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Budget Line 2.1. Research
on Health Care Cost, Quality and Outcome
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.
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:
accelerate the impact of health services research on direct patient care.
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
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).
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.
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™
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.
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.
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
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.
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
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.
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.
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.
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
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
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
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.
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.
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
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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