Kline-Rogers Eva, Share David, Bondie Diane, Rogers Bruce, Karavite Dean, Kanten Sherri, Wren Patricia, Bodurka Cindy, Fisk Cathy, McGinnity John, Wright Susan, Fox Susan, Eagle Kim A, Moscucci Mauro
University of Michigan, Division of Cardiology, Blue Cross Blue Shield of Michigan Cardiovascular Consortium Coordinating Center, Ann Arbor, Michigan, USA.
J Interv Cardiol. 2002 Oct;15(5):387-92. doi: 10.1111/j.1540-8183.2002.tb01072.x.
The technical challenges in the development of a quality-controlled registry of percutaneous coronary interventions (PCIs) are currently unknown. This article describes the authors' experience in the development of a regional, quality-controlled PCI registry. In 1996, 16 centers in Michigan were invited to participate in a multicenter PCI registry. Nine centers agreed to a pilot data collection and, as of July 2001, eight centers are still actively collecting data. An Oracle database was developed by the coordinating center. A common data collection form and a standard set of definitions were agreed on during several meetings. Data validity was insured through review of each form by a trained nurse, by automatic database diagnostic routines, and by site visits that included a review of the catheterization laboratory logs and a review of randomly selected charts. The average number of forms requiring query resolution was 33% in 1997 (range 7-76%), and it decreased to 5% in 1999 (range 1.4-10%). The most commonly queried variables were outcomes prior to discharge, lesion category, lesion complexity, date of birth, device used, gender, postprocedural percent stenosis, presence of left main disease, and MI date. Invalid dates, identification of the doctor, the presence of duplicate forms, and of duplicate outcomes were additional common queries generated by the internal diagnostic routines. In conclusion, the number of queries and diagnostic reports generated in the database suggests that the development of a quality-controlled PCI registry requires the institution of a careful diagnostic and data quality assessment system.
目前尚不清楚在开发质量可控的经皮冠状动脉介入治疗(PCI)注册系统时会面临哪些技术挑战。本文介绍了作者在开发一个地区性、质量可控的PCI注册系统方面的经验。1996年,密歇根州的16个中心受邀参与一个多中心PCI注册系统。9个中心同意进行试点数据收集,截至2001年7月,仍有8个中心在积极收集数据。协调中心开发了一个甲骨文数据库。在几次会议上商定了一份通用的数据收集表和一套标准定义。通过由经过培训的护士对每份表格进行审查、通过数据库自动诊断程序以及通过现场访问(包括审查心导管实验室日志和随机抽取的病历)来确保数据有效性。1997年需要解决查询的表格平均数量为33%(范围为7% - 76%),到1999年降至5%(范围为1.4% - 10%)。最常被查询的变量是出院前的结果、病变类别、病变复杂性、出生日期、使用的器械、性别、术后狭窄百分比、左主干病变的存在情况以及心肌梗死日期。无效日期、医生身份识别、重复表格的存在以及重复结果是内部诊断程序产生的其他常见查询内容。总之,数据库中产生的查询和诊断报告数量表明,开发一个质量可控的PCI注册系统需要建立一个仔细的诊断和数据质量评估系统。