Full Text PA-97-066 SECONDARY ANALYSIS OF EXISTING HEALTH SERVICES DATA SETS NIH GUIDE, Volume 26, Number 19, June 6, 1997 PA NUMBER: PA-97-066 P.T. 34 Keywords: Alcohol/Alcoholism Health Services Delivery Health Care Economics National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting exploratory/developmental research grant applications (R21) to support the secondary analysis of existing data sets relevant to developing a knowledge base to improve the delivery of services for alcohol-related problems, including both treatment and preventive interventions. Exploratory/developmental grants for the Secondary Analysis of Existing Health Services Data Sets are intended to more fully utilize currently available data sets and to provide support for substantive exploratory or confirmatory studies that increase knowledge related to improving the availability, accessibility, delivery, quality, effectiveness, cost-effectiveness, and outcomes of alcohol-related treatment and prevention services. Data used in secondary analyses may be obtained from current or past investigator-initiated research activities or from other archival data sets from public or private sources. In addition, research that employs new analytic techniques that demonstrate or promote methodological advances in the area of alcohol-related health services research are of particular interest. Grants supported under this announcement must be limited to a 2-year effort and a maximum of $100,000 in direct costs per year. Research objectives of this announcement include, but are not limited to, five major areas: (1) determining the effects of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in access to and utilization of treatment and prevention interventions for alcohol-related problems; (3) identifying organizational and managerial factors that influence the delivery of treatment and prevention services for alcohol-related problems, either within or across regions, populations, and settings; (4) evaluating the cost, cost-effectiveness, cost-benefit, and cost-utility of alcohol-related treatment and prevention services; and (5) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services. 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 is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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, D.C. 20402-9325 (Telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, 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 AND PERIOD OF SUPPORT Research support may be obtained through an application for an exploratory/developmental research grant (R21). Grant applications must be limited to up to $100,000 in direct costs per year for up to 2 years. The number of new awards made in any fiscal year will depend on the quality of applications, the availability of funds, and program priorities at the time of award. Continuation awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism wishes to promote the use of secondary analyses of data in the expansion of knowledge to improve the delivery of services for alcohol-related problems where appropriate data sets and analytic techniques are available and can be employed. The specific objectives of this announcement on the Secondary Analysis of Existing Health Services Data Sets are to provide support for (a) applying new approaches to analyze current data sets that would benefit from further exploration or (b) reanalyzing previously collected data that would provide cost effective ways of obtaining additional insights into alcohol-related health services research issues. Grants under this announcement are not intended as a means to carry out currently ongoing data analysis or for the maintenance and distribution of data sets. BACKGROUND Health services research projects typically generate data sets with potential utility beyond the specific hypotheses and questions for which the study was designed. Very often these data are not fully analyzed, sometimes due to a lack of resources once a project's funding has ended. Reanalysis of existing data may be prompted by a need to confirm new findings in the field or to aid in the development of new research questions. Other data sets, including survey and epidemiologic data as well as health care utilization, cost, and insurance claims data, are compiled by Federal, State, and local government agencies, or by private entities such as insurance companies, third-party payors, and large to mid-size corporations. Such data sets are potentially rich sources of information that can illuminate a wide range of research questions and policy-relevant topics. In some cases, use of existing data sets may provide an expeditious and cost-effective means of advancing knowledge. When appropriate, secondary data analyses may serve as an alternative approach to expensive and time-consuming data collection projects. Existing data sets may be used to cross-validate exploratory analyses in ongoing studies, to test specific hypotheses or complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Meta-analyses, in which effects from many studies may be compared or combined, may also be considered a form of secondary data analysis for the purposes of this program announcement. Moreover, potential applicants should note that secondary analysis may extend to all types of data, including qualitative information, and also covers the integration of quantitative and qualitative data. AREAS OF RESEARCH INTEREST Health services research is defined as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (PL 101-321, Section 409). Health services research also is concerned with assessing the effectiveness of health services in everyday practice. For the purposes of this announcement, health services research includes: (a) the assessment of the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism or with medical problems consequent to alcoholism; and (b) the assessment of the impact of prevention services on the demand for and utilization of alcohol-related services as well as the financing, organization, management, implementation, cost, and utilization of the prevention services themselves. It should be noted further that, as directed by legislation (P.L. 103-43), for the purposes of this announcement, health services research does not include studies of the efficacy of preventive, diagnostic, and treatment modalities. Applicants may choose to carry out analyses relevant to alcohol-related health services research using large, nationally-representative data sets or smaller, regional, and locally-based data sets. A number of such data sets exist in the public domain, which contain items relevant to alcohol use and abuse and may not have been fully analyzed. Two resource documents are readily available from NIAAA which list data sets that may be of potential interest to health services researchers: (1) Inventory of Databases for Health Services Research on Alcohol Treatment and Prevention, which lists publicly- and privately-supported data sets containing information on the utilization, cost, financing, management, organization, or effectiveness of alcohol treatment or prevention services (copies may be obtained from the NIAAA Health Services Research Program, 6000 Executive Boulevard, MSC 7003, Bethesda, MD 20892-7003; 301/443-0786); and (2) Alcohol Epidemiologic Data Directory, which identifies national-scope and special population data sets that are available for expanded epidemiologic study (copies may be obtained from CSR Incorporated, Suite 200, 1400 Eye Street, NW, Washington, D.C. 20005; 202/842-7600). Other examples include many longitudinal or cross-sectional surveys carried out by agencies of the Federal Government (including, for example, the National Center for Health Statistics and the Centers for Disease Control and Prevention), various State governments, and regional or local governments. Alternatively, applicants may of their own initiative secure access to other data sets that are not in the public domain, such as those collected under research grant funds, sponsored by private agencies, or originally collected for purposes other than research. Examples of general types of secondary analyses that may be considered within the scope of this announcement are given below. This list is illustrative and not exhaustive; prospective proposals should not be limited by these examples. Any proposed research should be guided by scientific considerations and the potential benefit of the proposed analyses. Large sample or multiple sample comparisons: In this category, investigators may seek large archival data sets with identified subgroups or multiple data sets for comparison with each other. For example, an investigator may wish to obtain two or more data sets for the development and testing of integrated research hypotheses for multiple cohorts, different genders, or different ethnic groups. Methodology development: Single or multiple data sets may be obtained to demonstrate new or improved research design, measurement, or analytic techniques. For example, researchers may wish to develop new analytic techniques for longitudinal designs that take into account transitions between alcohol and other drug use behavior over time, or the simulation of complex systems that predict alcohol use at an individual, group, or community level. Measurement issues may also be addressed for different variable and construct domains to facilitate more accurate item equating, norming and further validation of outcome measures, or the development of new measures. The development of improved techniques to measure the costs, cost-effectiveness, or cost-benefits of alcohol treatment and prevention services is encouraged under this announcement. New analyses of a current study: This would allow the investigator to take advantage of opportunities for additional analyses if they are justified as a new stand-alone research project grant for secondary data analysis. These additional analyses may be ideal for cross-validation of results on appropriate comparison groups and lead to improved generalizability of results. Developmental Projects: Some investigators may be interested in examining the feasibility of using certain types of data records or certain kinds of data sets as resources for answering alcohol-related health services research questions, especially if the proposed secondary analyses have not yet been widely-used on those types of records or data sets. Examples include abstracting from medical encounter records, accessing insurance claims and reimbursement data, and analyzing epidemiological or general health data. 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 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 the 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 Office 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@odrockm1.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 completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement 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 and undergo a process in which only those applications 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. REVIEW CRITERIA Scientific, technical, or medical significance and originality of proposed research; Appropriateness and adequacy of the analytic approach and methodology proposed to carry out the research; Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; Availability of the resources necessary to perform the research; Appropriateness of the proposed budget and duration in relation to the proposed research; and Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human subjects, confidentiality of information, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. 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. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Harold I. Perl, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-0788 FAX: 301-443-8774 E-mail: hperl@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4703 FAX: 301-443-3891 E-mail: eellis@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 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 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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