Hemophilia A and B
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
World Federation of Hemophilia
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients of participating Hemophilia Treatment Centres with Hemophilia A or B. * Ability to provide data in English
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of HTCs which agree to participate in the pilot phase of the WBDR | 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 | 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. | 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. | 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. |
Outcome results
None listed