MANAGEMENT OF SYMPTOMS AT THE END OF LIFE NIH GUIDE, Volume 26, Number 40, December 19, 1997 PA NUMBER: PA-98-019 P.T. National Institute of Nursing Research National Cancer Institute National Institute of Allergy and Infectious Diseases National Institute of Mental Health Office of Alternative Medicine PURPOSE The National Institute of Nursing Research (NINR), National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), and Office of Alternative Medicine (OAM) seek research grant applications concerning the clinical management of symptoms and syndromes that are associated with life-limiting illness, such as pain, dyspnea, delirium, cachexia, nausea, fatigue, and depression. The purpose of this initiative is to stimulate research that will lead to improved quality of life for those at the end of life and decreased distress for their caregivers. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Management of Symptoms at the End of Life, is related to the priority areas of heart disease and stroke, cancer, diabetes and chronic disabling conditions, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health (NIH) research project grants (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background Patients at the end of life experience many of the same symptoms, regardless of their underlying medical condition. Pain is the most obvious example, but others are dyspnea, nausea, fatigue, depression, and the symptoms associated with delirium and cachexia. Taken together, these symptoms add significantly to the suffering of patients and their families, and to the costs and burden of their medical care. Yet in many cases the symptoms could be treated or prevented. There is widespread dissatisfaction in the United States with care at the end of life. A recent investigation, the "Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments" (SUPPORT) documented many problems with the delivery of palliative care. Forty percent of the dying patients studied were treated aggressively in intensive care units; pain was common; there were discrepancies between patient desires and actual treatment; and almost half of the physicians in the study did not know that their patients' preference was not to be resuscitated. Broad public interest in and support for physician-assisted suicide is widely viewed as another indicator of major public dissatisfaction with treatment of the terminally ill. In the recommendations made at the conclusion of its study "Approaching Death: Improving Care at the End of Life", the Institute of Medicine recognized the need for action on the part of clinicians, educators, researchers, policy makers and the public. There has been substantial response. Many of the major health professional organizations now have initiatives to improve health care provider education, quality of care of the terminally ill, and public perceptions of palliative care. Several major foundations have established multi-million dollar initiatives in various aspects of palliative care. This effort is much needed to implement current knowledge to improve care. However, there are also important gaps in understanding of the process of dying, including the best way to manage diverse but interrelated symptoms in order to optimize comfort and alertness for those experiencing life-limiting illnesses. The IOM recommendations included encouragement of the nation's research establishment to strengthen the knowledge base of the end-of-life and specifically to advance basic and clinical research on the physiological mechanisms and treatment of commonly experienced symptoms. The end of life is recognized as an important phase of life, one in which individuals have the right to expect quality of life and the opportunity to address key personal issues. When symptoms are well controlled, people with life-threatening illnesses can focus on important personal concerns. Good symptom control is an essential component of quality care at the end of life. Significant advances have been made in recent years in the knowledge necessary for adequate pain control. Important lessons have been learned in the study of this symptom that will inform research on other symptoms associated with life-limiting illness. However, significant challenges remain. With respect to pain management, health providers still need better assessment tools for diverse settings and special populations, as well as more selective and individualized therapies. Moreover, most patients with advanced disease experience multiple symptoms, requiring that their care be based on an understanding of the complex interactions of multiple pathologies and therapies. A Research Workshop, "Symptoms in Terminal Illness," was convened by the National Institutes of Health (NIH) in September 1997. The workshop had three principal goals: (1) to summarize the current state of knowledge concerning the most common symptoms associated with terminal illness; (2) to identify important needs and opportunities for research that would be appropriate for NIH funding; and (3) to initiate a process for enhancing interdisciplinary collaboration and interagency collaboration in research in palliative care. The report of this workshop is available at www.nih.gov/ninr. Consistent with the recommendations made by that panel, this initiative seeks to stimulate integrative, multidisciplinary research that brings basic and clinical investigators together to address the constellation of symptoms at the end of life across disease conditions. Objectives Specific areas of interest include, but are not limited to, the following topics: o studies comparing the incidence and combinations of symptoms that are experienced at the end of life in specific populations, such as persons with cancer, AIDS, end-stage heart disease, etc. o research on the mechanisms and interactions of these symptoms, including biochemical, neurological, endocrine, and immune approaches. o studies of the efficacy of combination therapies to address clusters of symptoms with multiple determinants o small scale studies to develop and test instruments that are sensitive to the distress associated with symptoms at the end of life and useful for monitoring the effectiveness of interventions, especially for culturally diverse populations and disadvantaged groups, such as the cognitively impaired o research on the impact of depression and anxiety and of their treatment on patient status and management at the end of life o research on the ethical issues associated with research at the end of life, including the needs and expectations of dying persons and their families Projects may be descriptive or experimental. The ultimate goal is clinical intervention, but descriptive data is important to enhance the development of targeted interventions. Where appropriate, interventions that are designed to reduce the severity, frequency, duration or distress of symptoms should be evaluated for efficacy under conditions that will permit comprehensive analysis of appropriate outcome measures. Interventions should also have the potential for implementation in routine clinical practice, particularly in the home or hospice setting. Because of the complex interaction of clinical symptoms and the associated subjective responses, a multidisciplinary research approach is recommended. Expertise from health-related disciplines should be included as appropriate for both the target symptom and the clinical population. The participating NIH agencies anticipate collaborating to fund meritorious applications that address multiple institutes' missions. Applicants are encouraged to make use of ongoing research efforts where feasible. Applications from institutions that have a General Clinical Research Center (GCRC) may wish to identify these programs as a resource for conducting the proposed research. If so, a letter of agreement from the program director or the Principal Investigator should be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The complete original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications will also undergo a process in which only those deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. 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 review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score: (1) Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute or center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: June R. Lunney, PhD, RN Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: Lunneyj@ninr.nih.gov Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496 8667 Email: varriccc@dcpcepn.nci.nih.gov Dr. Fred Batzold Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2B27 Bethesda, MD 20892-7640 Telephone: (301) 402-0143 FAX: (301) 402-3171 Email: fb10c@nih.gov Benedetto Vitiello, M.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 18/103 Bethesda, MD 20892-8030 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: Bvitiell@nih.gov Richard L. Nahin, M.P.H., Ph.D. Office of Alternative Medicine National Institutes of Health Building 31, Room 5B-36 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 480-3519 Email: Richard_Nahin@nih.gov Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Office National Institute of Nursing Research 6300 Center Drive, Room 3AN-12 - MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: carowj@ninr.nih.gov William T. Wells Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 250 FAX: (301) 496-8601 Email: William_Wells@nih.gov Mary Kirker Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B21 Bethesda, MD 20892-7610 Telephone: (301) 402-6400 FAX: (301) 480-3780 Email: mk35h@nih.gov Diana S. Trunnell Grant Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20892-8030 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.361, 93.399, 93.855, 93.856, 93.242, and 93.213. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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