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Research ArticleOMERACT 2018: International Consensus Conference on Outcome Measures in Rheumatology, Terrigal, Australia, May 2018 Special Interest Groups, Part 1

Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

Louise Klokker, Dorthe B. Berthelsen, Thasia Woodworth, Kathleen M. Andersen, Daniel E. Furst, Dan Devoe, Paula R. Williamson, Maria E. Suarez-Almazor, Vibeke Strand, Amye L. Leong, Niti Goel, Maarten Boers, Peter M. Brooks, Lyn March, Victor S. Sloan, Peter Tugwell, Lee S. Simon and Robin Christensen
The Journal of Rheumatology September 2019, 46 (9) 1173-1178; DOI: https://doi.org/10.3899/jrheum.190196
Louise Klokker
From the Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA), Los Angeles; Division of Immunology and Rheumatology, Stanford University, Stanford; Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Rheumatology, Duke University School of Medicine, Durham; UCB Bio Sciences Inc., Raleigh, North Carolina; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey; SDG LLC, Cambridge, Massachusetts, USA; Department of Family Medicine, McGill University, Montreal, Quebec; Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne, Melbourne; University of Sydney, Sydney, Australia.
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Dorthe B. Berthelsen
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Thasia Woodworth
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Kathleen M. Andersen
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Daniel E. Furst
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Dan Devoe
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Paula R. Williamson
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Maria E. Suarez-Almazor
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Vibeke Strand
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Amye L. Leong
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Niti Goel
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Maarten Boers
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Peter M. Brooks
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Lyn March
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Victor S. Sloan
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Peter Tugwell
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Lee S. Simon
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Robin Christensen
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  • For correspondence: Robin.Christensen{at}regionh.dk
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Article Information

vol. 46 no. 9 1173-1178
DOI 
https://doi.org/10.3899/jrheum.190196
PubMed 
31043547

Published By 
The Journal of Rheumatology
Print ISSN 
0315-162X
Online ISSN 
1499-2752
History 
  • Accepted for publication April 12, 2019
  • Published online September 1, 2019.

Article Versions

  • Latest version (May 1, 2019 - 04:00).
  • Latest version (May 15, 2019 - 04:00).
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Copyright & Usage 
© 2019

Author Information

  1. Louise Klokker,
  2. Dorthe B. Berthelsen,
  3. Thasia Woodworth,
  4. Kathleen M. Andersen,
  5. Daniel E. Furst,
  6. Dan Devoe,
  7. Paula R. Williamson,
  8. Maria E. Suarez-Almazor,
  9. Vibeke Strand,
  10. Amye L. Leong,
  11. Niti Goel,
  12. Maarten Boers,
  13. Peter M. Brooks,
  14. Lyn March,
  15. Victor S. Sloan,
  16. Peter Tugwell,
  17. Lee S. Simon and
  18. Robin Christensen⇑
  1. From the Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA), Los Angeles; Division of Immunology and Rheumatology, Stanford University, Stanford; Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Rheumatology, Duke University School of Medicine, Durham; UCB Bio Sciences Inc., Raleigh, North Carolina; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey; SDG LLC, Cambridge, Massachusetts, USA; Department of Family Medicine, McGill University, Montreal, Quebec; Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne, Melbourne; University of Sydney, Sydney, Australia.
  2. L. Klokker, PT, MSc, PhD, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; D.B. Berthelsen, PT, MSc, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; T. Woodworth, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; K. Andersen, MSc, PhD Fellow, Department of Family Medicine, McGill University; D.E. Furst, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; D. Devoe, BA, MSc, PhD Student, Research Associate, Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine; P. Williamson, MSc, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; M.E. Suarez-Almazor, MD, PhD, Barnts Family Distinguished Professor, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center; V. Strand, MD, Biopharmaceutical Consultant; A.L. Leong, MBA, President and CEO, Healthy Motivation, and Director of Strategic Relations, Global Alliance for Musculoskeletal Health, Bone and Joint Decade; N. Goel, MD, Vice President, Strategic Drug Development, Advisory Services, Quintiles and Adjunct Assistant Professor, Division of Rheumatology, Duke University School of Medicine; M. Boers, MSc, MD, PhD, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center; P.M. Brooks, MD, FRACP, Honorary Professor Fellow, Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne; L. March, PhD, University of Sydney; V.S. Sloan, MD, UCB Bio Sciences Inc., and Clinical Associate Professor of Medicine, Rutgers-Robert Wood Johnson Medical School; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; L.S. Simon, MD, SDG LLC; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital. L. Klokker and D.B. Berthelsen are first co-authors.
  1. Address correspondence to R. Christensen, Professor of Biostatistics and Clinical Epidemiology and Head of Musculoskeletal Statistics Unit (MSU), The Parker Institute, Bispebjerg og Frederiksberg Hospital, Nordre Fasanvej 57; DK-2000 Copenhagen F, Denmark. E-mail: Robin.Christensen{at}regionh.dk

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Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials
Louise Klokker, Dorthe B. Berthelsen, Thasia Woodworth, Kathleen M. Andersen, Daniel E. Furst, Dan Devoe, Paula R. Williamson, Maria E. Suarez-Almazor, Vibeke Strand, Amye L. Leong, Niti Goel, Maarten Boers, Peter M. Brooks, Lyn March, Victor S. Sloan, Peter Tugwell, Lee S. Simon, Robin Christensen
The Journal of Rheumatology Sep 2019, 46 (9) 1173-1178; DOI: 10.3899/jrheum.190196

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Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials
Louise Klokker, Dorthe B. Berthelsen, Thasia Woodworth, Kathleen M. Andersen, Daniel E. Furst, Dan Devoe, Paula R. Williamson, Maria E. Suarez-Almazor, Vibeke Strand, Amye L. Leong, Niti Goel, Maarten Boers, Peter M. Brooks, Lyn March, Victor S. Sloan, Peter Tugwell, Lee S. Simon, Robin Christensen
The Journal of Rheumatology Sep 2019, 46 (9) 1173-1178; DOI: 10.3899/jrheum.190196
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Keywords

ADVERSE EVENTS
SAFETY
HARM
CORE OUTCOME SET
OMERACT
ARTHRITIS

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Show more OMERACT 2018: International Consensus Conference on Outcome Measures in Rheumatology, Terrigal, Australia, May 2018 Special Interest Groups, Part 1

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