Information for Hemophilia Treatment Centers (HTCs)
The Universal Data Collection (UDC) system is being carried out with the help of federally funded hemophilia treatment centers (HTCs) in the United States. Since the UDC system began in 1998, more than 24,000 people with bleeding disorders have participated in the activities of UDC. More than 80% of all people with hemophilia who receive care at these centers hasve participated in the UDC system.
As an HTC provider, your practice stands to benefit greatly from the findings generated by UDC. This system provides the most complete national portrait to date of the bleeding disorders population and its health complications. This information forms critical groundwork for future research to reduce and prevent these complications.
The UDC system works through a partnership between CDC and the HTCs.
CDC is committed to achieving UDC’s goals with as little disruption as possible to patient care. Input from HTCs will continue to be solicited to improve the program’s efficiency and effectiveness. Feedback, including sharing ongoing summaries of data, is a critical component. With input from the HTC and patient communities, CDC will pose questions for further study to develop effective strategies to reduce or eliminate the complications of bleeding disorders. Upon identification of seroconversions among patients consistent with a potential product safety issue, CDC will promptly launch an investigation and share the results with the bleeding disorders community. The results of these investigations may suggest safeguards that could decrease risks and improve the safety of blood products.
Each HTC must have trained professionals who can accomplish the following:
- Encourage Full Participation
A high degree of community participation is necessary for UDC to fulfill its goals. As an HTC team member, you can play a crucial role in this program by enrolling as many people as possible in UDC.
- Provide Information
As an HTC provider, your role is to inform patients about UDC and, to the extent possible, answer their questions about the program. CDC has created an information packet for patients to help answer their questions about UDC. This packet includes a question-and-answer brochure and a brief fact sheet, both written in easy-to-understand language. You also must discuss the informed consent process with patients.
- Obtain Consent
Patients agreeing to participate in UDC must provide written consent via a consent form. How you tailor this discussion is up to you; however, it is important that all eligible patients be given the opportunity to participate in the program and to have their questions and concerns answered as completely as possible. Parental consent is needed for participants younger than 18 years of age. Children younger than 18 but older than 7 years also sign an “assent” form to acknowledge their agreement to participate in UDC.
- Collect routine clinical data using uniform data collection tools provided by CDC.
- Measure and record joint range of motion on appropriate patients. CDC has developed a video showing how to take these measurements and record the results correctly.
- Draw a blood sample and ship the specimen to CDC.
- Respond to queries for data validation from CDC and other authorized parties.
- Provide feedback to the regional coordinators and to CDC regarding study procedures and problems.
- Give test results to patients and offer counseling and/or medical management as necessary.
UDC data are available to HTC staff. Staff at each HTC can download electronic files containing UDC data collected from participants at their HTC and view reports of their center’s UDC data. In addition, national and regional reports of the data are available to HTC staff and the general public.
Use the directory to search for the names and contact information of HTCs and staff, create lists, print mailing labels, and send emails.
Healthcare providers might use this directory to find and consult with other experts in the field. Patients might use this directory to obtain care when they are away from their usual care provider. It is important that the HTC directory has accurate information about your HTC. Please inform your regional coordinator of any changes in HTC staff or contact information so that the directory can be updated.
All patients with an inherited coagulation factor deficiency of less than 50% of normal, including factor VIII (FVIII) or hemophilia A, FIX or hemophilia B, or FI, FII, FV, FVII, FX, FXI, FXIII OR a physician’s diagnosis of von Willebrand disease are eligible to participate in UDC.
Females Older Than 2 Years of Age
In certain HTCs, girls older than 2 years of age and women with bleeding disorders are eligible for the Female UDC Phase I. For females, the diagnostic criteria for eligibility are as follows:
- Inherited coagulation factor deficiency of less than 50% of normal, including FI, FII, FV, FVII, FVIII, FIX, FX, FXI, FXIII, OR PAI-1 or a2anti-plasmin deficiency
- Physician-diagnosed von Willebrand disease
- Inherited platelet disorder (for example, Glanzmann’s thrombasthenia, Bernard Soulier, Grey platelet syndrome, Hermanski-Pudlak syndrome, inherited thrombocytopenia, storage pool defect, platelet release defect)
- Connective tissue disorder (for example, suspected Ehlers-Danlos syndrome or hypermobility syndrome)
- Physician-diagnosed hereditary hemorrhagic telangiectasia (HHT), also sometimes referred to as Osler-Weber-Rendu (OWR)
Infants and Toddlers Younger Than 2 Years of Age
Boys and girls younger than 2 years of age should be enrolled in the Baby UDC. At age 2, all eligible male patients should be encouraged to participate in the regular UDC, and all eligible females two years of age or older should be encouraged to participate in the Female UDC Phase I where available.
Quality of Life
Female Annual Visit
Model Patient Consent
Organizational Structure and Guidelines for the CDC Cooperative Studies
Joint Range of Motion Video
UDC Fact Sheet
Baby UDC Fact Sheet
Female UDC Fact Sheet
UDC Inhibitor Project Fact Sheet
UDC Supply Order Form
The Universal Data Collection (UDC) System: Lessons Learned and Future Directions
Sistema de Recolección Universal de Datos (UDC): Lecciones aprendidas y dirección futura
The UDC Working Group is seeking proposals from investigators with research questions that may be addressed using data collected as part of UDC. Investigators from any discipline are encouraged to submit proposals using the following template and instructions.
- Centers for Disease Control and Prevention
National Center on Birth Defects and Developmental Disabilities
Division of Blood Disorders
1600 Clifton Road
Atlanta, GA 30333
TTY: (888) 232-6348
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