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Performance Budget Submission for Congressional Justification

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Fiscal Year 2001 Research on Health Care Costs, Quality and Outcomes (HCQO)


Purpose and Method of Operation
Support Improvements in Health Outcomes
Strengthen Quality Measurement and Improvement
Identify Strategies to Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures
AHRQ's Commitment to Improved Health Care for Vulnerable Populations
Activities in Support of All Goals
Funding Summary
Prior Year Funding
Rationale for the Fiscal Year 2001 HCQO Request

Purpose and Method of Operation

The purpose of the Research on Health Care Costs, Quality and Outcomes (HCQO) activity is to support and conduct research that improves the outcomes, quality, cost, use and accessibility of health care. Accordingly, the Agency has identified three strategic plan goals that feed into this budget activity:

  1. Supporting improvements in health outcomes.
  2. Strengthening quality measurement and improvement.
  3. Identifying strategies to improve access, foster appropriate use, and reduce unnecessary expenditures.

The key themes throughout all three goals are to fund new research and to translate research into practice. In addition, AHRQ also has strengthened its commitment to support research that will improve health care for vulnerable populations. Lastly, AHRQ has enhanced specific activities that support all of our strategic goals.

In the last 12 months the Agency has made important strides toward meeting its strategic goals. Specific achievements in the Agency's core programs are reviewed here as well as activities initiated in response to the increase in the Agency's budget in Fiscal Year 2000.

The first section, Support Improvements in Health Outcomes, reviews the Agency's progress on several initiatives:

The second section, Strengthen Quality Measurement and Improvement, provides updates on activities in the following areas:

The third section, Identify Strategies to Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures, encompasses critical sources of data and information for policymakers:

The fourth section, AHRQ's Commitment to Improved Health for Vulnerable Populations, outlines AHRQ's efforts and findings on the following issues:

The final section, Activities that Support All Goals, includes a discussion of our enhanced training and dissemination activities.

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Support Improvements in Health Outcomes

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 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 close the gap on variation and provide our customers with the information on what care is appropriate, 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.

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Outcomes Research

In Fiscal Year 1999, AHRQ completed an in-depth assessment of its past decade of activities in outcomes research to inform future program directions. This project, titled "The Outcomes of Outcomes Research" entailed consultation with researchers and users of outcomes research, an assessment of the nature and scope of the findings, and an initial determination of the extent of impact of outcomes research.

Outcomes and effectiveness research has provided the descriptive information that has challenged prevailing clinical ideas about how to manage specific clinical problems. For example, AHRQ-supported research demonstrated that multiple interventions thought to be effective for reducing preterm birth—including bed rest, risk-scoring systems, iron supplementation, most labor inhibiting drugs/agents, cessation programs, intravenous hydration for premature labor, and home uterine activity monitoring—are not effective. These findings clarified directions for future research and enhanced guidance to clinicians and patients.

Among the most important accomplishments of the past decade of outcomes and effectiveness research are the tools and analytic methods that have been developed. These include strategies for conducting systematic reviews, analyses and syntheses of a voluminous scientific literature to enable decisionmakers to act on what is known to work in health care, instruments for measuring health outcomes important to patients, and sophisticated techniques for analyzing observational data to adjust for disease severity and minimize bias.

This evaluation has informed the Agency's future strategy for outcome research, where concerted efforts will be made to take the results of research and work systematically with public and private-sector partners to foster the implementation of these findings. In Fiscal Year 1999, AHRQ focused its outcomes portfolio on health care for the chronically ill and elderly by publishing a special emphasis notice and fostering additional investigator activity in this area. Examples of projects funded include the following studies:

  • Guideline to Improve Quality of Initial Pneumonia Care. This study is examining strategies guiding clinical decisions regarding which patients with community-acquired pneumonia require hospitalization, and which can be safely treated at home. For patients who do require hospital admission, the researchers will evaluate and implement strategies to improve the quality of hospital care. (University of Pittsburgh, in collaboration with quality-improvement organizations in Pennsylvania and Connecticut) .
  • Identification of Clinically Relevant Changes in Health-Related Quality of Life. This project is evaluating patient-reported outcome measures for three common chronic conditions (heart failure, chronic lung disease and asthma) to enhance their value for clinicians and patients. St. Louis University).
  • Automated Assessments and the Quality of Diabetes Care. This study is evaluating the variation in outcomes for patients with diabetes using an automated telephone disease-management system. Half of the patients speak primarily Spanish; the other half, primarily English. A rich array of information will be collected and assessed to predict adverse outcomes. (Palo Alto Institute for Research, Palo Alto, California).
  • Inguinal Hernia Management: Watchful Waiting Vs. Operation. Inguinal hernia is one of the most common worldwide afflictions of men, with approximately 700,000 herniorrhaphies performed in the United States each year. The indications for surgical repair of a minimally symptomatic hernia are vague, and it is not known whether patients with inguinal hernias can safely delay surgical treatment. This study is testing the safety and outcome of watchful waiting, which could change the management of many men with minimally symptomatic hernias.(American College of Surgeons, Northwestern University, and the VA Cooperative Studies).

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Patient Safety and Reducing Errors in Medicine

A recent report by the Institute of Medicine, "To Err is Human," revealed that medical errors are one of the Nation's leading causes of death. As many as 98,000 people die each year as a result of mistakes in the health care they receive. This would make medical errors the fifth-leading cause of death in the country—more than highway accidents, breast cancer, or AIDS.

Although this level of public attention on the issue is a recent phenomenon, AHRQ has recognized for some time that reducing medical errors is critically important for improving the quality of health care. In 1993, the Agency funded the initial research on medical errors—a landmark report which found that 78 percent of adverse drug reactions were due to system failures, such as the misreading of handwritten prescriptions. Subsequent studies sponsored by the Agency have focused on the detection of medication errors, investigation of diagnostic inaccuracies, the relationship between nurse staffing and adverse events, computerized adverse drug event monitoring, and computer-assisted decisionmaking tools to mitigate errors and improve safety.

AHRQ continues to break new ground in the research of medical errors. For example, the Agency is currently funding a project with the National Institute on Aging that examines sources of errors in ambulatory care for the elderly and evaluates the implications of those errors on the quality and cost of care. This project is being conducted at the Fallon Clinic in Worcester, Massachusetts—a health care organization with one of the most extensive histories in Medicare managed care. This type of research in the ambulatory setting is unprecedented.

In addition, AHRQ is directing $2 million in Fiscal Year 2000 specifically toward research that tests the effectiveness of the application of best practices to improve patient safety through the reduction of preventable systems-related medical errors with high prevalence and severe consequences. These projects will be required to detect tangible and measurable improvements in patient safety that may result from the use of those best practices. These projects will be capable of making conclusions that produce relevant and feasible best practices for improving patient safety across a variety of health care settings and institutions.

The Agency is also well positioned to coordinate a comprehensive and sustained effort on reducing medical errors among Federal departments and agencies through the Quality Interagency Coordination Task Force (QuIC), as well as integrating public-sector efforts with those of the private sector through collaborative work with the National Quality Forum, National Patient Safety Foundation, and other entities working on this agenda.

Although the Agency has spearheaded much research on the issue, there is clearly a need for more research on measuring errors, understanding why they occur, exploring the options for reporting them, developing means to address them, and testing the effectiveness and cost-effectiveness of various approaches to improving patient safety. These and other issues are addressed in the Fiscal Year 2001 Request section.

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Centers for Education and Research on Therapeutics (CERTs)

In September 1999, AHRQ established four Centers for Education and Research on Therapeutics (CERTs) to boost the positive impact on patient care of medical products—drugs, biologics and medical devices. These Centers will play a part in AHRQ's Patient Safety and Reducing Errors in Medicine agenda in the area of reducing adverse drug events. AHRQ awarded $7.7 million over a 3-year period in cooperative agreements to four centers that will conduct pilot studies using state-of-the-art clinical, laboratory and health services research methodologies:

  • Duke University Clinical Research Institute Cardiovascular CERT. This center focuses on currently approved therapies in cardiovascular medicine, including special surveillance programs for cardiovascular devices, revascularization, new prosthetic valves and coronary stents. In addition, the center will conduct demonstration projects involving the treatment of congestive heart failure, chest pain and abnormal heart rhythms.
  • University of North Carolina CERT on Rational Therapeutics for the Pediatric Population. Improvement in child health is the focus of this center. Activities will include innovative education and research on new drugs and devices used in pediatric care and new uses of existing drugs and devices. Studies including therapeutic drug monitoring in HIV-infected children, drug metabolism, vitamin D-deficient rickets, asthma care, attention deficit/hyperactivity disorder and adverse drug reactions may be undertaken.
  • Vanderbilt University CERT. The goal of this center is to improve prescription medication use in Medicaid managed care by combating three specific threats to rational pharmacotherapy: inadequate knowledge of medications and their benefits and risks, inadequate provider and patient behavior, and policies that lead to poor patient outcomes. A major focus of this project will be the treatment of arthritis.
  • Georgetown University Medical Center CERT. The center will focus on reducing drug interactions, particularly in women, by improving prescribing. Objectives include identifying potential candidates for investigations of drug interactions, and designing and implementing a comprehensive educational program on specific drug interactions aimed at physicians, pharmacists and patients.

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Health of the Elderly and Chronically Ill

Most of the burden of illness and most of the medical costs borne by our society are due to chronic diseases and their risk factors. Chronic diseases are leading causes of disability and death in the United States, and treatment for people with chronic conditions accounts for three-quarters of national health care costs. Examples of grants funded in Fiscal Year 1999 on health care for those with chronic conditions include:

  • Best Managed Care Practices for Children with Chronic Conditions. This observational study will examine how the structural characteristics, incentives, and quality assurance efforts of managed care organizations in Washington state affect the quality of care for children with chronic conditions, such as asthma, diabetes, low birth weight and cerebral palsy. (University of Washington).
  • Disease Management for Asthmatics in Medicaid HMOs. This study will address the following questions concerning the effectiveness of disease management:
    1. How to improve patient and physician compliance with asthma practice guidelines.
    2. How to improve the effectiveness and outcomes of care for adult patients with asthma.
    (University of Pennsylvania).
  • Organizational Characteristics and Chronic Disease Care. This research will study the relationship of health plan, medical group and clinic characteristics to measures of chronic disease care and resource utilization for patients with diabetes or coronary heart disease.(Group Health, Minneapolis).
  • PREP: Family-based Care for Frail Elderly Persons. The aim of this study is to examine "PREP," an intervention program designed to increase preparedness, enrichment and predictability in family caregiving situations. The study will assess, refine and determine the potential widespread use of the four components of the program: care planning and management; 24-hour PREP Advice Line; follow-up contacts by nurses using the Keep-in-Touch system; and completion of the program, by the PREP nurses ending their participation with families.(Oregon Health Sciences University).

In addition, AHRQ initiated the development of a research agenda on the elderly by convening an internal workgroup which prepared a draft report and presented it to the Agency's National Advisory Council. This report will serve as the basis for consultation with other users and stakeholders of the Agency to establish future directions in health services research on the elderly which are responsive to the users of the findings.

MEPS and Nursing Home Data

In June 1999, AHRQ released a new chartbook, Nursing Home Trends, 1987 and 1996, presenting characteristics of nursing home facilities, special care units, and their residents. As the number of Americans over 75 grows, we need to understand the needs of the frail elderly and what long-term care options may help them. This chartbook provides important data about the nursing home industry that will contribute to more informed discussions and decisionmaking about long term care needs in the future.

Significant findings include:

  • Nursing homes in 1996 served an older population than they served in 1987. From 1987 to 1996, the proportion of nursing home residents who were 85 and over rose from 49 percent to 56 percent for women and from 29 percent to 33 percent for men.
  • The number of nursing homes and the number of nursing home beds both increased almost 20 percent from 1987 to 1996, from 14,050 homes with 1.48 million beds in 1987 to 16,840 homes and 1.76 million beds in 1996.
  • Residents were more functionally disabled in 1996 than in 1987 (select Figure 2, 3 KB). The number of nursing home residents who needed help with three or more activities of daily living (bathing, dressing, transferring, feeding, and toileting) increased from 72 percent in 1987 to 83 percent in 1996.
  • In 1996 the most common type of special care unit was for treatment of Alzheimer's and related dementias (select for Figure 3, 4 KB). Most Alzheimer units are relatively new; only 10 percent have been operating for more than 10 years. No data on 1987 special care units is available.
  • Between 1987 and 1996, there was a trend away from traditional nursing homes toward nursing homes that included assisted or independent living beds in addition to nursing home beds. The proportion of non-nursing beds rose from 6.9 percent in 1987 to 11.3 percent in 1996.

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Evidence-based Practice Centers (EPCs)

In August 1999, AHRQ announced the third-round topics for the Agency's Evidence-based Practice Centers (EPCs). These centers serve as science partners to the Agency and produce reports that facilitate the translation of evidence-based research findings into clinical practice. The reports form the basis of other organizations' efforts to develop and implement their own practice guidelines, performance measures, review criteria, and other clinical quality improvement tools.

Potential users of the evidence reports and technology assessments include a wide range of health care providers, medical and professional associations, health system managers, researchers, and others who play key roles in the effort to improve the quality of health care services nationwide. In addition, the reports may give health plans and payers information needed to make informed decisions about coverage policies for new and changing medical devices and procedures.

Results released in 1999 for two of the evidence topics are discussed below.

Antidepressant Drugs

Results from one AHRQ evidence report on drug treatments for depression found that newer categories of antidepressant drugs are equally as effective as older-generation antidepressants, and that roughly equal numbers of patients drop out of clinical trials because of side effects. The evidence report, conducted by the San Antonio EPC, found that selective serotonin reuptake inhibitors (SSRIs) are equally as effective in treating depression as older-generation antidepressants, such as tricyclics. Select for Summary or full report.

The study found that both newer- and older-generation antidepressants have side effects. Patients taking the newer antidepressants were more likely to have higher rates of diarrhea, nausea, insomnia and headache. The older drugs were likely to cause adverse effects on the heart and blood pressure, and result in dry mouth, constipation, dizziness, blurred vision and tremors.

The report was designed to provide a comprehensive evaluation of the efficacy of newer pharmacotherapies and herbal medications, such as St. John's wort, kava kava and Valeriana, for depressive disorders. The literature review found no evidence of effectiveness of kava kava and Valeriana, and concluded that the evidence about the effectiveness of St. John's wort is unclear. However, compared to a placebo, the literature suggests that St. John's wort shows promise for mild to moderate depression, and may have fewer adverse effects reported than older-generation antidepressants. The National Institutes of Health, through the National Institute of Mental Health, the National Center on Complementary and Alternative Medicine, and the Office of Dietary Supplements, is now sponsoring a placebo-controlled, blinded clinical trial comparing St. John's wort to a selective serotonin reuptake inhibitor.

Treatment of Sinusitis

The New England Medical Center EPC found that in treating uncomplicated acute bacterial sinusitis, inexpensive antibiotics, such as amoxicillin and folate inhibitors, are just as effective as newer and more expensive antibiotics, such as third-generation cephalosporins. However, for many patients with acute sinusitis, symptoms will resolve without any antibiotics. Select for Summary.

Even though sinusitis is common, its management is challenging. In most cases, the condition involves inflammation of both the sinuses (sinusitis) and nasal passages (rhinitis), but the causes vary. If the sinusitis is not caused by bacteria, treatment with antibiotics will have limited or no effect, and may have adverse side effects. However, because patients with bacterial sinusitis may develop a more serious sinus infection, it is important to properly diagnose and treat these patients. The Center's report focuses on the diagnosis and treatment of uncomplicated, community-acquired, acute bacterial sinusitis in children and adults.

The research found that using X-rays or other diagnostic procedures is not a cost-effective initial strategy for uncomplicated patients. The study concluded that:

  • More patients were cured, and cured earlier, when treated with antibiotics rather than placebo; however, about two-thirds of patients receiving placebos recovered without antibiotics.
  • More research is needed to identify simple, inexpensive diagnostic methods to help distinguish patients requiring treatment with antibiotics from those not requiring antibiotics or further evaluation.
  • Children need to be the specific focus of clinical research to determine the proper methods to diagnose and treat their sinusitis.
  • Future studies should examine the connection between treatment and relapse rates or the development of recurrent sinusitis. Such results will help clarify the relationship between treatment and the amount of time it takes for symptoms to resolve. Studies also should address the optimal length of antibiotic treatment, the role of patient preferences in clinical decisionmaking, and the issue of emerging antibiotic resistance.

This evidence report was developed in partnership with the American Academy of Otolaryngology-Head and Neck Surgery (AAOHN), American Academy of Pediatrics (AAP), American College of Physicians (ACP), and American Academy of Family Physicians. The AAOHN, AAP and ACP each have plans to develop or update clinical guidelines on acute sinusitis.

Acute sinusitis is one of the most common primary care problems in the United States. Millions of cases occur each year, affecting all age groups and all segments of the general population. Although not all people who contract the condition seek treatment from a physician, most still incur costs in work time lost or over-the-counter medications. In 1992, Americans spent $200 million on prescription cold medications and more than $2 billion for over-the counter medications.

Third Round of EPCs

In the third round, the University of California-San Francisco (UCSF)/Stanford University EPC will focus largely on indicators that could be used to screen pediatric admissions and chronic medical condition inpatient care. This EPC will also look at hospital admissions that might have been avoided had the patients been managed appropriately at the primary care level.

The findings will be used by AHRQ to enhance the utility of its quality screening software tool, HCUP Quality Indicators, which is currently employed by hospitals and others to improve care. The upgrade, expected to be ready by 2001, will also include state-of-the-art risk adjustment methods so users can compare hospital quality over time and across communities. As part of its assignment, the UCSF-Stanford EPC will solicit recommendations from researchers and developers on potential measures of hospital quality, including those that are not yet part of the published literature.

Other assignments and the organizations that nominated them are detailed on page A-1 in the Appendix. AHRQ has released evidence reports on the first and second rounds of topics and technology assessments. (See page A-2 in the Appendix for an index of reports by condition.)

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National Guideline Clearinghouse™ (NGC)

The National Guideline Clearinghouse™ (NGC), an Internet resource for evidence-based clinical practice guidelines located at, has now been operational for 1 year. 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.

When NGC first became operational on December 15, 1998, it contained 200 evidence-based clinical practice guidelines submitted by over 50 health care organizations and other entities. Since then, the content on NGC has more than tripled to close to 700 clinical practice guidelines submitted by over 120 health care organizations and other entities. New guidelines are being added to NGC weekly.

Use of NGC has exceeded initial expectations. Over the past year, NGC has had over three-quarters of a million visitors, processed over 8 million requests, and received over 14 million hits. More than 20,000 users per week are now using the site.

All guidelines contained on NGC are abstracted into a standardized format that enables users to compare clinical practice guideline recommendations more quickly than ever before. After the first five years of operation, this Internet repository is expected to contain 3,500 clinical practice guidelines. NGC's electronic database is updated continually to reflect the most recent clinical practice guidelines.

NGC recently made it possible for users to selectively search for guidelines that have accompanying patient resources and education materials. In the spring, annotated bibliographies will be available on NGC covering guideline development, dissemination, implementation and use. Finally, NGC will launch its first customer satisfaction survey in spring 2000.

"The NGC saves time for clinicians in practice settings. The layout of the Web site and the structured abstract format make it much easier to quickly compare similar guidelines by different organizations."

—David M. Goldstein, MD
Director of Georgetown University Medical
Center's Mood Disorder Program

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Clinical Preventive Services

The vast majority of premature deaths and disabilities in the United States result from preventable causes. Research has concluded that there is strong evidence that a variety of clinical preventive services can prevent many of the leading causes of death or disability. At the same time, research also shows that clinicians do not provide all the services their patients need and that patients request services that have been found to be ineffective or to have unproven benefits.

In Fiscal Year 1999, AHRQ funded a number of grants to evaluate the use and effectiveness of preventive services. For example, researchers at the University of Minnesota are determining why flu immunization, which is typically very effective in the general population, has not led to a decrease in hospitalizations from pneumonia and influenza among fee-for-service Medicare beneficiaries. In Fiscal Year 2000, AHRQ is devoting $1 million to perform research on interventions such as screening tests, counseling, immunizations and chemoprophylaxis provided in clinical practice to prevent or detect specific conditions. Most of these funds will go toward examining minority health disparities in the provision of these preventive services.

AHRQ also supports the work of the U.S. Preventive Services Task Force (USPSTF) and the Put Prevention Into Practice program. Over the next 4 years, the USPSTF will update its 1996 recommendations to clinicians regarding preventive services for over 70 major health conditions. Important updates include screening for lipid abnormalities; screening for skin cancer; screening for chlamydia; and counseling about postmenopausal hormone therapy. Some of the new assessments nearing completion are: chemoprophylaxis for breast cancer (tamoxifen and other agents); screening for bacterial vaginosis to prevent preterm delivery; vitamin supplementation to prevent cancer and heart disease; and screening for developmental delay in children.

The Put Prevention into Practice program will work with outside partners to translate information from the USPSTF for other audiences interested in prevention, including patients, health plans, employers and other purchasers, as well as policymakers. A preventive health guide for persons over 50, developed in partnership with the AARP, was released in January 2000, and the first reports based on USPSTF work will be released in fall 2000.

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Domestic Violence

Domestic violence is a public health problem affecting millions of women and their families each year. It is the second leading cause of injuries and death among women of childbearing age and the leading cause of maternal mortality in at least two major cities. Domestic violence is prevalent among all racial and ethnic minority groups and is not exclusive to one socio-economic stratum.

The consequences of domestic violence include acute injuries as well as chronic injury, chronic stress and fear, and lack of control over health care or support systems. The consequences are manifest in a range of medical, obstetric, gynecological and mental health problems. Direct health care costs to victims of domestic violence are estimated to be $1.8 billion per year. One large health plan showed victims of intimate partner violence incurred expenses approximately 92 percent greater than a random sample of general female enrollees.

In Fiscal Year 1999, AHRQ worked with partners in the Department of Health and Human Services to convene a meeting of experts to help develop the health services research agenda in health care aspects of domestic violence. In Fiscal Year 2000, AHRQ is investing $1 million in research for evaluating health system response to domestic violence in patient populations. The longitudinal studies will be the first of their kind to be undertaken. This research moves beyond the study of prevalence, screening and training, and will take a rigorous look at health care interventions and their effectiveness. It will encompass important aspects of the health care response to domestic violence, including the implementation of protocols and practice guidelines, routine screening for domestic violence, on-site capacity to provide treatment and safety planning, and follow-up of victims. Patients will be evaluated over time to measure and determine which interventions improve the health and safety of victims, predicts or improves health care utilization patterns, prevents or reduces the occurrence of domestic violence, or helps develop better techniques to detect women at risk.

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