Testimony

Statement by
Carolyn Clancy, M.D.
Director
Agency for Healthcare Research and Quality

on
Clinical Preventive Services: The U.S. Preventive Services Task Force and the Role of the Agency for Healthcare Research and Quality
before the
Subcommittee on Health House Energy and Commerce Committee

September 21, 2004

Mr. Chairman, I welcome this opportunity to testify about the role of the United States Preventive Services Task Force in assessing the effectiveness of preventive health care services. In fact, this year marks the twentieth anniversary of the Task Force. Now in its third incarnation, the Task Force is widely viewed by primary care clinicians as providing the "gold standard" regarding those preventive services for which there is good quality scientific evidence of effectiveness.

I will also comment briefly on the research and synthesis work undertaken by the Agency for Healthcare Research and Quality (AHRQ). We support the work of the Task Force, a statutory requirement since our 1999 reauthorization, but we also develop new information regarding the effectiveness of preventive health care; synthesize "state of the art" information regarding preventive health care services for patients and their caregivers, and identify approaches for increasing the rates at which effective clinical preventive services are delivered and used.

AHRQ's work provides an important complement to the community-based, public health strategies and interventions that are developed and promoted under the leadership of the Centers for Disease Control and Prevention (CDC). Both CDC and AHRQ also benefit from the work of the National Institutes of Health in developing the basic building blocks that underpin public health and clinical preventive services interventions. Prevention research is a good example of how the Department of Health and Human Services (HHS) is increasingly functioning as "one Department."

As requested, my testimony will provide background information on how the Task Force and AHRQ approach their work in prevention. However, I want to stress that AHRQ maintains a focus on effective preventive services for the elderly. In that capacity, each year we submit to the Congress a report on the latest recommendations of the Task Force. I welcome the opportunity to address any substantive issue following the conclusion of my statement.

THE UNITED STATES PREVENTIVE SERVICES TASK FORCE

Context and Scope

Before turning to how the Preventive Services Task Force undertakes its work, there are 3 points that need to be made regarding the context and scope of its work.

First, the Task Force focuses on primary and secondary prevention. Since the Office of the Secretary established the first Preventive Services Task Force 20 years ago, the Task Force's mandate has focused on the delivery in primary care settings of primary or secondary prevention services. The Task Force was originally created to provide guidance for primary care clinicians in the area of preventive care for apparently healthy individuals. Primary prevention is defined as interventions that reduce the risk of disease occurrence in otherwise healthy individuals. Counseling patients not to smoke and prescribing fluoride to children to prevent cavities are examples of primary prevention. Secondary prevention can be defined as screening to identify risk factors for disease or the detection of disease among individuals who are at risk for that disease. Evaluating blood pressure in adults is an effective way to identify individuals at risk for heart disease and provides an opportunity to intervene before the disease occurs. Screening for colon cancer using colonoscopy to detect pre-cancerous polyps is another example of secondary prevention. The bottom line is that individuals who receive primary or secondary prevention services have no obvious signs of illness; in clinical terms, they are asymptomatic. Consistent with the longstanding commitment by physicians and other health care professionals to 'first do no harm,' providing services to individuals who are apparently free of disease requires a careful approach to balancing benefits and harms.

By contrast, the Task Force does not address the category of services known as tertiary prevention. Tertiary prevention services are provided to individuals who clearly have a disease and the goal is to prevent them from developing further complications. For example, diabetes care would be considered tertiary prevention in that the care provided is focused on limiting the complications of a disease that is already present. Tertiary prevention interventions are a focus of research by AHRQ and an important component of prevention public policy, but they are not within the purview of the Task Force. Unlike primary and secondary prevention, there are numerous groups who review the literature on medical treatment in order to advise clinicians on the optimal way to treat chronic illnesses. Therefore, it remains critical for a group such as the Task Force to remain focused on the types of preventive service decisions for which most primary care clinicians have limited evidence-based guidance.

Second, the role of the Task Force is to identify those preventive services for which there is good quality evidence of effectiveness. This is a high standard to meet and has implications for interpreting the work of the Task Force and determining what to do in the absence of evidence. The first point to recognize is that good quality scientific evidence takes time. Thus, when the Task Force concludes that there is insufficient evidence upon which to make a recommendation, the Task Force is not concluding that a service is ineffective. It may simply reflect the fact that few studies have been conducted, or that existing studies are flawed, contradictory, or simply not powerful enough statistically to provide good quality evidence. Should a finding of insufficient evidence preclude guidance from Federal agencies, medical societies, or action by policymakers? Not necessarily. Patients and their caregivers often need advice or assistance in the absence of perfect information and there may be an important public health rationale for action before good quality evidence is available. In such cases, guidance from Federal agencies or medical societies or action by policymakers may be appropriate.

Third, the Task Force does not speak for AHRQ or HHS. While the Director of AHRQ is statutorily required to appoint its members, the Task Force is not a Federal advisory body under the law. The Task Force is a body of private sector primary care experts and methodologists. It is configured to provide expertise in the area of primary and secondary clinical prevention to a broad patient population and their primary caregivers. I have included at the end of my testimony, a roster of the current Task Force membership, which includes a mix of internists, family physicians, pediatricians, obstetrician/gynecologists, nurses, and methodologists with expertise in issues of screening, counseling, and prescribing drugs for reducing the risk of disease in the primary care setting.

How the Task Force Operates

To date the current Task Force has reviewed numerous topics in the area of primary and secondary clinical preventions, ranging from childhood vision screening to obesity counseling to postmenopausal hormone replacement therapy. This range of topic areas and population age groups reflects the breadth of such interventions encountered in primary care settings. The process that the Task Force uses is as follows:

  • Topic Selection: To determine which clinical preventive topics to review, the Task Force solicits topics from its members, Federal agencies, professional organizations and the public. The Task Force then prioritizes these topics based on the magnitude of the problem as defined by the number of people affected or the severity of the problem, evolving evidence, and potential impact of the recommendation on primary care practice.

  • The Framework for Evidence-Based Reviews: For each topic, the Task Force establishes the scope of the review by identifying the specific populations for which evidence will be evaluated. This decision reflects the prevalence of the disease and its manifestation among different groups, expressed in terms of age, gender, and risk status. The analysis of the scientific literature is guided by the ultimate outcomes on which the Task Force focuses. Is a clinical preventive service -- screening, counseling or prescribing drugs to reduce the risk of disease -- associated with reduced morbidity and mortality? Does earlier identification of disease lead to an improved outcome compared to the result that would occur if the disease was not detected and treated early? The Task Force then works with external experts to develop the specific key questions for each point in the analytic framework that will illuminate the effectiveness of screening, counseling or treatment on reducing mortality and morbidity. As the graphic below demonstrates, the framework also takes into account potential harms associated with these activities such as false positives, increased anxiety, or adverse effects.

  • Rating the quality of the evidence:The Task Force relies on AHRQ to coordinate the systematic reviews of the evidence through the Evidence-based Practice Centers (EPCs) supported by the Agency. Before an EPC can synthesize the scientific literature, it must first assess the methodological rigor of each study, asking questions such as:

    • Did the investigators use an appropriate research design for the question being asked?
    • Did they control for other factors that might affect the outcome (what researchers call "threats to validity")?
    • Did they use the right statistical tests and calculate them properly?
    • Did the study address services provided in the primary care setting?
    After evaluating the relevance and rigor of each individual study, the EPC also considers the consistency of evidence across the entire body of studies. Based on these components the strength of the evidence is categorized as good, fair, or poor and then synthesized. Consistent with its approach in other areas, AHRQ directs its EPCs to identify strengths and limitations of the existing knowledge base, but these evidence reports make no recommendations.

  • Developing a recommendation: After reviewing the EPC report and considering the overall strength of the evidence and estimates the magnitude of the net benefits (based on the balance of benefits and harms), the Task Force then establishes recommendations by a formal vote. To guide interpretation of its recommendations, it assigns a letter grade to each recommendation, reflecting the strength of the evidence and the magnitude of benefit. The letter grades include:

    A - The Task Force strongly recommends a service, there is good evidence, and benefits substantially outweigh the harms.

    B - The Task Force recommends a service if there is at least fair evidence, and the benefits outweigh the harms.

    C - The Task Force makes no recommendations for or against a service if there is at least fair evidence, and the benefits and harms are closely balanced.

    D - The Task Force recommends against routine use of a service that is ineffective or if the harms outweigh the potential benefits.

    I - The Task Force found insufficient evidence to recommend for or against a service since the balance of benefits and harms is not known.

    The "I" letter grade simply reflects the lack of adequate evidence to make a recommendation; it is neither a recommendation for nor a recommendation against providing the service on a routine basis. A preventive service could receive an "I" letter grade for several reasons: Studies may be lacking, existing studies may be of poor quality, or good-quality studies may have conflicting results. Therefore, an "I" recommendation is a call for additional research that would provide the appropriate evidence base for the USPSTF to make either a positive or negative recommendation.

Two Methodological Issues now under Consideration

Mr. Chairman, there are two methodological issues under consideration by the Task Force that may be of interest to the Committee, and we would welcome your input. The first relates to special populations. The Task Force addresses recommendations across all age groups from birth to death. While the majority of recommendations focus on the adult population, the current Task Force has addressed 13 topics relating to children and adolescents. Challenges exist in making recommendation for these populations for multiple reasons. Defining the clinical endpoint can be difficult in children because the reduction of morbidity and mortality may not be realized until they reach adulthood. The potential benefits or harms of clinical preventive services need to be considered for the child and adolescent as well as their family. Finally, youth often receive services in the school or community setting. To address these challenges the Task Force established the Child Health Workgroup which is currently discussing these issues and is planning a child health expert conference.

The second issue relates to the consideration of costs and cost-effectiveness. With the convening of the current Task Force, members recognized that cost-effectiveness and value are important issues to users of the Task Force recommendations. The Task Force convened a work group to assess approaches for addressing cost and cost-effectiveness. That assessment is still under way. At this point, the Task Force does not consider cost or cost effectiveness as a primary determinate in making its recommendations but rather in selected cases summarizes the cost data for users in the discussion section of its recommendation statement.

THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

Mr. Chairman, supporting the work of the Task Force is but one aspect of AHRQ's much broader prevention agenda. Unlike the Task Force, our agenda includes tertiary prevention interventions in addition to primary and secondary activities. Rather than provide a laundry list of those activities, I would like to highlight three unique strengths that AHRQ brings to all of its work, including the Department's prevention initiatives.

In recent years we have come to appreciate that there is a large gap between what is known and what is done in practice. It is reflected in the unacceptably long time line between the funding of pioneering research and the point at which most Americans benefit from that research investment; at least one analyst estimates that it takes 17 years. Our work suggests that there are a number of challenges we must overcome if we are to ensure that Americans benefit more rapidly from our past research investments. Let me highlight just three.

First, it is hard for physicians and their patients to keep abreast of the latest scientific knowledge. The increased pace of publication of new scientific findings also enhances this difficulty. As a practicing physician, I know how difficult it is to determine whether to change my practice on the basis of the latest finding about one of many clinical issues I face. Unless research findings are put into context, my colleagues and I cannot answer for our patients that vital but deceptively simple question: what is known? I am increasingly convinced that AHRQ's role in the synthesis of evidence -- which we undertake for (among others) the Task Force, CMS, FDA, and even NIH as a prelude to its consensus conferences -- is a vital first step to reducing lag time. We need to understand what is known - the "state of the art" - before we can improve. In the area of prevention, for example, we have completed three important evidence reports on obesity. I expect these reports will be as useful to policymakers as they will be for patients and their caregivers.

  • CMS commissioned a technology assessment from us to review and analyze the scientific literature on treatments for obesity in the elderly, including behavioral therapies and dietary counseling.
  • At the request of Congress, we developed a report on a cost effectiveness analysis of weight loss programs in the elderly.
  • One of our Evidence-based Practice Centers recently completed an evidence report on pharmacological and surgical management of obesity. This report was requested by primary care specialty societies. It will be released in the next few days.

The Medicare Modernization Act (MMA) requires AHRQ to undertake more of this type of work so that those who manage and are served by the Medicare, Medicaid and SCHIP programs can benefit faster from existing knowledge. The MMA also challenges AHRQ to see that physicians and patients can access the information on "what is known" when they need it. We already have an innovative arrangement with the vendor, ePocrates, to provide physicians with fast access on their PDAs to the bottom line of recommendations from the Task Force. Since a growing number of clinicians rely on their PDAs to help keep them current with the latest science, AHRQ has developed a free Interactive Preventive Services Selector Program for PDAs. Since we made the software available for downloading, the web site has been accessed 7,847 times and the software has been installed on 1,837 Palm-based PDAs and 775 Pocket PC PDAs.

Second, recent experience demonstrates that knowing the right thing to do is only the first step. The real challenge is ensuring that our broad range of health care delivery systems supports, rather than frustrates, the efforts of harried caregivers to do the right thing. AHRQ has a unique dual focus on effective services and effective and efficient ways to organize, manage, and deliver those services. We pioneered the use of preventive services reminder systems and some concepts for workflow redesign to improve the rates at which preventive services were delivered and used. As my colleagues and I work to make AHRQ more of a "problem solving" agency, we will focus increasing attention on options for overcoming those system, organization, and behavioral barriers to increased use of effective clinical services.

In addition, we will soon be announcing a series of grant and contract awards to increase the deployment and use of health information technology -- precisely because health information technology can make the right thing to do the easy thing to do. The awards we will be announcing will advance the President's and Secretary's commitment to improve the safety and quality of health care and increase the utilization of preventive services.

Third, as the "baby boomer" generation ages, the ranks of chronic care patients are swelling. AHRQ has and will continue to contribute to efforts to develop and assess specific disease management strategies. But the unique perspective we bring to chronic care management is a patient-centered, not disease-centered, focus. For example, 82% of patients with diabetes have another chronic condition and 20% of Medicare beneficiaries have 5 or more chronic conditions. In our view, the challenge of developing effective individual disease management strategies is easily matched, if not exceeded, by the need to reconcile disparate disease management programs for patients with multiple chronic diseases. Increasingly, our work is shifting to meet this need. The number of multiple chronic care patients will only continue to grow in the years ahead and we need tertiary prevention strategies that can be reconciled at the level of the primary carergiver.

CONCLUSION

Mr. Chairman, this concludes my prepared testimony. I would be happy to answer questions.

U.S. Department of Health and Human Services
Agency for Healthcare Research and Quality

U.S. Preventive Services Task Force

Task Force

Janet D. Allan, Ph.D., R.N., C.S., F.A.A.N.
Dean and Professor
School of Nursing

Alfred O. Berg, M.D., M.P.H.
Professor and Chair
Department of Family Medicine
University of Washington

Ned Calonge, M.D., M.P.H.
Chief Medical Officer and State Epidemiologist
Colorado Department of Public Health and Environment

Paul S. Frame, M.D.
Family Physician
Tri-County Family Medicine

Leon Gordis, M.D., Dr.P.H.
Professor
Epidemiology Department
Johns Hopkins Bloomberg School of Public Health

Kimberly D. Gregory, M.D., M.P.H.
Director, Women's Health Research and
Maternal-Fetal Medicine

Russell Harris, M.D., M.P.H.
Associate Professor of Medicine
University of North Carolina School of Medicine

Mark S. Johnson, M.D., M.P.H.
Chair
Department of Family Medicine
New Jersey Medical School
University of Medicine and Dentistry of New Jersey

Jonathan D. Klein, M.D., M.P.H.
Associate Professor
Department of Pediatrics
University of Rochester

Carol Loveland-Cherry, Ph.D., R.N.,
F.A.A.N.
Executive Associate Dean
School of Nursing
University of Michigan

Virginia A. Moyer, M.D., M.P.H.
Professor
Department of Pediatrics
University of Texas Health Science Center

Judith K. Ockene, Ph.D.
Professor of Medicine and Chief
Division of Preventive and Behavioral Medicine
University of Massachusetts Medical School

Diana B. Petitti, M.D., M.P.H.
Director
Research and Evaluation
Kaiser Permanente Southern California

Albert L. Siu, M.D., M.S.P.H.
Professor and Chairman
Brookdale Department of Geriatrics and Adult Development
Mount Sinai Medical Center

Steven Teutsch, M.D., M.P.H.
Executive Director
Outcomes Research and Management
Merck and Company, Inc.

Barbara P. Yawn, M.D., M.Sc., F.A.A.F.P.
Director of Research
Olmstead Research Center

Last Revised: September 21, 2004