impact factor

B. Clinical trials


Patient self-report outcomes to guide a treat-to-target strategy in clinical trials and usual clinical care of rheumatoid arthritis



2012 Vol.30, N°4 ,Suppl.73
PI 0050, PF 0055
B. Clinical trials

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PMID: 23079199 [PubMed]

Received: 25/09/2012
Accepted : 25/09/2012
In Press: 16/10/2012
Published: 20/11/2012


Patient self-report questionnaires provide an easily-implemented approach for quantitative assessment of patients with rheumatoid arthritis (RA) in usual care settings. Patient reported outcomes (PROs) on these questionnaires and an index including only patient self-report measures, RAPID3 (Routine Assessment of Patient Index Data), distinguish active from control treatments as effectively as other measures in clinical trials of methotrexate, leflunomide, adalimumab, abatacept, and certolizumab. RAPID3 is correlated significantly with indices that include formal joint counts and laboratory tests, such as disease activity score 28 (DAS28) and clinical disease activity index (CDAI), in clinical trials and clinical care, including categories for high, moderate, low severity, and remission. Patient self-report questionnaires present additional advantages that the same observer (the patient) completes quantitative scores at each encounter regardless of the setting and the patient does most of the work to provide an index. Completion of a questionnaire helps the patient prepare for the visit, and improves doctor-patient communication. This article summarises evidence concerning PROs in clinical trials and clinical care in documenting low disease activity and remission, including a meta-analysis of studies that document the value of using PROs to implement `treat-to-target.` Patient self-report questionnaires must be complemented by a careful joint examination, and do not prevent performance of a formal joint count or any other measure by a treating physician. Patient self-report questionnaires may provide a useful, cost-effective method to implement treat-to-target in patients with RA as well as other rheumatic diseases.

Rheumatology Article