kristoff@GENBANK.BIO.NET (Dave Kristofferson) (07/04/90)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------
NIH GUIDE - Vol. 19, No. 25, July 6, 1990
NOTICES
NOTICE OF MEETING: E-GUIDE ACCESS .....................(84/202)............. 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NIH EXTRAMURAL PROGRAM INFORMATION AVAILABLE ELECTRONICALLY VIA
THE NIH GRANT LINE .....................................(205/296)............ 2
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CVD NUTRITION EDUCATION FOR LOW LITERACY SKILLS (RFA HL-90-11-P) ............ 3
National Heart, Lung, and Blood Institute (302/359, 644/1110)
Index: HEART, LUNG, BLOOD
ONGOING PROGRAM ANNOUNCEMENTS
RESEARCH ON THE PREVALENCE AND IMPACT OF DRUG USE IN THE
WORKPLACE (PA-90-19) ...............................(365/568)................ 4
National Institute on Drug Abuse
Index: DRUG ABUSE
ERRATUM
COOPERATIVE CLINICAL TRIALS IN TRANSPLANTATION (RFA AI-90-07) ..(574/593).... 7
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
NOTICES
NOTICE OF MEETING: E-GUIDE ACCESS
P.T. 16; K.W. 1004017
National Institutes of Health
Nearly a year has passed since the NIH Guide for Grants and Contracts became
widely available electronically, mainly via BITNET. This electronic form of
the Guide, known as the E-Guide, eventually will become the sole means for
distributing the NIH Guide for Grants and Contracts. The present version of
the Guide has been made possible because of the input, ideas, and cooperation
of a large number of individuals, both outside of and within the National
Institutes of Health.
As stated in some earlier announcements, a meeting will be held in the
Bethesda area on Friday, September 7, 1990, to discuss the E-Guide. This
meeting is an opportunity for new users to become familiar with the E-Guide
and for current users to help shape the E-Guide of the future. The goals of
the meeting are to:
o help users and institutions gain additional information about the
use and structure of the E-Guide
o share useful approaches for accessing, using, and distributing the
Guide
o provide demonstrations and opportunities for hands-on experience
with using the E-Guide
o define format changes that could be made at the NIH and other
changes that could be made locally at institutions which would
maximize the usefulness of the E-Guide.
This meeting is intended to bring people together to address issues of
importance to both small and large institutions regarding electronic access of
the Guide and should be of interest to less experienced, as well as more
sophisticated, users of the electronic system.
The meeting, which will begin at 8:30 a.m. and last until 4:30 p.m., will
include formal presentations, on-line and simulated demonstrations, and lots
of general and small-group discussions. The following presentations are
planned:
o The current E-Guide System and How it is Prepared, by William K.
Jones, NIH
o Primary E-Mail Distribution Via The BITNET LISTSERV System, by John
Paul Elrod, Johns Hopkins University
o Access By Anonymous FTP Via Internet, by Kenneth Yow, The
University of North Carolina
o Tools for Managing the E-Guide, by Karl Hittelman, The University
of California at San Francisco
o Indexing: Current Reality and Dreams for the Future, by John
James, NIH
o Options and Issues of Particular Interest to the Smaller
Institutions, by Nicholas Suszynski
There is no charge for the meeting, but registration is limited to ninety
participants. You may register by sending the information requested below, by
August 7, to:
Ms. Claire Blados
Institutional Liaison Office
Building 31, Room 5B31
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-5366
BITNET: Q2C@NIHCU
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 1
E-GUIDE ACCESS MEETING REGISTRATION
NAME___________________________________
INSTITUTION____________________________
ADDRESS________________________________
__________________________________
__________________________________
BITNET ADDRESS_________________________
TELEPHONE______________________________
Additional information will be sent to registrants in August. You should make
your own hotel arrangements directly, by August 7. Three hotels that are
fairly nearby are:
Crowne Plaza Holiday Inn
1750 Rockville Pike
Rockville, MD 20852
Telephone: (301) 468-1100
Government rates: $84.00 plus 10% tax - single
$94.00 plus 10% tax - double
(A block of rooms has been reserved at the Crowne Plaza for September 6. In
calling to make a reservation, please identify yourself as an attendee at the
September 7 Electronic Transmission of the Guide (NIH) meeting.)
Days Inn
1775 Rockville Pike
Rockville, MD 20850
Telephone: (301) 881-2300
Government rates: $79.00 plus 10% tax - single
$84.00 plus 10% tax - double
Bethesda Marriott
5151 Pooks Hill Road
Bethesda, MD 20814
Telephone: (301) 897-9400
Government rates: $84.00 plus 10% tax - single or double
NIH EXTRAMURAL PROGRAM INFORMATION AVAILABLE ELECTRONICALLY VIA THE NIH GRANT
LINE
P.T. 16; K.W. 1004017
National Institutes of Health
Previous issues of the NIH Guide announced the electronic availability of the
NIH Guide for Grants and Contracts (Vol. 18, No. 20, June 9, 1989) and the
DRG Grants Inquiries On-Line System of extramural program guidelines (Vol.
18, No. 28, August 18, 1989) through computer networks such as Bitnet (CREN)
and Internet. Since then, participants have been sent these files
automatically at the time of update. A new and additional electronic
information service, the NIH GRANT LINE, merges files containing the NIH
Guide, the Grants Inquiries On-line NIH extramural program guidelines, and the
organizational section of the NIH Telephone Directory. This makes it more
convenient for research organizations with modest computer resources to obtain
NIH extramural program information electronically. Institutions that
currently receive the NIH Guide and other NIH program related materials
electronically via computer networks through their institutional hubs will
continue to receive those materials by the previously established pathways,
with no change in existing arrangements.
Now, organizations and individuals who do not have access to information
networks such as Internet or Bitnet may receive NIH extramural program
information electronically using a personal computer, modem, and
communications software that is available in most colleges, universities and
research organizations. The NIH GRANT LINE can be used to download weekly
issues of the NIH Guide, the latest revisions of Program Announcements and
Guidelines, the Extramural Green Pages (abbreviated NIH Telephone Directory)
and other items such as indexes to the Guide. The Program Announcements and
Guidelines are the same as those that have been distributed by the Grants
Inquiries Office in the Division of Research Grants. Those who are currently
receiving documents electronically from the DRG Grants Inquiries On-Line
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 2
System may use either the old or the new system at the present time; however,
we plan to merge the two systems into the NIH GRANT LINE in the near future.
Any questions about the Grants Inquiries files relating to program guidelines
may be addressed to Ms. Sue Meadows, tel. (301) 496-7441. Questions about
obtaining either the NIH Guide (and its indexes) or the Extramural Green Pages
via the NIH GRANT LINE may be addressed to Dr. John C. James at (301)
496-7554.
The brief description, in this announcement, of the technical requirements for
receiving the NIH GRANT LINE files electronically is intended to help users to
get started as soon as they are ready. If you have difficulty downloading the
documents, we suggest that you first seek technical assistance locally before
contacting the NIH.
Please note that this facility is intended only for those whose organizations
are not members of Bitnet or Internet. After a trial period of approximately
six months, the data on usage of the files will be analyzed and comments from
users will be welcomed to assist in the evaluation of the trial.
To those who have already tested a prototype of the NIH GRANT LINE by using
the public initials "GT4", we express our thanks for their comments and for
the experience we have gained. That early system will be discontinued on
August 1, 1990. However, the new service described in this announcement will
have the same kinds of information plus some new items such as bulletins,
notices of publications and other features that will be added in the future.
INSTRUCTIONS FOR DOWNLOADING MATERIAL INTERACTIVELY
It is possible to download copies of the NIH GRANT LINE documents, stored at
the NIH Computer Center in Bethesda, Maryland, using a personal computer and a
modem. For this process, you will need a personal computer, a 1200 or 2400
baud modem, and a terminal emulation program to run on your PC. The terminal
emulation program must support raw file downloading (a facility that allows
you to store in a file everything that is displayed on the PC screen during
the downloading process). All the most popular terminal emulators, KERMIT,
Telios, PROCOM, etc. for the IBM, and VersaTerm for the MAC, support raw file
downloading. Consult the documentation for your particular terminal emulator
to find how it is done.
1. Configure your terminal emulator as: speed indicated by the modem
being used, even parity, 7 data bits, 1 stop bit, Local Echo on
(sometimes referred to as Local Copy on or Half Duplex).
2. Using the procedure specified in your setup, dial 1-301-492-2221.
When you get a response indicating that you have been connected,
type ",GEN1" and press ENTER; you will be prompted by the NIH
system for "INITIALS?". Type BB5 and press ENTER. You will then
be prompted for "ACCOUNT?". Type CCS2 and press ENTER.
This process will cause a menu to be displayed that will allow you to access
the online NIH Telephone Directory (the Extramural Green Pages), download one
or more versions of the NIH Guide, or download one or more of the files from
NIH Program Announcements and Guidelines. Follow the instructions given by
the program to successfully download the desired information. When you have
finished the session, you will automatically be signed off and can process the
downloaded information on your personal computer.
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CVD NUTRITION EDUCATION FOR LOW LITERACY SKILLS
RFA AVAILABLE: HL-90-11-P
P.T. 34; K.W. 0710095, 0502028, 0715040, 0411005
National Heart, Lung, and Blood Institute
Letter of Intent Receipt Date: August 15, 1990
Application Receipt Date: October 16, 1990
The Prevention and Demonstration Research Branch of the Division of
Epidemiology and Clinical Applications, National Heart, Lung, and Blood
Institute (NHLBI), announces the availability of a Request for Applications
(RFA) for the development and validation of nutrition education programs to
reduce cardiovascular disease (CVD) risk factors related to nutrition
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 3
(elevated blood cholesterol, moderately elevated blood pressure, and obesity)
in at-risk adults with low literacy skills.
This special grant program will support research to develop innovative
nutrition education methods and materials for adults with low literacy skills
and CVD risk factors and to evaluate these materials for comprehension and
efficacy in modifying CVD risks.
Prospective applicants are advised that the RFA solicits a multi-disciplinary
approach to developing materials for this underserved population, with
involvement of various members of the health care team (such as physicians,
nutritionists, nurses, educators, behavioral scientists, including cognitive,
social, and clinical psychologists) as well as specialists in communication,
educational technology, and instructional design. This RFA is limited to
education in the English language.
The mechanism for this program will be the traditional, individual,
research-project grant. Although the financial plans for fiscal year 1991
include approximately $1,000,000 for the total costs (direct and indirect) of
this program, support of grants pursuant to this RFA is contingent upon
receipt of funds for this purpose. It is anticipated that approximately three
or four grants will be awarded under this one-time solicitation.
Timetable
Letters of Intent August 15, 1990
Application Receipt Date October 16, 1990
Technical Review February/March 1991
Advisory Council Review May 1991
Award Date August 1, 1991
Inquiries and requests for copies of the RFA should be made to:
Nancy C. Santanello, M.D., M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung and Blood Institute
Federal Building, Room 604
7550 Wisconsin Avenue
Bethesda, MD 20892
ONGOING PROGRAM ANNOUNCEMENTS
RESEARCH ON THE PREVALENCE AND IMPACT OF DRUG USE IN THE WORKPLACE
PA: PA-90-19
P.T. 34; K.W. 0404009, 0725020, 0755030, 0404000, 0414000, 0715195
National Institute on Drug Abuse
The National Institute on Drug Abuse (NIDA) has an interest in research on
drug use and drug abuse as they relate to the workplace. NIDA's interest
encompasses a broad range of topics generally subsumed under the areas of
prevalence, etiology, and impact of drug use by the workforce. This differs
from previous program efforts in that the focus is upon the worksite and the
workforce. Given that a large majority of the adult population of the U.S. is
employed, worksite programs may have unique potential for reducing drug use
and its adverse consequences in a large proportion of the drug using
population. Estimates from NIDA's National Household Survey suggest that 70
percent of illicit drug users are employed.
The goals of this program are to encourage systematic research on the impact
of drug use and abuse in the workplace and studies of the prevalence and
etiology of workplace-related drug use and abuse. This effort will, by
necessity, be cross-disciplinary, and individual and collaborative proposals
are encouraged from researchers from relevant areas, including but not limited
to psychology, epidemiology, sociology, business and labor relations, public
health, management, and economics.
Areas of Interest
I. Impact of drug use in the workplace
Of primary importance to NIDA are studies of the direct and indirect effects
of acute and chronic use of drugs on behaviors relevant to job performance.
While laboratory research has demonstrated that basic psychomotor and
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 4
cognitive skills relevant to job performance are impaired by some drugs,
research on simulated job performance as well as field studies of the
relationships between drug use and other indicators of performance, such as
absenteeism, accidents and injuries, job turnover, health care costs,
supervisory ratings, and other measures of productivity, are generally
lacking.
A. Productivity, health, and safety research
Research on the relationships between drug use and accidents and injuries
under various conditions in various occupations is encouraged.
Increasing use of sick leave, rising costs of medical and disability benefits,
early retirement, and compensation settlements all have costs that may, in
part, be attributable to drug abuse. As the focus of health care in our
society shifts more and more to cost containment, more accurate estimates of
the impact of drug abuse on health costs are needed.
Investigation of the effects of drug use on measures of productivity, such as
absenteeism, turnover, worker output, supervisory ratings, and quality of
products and services, are of interest. In addition to such
performance-related issues, an important area of research is the determination
of the impact of acute and chronic use of drugs on learning, motivation, and
memory. These functional changes can impact job productivity in a direct
manner. Also of interest are studies of the impact of workplace drug use or
perceived drug use on the productivity of non-users.
Since drug-seeking behavior, administration, acute and chronic intoxication,
hangover and withdrawal phases of drug usage may all have effects on
performance, studies that attempt to avoid concentrating on a single phase of
the drug-use cycle are encouraged.
B. Development of Performance Assessment Methods
NIDA is interested in supporting studies to develop and apply performance
assessment methods for assessing drug-impaired functioning in the workplace.
1. Job Performance Standards
Advances in performance measurement, appraisal procedures, and utility
analysis (i.e., estimating the value of an employee's performance to an
organization), offer promise for application to the field of drug abuse
research. For example, job analysis and behavioral rating scale techniques
could be used to establish baseline standards of job performance for detection
of changes induced by drug use. Indicator menus for performance difficulties
(e.g., ways to recognize changes in performance over time that can be used by
peers and supervisors) can be developed to provide for more reliable and valid
assessment of performance change.
2. Performance Assessment Batteries
Intrusive means of obtaining biological samples (such as drawing blood) are
generally problematic, and research to date indicates that behavioral
impairment does not correlate well with the plasma concentrations of most
drugs. NIDA is interested in exploring alternative non-intrusive ways of
assessing drug-impaired functioning. In addition to interest in the
development and application of job performance standards, it seems plausible
that research methods from the areas of behavioral pharmacology, human factors
and engineering psychology, psychophysics, and complex human performance could
be applied to develop a single or perhaps small battery of test procedures to
assess acute and chronic drug effects on work and academic performance.
The performance assessment battery should yield indices that are strongly and
consistently correlated with changes in the criterion performance. It also
should provide indices that permit estimation of the contribution to
performance change due to both non-drug-related factors, (e.g., fatigue, age,
primary sensory or motor impairment) and drug-related factors. Moreover, if
drugs are judged as significant contributors to the impairment, the battery
should provide at least a rough estimate of the class of substance likely to
be involved (e.g., stimulants, depressants, hallucinogens, narcotics, and
possible drug combinations).
C. Simulation and Field Studies
The question of whether studying drug effects on an isolated aspect of a
particular task (e.g., tracking or reaction time) adequately represents the
more complex behavior one is attempting to assess (e.g. monitoring radar,
driving a motor vehicle, decision-making), remains controversial. Proposals
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 5
to utilize simulations of workplace environments and actual field studies are
encouraged to examine the correlations among drug use, simple and complex
measures of workplace performance, and other simpler behavioral measures.
Both acute and chronic effects of drugs, as well as "hangover" effects, are
important to consider.
II. Prevalence and etiology of workplace-related drug use
While national research efforts provide information on the prevalence of drug
use in the general public it has proven difficult to characterize the general
nature and extent of drug use and abuse in the workforce. Prevalence
estimates of the extent of drug use in the American workforce, as well as for
specific companies or types of businesses or occupations, are important both
as indicators of the extent of drug use and as baseline/followup measures for
evaluations of workplace drug programs.
Studies are encouraged to develop and utilize valid and reliable methods of
assessing incidence and prevalence of drug use by the workforce and at the
workplace in various segments of business and industry and in various
occupations. Research is needed to compare and contrast prevalence estimation
techniques currently in use in work-related populations, with appropriate
consideration of issues of reliability and validity. The three principal
data-collection methods currently in use are chemical testing of biological
samples, self-report surveys, and on-the-job observation and referral.
Prevalence estimates based on chemical testing, such as urinalysis, provide a
tool for epidemiological investigations of drug use by the workforce but have
limitations because traces of most drugs are detectable for only a few days.
Self-report data can provide an accurate estimate of prevalence rates and
patterns of drug use, as long as these data are collected appropriately.
Observation and referral are most useful in detecting acute impairment or
later stage impairment due to chronic use.
While NIDA has long had an interest in the etiology of drug use and abuse,
research has focused primarily on adolescent populations. This announcement
encourages research to examine the relationships among worker characteristics,
job characteristics, organizational environment, and patterns of drug use and
its consequences. Studies to identify workers who may be vulnerable to
specific kinds of stressors in the work environment are of interest along with
those that focus on job/organizational characteristics across different worker
populations.
Inclusion of Women in Study Populations
Applicants are urged to consider the inclusion of women in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases which exclusively affect males or where involvement of pregnant women
may expose the fetus to undue risks. Gender differences should be noted and
evaluated. If women are not to be included, a clear rationale should be
provided for their exclusion.
In order to provide more precise information to the treatment community, it is
recommended that publications resulting from Alcohol, Drug Abuse, and Mental
Health Administration-supported research in which the study population was
limited to one sex for any reason other than that the disease or condition
studied exclusively affects that sex, should state, in the abstract summary,
the gender of the population studied, e.g., "male patients," "male
volunteers," "female patients," "female volunteers".
Inclusion of Minorities in Study Populations
Applicants are urged to give attention (where feasible and appropriate) to the
inclusion of minorities in study populations for research into the etiology of
diseases, research in behavioral and social sciences, clinical studies of
treatment and treatment outcomes, research on the dynamics of health care and
its impact on disease, and appropriate interventions for disease prevention
and health promotion. If minorities are not included in a given study, a
clear rationale for their exclusion should be provided.
Inquiries
Further information and consultation on NIDA's program requirements can be
obtained from:
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 6
Steven W. Gust, Ph.D.
Workplace Performance and Technical Research Branch
Division of Applied Research
National Institute on Drug Abuse
Parklawn Building, Room 9A-53
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-6014
ERRATUM
COOPERATIVE CLINICAL TRIALS IN TRANSPLANTATION
RFA: AI-90-07
P.T. 34; K.W. 0745065, 0755015, 0745045, 0745040
National Institute of Allergy and Infectious Diseases
The following is a correction notice to reflect a change in the Request for
Applications (RFA) entitled "Cooperative Clinical Trials in Transplantation",
published in the NIH Guide for Grants and Contracts Volume 19, No. 19, on May
18, 1990.
As written, the objective of this study is to evaluate new and currently used
immunotherapeutic protocols in the treatment and prevention of acute kidney
graft rejection. It is the desire of NIAID staff not to limit the protocols
to acute kidney graft rejection. Therefore, every place where acute kidney
graft rejection is mentioned in the Announcement and in the RFA, the word
acute should be deleted. Copies of the RFA requested from Program staff as
listed in the Announcement reflect this change.
NIH GUIDE - Vol. 19, No. 25, July 6, 1990 - Page 7
REQUEST FOR RESEARCH GRANT APPLICATIONS: HL-90-11-P
CVD NUTRITION EDUCATION FOR LOW LITERACY SKILLS
P.T. 34; K.W. 0710095, 0502028, 0715040, 0411005
National Heart, Lung, and Blood Institute
Letter of Intent Receipt Date: August 15, 1990
Application Receipt Date: October 16, 1990
PURPOSE
The immediate objective is to develop and validate a
nutrition education program designed to reduce cardiovascular
disease (CVD) risk factors related to nutrition (elevated
blood cholesterol, moderately elevated blood pressure, and
obesity) in at-risk adults with low literacy skills. The
long-term objective is to provide health professionals with
nutrition intervention programs for this underserved
population.
DISCIPLINES AND EXPERTISE
Participation from various members of the health care team
(such as physicians, nutritionists, nurses, educators,
behavioral scientists, including cognitive, social, and
clinical psychologists) as well as specialists in
communication, educational technology, and instructional
design is sought. The initiative is limited to education in
the English language. Ultimately, results of this research
would provide information so that similar research
initiatives for persons who speak other languages could be
developed.
BACKGROUND
Cardiovascular diseases cause almost one million deaths each
year; 73.1% are due to atherosclerosis. Heart disease is the
leading cause of death; the main form is coronary heart
disease (CAD), which caused 524,000 deaths in 1986 (NHLBI
Fact Book, 1987). Hypercholesterolemia, hypertension and
smoking are established risk factors for CAD, and often these
risk factors are found in combination in the same individual.
Persons with only one of these risk factors show a two to
four times increase in the incidence of CAD; the combination
of two of these risk factors has been found to increase the
incidence of CAD by as much as nine times, and by as much as
16 times when all three of these risk factors are present.
The necessity of both prevention and treatment of the risk
factors of CAD is apparent.
The estimates of the level of "illiteracy" in the United
States varies with the definition used. Based on the 1982
United States Bureau of Census English Language Proficiency
Survey about 13% (17-21 million) of Americans aged 20 years
and older are "functionally illiterate" (4th grade readers or
less) and another 70 million are "marginally illiterate"
(5th-8th grade readers). The population of functionally
illiterate grows by an estimated 2.3 million persons each
year.
Although low-level readers are found in all socioeconomic and
racial groups (more whites than minorities are functionally
illiterate), a greater proportion of minority populations are
classified as functionally illiterate (44% blacks, 56%
Hispanics). Minorities also manifest a high prevalence of
cardiovascular risk factors. Disparity in the death rate
between non-minority and minority populations was highlighted
by the 1985 Report of the Secretary's Task Force on Black and
Minority Health [Department of Health and Human Services
(DHHS)]. It noted that many of the identified behavioral
and environmental risk factors associated with the causes of
excess deaths among minorities can be controlled; more work
is needed to educate minority populations about the risk
factors having the greatest impact on minority health. One
of those areas is cardiovascular disease. The report
stressed that the DHHS should ensure that patient education
materials and programs should be suitable for specific
groups. The report also stated that programs should prepare
and test health education materials that are sensitive to
various minority cultures and appropriate to their language
and reading level.
Current recommendations for reduction of several CVD risk
factors -- elevated blood cholesterol, elevated blood
pressure and obesity -- stress dietary treatment. The Adult
Treatment Panel Guidelines for the Detection and Evaluation
and Treatment of High Blood Cholesterol includes weight
reduction and dietary fat modification for reducing blood
cholesterol. The Joint National Committee for the Control of
High Blood Pressure advises diet modification for weight loss
and sodium restriction among the treatments for
hypertension. If drug management is undertaken, dietary
treatment is still to be included. To implement these
recommendations most effectively, the education programs and
materials must be appropriate for the target audiences. The
NHLBI has supported numerous nutrition education programs in
which dietary changes for risk factor reduction have been
achieved, such as the National Diet Heart Study, the Multiple
Risk Factor Intervention Trial, the Hypertension Control
Program, and the Dietary Intervention Study in Hypertension.
However, these programs were developed for highly literate
populations and are not appropriate for all persons in the
general population. Methods and materials used in individual
and group counselling in these and other projects rely
heavily on printed materials for initial counselling and for
reinforcement.
Results of the National High Blood Pressure Education Program
telephone survey of 4,000 adult respondents in 1982 revealed
that 12% (458) of the respondents reported they had been
advised to go on a low-salt or low-sodium diet. (This advice
was received by a higher proportion of persons with
hypertension, females and persons 50 years of age and older.)
It indicated that health professionals provided written
instructions or diet plans to almost one-half (46%) of the
patients advised to restrict their salt intake. As for
educational attainment, 52% of the group receiving written
material were not high school graduates. Blacks reported
receiving advice more frequently from their health
professionals on ways to shop or cook to reduce sodium than
did whites (57% vs. 30%). Overall, however, respondents
reported receiving advice on shopping and cooking less
frequently than diet plans. It appears that health
professionals may be tailoring their advice concerning
reading food labels to the educational level of the patient.
Of the one-fifth reported receiving such advice, those with
high school and college education were given sodium labeling
advice almost twice as frequently (23%) as were those with
less than a high school education (13%). Therefore, it would
appear that the latter group may be at a disadvantage in
buying appropriate food to decrease sodium intake.
Limited reading skills hamper the ability of a large number
of adults to understand written nutrition information; yet
this is the traditional means by which this information is
conveyed. Patients with limited reading skills are found in
public health settings and ambulatory care facilities as
well as in hospitals. The extent to which patient health
educators assess reading levels accurately before delivering
nutrition information, and the methods they use to accomplish
this, is unknown.
A 1979 study by Doak and Doak at the USPHS Hospital in
Norfolk, Virginia, assessed the match between the literacy
requirements of the health instructions used with the
literacy skills of patients. They collected 100
instructional items and found that the mean reading level
required to understand them was at the 10th grade level. The
patients tested had mean word-recognition skills at the
seventh grade level, indicating a gross mismatch between the
level of difficulty of the materials and the word-
recognition ability of the patients. The results of the
Diabetes Control Project of the South Carolina Department of
Health and Environmental Control, l980-8l, which replicated
the Doak study, were similar.
In the broader area of consumer economics and health, 20 to
30% of the adults in the U.S. are severely limited by low
literacy skills. According to material prepared by the
College of Agricultural and Life Sciences, University of
Wisconsin, 58 million Americans do not have skills adequate
to perform basic tasks such as reading food labels.
Comprehension may be limited due to limited vocabulary or
perception and/or differences in ability to organize
thoughts. The situation is aggravated by the rapid advances
being made in many industries. As new technology and new
products raise the basic language skills necessary for
survival, more and more people fall behind by not being able
to keep up with the increased demands of our culture. Under
present conditions, which include a high rate of children
dropping out of school, the number of people with limited
reading skills is growing.
Needs for research in this area include:
l. Adaptation of known methods to identify and classify
adults with low literacy skills so that nutrition educators
can use appropriate strategies.
2. Identification or development of innovative nutrition
education methods and materials for adults with low literacy
and CVD risk and evaluation of these materials for
comprehension and applicability in varied health care
settings.
3. Studies to test the efficacy of programs using these
approaches. These should include identification of
environmental factors which may have a negative or positive
impact on learning and dietary compliance, and the assessment
of the influence of individual differences (e.g., age,
socioeconomic factors, literacy, attitude, social support) on
behavior change.
OBJECTIVES AND SCOPE
This solicitation is intended to simulate research that will
result in the development of innovative methods and materials
to modify cardiovascular risk factors related to nutrition
(elevated blood cholesterol, moderately elevated blood
pressure, and obesity) in adults with low literacy skills.
The scope of these research projects should include all of
the following:
l. Development or adaptation of nutrition education modules in
the English language for adults with low literacy skills,
including materials that can be tested for their ability to
effect change in food habits.
2. Clear definition of measurable outcomes, behavior changes
(e.g. assessment of food and nutrient intake, urinary
sodium), knowledge change and physiological changes (e.g.
blood cholesterol, blood pressure, weight change).
3. Depending upon the risk factors selected, modules should be
tested for independent (i.e. sodium reduction or fat
modification) or combined (sodium and weight reduction or fat
modification and weight reduction) effects.
4. Reliable and valid assessments of literacy levels.
5. Attention to sample-size estimations which will allow for
characterization of the population examined and the ability
to test the proposed educational modules.
6. Randomization of patients into study groups such as "Usual
Care" (e.g. verbal instructions or handouts of already
available printed educational materials) and "improved" or
"innovative care" representing different levels of
intervention and educational methods (e.g. food or product
demonstrations, food selection, interactive computer programs
or other audiovisual techniques).
7. Programs and materials for effecting change in blood
cholesterol, blood pressure and obesity that are consistent
with recommendations of the National Cholesterol Education
Program's Expert Panel on Detection, Evaluation and Treatment
of High Blood Cholesterol in Adults and with the report and
recommendations of the Joint National Committee on Detection,
Evaluation, and Treatment of High Blood Pressure (IV).
8. Formative evaluation of the programs or materials as they
are developed to determine their applicability to the target
population.
9. Summative evaluation of developed programs or materials
to assess their ability to reduce
cardiovascular risk factors in the target populations.
10. Successfully tested programs and materials that are in a
form suitable for widespread dissemination to other health
professionals and health care settings. Preliminary plans
for how materials would be disseminated should be included.
11. Grantees will be expected to participate in annual
meetings in Bethesda, Maryland, to collaborate on
standardization of assessment instruments and formative and
summative evaluations.
Additionally, projects could include the following:
1. Assessment of costs to implement the nutrition education
program.
2. Identification and assessment of individual and
environmental factors related to learning and compliance to
dietary change.
EXCLUSIONS
Awards to foreign institutions will be made only in cases of
exceptional merit or promise, or where unique capabilities
are evident, and in accordance with relevant PHS policies.
INCLUSION OF WOMEN AND MINORITIES
The NIH urges applicants for grants and cooperative
agreements to give added attention (where feasible and
appropriate) to the inclusion of women and minorities in
study populations for research into the etiology of diseases,
research in behavioral and social sciences, clinical studies
of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate
interventions for disease and disease prevention and health
promotion. If minorities and women are not included in a
given study falling into one of these areas, a clear rationale
for their exclusion should be provided.
Investigators are
reminded that merely including arbitrary numbers of women
and/or minority group participants in a given study is not
sufficient to guarantee generalization of the results.
MECHANISM OF SUPPORT
The mechanism for this program will be the traditional,
individual, research-project grant. Although the financial
plans for fiscal year 1991 include approximately $1,000,000
for the total costs (direct and indirect) of this program,
support of grants pursuant to this Request for Applications
(RFA) is contingent upon
receipt of funds for this purpose. It is anticipated that
approximately three or four grants will be awarded under this
one-time solicitation. The specific number to be funded
will, however, also depend on the merit and scope of the
applications received and their relevance to the program
objectives. Since a variety of valid approaches are
appropriate in response to this announcement, it is
anticipated that there will be a range of costs among the
individual grants awarded.
Upon initiation of the program, the Prevention and
Demonstration Research Branch will sponsor periodic meetings
to encourage exchange of information among investigators and
collaboration on standardization of assessment instruments
and formative and summative evaluations. In the preparation
of the budget for the grant application, applicants should
request travel funds for a two-day meeting each year, most
likely to be held in Bethesda, Maryland. Applicants should
also include a statement in their application indicating
their willingness to participate in such meetings.
Applicants are requested to furnish their own estimates of
the time required to achieve the objectives of the proposed
research project; however, the award period for this activity
must not exceed five years. At the end of the initial award
period, renewal applications may be submitted for further
competitive review through the regular grant program of the
NIH. It is anticipated that support for this program will
begin in August 1991.
The current policies and requirements that govern the
research grant programs of the PHS will prevail, including
the institutional requirements for safeguarding the welfare
of animals and the rights of human subjects who participate
in the proposed studies.
REVIEW PROCEDURES AND CRITERIA
Review Method. All applications responding to this RFA will
be reviewed for scientific and technical merit by an initial
review group, which will be convened by the Division of
Extramural Affairs, NHLBI, solely for this purpose. Upon
receipt, applications will be reviewed for their
responsiveness to the objectives of this RFA. If an
application is judged unresponsive at this stage, the
applicant will be contacted and given an opportunity to
withdraw the application or to have it considered for the
regular research grant program of the NIH.
If the proposal submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but which has not yet been
reviewed, the applicant will be asked
to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be
allowed nor will essentially identical applications be reviewed
by different review committees. This does not preclude the submission
of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.
Review Criteria. The factors to be considered in the
evaluation of scientific merit of each application will be
similar to those used in the review of traditional research
project applications, including: the scientific merit of the
proposed project, including the novelty, originality, and the
feasibility of the approach and adequacy of the experimental
design; the competence and commitment of the investigator(s);
the adequacy of the laboratory, clinical facilities,
instrumentation and data management systems to carry out the
proposed design; the institutional commitment; and the
appropriateness of the budget.
METHOD OF APPLYING
Letter of Intent
Prospective applicants are asked to submit a one-page, non-
binding letter of intent that includes identification of
other participating institutions or investigators. The
Institute requests such letters only for the purpose of
providing a indication of the number and scope of the
applications to be received and, therefore, usually does not
acknowledge their receipt. A letter of intent will not enter
into the review of any application subsequently submitted,
nor is it a necessary requirement for application.
This letter should be received no later than August 15, 1990,
and sent to:
Dr. James C. Scheirer
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
Westwood Building, Room 548
Bethesda, MD 20892
Format for Applications
Submit applications on form PHS 398 (rev. 10/88), the application for the
traditional research-project grant. This form is available
in an applicant institution's office of sponsored research or
business office or from the Division of Research Grants,
NIH. Use the conventional format for research-project grant
applications and ensure that the points identified in the
section of "Review Procedures and Criteria" are fulfilled.
To identify the application as a response to this RFA, check
"yes" on Item 2 of page 1 of the application form and enter
the title "CVD Nutrition for Low Literacy Skills", and the
RFA number HL-90-11-P.
The RFA label available in the PHS Form 398 (rev. 10/88) must
be affixed to the bottom of the application face page. 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.
Application Procedure
Send or deliver the completed application and four (4)
signed, exact copies to:
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Send an additional two (2) copies of the application to Dr.
James C. Scheirer at the address listed under Letter of
Intent.
Applications must be received by October 16, 1990.
Timetable
Letter of Intent: August 15, 1990
Application receipt date: October 16, 1990
Review by the National Heart,
Lung, and Blood Advisory Council: August 1991
Anticipated Award Date: June 1, 1991
Inquiries
Inquiries regarding this announcement may be directed to:
Dr. Nancy C. Santanello
Prevention and Demonstration Research Branch
National, Heart, Lung and Blood Institute
Federal Building, Room 604
Bethesda, MD 20892
Telephone: (301) 496-2465
The programs of the Division of Epidemiology and Clinical
Applications, National Heart, Lung, and Blood Institute, are
identified in the Catalog of Federal Domestic Assistance,
Numbers 13.837-13.839. Awards will be made under the
authority of the Public Health Service Act, Section 301 (42
USC 241) and administered under PHS grant policies and
Federal regulations, most specifically 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.