Homepage

OMERACT 1. Maastricht, Netherlands, 1992.

J Rheumatol 1993: vol. 20: 526-591.

Outcome measures in rheumatoid arthritis clinical trials.

OMERACT Conference on Outcome Measures in RA Clinical Trials: Introduction
P. Tugwell, M. Boers .........528

OMERACT Conference on Outcome Measures in RA Clinical Trials: Conclusion
P. Tugwell, M. Boers .........590

Volume 21, Supplement 41

World Health Organization and International League of Associations for Rheumatology Core Endpoints for Symptom Modifying Antirheumatic Drugs in RA Clinical Trials
M. Boers, P. Tugwell, D.T. Felson, et al .........86

OMERACT 2. Ottawa, Canada, 1994.

J Rheumatol 1995; vol. 22:

OMERACT: State of the "ACT"
M. Boers, P.M. Brooks, P. Tugwell .........980

Toxicity of Antirheumatic Drugs
P.M. Brooks and R.O. Day for the Toxicity Workgroup Leaders .........998

Health Status Instruments/Utilities
N. Bellamy, M. Boers, D. Felson, et al .........1203

Economic Analysis Alongside Clinical Trials: Practical Considerations
M. Drummond, B. O'Brien for the Economics Workgroup .........1418

OMERACT II Conference -- Outcome Measures in RA Clinical Trials: Conclusion
P. Tugwell, M. Boers, P. Brooks .........1431

OMERACT 3. Cairns, Australia 1996.

J Rheumatol 1997; vol 24:

Recommendations for a Core Set of Outcome Measures for Future Phase III Clinical Trials in Knee, Hip, and Hand OA. Consensus Development at OMERACT III
N. Bellamy, J. Kirwan, M. Boers, et al .........799

Psychosocial Measures in Musculoskeletal Trials
S.P. Newman .........979

Psychosocial Measures
P. Brooks, A.C. McFarlane, S. Newman, J.J. Rasker .........1008

Guidelines of Osteoporosis Trials
P.N. Sambrook, S.R. Cummings, J.A. Eisman, et al .........1234

OMERACT 4. Cancun, Mexico, 1998.

J Rheumatol 1999; vol. 26

The OMERACT Filter for Outcome Measures in Rheumatology
M. Boers, P. Brooks, C.V. Strand, P. Tugwell .........198

Volume 26, No. 1-4

OMERACT IV: Fourth International Consensus Conference on Outcome Measures in Rheumatology: Introduction
M. Boers, P. Brooks, V. Strand, P. Tugwell .........199

Reporting Requirements for Longitudinal Observational Studies in Rheumatology
A. Silman, D. Symmons .........481

Preliminary Core Set of Domains and Reporting Requirements for Longitudinal Observational Studies in Rheumatology
F. Wolfe, M. Lassere, D.M.F.M. van der Heijde, et al .........484

Outcome Measures To Be Used in Clinical Trials in SLE
V. Strand, D.D. Gladman, D. Isenberg, M. Petri, J. Smolen, P. Tugwell .........490

Randomized Clinical Trials and Longitudinal Observational Studies in SLE: Consensus on a Preliminary Core Set of Outcome Domains
J.S. Smolen, V. Strand, M. Cardiel, et al .........504

ACR and EULAR Improvement Criteria Have Comparable Validity in RA Trials
A.M. Van Gestel, J.J. Anderson, P.L.C.M. van Riel, et al .........705

Smallest Detectable Difference in Radiological Progression
M. Lassere, M. Boers, D. van der Heijde, et al .........731

Imaging in RA: Results of Group Discussions
E.T.H. Molenaar, M. Boers, D.M.F.M. van der Heijde, et al .........749

Which Domains Should Be Included in a Core Set for Endpoints in Ankylosing Spondylitis? Introduction to the AS Module of OMERACT IV D.M.F.M. van der Heijde, S.M. van der Linden,
N. Bellamy, et al .........945

AS: Plenary Discussion and Results of Voting on Selection of Domains and Some Specific Instruments
D.M.F.M. van der Heijde, S.M. van der Linden, M. Dougados, et al ........1003

OMERACT 5. Toulouse, France, 2000.

J Rheumatol 2001; vol. 28:

OMERACT 5: International Consensus Conference on Outcome Measures in Rheumatology: Introduction
P. Tugwell, M. Boers, P.M. Brooks, L. Simon, C.V. Strand .........395

Minimal Clinically Important Difference Module

Introduction
G.A. Wells .........398

Looking for Important Change/Differences in Studies of Responsiveness
D.E. Beaton, C. Bombardier, J.N. Katz, et al .........400

Minimal Clinically Important Difference Module: Summary, Recommendations, and Research Agenda
G.A. Wells, J. Anderson, D. Beaton, et al .........452

OMERACT 5 Economics Working Group Report: Introduction
S.E. Gabriel .........640

OMERACT 5 Economics Working Group: Summary, Recommendations, and Research Agenda
S. Gabriel, M. Drummond, D. Coyle, et al .........670

OMERACT 5 Imaging Working Group Report on Plain Films: Introduction
D.M.F.M. van der Heijde .........880

Minimal Clinically Important Difference in Plain Films in RA: Group Discussions, Conclusions, and Recommendations
D.M.F.M. van der Heijde, M. Lassere, J.P. Edmonds, et al .........914

OMERACT 5 MRI Module

Introduction
J. Edmonds .........1133

MRI in RA: Summary of OMERACT Activities, Current Status, and Plans
P. Conaghan, J.P. Edmonds, P. Emery, et al .........1158

OMERACT 5 Drug Safety Working Group Report

Introduction
P.M. Brooks, R.O. Day .........1162

Standardizing Assessment of Adverse Effects in Rheumatology Clinical Trials. Status of OMERACT Toxicity Working Group March 2000: Towards a Common Understanding of Comparative Toxicity/Safety Profiles for Antirheumatic Therapies
T.G. Woodworth, D.E. Furst, V. Strand, et al .........1163

Drug Safety Module: Summary and Recommendations
P.M. Brooks, R.O. Day .........1192

OMERACT 6. Gold Coast, Australia, April 11-14, 2002.

J Rheumatol 2003; vol 30:

Introduction
P. Brooks, P. Tugwell, C.V. Strand, L. Simon .........866

Patient Perspectives

Outcomes from the Patient Perspective Workshop at OMERACT 6
J. Kirwan, T. Heiberg, S.A. Hewlett, et al .........868

Patient Perspective in Outcome Assessments - Perceptions or Something More?
T.K. Kvien, T. Heiberg .........873

Patients and Clinicians Have Different Perspectives on Outcomes in Arthritis
S.A. Hewlett .........877

Rheumatology Outcomes: The Patient's Perspective
A. Carr, S.A. Hewlett, R. Hughes, et al .........880

Patient's Perspective
E. Quest, G.J. Aanerud, S. Kaarud, et al .........884

Economics

OMERACT 6 Economics Working Group Report: A Proposal for a Reference Case for Economic Evaluation in RA
S. Gabriel, M. Drummond, A. Maetzel, et al .........886

Economic Evaluation of Programs or Interventions in the Management of RA: Defining a Consensus-based Reference Case
A. Maetzel, P. Tugwell, M. Boers, et al .........891

Imaging (Repair)

Repair of Erosions in RA Does Occur. Results from 2 Studies by the OMERACT Subcommittee on Healing of Erosions

J.T. Sharp, D. van der Heijde, M. Boers, et al .........1102

OMERACT Workshop: Repair of Structural Damage in RA
D. van der Heijde, J.T. Sharp, R. Rau, V. Strand .........1108

MCID/Low Disease Activity State

MCID/Low Disease Activity State Workshop: Low Disease Activity State in RA
G. Wells, M. Boers, B. Shea, et al .........1110

Deriving an Operational Definition of Low Disease Activity State in RA
M. Boers, J.J. Anderson, D.T. Felson .........1112

MCID/Low Disease Activity State Workshop: Summary, Recommendations, and Research Agenda
G. Wells, J.J. Anderson, M. Boers, et al .........1115

Magnetic Resonance Imaging

OMERACT RA MRI Studies Module
C. Peterfy, J. Edmonds, M. Lassere, et al .........1364

OMERACT RA MRI Studies. Exercise 3: An International Multicenter Reliability Study Using the RA-MRI Score
M. Lassere, F. McQueen, M. ?tergaard, et al .........1366

OMERACT RA MRI Studies. Exercise 4: An International Multicenter Longitudinal Study Using the RA-MRI Score
P. Conaghan, M. Lassere, M. ?tergaard, et al .........1376

OMERACT RA MRI Studies. Exercise 5: An International Multicenter Reliability Study Using Computerized MRI Erosion Volume Measurements P. Bird, B. Ejbjerg, F. McQueen, et al .........1380

OMERACT RA MRI Studies. Core Set of MRI Acquisitions, Joint Pathology Definitions, and the OMERACT RA-MRI Scoring System M. ?tergaard, C. Peterfy, P. Conaghan, et al .........1385

OMERACT RA MRI Studies. Summary of OMERACT 6 MRI Module.
F. McQueen, M. Lassere, J. Edmonds, et al .........1387

Current Status of Outcome Measure Development for Clinical Trials in Systemic Sclerosis. Report from OMERACT 6 P.A. Merkel, P.J. Clements, J.D. Reveille, M.E. Suarez-Almazor, G. Valentini, D.E. Furst .........1630

Outcome Variables for OA Clinical Trials: The OMERACT-OARSI Set of Responder Criteria
T. Pham, D. van der Heijde, M. Lassere, et al .........1648

Acknowledgements.........1655

OMERACT 7. Asilomar, California, USA. May 8–12, 2004.

Introduction
C.V. Strand, L.S. Simon, P. Tugwell, P. Brooks, M. Boers ......... 2014

Modules

Minimal Disease Activity for RA: A Preliminary Definition
G.A. Wells, M. Boers, B. Shea, et al ......... 2016

Minimal Clinically Important Difference, Low Disease Activity State, and Patient Acceptable Symptom State: Methodological Issues
F. Tubach, G.A. Wells, P. Ravaud, M. Dougados ......... 2025

Challenges and Progress in Adverse Event Ascertainment and Reporting in Clinical Trials
M.N.D. Lassere, K.R. Johnson, for the OMERACT Drug Safety Working Group .........2030

Generic Patient Self-Report and Investigator Report Instruments of Therapeutic Safety and Tolerability
M.N.D. Lassere, K.R. Johnson, S. Van Santen, et al .........2033

Standardized Assessment of Adverse Events in Rheumatology Clinical Trials: Summary of the OMERACT 7 Drug Safety Module Update
M.N.D. Lassere, K.R. Johnson, M. Boers, et al .........2037

Application of the OMERACT Filter to Scoring Methods for MRI of the Sacroiliac Joints and the Spine. Recommendations for a Research Agenda at OMERACT 7
D.M.F.M van der Heijde, R.B.M. Landewé, K-G.A. Hermann, et al.........2042

Selection of a Method for Scoring Radiographs for AS Clinical Trials, by the Assessment in AS Working Group and OMERACT
D.M.F.M. van der Heijde, R.B.M. Landewé, and the ASAS Working Group.........2048

Scoring Sacroiliac Joints by MRI. A Multiple-Reader Reliability Experiment
R.B.M. Landewé, K-G.A. Hermann, D.M.F.M. van der Heijde, et al.........2050

MRI of Inflammatory Lesions in the Spine in AS Clinical Trials: Is Paramagnetic Contrast Medium Necessary?
K-G.A. Hermann, R.B.M. Landewé, J. Braun, D.M.F.M. van der Heijde.........2056

Workshops

Progress since OMERACT 6 on Including Patient Perspective in Rheumatoid Arthritis Outcome Assessment
J.R. Kirwan, M. Ahlmén, M. De Wit, et al.........2246

Incorporating the Patient Perspective into Outcome Assessment in Rheumatoid Arthritis — Progress at OMERACT 7
J.R. Kirwan, S.E. Hewlett, T. Heiberg, et al.........2250

Attributes and Skills of an Effective Musculoskeletal Consumer
P.S. Tugwell, A. Wilson, P.M. Brooks, et al.........2257

Outcome Measures in Psoriatic Arthritis
D.D. Gladman, P.J. Mease, G. Krueger, et al.........2262

Fibromyalgia Syndrome
P.J. Mease, D.J. Clauw, L.M. Arnold, et al.........2270

Special Interest Groups

Concomitant Therapies as an Outcome Measure. Part 1: Drugs
L. Gossec, R.B.M. Landewé, J-F. Maillefert, M. Dougados.........2447

Concomitant Therapy: An Outcome Variable for Musculoskeletal Disorders? Part 2: Total Joint Replacement in Osteoarthritis Trials
J-F. Maillefert, G.A. Hawker, L. Gossec, et al.........2449

Outcome Measures for Acute and Chronic Gout
H.R. Schumacher, L.N. Edwards, F. Perez-Ruiz, et al.........2452

Measurement of Joint Space Width and Erosion Size
J.T. Sharp, D.M.F.M van der Heijde, J. Angwin, et al.........2456

Magnetic Resonance Imaging in Rheumatoid Arthritis — Advances and Research Priorities
M. Østergaard, F.M. McQueen, P. Bird, et al.........2462

The Evidence for Magnetic Resonance Imaging as an Outcome Measure in Proof-of-Concept Rheumatoid Arthritis Studies
P.G. Conaghan, F.M. McQueen, C.G. Peterfy, et al.........2465

The Design and Evaluation of Psychoeducational/Self-Management Interventions
K. Mulligan, S.P. Newman, E. Taal, M. Hazes, J.J. Rasker.........2470

Reconciling Subject Differences in Recruitment to Clinical Trials and Clinical Practice
K.L. Hyrich, D.P.M. Symmons, A.J. Silman.........2475

Scleroderma — Developing Measures of Response
D.E. Furst, D. Khanna, M. Mattucci-Cerinic, A.J. Silman, P.A. Merkel, I. Foeldvari.........2477

Synovial Tissue Analysis in Clinical Trials
B. Bresnihan, D. Baeten, G.S. Firestein, et al.........2481

Musculoskeletal Ultrasound Including Definitions for Ultrasonographic Pathology
R.J. Wakefield, P.V. Balint, M. Szkudlarek, et al.........2485

Current Status of Outcome Measures in Vasculitis: Focus on Wegener’s Granulomatosis and Microscopic Polyangiitis. Report from OMERACT 7
P.A. Merkel, P. Seo, P. Aries, et al.........2488

Acknowledgments.........2496

OMERACT 8. St. Julian's Bay, Malta. May 10-14, 2006

Introduction
M. Boers, V. Strand, L.S. Simon, P. Tugwell, P. Brooks .........599

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

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

Simulation Studies of Surrogate Endpoint Validation Using Single Trial and Multitrial Statistical Approaches
M. Lassere, K. Johnson, M. Hughes, et al .........616

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

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

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

Assessing Single Joints in Arthritis Clinical Trials
J.T. Giles, P. Mease, M. Boers, et al .........641

Imaging

Summary Findings of a Systematic Review of the Ultrasound Assessment of Synovitis
F. Joshua, M. Lassere, G.A. Bruyn, et al .........839

The OMERACT Ultrasound Group: Status of Current Activities and Research Directions
R.J. Wakefield, M-A. D'Agostino, A. Iagnocco, et al .........848

The OMERACT MRI Inflammatory Arthritis Group — Advances and Priorities
M. Østergaard, F. McQueen, P. Bird, et al .........852

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

A Multicenter Reliability Study of Extremity-MRI in the Longitudinal Evaluation of RA
P.G. Conaghan, B. Ejbjerg, M. Lassere, et al .........857

Developing a MRI Scoring System for Peripheral Psoriatic Arthritis
F. McQueen, M. Lassere, P. Bird, et al .........859

Scoring Inflammatory Activity of the Spine by MRI in AS: A Multireader Experiment
C. Lukas, J. Braun, D. van der Heijde, et al .........862

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

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

Repair in RA, Current Status. Report of a Workshop at OMERACT 8
D. van der Heijde, R. Landewé, J.T. Sharp for the OMERACT Subcommittee on Repair .........884

Outcome Measures

Outcome Measures in PsA
D.D. Gladman, P.J. Mease, P. Healy, et al .........1159

Consensus on a Core Set of Domains for PsA
D.D. Gladman, P.J. Mease, V. Strand, et al .........1167

Patient Perspective: Reasons and Methods for Measuring Fatigue in RA
J.R. Kirwan, S. Hewlett .........1171

Patient Perspective: Fatigue as a Recommended Patient Centered Outcome Measure in RA
J.R. Kirwan, P. Minnock, A. Adebajo, et al.........1174

Considerations and Preliminary Proposals for Defining a Reference Case for Economic Evaluations in AS
N. Bansback, A. Maetzel, M. Drummond, et al .........1178

Rationale and Strategies for Reevaluating the ACR20
D.T. Felson, D.E. Furst, M. Boers.........1184

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

SSc — Continuing Progress in Developing Clinical Measures of Response
D. Furst, D. Khanna, M. Matucci-Cerinic, et al .........1194

Workshops and Special Interest Groups

The Future of Damage Assessment in Vasculitis
P. Seo, R.A. Luqmani, O. Flossmann, et al.........1357

Worker Productivity Outcome Measures in Arthritis
R. Escorpizo, C. Bombardier, A. Boonen, et al.........1372

Outcome Evaluations in Gout
H.R. Schumacher, W. Taylor, N. Joseph-Ridge, et al .........1381

Preliminary Development of a Responder Index for Chronic Low Back Pain
L.S. Simon, C. Evans, N. Katz, et al.........1386

Development of the Effective Musculoskeletal Consumer Scale
E. Kristjansson, P.S. Tugwell, A.J. Wilson, et al.........1392

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

Fibromyalgia Syndrome
P. Mease, L.M. Arnold, R. Bennett, et al .........1415

Improving Patient Reported Outcomes Using Item Response Theory and Computerized Adaptive Testing
E.F. Chakravarty, J.B. Bjorner, J.F. Fries .........1426

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

Acknowledgment.........1436

OMERACT 9. Kananaskis Village, Rocky Mountains Canada. May 27 - 31, 2008

Introduction
P. Tugwell, M. Boers, V. Strand, L.S. Simon, P. Brooks .........1767

Biomarkers and Imaging

Testing of the OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage in RA: A Systematic Literature Search on 5 Candidate Biomarkers
S.W. Syversen, R. Landewé, D. van der Heijde, et al .........1769

Reappraisal of OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage Endpoints in RA, PsA, and Spondyloarthritis: The OMERACT 9 v2 Criteria
W.P. Maksymowych, R. Landewé, P-P. Tak, et al .........1785

Proposal for Levels of Evidence Schema for Validation of a Soluble Biomarker Reflecting Damage Endpoints in RA, PsA, and AS, and Recommendations for Study Design
W.P. Maksymowych, O. Fitzgerald, G.A. Wells, et al .........1792

Synovial Tissue Sublining CD68 Expression as a Biomarker of Therapeutic Response in RA Clinical Trials: Consist--- Across Centers
B. Bresnihan, E. Pontifex, R.M. Thurlings, et al .........1800

The OMERACT MRI Inflammatory Arthritis Group: Advances and Future Research Priorities
P.G. Conaghan, P. Bird, F. McQueen, et al .........1803

Reducing Invasiveness, Duration, and Cost of MRI in RA by Omitting IV Contrast Injection — Does It Change the Assessment of Inflammatory and Destructive Joint Changes by the OMERACT RAMRIS?
M. Østergaard, P.G. Conaghan, P. O’Connor, et al .........1806

Testing an OMERACT MRI Scoring System for Peripheral PsA in Cross-sectional and Longitudinal Settings
F. McQueen, M. Lassere, A. Duer-Jensen, et al .........1811

The OMERACT PsA MRI Scoring System (PsAMRIS): Definitions of Key Pathologies, Suggested MRI Sequences, and Preliminary Scoring System for PsA Hands
M. Østergaard, F. McQueen, C. Wiell, et al.........1816

Multiple Computer-based Methods of Measuring JSW Can Discriminate Between Treatment Arms in the COBRA Trial — Update of an Ongoing OMERACT Project
J.T. Sharp, J. Angwin, M. Boers, et al .........1825

The OMERACT Ultrasound Task Force — Advances and Priorities
M-A. D’Agostino, P.G. Conaghan, E. Naredo, et al .........1829

Methods

The OMERACT Initiative. Towards a Reference Approach to Derive QALY for Economic Evaluations in Rheumatology
A. Boonen, A. Maetzel, M. Drummond, et al ......... 2045

Variation in Outcome Measures in Hip and Knee Arthroplasty Clinical Trials: A Proposed Approach to Achieving Consensus
D.L. Riddle, P.W. Stratford, J.A. Singh, C.V. Strand .........2050

The OMERACT-ICF Reference Group: Integrating the ICF into the OMERACT Process: Opportunities and Challenges
A. Boonen, G. Stucki, W. Maksymowych, A.C. Rat, R. Escorpizo, M. Boers, and the OMERACT-ICF Reference Group .........2057

Progress in Assessing Physical Function in Arthritis: PROMIS Short Forms and Computerized Adaptive Testing
J.F. Fries, D. Cella, M. Rose, E. Krishnan, B. Bruce .........2061

Patient Perspective on Outcomes in Rheumatology — A Position Paper for OMERACT 9
J.R. Kirwan, S. Newman, P.S. Tugwell, G.A. Wells .........2067

Progress on Incorporating the Patient Perspective in Outcome Assessment in Rheumatology and the Emergence of Life Impact Measures at OMERACT 9
J.R. Kirwan, S. Newman, P.S. Tugwell, et al .........2071

Assessing Quality of Sleep in Patients with RA
G.A. Wells, T. Li, J.R. Kirwan, et al .........2077

Responsiveness of the Effective Consumer Scale (EC-17)
N. Santesso, T. Rader, G.A. Wells, et al .........2087

Assessing Single Joints in Arthritis Clinical Trials
H.I. Keen, C.O. Bingham III, L.A. Bradley, et al .........2092

OARSI/OMERACT Criteria of Being Considered a Candidate for Total Joint Replacement in Knee/Hip OA as an Endpoint in Clinical Trials Evaluating Potential DMOAD
M. Dougados, G. Hawker, S. Lohmander, et al .........2097

Measuring Worker Productivity: Frameworks and Measures
D. Beaton, C. Bombardier, R. Escorpizo, et al .........2100

Observations from the OMERACT Drug Safety Summit, May 2008
L.S. Simon, C.V. Strand, M. Boers, P.M. Brooks, D. Henry, P.S. Tugwell .........2110

How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns
L.S. Simon, C.V. Strand, M. Boers, et al .........2114

Disease Specific

Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct
P. Mease, L.M. Arnold, E.H. Choy, et al, on behalf of the OMERACT Fibromyalgia Working Group .........2318

Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome
E.H. Choy, L.M. Arnold, D.J. Clauw, et al .........2330

Developing a Standardized Definition for Disease “Flare” in RA (OMERACT 9 Special Interest Group)
C.O. Bingham III, C. Pohl, T.G. Woodworth, et al .........2335

Outcome Domains for Studies of Acute and Chronic Gout
H.R. Schumacher, W. Taylor, L. Edwards, et al.........2342

Progress in Measurement Instruments for Acute and Chronic Gout Studies
R. Grainger, W.J. Taylor, N. Dalbeth, et al.........2346

Measures of Response in Clinical Trials of Systemic Sclerosis: The Combined Response Index for Systemic Sclerosis (CRISS) and Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis (EPOSS)
D. Khanna, O. Distler, J. Avouac, et al .........2356

Progress Towards a Core Set of Outcome Measures in Small-vessel Vasculitis. Report from OMERACT 9
P.A. Merkel, K. Herlyn, A.D. Mahr, et al .........2362