A 3-page standard protocol to evaluate rheumatoid arthritis (SPERA): efficient capture of essential data for clinical trials and observational studies.
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.
Pincus
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Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. t.pincus@vanderbilt.edu
D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy; D001175:Arthrography; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D018450:Disease Progression; D006801:Humans; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D012219:Rheumatology / Q000379:methods / Q000592:standards*