Researchers

Facilitating research to increase knowledge and improve care.

At ATHN, we proudly collaborate with researchers to facilitate a variety of studies through our network of over 135 federally funded hemophilia treatment centers (HTCs). ATHN offers data and samples from the ATHNdataset, Community Counts, the CDC Public Health Surveillance for Bleeding Disorders project, and My Life, Our Future, study implementation and support services, scientific leadership, and funding opportunities. For sponsors, the synergy created by working through ATHN helps reduce time, costs, and hassles of project start-up.

ATHN has research capabilities that can be mixed and matched to meet your specific study needs.

  1. Datasets and biologic samples offer study-specific data and research repository samples drawn from the materials that have been and continue to be collected through projects like the ATHNdataset; Community Counts, the CDC Public Health Surveillance for Bleeding Disorders project; and My Life, Our Future.
  2. Study implementation and support services, including:
    1. Electronic Data Capture – ATHN provides standardized, web-based applications to our network of over 135 federally funded HTCs that support clinical data management (ATHN Clinical Manager) and study data collection and submission (ATHN Study Manager). Seamless integration between these applications ensures that relevant clinical data can be leveraged to populate electronic case report forms. Leveraging data across applications maximizes efficiency and reduces errors.
    2. Data Management Services – ATHN services range from feasibility assessments and power calculations to the development of electronic study forms, coding, and validation, through status reporting, biostatistical analyses and delivery of the final dataset. By providing comprehensive and coordinated support to researchers, participating sites, and stakeholders, ATHN helps ensure that findings are accurate, complete, and timely. All study data is securely stored in a commercial-grade hosting environment, backed by a disaster recovery system.
    3. Study Management – ATHN offers services across the research study timeline and throughout the study life cycle such as supporting sites with IRB submissions, assisting researchers with preparing and compiling study-related data, reports and documents, monitoring the progress of each study, assuring compliance with relevant regulations, and validating accuracy of the data.
    4. Communications Services – ATHN’s communications and community relations team assists with educational and recruitment materials for patients, physicians, site staff, and advocacy groups to help achieve study-specific enrollment and engagement goals; translations of study materials, if needed; and also assists with manuscript and poster development for publication and dissemination of study milestones and results. A study-specific document repository keeps all documents at the fingertips of study teams.
    5. Administrative Services – ATHN offers project administration including the use of standard contracts and data sharing agreements, meeting coordination, and project financial management by staff who work with ATHN-affiliated HTCs on a regular basis.
  3. Network of sites and scientific leadership – ATHN’s relationship with the network of HTCs and their regional leadership facilitates opportunities for new clinical research and surveillance projects that are nationwide and/or regional. This network is comprised of centers of excellence from across the country with a long history of collaboration. Each project is driven by a study-specific committee focused on the research question. Fiscal and scientific leadership is provided by ATHN’s Board of Directors and Research Committee. In addition, the broad base of medical directors and staff at HTCs provide input, and ultimately implement studies to support long-term and short-term research goals.
  4. Funding opportunities – ATHN provides funding opportunities to support research projects designed to transform the care of patients with bleeding and clotting disorders. One of those is the DREAM Award, which supports young investigators at ATHN-affiliated HTCs, working under the guidance of experienced mentors. The DREAM Award is offered through a collaboration of Hemophilia and Thrombosis Research Society (HTRS) and ATHN. Additional funding options for research are announced to the ATHN-affiliated HTC network as they become available.

Each of ATHN’s capabilities play a key role throughout the lifecycle of a research project as noted in the following:

Lifecycle of a Research Project

  1. Project Development – Datasets and Sample Repository, Sites and Scientific Leadership, Funding (if available), Administration, Electronic Data Capture, Data Management Services
  2. Project Initiation – Study Management, Regulatory Assistance, Data Management Services
  3. Project Execution – Study Management, Data Management Services, Communication Services
  4. Project Close Out – Data Management Services (for biostatistical analysis and for dissemination of results in publications and posters) and Communication Services (to inform all stakeholders including providers and patients using a wide-range of communication pathways)

ATHN Resources for Researchers

The following key resources are available to researchers to assist in the design of a study, create study-specific electronic forms, and expedite their development:

  1. ATHN Core Data Elements – Lists the breadth of the core data that makes up the ATHNdataset
  2. ATHN Data Dictionary – Provides a definition and description of each data element offering insight into the type of data represented, acceptable values and how that element has been used
  3. ATHN Question Library – A web-based tool that contains a sampling of the standardized questions that are being used for existing ATHN studies and projects

ATHNdataset Core Data Elements

The ATHNdataset Core Data Elements represent the vast body of data that has been and continues to be collected through our 135 ATHN-affiliated hemophilia treatment centers. Here is a sampling of the more than 150 core data elements included in the ATHNdataset:

  • Demographics – Age, gender, ethnicity, education, employment status, date of death, cause of death
  • Health services – Insurance type, ER visits
  • Diagnosis – Primary bleeding or clotting disorder, disease severity, date of diagnosis, inhibitor status, co-morbidities, age at diagnosis, age at first bleed
  • Pharmaceutical treatment – Coagulation medication, reason for use, vaccination status, allergies
  • Surgeries and procedures (including lab tests) – Factor level, inhibitor titer, diagnostic and monitoring labs
  • Objective parameters – BMI, height, weight

The breadth of the data in the ATHNdataset is increased as patients participating in the ATHNdataset also participate in other ATHN projects such as ATHN 1 – A Cross-Sectional Study of Cardiovascular Disease in the Aging Hemophilia Population, My Life, Our Future, and Community Counts, the CDC Public Health Surveillance for Bleeding Disorders project. For patients participating in the ATHNdataset and these projects, data in the ATHNdataset is updated when study forms are submitted, keeping information in the ATHNdataset current and relevant.

Download the ATHNdataset Core Data Elements.

ATHN Data Dictionary

The ATHN Data Dictionary is a companion resource to the ATHN Question Library. The dictionary provides a definition and a description of each data element to assist researchers in selecting the appropriate data elements for their project and assessing whether adequate data is likely to be available.

With information from the Data Dictionary, researchers can confirm that a data element is consistent with their research needs.

As shown below, the dictionary provides six separate types of information for each data element:

  1. Definition of the data element
  2. Type of variable
  3. Value – Numeric, Y/N/Unknown, or specific response/dropdown choices
  4. Completeness – % complete in database vs. missing/incomplete
  5. Note – Ancillary information
  6. Use – Use of data for specific reports, projects, publications

If you are an ATHN Affililate, you can access the ATHN Data Dictionary in ATHN Clinical Manager.

ATHN Question Library

The ATHN Question Library is a web-based tool designed to assist researchers during the process of conceptualizing data collection and assessing feasibility of collecting certain data elements for new studies and projects.

As a companion resource to the ATHN Data Dictionary, the library helps researchers avoid “reinventing the wheel” for each study. Using the library, researchers can quickly ascertain the availability of questions used to gather specific data elements and determine if any new questions, response selections, or validation criteria are needed to fulfill the requirements for their proposed study. Ultimately, standardizing questions helps streamline collecting data thus reducing the burden at the sites and the cost of developing electronic study forms by ATHN.

The ATHN Question Library is organized by data categories, and currently contains over 200 standardized questions, a number that will grow over time. Users are able to filter by question category or question text.

Access to the ATHN Question Library is available to researchers at ATHN-affiliated sites via the ATHN Clinical Manager or by contacting support@athn.org.

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