REPORT

Clinical aspects

Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa?

T Pincus¹ and T Sokka^1,2

¹ Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
² Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland

Correspondence to:
Correspondence to:
Dr T Pincus
Professor of Medicine, Division of Rheumatology and Immunology, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA; t.pincus{at}vanderbilt.edu

The information used by rheumatologists when delivering care to patients with rheumatoid arthritis (RA) is derived mainly from two sources: randomised controlled clinical trials and experience in clinical care. However, these two sources differ significantly because (a) the extensive inclusion and exclusion criteria result in clinical trial participants being recruited from only a minority of patients seen in standard clinical care; (b) assessments in clinical trials are conducted according to standard quantitative measures and indices, while standard clinical care of most patients with RA is generally conducted empirically, without collection of any quantitative data other than laboratory tests to estimate prognosis and document change in status; and (c) although baseline databases of various clinical trials (and observational studies) are 60–90% identical in content, they are not standardised and therefore not amenable to direct comparisons. Strategies to promote similarities between clinical trials and standard clinical care in patients with RA may include: more generalised inclusion criteria; incorporation of quantitative measurement into standard care, easily accomplished by asking each patient to complete a simple questionnaire at each visit to a rheumatologist; and consensus among rheumatologists for databases with standard content and format in clinical care and research involving patients with RA.

Abbreviations: ACR, American College of Rheumatology; CRP, C-reactive protein; DAS, Disease Activity Score; DMARD, disease modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; RA, rheumatoid arthritis; SPERA, standard protocol for evaluation of RA

Keywords: rheumatoid arthritis; clinical trials; exclusion criteria; indices; patient questionnaires

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