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西班牙切口疝手术登记处(EVEREG)的数据质量验证:初步研究。

Data quality validation of the Spanish Incisional Hernia Surgery Registry (EVEREG): pilot study.

机构信息

General and Digestive Surgery Department, University Hospital of Tarragona Joan XXIII, Tarragona, Spain.

General and Digestive Surgery Department, University Hospital Parc de Salut Mar., Barcelona, Spain.

出版信息

Hernia. 2023 Jun;27(3):665-670. doi: 10.1007/s10029-023-02782-3. Epub 2023 Mar 24.

Abstract

PURPOSE

The Spanish Incisional Hernia Surgery Registry (EVEREG) was promoted by the Abdominal Wall Section of the Spanish Association of Surgeons, starting data collection in July 2012 and currently has more than 14,000 cases. The objective of this study was to validate the data collected through a pilot audit process.

METHODS

A sample of hospitals participating in the EVEREG registry since the beginning was selected. Patients registered in these centers in the 2012-2020 period were included. A stratified random sampling was carried out, with the inclusion of 10% of registered cases per center with a minimum of 20 cases per center. At each participating center, two researchers not belonging to the center undergoing the audit checked (on site or telematically) the concordance between the data in the registry and the data contained in the case history of each patient.

RESULTS

330 patients have been analyzed, out of a total of 2673 registered, in 9 participating centers. The average accuracy has been 95.7%. Incorrect data 1.5% and missing data 2.3% CONCLUSION: The group of pilot hospitals from this EVERG incisional hernia surgery registry shows a very high precision of 95.7%. The confirmation of these findings in all the centers participating in the registry will make it possible to guarantee the quality of the studies made and their comparability with other similar national registries.

TRIAL REGISTRATION

nnTrial registration number: ClinicalTrials.gov ID:NCT03899012.

摘要

目的

西班牙切口疝手术登记处(EVEREG)由西班牙外科医生协会腹壁科发起,于 2012 年 7 月开始收集数据,目前已有超过 14000 例病例。本研究的目的是通过试点审核过程验证所收集的数据。

方法

选择自 EVEREG 登记处开始参与的一组医院。纳入这些中心在 2012-2020 年期间登记的患者。进行分层随机抽样,每个中心纳入登记病例的 10%,每个中心至少纳入 20 例。在每个参与中心,两名不属于正在审核中心的研究人员(现场或远程)检查登记处数据与每位患者病历中数据的一致性。

结果

在 9 个参与中心的 2673 例登记病例中,分析了 330 例患者。平均准确率为 95.7%。错误数据为 1.5%,缺失数据为 2.3%。

结论

来自 EVERG 切口疝手术登记处的试点医院组显示出非常高的准确率(95.7%)。在参与登记处的所有中心确认这些发现,将能够保证所进行研究的质量及其与其他类似国家登记处的可比性。

试验注册

nn试验注册号:ClinicalTrials.gov ID:NCT03899012。

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