Harmonization, data management, and statistical issues related to prospective multicenter studies in Ankylosing spondylitis (AS): Experience from the Prospective Study Of Ankylosing Spondylitis (PSOAS) cohort

Abstract

Ankylosing spondylitis (AS) is characterized by inflammation of the spine and sacroiliac joints causing pain and stiffness and, in some patients, ultimately new bone formation, and progressive joint ankyloses. The classical definition of AS is based on the modified New York (mNY) criteria. Limited data have been reported regarding data quality assurance procedure for multicenter or multisite prospective cohort of patients with AS. Since 2002, 1272 qualified AS patients have been enrolled from five sites (4 US sites and 1 Australian site) in the Prospective Study Of Ankylosing Spondylitis (PSOAS). In 2012, a Data Management and Statistical Core (DMSC) was added to the PSOAS team to assist in study design, establish a systematic approach to data management and data quality, and develop and apply appropriate statistical analysis of data. With assistance from the PSOAS investigators, DMSC modified Case Report Forms and developed database in Research Electronic Data Capture (REDCap). DMSC also developed additional data quality assurance procedure to assure data quality. The error rate for various forms in PSOAS databases ranged from 0.07% for medications data to 1.1% for arthritis activity questionnaire-Global pain. Furthermore, based on data from a sub study of 48 patients with AS, we showed a strong level (90.0%) of agreement between the two readers of X-rays with respect to modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). This paper not only could serve as reference for future publications from PSOAS cohort but also could serve as a basic guide to ensuring data quality for multicenter clinical studies. Keywords: Ankylosing spondylitis, Data quality, Harmonization, PSOAS cohort, Reliability of data