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Recommendation
2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis
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  1. Lisa Ehlers1,
  2. Johan Askling2,
  3. Hans WJ Bijlsma3,
  4. Maria Cinta Cid4,
  5. Maurizio Cutolo5,
  6. Bhaskar Dasgupta6,
  7. Christian Dejaco7,8,
  8. William G Dixon9,
  9. Nils Feltelius10,11,
  10. Axel Finckh12,
  11. Kate Gilbert13,
  12. Sarah Louise Mackie14,
  13. Alfred Mahr15,
  14. Eric L Matteson16,
  15. Lorna Neill17,
  16. Carlo Salvarani18,
  17. Wolfgang A Schmidt19,
  18. Anja Strangfeld20,
  19. Ronald F van Vollenhoven21,
  20. Frank Buttgereit1
  1. 1 Department of Rheumatology and Clinical Immunology, Charité University Medicine Berlin, Berlin, Germany
  2. 2 Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden
  3. 3 Rheumatology, UMC Utrecht, Utrecht, Netherlands
  4. 4 Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
  5. 5 Department Internal Medicine University of Genova, Research Laboratory and Academic Clinical Unit of Rheumatology, Viale Benedetto, Italy
  6. 6 Rheumatology, Southend Hospital NHS Trust, Westcliff-on-Sea, UK
  7. 7 Rheumatology, Medical University Graz, Graz, Austria
  8. 8 Rheumatology, Hospital Of Bruneck, Bruneck, Italy
  9. 9 Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, UK
  10. 10 Medical Products Agency, Uppsala, Sweden
  11. 11 Cross-Committee Task Force on Registries at the European Medicines Agency, London, UK
  12. 12 Division of Rheumatology, University of Geneva, Geneva, Switzerland
  13. 13 PMRGCAuk, London, UK
  14. 14 UK and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  15. 15 Department of Internal Medicine, Hospital Saint-Louis, University Paris Diderot, Paris, France
  16. 16 Division of Rheumatology and Department of Health Sciences Research, Mayo Clinic, Rochester, New York, USA
  17. 17 Patient Charity Polymyalgia Rheumatica and Giant Cell Arteritis Scotland, Dundee, UK
  18. 18 Division of Rheumatology, Azienda Ospedaliera IRCCS di Reggio Emilia and University of Modena and Reggio Emilia, Modena, Italy
  19. 19 Rheumatology, Medical Centre for Rheumatology Berlin Buch, Berlin, Germany
  20. 20 Forschungsbereich Epidemiologie, Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany
  21. 21 Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands
  1. Correspondence to Lisa Ehlers, Department of Rheumatology and Clinical Immunology, Charité University Medicine Berlin, Berlin 10117, Germany; lisa.ehlers{at}charite.de

Abstract

Giant cell arteritis (GCA) represents the most common form of primary systemic vasculitis and is frequently associated with comorbidities related to the disease itself or induced by the treatment. Systematically collected data on disease course, treatment and outcomes of GCA remain scarce. The aim of this EULAR Task Force was to identify a core set of items which can easily be collected by experienced clinicians, in order to facilitate collaborative research into the course and outcomes of GCA. A multidisciplinary EULAR task force group of 20 experts including rheumatologists, internists, epidemiologists and patient representatives was assembled. During a 1-day meeting, breakout groups discussed items from a previously compiled collection of parameters describing GCA status and disease course. Feedback from breakout groups was further discussed. Final consensus was achieved by means of several rounds of email discussions after the meeting. A three-round Delphi survey was conducted to determine a core set of parameters including the level of agreement. 117 parameters were regarded as relevant. Potential items were subdivided into the following categories: General, demographics, GCA-related signs and symptoms, other medical conditions and treatment. Possible instruments and assessment intervals were proposed for documentation of each item. To facilitate implementation of the recommendations in clinical care and clinical research, a minimum core set of 50 parameters was agreed. This proposed core set intends to ensure that relevant items from different GCA registries and databases can be compared for the dual purposes of facilitating clinical research and improving clinical care.

  • Adverse Events, Antirheumatic Agents
  • therapeutic use, Biomedical Research
  • methods, Giant Cell Arteritis, Glucocorticoids, Polymyalgia Rheumatica, Registries, Rheumatic Disease and Risk, Treatment Outcome

https://doi.org/10.1136/annrheumdis-2018-214755

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    Footnotes

    • Handling editor Josef S Smolen

    • Contributors All listed authors meet the Uniform Requirements for Manuscripts Submitted to Biomedical Journals criteria for authorship.

    • Funding This study was funded by European League Against Rheumatism (http://dx.doi.org/10.13039/501100008741).

    • Disclaimer The views in this paper are those of the authors and not necessarily representative of the MPA nor the European Medicines Agency.

    • Competing interests JA has or has had research agreements with Abbvie, BMS, MSD, Pfizer, Roche, Astra-Zeneca, Eli Lilly, Samsung Bioepis and UCB, mainly in the context of safety monitoring of biologics via ARTIS. Karolinska Institutet has received remuneration for JA participating in advisory boards arranged by Pfizer and Eli Lilly. HWJB reported serving as coordinating investigator (Roche and SUN) in GCA and GC trials and consultant and speaker for Roche. MCC reported receiving consultation/lecturing fees from Roche, GSK, Novartis, Boehringer-Ingelheim, Vifor and Abbvie and research funding from Kiniksa. MC reported serving as coordinating investigator (Mundipharma, Horizon) and consultant (Mundipharma, Horizon) in PMR trials. BD reported clinical trials design advisory board consultancies (Roche, Servier, GSK, Mundipharma, Pfizer, Merck, Sobi) and unrestricted grant support from Napp and Roche and speakers honoraria from UCB and Merck. CD reported receiving consultancy fees and honoraria from MSD, Pfizer, UCB, AbbVie, Roche, Novartis, Lilly, Celgene, Merck, Sandoz, clinical trials design advisory board consultancies from GSK and an unrestricted grant support from Pfizer and MSD. WGD reported that the University of Manchester has received remuneration for WGD providing consultancy to Bayer. NF is an employee of the Swedish Medical Products Agency (MPA). AF received speaker honoraria or consultancies within the past 5 years from AbbVie, AB2BIO, BMS, Eli-Lilly, MSD, Pfizer, Roche, not related to the submitted work. KG has received consultancy fees from PMRGCAuk re facilitation of patient engagement with medical research in PMR and GCA. SLM has been an investigator for GCA trials (Roche, GSK), has had medical advisory group consultancies (Roche, Sanofi, Chugai) and is a Patron of the charities PMRGCAuk and PMR and GCA North East. AM reported receiving consultancy fees and honoraria from Roche-Chugai. EM reported serving as coordinating investigator (Novartis) and consultant (Glaxo-Smith-Kline) in PMR trials, consultant (Glaxo-Smith-Kline, Endocyte) and as site investigator in GCA trials (Bristol Meyer Squibb, Hoffman-La Roche, Genentech, Glaxo-Smith-Kline) and editor, contributor for PMR/GCA (UpToDate, Paradigm). CS reported serving as coordinating investigator (Roche) and consultant (Roche) in GCA trials. WAS reported receiving consultancy fees, honoraria and a grant support from Roche, consultancy fees and honoraria from GlaxoSmithKline and consultancy fees from Sanofi. He was principle investigator in a GCA trial (GlaxoSmithKline). AS received speaker honoraria within the past 5 years from AbbVie, BMS, Lilly, MSD, Pfizer, Roche, Sanofi-Aventis and UCB outside the submitted work. RFvV reported receiving research support and grants from AbbVie, BMS, GSK, Pfizer and UCB. He served as consultant for AbbVie, AstraZeneca, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche and UCB. FB reported receiving consultancy fees, honoraria and travel expenses from Horizon Pharma (formerly Nitec Pharma), Mundipharma Int. Ltd, Roche and Galapagos and grant support from Horizon Pharma. He serves as co-principal investigator and site investigator in a Mundipharma sponsored trial in PMR investigating the effects of MR prednisone.

    • Patient consent for publication Not required.

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