Supplier
CDC/NCBDDD and ATHN
Years Available
2015 to present
Periodicity
Annual
Mode of Collection
Surveillance data: active data collection.
Description
Conducted through a cooperative agreement, Community Counts Registry is a national surveillance project for inherited bleeding disorders in the United States led by the Centers for Disease Control and Prevention (CDC), along with its partners, the American Thrombosis and Hemostasis Network (ATHN) and the U.S. Hemophilia Treatment Center Network (USHTCN). The Registry gathers detailed information on patients who have been seen at federally-funded Hemophilia Treatment Centers (HTCs) since December 2013 and who have given authorization to share their data. HTCs are specialty care centers that receive funding from the Health Resources and Services Administration (HRSA) to provide comprehensive (integrated) and coordinated diagnosis, treatment, prevention, education, outreach and surveillance services to improve the health of people with genetic bleeding disorders. The Registry includes patients recruited from HTCs located throughout the United States, Puerto Rico and Guam.
Selected Content
The Registry collects information on patient characteristics, diagnoses, bleeding events (including bleeding into joints and/or brain), history of inhibitors, treatments (including preventive measures), treatment product use, and the presence of other medical conditions.
Population Covered
Persons diagnosed with a bleeding disorder who receive care at federally funded HTCs. The condition must have been present at birth and must be one of the following bleeding disorders: Hemophilia A (Classic Hemophilia/hereditary factor VIII deficiency); Hemophilia B (Christmas disease/hereditary factor IX deficiency); Von Willebrand Disease (VWD); and certain rare clotting factor disorders and platelet disorders.
Methodology
An Initial Visit form is completed when the patient is enrolled into the study. During this visit, HTC staff collect information about the patient's historic and current clinical status. When the patient returns to the clinic for their next comprehensive visit the Subsequent Visit form is completed. The subsequent visit form collects clinical information and outcomes since the last surveillance visit. All persons with a bleeding disorder diagnosis who receive care at an HTC are eligible for inclusion in the data collection effort. Data on their patient populations are contributed by approximately 130 HTCs in the United States. The national HTCs treat over 35,000 persons with inherited bleeding disorders, estimated to be 80 percent of the entire population of persons with bleeding disorders. The Community Counts Registry consists of three data collection components: (1) HTC Population Profile, (2) Registry for Bleeding Disorders Surveillance, and (3) Mortality Reporting. Eligible diagnoses include hereditary factor VIII deficiency, factor IX deficiency, VWD, certain rare bleeding disorders, and hereditary/functional platelet disorders. The Registry collects information on patient characteristics, diagnoses, bleeding events (including bleeding into joints and/or brain), history of inhibitors, treatments (including preventive measures), treatment product use, and the presence of other medical conditions. Persons who volunteer to participate have medical information collected during routine comprehensive care visits at the HTC. The data collected are a limited data set that is compliant with the Health Insurance Portability and Accountability Act (HIPPA). The data are collected and transmitted to CDC continuously throughout the year.
Response Rates and Sample Size
A true response rate cannot be calculated because the number of people approached for participation is not reported. Based on the forms received during 2017, the most recent full year of data collection, 49% (3,336/7,010) of eligible patients were enrolled in the Registry. The demographic and clinical characteristics of the enrolled patients are similar to, and representative of, the U.S. HTC patient population.
Interpretation Issues
This data source collects information only on patients seen at the HTCs (estimated at 70 percent of persons with hemophilia) and cannot be generalized to those not seen at the HTCs. Not all HTCs are represented in all years of data collection. The Registry data do not represent all of the severe hemophilia patients who were seen in the HTCs; severe hemophilia patients who did not enroll in the Registry and those who did enroll, but did not have a subsequent visit that met the eligibility criteria, were excluded.
References
Manco-Johnson MJ et. al. Community Counts: Evolution of a national surveillance system for bleeding disorders. Am J Hematol 2018; epub.
