Format

Send to

Choose Destination
J Rheumatol. 2017 Dec;44(12):1916-1919. doi: 10.3899/jrheum.161105. Epub 2016 Oct 15.

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

Author information

1
From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Immunology and Rheumatology, Stanford University, Stanford, California; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA); Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Strategic Drug Development, Advisory Services, Quintiles and Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina; SDG LLC, Cambridge, Massachusetts, USA; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, Amsterdam; 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, Australia.
2
L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa; 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; C.B. Terwee, PhD, Associate Professor, Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center; 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, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University, and Healthy Motivation; T. Woodworth, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; 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.S. Simon, MD, SDG LLC; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital.
3
From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Immunology and Rheumatology, Stanford University, Stanford, California; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA); Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Strategic Drug Development, Advisory Services, Quintiles and Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina; SDG LLC, Cambridge, Massachusetts, USA; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, Amsterdam; 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, Australia. Robin.Christensen@regionh.dk.
4
L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa; 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; C.B. Terwee, PhD, Associate Professor, Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center; 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, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University, and Healthy Motivation; T. Woodworth, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; 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.S. Simon, MD, SDG LLC; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital. Robin.Christensen@regionh.dk.

Abstract

OBJECTIVE:

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions.

METHODS:

The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved.

RESULTS:

Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.

CONCLUSION:

The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

KEYWORDS:

CORE OUTCOME SET; HARM; OMERACT; RHEUMATOLOGY; SAFETY

PMID:
27744393
DOI:
10.3899/jrheum.161105
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center