2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis Aim Rationale Giant cell arteritis (GCA): most common primary systemic vasculitis in western countries Lifetime risk: 1.0% for women and 0.5% for men over the age of 50 years Severe potential complications: sight loss, stroke, cranial nerve palsy, large-vessel aneurysms, vascular stenoses New therapeutic approaches Recent approval of tocilizumab for GCA treatment Novel therapies currently investigated: inhibition of IL-1beta, T cell co-stimulation, Janus kinases 1/2 Unanswered questions regarding disease outcome, co-morbidities, and treatment course Data lag behind what is available for other rheumatic diseases like rheumatoid arthritis Establishing national and supranational registries would enable the systematic collection of important data on demographics and diagnostic and therapeutic approaches and thereby improve clinical care 2 01/25/2020 Aim Objective Develop a minimum core set of parameters collected for newly and previously diagnosed patients with GCA
Ensure that data from different registries and databases are standardised Facilitate collaborative analyses Standardised core set to be used a) in national and supra-national registries b) for post-marketing surveillance purposes c) in creating an international cohort of GCA patients to support initiatives of individual researchers Ultimately increase the quality of GCA data collection and care in clinical practice and research 3 01/25/2020 Methodological approach Task force members Lisa Ehlers1 Johan Askling2 Johannes W. J. Bijlsma3 Maria C. Cid4 Maurizio Cutolo5 Bhaskar Dasgupta6 Christian Dejaco7 William G. Dixon8 Nils Feltelius9 Axel Finckh10 Kate Gilbert11 Sarah Mackie12 Alfred Mahr13 Eric L. Matteson14 Lorna Neill15 Carlo Salvarani16,17 Wolfgang A. Schmidt18 Anja Strangfeld19 Ronald van Vollenhoven20 Frank Buttgereit1 Department of Rheumatology and Clinical Immunology, Charit University Medicine, Berlin, Germany; 2 Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden; 3 Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands; 4 Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut dInvestigacions Biomdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain; 5 Research Laboratory & Academic Division of Clinical Rheumatology, Dept. of Internal Medicine, IRCCS Polyclinic San Martino, University of Genoa, Italy; 6 Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, Essex, UK; 7
Department of Rheumatology, Medical University Graz, Graz, Austria and Rheumatology Service, Hospital of Bruneck, South Tyrol Health Trust, Italy; 8 Arthritis Research UK Centre for Epidemiology, School of Biological Sciences, University of Manchester, Manchester, UK; 9 Medical Products Agency, Uppsala, Sweden, and Cross-Committee Task Force on Registries at the European Medicines Agency, London, UK; 10 Division of Rheumatology, Geneva University Hospital, Geneva, Switzerland; 11 Patient Representative from PMRGCAuk; 12 Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; 13 Department of Internal Medicine, Hospital Saint-Louis, University Paris Diderot, Paris, France; 14 Division of Rheumatology and Department of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, USA; 15 Patient Representative from PMR-GCA Scotland; 16 Division of Rheumatology, Azienda USLIstituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia, Reggio Emilia, Italy; 17 Universita di Modena e Reggio Emilia, Modena, Italy; 18 Immanuel Krankenhaus Berlin: Medical Center for Rheumatology Berlin-Buch, Berlin, Germany; 19 Epidemiology Unit, German rheumatism research Centre, DRFZ Berlin, Berlin, Germany; 20 Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands 1 4 01/25/2020 Methodological approach Task force members registries patient partners expertise giant cell arteritis rheumatologists 16 countries glucocorticoid treatment internal medicine specialists epidemiologists EMA representative patient representatives rheumatology fellow 5 01/25/2020 Methodological approach Consensus process 117 items Task force meeting
Breakout group discussions Refinement of candidate items Development of a framework for the core set of items Parameter collection and allocation to domains 6 50 items Item refinement and prioritisation Item compilation Literature review 66 items Consensus and level of agreement Three-round Delphi survey Email discussions 01/25/2020 Methodological approach Consensus process General Examiner, ethnicity, heart rate General GCA-related Menopause, number Scalp necrosis, tongue claudication, of pregnancies/births dry cough, limb claudication, peripheral Night sweats GCA-related arthritis/bursitis, distal extremity swelling Pain related to GCA, Laboratory with pitting edema, health-related function, healthROM proximal muscles,
Leukocytes, thrombocytes, related quality of life, fatigue malaise, hearing loss erythrocytes, fibrinogen Comorbidities & adverse events Comorbidities & adverse Large vessel involvement Allergic drug reaction, complication during Core items Core items events Bruits, PET activity diagnostic/therapeutic procedure, hemiplegia, DVT, Alcohol/drug abuse, see below see below Comorbidities & adverse Items excluded during final votingevents procedure PAD, dyslipidaemia, Cushing, gastric/duodenal chronic bacterial infections Congestive heart failure, ulcers, diverticulitis, chronic liver disease, infection (HBV, Blood glucose, sodium, HCV, HIV, VZV), gastrointestinal perforation, potassium Depression, insomnia, mood changes, latent tuberculosis Medication dementia, cataract, glaucoma, COPD, asthma, ILD, Bisphosphonates, PPI, CKD ACE inhibitors/ARB, Medication statins, anticoagulants Currentbut GC tapering, cumulative Excluded items considered important, not obligatory GC dosage
Excluded items considered relevant for the creation of a GCA registry 7 01/25/2020 Results Overarching principles Core set of parameters informed by the trade-off between what is scientifically desirable and what is clinically feasible Comprehensive dataset that can be collected in routine clinical care Items facilitate the assessment of the outcome and prognosis in subgroups of patients with GCA effectiveness of instruments to diagnose and monitor GCA effectiveness and safety of different therapeutic approaches Ensure comparability of data collected in different registries Parameters can individually be added to meet the specific needs of the respective registry or database 8 01/25/2020 Results Minimum core set of parameters to be collected in giant cell arteritis registries and databases Item General patient identifier visit date Demographics age sex weight2 height4
smoking2 GCA diagnosis date of GCA diagnosis onset of symptoms 9 Instrument Baseline date x x date of birth (convert to year of birth for anonymization) male/female kg (measure) cm (measure) no/past/current, pack-years: ______ ICD-10 code (M31.5 / M31.6) date (medically reported diagnosis) date (interview) x x x x x x x x Follow-up x x x x x 01/25/2020 Results Minimum core set of parameters to be collected in giant cell arteritis registries and databases Item GCA-related signs & symptoms cranial2 ocular involvement ocular symptoms: diplopia, blurring, transient visual loss (amaurosis fugax)
permanent partial visual loss / field defect / blindness / RAPD headache scalp tenderness jaw claudication cranial artery abnormality cord-like thickening / nodularity / tenderness / reduced pulse and/or pulselessness sonographic evidence of arteritis3 histological arteritis constitutional: fever/pyrexia symptoms2 laboratory2 ESR CRP haemoglobin PMR2 (inflammatory bilateral shoulder/hip pain and stiffness) 10 Instrument Baseline Follow-up y/n (interview) x x y/n (examination), if yes: AION/CRAO/other x x y/n (interview) y/n (interview) y/n (interview) x x x x x x y/n (examination) x x
not assessed/y/n (ultrasound) not assessed/y/n, anatomical region, date of biopsy y/n (interview) x x x x mm/h (1st h) e.g. in mg/dL e.g. in g/dL y/n (interview/examination) x x x x x x x x x 01/25/2020 Results Minimum core set of parameters to be collected in giant cell arteritis registries and databases Item GCA-related signs & symptoms large vessel involvement2 peripheral pulses (carotid, axillary, brachial, radial, femoral): pulsation blood pressure dilatation/aneurysm wall thickening3 stenosis3 disease activity2 patients global assessment of disease activity evaluators global assessment of disease activity 11 Instrument Baseline Follow-up y/n (examination)
x x mmHg (left & right arm) not assessed /y/n5, vessels involved: ___________ not assessed /y/n5, vessels involved: ___________ not assessed /y/n5, vessels involved: ___________ x x x x x x x x NRS scale capturing global assessment of disease activity attributable to GCA and today NRS scale capturing global assessment of disease activity attributable to GCA and today x x x x 01/25/2020 Results Minimum core set of parameters to be collected in giant cell arteritis registries and databases Item Other medical events or conditions7 death1 cardiovascular TIA1 stroke1 ischaemic haemorrhagic myocardial infarction1 arterial hypertension requiring treatment2 endocrine diabetes mellitus2 osteoporosis8 infection1 active tuberculosis
serious infection requiring hospitalisation malignancy1 haematopoietic solid tumour skin other serious event1 12 Instrument Baseline if yes: cause:______________ Follow-up x date5, evidence of vasculitic change of supplying arteries x x date5, evidence of vasculitic change of supplying arteries date5, evidence of vasculitic change of supplying arteries Date yes6/no x x x x x x x x yes6/no yes6/no radiological evidence of a fragility fracture BMD: ________ (date) (DXA or qCT not older than 12 months) x x x x yes6/no date, type: ___________ x
x x x date, date, date, date, x x x x x x x x type: ___________ type: ___________ type: ___________ specify:_________ 01/25/2020 Results Minimum core set of parameters to be collected in giant cell arteritis registries and databases Item Treatment2 glucocorticoids current use recent use immunosuppressants/-modulators conventional synthetic DMARDs biological DMARDs targeted synthetic DMARDs antiplatelet agents Instrument Baseline Follow-up mg per day in prednisone equivalent, route of administration continuous (> 3 months) intake: y/n (interview) x x
x x current medication9 historical treatment10 current medication9 historical treatment10 current medication9 historical treatment10 current medication9 historical APT10 x x x x x x x x x x x x report with date if it occurs record every 3-6 months; clinically relevant changes/events need to be recorded whenever they occur (e.g. new medication, imaging finding, osteoporotic fracture) 3 record every 6-12 months; clinically relevant changes/events need to be recorded whenever they occur (e.g. new medication, imaging finding, osteoporotic fracture) 4 record annually; clinically relevant changes/events need to be recorded whenever they occur (e.g. new medication, imaging finding, osteoporotic fracture) 5 record whether the item was assessed by CT / PET-CT / US / MR 6 if yes, record: date of first diagnosis, indicate if worsened since the last visit 7 unless otherwise indicated, items are to be assessed with the help of information reliably provided during the patient interview or clinical records if available 8 perform testing if indicated 9 collect the following information: drug (generic name), start date, dose, route of administration; if applicable: stop date, stop reason (inefficacy / AE / both / other) 10 only applicable for patients with existing disease at baseline: list previous drugs (generic name) 1 2 13 01/25/2020 Results Level of agreement
Item General patient identifier visit date Demographics age sex weight height smoking GCA diagnosis date of GCA diagnosis onset of symptoms GCA-related signs & symptoms cranial ocular involvement ocular symptoms: diplopia, blurring, transient visual loss (amaurosis fugax) permanent partial visual loss / field defect / blindness / RAPD headache scalp tenderness jaw claudication cranial artery abnormality cord-like thickening / nodularity / tenderness / reduced pulse and/or pulselessness sonographic evidence of arteritis histological arteritis constitutional: fever/pyrexia symptoms laboratory ESR CRP haemoglobin PMR (inflammatory bilateral shoulder/hip pain and stiffness) large vessel involvement peripheral pulses (carotid, axillary, brachial, radial, femoral): pulsation blood pressure dilatation/aneurysm wall thickening stenosis disease activity patients global assessment of disease activity evaluators global assessment of disease activity 14 LoA* 9,85 0,49 [8;10] (100%) 9,90 0,31 [9;10] (100%) 9,95 0,23 [9;10] (95%) 9,95 0,22 [9;10] (100%) 8,65 1,42 [5;10] (95%) 8,50 1,36 [5;10] (95%) 9,25 0,91 [8;10] (100%) 9,60 0,75 [8;10] (100%)
antiplatelet agents LoA* 9,70 0,73 [8;10] (100%) 8,70 1,84 [3;10] (90%) 8,84 2,14 [2;10] (85%) 8,10 2,25 [1;10] (85%) 8,42 2,12 [1;10] (90%) 8,45 2,35 [0;10] (90%) 8,70 1,69 [4;10] (90%) 8,60 1,43 [5;10] (90%) 8,00 2,03 [4;10] (75%) 9,00 1,12 [7;10] (100%) 9,05 1,05 [7;10] (100%) 9,05 1,05 [7;10] (100%) 7,95 1,85 [4;10] (85%) 8,15 2,01 [3;10] (75%) 9,80 0,52 [8;10] (100%) 9,75 0,55 [8;10] (100%) 9,75 0,55 [8;10] (100%) 9,90 0,31 [9;10] (100%) 9,80 0,41 [9;10] (100%) 9,15 0,93 [7;10] (100%) * Level of agreement was based on an anonymized survey with a 0-10 scale by all members of the task force (data are mean standard deviation [minimum; maximum rating] and in brackets the percentage of task force members with an agreement 7)) 01/25/2020 Summary 2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis This EULAR task force proposes a minimum core set of 50 parameters, subdivided into the following categories: General, Demographics, GCA-related signs and symptoms, Other medical conditions, and Treatment. Each item achieved a level of agreement of at least 7 in a group of experts in the field of rheumatology and epidemiology supported by patient research partners. The dataset represents a compromise derived from high scientific interest conflicting with feasibility in clinical routine care. The implementation of this core set in existing and evolving GCA registries will ensure harmanised data exchange
and increase the quality of GCA data collection. The ultimate goal of these recommendations is to enhance collaboration and comparability and eventually improve GCA research and clinical care. 15 01/25/2020 Summary 2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis Recommendation A minimum of 50 items should be collected in giant cell arteritis registries and databases. These items represent parameters routinely collected in clinical practice. By implementing our recommendations practitioners and patients make a significant contribution to the improvement of research and clinical care in the field of giant cell arteritis. Standardised data collection ensures comparibility and thereby enlarges the amount of information available for future research. The proposed set of items can be extended depending on the intended investigation. 16 01/25/2020 Acknowledgements Funding We thank EULAR for financially supporting the activities of this task force. The icons used in this slide deck were made by Freepik and Becris from www.flaticon.com. 17 01/25/2020
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