A Data Capture System for Outcomes Studies that Integrates with Electronic Health Records: Development and Potential Uses

  • Authors:

  • Keiichi Yamamoto;Shigemi Matsumoto;Harue Tada;Kazuhiro Yanagihara;Satoshi Teramukai;Tadamasa Takemura;Masanori Fukushima

  • Affiliations:

  • Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan 606-8507;Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan;Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan 606-8507;Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan;Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan 606-8507;Department of Medical Informatics, Kyoto University Hospital, Kyoto, Japan;Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan 606-8507 and Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, ...

  • Venue:
  • Journal of Medical Systems
  • Year:
  • 2008

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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.