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肾结石逆行肾内手术前瞻性数据登记系统的开发:土耳其泌尿外科学会前瞻性研究组(ACUP研究)

Development of a prospective data registry system for retrograde intrarenal surgery in renal stones: Turkish Academy of Urology Prospective Study Group (ACUP study).

作者信息

Akand Murat, Sarıca Kemal, Kiremit Murat Can, Soytaş Mustafa, Güven Selçuk

机构信息

Department or Urology, Selçuk University School of Medicine, Konya, Turkey.

Department of Urology, Kafkas University School of Medicine, Kars, Turkey.

出版信息

Turk J Urol. 2019 Nov 14;46(1):57-62. doi: 10.5152/tud.2019.19143. Print 2020 Jan.

Abstract

OBJECTIVE

We aimed to report the development of a prospective data registry by generating a retrograde intrarenal surgery (RIRS)-specific electronic case report form (eCRF), which can be used by multiple centers in Turkey.

MATERIAL AND METHODS

The Stone Disease Study Group of Turkish Urology Academy developed a template for the necessary data to be collected, which was then implemented within a dedicated server. Urologists from different universities, research and training centers, and private hospitals were invited to participate in this data registry. Each urologist was provided with a unique username and password after they agreed to participate in the study.

RESULTS

In March 2015, the development of the eCRF was completed, and the server was opened for data input in April 2015. We started a prospective clinical data registry for all patients undergoing RIRS for renal stone(s) in 15 participating hospitals. Until the end of June 2016, 1112 RIRSs on 1264 patients have been included in the dataset.

CONCLUSION

The easy-to-use eCRF specifically developed for RIRS was first of its kind in Turkey. This prospective data registry harvests important data that will be used to identify real-world demographic, clinical and operative data of patients with renal stone who undergo RIRS in various urology departments throughout Turkey. The results of this dataset will be presented in various papers.

摘要

目的

我们旨在通过生成一份专门用于逆行性肾内手术(RIRS)的电子病例报告表(eCRF)来报告一个前瞻性数据登记系统的开发情况,该报告表可供土耳其的多个中心使用。

材料与方法

土耳其泌尿外科学会的结石病研究小组制定了一份收集所需数据的模板,然后在一台专用服务器上实施。邀请了来自不同大学、研究和培训中心以及私立医院的泌尿外科医生参与这个数据登记系统。每位泌尿外科医生在同意参与研究后都会获得一个唯一的用户名和密码。

结果

2015年3月,eCRF的开发完成,服务器于2015年4月开放供数据录入。我们开始为15家参与医院中所有接受RIRS治疗肾结石的患者建立一个前瞻性临床数据登记系统。截至2016年6月底,数据集已纳入1264例患者的1112例RIRS手术。

结论

专门为RIRS开发的易于使用的eCRF在土耳其尚属首次。这个前瞻性数据登记系统收集了重要数据,这些数据将用于确定土耳其各泌尿外科接受RIRS治疗的肾结石患者的真实世界人口统计学、临床和手术数据。该数据集的结果将在多篇论文中呈现。

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