Full Text NR-93-003

STUDIES OF CLINICAL OUTCOMES AND NURSING PRACTICE

NIH GUIDE, Volume 22, Number 5, February 5, 1993

RFA:  NR-93-003

P.T. 34

Keywords: 
  Nursing 
  Data Management/Analysis+ 


National Center for Nursing Research

Letter of Intent Receipt Date:  March 26, 1993
Application Receipt Date:  April 29, 1993

PURPOSE

The National Center for Nursing Research (NCNR) invites research
grant applications to investigate methodological and measurement
issues that occur when studying clinical outcomes that result from
nursing care.  The intent of this Request for Applications (RFA) is
to support methodological research that facilitates the collection
and analysis of data to be used to answer questions about the
effectiveness of clinical intervention strategies.  Specific
measurement issues to be supported include examination of existing or
development of new clinical outcomes measures to determine their
sensitivity, appropriateness, validity, and reliability for
differentiating and measuring the influence of nursing practice.

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 RFA,
Studies of Clinical Outcomes and Nursing Practice, is related to most
of these priority areas.  Potential applicants may obtain a copy of
the "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 may be submitted by domestic and foreign, for-profit or
non-profit, public and private, organizations 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.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the
applicant.  This RFA is a one-time solicitation and it anticipated
that most of the awards will be for new (Type 1) applications.
Future unsolicited competing continuation applications will compete
with all investigator-initiated applications and be reviewed
according to customary peer review procedures.  The total project
period for applications submitted in response to the present RFA may
not exceed four years.  Because the nature and scope of the research
proposed in response to the RFA may vary, it is anticipated that the
size of an award will vary also.  The anticipated average direct cost
award per year is $75,000.  The anticipated award date will be
September 30, 1993.

FUNDS AVAILABLE

It is estimated that up to $600,000 dollars will be available to fund
the first-year total costs of applications submitted in response to
this RFA.  It is anticipated that five 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 NCNR, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

1.  Develop and test methods to assess the effect of clinical
interventions on outcomes of patients receiving nursing care.

2.  Examine existing or develop new measures of clinical outcomes to
determine their appropriateness, sensitivity, validity and
reliability in measuring the effect of nursing care.

This initiative is based on the recommendations of an NCNR sponsored
conference held in 1992 to review the state-of-the-science of patient
outcomes research, specifically focusing on the effectiveness of
nursing practice.  The proceedings of this conference, "Patient
Outcomes Research:  Examining the Effectiveness of Nursing Practice,"
are available from the NCNR program contact listed under INQUIRIES.
This publication contains all the scientific papers presented at the
conference, including analyses of current approaches to methods and
measurement in clinical outcomes research.

The NCNR is interested in methodological studies that consider ways
of measuring the effect of nursing practice on the outcomes of
clinical care.  This information is needed to assist in improving
quality of care, to increase knowledge about the most appropriate use
of clinical intervention strategies, and to inform overall clinical
decision making.  All populations who are recipients of nursing care
and who receive nursing interventions are appropriate target
populations of studies in response to this RFA (for example,
populations with clinical conditions such as pain, pressure ulcers,
urinary incontinence, nausea and vomiting, depression, fatigue, and
illness-related stress; or who are receiving nursing home care, home
care or acute care).  Applicants are encouraged to take an
interdisciplinary approach in the design of the studies proposed and
to include interdisciplinary scientific team members.  It is
anticipated that applications submitted in response to this RFA will
focus on quantitative approaches to study designs.

The traditional approaches to examining clinical outcomes have
focused on measures of mortality, morbidity, and disability.  These
approaches are used on groups of individuals across settings who have
common diagnoses or clinical conditions, frequently using existing
databases, such as the Medicare administrative files.  More recently
other measures of clinical outcomes, such as quality of life,
functional status, health status, and patient satisfaction have been
used.  Questions have been posed about the extent to which these
approaches to measuring patient outcomes are sensitive to the
influence of nursing practice, particularly the results of nursing
interventions.  Considering ways to distinguish the influence of
clinical care provided by clinicians of various disciplines,
particularly nurses, on patient outcomes from a measurement
perspective may assist in the development of more effective
treatments and interventions.  Examination of more recent measures
from the perspective of appropriateness, sensitivity, validity and
reliability in determining the influence of nursing practice on
clinical outcomes is needed.

An example of an issue important to outcome measurement that needs to
be developed is symptom intensity.  The management of clinical
symptoms is a major concern of nurses in clinical practice, and a
number of clinical interventions strategies have been tested for
commonly occurring symptoms.  Measures of symptom intensity are
available for some symptoms, such as pain and pressure ulcers.
Studies are needed that examine existing or new measures of symptom
intensity as clinical outcomes measures that may capture the results
of nursing interventions.

Studies of clinical outcomes have used existing data sets as sources
of information, such as those for Medicare recipients.  Other types
of existing data sets include those developed from  hospital medical
records using the discharge summary or registries of patients with
specific diagnoses or receiving specific treatments.  These data sets
are rich in clinical information, but they rarely have information
specific to the nursing care planned for or received by the persons
whose medical records are included in the data sets. Studies focused
on developing proxy measures for nursing care in such data sets could
facilitate the use of existing data sources in clinical outcomes
research.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS'

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be 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 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 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 should 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 should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should 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 includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
disease, 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
minorities.

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 will be
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
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 26, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the names of other key personnel and consultants, the
participating institution(s), 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 is extremely helpful in planning for the review of
applications.  It allows NCNR staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
to apply for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449 Bethesda, MD 20892, telephone
301-496-7441.

The RFA label available in the application form must be affixed to
the bottom of the face page. Failure to use this label could delay
processing of the application such that it may not reach the review
committee in time for review.  In addition, on line 2a of the face
page of the application, enter "Studies of Clinical Outcomes and
Nursing Practice, NR-93-003" in the provided space and the YES box
must be marked.

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

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

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

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
Bethesda, MD  20892

If the applicant has an approved assurance covering the research, the
applicant must provide it with the application certification of
Institutional Review Board (IRB) approval if human subjects are
involved.  These reviews and approvals should occur prior to
submission of the application for award and the certifications should
be submitted with the application.  There is no 60 day grace period
for RFAs.  If human subjects will be subjects of the research at
performance sites other than the applicant organization, the
applicant must identify, in the application, the assurance status of
each participant.  Failure to provide required certifications in the
application could result in delay of an award.  Instructions
regarding inclusion of human subjects are given on pages 22-23 and
25-26 of PHS 398 (rev. 9/91).

Applications must be received by April 29, 1993.  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 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.

REVIEW CONSIDERATIONS

Applications submitted to the NIH will be reviewed according to
customary NIH peer review procedures.

Review Procedure.  Upon receipt, applications will be reviewed by the
NCNR for completeness and responsiveness.  Incomplete applications
will be returned to the applicant without further consideration.  If
the application is not responsive to the scientific intent identified
in the RFA or to the time frame and budget guidelines, the NCNR will
return it to the applicant.

Applications may be subjected to triage by a peer review group to
determine their scientific merit relative to other applications
received in response to this RFA.  Criteria for triage will be the
same as the review criteria listed below.  The NIH will
administratively withdraw from competition those applications judged
to be noncompetitive and notify the applicant and institutional
official.

Those applications judged to be complete, responsive, and competitive
will be further evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NCNR.  The second level of review will be
provided by the National Advisory Council for Nursing Research.

Review Criteria.  Applications will be reviewed in accord with the
usual NIH peer review criteria:

o  scientific and technical 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 resources necessary to perform the research; and

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

AWARD CRITERIA

The anticipated date of award is September 30, 1993. Decisions to
make awards are based on the scientific merit of the application
reflected in the priority score, availability of funds with NCNR for
this purpose, and NCNR research program priorities.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The program staff welcomes the opportunity to clarify any issues or
questions from potential applicants.

Inquiries regarding programmatic issues, requests for the RFA may be
directed to:

Patricia Moritz, Ph.D., R.N.
Nursing Systems Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (303) 844-6163 (for discussion of scientific matters)
Telephone:  (301) 496-0523 (for copies of the RFA)

Requests for copies of the conference proceedings, "Patient Outcomes
Research:  Examining the Effectiveness of Nursing Practice," may be
directed to:

Office of Information and Legislative Affairs
National Center for Nursing Research
Building 31, Room 5B13
Bethesda, MD  20892
Telephone:  (301) 496-0207

Direct inquiries regarding fiscal and administrative matters to:

Sally A. Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 496-0237

Schedule

Letter of Intent Receipt Date:  March 26, 1993
Application Receipt Date:       April 29, 1993
Initial Review:                 July 1993
Secondary Review:               September 1993
Anticipated Award Date:         September 30, 1993

AUTHORITY AND REGULATIONS

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 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, April 6, 1988.

.

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