdam, Netherlands University Medical Center Amsterdam, Netherlands for for slides slides
Outline Outline What is a core set and why do we need them? What is a core set and why do we need them? Issues with Trials Issues with Trials Current initiatives to develop core sets Current initiatives to develop core sets Outcome Outcome Measures in Measures in Rheumatology ( Rheumatology (OMERACT OMERACT) Core Outcome Measures in Effectiveness Trials Core Outcome Measures in Effectiveness Trials Core Outcome Measures in Effectiveness Trials Core Outcome Measures in Effectiveness Trials (COMET (COMET) Existing definitions, conceptual structures Existing definitions, conceptual structures and their history and their history OMERACT proposal for core areas of measurement OMERACT proposal for core areas of measurement OM&core Boston 2
Problems with trials Problems with trials Trials are done to evaluate Trials are done to evaluate whether an intervention is effective and safe whether an intervention is effective and safe Choice of measures to reflect benefit and harm Choice of measures to reflect benefit and harm In most areas choices not standardized In most areas choices not standardized In most areas choices not standardized In most areas choices not standardized heterogeneity between trials heterogeneity between trials potential for bias (selective outcome reporting) otential for bias (selective outcome reporting) c choice of measures less relevant to users hoice of measures less relevant to users OM&core Boston 3
Solution Solution Development of Development of trial core sets trial core sets Minimum inimum set of set of outcomes that outcomes that should be should be measured and reported in all clinical trials measured and reported in all clinical trials of of a specific a specific condition condition What is an outcome? What is an outcome? How to decide what belongs in a core set? How to decide what belongs in a core set? OM&core Boston 4
“ O utcome utcome ME ME asures asures in in R heumatoid heumatoid A rthritis rthritis C linical linical T rials rials” Outcome Measures in Rheumatology* Outcome Measures in Rheumatology* Informal, unofficial Informal, unofficial Group of health professionals and Group of health professionals and patient experts interested in outcome patient experts interested in outcome measures and endpoints in rheumatology measures and endpoints in rheumatology * www.omeract.org OM&core Boston 5
Rheumatology, 1980- Rheumatology, 1980 -1990 1990 No consensus over No consensus over which measures to include in RA trials which measures to include in RA trials > 25 different measures available > 25 different measures available 5 meetings: no single consensus 5 meetings: no single consensus 5 meetings: no single consensus 5 meetings: no single consensus Confusion: purpose, focus of measurement, Confusion: purpose, focus of measurement, and selection of measures and selection of measures Increasing recognition of the importance Increasing recognition of the importance of of sensitivity to change sensitivity to change Transatlantic divide Transatlantic divide OM&core Boston 6
OMERACT 1 OMERACT 1 Maastricht, 1992 Maastricht, 1992 Core set for RA trials Core set for RA trials Minimum relevant improvement Minimum relevant improvement patients/trials patients/trials patients/trials patients/trials Composite measures/ Composite measures/ improvement criteria improvement criteria OM&core Boston 7
WHO/ I LAR WHO/ I LAR core set core set RA clinical trials RA clinical trials global assessments patient & assessor global assessments patient & assessor pain pain painful joint count painful joint count swollen joint count swollen joint count swollen joint count swollen joint count physical disability physical disability acute phase protein acute phase protein in studies ≥ 1 year: X in studies ≥ 1 year: X-rays hands & feet rays hands & feet OM&core Boston 8
OMERACT 11 OMERACT 11 (Pinehurst, 2012) (Pinehurst, 2012) extra activities extra activities preconference symposium preconference symposium Fellow training Fellow training CAT/IRT CAT/IRT extended interest group extended interest group mini- mini -module module Flares in RA Flares in RA Psoriatic Arthritis Psoriatic Arthritis special interest groups special interest groups workshops workshops Myositis Myositis Myositis Myositis Worker Productivity Worker Productivity Worker Productivity Worker Productivity MRI MRI- -Juvenile Infl. Arthritis Juvenile Infl. Arthritis Acute Gout Acute Gout PROMIS PROMIS Ultrasound responsiveness RA Ultrasound responsiveness RA Hand Osteoarthritis Hand Osteoarthritis Vasculitis Vasculitis Equity Equity OMERACT Filter 2.0 OMERACT Filter 2.0 Polymyalgia Polymyalgia Rheumatica Rheumatica Truth: Areas/Domains Truth: Areas/Domains MRI MRI- -inflammatory arthritis inflammatory arthritis Truth: Instruments Truth: Instruments Item Response Theory Item Response Theory Hip Osteoarthritis Hip Osteoarthritis Discrimination & Feasibility Discrimination & Feasibility Connective Tissue Disease/ Connective Tissue Disease/ Putting it all together Putting it all together Interst Interst. Lung disease . Lung disease Patient Reported Outcomes Patient Reported Outcomes Imaging & Biomarkers Imaging & Biomarkers OM&core Boston 9
Bottom line Bottom line Achieving consensus over measures Achieving consensus over measures involves: involves: Content Content Content Content Education in methodology Education in methodology Agreeing on: Agreeing on: Purpose Purpose Domain(s) Domain(s) Applicability of specific measures Applicability of specific measures Iteration Iteration OM&core Boston 10
Bottom line Bottom line Achieving Achieving consensus over measures consensus over measures involves: involves: Content Content Content Content Process Process Data Data- -driven driven Iterative, stepwise Iterative, stepwise Inclusivity Inclusivity Important role for dissenters Important role for dissenters Harsh data softened by political considerations Harsh data softened by political considerations OM&core Boston 11
OMERACT Filter 1.0 OMERACT Filter 1.0 OMERACT Filter 1.0 OMERACT Filter 1.0
OMERACT Filter OMERACT Filter to select measures to select measures To be applicable in its intended setting, To be applicable in its intended setting, a measure must be a measure must be truthful truthful discriminative discriminative feasible feasible OM&core Boston 13
OMERACT Filter OMERACT Filter Truth Truth free from bias free from bias criterion, construct validity criterion, construct validity criterion, construct validity criterion, construct validity relevant relevant content, face validity content, face validity OM&core Boston 14
OMERACT Filter OMERACT Filter Discrimination Discrimination able to distinguish between states able to distinguish between states that are of interest: that are of interest: that are of interest: that are of interest: at one time point at one time point at different time points at different time points reliability, reproducibility, reliability, reproducibility, sensitivity to change sensitivity to change OM&core Boston 15
OMERACT Filter OMERACT Filter Feasibility Feasibility time time costs costs costs costs interpretability interpretability OM&core Boston 16
OMERACT Filter OMERACT Filter Filter works best to select instruments Filter works best to select instruments once the once the areas of measurement areas of measurement have been decided on have been decided on Truth: “…measure what it’s supposed to…” Truth: “…measure what it’s supposed to…” but how to decide on the supposition? but how to decide on the supposition? but how to decide on the supposition? but how to decide on the supposition? For any core set we need to decide For any core set we need to decide in what areas we need to measure in what areas we need to measure core areas of measurement core areas of measurement OM&core Boston 17
Example Example WHO/ I LAR WHO/ I LAR core set core set rheumatoid arthritis clinical trials rheumatoid arthritis clinical trials global assessments by patient & assessor global assessments by patient & assessor pain pain painful joint count painful joint count painful joint count painful joint count swollen joint count swollen joint count physical disability physical disability acute phase protein acute phase protein in studies ≥ 1 year: X in studies ≥ 1 year: X-rays hands & feet rays hands & feet OM&core Boston 18
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