Full Text NR-94-003


NIH GUIDE, Volume 23, Number 1, January 7, 1994

RFA:  NR-94-003

P.T. 34

  Disease Prevention+ 
  Biomedical Research, Multidiscipl 

National Institute of Nursing Research

Letter of Intent Receipt Date:  March 15, 1994
Application Receipt Date:  April 21, 1994


The focus of this RFA is on interventions to improve the assessment,
management, and prevention of acute pain.  Studies that address the
multidimensional nature of pain, which includes a range of
physiological, sensory, affective, behavioral, cognitive, and
sociocultural factors, are encouraged in order to provide a
scientific basis for clinical practice.


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 Request
for Applications (RFA), "Symptom Management: Acute Pain," is related
to the priority areas of cancer and other disabling conditions.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).


Applications may be submitted by domestic and foreign 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.
Applications from minority individuals and women are encouraged.


This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant. Awards will be administered under PHS grants policy
as stated in the Public Health Service Grants Policy Statement
(October 1, 1990).  The total project period for applications
submitted in response to the present RFA may not exceed three years.
The anticipated award date is September 30, 1994.  Because the nature
and scope of the research proposed in response to this RFA may vary,
it is anticipated that the size of an award will vary also, but will
generally be in the range of $150,000 to $180,000 direct costs.  This
RFA is a one-time solicitation for applications for new awards.
Future unsolicited competing continuation applications will compete
with all investigator-initiated applications and be reviewed
according to the customary peer review procedures.


Approximately $1,200,000 in total costs for the first year will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that four to six applications will be funded.  This
level of support is dependent on the receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NINR, awards pursuant to
this RFA are contingent upon the availability of funds for this


The NINR is interested in innovative studies relevant to the
management of acute pain.  The focus of this RFA is on interventions
to improve the assessment, management, and prevention of acute pain
and exacerbations of acute pain associated with chronic conditions
such as cancer, arthritis, and sickle cell anemia.

Pain is a critical and prevalent health problem.  Acute pain, such as
that experienced following surgery, was once considered inevitable
and relatively harmless. However, current research in animal models
indicates that pain, in and of itself, may have severe deleterious
effects on immune function and may even be related to increased tumor
growth.  The prevalence of pain among hospitalized individuals is
high.  Estimates suggest that 40 to 60% of hospitalized verbal
children report moderate to severe pain and 58 to 75% of hospitalized
adults report excruciating pain.   Pain is costly for individuals and
society; an adult experiencing pain loses an average of 23 days of
productivity per year.  Moreover, pain can significantly affect the
quality of life of an individual and cause disruptions in sleep,
eating, mobility, and overall functional status.  In the hospitalized
patient, pain may be associated with increased length of stay, longer
recovery time, and poorer patient outcomes, all of which have health
care quality and cost implications.

For the purposes of this RFA, acute pain is defined as pain that has
a recent onset, has a duration of less than three months, subsides as
healing occurs, may be associated with hyperactivity of the autonomic
nervous systems, and is often accompanied by anxiety.  In addition to
this category of pain that generally accompanies acute injury,
disease, or surgery, episodic acute pain, which accompanies the
exacerbations of chronic conditions such as arthritis, cancer, and
sickle cell anemia, is included in this initiative.

Studies may address issues relating to pharmacological and
nonpharmacological interventions, although studies addressing drug
development and testing for pain relief are not acceptable.  Clinical
questions addressing pain management practice guidelines are a needed
area of study, particularly as they relate to issues of
undertreatment and inappropriate treatment of pain.  Additional
investigations of prevention regimens are needed, particularly for
surgical and cancer patients.  Results of studies on the use of
patient controlled analgesia have had mixed results.  Additional
studies are needed with larger samples and different populations of

Research is also needed on nonpharmacological interventions intended
to supplement pharmacological regimens.  Broadly categorized, these
interventions may be either cognitive-behavioral or physical agents.
Research has been done on approaches such as biofeedback and
relaxation training, but many of these studies did not report control
over clinical variables such as disease state, and had small sample
sizes and varying medication approaches to pain management.  Studies
on educational interventions using procedural, sensory, and/or coping
behaviors are extensive, but some gaps exist for selected clinical
conditions and some population groups.  Physical agents such as heat,
cold, massage, and transcutaneous electrical nerve stimulation have
been the focus of research with some promising results, although
additional work is needed to identify groups of patients who are most
likely to benefit from these approaches.

Although this RFA is not limited to any population, particular
attention may be given to addressing the special needs of vulnerable
populations and those for which an inadequate base of research
exists, such as preverbal children, children and adolescents, the
elderly, and minority populations.  Either formal or informal
caregivers may be included in the research, but outcome measures must
include one or more patient variables.  If an application proposes an
experimental study within a basic science framework, the ultimate
link with clinical practice must be explicit.

This initiative builds directly on the work of a panel of scientific
experts on assessment and management of pain convened as part of the
development of the National Nursing Research Agenda.  The Priority
Expert Panel evaluated the state of the science, determined research
needs and opportunities, and made recommendations for nursing
research in the area of acute pain.  The work of this panel is
currently nearing completion with the anticipated publication of the
report in 1994.  (Requests for a copy of the panel report may be made
in advance of publication by sending a mailing label and request to
the Office of Information and Legislative Affairs, National Institute
of Nursing Research, Building 31, Room 5B03, Bethesda, MD 20892.)

Pain is a complex phenomenon that may encompass physiologic, sensory,
affective, cognitive, behavioral, and sociocultural dimensions.  A
critical piece missing in previous pain research is lack of attention
to an integrated perspective of the pain experience.  The following
factors highlight one framework which elucidates the multidimensional
nature of pain:

o  Physiologic dimension:  includes location, onset, duration,
etiology, syndrome, type of pain, anatomic factors, physiological
processes, pharmacologic agents, bimolecular mediators;

o  Sensory dimension:  includes intensity, quality, pattern;

o  Affective dimension:  includes distress, anxiety, depression,
mood, suffering, mental state, irritability, agitation;

o  Cognitive dimension:  includes meaning of pain, thought processes,
coping strategies, knowledge, attitudes, beliefs;

o  Behavioral dimension:  includes communication, interpersonal
factors, activities, behaviors, medications, sleep and fatigue;

o  Sociocultural dimension:  includes ethnocultural factors, family
and social factors, environmental issues, work/home issues,
recreation/leisure activities;

This multidimensional conceptualization of pain postulates that the
six dimensions are integrated and interactive, yet their contribution
as an integrated entity to individuals' experiences of pain has not
been adequately explored.  Do existing multidimensional tools measure
the salient components of the dimensions, and are the tools
clinically feasible?  Do they provide useful information in assessing
and/or managing pain as it changes over time?  Does use of these
tools result in improved patient outcomes?  Does the framework assist
in selection of effective interventions?  Many interventions target
one or more dimensions of pain, but their influence on components
within each dimension and on other dimensions is not clear.  Thus,
when an intervention is initiated within one area, what is the effect
on other dimensions?  For example, if an opioid analgesic is given to
alleviate sensory aspects of acute postoperative pain, does it
influence the affective dimension, and if so, how?  The framework
provides opportunities to propose new interventions, or combinations
of interventions, and test them through systematic research.  Do
multimodal therapeutic approaches result in improved patient
outcomes?  Is this dimensional approach effective for patient
populations other than cancer patients in whom it was initially

Researchers do not have to use this framework in their applications
nor include all dimensions in a proposed study.  The material is
provided to stimulate ideas and to provide a contextual perspective
to variables that may be considered.  However, the theoretical basis
for the planned study must be clearly explicated and linked to the
intervention to be tested.  It is important that the intervention be
carefully and clearly defined in terms of purpose, composition, means
of implementation and anticipated effect.  Particular attention
should be paid to ensuring that the anticipated effects have clearly
defined outcome measures.  Cost benefits of the intervention may be
considered as one of the intended outcomes.

Health care providers such as nurses have a key role in the
assessment, management, and prevention of pain.  Because of the
complexity of the pain phenomenon and the need for a multimodal
approach to its treatment, an interdisciplinary research team may
make a significant contribution to the scientific knowledge generated
by studies responsive to this initiative.

Applications are invited for the support of projects that address
issues including, but not limited to:

o  testing appropriateness and adequacy of pharmacologic regimens for
pain, including their impact on the dimensions of pain and the
relationship to adjunctive non-pharmacologic approaches;

o  evaluating the effectiveness of pain practice guidelines,
including measures to prevent pain;

o  examining the link between biological indicators of pain and
behavioral and self-report responses as part of an intervention

o  testing culturally sensitive approaches to pain assessment and

o  investigating the effects of combined non-pharmacological and
pharmacological interventions in infants, children, older persons, or
the cognitively impaired;


NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
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 must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes 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., Native Americans [including American Indians or Alaskan
Natives], Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including, but not limited to,
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected
in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these


Prospective applicants are asked to submit by March 15, 1994 a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information that it contains allows
ICD staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Ernest Marquez
Office of Review
National Institute of Nursing Research
Westwood Building, Room 740
Bethesda, MD  20892** (for express mail use zip code 20814)
Telephone:  (301) 594-7865
FAX:  (301) 594-7894


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892 (for express mail, use the zip code 20814)

At the time of submission, two additional copies of the application
must also be sent to:

Dr. Ernest Marquez
Office of Review
National Institute of Nursing Research
Westwood Building, Room 740
Bethesda, MD  20892**  (for express mail use zip code 20814)

Applications must be received by April 21, 1994.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NINR. Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NINR staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications may be triaged by an NINR peer review group on the basis
of relative competitiveness.  The NIH will withdraw from further
competition those applications judged to be non-competitive for award
and notify the applicant Principal Investigator and institutional
official.  Those applications judged to be competitive will undergo
further scientific merit review.  Those applications that are
complete and responsive will be evaluated in accordance with the
criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the ICD. The second level
of review will be provided by the National Advisory Council for
Nursing Research.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  scientific, technical, or clinical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;


The anticipated date of award is September 30, 1994. The following
will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement.


Written and telephone inquiries concerning this RFA are encouraged.

Direct inquiries regarding programmatic issues to:

Mary D. Lucas, PhD, RN
Chief, Acute and Chronic Illness Branch
National Institute of Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 594-7397

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 594-7498

The National Cancer Institute is also interested in research focused
on cancer pain management.

Inquiries may be directed to:

Dr. Claudette Varricchio
Division of Cancer Prevention and Control
Executive Plaza North, Suite 300
Bethesda, MD  20892
Telephone:  (301) 496-8541.


This program is described in the Catalog of Federal Domestic
Assistance No. 93.361, Nursing Research. Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 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.


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