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Department of Health and Human Services


Research, Demonstration, and Evaluation Activities
FY 2003 Plan and Budget
February 2002


RESEARCH AND DEMONSTRATIONS

(by HHS Strategic Plan Objective)


IMPROVE OUR UNDERSTANDING OF HOW TO PREVENT, DIAGNOSE, AND TREAT DISEASE AND DISABILITY (OBJECTIVE 6.2)

Table XXIX
(Dollars in thousands)
PROGRAM FY 2001
Actual
FY 2002
Appropriation
FY 2003
President’s Budget Request
Chronic Disease Prevention and Health Promotion (CDC) $14,471 $15,000 $15,000
Infectious Disease - Sexually Transmitted Diseases (CDC) $2,611 $1,357 $2,907
Health Statistics (CDC) $211 $211 $211
Health Services Research (NIH) $245,765 $267,332 $287,739
Total $263,058 $283,900 $305,857
FY 2003 Priorities

CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION (CDC)

Research: Cancer Prevention and Control: CDC will support research to broaden the use of science as the basis for decision-making, policy development, program management, and action to reduce morbidity and mortality from cancer. Priorities will include:

Heart Disease and Stroke: CDC will strengthen and expand the scientific basis for prevention of heart disease and stroke by examining the health effects of major risk factors, e.g., the relationship between levels of cholesterol and other relate lipids and the risk of developing heart disease.

Diabetes Prevention and Control: CDC will translate and share the results of the NIH-lead and CDC supported Diabetes Prevention Program (DDP) to health care professional, health care policy makers, and people who are at high risk of developing diabetes. CDC will also initiate focused research projects to translate results of the DPP into clinical and public health practice.

Evaluation: CDC will conduct evaluation activities in the following areas:

States in the Cardiovascular (CVD) Health Program must meet at least five of seven core capacities to reduce the burden of CVD. The core capacities to be achieved are to: (1) develop scientific capacity; (2) develop an inventory of policy and environmental interventions; (3) develop or update the CVH plan; (4) provide training and technical assistance; (5) population- based strategies; (6) develop a work plan to address priority populations; and (7) develop infrastructure as well as further develop data systems. CDC is developing an evaluation plan that will not only evaluate the ability of the states to build core capacity, but also:

INFECTIOUS DISEASE - SEXUALLY TRANSMITTED DISEASES (CDC)

Research: FY 2003 priorities include:

HEALTH STATISTICS (CDC)

Research: CDC will support research to evaluate methods to expand the scope of the National Hospital Discharge Survey (NHDS) to include pharmaceutical data for inpatients CDC will also:

HEALTH SERVICES RESEARCH (NIH)

In FY 2003, NIH funds will be used to support programs that focus on improving prevention, diagnosis, and treatment in a variety of areas such as cancer, diabetes, obesity, age-related diseases and disorders, and neurological diseases and disorders. FY 2003 priorities include:

Research: The National Center for Complementary and Alternative Medicine (NCCAM) will support research to develop strategies to incorporate complementary and alternative medicine interventions into standard practice and to evaluate the effects of this incorporation. NCCAM will determine if patients, with uncomplicated acute low back pain, when offered their choice of expanded benefits, will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care.

The National Institute of Neurological Disorders and Stroke (NINDS) will support research to: 1) investigate the efficacy of a family-based, telephone-administered intervention for acute stroke patients and their caregivers; 2) evaluate the effectiveness of a psychosocial intervention for post-stroke depression, which will also provide important new information about post-stroke quality-of-life, effects of depression on functional recovery, outcomes of caregivers, and the practical effectiveness of the intervention in clinical practice; 3) ascertain and correlate health care utilization and costs with severity of disorder in newly diagnosed Tourette syndrome cases; 4) develop a computer simulation model to examine optimal neurosurgical decision making in patients with cerebral aneurysms, and to analyze cost-effectiveness relative to management and outcomes of aneurysm patients that could guide resource allocation; and 5) develop risk-adjusted models that predict in-hospital morbidity and mortality for stroke patients based on admissions characteristics and can be used to assess quality of care in both the outpatient and inpatient settings.

Research studies supported by the National Heart, Lung, and Blood Institute (NHLBI) will include: 1) evaluating the cost-effectiveness and medical outcomes of three diabetic treatment strategies to prevent cardiovascular disease in Type 2 diabetics; 2) assessing in four large population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80 and over, including to death, and during the last one to two years of life; 3) developing and evaluating the effectiveness of a new model of clinician-patient interaction, shared decision-making, in improving outcomes in asthmatic adults ages 18 to 70 years; and 4) assessing the impact of an innovative asthma education management program based on the principles of self-regulation and tailored to the unique needs of women with asthma.

The National Human Genome Research Institute (NHGRI) is supporting a large multi-center study on the prevalence, genetic, and environmental determinants, and potential clinical, personal and societal impact of iron overload and hereditary hemochromatosis in diverse populations. We will examine the ethical, legal, and social issues related to the possibility of implementation of primary care-based screening for iron overload and hemochromatosis, including identification of appropriate health care delivery models and the potential personal, societal, or family-related impact of and barriers to primary care- or population-based screening and genetic testing.

Research supported by the National Institute of Dental and Craniofacial Research (NIDCR) will include: 1) a study on the outcomes of two different protocols for placing dental sealants and two research projects aimed at developing better quality of life outcome measures for oral health care; 2) studies looking to improve dentists’ practice decisions and patients’ treatment decisions, especially as these decisions relate to disease risk; and 3) training programs to encourage young scientists engaged in health services research.

Research supported by the National Library of Medicine (NLM) will: 1) determine the impact of telemedicine on cost, quality, and access to health care, assessing various approaches to ensure the confidentiality of health data transmitted via electronic networks, and testing merging health data standards; and 2) develop innovative medical projects that demonstrate the application and use of Next Generation Internet capabilities, such as quality of service, medical data privacy and security, nomadic computing, network management, and infrastructure technology for scientific collaboration.

The National Eye Institute (NEI) will support research to: 1) assess the impact of eye disease and visual impairment on the Nation’s health; and 2) determine the most appropriate use of diagnostic strategies and treatments scientifically demonstrated to improve vision and preserve sight.

The National Institute of Nursing Research (NINR) will continue to support research on: 1) informal caregiving and community-based caregiving, focusing on both on caregivers and on the individuals provided caregiving; 2) examining the effect of nurses and nurse-delivered models of care on patient outcomes in a variety of settings, such as home, community, hospital and in the transitions between care settings and looking at variables such as cost-effectiveness, organizational characteristics, and the effect of reducing staffing (numbers of nurses) on mortality, morbidity and medical errors; and 3) assessing the effects of nurse-managed pathways and models on clinical, functional and cost outcomes of patients with various compelling public health diseases or conditions such as congestive heart failure, diabetes, asthma, ischemic heart disease, general critical illness, sleep apnea, and severe mental illness.

The National Institute of Dental and Craniofacial Research (NIDCD) will continue to support research focusing on early hearing impairment detection and intervention (EHDI) programs, specifically looking at identifying and prioritizing content and presentation for family and professional resources, developing and testing an accessible digital format for EHDI resources, assessing the effectiveness of EHDI resources through systematic field testing, and disseminating and distributing EHDI resources nationally.

The National Institute of Allergy and Infectious Diseases (NIAID) will continue to support research on: 1) management of HIV, including studies designed to assess the utilization and cost-effectiveness of a range of screening sites and methods to facilitate the early identification of HIV-infected persons and their entry into care, to assess the cost-effectiveness of different HIV management strategies through the course of disease, and to compare different strategies of sequential anti-retroviral therapy for the management of HIV-infected persons; and studies focused on estimation of outcomes such as life expectancy, quality of life, and costs of care, as well as studies focused on behavioral issues, intervention, adherence to HIV medications, access to care, and disease progression; 2) development of methods for estimating vaccine efficacy and effectiveness in the field and for characterizing complex and long-term properties of vaccines in individuals and populations; 3) identification of factors that influence screening acceptance, cost- effectiveness of screening, health care seeking, and health care utilization by young people with or at risk of STDs; 4) assessment of the effectiveness of outpatient treatment of Pelvic Inflammatory Disease; and 5) the management of asthma, focusing on a study determining risk factors for asthma exacerbations requiring hospital care, characterizing medication utilization patterns that predict such events, and developing a management scheme based on identification of medication use through a pharmacy-based drug utilization program.

The National Center for Research Resources (NCRR) will continue to sustain research on: efforts to prolong survival from localized breast cancer through dietary-fat intake reduction; nutritional status of disabled older veterans in long term care; nutritional assessments and interventions for HIV-infected infants, children, and hispanic drug abusers; self-management program to improve adherence to HIV therapy; natural history and access to care among HIV- infected women; promoting pediatric preventive health care services.

The National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS) will support research that compares two treatment approaches of three back disorders; the project is expected to have a major impact on clinical practice and on the cost of medical services for persons with one of the three back disorders. Another part of this project will involve observing additional people with back pain to assess health and resource outcomes. NIAMS also will support research on: 1) outcomes, including the relative importance of socioeconomic-demographic, behavioral-cultural and immunogenetic features in the clinical manifestations of systemic lupus erythematosus (SLE) over time; 2) the development of new and innovative early intervention strategies to prevent long-term negative outcomes and promote the health and quality of life of young women with fibromyalgia; and 3) determining whether disability and pain caused by drug toxicities deserve greater weight in decision-making than similar outcomes caused by disease progression, and a comparison of patients’ values for outcomes to those of a sample of rheumatologists.

The National Institute of Neurological Disorders and Stroke (NINDS) will support research to: 1) assess trends in stroke rates in different racial and ethnic populations in various community settings to identify factors that may account for racial, gender, socioeconomic, and/or geographic differences in stroke incidence; and 2) develop methodological tools to improve clinical trial design and sensitivity of treatment effects measures to reduce costs and required sample sizes in conducting clinical trials.

Research supported by the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) will include: 1) the Diabetes Prevention Program (DPP) to focus on improved methods of health care delivery to patients with or at risk of diabetes; improved methods of diabetes self-management; and cost-effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity; 2) the National Diabetes Education Program to improve the treatment and outcomes for people with diabetes, to promote early diagnosis, and ultimately, to prevent the onset of diabetes; 3) the National Kidney Disease Education Program to enhance awareness about the seriousness of kidney disease; the importance of prevention, early diagnosis, and appropriate management of kidney disease; and the prevention and management of complications; 4) the Weight-Control Information Network (WIN) to provide health professionals and consumers with science-based information on obesity, weight control, and nutrition; 5) the Type 2 Diabetes In Children project to focus on cost-effective, school or community based interventions with the potential for broad, population-wide application; and 6) appropriate patient care methodology, including diagnostic, preventive and treatment methods.

The National Institute of Mental Health (NIMH) will support research to examine mental health care needs and develop preventive intervention strategies for diverse populations including youth in foster care, children of depressed and/or abused parents, patients with first episodes of schizophrenia, and others.

Research supported by the National Institute of Child Health and Human Development (NICHD) will: 1) improve knowledge about HIV infection, particularly in low income, minority youth through the Adolescent Medicine HIV/AIDS Research Network; 2) test the feasibility of a prototype system that allows a therapist in a remote location to provide motor training, to conduct treatment, and to monitor a recovering stroke victim’s progress while the patient is located at home; and 3) examine adherence rates and patterns of poor adherence in HIV-infected children, who are receiving highly active antiretroviral therapy (HAART), compare adherence rates to hypothesized compliance predictors for the children and their care givers, and evaluate the value of peer home health educator visits as a means of identifying barriers to adherence and of optimizing compliance.

(Cross-reference 4.1 Enhance the Appropriate Use of Effective health Services)

Studies to be supported by the National Cancer Institute (NCI) include: 1) the investigation of the role of framing in developing maximally persuasive messages promoting cancer prevention and early detection behaviors; and 2) the Cancer Research Network (CRN) to determine and improve the effectiveness of cancer control interventions that span the natural history of major cancers among diverse populations and health systems. Additional studies will focus on: 1) studies of the impact of cutting-edge interventions on patient-centered outcomes, investigating the dissemination of state-of-the-science therapies into community practice, and analyzing disparities in the delivery of quality cancer care; and 2) promoting collaborative cancer research among managed care systems for studies such as identification of patient, provider, and systems factors that could have prevented late stage breast or invasive cervical cancer cases.

NCI will continue to sponsor: 1) the SEER Patterns of Care Study, and 2) the SEER-Medicare database (Surveillance, Epidemiology, and End Results), a large population-based source of information for cancer related epidemiologic and health services research.

NCI also will continue to: 1) translate advances in molecular genetics into evidence-based management strategies, including screening, prevention and, assessment of behavioral consequences; 2) evaluate population-based screening mammography in the United States to better understand screening practices, assess the accuracy, cost and quality of screening programs and the relationship of these practices to changes in breast cancer mortality or other shorter-term outcomes; 3) assess the health-related quality of life among men recently diagnosed with prostate cancer; 4) enhance understanding of quality of cancer care issues; 6) promote collaborative cancer research among managed care systems for studies such as identification of patient, provider, and system factors that could have prevented late stage breast or invasive cervical cancer cases thru the HMO Cancer Research Network; and 7) encourage the expansion of collaborative cancer research among health care provider organizations that are oriented to community care, have access to large, stable, and diverse patient populations and are able to take advantage of existing integrated databases that can provide patient-level information relevant to research studies on cancer control and cancer-related population studies.

Evaluation: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is conducting an evaluation of research efforts supported by the special funds for Type 1 diabetes research appropriated in P.L. 105-33 and P.L. 106-554. This assessment will be based on research progress, scientific publications, and feedback from researchers who received these funds.

The National Institute of Dental and Craniofacial Research (NIDCR) will conduct evaluations to examine the effectiveness of reducing oral health disparities in the areas of caries, periodontal diseases, oral cancer, and craniofacial anomalies. We will review original scientific research literature and interventions resulting from these activities and assess the role of funding mechanism in the effectiveness of efforts to reduce oral health disparities. We will evaluate the impact of NIDCR support on the scientific literature, on the development of new interventions, on the training of new scientists, and on the health and quality of life for the public.

The Center for Scientific Review (CSR) is evaluating reviewer workload and other barriers in the NIH Peer Review Process. Participation of the most talented biomedical scientists and clinicians as reviewers is a cornerstone of the NIH peer review process. However, there are both perceived and real mitigating barriers to participation and these barriers need to be identified and then minimized as appropriate. This study will be composed of two parts: 1) A time-log survey of current reviewers will determine the amount of time study section members spend reading applications and preparing their reviews; and 2) A survey of current study section members and scientists who may be asked to serve in the future that will be designed to identify incentives and disincentives for study section service.

The CSR will also survey behavioral and social science grant applications, and NIH Institute program review staff, to evaluate changes in the review of neuroscience research at NIH Public Law 103-32 transferred most of the grant review responsibilities of former Alcohol, Drug Abuse, and Mental Health Administration Institutes including the National Institute of Mental Health and the National Institute of Drug Abuse to the Center for Scientific Review (CSR). To accommodate this change and improve the quality of behavioral and social science review, sixteen (16) new CSR behavioral and social science study sections were created in 1998 to review behavioral and social science grant applications. To assess the impact of this transformation and help determine if additional modifications of the existing review structure are warranted, CSR will conduct a survey of behavioral and social science grant applicants and Institute/Center program staff.

In addition, CSR will evaluate Study sections assess innovative science and innovative approaches to problems in grant applications they review. However, applicants and some study section members often feel that reviewers tend to become entrenched in traditional and proven ideas and appear reluctant to take the risk necessary to score highly innovative applications. The first phase of this study will survey will current study section members to to access reviewer's opinions and attitudes toward innovative applications versus applications that follow an established paradigm. The second phase will assess the quality of review and impact of newly created "wild card" review groups that focus on innovative applications.

CSR also will survey trainees and CSR staff to evaluate success in meeting objectives of its internship program. CSR began a pilot 2-year internship program in 2001 for training individuals interested in research administration. The program's objectives include 1) providing an excellent training opportunity 2) establishing a source of flexible workload assistance for CSR and 3) creating a source of trained applicants for future Scientific Review Administrator positions.

The National Institute of Child Health and Human Development (NICHD) is evaluating its research center reviews. The research center reviews assist the NICHD leadership, research center program directors, staff, and research stakeholders in the ongoing assessment of the structure, processes, outcomes, and impact of collaborative specialized research efforts to achieve NICHD’s strategic science goals and objectives. Each review project uses qualitative and quantitative evaluation methods tailored to the particular research context. The findings and recommendations will be used to improve research center operations and training-related efforts, and to assist in long-range science planning and policy decisions regarding the program.

The National Center for Complementary and Alternative Medicine (NCCAM) is planning an evaluation of its Centers Program to determine statutory compliance, capacity, and future directions. Specifically: 1) the extent to which the program meets its statutory definition; 2) the capacity of the program as currently constructed to support the best possible research on complementary and alternative modalities, including identification of inherent strengths and weaknesses in the program; and 3) the future directions for the Program including size and types of research mechanisms to be employed.

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