Community Counts Registry for Bleeding Disorders Surveillance
Conducted through a cooperative agreement, Community Counts is a national surveillance project for inherited bleeding disorders 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)in the United States in the. 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 70% of the entire population of persons with bleeding disorders. Community Counts consists of three data collection components: 1. HTC Population Profile, 2. Registry for Bleeding Disorders Surveillance, and 3. Mortality Reporting.
The Registry includes an Initial Visit form, which 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 information. When the patient returns to 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. Eligible diagnoses include hereditary factor VIII deficiency, factor IX deficiency, VWD, certain rare bleeding disorders, and hereditary/functional platelet disorders. Clinical information to be collected includes demographics, bleeding disorder diagnoses, treatments, bleeding events, related complications (e.g. inhibitor development), health care utilization, and presence of other health conditions.
The Registry gathers detailed information on patients who have been seen at federally-funded 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.
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.
People who volunteer to participate have medical information collected during routine comprehensive care visits at the HTC. The 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 information.
When the patient returns to 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.
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.
A true response rate cannot be calculated because the number of people approached for participation is not reported. Based on the forms received at the time of this analysis the enrollment rate in the first year of the Registry was 9.6% (490/5,092) of eligible patients. While representing a small percentage of the eligible population, the demographic and clinical characteristics of the enrolled patients are similar to and representative of the U.S. HTC patient population.
The data source collects information only on patients seen at the HTCs (estimated at 70% of persons with hemophilia (Baker, et al., 2013)) and cannot be generalized to those not seen at the HTCs. Not all HTCs are represented in all years of data collection (the Data Details Trend Issues section of objectives using this data source will list the percentage of HTCs represented in a given year).
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.