Table 1

Minimum core set of parameters to be collected in giant cell arteritis registries and databases

ItemInstrumentBaselineFollow-upLoA*
General
 Patient identifierxx9,85±0,49(8;10)(100%)
 Visit dateDatexx9,90±0,31(9;10)(100%)
Demographics
 Age†Date of birthx9,95±0,23(9;10)(95%)
 SexMale/femalex9,95±0,22(9;10)(100%)
 Weightkg (measure)xx8,65±1,42(5;10)(95%)
 Heightcm (measure)xx8,50±1,36(5;10)(95%)
 SmokingNever/past/current, pack-yearsxx9,25±0,91(8;10)(100%)
 GCA diagnosisICD-10 code (M31.5/M31.6)x9,60±0,75(8;10)(100%)
 Date of GCA diagnosisDate (medically reported diagnosis)x9,60±0,82(8;10)(100%)
 Onset of symptomsDate (interview)x8,95±1,73(3;10)(95%)
GCA-related signs and symptoms
 Cranial
  Ocular involvement
   Ocular symptoms: diplopia, blurring, transient visual loss (amaurosis fugax)Interviewxx9.25±1.48 (4;10) (95%)
   Permanent partial visual loss/field defect/blindness/RAPD†Examinationxx9.20±1.36 (5;10)(95%)
  HeadacheInterviewxx9.05±1.88 (2;10)(95%)
  Scalp tendernessInterviewxx8.45±2.14 (1;10)(90%)
  Jaw claudication Interviewxx8.40±2.21 (1;10)(90%)
  Cranial artery abnormality
   Cord-like thickening/nodularity/tenderness/reduced pulse and/or pulselessnessExaminationxx8.35±2.56 (0;10) (85%)
   Sonographic evidence of arteritis†Ultrasoundxx8.30±2.64 (0;10) (80%)
   Histological arteritis†Biopsyx8.84±2.54 (0;10) (85%)
 Constitutional: fever/pyrexia symptoms†Interviewxx8.10±2.20 (3;10) (75%)
 Laboratory
  ESR mm/hour (first hour)xx9.10±1.29 (6;10) (95%)
  CRP eg, in mg/dLxx9.55±0.94 (7;10) (100%)
  Haemoglobin eg, in g/Lxx7.50±2.59 (0;10) (75%)
 PMR†Interview, examinationxx9.45±0.94 (7;10) (100%)
 Large vessel involvement
  Peripheral pulsesExaminationxx8.10±2.34 (2;10) (70%)
  Blood pressure mm Hg (left and right arm)xx7.90±2.15 (1;10) (80%)
  Dilatation/aneurysmUS/MR/CTxx7.79±3.05 (0;10) (75%)
  Inflammatory wall thickeningUS/MR/CTxx7.15±3.17 (0;10) (65%)
  StenosisUS/MR/CTxx7.50±3.00 (0;10) (75%)
 Disease activity
  Patient’s global assessment of disease activityNRSxx8.70±2.27 (1;10) (90%)
  Evaluator’s global assessment of disease activityNRSxx8.55±2.50 (0;10) (85%)
Other medical events or conditions
 DeathDate, causex9.70±0.73 (8;10) (100%)
 Cardiovascular
  TIADatexx8.70±1.84 (3;10) (90%)
  Stroke
   IschaemicDatexx8.84±2.14 (2;10) (85%)
   HaemorrhagicDatexx8.10±2.25 (1;10) (85%)
  Myocardial infarction Datexx8.42±2.12 (1;10) (90%)
  Arterial hypertensionInterview, medical reportxx8.45±2.35 (0;10) (90%)
 Endocrine
  Diabetes mellitusInterview, medical reportxx8.70±1.69 (4;10) (90%)
  OsteoporosisInterview, medical report, BMDxx8.60±1.43 (5;10) (90%)
 Infection
  Active tuberculosis Datexx8.00±2.03(4;10) (75%)
  Serious infectionDate, typexx9.00±1.12 (7;10) (100%)
 Malignancy
  Haematopoietic Date, typexx9.05±1.05 (7;10) (100%)
  Solid tumour Date, typexx9.05±1.05 (7;10) (100%)
  Skin Date, typexx7.95±1.85 (4;10) (85%)
 Other serious event†Date, specifyxx8.15±2.01 (3;10) (75%)
Treatment
 Glucocorticoids
  Current useDosexx9.80±0.52 (8;10) (100%)
  Recent useInterview, medical reportxx9.75±0.55 (8;10) (100%)
 Immunosuppressants/-modulators†
  Conventional synthetic DMARDs Current medicationxx9.75±0.55 (8;10) (100%)
Historical treatmentx
  Biological DMARDs Current medicationxx9.90±0.31 (9;10) (100%)
Historical treatmentx
  Targeted synthetic DMARDs Current medicationxx9.80±0.41 (9;10) (100%)
Historical treatmentx
 Antiplatelet agentsCurrent medicationxx9.15±0.93 (7;10) (100%)
Historical APTx
  • *LoA was based on an anonymised survey with a 0–10 scale by all members of the task force (data are mean±SD [minimum; maximum rating] and in brackets the percentage of task force members with an agreement ≥7).

  • †See online supplementary text for a more detailed item description and information on collection instruments and intervals.

  • AE, adverse event; APT, antiplatelet therapy; BMD, bone mineral density; CRP, C reactive protein; CT, computed tomography scan; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; GC, glucocorticoid; GCA, giant cell arteritis; HCP, healthcare professional; LoA, level of agreement; NRS, numeric rating scale; PMR, polymyalgia rheumatica; RAPD, relative afferent pupillary defect; TIA, transient ischaemic attack; US, ultrasound.