Budget Line 2.1. Research on Health Care Cost, Quality and Outcome

Funding Levels

FY 2002:       $247,645,000 (Actual)
FY 2003:       $194,000,000 (President's Budget)
FY 2004:       $221,000,000 (Request)

2.1.1 Performance Goal 1: To have measurable improvement in the quality, safety and outcome of health care for Americans

Outcome of Health Care

Program Description and Context

At its most basic level, providing high quality health care is doing the right thing, at the right time, in the right way, for the right person.  The challenge that health care providers and health systems managers face everyday is knowing what the right thing is, when the time is right, and what the right way is.  Patients and their families are also faced with making choices about treatments and care settings with little information on the relative quality, risks and benefits available to them. 

One of the AHRQ's most important priorities is to translate and disseminate the findings of research supported by the Agency into tools and information that can be used by its customers to make good health care decisions and to improve the outcomes of care.  The research supported by AHRQ has historically concentrated on conditions that are common, costly, and for which there is substantial variation in practice.  This research includes many of the conditions that represent major expenditures for Medicare and Medicaid.   AHRQ's research attempts to reduce inappropriate variation and provide the health care decisionmaker with information on what care is appropriate, which clinical services work best in what circumstances and for which patients, how much is enough, and what resources are used to provide it.  Outcomes research also attempts to help decisionmakers understand the implications of structural and financing changes in the health care system on the outcomes of care delivered in the system.

Outcomes and effectiveness research seeks to understand the end results of particular health care practices and interventions.  Outcomes include effects that people experience and care about, such as change in the ability to function.  In particular, for individuals with chronic conditions—where cure is not always possible—end results include quality of life as well as mortality.  By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care.

Strategies to Improve Health Outcomes. At the requested level, AHRQ's programs assist with Secretarial initiatives, particularly in the area of chronic illness, such as diabetes and asthma.  Comprehensive primary care services can reduce the morbidity associated with these illnesses.  Hospital admission rates for "ambulatory care sensitive conditions" serve as a marker for both impaired access to primary care and sub-optimal quality of primary care delivered.  Disparities in admission rates for racial and ethnic minorities and low-income populations have been well documented.

Programs that support AHRQ's efforts to improve the outcomes include:

• Centers for Education and Research on Therapeutics (CERTS).
• Evidence-based Practice Centers (EPCs).
• The U.S. Preventive Services Task Force (USPTF).
• The National Guideline  Clearinghouse™ (NGC).

Centers for Education and Research on Therapeutics (CERTS). The CERTS program is a national initiative designed to increase the awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research.  The CERTs program grew out of recognition that physicians need more information about the therapies they prescribe.  Although information is available through the pharmaceutical industry, continuing medical education programs, professional organizations, and peer reviewed literature, comparative information about the risks and benefits of new and older agents and about drug interactions is limited. 

The research conducted by the CERTs program contributes to improving the health of Americans.  The program does this by increasing awareness of both the appropriate use and risks of new drugs, drug combinations, biological products, devices and mechanisms.  This clinical information is used to improve their safe and effective use by physicians, patients, pharmacists, pharmacy benefit managers, purchasers, insurers government agencies and others.

Translating Research Into Practice (TRIP). Translating research findings into sustainable improvements in clinical outcomes remains a substantial obstacle to improving the quality of health care in America.  What has been learned in the research setting is often not incorporated into daily clinical practice.  To address this gap, AHRQ funded 13 new projects in September 2000 to evaluate different strategies for translating research findings into clinical practice.  The aim of these three-year cooperative agreements was to identify sustainable and reproducible strategies to:

• Help accelerate the impact of health services research on direct patient care.
• Improve the outcomes, quality, effectiveness, efficiency, and/or cost effectiveness of care through partnerships between health care organizations and researchers.

These new projects join 14 others funded in 1999 as part of a major initiative by AHRQ to close the gap between knowledge and practice or between what we know and what we do to ensure continuing improvements in the quality of the Nation's health care. 

The 14 studies supported in the initial phase of the TRIP initiative address a variety of health care problems, primarily through randomized controlled trials.  These studies, which represent important prototypes of what is possible under ideal circumstances, generally require an elaborate strategy for superimposing data collection on the demands of routine practice.

The second phase of this initiative, TRIP-II, is aimed at applying and assessing strategies and methods that were developed idealized practice settings or that are in current use but have not been evaluated.  Furthermore, increased demands for accountability in health care, including reporting of clinical performance using standardized quality measures, have created a sense of urgency regarding improvement within health care organizations.  With this as a basis, TRIP-II focuses on implementation techniques and factors such as organizational and clinical characteristics associated with successfully translating research findings into diverse applied settings, including AHRQ-sponsored Practice Base Research Networks (PBRNs).

Evidence-based Practice Centers (EPCs). As the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of healthcare services and access to such services, AHRQ conducts and funds research that develops and presents evidence-based information on healthcare outcomes, quality, cost, use and access.  Included in AHRQ's legislative mandate is support of syntheses and widespread dissemination of scientific evidence, including dissemination of methods or systems for rating the strength of scientific evidence.  These research findings and syntheses assist providers, clinicians, payers, patients, and policymakers in making evidence-based decisions regarding the quality and effectiveness of health care.

As a part of its charge to improve the quality and effectiveness of health care through the development of state-of-the-art health care information, and to respond to significant changes within the health care industry, AHRQ established 12 Evidence-based Practice Centers in 1997.  AHRQ has become a science partner with private and public-sector organizations in their efforts to improve the quality, effectiveness and appropriateness of clinical practice. 

Since 1997, the EPCs have conduced more than 80 systematic reviews and analyses of scientific literature on a wide spectrum of topics, incorporating the results and conclusions into evidence reports and technology assessments.

The EPC program contributes to AHRQ's goal of improving the health of the American public by producing synthesis of clinical research findings through systematic methods for searching, reviewing, and evaluating the clinical literature.  Evidence reports and technology assessments are used by systems of care, professional societies, health plans, public and private purchasers, States, and other entities as the scientific foundation for development and implementation of their own clinical practice guidelines, clinical pathways, review criteria, performance measures, and other clinical quality improvement tools, as well as for formulation of evidence-based policies related to specific health care technologies.

U.S. Preventive Services Task Force (USPSTF). Premature or early deaths and disabilities due to preventable causes continue to extract a significant toll in the United States.  Health care providers and health care organizations play an essential role in national prevention efforts, by delivering effective vaccines, screening patients for early disease or risk factors, counseling about health lifestyles, and prescribing preventive medications.  Despite steady progress in the delivery of effective preventive care, important gaps remain.  For example, as of 1998 more than one-third of women over 50 had not had a mammogram and breast exam in the last two years to screen for breast cancer, and more than a third of older adults had not received a flu shot that year.  Inequities in preventive care also contribute to the disparities in the health of specific populations, such as racial and ethnic minorities, the elderly, and the poor and disabled. 

The USPSTF as well as AHRQ's Put Prevention Into Practice (PPIP) program make significant contributions to the Department of Health and Human Services prevention activities.  The USPSTF, first convened in 1984, is charged with systematically reviewing the evidence of the effectiveness of a wide range of clinical preventive services, including screening tests, counseling, immunizations, and chemo-prevention.  The PPIP program then works to translate information from USPSTF reports into a format that meets the needs of a wide variety of patients, clinicians, health plans, and health care purchasers.

National Guideline Clearinghouse™ (NGC). The NGC is a publicly available, Web-based database of evidence-based clinical practice guidelines and related documents.  Updated weekly with new content, the NGC is a partnership between AHRQ, the American Medical Association (AMA) and the American Association of Health Plans (AAHP) Foundation. 

In its two years of operation, the NGC has become a resource for physicians, nurses and other health care professionals as well as purchasers and policymakers.  Individual physicians and other clinicians can review and use the NGC in clinical decisionmaking and patient counseling; health care organizations and integrated delivery systems can use information accessible through the NGC to adopt or adapt guidelines for their networks; medical specialty and professional societies can use NGC resources in their own guideline development efforts; employers and other large purchasers can use information from the NGC to assist them in making health care benefits purchasing decisions; educational institutions can incorporate information accessible through the NGC into their curricula and continuing education activities; and, State and local governments can use the NGC in their quality assurance and program oversight efforts.

Program Performance Analysis

One of the most important priorities of AHRQ is to translate and disseminate the findings of research supported by the Agency into tools and information that can be used by its customers to make good health care decisions and to improve the outcome of care.  The research supported by AHRQ has historically concentrated on conditions that are common, costly, and for which there is substantial variation in practice.  This research includes many of the conditions that represent major expenditures for Medicare and Medicaid.   AHRQ's research attempts to reduce inappropriate variation and provide health care decisionmakers with information on what care is appropriate, which clinical services work best in what circumstances and for which patients, how much is enough, and what resources are used to provide it.   Outcomes research also helps decisionmakers understand the implications of structural and financing changes in the health care system on the outcomes of care delivered in the system.

Centers for Education and Research on Therapeutics. Neither patients nor their caregivers should have to guess which therapies are best or live in fear that a mistake will be made in treatment.  This is the basis of AHRQ's Centers for Education and Research on Therapeutics (CERTs) program.  AHRQ was given authority to support the CERTS initiative under the Food and Drug Modernization Act of 1997.  Between 1999 and 2000, AHRQ established seven centers under the CERTS program, each of which focuses on therapies used in a particular population or therapeutic area, e.g., condition.  The CERTs conduct research and provide education that will advance the optimal use of drugs, medical devices and biological products.

While drugs, medical devices, and biological products improve health for thousands of people, side effects, misuse, and overuse of products can seriously impair the health of many others. Many patients potentially could benefit from a therapy but do not receive it through lack of information, oversight, or in the mistaken belief that the therapy will do them harm.  In addition, studies conducted prior to FDA approval may not test medical products in combination with other therapies often used by the same patients.  Further, once approved, drugs and devices often are used for purposes other than those for which they were approved—sometimes these uses are supported by studies but not always.  Finally, some side effects of medical products emerge only after they have been approved for sale—when large numbers of people begin to use them. 

The CERTs program aims to fill these information gaps by answering important questions that have not been addressed and implementing effective educational interventions for current and future caregivers.  The CERTs is also a critical complement to FDA's post-marketing studies.  Besides AHRQ, the participants in the CERTs include academic organizations, managed care organizations, drug and device companies, practitioners, commercial research groups and consumer groups.  The following are a few examples of how the CERTs seek to improve health through the best use of medical therapies.

Why are patients with certain types of heart disease not taking medicines that may save their lives?  Aspirin, inexpensive and available over-the-counter, greatly reduces the risk of heart attack, stroke, and related death for people with coronary artery disease (CAD; blockage of the blood vessels that supply blood to the heart).  Similarly, another class of drugs, beta-blockers, have been shown to help people with congestive heart failure (CHF).  Data collected by the Duke University CERT confirmed that 13 percent of people with CAD were not taking aspirin, and 55 percent of people with CHF were not taking a beta-blocker.  More importantly, the people with CAD whom were not taking aspirin were almost twice as likely to die within one year as those that were.

The news was only slightly better for people with CHF who were not taking a beta-blocker; they had 1.5 times the risk of dying compared with people who were taking the medicine.  The Duke CERT is now investigating ways to get the right life-saving medicines to the right people.  Once more is understood about why people may not be taking these medicines, programs to overcome these barriers and save lives can be designed.

Monitoring anti-HIV drug levels. The ability of drugs to help women and children with HIV can be affected by the way they take the drugs and how their bodies handle the medicine.  The University of North Carolina CERT developed a screening test for kids to measure the levels of anti-HIV drugs called protease inhibitors in the bloodstream.  The test will determine whether the level of drugs is too high or too low as a result of a problem in the way the drug was taken or absorbed.

Research involving the test had an unexpected, important finding: giving anti-HIV drugs to babies with water can speed the passage of the drugs through babies' systems before they have a chance to work.  Giving drugs with infant formula greatly improves results.  In another case, the test showed high levels of protease inhibitor in a child whose parent had readjusted the dose of the drug without telling anyone.  Some patients were not getting their drugs at all.  In one case, a child's mother was too ill herself to medicate her child, but only through the screening test could the problem be uncovered.

The test demonstrated that there might be a big difference between what a doctor prescribes and what is at work in the body.  Providing this test to HIV-infected individuals can go a long way in ensuring that people are getting the level of drugs they need.  The test also may help reduce the incidence of drug-resistant viruses and the cost of caring for patients with HIV.

Rethinking antibiotics before dental treatment. Many people are prescribed antibiotics before they go to the dentist in the belief that it will reduce the risk of endocarditis (infection of the heart lining and valves).  Because conventional wisdom suggests that patients with heart problems are at risk, this preventive measure has been recommended for more than 45 years.  The University of Pennsylvania CERT conducted a study to evaluate and quantify the risk of such infection.  They found that the incidence of infection remained the same even after the introduction of widespread antibiotic prophylaxis and that neither dental work in general nor any individual procedures were associated with infective endocarditis—with the possible exception of tooth extraction. The study also determined that flossing daily slightly reduced the risk of infection.  Efforts are under way by the researchers to have these findings incorporated into American Heart Association guidelines.  These findings will affect an important source of antibiotics used without benefit.

Evidence-Based Practice Centers. While outcomes research is developing new knowledge on what works in health care, for whom, and under what conditions to improve practice in the years ahead, AHRQ's Evidence-based Practice Centers (EPCs) program synthesizes the existing literature to inform practice improvements today.  AHRQ's 12 EPCs develop evidence reports and technology assessments on therapies and technologies that are common, expensive, and/or significant for the Medicare and Medicaid populations. The EPCs systematically review and analyze the published scientific literature to develop the reports.  Since 1997, the EPCs have conducted more than 80 systematic reviews and analyses of the literature on a wide spectrum of topics and they have incorporated the results and conclusions into evidence reports and technology assessments. Some of these reviews are ongoing, and others have been published.

Users of these reports and assessments include doctors, medical and professional associations, health system managers, researchers, consumers organizations, and policymakers.  These public- and private-sector organizations use the reports as the basis for developing their own clinical guidelines, performance measures, and other quality improvement tools and strategies.  The reports and assessments often are used in formulating reimbursement and coverage policies.  All EPCs collaborate with other medical and research organizations so that a broad range of experts can be included in the development process.

EPC—Technology Assessment: Actinic Keratoses CMS revised its Medicare Coverage Issues Manual to include a National coverage policy permitting coverage for the treatment of actinic keratoses (AK), a common skin condition that is often the precursor of skin cancer. The decision to cover the treatment of AKs was based largely on the AHRQ technology assessment for Actinic Keratoses treatment. This assessment suggested that the presence of AKs is associated with the development of squamous cell carcinoma (SCC) more than other factors. SCC has the potential to metastasize and accounts for a large percentage of all non-melanoma skin cancer deaths in the Medicare population.

Professional associations that create clinical practice guidelines, as well as Federal agencies, academic institutions, patient groups and health systems are using AHRQ's evidence reports and technology assessments.  Examples include the development of a guideline by the American Psychiatric Association (APA) based on the evidence report, Treatment of Depression—Newer Pharmacotherapies; use by the VA of the meta-analysis on Androgen Suppression in the Treatment of Advanced Prostatic Cancer as part of its continuing medical education program; and, the development of a practice guideline by the American Academy of Pediatrics (AAP) based on the evidence report on Treatment of Attention-Deficit/Hyperactivity Disorder.   The AAP has released a second guideline on the management of this disorder, also based on an AHRQ-sponsored evidence report, prior to launching a three-year, multi-faceted campaign to promote the implementation of these guidelines in practice.  The program will include a variety of media events, development of physician tool kits, patient materials, and educational curricula and conferences, all designed to facilitate improvements in clinical practice and patient behavior consistent with the scientific evidence outlined in the EPC evidence reports.

The National Guideline Clearinghouse™ (NGC), an Internet resource for evidence-based clinical practice guidelines located at www.guideline.gov has now been operational for three years. The NGC was developed by AHRQ, in partnership with the American Medical Association (AMA) and the American Association of Health Plans (AAHP), to be a resource for physicians, nurses and other health care professionals.

NGC has more than 1,000 clinical practice guidelines submitted by over 165 health care organizations and other entities.  New guidelines are being added to NGC weekly.  Over the last three years, NGC has had over four million visitors, processed over 40 million requests, and received over 81 million hits.  NGC now has over 46,000 visits a week. 

AHRQ does not require users of the National Guideline Clearinghouse™ to register in order to use the site.  However, AHRQ recently completed the second customer satisfaction survey of NGC that does provide some insight into who uses the site.  Physicians represented the largest portion of survey respondents (40.6 percent) followed by nurses and/or nurse practitioners (18.9 percent).  93.5 percent of respondents rated their overall satisfaction with NGC as either "fairly satisfied" or "very satisfied" compared with 89.1 percent for the first annual survey.  Respondents to the survey also provided many useful comments on how they used it in their clinical work.  For instance, a number of respondents reported using NGC to identify guidelines for adaptation in their health system or institution and a desire to find the best approach to treating their patients.

The University of Michigan Health System (UMHS) in Ann Arbor has developed a program entitled Guidelines Utilization, Implementation, Development and Evaluation Studies (GUIDES). Now in its sixth year, UMHS has 10 of its guidelines in the National Guideline Clearinghouse™ (NGC). "We consider the NGC a wonderful enhancement to our existing processes, and this is true across the spectrum of activity. The NGC is especially valuable in disseminating our work to colleagues in other institutions, and the variety of users is impressive. We have received inquiries from all over the world, and from a range of organizations." —Dr. Renee Stiles, Project Manager, GUIDES.

U.S. Preventive Services Task Force. AHRQ links prevention research with clinical practice by sponsoring the U.S. Preventive Services Task Force (USPSTF) and the Put Prevention Into Practice (PPIP) program.  The Task Force synthesizes the evidence-base and the PPIP program promotes the application of the Task Force results.

The USPSTF is a critical source of information on what does and does not work in the health care system specific to prevention.  First convened in 1984, the USPSTF is an independent panel of preventive health experts charged with evaluating the scientific evidence for the effectiveness of a range of clinical preventive services including common screening tests, immunizations, counseling for health behavior change and chemo-prevention and producing age- and risk-factor-specific recommendations for these services.

In FY 2002, the USPSTF announced several important recommendations which when implemented will significantly improve the quality of preventive services received by the American public.  Of these recommendations two particularly are of note: screening for depression and the frequency for mammography.

Depression Screening. In May 2002, the USPSTF concluded that asking all patients who walk into offices for tests, physicals and appointments two simple questions about whether they have experienced some of the warning signs of depression.  These questions can swiftly begin to identify 90 percent of people who suffer from major depression.

The recommendation is the latest manifestation of the growing recognition that depression is one of the most common—and most commonly undiagnosed and untreated—chronic illnesses.  About 19 million American adults suffer from depression and estimates suggest that as many as two-thirds do not get treatment.  The new recommendations could bring many of these people into treatment and add millions to the numbers who are taking antidepressants.

The two questions that ought to become part of the basic repertoire of every patient visit are: "Over the past two weeks, have you felt down, depressed or hopeless?" and "Over the past two weeks, have you felt little interest or pleasure in doing things?"

If a patient answers yes to either question, the task force recommended that doctors offer patients written or oral questionnaires.  These ask more specific questions and establish whether the problems are transient or persistent.  If the problems have lasted throughout the previous two weeks and have interfered with the patient's ability to perform day-to-day tasks doctors may make a diagnosis of depression.

But screening is only the first step in the task force's recommendation.  Asking, 'Are you depressed?' and having the patient say, 'Yes,' and then moving on is not enough.  A patient must have access to the right therapy or medicines.

Screening for Breast Cancer. In February 2002, HHS Secretary Tommy G. Thompson announced an updated USPSTF that calls for screening mammography, with or without clinical breast examination, every one to two years for women ages 40 and over.  This recommendation affirms the HHS' existing position on the value of mammography.

"The Federal Government makes a clear recommendation to women on mammography: if you are 40 or older, get screened for breast cancer with mammography every one to two years."  Secretary Thompson said further, "While developing technology certainly holds the promise for new detection and treatment methods, mammography remains a strong and important tool in the early detection of breast cancer.  The early detection of breast cancer can save lives."

Breast cancer is the most common cancer among women in the United States.  In 2001, an estimated 192,200 women were diagnosed with breast cancer while 40,600 women died from the disease.

In addition to age other factors may increase a woman's risk of breast cancer.  The strongest risk factors are a family history of breast cancer in a mother or sister, having already been diagnosed with breast cancer or having had a previous breast biopsy showing atypical hyperplasia, an irregular pattern of cell growth.

"Mammography is an important tool for detecting breast cancer," said Janet Allan, Ph.D., R.N., Vice Chair of the USPSTF.  "Clinicians and women should discuss individual risk factors to determine when to have a first mammogram and how often to have them after that."

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