World Bleeding Disorders Registry Pilot Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 主要终点
- Proportion of HTCs which agree to participate in the pilot phase of the WBDR
研究概览
简要总结
The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.
详细描述
The pilot phase of the WBDR is an observational disease registry of patients with hemophilia. Forty hemophilia treatment centres (HTCs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in English, were invited to participate in the pilot phase. Participating HTCs will complete a Minimal Data Set (MDS) of data on approximately 10 patients each.
A series of performance indicators have been identified by the Steering committee and will be used to assess the feasibility of expanding the pilot phase to the WBDR. The performance indicators include: proportion of HTCs invited that are willing to participate; proportion of participating HTCs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.
- •Ability to provide data in English
排除标准
- 未提供
结局指标
主要结局
Proportion of HTCs which agree to participate in the pilot phase of the WBDR
时间窗: 6 months
This is be measured by the number of HTCs who agree to participate, divided by the number of HTCs invited.
Proportion of participating HTCs who successfully obtain necessary regulatory approval
时间窗: 6 months
This will be measured by the number of HTCs who obtain approval, divided by the number of HTCs who have agreed to participate in the pilot phase of the WBDR.
Proportion of patients who agree to participate in this pilot phase of the WBDR.
时间窗: 6 months
This will be measured by the number of patients who provided consent to participate, divided by the number of patients who were approached to participate.
Proportion of enrolled patients on which data collection and database entry is successful.
时间窗: 6 months
This will be measured by the number of patients on who data is collected and entered successfully into the database, divided by the number of patients who are enrolled in the pilot phase of the WBDR.
次要结局
未报告次要终点