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来自结果登记数据库的未经审计的记录准确吗?

Are unaudited records from an outcomes registry database accurate?

作者信息

Herbert Morley A, Prince Syma L, Williams Janet L, Magee Mitchell J, Mack Michael J

机构信息

Department of Research, Medical City Dallas Hospital, Dallas, TX 75230, USA.

出版信息

Ann Thorac Surg. 2004 Jun;77(6):1960-4; discussion 1964-5. doi: 10.1016/j.athoracsur.2003.12.018.

Abstract

BACKGROUND

Data from outcomes registry databases are being increasingly used for peer review and public reporting. However, administrative and clinical databases are mostly unaudited; thus, their accuracy has not been verified.

METHODS

Outcomes data from all coronary artery bypass operations from a single cardiac surgery practice were entered into The Society of Thoracic Surgeons (STS) National Cardiac Database. From our practice of 18 surgeons, we audited 247 (10%) of the clinical records of patients undergoing surgery in 2001 and correlated them with all 315 elements of the STS National Cardiac Database for verification of accuracy. Inaccuracies were defined as a disagreement with a nominal or categorical variable or, for continuous variables, as the value not being within a predetermined window. When discrepancies existed, the hospital clinical record was assumed to be accurate. Outcomes discrepancies were then analyzed by four major categories: components of the preoperative risk algorithm, operative mortality, major complications, and other outcomes.

RESULTS

Discrepancies were noted in 5% (16) or fewer of the audited fields for 98.8% of the records. Of the 32 variables in the mortality risk algorithms, discrepancies were present in fewer than 10% of the audits on 30 of the 32 variables. More than 95% of the audited charts had zero or one discrepancy in the seven most important variables in the mortality risk models. Operative mortality was determined to be completely accurate with no discrepancies between the database and the audited clinical record. Among major complications, the error rate was less than 1% for all complications except prolonged ventilation (4.0%). A higher rate of discrepancies did exist in some of the other variables, including discharge medications (14.1%) and ventilator time (36.4%).

CONCLUSIONS

A detailed audit of a clinical outcomes registry database demonstrated that the major fields within this specific database including operative mortality, major complications, and the significant factors in the risk algorithm were highly accurate. Process improvement factors were identified to further increase the accuracy of data collection.

摘要

背景

来自结局登记数据库的数据越来越多地用于同行评审和公开报告。然而,行政和临床数据库大多未经审核;因此,其准确性尚未得到验证。

方法

将单一心脏外科实践中所有冠状动脉搭桥手术的结局数据录入胸外科医师协会(STS)国家心脏数据库。在我们18位外科医生的实践中,我们审核了2001年接受手术患者的247份(10%)临床记录,并将其与STS国家心脏数据库的所有315个元素进行关联以验证准确性。不准确被定义为与名义变量或分类变量不一致,对于连续变量,则为值不在预定范围内。当存在差异时,假定医院临床记录是准确的。然后按四个主要类别分析结局差异:术前风险算法的组成部分、手术死亡率、主要并发症和其他结局。

结果

98.8%的记录在5%(16项)或更少的审核字段中存在差异。在死亡率风险算法的32个变量中,32个变量中有30个变量的审核差异少于10%。超过95%的审核图表在死亡率风险模型的七个最重要变量中存在零个或一个差异。手术死亡率被确定为完全准确,数据库与审核的临床记录之间无差异。在主要并发症中,除延长通气(4.0%)外,所有并发症的错误率均低于1%。在一些其他变量中确实存在较高的差异率,包括出院用药(14.1%)和呼吸机使用时间(36.4%)。

结论

对临床结局登记数据库的详细审核表明,该特定数据库中的主要字段,包括手术死亡率、主要并发症和风险算法中的重要因素,具有高度准确性。确定了流程改进因素以进一步提高数据收集的准确性。

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