The Health and Human Services Department on Monday issued a request for information on constructing an online catalog of studies that compare the outcomes of medical treatments. The effort, largely funded by stimulus dollars, is aimed at aiding decisions on cost reimbursements and courses of treatment.
HHS asked the health care community for help organizing a database of comparative effectiveness research, which is scientific evidence demonstrating what treatments work best for individual patients. The Obama administration says such information is critical to lowering health care costs and to improving patient results. The 2009 Recovery Act dedicated $1.1 billion to comparative effectiveness research.
Officials sought suggestions on data sources that should feed into the website, a way to organize the content and incentives for encouraging the medical community to contribute research.
HHS envisions a site that is searchable, simple to update and makes it easy to gauge gaps in available research, according to the notice. The site also will supply users with information on how to conduct comparative effectiveness research and how to translate findings into language that is understandable to policymakers and health care decision-makers. The government did not seek advice on research methodologies or on specific studies to include.
The use of comparative effectiveness has stirred up debate among patient advocacy groups, budget analysts and drug companies. Organizations representing people suffering from cancer, AIDS, mental illness and other debilitating diseases are anxious to establish a sophisticated repository quickly. Some health care experts have said doctors participating in government-administrated health plans should be required to disclose claims paid by the government for analysis of outcomes, especially since part of the goal is to eradicate improper Medicare and Medicaid payments. The pharmaceutical industry sees value in the effort but has concerns the government will use the data to deny Medicare or Medicaid coverage for needed therapies.
According to Monday's announcement, the medical interventions that will be cataloged might include drugs, procedures, medical devices and technologies, laboratory testing, behavioral change and health care delivery strategies. A key challenge will be ensuring the research on therapies remains up-to-date, so as not to diminish treatments that new research proves to be more successful than previously thought -- or to promote treatments that recent evidence demonstrates carry severe risks.
The website will pull from publicly available government databases such as PubMed, which provides tens of millions of citations for biomedical literature, and Clincaltrials.gov, a registry of federally and privately supported clinical trials conducted worldwide. HHS officials sought ideas on privately funded databases and currently inaccessible literature from which to draw. They also have to determine how to motivate scientists to submit research abstracts and other relevant materials. And the government must figure out how to make the site easy to navigate for a wide audience that includes researchers, policymakers, doctors, patients and consumers.
Monday's notice asked what kind of metadata, or data describing data entries, scientists should type in when they contribute documents. The request for ideas also touched on funding in noting that people who submit comments should propose business models that will enable "a sustainable inventory over time."
Comments are due in three weeks, and can be submitted through Regulations.gov.