OMERACT 8
International Consensus Conference on Outcome Measures in Rheumatology Clinical Trials
St. Julian's Bay, Malta
May 10-14, 2006
Introduction
M. Boers, V. Strand, L.S. Simon, P. Tugwell, P. Brooks .........599
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Biomarkers and Surrogate Endpoints
The WHO International Classification of Functioning, Disability and Health: A Conceptual Model and Interface for the OMERACT Process
G. Stucki, A. Boonen, P. Tugwell, A. Cieza, M. Boers .........600
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Definitions and Validation Criteria for Biomarkers and Surrogate Endpoints: Development and Testing of a Quantitative Hierarchical Levels of Evidence Schema
M.N. Lassere, K.R. Johnson, M. Boers, et al .........607
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Simulation Studies of Surrogate Endpoint Validation Using Single Trial and Multitrial Statistical Approaches
M. Lassere, K. Johnson, M. Hughes, et al .........616
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Synovial Macrophages as a Biomarker of Response to Therapeutic Intervention in RA: Standardization and Consistency Across Centers
B. Bresnihan, D.M. Gerlag, T. Rooney, et al .........620
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Testing of the Preliminary OMERACT Validation Criteria for a Biomarker to Be Regarded as Reflecting Structural Damage Endpoints in RA Clinical Trials: The Example of CRP
S.O. Keeling, R. Landewé, D. van der Heijde, et al .........623
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Development of Draft Validation Criteria for a Soluble Biomarker to Be Regarded as a Valid Biomarker Reflecting Structural Damage Endpoints in RA and SpA Clinical Trials
W.P. Maksymowych, R. Landewé, M. Boers, et al .........634
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Assessing Single Joints in Arthritis Clinical Trials
J.T. Giles, P. Mease, M. Boers, et al .........641
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Imaging
Summary Findings of a Systematic Review of the Ultrasound Assessment of Synovitis
F. Joshua, M. Lassere, G.A. Bruyn, et al.........839
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The OMERACT Ultrasound Group: Status of Current Activities and Research Directions
R.J. Wakefield, M.A. D'Agostino, A. Iagnocco,et al .........848
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The OMERACT MRI Inflammatory Arthritis Group — Advances and Priorities
M. Østergaard, F. McQueen, P. Bird, et al.........852
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A Multireader Reliability Study Comparing Conventional High-Field MRI with Extremity Low-Field MRI in RA
P. Bird, B. Ejbjerg, M.Lassere, et al .........854
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A Multicenter Reliability Study of Extremity-MRI in the Longitudinal Evaluation of RA
P.G. Conaghan, B. Ejbjerg, M. Lassere, et al.........857
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Developing a MRI Scoring System for Peripheral Psoriatic Arthritis
F. McQueen, M. Lassere, P. Bird, et al .........859
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Scoring Inflammatory Activity of the Spine by MRI in AS: A Multireader Experiment
C. Lukas, J. Braun, D. van der Heijde, et al.........862
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Is There a Preferred Method for Scoring Activity of the Spine by MRI in AS?
D. van der Heijde, R. Landewé, K.G. Hermann, et al.........871
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Computer Based Methods for Measurement of Joint Space Width: Update of an Ongoing OMERACT Project
J.T. Sharp, J. Angwin, M. Boers, et al .........874
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Repair in RA, Current Status. Report of a Workshop at OMERACT 8
D. vander Heijde, R. Landewé, J.T. Sharp for the OMERACT Subcommittee on Repair .........884
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Outcome Measures
Outcome Measures in PsA
D.D. Gladman, P.J. Mease, P. Healy, et al .........1159
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Consensus on a Core Set of Domains for PsA
D.D. Gladman, P.J. Mease, V. Strand, et al .........1167
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Patient Perspective: Reasons and Methods for Measuring Fatigue in RA
J.R. Kirwan, S. Hewlett .........1171
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Patient Perspective: Fatigue as a Recommended Patient Centered Outcome Measure in RA
J.R. Kirwan, P. Minnock, A. Adebajo, et al.........1174
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Considerations and Preliminary Proposals for Defining a Reference Case for Economic Evaluations in AS
N. Bansback, A. Maetzel, M. Drummond, et al .........1178
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Rationale and Strategies for Reevaluating the ACR20
D.T. Felson, D.E. Furst, M. Boers.........1184
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Minimal Clinically Important Improvement and Patient Acceptable Symptom State for Subjective Outcome Measures in Rheumatic Disorders
F. Tubach, P. Ravaud, D. Beaton, et al .........1188
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SSc—Continuing Progress in Developing Clinical Measures of Response
D. Furst, D. Khanna, M. Matucci-Cerinic, et al .........1194
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Workshops and Special Interest Groups
The Future of Damage Assessment in Vasculitis
P. Seo, R.A. Luqmani, O. Flossmann, et al.........1357
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Worker Productivity Outcome Measures in Arthritis
R. Escorpizo, C. Bombardier, A. Boonen, et al.........1372
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Outcome Evaluations in Gout
H.R. Schumacher, W. Taylor, N. Joseph-Ridge, et al .........1381
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Preliminary Development of a Responder Index for Chronic Low Back Pain
L.S. Simon, C. Evans, N. Katz, et al.........1386
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Development of the Effective Musculoskeletal Consumer Scale
E. Kristjansson, P.S. Tugwell, A.J. Wilson, et al.........1392
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Standardizing Assessment and Reporting of Adverse Effects in Rheumatology Clinical Trials II: the Rheumatology Common Toxicity Criteria v.2.0
T. Woodworth, D.E. Furst, R. Alten, et al.........1401
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Fibromyalgia Syndrome
P. Mease, L.M. Arnold, R. Bennett, et al .........1415
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Improving Patient Reported Outcomes Using Item Response Theory and Computerized Adaptive Testing
E.F. Chakravarty, J.B. Bjorner, J.F. Fries .........1426
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OMERACT/OARSI Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee OA
L.Gossec, G. Hawker, A.M. Davis, et al .........1432
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Acknowledgment.........1436
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