A 3-page standard protocol to evaluate rheumatoid arthritis (SPERA): Efficient capture of essential data for clinical trials and observational studies

T. Pincus

Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

ABSTRACT
An efficient 3-page format known as the “standard protocol to evaluate rheumatoid arthritis” (SPERA) has been developed to collect essential baseline clinical data in clinical trials and clinical research studies.
The three pages address: 1) clinical features of rheumatoid arthritis (RA), 2) medications taken, and 3) a 42-joint count. Two additional documents, a patient questionnaire and a radiographic scoring sheet, are included for a comprehensive database. The 15-20 minutes needed to complete the SPERA generally adds efficiency over time in standard clinical care, and does not preclude the collection of additional information for clinical care and/or clinical research. The SPERA is presented not as the most desirable format, but rather as an example of a possible approach to the development of a consensus in the rheumatology community regarding a common format for the collection of core clinical data in RA.

Key words
Rheumatoid arthritis, extra-articular disease, MDHAQ, comorbidities, DMARD.

Supported in part by grants from the Arthritis Foundation and the Jack C. Massey Foundation.
Please address correspondence to: Theodore Pincus, MD, Professor of Medicine, Division of Rheumatology and Immunology, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA:
E-mail: t.pincus@vanderbilt.edu

Clin Exp Rheumatol 2005; 23 (suppl. 39): S114-S119.
© CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2005.