Karam Vincent, Gunson Bridget, Roggen Francine, Grande Luis, Wannoff Wolfgang, Janssen Magda, Guckelberger Olaf, Delvart Valérie, Bismuth Henri, Höckerstedt Krister, Rogiers Xavier, Adam René
Centre Hépatobiliaire, Hôpital Paul Brousse, Villejuif, France. vincent.
Transplantation. 2003 Jun 27;75(12):2167-73. doi: 10.1097/01.TP.0000080271.20145.07.
The number of registries is increasing, but few of them perform reliability audits by comparing the data contained in the database with data contained in hospital charts.
The European Liver Transplant Registry (ELTR) cocoordinating committee appointed an independent team to check the reliability of data contained in ELTR. Centers were selected at random. Ten percent of each center's files were selected at random, and 25 items per file were checked during the site visits. The rates of completeness and inconsistencies and the agreement between ELTR and charts were established. We also assessed the correlation between the quality of data and the visited centers' activity.
Seven hundred thirty-four files from 21 centers have been audited between June 1998 and June 2001. The rate of ELTR completeness was 95%, and the rate of consistency between charts and ELTR was 98%. The agreement between the ELTR and charts review was very good for all conditions (kappa value < or =0.81). However, comparisons of rates between items indicated that specific items, mostly cause of death or graft failure and patient outcome, should be targeted for improvement. No significant correlation was found between the quality of data and the experience of visited centers. The mean (min-max) and median cost per audited file were EUR 60 (8-150) and EUR 44, respectively.
The results of audit visits indicate that ELTR data are reliable, and the scientific results of ELTR can be considered credible and representative of liver transplantation in Europe. The method could serve as a model for auditing a registry.
登记处的数量在不断增加，但其中很少有通过将数据库中的数据与医院病历中的数据进行比较来进行可靠性审核的。
欧洲肝脏移植登记处（ELTR）协调委员会任命了一个独立团队来检查ELTR中数据的可靠性。随机选择中心。在现场访问期间，从每个中心的文件中随机抽取10%，并对每份文件中的25项内容进行检查。确定了完整性和不一致率以及ELTR与病历之间的一致性。我们还评估了数据质量与受访中心活动之间的相关性。
在1998年6月至2001年6月期间，对来自21个中心的734份文件进行了审核。ELTR的完整性率为95%，病历与ELTR之间的一致性率为98%。在所有情况下，ELTR与病历审查之间的一致性都非常好（kappa值≤0.81）。然而，各项之间的比率比较表明，特定项目，主要是死亡原因或移植物失败以及患者结局，应作为改进目标。在数据质量与受访中心的经验之间未发现显著相关性。每份审核文件的平均（最小-最大）成本和中位数成本分别为60欧元（8-150欧元）和44欧元。
审核访问的结果表明，ELTR数据是可靠的，ELTR的科学结果可以被认为是可信的，并且代表了欧洲的肝脏移植情况。该方法可作为登记处审核的一个模型。
