The World Federation of Hemophilia (WFH) has created a universal case report form for the collection of core data on hemophilic patients in a standardized format that will include relevant diagnosis, therapies, and outcome.
Previous WFH forms provided only an overview of the number of patients and access to treatment. Information on how treatments were performed or patient outcomes were not included.
The creation of the universal form is meant to help hemophilia treatment centers (HTCs) provide more comprehensive data on patients, increase access to therapy, improve the quality of care, and enable the comparison of outcomes among different patient groups.
A commentary on the characteristics and advantages of the implementation of the universal case report form (U-CRF) was written by Drs. Alok Srivastava and H. Marijke Van den Berg and published in the journal Haemophilia, under the title “Standardizing Patient Outcomes Measurement To Improve Haemophilia Care.”
“While the primary goal of this exercise is to provide a uniform template for data collection at each HTC to help the management of individual PWH (Person With Haemophilia), the WFH hopes that this will ultimately lead to the development of meaningful national and international registries,” the authors wrote.
According to the authors, the new form includes a complete list of care and outcome parameters for data to be collected for each patient. The creators of the U-CFR also considered the existing CRFs already in use, from which they extracted features that could be used globally.
In terms of structure and content, the U-CRF is composed of three different parts to account for differences in clinical practices at HTCs around the world.
• Part 1 – Registration Form. This provides information on the location, contact and responsible personnel, and number of registered patients in each HTC.
• Part 2 – Minimal Data Set. This includes very basic information such as the demographic details of the patient, diagnosis data at registration, annual follow-up with details of bleeding, CFC replacement and inhibitor status.
• Part 3 – This includes full details of the relevant parameters in patient outcome.
According to the authors, the new platform can also be very useful for future or retrospective studies on hemophilia.
“Requests for specific projects from researchers will need to be handled through a defined process, consent for use of data being always with the HTCs providing the data,” the authors wrote.
View the new U-CRF here.