Full Text PA-97-066
NIH GUIDE, Volume 26, Number 19, June 6, 1997
PA NUMBER: PA-97-066
P.T. 34

  Health Services Delivery 
  Health Care Economics 

National Institute on Alcohol Abuse and Alcoholism
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.
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).
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.
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
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.
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.
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
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;
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
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.
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.
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
The completed original application and five legible copies must be
sent or delivered to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)
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.
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.
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 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
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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