Guidelines For
DEMONSTRATION AND EDUCATION RESEARCH GRANTS
National Heart, Lung, and Blood Institute
National Institutes of Health
September 2006
In this document:
PURPOSE The purpose of these guidelines is to provide information to assist members of the scientific community interested in applying to the National Heart, Lung, and Blood Institute for Demonstration and Education Research Grants. This document is intended to provide background information relating to the program areas.
INTRODUCTION Demonstration and education research is an integral part of the National Heart, Lung, and Blood Institute's (NHLBI) systematic approach to the support of research throughout the biomedical spectrum. Demonstration and Education (D&E) research involves extension or adaptation of generally accepted interventions to broader populations or settings. The Institute is particularly interested in encouraging high quality applications in the area of D&E research that incorporate rigorous design and analysis. In issuing these guidelines, NHLBI intends to provide information to assist members of the scientific community interested in applying for D&E research grants in the cardiovascular, pulmonary, blood, and sleep areas.
DEFINITION OF DEMONSTRATION AND EDUCATION RESEARCH As the concept is used at NHLBI, D&E Research takes interventions that are generally accepted as beneficial and addresses their extension or adaptation to specific populations or settings. Examining the ability to implement interventions whose efficacy has been demonstrated is thus the focus of demonstration and education research. Studies of intervention or treatment efficacy are not supported by the D&E mechanism but are supported by other mechanisms. Definitions of effectiveness and efficacy appear in the glossary.
Interventions tested in D&E research are based on strategies designed to promote healthful behaviors, to prevent disease, or ameliorate disease in defined populations. The intervention strategies include, but are not limited to, educational strategies, behavioral techniques, and environmental or organizational strategies that may improve the prevention or management of heart, lung, and blood diseases and sleep disorders, including the delivery of healthcare services. The interventions should be based on the application of valid theories and strategies drawn from the biomedical sciences and behavioral and/or social sciences.
D&E research is the last phase of five phases of the NHLBI biomedical research spectrum, the others being basic research, applied research and development, clinical investigations, and clinical trials. Together, the phases may be viewed as a continuum with overlapping areas of research and a feedback loop, with findings from research conducted in later phases serving to identify needs for additional research in earlier phases.
The purpose of each phase is indicated below:
- BASIC RESEARCH seeks new knowledge about normal and abnormal functions of the heart, lungs, and blood and the etiology and pathogenesis of the related diseases
- APPLIED RESEARCH AND DEVELOPMENT seeks to develop new ways of using basic research results to achieve specific practical goals
- CLINICAL INVESTIGATIONS evaluate the application of fundamental research results in the clinical setting, usually in a relatively small number of patients, or identify causes of disease and risk factors in defined populations
- CLINICAL TRIALS determine the efficacy and safety of clinical interventions in samples of individuals drawn from larger population groups
- DEMONSTRATION AND EDUCATION RESEARCH tests the effectiveness of interventions that are based on strategies designed to promote healthful behaviors, to prevent disease or to ameliorate disease in defined populations
GENERAL CHARACTERISTICS OF DEMONSTRATION AND EDUCATION RESEARCH
- D&E research should be designed to test interventions that are expected to enhance health promotion, or disease prevention or amelioration for a defined population. Randomized designs are encouraged but are not required. The strongest research design possible should be used. The delivery of the intervention needs to be documented and evaluated as part of the research design.
- The defined populations may be from a variety of settings. Examples include a general population living in a geographically defined area; employees in work sites; populations of schools; patients, physicians, or health care providers in physicians' offices, ambulatory care clinics, health maintenance organizations, or other clinical care delivery sites; and other community settings. Other appropriate populations might be those identified by some common demographic or other characteristic such as ethnic group membership, socioeconomic status, disease or at-risk status, age, or gender.
- The research studies will be based on the current medical understanding of heart and vascular, lung, and blood diseases, and sleep disorders and will usually use methodology from the fields of biomedical, social, and behavioral sciences. The research studies should draw upon the results of research from controlled laboratory or clinical investigations. Participation by investigators from a range of research disciplines may be required, e.g., cardiologists, pulmonologists, hematologists, public health physicians, industrial physicians, primary care physicians, epidemiologist, biostatisticians, psychologists, health educators, sociologists, nurses, nutritionists.
- D&E research may focus on the processes of implementation and diffusion. However, the D&E research program does not support the transfer of specific technology, development of educational programs, or the implementation of specific innovations by themselves outside of a research study. Direct service programs intended solely to provide preventive or therapeutic care for heart, lung, and blood diseases are not eligible for funding. Clinical testing of a new technology or a new drug for treatment is also not included in this research program.
AREAS OF INTEREST FOR DEMONSTRATION AND EDUCATION RESEARCH This section lists the major areas of research interest at the NHLBI. Topics are based on the national plan areas for the program areas of heart, lung, and blood. The following topics are intended as examples and are neither all-inclusive nor exhaustive nor listed in order of priority.
- Studies of improved methods of prevention or reduction of risk factors for coronary heart disease in children or adults including hypertension, elevated blood lipids, smoking, inadequate physical activity, obesity, diabetes, and stress; studies of approaches to improving the clinical delivery of proven efficacious treatments for cardiovascular disease and its risk factors; rehabilitation after a myocardial infarction, cardiac surgery, or complications of heart and vascular diseases; and arrhythmias and sudden cardiac death.
- Studies directed at the prevention of the complications of atherosclerosis, hypertension, coronary heart disease, peripheral vascular disease, congenital and rheumatic heart disease, cardiomyopathy, infections of the heart or cerebrovascular disease, excluding the neurological components of completed stroke.
- Studies of promotion and maintenance of respiratory health; asthma, emphysema, and chronic bronchitis; cystic fibrosis; sleep apnea; interstitial lung disease; occupational lung diseases; respiratory failure; pulmonary vascular disease; pulmonary complications of AIDS; and risk factors for lung disease, including smoking, occupational exposure, and environmental exposure. Cancers of the lung and upper respiratory infections are the responsibilities of other components of the National Institutes of Health and are not included in this program.
- Studies of appropriate use and safety of the blood supply and prevention and treatment of hematologic disorders: acquired immune deficiency syndrome or HIV-infection in blood donors; genetic and acquired risk factors for blood disorders, thromboembolic disorders, hemophilia and other bleeding disorders, platelet abnormalities, sickle cell anemia, Cooley's anemia, aplastic anemia, and other hemoglobin disorders; blood donor recruitment and blood collection; safety of blood therapy (transfusion-transmitted disorders and immunohematology); blood component therapy; and blood center and transfusion service management. Cancers of the blood are the responsibilities of other components of the National Institutes of Health and are not included in this program.
EXAMPLES OF DEMONSTRATION AND EDUCATION RESEARCH The following are examples of D&E research projects that have received support in the heart and vascular, lung, and blood programs at NHLBI. The brief descriptions are listed to provide potential applicants with an overview of some of the types of studies funded under this program.
Adherence Intervention for Minority Children with Asthma
Low income, minority children use emergency departments for asthma care at a disproportionately high rate. The purpose of this study is to demonstrate that improved adherence with asthma therapy can significantly reduce emergency department use for asthma care among high risk children. The effectiveness of an intensive adherence intervention using electronic medication monitors and medication measurement for monitoring and feedback will be compared to a home-based asthma education intervention and a usual care control group. Participants will be randomly assigned to the different treatment groups.
The primary outcome measure is medical record-documented emergency care for asthma over an 18-month follow-up period. Secondary outcomes include adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, school absences, restricted activity, nighttime symptoms, asthma medications, self and family asthma management, asthma management self-efficacy, functional status, and quality of life.
Receptivity to Sickle/Thalassemia Screening During Pregnancy
This project is examining the receptivity of pregnant women to unsolicited information from a screening test that identifies them as hemoglobinopathy carriers. The principal measure of receptivity used is whether pregnant carriers act on the information by referring their mates for carrier testing. In the first 34 months of the study, 61% of women made a special trip to receive counseling, 81% of counseled carriers wanted their mates tested, 59% of mates were actually tested, and 69% of couples found to be at risk and offered prenatal diagnosis chose it. Seventy-two percent of first prenatal visits of carriers occurred in time for prenatal diagnosis. The costs of the program are less than the costs of medical care for the estimated cases of hemoglobinopathies averted.
The majority of pregnant women act on information offered by tertiary providers. This study focuses on whether counseling by primary providers can be equally effective. The most current study is (1) training primary providers of obstetrical care to offer carrier patients appropriate genetic counseling, (2) comparing counseling by primary providers with counseling by tertiary providers, and (3) identifying effective and ineffective counseling techniques among primary providers. Primary providers and their staffs will be trained in genetic counseling and follow-up of hemoglobinopathy carriers.
A Community-based Intervention to Prevent Weight Gain
The purpose of this study is to implement and evaluate a community-based weight-gain prevention intervention that includes both environmental change and individual behavior change components. Households will be recruited and randomized to either weight-gain prevention program or control for a two-year intervention. The environmental change component focuses on reducing household availability of high fat and high energy convenience foods, and reducing access to television viewing. The behavioral change component focuses on changing individual eating and exercise behaviors.
The primary outcome measure is percent weight change over the two-year follow-up period. Secondary outcome measures are changes in physical activity, energy intake, and television viewing time. It is hypothesized that intervention households will gain less weight over the two-year period than households randomized to the control group.
Effect of Self-Regulatory Education on Women with Asthma
This study is implementing and evaluating an educational intervention (Women Breathe Free) in women with asthma to improve their physical functioning and quality of life and to reduce outpatient and inpatient health care utilization and costs. The program will rely predominately upon telephone counseling to teach self-regulation skills to manage asthma.
A controlled randomized design will be used with an intervention group and a control group. The control group will receive usual care, which includes education from a nurse. The intervention group will receive usual care plus an educational kit, patient diaries, a peak flow meter, an instruction video, and a photograph of the nurse health educator who will make five phone contacts. Each phone call will have specific objectives and goals consistent with the gender-specific theme and the self-regulation model. The effectiveness of the program will be evaluated from telephone interviews conducted prior to the intervention and at 6, 12, and 18 months. The interviewers will employ specifically developed and already established survey instruments and will also review health care records.
Heart Disease Management to Reduce Emergency Room Visits
This project tests the effectiveness of personalized telephone counseling for heart disease management on health care use of older women. Women who are likely to be hospitalized or use emergency department services for heart disease prevention or treatment are randomized into one of two groups: telephone counseling or "usual care" control. It is hypothesized that the telephone counseling group will have 1) fewer use of emergency department services and/or fewer hospitalizations; 2) lower health care costs; and 3) improved health-related quality of life defined as increased physical and psychosocial functioning, decreased symptoms and fewer depressive symptoms.
The primary outcome measure is number of emergency department visits as recorded in hospital billing records. Secondary outcome measures include cost of hospitalization, and psychosocial functioning measures such as quality of life, social support, and depressive symptoms.
Home Based Environmental Adherence Trial
Allergen avoidance has been shown to be a risk free treatment for asthma that reduces both asthma symptoms and hyperresponsiveness. The purpose of this study is to conduct a trial of the effectiveness of allergen avoidance as adjunct therapy, comparing a home-based allergen control education program to a customary education program.
Participants will be 240 children who have asthma and range in age from 6 to 17 years. Each child and its family will undergo baseline evaluations and a home visit to collect samples for allergen measurements. After receiving traditional allergen control education in the clinic, participants will be randomized to either usual care by a pediatrician or a home-based behavioral educational and support program provided by trained counselors. Children and families will be assessed in clinic visits at 6 to 12 months post randomization and home visits will be repeated at 6 to 12 months. Primary outcomes will be changes in Asthma-Related Quality of Life measures and target environmental allergen levels in the home. Secondary outcomes will be adherence with environmental control recommendations, changes in rhinoconjunctivitis, FEV1, changes in non-targeted environmental allergens, self efficacy for environmental allergy control, and health care utilization.
Asthma Self-Management for Adolescents
The purpose of this research is to evaluate strategies to help 9th and 10th grade students with persistent asthma learn to control and live without restrictions on physical or social activities. The study proposes that an intensive school-based asthma education program for students who have persistent asthma, coupled with intensive asthma education for their physicians, can improve the students' health status, quality of life, and ability to self-regulate their health behavior.
The effectiveness of the following program will be tested: 1) screen 9th and 10th graders to identify students with asthma and assess how well the it is controlled; 2) educate students with persistent asthma about their condition using Open Airways for Schools and Asthma Self-Regulation programs; 3) provide continuing medical education for the community physicians who treat the students, using the MD/Family Partnership program and an intensive academic program based on the NAEPP Guidelines for asthma care; 4) develop a written asthma management plan for each student; and 5) refer students who lack a primary medical care provider to physicians who have received training in asthma management. The primary outcome measures will be: reduced asthma symptom frequency, improved quality of life, and increased capacity for self-regulation of asthma.
APPLICATION PREPARATION This document is not a solicitation for D&E research grant applications. Consultation with NHLBI program staff, although not a prerequisite for submission of an application, is highly recommended prior to submission of a D&E research grant. Investigators are urged to contact program staff early in the process of preparing a grant application.
Applications submitted in response to an NHLBI Request for Applications (RFA) must comply with any additional instructions provided in the RFA announcement.
Applications for the D&E program should be identified by checking "yes" and typing "Demonstration and Education Research (R18)" in section 1, page 1, item 2; or by indicating the RFA, if applicable.
Applications for the D&E program should be prepared and submitted using the PHS 398 forms and instructions . This guidance is supplemental to the instructions in the PHS 398 - all applications must conform to the PHS 398 instructions, guidelines, and policies.
Applicants must address the following NIH and NHLBI policies, as appropriate for the research proposed. Do not hesitate to contact NHLBI staff if you have any questions regarding the policies.
Applications With Direct Costs Equal To Or Greater Than $500,000 In Any One Year: Any application requesting more than $500,000 in direct costs in any year must be formally approved for acceptance by the NHLBI by following the process described on the NHLBI Internet site ( http://www.nhlbi.nih.gov/funding/policies/500kweb.htm ) as required by NIH policy ( http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html ).
Plan For Disseminating Research Findings: An important element of D&E research is dissemination of results to patients, the health care community, and the public. Therefore, all D&E applications must contain a plan to disseminate the results. Characteristics of a dissemination plan are briefly described in the policy on accepting applications with direct costs equal to or greater than $500,000 in any one year. Additional information about the plan can be discussed during pre-application discussions with NHLBI staff and from the NIH policy on data sharing at http://grants.nih.gov/grants/policy/data_sharing/ .
Monitoring Plan And Data Safety And Monitoring Board: NIH policy requires that all clinical trials have data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html ). The NHLBI provides links to additional guidance regarding monitoring of clinical trials and non-intervention clinical studies on the NHLBI public web site at http://www.nhlbi.nih.gov/funding/ethics.htm .
Human Subjects Protection: Federal regulations (45CFR46) require applications and proposals involving human subjects to be evaluated with reference to the risks to the subjects, the adequacy of protection against the risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/4 5 cfr46.htm
Required Education On The Protection Of Human Subject Participants: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000 , at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html .
Inclusion Of Women And Minorities In Clinical Research: NIH policy requires that women and members of minority groups and their sub-populations be included in all NIH-supported clinical research projects, unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Additional guidance is available on the NHLBI public web site at http://www.nhlbi.nih.gov/funding/ethics.htm .
All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html ); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion Of Children As Participants In Research Involving Human Subjects: NIH policy requires inclusion of children (i.e., individuals under the age of 21) in all human subjects research conducted or supported by the NIH, unless scientific or ethical reasons justify their exclusion.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm .
Human Embryonic Stem Cells (HESC): Criteria for federal funding and resources related to research on research on HESC can be found at http://stemcells.nih.gov/index.asp . Only research using HESC lines that are registered in the NIH Human Embryonic Stem Cell Registry is eligible for Federal funding (see http://stemcells.nih.gov/registry/index.asp ). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access To Research Data Through The Freedom Of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm .
Applicants may wish to place data collected under this Program Announcement in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about it in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards For Privacy Of Individually Identifiable Health Information: (if applicable) The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those entities that must comply with the Privacy Rule (classified under the Rule as “covered entities”) were required to do so by April 14, 2004 (with the exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with the researchers and their institutions. The OCR web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html .
URLs in NIH Grant Applications Or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
APPLICATION SUBMISSION
Receipt dates for investigator-initiated new and revised applications for D & E Research Grants are the usual NIH research grant deadlines (February 1, June 1, or October 1).
Send the original and three copies of the application to the Center for Scientific Review, as instructed in the PHS 398. All applicants also should send two copies of the application and five copies of collated appendix material to:
Chief, Review Branch
Division of Extramural Research Activities
NHLBI
Rockledge Building, Room 7214
Bethesda , Maryland 20892-7924
(301) 435-0270
Submission of copies to the NHLBI will allow more time for the Scientific Review Administrator to plan for the review.
APPLICATION REVIEW
Applications for D&E programs assigned by the NIH Center for Scientific Review to the NHLBI usually will be reviewed by special review committees managed by the Review Branch, Division of Extramural Research Activities, NHLBI. The peer review panel for each application will be individuals with expertise in demonstration and education research programs in general and in the specific disease area of the application. All applications will undergo a secondary review by the National Heart, Lung, and Blood Advisory Council.
The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:
- Significance
- Approach
- Innovation
- Investigator
- Environment
The reviewers will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
- SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
- APPROACH: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
- INNOVATION: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
- INVESTIGATORS: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
- ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
ADDITIONAL REVIEW CONSIDERATIONS
- BUDGET AND PERIOD OF SUPPORT
: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
STAFF CONSULTATION
Inquiries about possible new D&E research grant applications may be directed to the offices listed; the appropriate staff member to contact for consultation will be identified. Applicants should consult Institute staff early in the planning phases. Consultation about renewal and supplemental grant applications should be sought from the NHLBI staff member who administers the current grant.
Division of Cardiovascular Diseases
Office of the Director
National Heart, Lung, and Blood Institute
Rockledge 2, Room 9160
6701 Rockledge Drive
Bethesda, Maryland 20892-7940
301-435-0466
Division of Lung Diseases
Airway, Biology and Diseases Program
National Heart, Lung, and Blood Institute
Rockledge 2, Room 10018
6701 Rockledge Drive
Bethesda, Maryland 20892-7952
301-435-0233
Division of Blood Diseases and Resources
Office of the Director
National Heart, Lung, and Blood Institute
Rockledge 2, Room 10160
6701 Rockledge Drive
Bethesda, Maryland 20892-7950
301-435-0080
Division of Prevention and Population Sciences
Clinical Applications and Prevention Program
National Heart, Lung, and Blood Institute
Rockledge 2, Room 8100
6701 Rockledge Drive
Bethesda, Maryland 20892-7936
301-435-0422
Division of Extramural Research Activities
Review Branch
National Heart, Lung, and Blood Institute
Rockledge 2, Room 7180
6701 Rockledge Drive
Bethesda, Maryland 20892-7924
301-435-0270
Unlike the Program Divisions in the NHLBI, the NHLBI Office of Prevention, Education, and Control (OPEC) does not fund research studies. However, it serves as the professional and public education and information dissemination arm of the Institute. OPEC coordinates the National High Blood Pressure Education Program, the National Cholesterol Education Program, and the NHLBI Smoking Education Program and emphasizes professional and patient education, the workplace, the schools, and minority health issues. Applicants may want to contact this office for materials or information. The telephone number for OPEC is 301-496-5437. Materials or information regarding sleep programs and sleep research can be obtained from the National Center on Sleep Disorders Research ( 301-435-0199 ).
GLOSSARY: KEY TERMS USED IN THE GUIDELINES Several terms related to D&E research are defined in this section to provide clarity for the scientific community and the NHLBI.
"Efficacy" is the extent to which an intervention can be shown to be beneficial under optimal study conditions.
"Effectiveness" is the extent to which an intervention can be shown to be beneficial under real world conditions.
"Health education" is any combination of learning experiences designed to facilitate voluntary adoption of behavior conducive to health.
"Health promotion" is any combination of health education and related medical, public health, organizational, political, and economic interventions designed to facilitate behavioral and environmental adaptations that will improve health. Health promotion differs from disease prevention in that it begins with people who are basically healthy and seeks to develop community and individual measures that can help them to adopt lifestyles that can maintain and enhance a state of well-being. Disease prevention begins with a threat to health, such as a disease or environmental hazard, and seeks to protect as many people as possible from harmful consequences of that threat. The two terms are complementary.
"Intervention" is a method or technique used as part of a program or protocol that introduces a change for individuals, patients, groups, or populations.
"Knowledge transfer" (technology transfer) is the process of disseminating validated research results to health providers and the public.
"Primary prevention" refers to actions undertaken prior to the development of disease, injury, or illness for the purpose of preventing the occurrence of a disease, injury, or illness.
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