Table 2.

Summary results of 3-stage Delphi consensus exercise addressing minimum standards for longitudinal study design for validation of biomarker reflecting damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Items lacking consensus are indicated in bold type (percentage of respondents voting in support of the item is indicated in parentheses).

Inclusion CriteriaACR (48%)17, EULAR early referral criteria (26%)18, ANTI-CCP arthritis (25%)CASPAR19Modified New York (67%)20
Pre-radiographic axial (24%)21
Treatment strategyAll treatments (68%)All treatmentsAll treatments
Selection of patient cohortConsecutive casesConsecutive cases (67%)Consecutive cases
Inception cohort (33%)
Study duration2 yrs4 yrs (69%)4 yrs
2 yrs (27%)
Frequency of assessmentEvery 3 moEvery 6 moEvery 6 mo
Analysis of radiographic endpointBlinded to timepointBlinded to timepointBlinded to timepoint
Allow steroidYesNot consideredNot considered
Rules for changes in treatmentBy predetermined DAS every 3 moNot consideredNot considered
Frequency of biomarker collectionQ6 mo and prior to new DMARD/anti-TNFQ6 mo and prior to new DMARD/anti-TNFQ6 mo and prior to new DMARD/anti-TNF
SymptomsPain, patient global, fatigue (50%), stiffness (51%)Pain, skin global, patient global, stiffness (61%), fatigue (40%)Pain, stiffness, patient global, fatigue (38%)
Physical functionPatient self-reported function, objective measures of function (47%)Patient self-reported functionPatient self-reported function, metrology
Psychosocial functionQuality of lifeQuality of lifeQuality of life
OtherWork status, work productivity (53%), participation (42%)Work status, work productivity (33%), participation (40%)Work status
Disease activityJoint inflammation, global disease activity (patient/physician), general labs (ESR, CRP), imaging/MRI (62%), imaging/US (31%)Joint inflammation, global disease activity, (patient/physician), clinical enthesitis, dactylitis, spinal, skin, general labs (ESR, CRP), nail (56%), extraarticular disease (67%)Joint inflammation, global disease activity (patient/physician), clinical enthesitis, metrology, general labs (ESR, CRP), extraarticular disease, imaging/MRI
Radiographic damage endpointModified SharpModified SharpmSASSS
  • ACR: American College of Rheumatology; EULAR: European League Against Rheumatism; CCP: cyclic citrullinated peptide; CASPAR: CASPAR Study Group Criteria; DAS: Disease Activity Score; DMARD: disease modifying antirheumatic drugs; TNF: tumor necrosis factor; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; MRI: magnetic resonance imaging; mSASSS: modified Stoke AS Spinal Score; US: ultrasonography.