Full Text PA-95-020


NIH GUIDE, Volume 24, Number 1, January 13, 1995

PA NUMBER:  PA-95-020

P.T. 34, II

  Clinical Medicine, General 
  Health Services Delivery 

National Institute of Nursing Research
Office of Research on Women's Health
Agency for Health Care Policy and Research


The National Institute of Nursing Research (NINR), the Office of
Research on Women's Health (ORWH), and the Agency for Health Care
Policy and Research (AHCPR) invite submission of research grant
applications to study the treatment and intervention decision making
processes associated with non-cancerous health problems of women that
frequently result in the surgical procedure, hysterectomy.  These
health problems have symptoms that may lead to a decision for
hysterectomy even when the underlying pathology is limited.  These
problems include dysfunctional uterine bleeding, leiomyota
(fibroids), endometriosis, pelvic pain, and uterine prolapse.
Cancerous conditions leading to hysterectomy are not included in this
Program Announcement (PA).

This PA is jointly sponsored by NIH and AHCPR and both agencies are
interested in applications in all the areas described under RESEARCH
OBJECTIVES.  The AHCPR is particularly interested in studies that
include an emphasis on the influence of market forces, cost factors,
health care payers, practice variation, and access issues.


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 PA,
Decision-Making Processes In Women's Health, is related to the
priority areas of health promotion and clinical preventive services.
Potential applications may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone


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.  The
AHCPR, by statute, can award grants to non-profit organizations only.
Applications from minority individuals and women are encouraged.


This PA will use the NIH/AHCPR individual research project grant
(R01).  Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant.  Though
the length of individual studies will vary, support will be provided
for a period up to five years, based on availability of funds and
sufficient scientific progress.  Costs of individual projects will


Women and their health care providers confront an increasingly
complex decision making process related to selecting hysterectomy
and/or alternatives as treatment/intervention options.  Current
scientific investigations are focused on evaluating the efficacy of
emerging medical and surgical treatments prior to, during and
following hysterectomy; but little investigative effort has focused
on the complexity of the decision making process itself.  The
interaction effect of endogenous and exogenous factors on decision
making has not been thoroughly examined.  Among these factors are the
woman's preferences and symptoms, the clinical practitioner's
assessment and treatment plan, and the utilization criteria of the
health care payers leading to the decision to implement or not
implement hysterectomy as a treatment option.

The purpose of this program announcement is to encourage exploration
of the treatment and intervention decision-making processes of women
experiencing non-cancerous health problems that frequently result in
a hysterectomy.  These problems, including dysfunctional uterine
bleeding, leiomyota (fibroids), endometriosis, and uterine prolapse,
have symptoms that may lead to a decision for hysterectomy even with
limited underlying pathology.  The symptomatology associated with
such problems include pelvic pain, excessive and/or frequent uterine
bleeding, changes in urination, and related symptoms.

In examining the decision making process, it is important to consider
the varying perspectives of, and influences on, women having the
health problems.  In addition, the role of their significant others,
their clinical  practitioners (nurses, physicians, and others), and
health care payers on decision outcomes need consideration.  These
differing viewpoints and interests are usually the major factors
leading to decisions for surgical treatment, such as hysterectomy,
rather than using alternative, less invasive and costly treatments or
interventions when they are available.  There is limited scientific
information about how women make these decisions, how they are
informed about their treatment options, and what influence, if any,
clinical practitioners and health care payers have on their decision

Numerous methodological approaches may be used to address the study
of decision making.  It is appropriate to propose both quantitative,
qualitative and combined approaches.

Currently, hysterectomy is the second most commonly performed major
surgery for women in the US.  Half of the hysterectomies are
performed on women 40 years old or younger.  There is considerable
regional variation.  Whether this variation is related to factors
other than clinical decisions and recommendations by clinical
practitioners is not clear.

Although, total hysterectomy for benign disease historically has been
justified on several grounds, there is no convincing evidence that
hysterectomy conveys a benefit proportional to the risks of the
surgery.  Recent advances in technology have enabled us to follow
more closely the status of many conditions which lead to
hysterectomy.  New conservative surgical approaches which spare the
uterus are growing in use.

A variety of conditions can be indications for hysterectomy, the most
common of which are benign conditions, such as uterine leiomyomas,
endometriosis, dysfunctional uterine bleeding, and uterine prolapse.
Conditions such as endometriosis and leiomyoma usually stabilize or
regress at the time of natural menopause.  When the effects of these
problems become more symptomatic, the usual first line of treatment
consists of medical therapies or conservative surgical approaches or
watchful waiting.  Abnormal uterine bleeding may also be treated with
drug therapy.  Pelvic pain, which must have a differential diagnosis
leading to a decision that it is occurring due to a non-cancerous or
other less serious condition, needs to be explored to determine the
extent to which it may be the important factor in a decision to treat
surgically.  Conventional treatment of chronic pelvic pain currently
consists of oral contraceptives or nonsteroidal anti-inflammatory
drugs.  Other treatments or interventions for symptom management of
pain may be less invasive and less costly in approach.  Approaches to
uterine prolapse may include exercise to strengthen the pelvic
muscles in mild or moderate prolapse, placement of a pessary
especially in older women, and surgery for severe prolapse.

Family members are frequently important partners for many women when
making health-related decisions. The role and influence of family
members in treatment/intervention decisions generally remains
unexplored, but could be of potential significance, especially for
certain cultural/ethnic groups.  Cultural beliefs, mores, and values
are factors that are seldom addressed in clinical investigations,
particularly in the area of health-related decision making.  Such
factors could be addressed from an individual, family and/or
community perspective.

The term clinical practitioner for this announcement refers to the
health care professional who is the principal source of care for the
patient's condition.  This provider may be a primary care physician
or nurse, an advanced nurse practitioner, a clinical nurse
specialist, a certified nurse midwife, a women's health care
specialist, a gynecologist, a general surgeon, or other health
professionals who fulfills the above role.  In situations where more
than one provider is involved, the responsibilities of each provider
should be clearly defined.

Health care practitioners as well as patients are said to be
influenced in making decisions by the policies and procedures of
employing organizations, referring organizations, health care payers
and other market forces.  These include hospitals and other
organizations providing clinical services, managed care
organizations, health insurance plans, and other "third party" payers
that can influence choices actually available or valued by
practitioners, patients, and their families.

Examples of possible research questions include, but are not limited

What are the sources of information most frequently used/consulted by
women in their self care of their uterine/pelvic symptoms, and for
treatment/intervention decisions?  What is the reliability of these
sources?  How do women resolve conflicting information, advice or
recommendations in these sources?

How do the various sources of information about treatment or control
of their clinical problems influence women to seek or use one
treatment over another?

What are the relationships of symptoms and their management to the
decision to have a hysterectomy or not?  Are there different levels
of symptom intensity related to these decisions?  What are the
methodological considerations in determining symptom influence on
treatment decisions?

How does the decision-making process vary within and across
cultural/ethnic groups or in geographic regions for different

Are there specific components of the decision-making process that
lead to satisfactory/unsatisfactory outcomes for the patient?

To what extent is watchful waiting recommended and adhered to, or are
other options sought by women with any frequency? What options are
considered and used?

How are the appropriateness and effectiveness of clinical decisions
for hysterectomy best evaluated?  What are the cost differentials
across treatment/intervention options? Are these influential to women
in making their treatment decisions?

Does the type of decision made depend more on the different health
care practitioners or on the individual characteristics and symptoms
of the woman?

Does the type of surgical procedure offered for hysterectomy
(abdominal versus vaginal hysterectomy, inclusion of the ovaries or
not) directly or indirectly influence the decision for surgery when
other options are also indicated?

What is the influence of clinical guidelines developed by
professional societies and groups related to the noncancerous
clinical conditions and their treatments, if any?


It is the policy of NIH and AHCPR that women and members of minority
groups and their subpopulations must be included in all NIH/AHCPR-
supported biomedical, behavioral, and health services research
projects involving human subjects, unless 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.  The new policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43) and
supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations) which have been in effect
since 1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.  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 reprinted in the NIH GUIDE
TO GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the


The research grant application form PHS 398 (rev. 9/91) is to be used
and will be accepted at the standard application deadlines indicated
in the application kit.  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 number and title of this program
announcement must be typed in item number 2a on the application face

The completed application and five signed, legible copies must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892-6300**


Applications received under this program announcement will be
assigned to an appropriate NIH or AHCPR Initial Review group (IRG) in
accordance with established PHS referral guidelines.  The IRG,
consisting primarily of non-Federal scientific and technical experts,
will review the application for scientific and technical merit in
accordance with standard NIH/AHCPR review procedures.  Notification
of the review recommendations will be sent to the applicant after the
initial review.  Applications assigned to the NIH, recommended for
further consideration, and receiving sufficiently high priority will
receive a second-level review by appropriate National Advisory
Council, whose review will be based on policy considerations as well
as scientific merit.

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 by the NIH/AHCPR in
accordance with the review criteria stated below.  As part of the
initial merit review, a process (triage) may be used by the initial
review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.


Decisions to make awards are based on the overall scientific merit of
the application reflected in the priority score, availability of
funds, and research program priorities within the NINR, ORWH, and


Written and telephone inquiries concerning this PA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding scientific or programmatic issues to:

Patricia Moritz, Ph.D., R.N.
National Institute of Nursing Research
Building 45, Room 3AN-12
45 Center Drive MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5966
FAX:  (301) 480-8260
Email:  pmoritz@ep.ninr.nih.gov

Virginia Cain, Ph.D.
Office of Research on Women's Health
Building 1, Room 201
Bethesda, MD  20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  virginia_cain@nih.gov

Anne Bavier, M.N., R.N.
Agency for Health Care Policy and Research
2101 E. Jefferson Drive
Rockville, MD  20852-4908
Telephone:  (301) 594-1357, ext. 129
FAX:  (301) 594-2155
Email:  abavier@po3.ahcpr.gov

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-32
45 Center Drive MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
Email:  snichols@ep.ninr.nih.gov

Ralph Sloat
Grants Management Officer
Agency for Health Care Policy and Research
2101 E. Jefferson Drive
Rockville, MD  20852-4908
Telephone:  (301) 594-1447
FAX:  (301) 594-2155
Email:  rsloat@po7.ahcpr.gov


This program is described in the Catalog of Federal Domestic
Assistance No. 93.361, Nursing Research; 93.180, Medical Treatment
Effectiveness Research;and 93.226, Health Services Research and
Development.  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 Federal Regulations 42
CFR 52.  AHCPR Awards are made under authority of the PHS Act, Title
IX (42 USC 299-299c-6) and Federal Regulations 42 CFR Part 67,
Subpart A.  Awards are administered under PHS grants policies and 45
CFR Part 74 (Part 92 for State and local governments).  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


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