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The provisional OMERACT ultrasonography score for giant cell arteritis
  1. Christian Dejaco1,2,
  2. Cristina Ponte3,4,
  3. Sara Monti5,6,
  4. Davide Rozza7,
  5. Carlo Alberto Scirè8,
  6. Lene Terslev9,10,
  7. George A W Bruyn11,
  8. Dennis Boumans12,
  9. Wolfgang Hartung13,
  10. Alojzija Hočevar14,15,
  11. Marcin Milchert16,
  12. Uffe Møller Døhn17,
  13. Chetan B Mukhtyar18,
  14. Markus Aschwanden19,
  15. Philipp Bosch1,
  16. Dario Camellino20,
  17. Stavros Chrysidis21,
  18. Giovanni Ciancio22,
  19. Maria Antonietta D’Agostino23,24,
  20. Thomas Daikeler25,
  21. Bhaskar Dasgupta26,
  22. Eugenio De Miguel27,
  23. Andreas P Diamantopoulos28,
  24. Christina Duftner29,
  25. Ana Agueda30,
  26. Ulrich Fredberg31,32,
  27. Petra Hanova33,34,
  28. Ib Tønder Hansen35,
  29. Ellen-Margrethe Hauge36,37,
  30. Annamaria Iagnocco38,
  31. Nevsun Inanc39,
  32. Aaron Juche40,
  33. Rositsa Karalilova41,
  34. Toshio Kawamoto42,43,
  35. Kresten Krarup Keller36,44,
  36. Helen Isobel Keen45,
  37. Tanaz A Kermani46,
  38. Minna J. Kohler47,
  39. Matthew Koster47,
  40. Raashid Ahmed Luqmani48,
  41. Pierluigi Macchioni49,
  42. Sarah Louise Mackie50,
  43. Esperanza Naredo51,
  44. Berit Dalsgaard Nielsen36,52,
  45. Michihiro Ogasawara43,
  46. Carlos Pineda53,
  47. Valentin Sebastian Schäfer54,
  48. Luca Seitz55,
  49. Alessandro Tomelleri56,
  50. Karina D Torralba57,
  51. Kornelis S M van der Geest58,
  52. Kenneth J Warrington47,
  53. Wolfgang A Schmidt59
  1. 1Department of Rheumatology, Medical University of Graz, Graz, Steiermark, Austria
  2. 2Department of Rheumatology, Brunico Hospital, Brunico, Trentino-Alto Adige, Italy
  3. 3Department of Rheumatology, Centro Hospitalar Universitário Lisboa Norte, Centro Académico de Medicina de Lisboa, Lisbon, Portugal
  4. 4Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisbon, Portugal
  5. 5Department of Internal Medicine and Therapeutics, Università di Pavia, Pavia, Italy
  6. 6Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  7. 7Italian Society for Rheumatology, Milan, Italy
  8. 8Epidemiology Unit, Italian Society for Rheumatology (SIR), Milan, Italy
  9. 9Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark
  10. 10Clinical Medicine, Copenhagen University, Copenhagen, Denmark
  11. 11Reumakliniek Lelystad, Lelystad, Netherlands
  12. 12Rheumatology and Clinical Immunology, Hospital Group Twente, Almelo, The Netherlands
  13. 13Rheumatology, Asklepios Medical Center, Bad Abbach, Germany
  14. 14Department of Rheumatology, Universitiy Medical Centre Ljubljana, Ljubljana, Slovenia
  15. 15Medical Faculty, University of Ljubljana, Ljubljana, Slovenia
  16. 16Department of Rheumatology, Internal Medicine, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland
  17. 17Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark
  18. 18Vasculitis Service, Rheumatology Department, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK
  19. 19Angiology, University Hospital Basel, Basel, Switzerland
  20. 20Division of Rheumatology, Department of Medical Specialties, Azienda Sanitaria Locale 3 Genovese, Arenzano, Genoa, Italy
  21. 21Rheumatology, Sydvestjysk Sygehus Esbjerg, Esbjerg, Denmark
  22. 22Department of Medical Sciences, University of Ferrara, Ferrara, Italy
  23. 23Rheumatology Department, Fondazione Policlinico Universitario A Gemelli, Rome, Italy
  24. 24INSERM, Paris, France
  25. 25Clinic for Rheumatology, University Hospital Basel, Basel, Switzerland
  26. 26Mid and South Essex University Hospitals NHS Foundation Trust, Southend University Hospital, Westcliff-on-Sea, UK
  27. 27Hospital Universitario La Paz, Madrid, Spain
  28. 28Section of Rheumatology, Division of Internal Medicine, Akershus University Hospital, Lorenskog, Norway
  29. 29Department of Internal Medicine, Clinical Division of Internal Medicine II, Medical University Innsbruck, Innsbruck, Austria
  30. 30Centro Hospitalar do Baixo Vouga E.P.E, Aveiro, Portugal
  31. 31Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark
  32. 32Rheumatology, Odense University Hospital, Odense, Denmark
  33. 33Rheumatology, Institute of Rheumatology, Prague, Czech Republic
  34. 34Rheumatology, Hána CB spol. s r.o, Ceske Budejovice, Czech Republic
  35. 35Department of Rheumatology, Aarhus Copenhagen Hospital, Aarhus, Denmark
  36. 36Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  37. 37Department Clinical Medicine, Aarhus University, Aarhus, Denmark
  38. 38Academic Rheumatology Center, Dipartimento Scienze Cliniche e Biologiche, Università degli Studi di Torino, Turin, Italy
  39. 39Rheumatology, Marmara University School of Medicine, Istanbul, Turkey
  40. 40Department of Rheumatology, Immanuel Hospital, Berlin, Germany
  41. 41Clinic of Rheumatology, Medical University Plovdiv, Plovdiv, Bulgaria
  42. 42Immunology, Juntendo University School of Medicine, Tokyo, Japan
  43. 43Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan
  44. 44Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  45. 45Medicine and Pharmacology, UWA, Murdoch, Perth, Australia
  46. 46Rheumatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA
  47. 47Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  48. 48Nuffield Department of Orthopaedicx, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK
  49. 49Arcispedale Santa Maria Nuova, Reggio Emilia, Italy
  50. 50University of Leeds, Leeds, UK
  51. 51Department of Rheumatology and Bone and Joint Research Unit, Hospital Universitario Fundación Jiménez Díaz, IIS Fundación Jiménez Díaz, Madrid, Spain
  52. 52Department of Medicine, Regional Hospital Horsens, Horsens, Denmark
  53. 53Division of Rheumatology, Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico
  54. 54Clinic of Internal Medicine III, University Hospital Bonn, Bonn, Germany
  55. 55Rheumatology and Immunology, Inselspital University Hospital Bern, Bern, Switzerland
  56. 56Unit of Immunology, Rheumatology, Allergy and Rare Diseases, San Raffaele Scientific Institute, Milan, Italy
  57. 57Division of Rheumatology, Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California, USA
  58. 58Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  59. 59Rheumatology, Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch, Berlin, Germany
  1. Correspondence to Dr Christian Dejaco, Department of Rheumatology, Medical University of Graz, Graz, Steiermark, Austria; christian.dejaco{at}gmx.net

Abstract

Objectives To develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.

Methods The OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima–media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.

Results Agreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72–0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from −1.19 to −2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corrcoeff 0.37–0.48).

Conclusion We developed a provisional OGUS for potential use in clinical trials.

  • giant cell arteritis
  • ultrasonography
  • outcome assessment, health care
  • systemic vasculitis

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • Handling editor Josef S Smolen

  • Twitter @cristinadbponte, @rthritis, @cmukhtyar, @adiamanteas, @Sarah_L_Mackie, @tomelleri_a

  • CD and CP contributed equally.

  • Contributors All authors were involved in data acquisition. CDe wrote the first version of the manuscript. All authors reviewed it and made extensive comments and appropriate changes to it. All authors approved the final version of the manuscript. CDe accepts full responsibility for the work, had access to the data, and controlled the decision to publish.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests CDe has received grant support from AbbVie and consulting/speaker’s fees from Abbvie, Eli Lilly, Janssen, Galapagos, Novartis, Pfizer, Sparrow, Roche and Sanofi, all unrelated to this manuscript. CPo is or has been the principal investigator of studies by AbbVie, Sanofi and Novartis and has received consulting/speaker’s fees from Vifor, AstraZeneca, GlaxoSmithKline and Roche, all unrelated to this manuscript. LT received speakers fee from Roche, Novartis, Janssen, Pfizer, UCB and GE. PB received grant support from Pfizer and speaker’s fees from Janssen. CDu has received consultancy or speaker fees and travel expenses from Abbvie, AOP Orphan, Astra-Zeneca, Bristol-Myers-Squibb, Eli-Lilly, Janssen, Galapagos, Merck-Sharp-Dohme, Novartis, Pfizer, Roche, Sandoz, UCB, Vifor and research support from Eli-Lilly, Pfizer, UCB, all unrelated to this manuscript. E-MH has received fees for speaking and/or consulting from Novartis, AbbVie, Sanofi, Sobi; research funding to Aarhus University Hospital from Novo Nordic Foundation, Danish Rheumatism Association, Danish Regions Medicine Grants, Roche, Novartis, AbbVie; travel expenses from Pfizer, Sobi, AbbVie. E-MH has been the principal investigator of studies by SynACT Pharma and involved as site principal investigator in trials by AbbVie, Novartis, Novo and Sanofi, all unrelated to this manuscript. AI received honoraria, advisory boards, speakers’ bureau, educational grants and research support from AbbVie, Alfasigma, Amgen, Biogen, BMS, Celgene, Celltrion, Eli-Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, Sanofi Genzyme, SOBI and UCB. KDT is or was a research investigator of studies for Novartis, Astra Zeneca, Glaxo SmithKline, Amgen; has received consulting fees from Aurinia, Novartis and Astra Zeneca; and is a contracted researcher of Bioclinica. KSMvdG received a speaker fee from Roche. WAS is or has been the principal investigator of studies by Abbvie, Amgen, GlaxoSmithKline, Novartis, Roche, Sanofi and has received consulting/speaker’s fees from Abbvie, Amgen, Bristol-Myers Squibb, Chugai, GlaxoSmithKline, Johnson & Johnson, Medac, Novartis, Roche and Sanofi, all unrelated to this manuscript. The other authors declare no conflicts of interest.

  • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.