Archive for October, 2008

BIG & A Rapid Learning Network for Children’s Health

October 14, 2008

There are so many possibilities for a BIG Health Consortium that is difficult to figure out where to begin! One of the areas with a lot of need – and potential — to be considered is children’s health. There are large gaps in the clinical evidence base for care of children, since they are usually excluded from randomized clinical trials. Moreover, most pediatric practices are small, which limits the ability to advance research on children’s health issues by using registries and databases. There is a particular scarcity of pediatric databases that included patient genetic data.

Pediatric oncology offers an example of where a national effort to develop collaborative research and share data about nearly all children with cancer has resulted in great advances in clinical outcomes. Another example of successful collaboration in a selected children’s health area is the CDC’s Vaccine Safety Datalink, which draws on databases from eight large HMOs. Recently, Children’s Hospital of Philadelphia has been discussing creating a research network of children’s specialty institutions, many of which use the EPIC software platform. There are many potential participants for a national children’s health network, ranging from large organized systems (like Kaiser-Permanente) to academic health centers and community practices.

BIG Health could be the catalyst to create a data-sharing framework for a comprehensive system for children’s health research.

-Lynn Etheredge

BIG Health & New Technologies

October 7, 2008

I think there are major opportunities for BIG Health to create a national system to learn as much as possible, as soon as possible, about the best uses of new technologies.

How might BIG Health contribute? Here’s a sketch of what could be done: Early after a new technology is introduced – ideally, the point of FDA approval, or Medicare coverage, of a new drug, device or procedure – HHS (BIG Health, NIH, FDA, AHRQ, and CMS), with the private sector (physician specialty societies, health plans, researchers, biotechnology and device industry) would develop a national research plan that identifies important effectiveness and safety questions to be answered (e.g. over the next three years), specifies the data needed to answer the questions, and blueprints a linked system of clinical registries to gather the data and make it available for research. In this initial period, major public and private insurers would agree to make their payments be contingent on provider reporting of the needed information to the registries.

BIG Health could have a key role in creating this national system: (1) as a convener, within HHS and with outside parties, to identify research questions and resolve the technical issues needed to create the registries and enable sharing of data; and (2) via BIG’s capabilities, to enable the data-sharing and research projects to proceed quickly and smoothly, connecting many interested parties and collaborators. Absent such an initiative, efforts to learn about new technologies will continue to be a huge problem area for everyone. Working with others, BIG Health could pick several new technologies for national demonstrations.

These BIG capabilities would likely have a lot of use. Both the new FDA Sentinel Network legislation to study drug safety (with up to 100 million patients) and pending legislation for a national comparative effectiveness initiative will need a capacity to carry out studies that can access many databases. Even more urgently, physicians and patients need to know quickly if new technologies offer better results for individual patients. And new technologies are a great place to start: by definition they are where we have the most to learn.

-Lynn Etheredge


October 2, 2008

Dr. Ken Buetow, BIG Health Catalyst

The last couple of weeks have definitely brought to mind the ancient Chinese blessing/cure – “May you live in interesting times”. As the world churns around us, we are reminded of the complex interactive networks that tie together so many apparently disparate pieces of the world. Biomedicine represents one of these complex interactive networks. I participated in two fascinating conferences during the past 2 weeks that provided two synergistic views of the biomedical ecosystem with implications for BIG Health.

The first conference was the 5th European Conference on Complex Systems held this year in Jerusalem. Wikipedia defines a complex system as “a system composed of interconnected parts that as a whole exhibit one or more properties not obvious from the properties of the individual parts”. At the conference, complex systems in physics, biology, economics, art, and music were discussed and analyzed. Work was presented from ecology studying “real” ecosystems. As well summarized in the Wikipedia entry, complex systems share common properties. Key among these are that the systems boundaries are difficult to determine, that they may be systems of systems, they operate as networks, contain feedback loops, have non-linear effects, and demonstrate emergent properties.

The second conference was titled “Health Care Systems of the Future” sponsored by University of California San Francisco Center of Excellence for Breast Cancer Care and Physicians’ Education Resource. The conference brought together diverse stakeholders in health care and research representing academia, government, and industry. The goal of conference was to begin creating the high quality, coordinated systems of care that are linked to the research community to facilitate evidence based management in medicine. The conference explored many of the challenges facing health care. It also highlighted several examples of success. Common among the examples of success was the organizations recognition and leveraging of the systems nature of the problem they were addressing. In one example, Kaiser Permanente Health Care, the systems approach is accomplished implicitly because the group is an integrated deliverer of health care, acting as both payer and provider. They can therefore describe their boundaries, can formally control portions of the network and leverage the appropriate feedback loops to get non-linear effects. A second example was Geisinger Health Care. While geographically defined and having an integtrated component, Geisinger is an open system. It has a system within a system. It explicitly leverages its internal system to maximize the effectiveness of the larger, open portion of its network.

The insights obtained at the intersection of the two meetings provide important lessons for our emerging BIG Health Consortia. As BIG Health moves forward with its demonstration projects it becomes clear that broad engagement of the diverse biomedical stakeholders will be essential for success and necessary to create a self-supporting ecosystem. Moreover, by consciously considering the network of interactions we will be able to leverage the non-linear aspects of the complex system, amplifying the contributions of the consortia.