CDC and NHLBI Launch RuSH Program for Thalassemia and Sickle Cell

Wednesday, July 13th, 2011 at 5:34 pm

July 11, 2011 – CAF speaks with Dr. Althea Grant, Chief, Epidemiology and Surveillance Branch at the Centers for Disease Control and Prevention (CDC) about the new RuSH (Registry and Surveillance for Hemoglobinopathies) program, a project of the CDC and the National Heart, Lung and Blood Institute (NHLBI).

CAF: How did the RuSH program come to be?
Dr. Grant: The RuSH program, which stands for Registry and Surveillance for Hemoglobinopathies, originated from the convergence of several interests. For some time, the National Heart, Lung and Blood Institute (NHLBI) had been interested in creating a registry and repository in hemoglobinopathies (including thalassemia and sickle cell disease) for use in research and clinical studies. At the same time, the Centers for Disease Control and Prevention (CDC) felt there was a need for a public health surveillance program for people with hemoglobinopathies. In addition, there was community interest, from the thalassemia community and the Sickle Cell Disease Association, the American Society of Pediatric Hematology/Oncology (ASPHO) and others, in some kind of population-based surveillance system and registry. Discussion about such a project began in earnest in 2007; the CDC and the NHLBI started meeting to determine how we could get all the interested parties together and make these wonderful ideas a reality.

There were several constraints for both agencies that made working together seem natural. In order for the clinical registry to be successful and representative, we first need to really know what the population looks like: what are its characteristics, what is the demographic distribution, etc. We need a strong foundation to start with in order to properly design the registry. The CDC has a very strong interest in public health surveillance, in monitoring complications and in designing programs to improve the health of these populations with hemoglobinopathies. But the CDC did not have sufficient Congressional funding for hemoglobinopathies to undertake this kind of project. So the NHLBI set up an inter-agency agreement with the CDC to transfer part of their funding to the foundational steps of the project, the public health surveillance. Once that is up and running, in subsequent years NHLBI will be able to design the registry component.

The proposal for the project went through several agencies for approval and then through about a year and a half of planning. The implementation phase began in 2010 as states began to implement the initial surveillance component.

Can you explain a little more about the role that the states play in RuSH?
There are seven states that are involved in this phase of the RuSH program: California, Florida, Georgia, Michigan, New York, North Carolina and Pennsylvania. They play a most critical role.

The CDC has historically worked very closely with states in developing public health surveillance programs; most are operated at the state level. That is because there are laws in different states which influence what data can be collected and how and from whom that data can be collected. When the CDC wants to start a public health surveillance program involving states, it usually puts together a funding opportunity announcement for a cooperative agreement for which states may apply. The cooperative agreement clearly states the objectives and activities of the public health surveillance program and usually defines how each state will work together with the CDC on implementation of the program. However, the states will have their own goals and objectives as well that may propose in their application

When we announced the initial cooperative agreement, 10 states applied, of which 6 were selected. As we got toward the end of the year, we discovered that there was sufficient funding left over to fund a seventh state, so we now have 6 states operating on one funding cycle and a seventh on a separate funding cycle.

How will the information that is gathered from RuSH be utilized? What will be the benefits to the thalassemia community?
The information will be utilized on multiple levels. On the federal side, this information will inform policymakers about the burden and complications associated with the thalassemia and other hemoglobinopathies, the healthcare needs of the patient population, and the program needs for the thalassemia population. It will provide information on how we need to change or enhance programs to better serve the population.

There are also a lot of programs, especially those involving healthcare and reimbursement, that occur at the state levels, and so states will be able to use this information in a similar way. Knowing how many patients there are , in which area patients reside, what services are needed, what resources already exist, etc. will aid in services and policy planning on a state level.

Researchers will also be helped. We often think of researchers solely in a clinical context, but even surveillance data is important for researchers; it provides researchers a foundation for the information they need to plan study. It’s hard to design a study if you don’t know how many people are available, where those people get their care, what their demographic characteristics are, what language barriers there may be, etc. This will also be a boost to epidemiological research, as we begin to assess population trends and related questions.

Community-based organizations will also benefit. They often don’t have access to the data that they need about the populations they’re trying to reach and serve: who the patients are, the number of patients, what their characteristics are, where they get their care, their geographic distribution. This information will help them to better target their outreach efforts and also to better advocate for the populations they serve populations with policymakers.

What are some of the challenges with which RuSH must contend?
There are many. From the data collection point of view, there are several. Firstly RuSH is non-research project and therefore is trying to collect data from existing data sets. But there is not uniformity as to how that data is collected. We’re collecting information from many different data sources that are often difficult to combine. The seven states all have their own systems for collecting data; it’s like having individual systems that don’t quite talk to each other.

Also, this is a multi-disciplinary partnership. In order to for the project to be successful, partners from different sectors – federal, state, community-based organization, clinical settings – have to work together. And even within one state health department, multiple sections such as newborn screening, vital records and Medicaid, all have to work together. Bringing all the parties together can be challenging.
There is also limited funding resources for the project. The states are each awarded about $500,000 per year, and when you take into consideration all the tasks that need to be accomplished and all the partners that need to be engaged, that actually isn’t a great deal of money. I think it’s impressive the amount of work that is getting done given these resources, and that the work is getting done because people are really dedicated to the objectives of the program and are determined to see it succeed; that is really one of the most gratifying parts of the whole project!

I know the RuSH project is still in its early stages, but can you give an opinion as to how it is going so far? Are there any particular steps that have been taken that you would want to highlight at this point?

I think it’s going great so far! I can honestly say that we are ahead of where we have been with any other surveillance program that I’ve worked with. Normally, as with our thalassemia data collection program, it takes about 3 years from the time the project starts to the time when you start really collecting data. This program has only been going on for one year and we already have data coming in. It really is amazing and again it just shows the dedication of the people working on project, especially at the state level. Every barrier that we encounter, we seem to find a way to come together as group and figure out ways to work around them. From CDC’s perspective, this project is truly establishing itself as a model for future projects.

CAF and other members of thethalassemia community have been helping to inform participating states about details related to thalassemia. When the project really gets going, is there anything that the states need individuals with thalassemia to do to make sure that they are counted?

We are collecting data mostly from healthcare encounters from either administrative data that tracks healthcare visits or clinical centers that collect data about the patients they serve, so it’s very important for people with thalassemia to make sure they’re in care, making regular appointments, going to annual visits, etc. so that they can be counted as part of the healthcare system. They also can reach out to CAF and other organizations to learn more about RuSH, particularly as the registry develops in the future. There may be an opportunity then to be more actively involved, so being more informed will make them better positioned to participate.

What else do you think the thalassemia community (or the general public) should know about RuSH?

One thing that the thalassemia community should know is that this is a long term commitment on behalf of the CDC, even though the initial funding is only short-term. Surveillance is by definition an ongoing activity; it’s only helpful if one can monitor a population over time. We are committed to continue monitoring health of the population and to achieve the Healthy People 2020 objectives for people with hemoglobinopathies. We do not think of this as finite; it is a long term program with long term implications that will give us the foundation to monitor health of the hemoglobinopathies populations over time.

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