Examples of application of standardisation in clinical trials of vasculitis and SLE (this is not an exhaustive list).
| Recommendations | Vasculitis | SLE | ||
|---|---|---|---|---|
| ACE, angiotensin-converting enzyme; ANCA, antineutrophil cytoplasmic antibody; ARA, American Rheumatism Association; BILAG Index, British Isles Lupus Assessment Group Index; BVAS, Birmingham Vasculitis Activity Score; BVAS/WG, Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis; CRP, C reactive protein; DEI, Disease Extent Index; dsDNA, double-stranded DNA; IV, intravenous; QALY, quality-adjusted life year; SF36, Short Form 36; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SLICC/ACR, Systemic Lupus International Collaborating Clinics/American College Of Rheumatology; VDI, Vasculitis Damage Index. | ||||
| *We recommend that these investigations are performed routinely as part of clinical protocol but cannot be used on their own to guide therapy unless the trial design is aimed at testing the validity of these markers. | ||||
| Classification: apply standard classification criteria | Chapel Hill consensus definitions or ACR classification criteria for vasculitis8,9 | ARA classification criteria for SLE10 | ||
| Staging/severity/eligibility: apply standardised structured clinical evaluation | BVAS, BVAS/WG, DEI, VDI11–14 | BILAG Index, SLEDAI, SLICC/ACR Index15–17 | ||
| Outcome measures: clinical evaluation of disease activity and damage, quality of life and economic impact | BVAS, BVAS/WG, DEI, VDI, SF36, QALY assessment11–14,18 | BILAG Index, SLEDAI, SLICC/ACR Index, SF36, QALY assessment15–18 | ||
| Biomarkers*: serological assessment of disease | ANCA, CRP, renal function | dsDNA, complement, renal function | ||
| Relapse/remission/refractory disease definitions: based on standardised clinical evaluation and qualified by use of ongoing therapy | BVAS, BVAS/WG, DEI12–14 | BILAG Index, SLEDAI15,16 | ||
| Immunosuppressive therapy: standardise | Standard or biological therapy, placebo where indicated | Standard or biological therapy, placebo where indicated | ||
| Steroid therapy: standardise | Dose and method of administration | Dose and method of administration | ||
| Concomitant therapy: standardise | Trimethoprim/sulfamethoxazole | ACE inhibitors | ||