title: A Paradox-based data collection and management system for multi-center randomized clinical trials.
abstract: We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.
authors.affiliation: Hines VA Cooperative Studies Program Coordinating Center (151K), P.O. Box 5000, 5th Ave. and Roosevelt Rd. Bldg. 1, Rm. B240, Hines, IL 60141-5000, USA. abdellat@research.hines.med.va.gov
authors.forename: Mazen
authors.initials: M
authors.lastname: Abdellatif
authors.forename: Domenic J
authors.initials: DJ
authors.lastname: Reda
mesh_terms: D003625:Data Collection / Q000379:methods; D003626:Data Display; D003628:Database Management Systems / Q000458:organization & administration*; D019992:Databases as Topic; D006801:Humans; D008838:Microcomputers; D008962:Models, Theoretical; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D014584:User-Computer Interface