Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016

Antoine G Sreih^{1

2}, Fatma Alibaz-Oner^{1

2}, Tanaz A Kermani^{1

2}, Sibel Z Aydin^{1

2}, Peter F Cronholm^{1

2}, Trocon Davis^{1

2}, Ebony Easley^{1

2}, Ahmet Gul^{1

2}, Alfred Mahr^{1

2}, Carol A McAlear^{1

2}, Nataliya Milman^{1

2}, Joanna C Robson^{1

2}, Gunnar Tomasson^{1

2}, Haner Direskeneli^{1

2}, Peter A Merkel^{3

4}

Affiliations

¹ From the Division of Rheumatology, and Department of Family Medicine and Community Health, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Fatih Sultan Mehmet Training and Research Hospital; Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; Division of Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Internal Medicine, University Paris Diderot, Paris, France; University of the West of England; University of Bristol; University Hospitals Bristol National Health Service (NHS) Trust, Bristol, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland.
² A.G. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Associate Professor of Rheumatology, Fatih Sultan Mehmet Training and Research Hospital; T.A. Kermani, MD, MS, Assistant Professor of Medicine, Division of Rheumatology, University of California at Los Angeles; S.Z. Aydin, Associate Professor in Rheumatology, Division of Rheumatology, University of Ottawa; P.F. Cronholm, MD, MSCE, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; T. Davis, Department of Family Medicine and Community Health, University of Pennsylvania; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University, Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; N. Milman, MD, Assistant Professor, Division of Rheumatology, University of Ottawa, and Division of Rheumatology, The Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant in Rheumatology, University Hospitals Bristol NHS Trust; G. Tomasson, MD, PhD, Assistant Professor of Epidemiology, Department of Public Health Sciences, University of Iceland; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University, School of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania.
³ From the Division of Rheumatology, and Department of Family Medicine and Community Health, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Fatih Sultan Mehmet Training and Research Hospital; Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; Division of Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Internal Medicine, University Paris Diderot, Paris, France; University of the West of England; University of Bristol; University Hospitals Bristol National Health Service (NHS) Trust, Bristol, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland. pmerkel@upenn.edu.
⁴ A.G. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Associate Professor of Rheumatology, Fatih Sultan Mehmet Training and Research Hospital; T.A. Kermani, MD, MS, Assistant Professor of Medicine, Division of Rheumatology, University of California at Los Angeles; S.Z. Aydin, Associate Professor in Rheumatology, Division of Rheumatology, University of Ottawa; P.F. Cronholm, MD, MSCE, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; T. Davis, Department of Family Medicine and Community Health, University of Pennsylvania; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University, Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; N. Milman, MD, Assistant Professor, Division of Rheumatology, University of Ottawa, and Division of Rheumatology, The Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant in Rheumatology, University Hospitals Bristol NHS Trust; G. Tomasson, MD, PhD, Assistant Professor of Epidemiology, Department of Public Health Sciences, University of Iceland; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University, School of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania. pmerkel@upenn.edu.

PMID: 28864646
PMCID: PMC5712274
DOI: 10.3899/jrheum.161467

Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016

Antoine G Sreih et al. J Rheumatol. 2017 Dec.

. 2017 Dec;44(12):1933-1937.

doi: 10.3899/jrheum.161467. Epub 2017 Sep 1.

Authors

Affiliations

¹ From the Division of Rheumatology, and Department of Family Medicine and Community Health, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Fatih Sultan Mehmet Training and Research Hospital; Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; Division of Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Internal Medicine, University Paris Diderot, Paris, France; University of the West of England; University of Bristol; University Hospitals Bristol National Health Service (NHS) Trust, Bristol, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland.
² A.G. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Associate Professor of Rheumatology, Fatih Sultan Mehmet Training and Research Hospital; T.A. Kermani, MD, MS, Assistant Professor of Medicine, Division of Rheumatology, University of California at Los Angeles; S.Z. Aydin, Associate Professor in Rheumatology, Division of Rheumatology, University of Ottawa; P.F. Cronholm, MD, MSCE, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; T. Davis, Department of Family Medicine and Community Health, University of Pennsylvania; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University, Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; N. Milman, MD, Assistant Professor, Division of Rheumatology, University of Ottawa, and Division of Rheumatology, The Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant in Rheumatology, University Hospitals Bristol NHS Trust; G. Tomasson, MD, PhD, Assistant Professor of Epidemiology, Department of Public Health Sciences, University of Iceland; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University, School of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania.
³ From the Division of Rheumatology, and Department of Family Medicine and Community Health, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Fatih Sultan Mehmet Training and Research Hospital; Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; Division of Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Internal Medicine, University Paris Diderot, Paris, France; University of the West of England; University of Bristol; University Hospitals Bristol National Health Service (NHS) Trust, Bristol, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland. pmerkel@upenn.edu.
⁴ A.G. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Associate Professor of Rheumatology, Fatih Sultan Mehmet Training and Research Hospital; T.A. Kermani, MD, MS, Assistant Professor of Medicine, Division of Rheumatology, University of California at Los Angeles; S.Z. Aydin, Associate Professor in Rheumatology, Division of Rheumatology, University of Ottawa; P.F. Cronholm, MD, MSCE, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; T. Davis, Department of Family Medicine and Community Health, University of Pennsylvania; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University, Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; N. Milman, MD, Assistant Professor, Division of Rheumatology, University of Ottawa, and Division of Rheumatology, The Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant in Rheumatology, University Hospitals Bristol NHS Trust; G. Tomasson, MD, PhD, Assistant Professor of Epidemiology, Department of Public Health Sciences, University of Iceland; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University, School of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania. pmerkel@upenn.edu.

PMID: 28864646
PMCID: PMC5712274
DOI: 10.3899/jrheum.161467

Abstract

Objective: Among the challenges in conducting clinical trials in large-vessel vasculitis (LVV), including both giant cell arteritis (GCA) and Takayasu arteritis (TA), is the lack of standardized and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group initiated an international effort to develop and validate data-driven outcome tools for clinical investigation in LVV.

Methods: An international Delphi exercise was completed to gather opinions from clinical experts on LVV-related domains considered important to measure in trials. Patient interviews and focus groups were completed to identify outcomes of importance to patients. The results of these activities were presented and discussed in a "Virtual Special Interest Group" using telephone- and Internet-based conferences, discussions through electronic mail, and an in-person session at the 2016 OMERACT meeting. A preliminary core set of domains common for all forms of LVV with disease-specific elements was proposed.

Results: The majority of experts agree with using common outcome measures for GCA and TA, with the option of supplementation with disease-specific items. Following interviews and focus groups, pain, fatigue, and emotional effect emerged as health-related quality of life domains important to patients. Current disease assessment tools, including the Birmingham Vasculitis Activity Score, were found to be inadequate to assess disease activity in GCA and standardized assessment of imaging tests were felt crucial to study LVV, especially TA.

Conclusion: Initial data from a clinician Delphi exercise and structured patient interviews have provided themes toward an OMERACT-endorsed core set of domains and outcome measures.

Keywords: GIANT CELL ARTERITIS; OUTCOME ASSESSMENT; TAKAYASU ARTERITIS; VASCULITIS.

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Figures

**Figure 1**
A draft core set (domains requiring some representation by a outcome measures in all trials) and additional preferred domains i) common to both giant cell arteritis (GCA) and Takayasu’s arteritis (TAK), and ii) separate disease-specific domains. The suggested core domains fall under the mandatory core areas of OMERACT filter 2.0: *Death, ‡life impact, and †pathophysiologic manifestations.

See this image and copyright information in PMC

References

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Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016

Affiliations

Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016

Authors

Affiliations

Abstract

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References

MeSH terms

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Full Text Sources

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Medical