Comparative Effectiveness (CE) is “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients”. “Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy. The analysis may focus only on the relative medical benefits and risks of each option, or it may also weigh both the costs and the benefits of those options.” (Source: CBO report)
Why comparative effectiveness research is receiving so much attention:
It is one of the disruptive components of health reform. Recent research by Institute of Medicines and articles published by Atul Gwande and others show that heath care cost and quality varies greatly among regions. High cost does not necessarily correlate with high quality of care; more care doesn’t mean better care. Comparative Effectiveness is a hot topic because it offers the prospect of cutting costs while improving health care quality.
CE research data and knowledge dissemination challenges:
In my mind, performing these types of research and disseminating and translating the knowledge is a challenging endeavor at this moment.
Current data sources are fragmented and limited in terms of clinical robustness and longitudinal data capture. We need patient registries, claims, pharmacy, and laboratory data, which may not be available for most part of the population. First, we need EHR in hospitals and clinics and then link those systems using NHIN. Then, data would be available to be used by researchers in a standardized format for apples to apples comparison. Meantime, the hope is VA, DoD, and IHS, who use some version of Vista and have considerable patient data (at least better than other private systems) that could be utilized as a starting point. However, the data will not cover all demographics, which is an important factor in CE research.
Second point is dissemination and usage of knowledge gathered by CE researchers. • Tools and mechanisms to support clinicians and patients in incorporating available CE information are lacking. This information needs to be delivered to the front line of care where health decisions are made and results measured. So, comprehensive approach is required to define how knowledge can become practice. We may need a separate body like FDA to coordinate the knowledgebase. The countries such as UK, Canada, Australia, and Germany have government bodies to handle similar knowledge dissemination.
Questions and Fears:
It is unclear at this time whether cost effectiveness will be part of CE. Also, people are concerned about how government will set priorities for research, what research methods would be used, and when will a new intervention be subject to CE. Additionally, it is not clear in what extent cost effectiveness will become part of the research I think these are natural anxieties for such a big change in medical practice.
Business Model Disruption and Innovation:
Some doctors mentioned that CE will create cook-book medicine and stifle innovation. As an engineer I do not agree with this thinking process. In Computer Science or in most branches of engineering, we have codified practices that most of us follow. That does not mean innovation has stopped. I think innovation will move to a different level and may be disruptive for some providers/payers/drug companies/medical device companies. In my next post I will describe some of the new business models that may emerge when CE could be used effectively in America.
Some initial thoughts on impact to various stakeholders:
Patients: Could make more informed decisions.
Providers/Hospitals: May reduce avoidable errors. Hospitals may be penalized for variations in outcome.
Payers: They may encourage the adoption of most valuable treatment options.
Drug Companies: Use of generics may become widespread if patented version is not more effective. The hurdle for new product adoption may increase as bar for new innovation would be higher.
Sunday, August 30, 2009
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