AHRQ update

Health Services Research, June, 2005

In the October 2004 issue of this journal, the Agency for Healthcare Research and Quality (AHRQ) Update traced the evolution of evidence-based medicine at the AHRQ. We described how the research we fund is driven by the needs of its users. A year and a half later, we again describe another evolutionary leap for evidence-based health care at AHRQ.

What's different now? Health care is again undergoing an industrial revolution. Leaps forward have been documented in the past, the development of polio vaccine, antibiotics, Medicare, managed care, and the list goes on. The amount and impact of medical innovation is staggering. From the melding of devices and pharmaceuticals, such as in drug eluding stents, to minimally invasive surgery for conditions that once required massive surgical intervention and long hospital stays. And new, as of yet, unproven technologies and interventions, where we don't know if everyone will benefit, or maybe only a few, or the harms are greater than the benefits. Now, more than ever, information is critical to charting a path through the maze of choices no matter whether you're a patient, purchaser, clinician, or policy maker. We're also lucky because part of the health care industrial revolution includes new advances in health information technology. Put together, we are facing an incredible opportunity to make the use and gathering of evidence of effectiveness part of everyday health care.

The Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003, signed by President George W. Bush on December 8, 2003, was significant for the drug benefit and other changes to the Medicare program. One of the less known sections of the MMA is remarkable for its focus on effectiveness and improved health outcomes--Section 1013. Section 1013 of MMA authorizes The AHRQ to conduct research, demonstrations, and evaluations designed to improve the quality, effectiveness, and efficiency of Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP). The essential goals of the Section 1013 mandate are to develop valid evidence, and make it easily accessible to decision makers, about the comparative effectiveness of different treatments and appropriate clinical approaches to difficult health problems. Achieving these key goals will encompass reviewing, synthesizing, and translating published and unpublished scientific evidence as well as identifying important issues for which existing scientific evidence is insufficient to inform decisions about health care. Hallmarks of the legislation are transparency and stakeholder input.

Through discussion with and extensive input from stakeholders, the Secretary of the Department of Health and Human Services chose 10 priority conditions to guide the work under the Section. The 10 conditions (Table 1) that make up the initial priority list are targeted to the Medicare beneficiaries. Subsequent lists will include conditions relevant to the Medicaid and SCHIP programs. Important questions for health care decision making pertinent to the 10 conditions have been identified through stakeholder input both in writing and through testimony at a public forum. This process will be used to continue to identify important and meaningful questions for health care decision makers.

In 2005, AHRQ received 15 million dollars to begin the implementation of Section 1013. The foundation for the effectiveness program is threefold. First, systematic appraisal of existing scientific evidence on key questions related to the priority conditions. The effectiveness reviews will not only highlight what we know about the effectiveness and comparative effectiveness of different health care interventions, but they will also highlight gaps in the evidence. Not all evidence gaps are equal and not all need to be addressed. The effectiveness reviews will focus on the nature of the gaps, their importance in the evaluation of effectiveness, and the best approaches for filling the gaps. The reviews will be kept current or "sunset-ed" if no longer relevant.

Second, a network of research centers capable of performing accelerated research will conduct a variety of practical studies designed to answer those questions that don't require or can't be addressed by large rigorous randomized clinical trials. The research centers will access patient level data sources, perform prospective observational studies, analyze registry data, and perform research on methodologies supporting accelerated research. The power of health information technology will significantly enhance the opportunities for "real world" data analysis. Administrative data sources linked with clinical data, electronic medical records, pharmaceutical data systems, and linked patient level databases all provide new opportunities for exploring different ways to evaluate what works, at what benefit, and at what risk.

Third, a systematic approach to translating findings into understandable actionable language for all decision makers is critical to making complex scientific findings understandable--for everyone. The Center will initiate activities that communicate the various factors that influence individual decision making and can be incorporated into decision aids. Developed decision aids will include: evidence-based information, values clarification methods, and guidance or coaching in communicating values and personal preferences. The premise for this important work is that correct interpretation of complicated findings and understanding of trade-offs in decision making will lead to greater implementation and better health outcomes. An important corollary is that the information generated must be useful and broadly accessible to be relevant.