Full Text HS-96-001 RESEARCH ON THE OUTCOMES OF PHARMACEUTICAL THERAPY NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: HS-96-001 P.T. 34 Keywords: Chemotherapy 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: March 1, 1995 Application Receipt Date: April 12, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on the outcomes of pharmaceutical therapy. This request for applications (RFA) focuses on the effects on patient outcomes of various proposed or existing mechanisms for managing selection, utilization, and cost of pharmaceutical therapies and services. Current restructuring within the health care system provides an important opportunity to enhance understanding of the interrelationships of pharmaceutical treatments and services with patient outcomes. Of particular interest are studies involving the comparative effectiveness and/or cost effectiveness of pharmaceutical therapies within the changing health care system. This is an activity of the research component of AHCPR's Medical Treatment Effectiveness Program (MEDTEP). Section 1142 of the Social Security Act, a part of AHCPR's authorizing legislation, refers specifically to the need to study the outcomes of prescription drug therapy. Awards are a part of the Outcomes of Pharmaceutical Therapy (OPT) program, as introduced in RFA HS-92-03. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non- profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This request for applications will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This is a one-time solicitation. The total requested project period may not exceed five years. Annual progress reviews by AHCPR and the availability of funds will determine the continuation of grants up to the five year limit. FUNDS AVAILABLE The AHCPR expects to award up to $2 million for first year support of four to six awards. RESEARCH OBJECTIVES Background The enabling legislation for AHCPR authorizes studies of the effectiveness and appropriateness of health care services and procedures. Section 1142 of the Social Security Act recognizes drug therapy as an important form of treatment and refers to the need to study effectiveness and appropriateness. As a component of MEDTEP, a program was established in March 1992 with RFA HS-92-03, focusing on the patient outcomes of pharmaceutical therapy. As a result of that RFA, AHCPR has awarded sixteen grants focusing on outcomes of pharmaceutical therapy in ambulatory care settings. This RFA initiates an extension of that work, but is not limited to studies in any particular care setting. It focuses on the effects on patient outcomes of various programs, proposed or existing, for managing selection, utilization, and cost of pharmaceutical therapies and services within the changing health care environment. MEDTEP Research Themes This RFA incorporates the themes and concepts common to all MEDTEP research (MEDTEP-Summary PA-94-074). "Effectiveness" refers to outcomes experienced by, or observed in, patients in routine clinical practice. This is distinct from "efficacy" which refers to the potential benefit of clinical interventions provided under ideal circumstances to patients who meet specific criteria. Cost effectiveness summarizes the cost and effect of treatment in terms of specified outcomes measured in nonmonetary units; it indicates value obtained for resources expended. MEDTEP studies focus on clinical conditions that affect large numbers of people (or a large proportion of a major subpopulation); that result in substantial expense; that are significant in Medicaid or Medicare programs; and for which there are large, unexplained variations in treatment. The outcomes to be studied, in addition to traditional measures such as survival and morbidity, include patient- reported outcomes such as perceived health status, functioning, and quality of life. MEDTEP studies typically involve a multidisciplinary team of researchers with clinical and methodological expertise, plus understanding of the perspectives of patients, providers, and policymakers. Methods MEDTEP studies draw on a wide range of research methods that include, but are not limited to: experimental and quasi-experimental designs, case-control and cohort studies, effectiveness trials, meta-analysis, cost effectiveness analysis, decision modeling, and combinations of these methods. Primary data will generally be required; however, these may be combined with, and occasionally replaced by, secondary data when the latter will provide adequate information and efficient means to address the research question(s). Data sources should allow for the detection, measurement, and/or control of: drug exposure, indication for drug use, severity of illness, comorbidities, relevant confounders, and costs of care when appropriate. Measures of short- and long-term outcomes, as well as pre-treatment health status information, are critical data elements. Applications must be explicit and detailed in describing data, methods, and tools for data collection and analysis. The research plan must be justified in terms of potential for answering the proposed research question(s). Applicants who propose to use Medicare or Medicaid data must specify the required data files and explore the availability and cost of obtaining these data with the Health Care Financing Administration (HCFA). The estimated cost must be presented, along with documentation from HCFA, as part of the grant application. This cost should not be included in the total budget request for the project. For more information about data budgets, contact Mr. Ralph L. Sloat, AHCPR Grants Management Officer (see INQUIRIES). Topic Selection Current restructuring within the health care system provides an opportunity to enhance understanding of the interrelationships of pharmaceutical treatments and services, with patient outcomes. The changing mix of payment mechanisms, benefit plans, and cost- containment strategies has widespread implications for patient care. Of particular interest are studies involving the comparative effectiveness and/or cost effectiveness of pharmaceutical therapies within the changing health care system. Studies are expected to compare different clinical approaches to the prevention, diagnosis, treatment, and/or management of common clinical conditions. While most of these studies will involve comparisons among drug therapies and/or related services, studies of drug versus non-drug treatment options also are responsive to the RFA. If it is not feasible to address all important treatment options in a single study, applicants must identify the specific interventions the study will address and justify selections and exclusions. Studies should focus on one or both of the following topic areas: 1. Pharmaceutical Economic Analyses Evaluations of the economic impact of drug therapy are of particular policy relevance in the changing health care environment. Economic information is needed by large-volume purchasers such as managed care organizations to guide formulary decisions, price negotiations, and clinical decision making. Cost-effectiveness, cost-benefit, and cost-utility analyses are responsive to this RFA provided patient outcomes are the central focus. Studies that evaluate monetary cost alone are not responsive. Of special interest are studies that develop tools or analytic models that will be useful in other research. Examples of suitable topics include the following: o Comparative cost effectiveness of alternative drug therapies for treatment of a selected common condition. Choice of condition and treatment options should be justified in terms of clinical and policy relevance. o Cost-utility studies that include user-friendly (to patients and providers) methods or measures for assessing patient preferences, values, and utilities. 2. Effects of Changes in the Health Care Environment There is a trend in health care toward systems of managed care, including health maintenance organizations, individual practice organizations, preferred provider organizations, and coordinated care networks. Often, these systems include some form of case management or pharmaceutical benefit management, for coordination of services and patient monitoring. They also include mechanisms for managing selection, utilization, and cost for pharmaceutical therapies and services. Previous studies have explored the effects of policy and educational interventions on the appropriateness of drug prescribing and use. Many questions remain, however, about the long-term effects of programs that monitor and intervene in the drug management process. Innovations that affect patient outcomes and cost, and that warrant evaluation include: o Interventions designed to change prescribing practices. These range from face-to-face academic detailing, to computer-generated reminders, to adoption of clinical practice guidelines and treatment algorithms that address drug selection and use. o Interventions such as those implemented by large-volume drug purchasers including HMOs, Medicaid programs, and pharmaceutical benefit managers, to optimize the clinical and/or cost effectiveness of drug utilization review (DUR). o Interventions designed to encourage the provision or alter the content of pharmaceutical care. These include reimbursement programs for pharmacist cognitive services within managed care organizations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1995, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, co-investigators and other key personnel; the applicant institution and other participating organizations or institutions; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent is to be sent to: Joanne S. Book Center for Medical Effectiveness Research Agency for Health Care Policy and Research East Jefferson Street, Suite 605 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 710-0267; and, for AHCPR applications, from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100 (FAX 301 652-5264). The RFA label available in the form PHS 398 (rev. 9/91) form must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, type "RFA HS-96-001" in Section 2a on the face page of the application form and mark the "YES" box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by April 12, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR staff for responsiveness to the RFA. Incomplete applications will be returned to the applicant without further consideration. Nonresponsive applications will be transferred to a standing AHCPR or other appropriate scientific review group for review through routine mechanisms. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. Applications may undergo triage by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. Review Criteria The general review criteria for AHCPR grant applications are: o significance and originality from a scientific and technical viewpoint; o adequacy of the proposed method(s); o availability of data or proposed plan to collect data required for the project; o adequacy of the plan for organizing and carrying out the project; o qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget; o adequacy of the facilities and resources available to the applicant; and o adequacy of plans to include both genders and minorities and their subgroups, as appropriate for the scientific goals of the research. 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 experimental subjects, and the safety of the research environments. Special Review Criteria In addition to the general review criteria noted above, the following special scientific and technical review criteria will apply to this RFA: o scientific importance and policy relevance of the topic; o generalizability of results; o feasibility of answering proposed research question(s) within the project period; o attention to technical issues in case definition, case finding, data collection, and analysis; o quality and adequacy of proposed data; o justification for focus on outcome(s) specified; o adequacy of outcome measure(s); o sensitivity to patient heterogeneity and individual preference; o specification of useful findings or products, and identification of constituency(ies) for these; and o efficiency of the research plan. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. In making funding decisions, AHCPR will consider: quality of the proposed project as determined by peer review, availability of funds, and program balance. INQUIRIES The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding program matters to: Richard J. Greene, M.D., Ph.D. Center for Medical Effectiveness Research Agency for Health Care Policy and Research East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485 Email: JBook@po4.ahcpr.gov Direct inquiries regarding fiscal matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 Email: RSloat@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.180. Awards are made under authorization of the Public Health Service Act, Title IX, and Section 1142 of the Social Security Act. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |