Title: Effect of the Womens Health Initiative on Hormone Replacement Therapy Prescribing Practices in a Sin
1 Effect of the Womens Health Initiative on
Hormone Replacement Therapy
Prescribing Practices in a Single
Physician Ob-Gyn Office
in Northeast Florida
- Catherine Greenblum, MSN, APRN-BC
- PhD Student University of Florida
2 Background
- Since the results of the Womens Health
Initiative study were published in July 2002,
millions of women and their healthcare
practitioners have had to re-examine decisions
about the use of hormone replacement therapy
3- The Womens Health Initiative, sponsored by the
NIH, was an ambitious multicenter
placebo-controlled study of the effects of HRT on
16,608 healthy postmenopausal women aged 50-79
(Beattie, 2003) - WHI unexpectedly ended the study prematurely
citing increased risks for breast cancer,
pulmonary embolism, stroke, cardiac events, and
dementia (NIH, 2004) contradicting years of
observational studies - A slight benefit of decreased fractures and
colorectal cancer was also found in this study
(NIH, 2004)
4.
- Before the results of WHI were published in July
2002, an estimated 6 million women were taking
HRT. By May 2003, that number decreased to an
estimated 2.7 million - Within a year, millions of women stopped using
HRT and many more did not start due to the
findings published by WHI (Goldstein, 2004) - The women who continued HRT despite the risks,
did so primarily to reduce menopausal symptoms
and maintain quality of life (Woodward, 2005) -
5.
- The average age of menopause today is 51.4 years
and a healthy 50 year-old has a life expectancy
of 91 years (Goldstein, 2004) - Women live as many as 1/3rd of their years in the
menopausal state - ¾ of women report vasomotor symptoms at menopause
and one-fourth of all menopausal women seek
treatment for menopausal symptoms (Poindexter
Wysocki, 2004)
6.
- Menopause is a, normal transition that occurs in
all women (Pearson, 2002, p.1). While some
women become menopausal with little difficulty,
other women have symptoms that disrupt their
lives - Discomfort from hot flashes is the most common
reason women seek HRT and these vasomotor
symptoms have been shown to have a significant
negative impact on quality of life (Barton,
Loprinzi, Waner-Roedler, 2001) - HRT has been shown to be the most effective
treatment for the vasomotor symptoms of menopause
(ACOG, 2004 Woodward 2005)
7Purpose
- The purpose of this study was to examine the
effects of the WHI results published in July 2002
on HRT prescribing practices in a single
physician Ob-Gyn office in northeast Florida.
8 Method
- A total non-probability convenience sample of
every medical record that met the inclusion
criteria was used - Inclusion criteria birth date in 1954 or earlier
- scheduled for gynecological care subsequent to
July 2002 (the date of the cessation of the first
arm of the WHI) - A computer search on March 1, 2004 revealed
approximately 1800 medical records that met the
inclusion criteria
9- A total of 1,783 charts were reviewed
- 301 were noted as no show for the scheduled
office visit - 19 were missing documented menopausal status
- 268 were seen for a non-gynecological
appointment. - N1,195.
10 Sample Demographic Data-
Nassau County Florida US
Census Bureau, 2006
11.
- 41 of the population of Nassau County is age 45
and older - (Nassau County Economic Development Board, 2004).
- An investigation of 100 randomly chosen medical
records at the practice site on April 11, 2004,
showed a close match with the demographic data of
the county
12 Demographic Characteristics of
Sample
13Results
14 Effect of WHI on estrogen dose
and HRT use
15.
- Based on physician recommendation, a significant
portion of women (77.2) had discontinued HRT - Of the women remaining on HRT, 54.7 changed
either the dose or type of hormones taken - Only 59.5 of women remained on the same estrogen
dose both before and after the WHI results were
published in 2002 - Only 29 women (4) initiated HRT use after July
2002
16.
- The average time on HRT for the sample as a whole
was 8.3 years (range 0 to 46) - 730 of the 1,195 women on whom charts were
reviewed (61.1) had been on hormone replacement
therapy prior to the release of the WHI results
in July 2002 - 443 of the women on whom charts were reviewed
(37.1) were on hormone replacement therapy at
the time of data collection
17.
- Of the women for whom both pre and post WHI data
on HRT use were available (n 724), 254
discontinued HRT on physician advice after July
2002 - Of the 75 women remaining on HRT, 41 changed
either the dose or type of hormones taken - Only 59.5 of women taking HRT after July 2002
remained on the same estrogen dose bother before
and after WHI results were published - Only 29 women (4) initiated HRT use after July
2002.
18.
19 Conclusions
- The application of the WHI results is limited
because the study used only one oral preparation
of HRT - The average age of participants was 63 (ACOG,
2004) with an average estrogen depletion of 10
years (Chlebowski, n.d.) - Nonetheless, recommendations to postmenopausal
women changed radically. No longer the panacea
for aging, millions of women were advised to
abruptly discontinue HRT. - Within two years, 1 in 4 of these women restarted
hormone therapy to relieve menopausal symptoms
(ACOG, 2004).
20.
- Hormone therapy remains controversial and many
questions remain unanswered. One thing experts
agree on is HRT should be used for treating
vasomotor symptoms and vaginal dryness at the
lowest effective dose for the shortest amount
time (ACOG, 2004 Woodward, 2005).
21.
- ACOG stressed that each woman individually with
her health care provider must evaluate use of
hormone replacement therapy for risks and
benefits. - HRT should be used for management of menopausal
symptoms only and not as a preventative for
chronic disease. - HRT use should be evaluated periodically and at
least annually, the lowest dose for the least
amount of time should be used, and alternative
therapies considered. - Current users of HRT are advised to taper doses
toward discontinuation of HRT (ACOG, 2004)
22 - Since the results of the Womens Health
Initiative study were published in 2002, millions
of women and their healthcare practitioners have
had to re-examine decisions about the use of
hormone replacement therapy. - Health care providers need to be current on the
research and recommendations regarding HRT and
treatment of menopausal symptoms and counsel
their patients appropriately. - Margaret Freda, editor of the American Journal of
Maternal Child Nursing, stated that while the
results of WHI were unexpected, health care
providers now have evidence-based research on
which to base their practices (Freda, 2003).
23.
24 The Seven Dwarves of Menopause
25 References
- ACOG issues state-of-theart guide to hormone
therapy. (2004). Retrieved February 7, 2006 from
http//www.acog.org/from_home/publications/
press_releases/nr09-30-04-2.cfm - Barton, D., Loprinzi, C., Waner-Roedler, D.
(2001). Hot flashes aetiology and management.
Drugs Aging, 18, 597-606. - Beattie, M. (2003). Current status of
postmenopausal hormone therapy. Advanced Studies
in Medicine, 3, 205-213. - Chlebowski, R.T. (n. d.) Breast cancer in the
womens health initiative trial of estrogen plus
progestin. Retrieved February 7, 2006, from
http//www.fda.gov/ohrms/ Dockets/ac/03/slides/
3992S1_04_Chlebowski.ppt - Freda, M. C. (2003). Surprise! HRT and the WHI.
The American Journal of Maternal Child Nursing,
28, 259. - Goldstein, S. R. (2004). Clinical management
after hormone therapy discontinuation. Menopause
Management, 13, 45-47.
26.
- Nassau County Economic Development Board. (2004).
Nassau County Florida A Diverse, Growing
Community. In Demographics. Fernandina Beach, FL
Nassau County Economic Development Board.
Retrieved February 7, 2006, from
http/?/?www.nassaucountyfla.com/?demographics.htm
- National Institutes of Health. (March 2, 2004).
NIH asks participants in women's health
initiative estrogen-alone study to stop study
pills, begin follow-up phase Electronic
version. Washington, DC U.S. Government
Printing Office. - Pearson, C. (2002). The truth about hormone
replacement therapy. A Friend Indeed for Women in
the Prime of Life, 19, 1-3. - Poindexter, A. N., Wysocki, S. (2004). WHI in
perspective- focus on quality of life. The Forum
a Working Group for Women's Healthcare, 1, 8-10. - U.S. Census Bureau State and County Quick Facts
Nassau County Florida. Retrieved February 7, 2006
from http//quickfacts.census.gov/qfd/states/12/12
080lk.html - Woodward, J. (2005). Hormone therapy in
menopause. Clinician Reviews, 15(4), 46-51.
27EFFECTS OF CLUSTERED CARE ON PAIN IN THE PRETERM
INFANT-A DESCRIPTIVE STUDY
- Elizabeth A. Gyland, MSN, ARNP
- University of Florida
- College of Nursing
- November 3, 2006
28The Problem
- The current standard of nursing care for preterm
infants (clustered care) within the neonatal
intensive care unit (NICU) may promote both
structural and functional reorganization of pain
pathways (plasticity) due to the windup
phenomenon created by repetitive painful
interventions.
29- The result of this repetitive pain leads to a
cumulative windup phenomenon that disrupts the
normal development of the brain, with effects
that potentially extend past postnatal brain
development (Aynsley-Green, 1996 Anand, 1997).
30This exposure to repetitive pain may promote
distinct behavioral phenotypes in the school-age
child, the adolescent, and the adult, which are
characterized by
- stress disorders
- decreased pain sensitivity
- hyperactivity/attention deficit disorder
- impaired social/cognitive skills and
- specific patterns of self-destructive behaviors
31The purpose
- The purpose of this longitudinal, descriptive
study is to explore relationships of pain scores
in the 28-34 week postconceptional age neonate
during clustered care (including both painful and
nonpainful procedures) in the first seven days
after birth and again at 34 weeks
postconceptional age in a level III NICU.
32Specific Aim 1
- To describe the within-subject differences in
pain scores (using the Premature Infant Pain
Profile or PIPP) before, during, and after
clustered care of one test session from birth to
seven days of age.
33Hypothesis 1
- A statistically significant increase in pain
scores will be noted within a session of
clustered care, from pre-procedure to
post-procedure, for sessions that include at
least one painful intervention.
34Specific Aim 2
- To describe between-group differences in
pre-procedure, peri-procedure, and post-procedure
pain scores (using the PIPP) between the two
groups before, during, and after clustered care
of one test session from birth to seven days of
age and between both groups again at 34 weeks
postconceptional age.
35Hypothesis 2
- The pain scores in group 2 (those between 31-32
6/7 weeks) will be higher than group 1 (those
between 28-29 6/7 weeks) during sessions of
clustered care that include at least one painful
intervention.
36Hypothesis 3
- The pain scores in group 1 (those between 28-29
6/7 weeks) will be higher when tested again at 34
weeks during sessions that include at least one
painful intervention and there will be no
significant difference in pain scores of group 2
when tested again at 34 weeks during sessions
that include at least one painful intervention.
37Design
- Longitudinal, descriptive
38Theoretical Framework
- Heidelise Als developed the Synactive Theory of
Development in 1982 as a model for understanding
the organization of neurobehavioral capabilities
in the development of the fetus, infant, and
young child.
39- Her theory states that infants are in continual
interaction with their environment via 5
subsystems - Autonomic/physiologic
- Motor
- State/organizational
- Attentional/interactive
- Self-regulatory
40Diagram of theory
41- The subsystems are interdependent and
interrelated. - The loss of integrity in one subsystem can
influence the organization of other subsystems.
42- Therefore, the burden and opportunity are on the
identification and provision of developmentally
appropriate and supportive environments to ensure
normal developmental functioning and
progression (Als, 1986).
43Sample
- A convenience sample of 20 neonates 28-32 weeks
postconceptional age admitted to a level III NICU
will be recruited. The neonates will be divided
into - two groups
- 10 subjects between 28-29 6/7 weeks
postconceptional age - 10 subjects between 31 32 6/7 weeks
postconceptional age
44RECRUITMENT OF SAMPLE ACCORDING TO GROUP
ASSIGNMENT N20 (10 in Group1-28-29 6/7
weeks) (10 in Group 2-31-32 6/7 weeks)
45RECRUITMENT AS PER COLUMN A
46RECRUITMENT AS PER COLUMN B
47RECRUITMENT AS PER COLUMN C
48Inclusion criteria
- Confirmation of post-conceptional age by Dubowitz
- 5-minute Apgar score gt3 (cord pH gt7.0)
- Infants requiring intubation and placement on
infant ventilator
49Exclusion criteria
- Severe genetic and/or cardiac anomaly
- Severe intrapartum asphyxia (a 5-minute Apgar
score lt/3 or a cord blood pH of lt7.0 - Use of a neuromuscular blocking agent that
produces skeletal muscle paralysis
50Parental consent
- To be obtained by primary investigator in a
private room in the hospital within the first
seven days of life.
51Procedure
- Neonates will be observed during one session of
clustered care during the first seven days of
life. - During each session, no research interventions
will be performed. - Pain scores will be calculated using the PIPP
tool. - Observational assessment of behavioral indicators
- Recording of the ECG to obtain heart rate and
oxygen saturation -
52Premature Infant Pain Profile
53Additional Behavioral Indicators of the PIPP
- Facial movements will be recorded onto a
videotape during each session - Brow bulge
- Eye squeeze
- Nasolabial furrow
54Within Subject Session Comparison of Pain Scores
- Pain scores will be obtained during a session of
clustered care as follows - Before session begins
- During each procedures of clustered care (this
will be variable as each infants care is
individualized) - After last procedure of clustered care
- 15-minutes post-procedure
- 30-minutes post-procedure
- 60-minutes post-procedure
- 90-minutes post-procedure
- 120-minutes post-procedure
- (as recommended by the Pain Assessment Guidelines
of the National Association of Neonatal Nurses,
2001)
55WITHIN-IN SUBJECT SESSION COMPARISON
56Statistical Analysis
- Specific Aim 1 To describe the within-subject
differences between pain scores before, during,
and after clustered care of one test session in
the first seven days of life. - Hypothesis 1 A statistically significant
increase in pain scores will be noted within a
session of clustered care, from pre-procedure to
post-procedure, for sessions that include at
least one painful intervention.
57- The general linear mixed model (GLMM) will be
used (SAS/STAT proc GENMOD software). - The fixed effects in this model are
post-conceptional age and pain scores
58- Specific Aim 2 To describe between-group
differences in pre-procedure, peri-procedure, and
post-procedure pain scores (using the PIPP)
between the two groups before, during, and
after clustered care of one test session in the
first seven days of life and between both groups
again at 34 weeks postconceptional age. -
59- Hypothesis 2 The pain scores in group 2 (those
between 30-32 6/7 weeks) will be higher than
group 1 (those between 28-29 6/7 weeks) during
sessions of clustered care that include at least
one painful intervention.
60- Hypothesis 3 The pain scores in group 1 (those
between 28-29 6/7 weeks) will be higher when
tested again 34 weeks during sessions that
include at least one painful intervention and
there will be no significant difference in pain
scores of group 2 (those between 31-32 6/7 weeks)
when tested again at 34 weeks during sessions
that include painful interventions.
61- The GLMM will be used (SAS/STAT pro GENMOD
software). Each indicator will be analyzed
separately. - The three effects that will be analyzed will be
- brow bulge x gestational age
- eye squeeze score x gestational age
- nasolabial furrow score x gestational age.
62Summary
- Determining the answers to these specific aims
has the potential to provide the impetus for a
change in the current standard of clustered care.
It would promote an ongoing assessment of infant
pain that would prevent or limit the windup
phenomenon by guiding our caregiving and
ultimately preventing permanent developmental
changes to the pain pathways in the newborn that
could lead to the distinct abnormal behavioral
phenotypes (Anand Scalzo, 2000).
63DissertationReady, Set, Go!?
64Background and Significance
- Increase of CHF diagnosis during the past 20
years of 150 - Average age of onset 65yrs
- 90 of CHF deaths occur in those over 65
- Aging population baby boomers
- CHF single most costly cardiovascular illness in
the US - Exercise is low cost, preventative AND feasible
65Symptoms of CHF
- Dyspnea upon exertion (DOE)
- Shortness of breath when completing physical
tasks (i.e. walking) - Persistent cough or wheezing
- Edema in extremities, primarily in lower
extremities - Fatigue
- Decreased appetite, nausea
- Tachycardia (increased heart rate)
- Confusion, impaired thinking
66Edema
67Pitting Edema
68Exercise and CHF
- Aerobic
- Increased VO2 max
- Improvement in Quality of Life Measures
- Decrease in inflammation markers (CRP, TNF-alpha,
IL-6) - Decrease in Depression measures
69Exercise and CHF
- Anaerobic
- Improvement in Quality of Life measures
- Increased endothelial function
- Increase in strength
70Why fluid status?
- Fluid balance has not been investigated with
exercise. - Fluid imbalance is the primary cause of edema.
- Edema (pulmonary and extremity) is the primary
source of physical symptoms. - Edema is directly related to quality of life for
the CHF patient.
71Purpose
- To determine if combination aerobic and anaerobic
exercise alters the natural physiological
processes that maintain fluid balance within the
CHF patient.
72Specific Aim
- To compare the combined effect of aerobic and
anaerobic exercise to no exercise on the fluid
balance status of the CHF patient.
73Design
- Multiple Baseline across subjects with three
subjects per study replicated at least once (6
subjects) and a goal of 3 replications (12
subjects).
74Subjects
- Inclusion Criteria
- Diagnosis of CHF and staged according to the NYHA
as Class I or II - Over the age of 50 years
- Must be medically stable for the past 12 months
- Desire to use exercise as an adjunct to current
treatment/therapy, have time for 1 hour of
exercise 3 days per week and have transportation. - Be ambulatory and able to conduct treadmill
walking exercise - Exclusion Criteria
- Can not be on transplant list
- Can not be staged as a NYHA III-IV
- Can not be medically unstable within last 12
,omths
75Variables
- Fluid Status
- Daily Weights
- Urinalysis (Specific Gravity)
- BP
- Physical Assessment
- Serum Values (BUN, Na, Osmolality, Potassium,
Creatinine) - Self-report Symptom checklist
- Other
- Minnesota Living with Heart Failure Questionnaire
- RANDs Inventory
- Health Hardiness Scale
- Self-report on ADLs
76Time Frame
- Baseline
- Until three point trend is established
- Exercise sessions
- Each session 1 hour long
- 3 sessions per week
- Performed until trend stabilizes
- Maintenance Probes
- At one month, three months, and six months
77Exercise Protocol
- 5-10 min stretch
- Anaerobic (60 of max of one rep)
- 15 min lower extremity work (Knee extensor
flexion/Hamstring curls/Toe raises) OR 15 min
upper extremity work (Bicep Curls/Tri-cep
extensions) - Aerobic (40-60 of max heart rate)
- 35 min aerobic work (Treadmill walking or arm
cycling) - 5-10 min stretch
78Treatment Integrity
- Heart rate will be continuously monitored via a
Holter Monitor and adjustments to intensity will
be done using this heart rate. - Heart will be taken manually every five minutes
to verify accuracy of Holter monitor. - The data will be downloaded after every exercise
session. - Heart rate will be manually recorded every five
minutes as a back up.
79Holter monitor
80Data Analysis Plan
- Visual Trend Analysis
- Time Series Analysis IF any of the following
occur - A trend in baseline is in the therapeutic
direction. - Variability is large.
- Treatment effects are neither rapid nor marked.
81Social Validity
- Pre and post measures using visual analog and
open-ended response format.
82Social Significance
- Exercise is low cost to consumer.
- Decrease in acute exacerbations will decrease
hospitalizations and subsequently overall
healthcare resource consumption. - Increase the quality of life of the CHF patient
through decreased symptomology. - The patient gains CONTROL of management of
disease.
83Limitations
- Generality (first study conducted)
- May be difficult to eliminate extraneous
variables from effecting the study - A new approach to exercise treatment in patient
populations. - No previous research demonstrating the effect of
exercise on fluid status.
84Strengths
- Ability to better assess exercise versus
adherence on CHF. - Ability to detect unknown effects due to
intensity of assessment. - Ability to detect unique or outlier behaviors
that may be influential in the practical use of
exercise in this population. - No need to alter current care due to medication
regime. - Multiple baseline accounts for uncontrollable
systematic changes (ie physician changes at
facilities, systematic drug formula changes).
85Great, Ready Set Go RIGHT?
86Lets Talk..
87Need Help?
88Dissertation Proposal The Journey Tips for
Success along the Way.
- Judy Campbell,
- MSN, ARNP, PhD student
I am here!
UF Alumni Fellowship Recipient UF Gerontology
Research Trainee BAGNC Hartford Scholar
89Background Interests
- Interest in Dementia syndromes began with nursing
home background - Masters thesis related to behaviors in dementia
- Taught gerontology content, including coverage
regarding dementia, to beginning Nursing students
90PhD program opportunity to work with Dr. Rowe on
CareWatch Study
- CareWatch is designed to improve sleep and
related variables in caregivers of those with
dementia - No measures of effect of CareWatch on person with
dementia included in study - Opinion that caregiver mood/affect (which may
change with CareWatch) may lead to changes in
behaviors in PWD /or CG appraisal of behaviors - During first semester Dr. Rowe allowed me to
evaluate tools that measured behaviors - chose tool and secured Dr. Rowe agreement to add
tool - assembled IRB revision as part of RA duties
(approved) - added to CareWatch study after a few subjects had
begun
91Dementia Caregiver Stress Health Process (as
conceptualized by Schulz Martire, 2004)
Primary Stressors Care recipient Disability,
Problem Behaviors, Loss
Secondary Stressors Family Conflict, Work
Difficulties
Appraisal of Demands Adaptive Capacities
Perceived Stress
Caregiver Model
Emotional/Behavioral Response
Morbidity/Mortality
92Dementia Caregiver Stress-Health Process Outcomes
PWD Nighttime Awakenings
Primary Stressors Care recipient Disability,
Problem Behaviors, Loss
Secondary Stressors Family Conflict, Work
Difficulties
Care Watch System
Negative changes in sleep Objective actigraphy
Subjective sleep diary Daytime effect
Sleepiness Fatigue
Appraisal of Demands Adaptive Capacities
Dyadic Model
CG Worry, Burden, Intent to Institutionalize
Perceived Stress
CG Depressed mood (CES-D) CG Affect (PANAS)
Emotional/Behavioral Response
NPI PWD Behavior Non-cognitive Behavioral
Expression in the PWD
Dyad Out- Comes
PWD Out- comes
CG Health
KEY Increase will yield increase OR
decrease will yield decrease
NPI CG Distress Caregiver Appraisal of Behaviors
93Outcome variables in original study
- Sleep in CG measured with actigraphy sleep
diary - Measures of CG sleepiness, fatigue, burden,
worry, intent to institutionalize the PWD,
depressed mood, and affect - Measures specific to my study
- NeuroPsychiatric Inventory Questionnaire NPI-Q
to measure PWD and CG Dyadic outcomes - PWD behaviors CG distress
94Design Methodology
- Retrospective secondary analysis using data
collected in CareWatch Study including my tool - CareWatch Study true experimental with repeated
measures at 9 time points - My proposed study will use CareWatch data and the
added tool to determine whether CareWatch use
changes behaviors in PWD /or CG appraisal of
behaviors - Additionally, to model certain CG variables to
determine what factors explain any difference
between the two dyad groups
95Subjects from Original Study
- 55 Dementia Caregiving dyads in the north-central
FL areacommunity-dwelling - Caregiver English-speaking with concern about
nighttime activity in the persons with dementia - Care recipients with a CG-reported diagnosis of
dementia
96Statistical Measures
- Missing Data
- Longitudinal analyseschange in PWD behaviors and
CG distress related to behaviors over time - Group comparisons
- Multi-Level modeling
97Post-Dissertation Plans
- Broader program of research to investigate dyadic
interventions that may help delay nursing home
placement as long as realistic for both CG PWD,
most likely through improving behaviors - Would like to utilize knowledge of actigraphy
within future research endeavors
Hope to be Here
98TIPS for Success
- Choose topic for dissertation early
- Choose primary mentor (for committee chair) with
interests similar to yours, preferably with
ongoing research in which you can be involved - Negotiate for 7979 objectives that allow real
research experience - Develop a 10-year plan
- As possible, negotiate time to allow immersion
into PhD (decrease or eliminate work and/or other
responsibilities) - Build relationships with fellow students