The New Effective Health Care Program at AHRQ

Increasingly, a common challenge for both health care providers and consumers is the difficulty they face trying to keep informed about the latest developments in research into effective treatments and assessing this research in the context of earlier studies. The new Effective Health Care Program, administered by the Agency for Healthcare Research and Quality (AHRQ), is designed to alleviate these problems through a combination of comparative effectiveness reports, accelerated gap-filling studies, and improved techniques for communicating research findings to both clinicians and patients.

The program was authorized in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, legislation better known for adding the new Part D prescription drug benefit to the Medicare program. Section 1013 of the MMA directs 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). A cardinal principle of the new program is that stakeholders should have available the best evidence on which to make decisions about health services and products. A second cardinal principle is that priorities for this new program will be driven by the needs of decision-makers; i.e., those who administer the Medicare, Medicaid, and S-CHIP programs.

Launched in September 2005, the Effective Health Care Program focuses on common clinical problems where significant questions exist about the relative effectiveness of alternative clinical interventions. While AHRQ and others in the health services research community have been involved in effectiveness research for years, the new program will take a more strategic and explicit approach (focusing on particular topics where there are urgent questions), employing systematic methods of generating evidence, and placing increased emphasis on getting evidence into use (including translating that evidence into usable formats).

The Effective Health Care Program exists in a dynamic environment, with continuing change in the evidence base. Across the program’s various components, there will be continued emphasis on examining new evidence as it becomes available, incorporating it into the knowledge base made available to decision-makers, and making sure that research questions are timely and relevant to the needs of decision-makers.

Background: The Pre-MMA Dilemma
Despite historic attempts to prioritize effectiveness research and to identify bases of knowledge systematically, prior to the Effective Health Care Program limited efforts had been made to synthesize and inventory available research, identify and resolve major gaps in this research, and address the problem of communicating with relevant audiences, including both clinicians and consumers. Long-established programs exist to synthesize research findings but little effort has been directed to translating these complex scientific findings for decision-makers. Similarly, linking research gaps identified through systematic review with research funding efforts has traditionally received less attention. Those seeking to negotiate this terrain were in a position like that of a motorist driving in strange territory without an adequate roadmap.

The high profile release of single study findings often leaves physicians, patients, and other medical decision-makers to attempt to understand a growing explosion of information on relative risks and benefits of commonly available and new treatments. The rapid increase of clinical evidence is so striking it is difficult even for specialists to stay current within their particular specialties; the problems confronting general practitioners are mindboggling. Health care decision-makers need an organized evidence base that corresponds to the essential questions confronting patients and clinicians on a daily basis.

Disturbing evidence of the disjuncture between evidence and practice has become apparent in recent decades. For example, in the 1970s and 1980s, research documented dramatic inconsistencies across the country in the treatment of identical conditions [1, 2]. These geographic variations in medical practice, among other things, suggested the lack of a reliable knowledge base to inform health care decision-makers about practices shown to be most effective.

The MMA-Congress Intervenes to Change the Medical Landscape
In enacting the MMA and establishing the Effective Health Care Program, Congress underscored the importance of effectiveness research on the quality quality and value of health care. The defining features of AHRQ’s new mandate are a more systematic approach to identifying the treatments that work best for specific health care conditions and an emphasis on putting those findings into practice.

Section 1013 of the MMA reflected growing awareness in Congress and among a variety of health care decision-makers of the importance of a strong clinical evidence base that is accessible and usable. The MMA charges AHRQ to take a systematic approach, wherein: • The most urgent needs for effectiveness information are identified through an inclusive and comprehensive public process; • Existing data are reviewed and synthesized based on sound, consistent, and transparent methodologies; • Significant gaps in data are targeted to help expedite productive research; and • Findings are disseminated widely and understandably to a variety of users, including clinicians, consumers, payers, and policy-makers.

The Three-Part Structure of the New Program
The new Effective Health Care Program is managed through a three-part structure.

First, the program capitalizes on AHRQ’s existing network of 13 Evidence-Based Practice Centers (EPCs), which were created in 1997 and are located across the United States and in Canada [3]. Initially established to review all relevant scientific literature to produce evidence reports and technology assessments, the EPCs have issued more than 125 reports to date and will produce as many as 20 Comparative Effectiveness Reviews annually as part of their new effectiveness mission. Under the Effective Health Care Program, the EPCs will focus on treatments for the priority conditions established by the Secretary of Health and Human Services through a public process and will synthesize currently available scientific evidence, including both published and unpublished studies. They will compare treatments, including drugs, to determine relative benefits and risks and, wherever possible, to measure these outcomes for subpopulation groups. In addition, the EPCs will identify major gaps in the existing knowledge base.

Second, AHRQ has established a new DEcIDE network (Developing Evidence to Inform Decisions about Effectiveness), a group of 13 research centers whose purpose is to address research gaps, including those identified by the EPCs, and to develop improved methodological approaches [4]. The DEcIDE network will perform prospective observational studies by evaluating patient-level data stripped of identifying information. The emphasis will be on generating findings expeditiously to address specific issues that do not necessitate larger, more time-consuming randomized clinical trials. The network will have access to databases that contain clinical information for more than 50 million patients but do not identify them individually. In a related development, AHRQ has also funded four additional Centers for Education and Research on Therapeutics (CERTs), bringing the total number of CERTs to 11. The CERTs conduct research and education on the safe and effective use of therapeutics. The four new CERTs will concentrate on mental health, patient adherence, older patients, and devices.

Finally, the new Clinical Decisions and Communications Science Center, based at the Oregon Health and Science University’s Department of Medicine, was established to ensure that the findings of the Effective Health Care Program are usable by those who need them. The establishment of the new center-named the John M. Eisenberg Center in honor of AHRQ’s late directorreflects Congressional interest in seeing that effectiveness research leads to real-world quality improvements. The Center will help assure that reports are presented in formats that make them useful and actionable to a range of audiences and will develop tools to facilitate consumer decisionmaking.

Stakeholder and Public Input
The new Effective Health Care Program requires opportunities for public input, which help ensure that the new program responds to the most pressing issues, that it continues to produce new knowledge, and that its products are useful for health care decision-makers. A Web site has been established ( www.effectivehealthcare.ahrq.gov ) to support a public comment process as well as address the vital goal of disseminating results. Through the Web site and a series of public listening sessions, input on virtually all aspects of the program is encouraged - creating an on-going relationship with industry, providers, patients, payers, and policy makers.

In December 2004, following public input, the Secretary of Health and Human Services identified 10 priority conditions-all of special significance to the Medicare program-to be addressed by the Effective Health Care Program:
• Arthritis and nontraumatic joint disorders
• Cancer
• Chronic obstructive pulmonary disease/asthma
• Dementia, including Alzheimer’s disease
• Depression and other mood disorders
• Diabetes mellitus
• Ischemic heart disease
• Peptic ulcer/dyspepsia
• Pneumonia
• Stroke, including control of hypertension

Future lists established by the Secretary will also include priority conditions relevant to Medicaid and SCHIP beneficiaries.

In June 2005, following additional input from stakeholders and the public, AHRQ announced 10 specific topics within these priority areas for the program’s first Comparative Effectiveness Reports.

In December 2005, AHRQ reached an important milestone with the issuance of its first Comparative Effectiveness Report on management strategies for gastroesophageal reflux disease (GERD), one of the most common health conditions affecting older Americans, resulting in $10 billion in direct annual health care costs. This report compared the two major types of medications available for GERD as well as surgical interventions. It found that one class of prescription medicines alones work about as well as surgery for relieving GERD symptoms, and that some people who have surgery still need to take medications. The report also uncovered important research gaps about the effectiveness of endoscopic surgery compared to medical therapy and the risks of long-term antisecretory medications.

A second comparative study, issued in February 2006, addressed the effectiveness of noninvasive diagnostic tests for breast abnormalities. Its principal finding was that none of the available noninvasive tests should substitute for biopsies when breast abnormalities are detected by mammograms and other preliminary examinations. Biopsies offer more reliable results than such less invasive approaches as PET scanning and MRIs. But the report identified deficiencies in the research base, particularly surrounding the lack of inclusion of low-risk women in the diagnostic studies.

Twelve more comparative effectiveness studies are underway, including one on comparative effectiveness of management strategies for renal artery stenosis and another on the pharmacologic basis of depression. On-going topics can be found on the Effective Health Care Program Web site and we encourage people to sign up for e-mail alerts to learn when research questions and draft reports are available for public comment.

Conclusion
With the Effective Health Care Program, the Federal government has established a transparent, systematic approach to synthesizing, generating, and translating knowledge about the effectiveness of a variety of clinical interventions. The new program will help health care decision-makers get the tools and information they need to make reasoned judgments about the effectiveness of alternative interventions for selected health conditions.

Perhaps now, more than ever, we are faced with a bounty of information from remarkable investments in biomedical research over the last decade. Health information technology offers additional opportunities to increase our capacity not only to do real world studies but to get findings to decision- makers quickly and creatively. Harnessing our previous research investments, informing future research investments, and developing the critical methodologies to make use of the data sources that are becoming progressively more available are important goals of the Effective Health Care Program.

We invite your input and participation in the process-please send your comments and suggestions to effectivehealthcare@ahrq.gov.

REFERENCES

1. Wennberg J, and Gittelsohn A. Small area variations in health care delivery. Science 1973:182:1102-8.
2. Wennberg JE and Gittelsohn A. Variations in Medical Care among Small Areas. Sci Am 1982:246:120-34.
3. The EPCs include: Blue Cross and Blue Shield Association/Technology Evaluation Center; Duke University; ECRI, Plymouth Meeting, PA; Johns Hopkins University; McMaster University (Canada); Oregon Health and Science University; RTI International/University of North Carolina; Southern California/RAND; Stanford University/University of California, San Francisco; Tufts University-New England Medical Center; University of Alberta (Canada); University of Minnesota; and University of Ottawa (Canada).
4. The 13 DEcIDE centers are: Acumen, LLC, Burlingame, CA; Brigham and Women’s Hospital, Boston; Duke University; Harvard Pilgrim Health Care/Harvard Medical School; Johns Hopkins University; Outcome Sciences, Cambridge, MA; RTI International, Research Triangle Park, NC; University of Colorado at Denver and Health Sciences Center, Aurora, CO; University of Illinois at Chicago; University of Maryland at Baltimore; University of North Carolina at Chapel Hill; University of Pennsylvania School of Medicine; and Vanderbilt University Medical Center.

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