RESEARCH OH ALCOHOLISM PATIENT-TREATMENT MATCHING NIH GUIDE, Volume 21, Number 17, May 8, 1992 PA NUMBER: PA-92-75 P.T. 34 Keywords: Alcohol/Alcoholism Demography Mental Disorders Addiction Data Management/Analysis+ National Institute on Alcohol Abuse and Alcoholism PURPOSE Current research indicates that alcohol dependence and problem drinking are neither unitary phenomena nor unidimensional syndromes. Instead, there appear to be different types of alcohol-dependent individuals. Individual characteristics other than the kind of alcohol problem also seem to affect treatment outcomes. It is becoming evident that both treatment outcomes and costs can be positively affected by carefully matching patients, by their characteristics, with specific treatments. This announcement seeks research grant applications to investigate the therapeutic impact of matching patients more specifically to various treatments. This announcement is a revision of "Alcoholism Treatment: Matching Clients to Treatments" (Revised April 1989). 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, Research on Alcoholism Patient-Treatment Matching, is related to the priority area of decreasing morbidity and mortality associated with alcohol abuse and alcoholism. 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 for alcohol research grants may be made by domestic and foreign, public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. However, foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT Research support may be requested through applications for a research grant (R01), small grant (R03), exploratory/developmental grant (R21) for Alcoholism Treatment Assessment Research, and FIRST Award (R29). Special announcements for exploratory/developmental grants (R21), the FIRST Award program (R29), and the small grant program (R03) are available from the National Clearinghouse for Alcohol and Drug Information as described under APPLICATION PROCEDURES. Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to conduct research projects including direct costs that can be specifically identified with the project and allowable indirect costs. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention service program. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Grants will be administered in accordance with the PHS Grants Policy Statement (rev. October 1990), which is usually available from the office of sponsored research. FUNDS AVAILABLE No specific funds are being allocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for this program. Applications received in response to this announcement will Compete with others submitted to the NIAAA for funding. The amount of funding available will depend on appropriated funds, quality of research proposals, and program priorities at the time of the award. In FY 1991, the NIAAA awarded two grants relating to this program area, including new and continuation grants, for $428,000. RESEARCH OBJECTIVES This announcement solicits research grant applications that propose to study differences among alcoholism treatment regimens in terms of efficacy and cost effectiveness for different types of patients. Specifically, this announcement seeks research projects that: (1) study the effects of the careful matching of patient variables with treatment and setting variables, (2) develop prediction techniques to identify treatments most suitable for patients at various points in the development of their alcohol dependency or recovery, and/or (3) assess the relative cost effectiveness of different types of treatment and settings for different client types. Although research on individualizing alcoholism treatment based on patient characteristics is rather new in nature, treatment matching a appears promising as a means of improving treatment outcomes. Well- conceived and rigorously designed research is needed to identify specific therapeutic elements that may contribute to favorable outcomes for particular subgroups. Patient factors of interest include, but are not limited to: type of alcoholism degree of alcohol dependency, family history of alcoholism, other drug use, psychiatric comorbidities (e.g., depression, panic attacks, antisocial personality), age (adolescent, adult, aged), gender, previous treatment history, neurophysiological status/severity, personality type, general adjustment status, ethnicity, motivation for treatment, patient preference regarding type of intervention, and drinking pattern. Potential treatment variables for patient-treatment matching include: treatment modality, program structure, therapist characteristics (such as perceived empathy, competence, or conceptual level), and treatment setting, among others. The use of well-established and validated instruments or techniques for assessing patient characteristics and treatment outcomes is recommended. In keeping with this, preference will also be given to applications that include both biochemical and self-report measures of outcome. Even when cost or cost-effectiveness factors are not a direct focus of the study, applicants are urged to collect cost data for the studies, if applicable, and to include an analysis of the comparative costs of the treatments studied in the final report, if relevant. Also, since an important as pct of treatment-effectiveness research is its generalizability to applied treatment programs, applicants are urged to report the percentage of patients who refuse to participate in the study or in a particular intervention. Studies may include patients at more than one facility in order to determine the generalizability of matching strategies. Researchers having access to data sets dealing with the general effectiveness of a treatment intervention variable may also propose research projects that involve secondary data analyses to address the question: What types of patients did particularly well with this intervention and which did poorly? When sample sizes permit, patient and treatment interactions to be studied also might include patient-treatment matches that consider two or more patient characteristics or treatment factors simultaneously (for example, patient emotional stability and locus of control matched to degree of structure in treatment). While a single study may not be sufficient to collect information from all types of persons seeking alcoholism treatment, applicants may wish to select certain demographic groups (e.g., women, minorities, military personnel, elderly, adolescents) and study them intensively for consideration. Justification for selection of certain groups is necessary, as specified in the following section on "Special Instructions for Inclusion of Women and Minorities as Subjects in Research." The NIAAA specifically encourages applications that evaluate patient and treatment factors that have already been shown to have some effect on outcome in the treatment of alcoholism, drug dependency, and other behavioral dysfunctions. The variables selected for study should be ones for which a strong clinical rationale or empirical argument can be made regarding their likely contribution to effective patient treatment matching. Studies investigating the appropriateness of pharmacotherapeutic techniques for particular patient types are also of special interest. Studies of matching and treatment techniques for severe chronic alcoholics and other difficult-to-treat categories of alcoholics and alcohol abusers are of special concern as well. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements and proposals for contracts that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, y clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH and ADAMHA recognize that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH/ADAMHA funding components will not make awards of grants, cooperative agreements, or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. Protection of Human Subjects The Department of Health and Human Services (DHHS) has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B59, Bethesda, MD 20892, telephone (301) 496-7041. Specific questions concerning protection of human subjects in research may be directed to the staff member listed under INQUIRIES. An applicant organization proposing to conduct nonexempt research involving human subjects must file an "Assurance of Compliance" with the Office for Protection from Research Risks. As part of this Assurance which commits the applicant organization to comply with the DHHS regulations, the applicant organization must appoint an institutional review board, which is required to review and approve all nonexempt research activities involving human subjects. APPLICATION PROCEDURES Applicants are to use the grant application form PHS 398 (rev. 9/91). The number and title of this announcement, "Research on Alcoholism Patient-Treatment Matching - PA-92-75," must be typed in item 2a on the face page of the PHS 398 application form. Application kits containing the necessary forms and instructions (PHS 398) may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: National Clearinghouse for Alcohol and Drug Information P.O. Box 2345 Rockville, MD 20852 Telephone: (301) 468-2600 or 1-800-729-6686 The signed original and five permanent, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 REVIEW PROCEDURES The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRGs consisting primarily of non-Federal scientific and technical experts will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate National Advisory Council. Only applications recommended by a Council may be considered for funding. Application Receipt and Review Schedule Applications will be accepted and reviewed according to the following schedule: Receipt Dates Initial Advisory Earliest New/Renewal Review Council Review Start Date Jun l/Jul l* Oct/Nov Jan/Feb Apr 1 Oct l/Nov l* Feb/Mar May/Jun Jul 1 Feb l/Mar l* May/Jun Sep/Oct Dec 1 * Competing continuation, supplemental, and revised applications are to be submitted on these dates. Consequences of Late Submission Applications received after the above receipt dates are subject to assignment to the next review cycle or may be returned to the investigator without review if requested by the applicant. Review Criteria Criteria for scientific/technical merit review of applications for research grants (R01) will include the following: o The overall scientific and technical merit and significance of the proposed research. o The appropriateness and adequacy of the experimental design including the adequacy of the methodology proposed for collection and analysis of data. o The adequacy of the qualifications (including level of education and training) and relevant research experience of the Principal Investigator and key research personnel. o The availability of adequate facilities, general environment for the conduct of proposed research, other resources, and any collaborative arrangements necessary for the research. o The appropriateness of budget estimates for the proposed research activities. o Where applicable, the adequacy of procedures to protect or minimize possible adverse effects on humans, animals, or the environment. o Conformance of the application to the ADAMHA/NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03), exploratory/developmental grants (R21), and FIRST Awards (R29) are contained in the specialized announcements that are available from the National Clearinghouse for Alcohol and Drug Information as described under APPLICATION PROCEDURES. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individual listed below for consultation in preparing an application under this announcement. Direct inquires to: Margaret Mattson, Ph.D. Treatment Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-20 Rockville, MD 20857 Telephone: (301) 443-0796 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authority of Sections 301 and 510 of the Public Health Service Act, as amended (42 USC 241 and 290bb). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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