american thrombosis & hemostasis network

ATHN’s mission is to provide stewardship of a secure national database, adherent to all privacy guidelines, which will be used to support clinical outcomes analysis, research, advocacy and public health reporting in the hemostasis and thrombosis community.

ATHN will foster collaboration with patients, providers, suppliers, government agencies and non-profit organizations in the thrombosis and hemostasis community. The organization’s core values are:

• Improving clinical outcomes and care
• Facilitating continuity of care
• Fostering collaboration
• Maintaining confidentiality
• Conserving resources through a common infrastructure

ATHN was formed in response to nationally identified needs delineated over the course of two years by representatives of the hemophilia provider and patient communities that included the following:

• Need for research that links medical interventions with clinical outcomes;
• Need for evidence-based clinical standards;
• Need for standardization and an improved means of collaboration with one national database;
• Need to conserve and consolidate scarce resources.

The ultimate decision to form ATHN as an independent organization was based on the recommendation of two working groups – clinical and operational - that included representation from a broad range of hemophilia organizations, institutions, clinical disciplines and fields of expertise.  Although the multiple constituencies had interest and need to develop an evidence base and an electronic infrastructure to support policy, research and patient care, no other organization was in a position to coordinate these efforts…hence, the birth of ATHN.

ATHN will be gathering information about patients with a wide range of bleeding and blood clotting disorders. (Some common examples are listed below.)

• Hemophilia (with and without inhibitors)

• Hemophilia A (Factor VIII deficiency)
• Hemophilia B (Factor IX deficiency)

• Other bleeding disorders due to factor deficiencies

• Factor I
• Factor II
• Factor V
• Factor VII
• Factor X
• Factor XI
• Factor XIII

• Von Willebrand Disease

• Type 1
• Type 2
• Type 3

• Thrombotic Disorders

• Protein C deficiency
• Protein S deficiency
• Factor V Leiden mutation
• Antithrombin III deficiency
• Prothrombin G20210A mutation
• Hyperhomocystinemia
• Elevated factor VIII
• Elevated factor XI
• Elevated lipoprotein
• Acquired thrombophilia
• Thrombophilia of ACA

• Platelet Disorders

• Glanzmann’s Disease
• Bernard Soulier Syndrome
• Hereditary Hemorrhagic Telangiectasia

Clearly the data points, beyond a core set collected, will vary dependent on a specific project and patient consent. Therefore, we cannot determine at this time all data points for the future, as the scope of projects required to advance patient care are dynamic not yet defined. Basic information may include: family history, risk factors, co-morbidities, allergies, diagnostic tests, treatment regimen, presence of inhibitors, procedures, bleed status, cost, access to care, utilization, outcomes, and quality of life. Over time, ATHN would be prepared to collect additional information as needed to address specific projects and research issues.

The ATHN Board of Directors is comprised of a prestigious and broad based group of healthcare professionals and other leaders. The present ATHN Board of Directors reflects the broader hemostasis and thrombosis community with representation of consumers, providers and HTC regions. Seven of its 17 members are physicians providing care as pediatric or adult hematologists. Included are the immediate past president and a current board member of the Hemostasis and Thrombosis Research Society (HTRS), as well as a former chair of the National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC), the professional body that recommends standards of care. Other ATHN board directors are drawn from different regions of the country to bring insight and expertise from clinical nursing, social services, law, and the management of treatment centers. A consumer member and the ATHN CEO complete the voting membership. In addition, to help ensure compatibility with the increasingly sophisticated public health network dedicated to bleeding and clotting disorders, a well respected hematologist represents the Centers for Disease Control and Prevention (CDC) Division of Blood Disorders as an ex officio member. The Co-chairs of the ATHN Board of Directors are:

Jeanne Lusher, M.D.
Co-Chair, ATHN Board of Directors
Director,
Hemostasis and Thrombosis Center;
Co-Director
Hematology / Oncology
Children's Hospital of Michigan
Distinguished Professor of Pediatrics,
Wayne State University
Detroit, MI

Amy Shapiro, M.D.
Co-Chair, ATHN Board of Directors
Medical Director
Indiana Hemophilia and Thrombosis Center
Indianapolis, IN

ATHN is a non-profit organization represented by a diverse board of directors.  We pursue our mission only through the willing participation of groups and individuals from across the bleeding and clotting disorders community.   While ATHN does not have a written specific “transparency policy” at this time, the board is committed to the highest ethical standards.  It has adopted a policy on disclosure of potential conflicts of interest.  And, it communicates its intent broadly as evidenced by the past and planned media relations and presentations at HFA, NHF and HTC regional meetings.  One recommendation being implemented is the posting of projects under consideration or being implemented by ATHN, similar to the listing of studies on www.clinicaltrials.gov.

Within the bleeding and clotting community, ATHN is, in many ways, a first.  However, collaboratives in other clinical areas have been successful and can serve as a model for development.  For example, the Children’s Oncology Group is a research collaborative focused on children’s oncology issues.   The group registers children and adolescents through member institutions with the goal of having clinical information about every child diagnosed with cancer in the U.S. and Canada.   Similarly, the Cystic Fibrosis Foundation built upon its network of accredited care centers to create a research network. 

Within the bleeding and clotting community, ATHN is, in many ways, a first.  However, collaboratives in other clinical areas have been successful and can serve as a model for development.  For example, the Children’s Oncology Group is a collaborative focused on children’s oncology issues.   The group registers children and adolescents through member institutions with the goal of having clinical information about every child diagnosed with cancer in the U.S. and Canada.   Similarly, the Cystic Fibrosis Foundation built upon its network of accredited care centers to create a research network.

The work of ATHN will help ensure that health care decisions, at the individual as well as population level, are optimally based on complete, standardized information, as opposed to fragmented data that must be pieced together.  The ATHN infrastructure will produce the breadth and scope of standardized data needed to better understand the epidemiology, genetics and natural history of these disorders, analyze clinical outcomes of persons with bleeding and blood clotting disorders, facilitate the development of standards of care, aid in the post-marketing surveillance of FDA approved therapies, as well as support advocacy and community education.  We believe that assessing high cost, but effective, necessary and expected therapies and regimens (e.g., immune tolerance, prophylaxis, etc.) will help to preserve access to high quality care.

ATHN is a non-profit organization with a mission and a commitment to community, not private, interests.  This is not privatization of data collection, and  ATHN will work to secure and provide support for publicly funded projects as well as private research in a way that existing organizations to date have not and/or cannot based on their missions and priorities. 

The question you are asking has a number of views. What is the value of solid clinical evidence to support the development of treatments for our patients? What is the value of reducing the time to conduct a study because a trained network can be deployed? What is the value of improving care and outcomes for the bleeding and clotting disorders community? What is the value of good clean data in establishing reimbursement policies and treatment access provisions? One thing is certain: ATHN will not have access to, nor sell, patient identifying information (e.g., name, street address, telephone number) for direct marketing or other purposes. We do not know the real commercial value of the data, in terms of dollars, to any entity, and it is important to stress that this is not our goal. For now, to the extent we are able to obtain funding to conduct select projects that improve care and outcomes as well as demonstrate our capabilities and test our infrastructure, we will influence the value of the data as well as ATHN’s services in the future.

The CDC’s congressional mandate is focused on public health research and surveillance.  ATHN was formed to identify and develop resources to promote a broader range of clinical studies that are outside the scope of the CDC Congressional mandate.  Many of the questions likely to be asked of the ATHN database relate to clinical outcomes, advocacy, best practices and new treatment modalities.

Yes!  The ATHN board includes the mother of a college aged individual with severe hemophilia.  Consumer representatives have been appointed to key ATHN committees related to privacy and access to data, the organization and security of the technological infrastructure, as well as community relations.

In terms of ATHN research, patients will have a choice.  And, the patient’s choice will be documented in a written patient consent form maintained at the treatment center, which will have been reviewed by the provider’s Institutional Review Board (IRB).  The choice is to participate in ATHN or to forego the opportunity.  The name and address of the patient will not be available to ATHN.  The patient and family will retain privacy and control over their lives.  If the patient’s decision is to contribute to scientific studies for the improvement of care, then a limited subset of data that has been stripped of identifying information will be available to ATHN.  If the patient chooses not to participate in ATHN, no data (i.e., neither personal demographic data nor de-identified data) will be transferred by the patient’s healthcare provider.  Whatever the patient’s decision, their choice will not influence the care received.

Today, over 80% of hemophilia patients treated at HTC’s choose to participate in the Universal Data Collection (UDC) project sponsored by the CDC.  Many also choose to participate in other specific clinical studies through their HTC.  We believe it is important that consumers be willing to share their de-identified clinical information with ATHN to conduct much needed research in order to preserve access to high cost, but effective, necessary and expected, therapies and regimens (e.g., immune tolerance, prophylaxis, etc.).  We believe that once informed, patients will recognize the enduring benefits of ATHN, and not only consent to be a part of this important community resource, but ask to be part of it.

At this time, ATHN’s vision encompasses the federally funded Hemophilia Treatment Centers and non-federally funded entities. The other entities HTCs might be university-affiliated programs conducting clinical research, community-based providers of hemostasis services, and/or thrombosis treatment centers. Their involvement could be on a continuous basis or simply limited to a particular project. We anticipate that integrating new entities into ATHN takes time, money and commitment, so we would phase in non-federally funded entities once the federally-funded centers are successfully up and running, and according to some guidelines which would have to be defined (for example number of patients served, area of country, etc.).

All HTCs will be encouraged to participate in ATHN as ATHN Affiliates. Toward that end, ATHN will create a formal coalition with the 30 year old network of 140 HTCs across the U.S. that are funded on a federal level by HRSA’s Maternal and Child Health Bureau (MCHB) and the Centers for Disease Control and Prevention (CDC). These centers provide comprehensive, multi-disciplinary care to the individuals and families in the U.S. with bleeding and thrombotic disorders. The goal of this approach is to conserve resources through use of a common information infrastructure and to foster collaboration within the thrombosis and hemostasis community.

Yes, absolutely.  The Community Liaison Group, comprised of representatives from key organizations, will enable professional and consumer organizations a voice in the future direction of ATHN.  ATHN will accept grants or other contributions from government and philanthropic organizations.   ATHN has recently submitted a grant to a non-profit foundation for a specific project.    ATHN also retains the right to accept funding from other for profit organizations, including other pharmaceutical companies, on a project specific basis (e.g., a thrombosis research project; rare bleeding disorder pilot study; etc).  The organization intends to seek philanthropic and government grants and to work with for profit organizations on an operational basis. 

Federal agencies will participate in ATHN through the Community Liaison Group.  Centers for Disease Control and Prevention (CDC), Maternal and Child Health Bureau (MCHB), the Food and Drug Administration (FDA), and the National Heart, Lung and Blood Institute (NHLBI) have accepted invitations to collaborate and to provide input through this group.  In addition, ATHN may work with individual agencies on specific projects.

To attain its vision, ATHN seeks to foster collaboration with patients, providers, suppliers, government agencies and non-profit organizations in the community.  During the planning meetings prior to the incorporation of ATHN, creation of a Resource and Liaison Group, now called the Community Liaison Group, with representation of key organizations was envisioned.  This group will meet for the first time in November, 2007.  Collaborating organizations were invited to appoint a representative who will provide advice to the ATHN Board of Directors, facilitate alignment with broader community needs and become a conduit for communication with their parent organization.   Some of the organizations that have agreed to participate are:  National Hemophilia Foundation (NHF), Hemophilia Federation of America (HFA), National Alliance for Thrombosis and Thrombophilia (NATT), Hemophilia and Thrombosis Research Society (HTRS), World Federation of Hemophilia (WFH), Centers for Disease Control and Prevention (CDC), Maternal and Child Health Bureau (MCHB), the Food and Drug Administration (FDA), and the National Heart, Lung and Blood Institute (NHLBI).  This list by no means precludes other organizations from becoming involved.

Earlier this year, ATHN issued a call for volunteers to serve on three key committees:  Community Relations and Communications; Privacy, Data Access and Security; and the Technology Committee.  Individuals with bleeding and clotting disorders and their family members as well as providers within the Hemophilia Treatment Center Network were encouraged to recommend qualified individuals and to submit written application through the ATHN website.  As a result of this effort and application process, twelve “first time” ATHN committee members were added in 2007.  A similar call for volunteers will occur in the fall of this year.

Yes, the Centers for Disease Control and Prevention Division of Blood Disorders will still be at the center of collecting, analyzing, strengthening, and publishing Universal Data Collection (UDC) data.  ATHN will collaborate closely with this initiative to avoid redundant data entry. 

Each is a non-profit organization established for its stated purpose.  There is no overlap of staff or services between ATHN and these organizations.  The Hemophilia Group Purchasing Organization (HAGPO) and The Hemophilia Alliance are separate and distinct tax exempt organizations with their own missions and governance.

The status of the HTRS registry is between HTRS and Novo Nordisk to decide. ATHN has no rights to the HTRS database. ATHN has sought a collaborative relationship with HTRS and would welcome an opportunity to discuss these issues.

One of ATHN’s core values is to conserve resources through a common infrastructure across the federally funded hemophilia treatment centers and other centers participating in the ATHN network. We hope that with the network, centers will be able to capture data once and then reuse it within the system again and again.

An “ATHN Affiliate” is a federally-funded hemophilia treatment center (HTC) or thrombosis site or other qualified provider organization that shares the vision, mission and values of ATHN, exemplifies the required characteristics of an ATHN Affiliate and commits to utilize the Lab Tracker/ its web-based version created by Ground Zero and hosted by the CDC, or other ATHN endorsed patient management software, which will allow the community to share HIPAA compliant non-identifiable patient data through ATHN.

ATHN will establish formal contractual relationships for data utilization with these organizations.  In turn, these organizations will play a distinct role in ATHN governance and will have access to specific projects and support services through ATHN.

ATHN Affiliates are central to the development of ATHN as a valued community resource. They help shape the direction of ATHN and may benefit from its projects and support services.  More specifically, ATHN Affiliates benefit from:

A Voice in ATHN Governance

• Guaranteed to be represented by at least six ATHN Affiliates on the ATHN Board
• Eligible to nominate and to be nominated for the ATHN Board of Directors or one of the ATHN committees
• Ability to serve on ATHN Project Review Panels
• Ability to vote on policies regarding data access, research agendas, criteria for becoming/remaining an ATHN Affiliate
• Right to determine disposition of data in the event of dissolution of ATHN

Access to Collaborative Projects and Studies

• A collaborating participant in the ATHN national database
• Full access to one’s own data, with access to the broader database per data access rule/regulations/policies
• Option to participate in special projects and studies
• Invitation to the ATHN annual meeting
• Eligibility for application for data manager support
• Potential to become principal investigator for ATHN projects
• Right to propose projects and/or take a leadership role in projects that may utilize the ATHN national database
• The support of centralized project management

Support Services

• Templates for development of institutionally accepted IRB submissions and patient consent forms for participation in ATHN
• Patient education/recruitment tools
• Eligibility for Data manager training
• Eligibility for Virtual help desk
• Quarterly update

Collaboration, competence, commitment and compliance are characteristics to be demonstrated by all ATHN Affiliates.  Evidence of these characteristics is listed below.

Collaboration

• Work cooperatively with other ATHN Affiliates, ATHN management and other participating entities in fulfilling projects and studies to which it has agreed to participate
• Respond in a timely manner to project inquiries
• Contribute to the continuous improvement of group processes, products and outcomes related to this important community resource

Competence

• Deliver multidisciplinary care to patients with bleeding and/or blood clotting disorders through a federally-funded hemophilia treatment center or thrombosis site, OR meet other criteria which may be published by ATHN
• Ensure that data managers are adequately trained in terms of data definitions, data standards and application systems and accurate, timely data submission

Commitment

• Use its best efforts to enroll patients into the ATHN database, achieving enrollment and minimum data requirements established by the network
• Maintain accurate and up-to-date core data for enrolled patients
• Designate a Principal Investigator to represent the affiliate organization in votes and to serve as the primary contact for communications.  An alternate communications contact may be designated as well.

Compliance

• Deploy Lab Tracker® -web created by Ground Zero and hosted by the CDC, or other ATHN endorsed patient management software, which will allow the community to share HIPAA compliant non-identifiable patient data through ATHN.
• Access to an Institutional Review Board (IRB) or willingness to utilize a central IRB adopted by ATHN
• Assure compliance with regulations related to IRB approvals, Patient Informed Consent, HIPAA Privacy and Security Rule.
• Adhere to minimum data standards, quality assurance standards, data utilization guidelines, training requirements, publication guidelines or other criteria which may be recommended by ATHN Affiliates and adopted as ATHN policy.

Each ATHN Affiliate will be expected to execute a letter agreement confirming the relationship.

Yes!  ATHN Affiliates will hold six (6) positions on the ATHN Board of Directors.  In addition, ATHN Affiliates will be able to influence policies regarding network operations such as data access, eligibility criteria for non-federally funded treatment centers, and even the disposition of data in the event of dissolution of ATHN.  ATHN committees and project review panels are open to ATHN Affiliates as well.

ATHN will support quality and consistency of data on a national level through HIPAA privacy and security compliant data management policies, procedures, training programs and support.  In addition, ATHN has committed to developing a process for evaluating and providing financial support for data managers at the local level so that all HTCs can contribute to a robust and accurate database.

Quite the contrary, we would hope that ATHN can collaborate with investigators who want to recruit study sites/patients from a nationwide network easily and efficiently.  As ATHN’s infrastructure is developed, its communications network, database, tools and processes should provide value add to projects.

Participation in special studies would be at the discretion of each ATHN Affiliate.  For special studies requiring incremental nursing time, patient visits or IRB submissions, ATHN would make every effort to secure funding that would compensate ATHN Affiliates for the added work.

There is no fee for becoming an ATHN Affiliate during this initial enrollment period.

ATHN, working with the CDC to secure and develop infrastructure resources, offers the greatest degree of protection and security for individual patient and center data with the maximum amount of flexibility.  As a federal agency, the CDC is limited in the services that it can legally provide.  The CDC cannot solicit private donations (raise funds) for research or other activities in the same way or as effectively as a private, community based organization like ATHN can.  However, the CDC has generously offered to provide the bleeding disorders community with access to state-of- the-art security and data protection by hosting the software which will allow ATHN Affiliates to pool their non-identifiable patient data to create a robust data source for research and other data needs of the bleeding disorders community at a fraction of the cost of private data hosting services.   To ensure that the CDC has no access to the data, there are strict limitations on physical access to the server and the database.  More importantly, however, the data that is stored at CDC will be encrypted using a code maintained separately by Ground Zero.  No ATHN Affiliate or individual patient protected health information data except defined data sets for which consent has been obtained will be accessible in any usable form by anyone except individual ATHN Affiliates.

For patients who have provided written consent, ATHN will receive a “Limited Data Set” that will be generated by Lab Tracker using pre-defined and agreed upon business rules.  The Lab Tracker Patient Management System will have powerful capabilities built in which will automatically transform the patient data into a non-identifiable form and send the resulting “Limited Data Set” to ATHN.  Limited Data Set is a type of de-identified data defined under the HIPAA Privacy Rule for the purposes of research. It permits covered entities to share this kind of non-identifiable patient data to researchers.  By definition, a Limited Data Set cannot include patient name, street address, telephone number or guardian information that would help to identify the patient.

CDC will not have access to any affiliated patient’s protected health information. Similar to the process currently used for patients who have provided written consent, the Lab Tracker Patient Management System’s capabilities will create a subset of the affiliate’s patient information into a pre-approved HIPAA compliant minimum necessary public health dataset and transmit that data to the CDC for public health surveillance as part of the Universal Data Collection (UDC) and Hemophilia Data Set (HDS) permitted under the HIPAA Privacy Rule.

No. The patient data hosted by CDC via Lab Tracker will be owned by the affiliates and not be used, controlled or accessed by the CDC or any other federal agency; therefore it is not a “federal system of records” which would subject it to this regulation. In addition, since this patient information will be protected by HIPAA, the Privacy Act will also not apply. The Privacy Act of 1974 applies to information in a system of federal records. The Privacy Act applies to information in a federal record, and HIPAA applies to covered health care entities. Since this patient information belongs to the health care provider and CDC will not have access to it; the HIPAA Privacy Rule provides the best protection of the patient’s privacy and confidentiality.

ATHN recognizes and respects a patient’s right to protect the confidentiality of their medical information, to determine who can access their personal information and to choose to participate in a research program such as ATHN, or not.  Be assured that a patient’s personal health information will continue to be protected by the Hemophilia Treatment Center chosen for clinical care.  A patient’s information is not automatically shared with ATHN or any other entity. The healthcare provider maintains and uses its medical record to manage a patient’s care.  That record, whether stored on paper or electronically, cannot be viewed or shared with others without the patient’s consent.

Absolutely not.    ATHN will not have access to information such as name and address that identifies the patient. Patient privacy will be protected.

An open and transparent process for requesting access to data will be established via ATHN’s Privacy and Data Security Committee, chaired by Tami Wood-Lively, JD, MPA an attorney who is the regional coordinator for region V-east and a member of the ATHN Board of Directors.  This committee of ATHN will have oversight with broad representation including consumers to assure that this process protects patient confidentiality and that data is available for meaningful purposes.  For 2007, we are honored that physician and ATHN co-chair Jeanne Lusher, MD, as well as Paul Haas, PhD, immediate past-President of NHF, have agreed to serve as members of this important committee along with a nurse, a consumer with extensive IT experience and a representative of the CDC.  As a new organization, ATHN’s specific written policies related to privacy, data security and access are in the formative stage.  ATHN envisions the data being useful for a wide range of issues: epidemiological, clinical, advocacy, patient safety, etc.  No one has preferential or carte blanche access to data.

Absolutely not.  The agreement explicitly states that Novo Nordisk will not have access to the database developed or the services provided by ATHN, except upon the same terms that are available to third parties.

CDC is providing secure servers and the hosting capabilities for the software which allows ATHN to pool the non-identified patient data.  This helps ensure that the data remains protected in the event that ATHN no longer exists.  Additionally, one of the contractual rights of ATHN Affiliates is the right to determine the disposition of the database in the event of dissolution of ATHN, further ensuring  that the data remains protected and that the best interests of the community continue to be served.

In 2004, the CDC foundation provided funds for the purpose of retaining a consultant to explore the feasibility of ATHN and to oversee the initial planning process.  After ATHN was incorporated, fundraising initiatives were directed toward both not-for-profit organizations and for profit entities.  In early 2007, ATHN received a significant 5-year non-restricted grant from Novo Nordisk that made it possible for ATHN to advance.  As time goes on, we expect that a number of organizations (profit and not-for-profit, private and public) will appreciate the value that ATHN can bring and be willing to fund project specific work going forward.

As a company, Novo Nordisk has a leading position within hemostasis management.  Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers.  ATHN is grateful that Novo Nordisk perceives our mission as a worthwhile cause and one way to fulfill its social responsibility to the community we all serve.

None.  ATHN has received an unrestricted grant from Novo Nordisk.  The agreement explicitly states that Novo Nordisk will not control or otherwise influence the content of the database or information collected by ATHN, nor will they assist in the development of the database or any materials or information disseminated by ATHN.  During the 5 year term of funding, ATHN will acknowledge “Novo Nordisk for supporting the founding and continued support of ATHN through an unrestricted grant.”

The simple answer to this complex question is that we don’t know.  It is not our primary goal to develop data for sale.  We know that to get off the ground, ATHN requires capital to build its infrastructure. In fulfilling its mission, ATHN’s funding requirements will be a function of the specific projects that are undertaken and the extent to which those projects will assist ATHN in developing and leveraging core infrastructure.  ATHN is in the stage of building its infrastructure; i.e., defining the relationships with the HTCs and the CDC, creating the tools and processes that will be required for the smooth functioning of the network for the collection of data, etc.  Today, ATHN has no data available for others to use.  From a broader, future perspective, “what might be accessible” must be more fully articulated.  For example, access can have multiple dimensions: access to the practitioners in the network for studies, access to standard analyses which could be developed, access to custom analyses of data in the database, access to unique data collected for specific purposes.  Each of these uses will require funding through ATHN and have different cost implications and work load requirements.  How those costs are supported by ATHN will vary depending upon the specific project.

Each of the organizations in the community contribute, in a unique way, to the community we all serve.  As an organization, we will work to make ATHN an organization that helps to conserve precious community resources so that the care of individuals affected by bleeding and thrombotic disorders is advanced and improved; and that ultimately, funds are preserved for the good works of other organizations.   ATHN does not anticipate that its funding will result in a diminution of funding to other agencies or programs.

Yes, each year ATHN will publish an annual report that will indicate sources of revenues, expenditures as well as key accomplishments.