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印度前瞻性医院静脉血栓栓塞症登记处的建立：研究方案。

Development of prospective hospital-based venous thromboembolism registry across India: a study protocol.

机构信息

Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi, India

Division of Epidemiology and Communicable Diseases, Indian Council of Medical Research, New Delhi, Delhi, India.

出版信息

BMJ Open. 2023 Aug 9;13(8):e066644. doi: 10.1136/bmjopen-2022-066644.

DOI:10.1136/bmjopen-2022-066644
PMID:37558443
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10414069/
Abstract

INTRODUCTION

Indian Council of Medical Research (ICMR), New Delhi has established a nationwide registry 'Indian Registry for Venous Thromoembolism Disorder (i-RegVeD)' for real-time analytics of sociodemographic profile of patients, disease patterns, management strategies, treatment choices and outcomes of patients with venous thromboemobolism (VTE). The purpose is to generate evidence on VTE in order to fill the gaps in the knowledge of the disease across various demographic regions.

METHODS AND ANALYSIS

This prospective hospital-based registry will be a continuous data collection process on the occurrence and characteristics of VTE from the 16 hospital sites pan India. This process would include obtaining clinical profiles, risk factors, diagnostic tests, treatment and outcome information of patients collected from medical records through an active method of data abstraction and data capture mechanism guided by an online web-based tool.

ETHICS AND DISSEMINATION

At centralised programme management unit, the study protocol was approved by the Institutional Ethics Committees (IEC) named ICMR-Central Ethics Committee on Human Research and similarly each of the participating site has obtained the ethical approval by their respective IECs. The results from this study will be disseminated publicly on the study website (https://iregved.icmr.org.in) as well as through scientific meetings and publications.

摘要

简介

印度医学研究理事会（ICMR）在新德里建立了一个全国性的登记处“印度静脉血栓栓塞疾病登记处（i-RegVeD）”，用于实时分析静脉血栓栓塞症（VTE）患者的社会人口统计学特征、疾病模式、管理策略、治疗选择和结局。其目的是生成有关 VTE 的证据，以填补不同人口统计学区域对该疾病认识的空白。

方法与分析

这项前瞻性的基于医院的登记处将是一个在全国范围内从 16 个医院站点连续收集 VTE 发生和特征的过程。这一过程将包括通过主动的数据提取方法和在线网络工具指导的数据捕获机制，从病历中获取患者的临床特征、危险因素、诊断测试、治疗和结局信息。

伦理与传播

在中央项目管理部门，该研究方案已获得中央人类研究伦理委员会（ICMR-Central Ethics Committee on Human Research）的机构伦理委员会批准，同样，每个参与的站点也已通过各自的伦理委员会获得了伦理批准。该研究的结果将在研究网站（https://iregved.icmr.org.in）以及科学会议和出版物上公开传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/b5b6cc9dfa33/bmjopen-2022-066644f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/54d6a9d57709/bmjopen-2022-066644f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/fdc8641b40b9/bmjopen-2022-066644f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/1ea8ead46e18/bmjopen-2022-066644f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/b5b6cc9dfa33/bmjopen-2022-066644f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/54d6a9d57709/bmjopen-2022-066644f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/fdc8641b40b9/bmjopen-2022-066644f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/1ea8ead46e18/bmjopen-2022-066644f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fd/10414069/b5b6cc9dfa33/bmjopen-2022-066644f04.jpg

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