Rheumatology Advance Access published online on February 10, 2005
Rheumatology, doi:10.1093/rheumatology/keh565
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1 Department of Rheumatology, GKT School of Medicine, Weston Education Centre, Kings College, 10 Cutcombe Road, London SE5 9RS, UK; Department of Rheumatology, University Hospital Lewisham, Lewisham High Street, London SE13 6LH, UK
* To whom correspondence should be addressed. Objective. Trials of disease-modifying anti-rheumatic drugs (DMARDs) enrol active rheumatoid arthritis patients identified using standard criteria (three out of four of: Methods. We studied 504 patients in a cross-sectional study, 156 in a longitudinal study and 94 starting new DMARDs or biologics. Patients were classified as ‘trial active’ (met entry criteria), in remission or ‘intermediately active’ (between the two). We also evaluated the effect of amendments to criteria. Results. Cross-sectionally only 38% patients were ‘trial active’, but longitudinally 68% were ‘trial active’ at least once. Thus, many clinic patients do have disease activity below the level required for trial entry, but over time most reach eligibility levels. More (62%) of the cohort starting new treatment were ‘trial active’, suggesting that recruitment criteria relate to clinical decisions. Criteria omitting morning stiffness and a disease activity score (DAS28) Conclusions. Trial results can be generalized to routine practice because most clinic patients are ‘trial active’ when their therapy is changed and most become ‘trial active’ over time. As DAS-based criteria are simpler and relate directly to response measures, their use should be considered in future.
Received October 4, 2004
Accepted January 7, 2005
Original Papers
Are clinical trials in rheumatoid arthritis generalizable to routine practice? A re-evaluationof trial entry criteria
2 Department of Rheumatology, GKT School of Medicine, Weston Education Centre, Kings College, 10 Cutcombe Road, London SE5 9RS, UK
3 Department of Rheumatology, GKT School of Medicine, Weston Education Centre, Kings College, 10 Cutcombe Road, London SE5 9RS, UK; Department of Rheumatology, Kings College Hospital, Denmark Hill, London SE5 9RS, UK
G. H. Kingsley, E-mail: gabrielle.kingsley{at}kcl.ac.uk
Abstract 
6 tender joints, 6 swollen joints, ESR 28 mm/h, 45 min morning stiffness). Concern has been expressed about generalizability, as many patients in routine practice have less active disease. Furthermore, these criteria do not map onto standard disease activity and treatment response measures. We examined how many routine patients were sufficiently active to meet trial recruitment criteria and whether alternative definitions of active disease were more appropriate.5.4 replicated the classification given by current criteria.
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