title: A data capture system for outcomes studies that integrates with electronic health records: development and potential uses.
abstract: In conventional clinical studies, the costs of data management for quality control tend to be high and collecting paper-based case report forms (CRFs) tends to be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records for this purpose could result in reductions in cost and improvements in data quality in clinical studies. The purpose of this study was to develop a data capture system for observational cancer clinical studies (i.e. outcomes studies) that would integrate with an electronic health records system, to enable evaluation of patient prognosis, prognostic factors, outcomes and drug safety. At the Outpatient Oncology Unit of Kyoto University Hospital, we developed a data capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. We expect that our new system will reduce the costs of data management and analysis and improve the quality of data in clinical studies.
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan. kyamamo@kuhp.kyoto-u.ac.jp
authors.forename: Keiichi
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Shigemi
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Harue
authors.initials: H
authors.lastname: Tada
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Tadamasa
authors.initials: T
authors.lastname: Takemura
authors.forename: Masanori
authors.initials: M
authors.lastname: Fukushima
mesh_terms: D000740:Anemia / Q000139:chemically induced / Q000453:epidemiology; D002986:Clinical Trials as Topic; D003625:Data Collection / Q000295:instrumentation / Q000379:methods; D006801:Humans; D007564:Japan / Q000453:epidemiology; D016347:Medical Records Systems, Computerized; D009369:Neoplasms / Q000188:drug therapy; D017063:Outcome Assessment, Health Care / Q000458:organization & administration*; D012189:Retrospective Studies