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thesis entitled

QUALITY OF LIFE FOR MEN AND WOMEN WITH
CONGESTIVE HEART FAILURE

presented by

Norma J. VanTol

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QUALITY OF LIFE FOR MEN AND WOMEN WITH
CONGESTIVE HEART FAILURE

By

Norma J. VanTol

Submitted to
Michigan State University
in partial fulfillment of the requirements for the degree of

MASTER OF SCIENCE IN NURSING
College of Nursing

2001

ABSTRACT

QUALITY OF LIFE FOR MEN AND WOMEN WITH
CONGESTIVE HEART FAILURE

By

Norma J. VanTol

Congestive heart failure (CHF) impacts the quality of life (QOL) for men and
women. Representative samples of men and women are needed to assess potential gender
dependent QOL issues. Statement of Purpose: To compare the perceived QOL of men
and women with CHF, QOL across the level of disease severity, and to determine if QOL
is different for CHF men and women based on their New York Heart Association
(NYHA) functional classification. Methodology: A retrospective design with a
comparison of 92 men and 92 women from a community heart failure clinic was used.
Medical records were reviewed to determine the disease severity and patient
demographics. Disease severity was measured with the NYHA, and QOL was measured
with the Living with Heart Failure Questionnaire (LHFQ). Results: As disease severity
worsened, there was a significant decrease in QOL (p=<0.000l ), but no significant
interaction was found between men and women across disease severity (p=0.2870).
Significant differences were found between the men and women on the emotional
subscale of the LHFQ, with both NYHA class (p=0.0002), and with gender (p=0.0l 75),
but failed to show an interaction on the emotional subscale across the NYHA and gender
(p=0.5074). As a secondary analysis, ejection fraction (EF) was found to have little

correlation with QOL (p=0.309) or with NYHA classification (p> 0.05).

Copyright by
NORMA JEAN VANTOL
2001

DEDICATION

This thesis is dedicated to my husband, Paul. He has helped make my dream a
reality with his continuous support as my cheering section and offered support on every

level of this research journey.

ACKNOWLEDGMENTS

I would like to express my extreme appreciation to my committee chairperson,
Audrey Gift, and committee members, Valerie DiVecchio and Brigidanne Warren for
their time, guidance, and continual encouragement of nursing scholarship. They are
exemplary role models and helped facilitate my growth in nursing research, creating
future opportunities and possibilities for my career as an advanced practice nurse.

I would also like to thank all of those individuals with CHF who were included in
my study and the dedicated health care professionals who work at the Spectrum Health
Heart Failure Clinic. It is my hope, that through future study of CHF, that the quality of
life for those with CHF will be maximized.

Finally, I would like to acknowledge the funding of this research project through a
grant received by the American Nurses Foundation. As a beginning researcher, it has been

a great honor to receive funding for this study through such a prestigious organization.

TABLE OF CONTENTS

Page
CHAPTER I
Introduction ............................................................ 1
Definition, Incidence, and Prevelance ........................................ 1
CHAPTER II
Quality of Life .......................................................... 5
Quality of Life - Drug Studies .............................................. 6
Quality of Life - Transplant Candidates ....................................... 8
Quality of Life - Women with CHF .......................................... 9
Quality of Life - Men and Women Comparison ............................... 10
Level of Severity ....................................................... 12
Theoretical Framework .................................................. 14
CHAPTER III
Methods and Procedures ................................................. 17
Measures ............................................................. 18
Analysis .............................................................. 21
CHAPTER IV
Results ............................................................... 22
Subjects .............................................................. 22
Quality of Life and Gender ............................................... 28
Quality of Life and NYHA Classification .................................... 29
Total Scores ..................................................... 29
Physical Subscale Scores ........................................... 31
Emotional Subscale Scores ......................................... 31
Quality of Life - NYHA and Gender ........................................ 32
Physical Subscale Scores ........................................... 33
Emotional Subscale Scores ......................................... 33
CHAPTER V
Discussion ............................................................ 35
Summary of Results ..................................................... 35
Discussion of Unexpected Findings ......................................... 38
Study Limitations ....................................................... 40
Implications for Education and Research .................................... 4l
Implications for Primary Care Practice ...................................... 42
LIST OF REFERENCES ................................................. 44

vi

LIST OF FIGURES

Page

Figure l: QOL with CHF across NYHA Classification .......................... 15

vii

LIST OF TABLES

Page
Table 1: Race .......................................................... 23
Table 2: Age ........................................................... 23
Table 3: Medications .................................................... 24
Table 4: Ejection Fraction ................................................ 24
Table 5: Symptoms Reported as Most Severe ................................. 27
Table 6: LHFQ Scores ................................................... 30

viii

CHAPTER I
INTRODUCTION

Definition, Incidence, and Prevalence

Congestive heart failure (CHF) is a significant global public health care problem.
In this country alone, it is estimated to affect 2 to 3 million individuals (Konstam et al.,
I994; Buchanan & Tan, 1997; Moser, 1997), with some estimates as high as 4.7 million
individuals (Stull, Starling, Haas, & Young, 1999). There are approximately 400,000 new
cases of CHF diagnosed each year (Funk, I993; Stull et al., 1999).

CHF is defined by the Agency for Health Care Policy and Research, now the
Agency for Healthcare Research and Quality, as “a clinical syndrome or condition
characterized by 1) signs and symptoms of intravascular and interstitial volume overload,
including shortness of breath, rales, and edema, or 2) manifestations of inadequate tissue
perfusion, such as fatigue or poor exercise tolerance” (Konstom et al., 1994, p. iii). These
symptoms result when the heart is unable to meet the metabolic needs of the body
(Konstom et al., 1994; McCloskey, I998) and is the end result of numerous diseases
including hypertension, ischemic coronary artery disease, congenital heart disease,
idiopathic dilated heart disease, rheumatic fever, valvular dysfunction, cardiomyopathies,
pericardial disease, medications, and alcohol abuse (English & Mastrean, I995;
McCloskey, I998).

The incidence of CHF, based on the F rarningham Heart Study, doubles with each
decade of life, rising sharply after the age of 75, with onset in women surpassing onset in

men after this age (Funk, I993; Buchanan & Tan, I997). It is the most common cause of

hospitalization in the elderly and it is the most common diagnostic category at the time of
discharge (Stull et al., 1999; Candlish, Watts, Redman, Whyte, & Lowe, 1998; English &
Mastrean, 1995), with women hospitalized more frequently than men (Moser, 1997).

The incidence of CHF appears to be greater in men than women, increasing with
age in both groups, however women tend to have a later onset of diagnosis than men (72
+/- 1 I years, verses 68 +/- l 1 years for men). Prevalence is similar for men and women
ages 25 to 74, but is higher in women ages 80 and older (Moser, 1997). A significant
difference however, exists in the longevity between men and women. For reasons still
unknown, women have a longer survival rate with CHF than men (Moser, 1997).

The mortality from heart failure is astonishing, and increases with age (English &
Mastrean, I995). The Framingham study reported a five year mortality rate for CHF as
75% in men and 62% in women, six year mortality rate as 82% for men and 67% for
women, ten year mortality as 89% and 79% (Berry & McMurray, 1999; Funk, I993;
Massie & Shah, 1997; Kannel & Belanger, 1991). However, the National Health and
Nutrition Examination Survey (NHANES-I) revealed conflicting information when they
report the 15 year mortality rate for those older than 55 years as 39.1% for women and
71.8% for men (Funk, 1993).

Not only is there a high prevalence and mortality rate associated with CHF, but
the care of this patient population places a tremendous economic burden on our society.
Total treatment costs for CHF are estimated at more than $10 billion dollars and
hospitalizations for CHF have tripled since the 1970’s (Konstarn et al., 1994; English &
Mastrean, 1995). With the aging of the population, decreased mortality from coronary
heart disease, and the decrease in premature deaths, the prevalence of CHF is expected to

2

increase (Funk, 1993). In our economic obsessed culture these projections should be
viewed as a magnet for expenditure of research, time, and money.

Poor quality of life (QOL) is regularly described by patients with heart failure.
Common symptoms include fatigue, shortness of breath, problems with physical activity,
loss of energy, fluid retention, and sexual dysfunction (English & Mastrean, 1995). CHF
impacts the QOL for both men and women, but may affect women differently than men
(Bennett, Baker, & Huster, 1998; Murberg, Bru, Aarsland, & Svebak, I998; Friedman,
I993; Chin & Goldman, 1998; Moser, 1997; Berry & McMurray, I999). The majority of
research studying QOL with heart failure has been done on male subjects. Research
involving women with CHF is minimal. Women have either been represented in small
proportions, not included in major clinical trials, or not compared with men (Moser,
I997; Friedman, 1993; Martensson, Karlsson, & Fridlund, 1998). CHF studies with
representative samples of both men and women are needed to assess QOL issues that may
be dependent on gender. As cited by Chin and Goldman (1998), women have been found
to have a poorer QOL than men with other diseases. Therefore, gender specific inquiry
may offer insight necessary for the development of practical interventions tailored to
women and men.

Gender specific inquiry on QOL of individuals with coronary artery disease
(CAD) have had similar findings. Men and women differ in their QOL. In a prospective,
cross sectional survey of 280 patients with CAD in Finland, women with CAD scored
significantly poorer in the health related quality of life (HR-QOL), than their male

counterparts (Lukkarinen & Hentinen, I998).

Similar results were also found in two separate studies of patients with CAD
enrolled in a cardiac rehabilitation program. The results of both of these comparative
research designed studies showed the QOL of women with CAD was significantly poorer
than men (Deshotels et al., 1995; Loose & F emhall, 1995).

Lack of representative sampling of women is also observed in the research of
CAD. Historically, women have been left out of major medical trials involving CAD.
Because of the lack of representation of women in CAD research, the male model has
been made the standard for treatment of heart disease. Women with health problems
generally experience their conditions differently than men and therefore gender specific

health inquiry is necessary (Gijsbers Van Wijk, Van Vliet, & Kolk, I996).

CHAPTER 11
Quality of Life

As people are living longer with heart failure, it is the subject of intense research,
with recent investigation shifting from an emphasis on mortality, to maximizing the QOL
of those with CHF. Costs have been estimated to be 10 to 38 billion dollars per year for
inpatient and outpatient care combined, with the incidence of CHF doubling with each
decade of life and CHF being the most common reason for hospital admission for those
over age 65 (Smith, Fabbri, Pai, Fen-y, & Heywood, 1997; English & Mastrean, 1995;
Wenger, 1989), it is no wonder QOL with CHF is a topic of much discussion.

Difficulty lies in the lack of a common standard definition for QOL (Grady, 1993;
Linden, 1995). QOL is a highly subjective and multidimensional term which cannot be
directly measured, but can be examined by using self-administered questionnaires
regarding QOL domains, such as the physical and emotional domains of an individual,
yielding reliable information (Martin & Stockler, 1998). Living longer with CHF means
living with increased symptoms greatly affecting the QOL in those with heart failure.
Persons with CHF experience an impaired QOL secondary to physical symptoms,
psychological distress, limitations of social activity, and side effects of treatments (Berry
& McMurray, 1999).

A recent attempt to delineate what constitutes general QOL lead to the emergence
ofthe temi, health-related quality oflife (HR-QOL). This tenn is considered more
specific to disease conditions than general QOL and is used to assess the impact of the

disease on the daily lives of individuals with heart failure (Nanda & Andresen, I998;

Schron, Gorkin, & Gary, 1994; Bennett, Baker, & Huster, I998). HR-QOL is a
multidimensional concept involving the measurement of several domains of the patient’s
life. These domains include physical symptoms and their consequences, functional
ability, and perceptions about their general health, well-being, and life satisfaction
(Bennett et al., 1998; Wenger, 1989; English & Mastrean, 1995). Measuring HR-QOL is
an important assessment because it includes the patient’s perception of their health and
well-being (Berry & McMurray, 1999) in addition to their symptoms and functioning.
Measuring QOL has been known to guide health-related public policies (Wenger, 1992),
such as clinical pathways and specialty care clinics. Increase in knowledge of gender
specific HR-QOL in persons with CHF will impact not only delivery of individual care,
but also may affect public policy on health promotion and disease prevention.

Quality of Life-Drug Studies

QOL has been used as the outcome for testing the effectiveness of experimental
medical interventions such as trials comparing drugs verses placebos. Although these
clinical trials have demonstrated the relationships of CHF to QOL, the purpose of many
of these trials was focused on physiological parameters altered by the medication, with
only a secondary analysis on quality of life.

With the Studies of Left Ventricular Dysfunction (SOLVD) QOL substudy trial,
the affects of an angiotension-converting enzyme inhibitor was examined in the context
of QOL measurement. A battery approach was used with outcome measurement tools that
included QOL measures. Generalizability however, of this non-representative sample,
consisting primarily of men, is questionable. This experimentally designed drug
intervention study with 27 out of 308 recruited subjects women, did not allow comparison

6

of men and women’s perceived QOL, and focused only on quality of life in general
(Gorkin et al., 1993). The results however, did show a correlation between the patient’s
NYHA classification and their perceived QOL. Others have found, as would be expected,
those with worse NYHA classification showed poorer QOL (Schron et al., 1994).

The exclusion of women in clinical drug trials measuring QOL is all too common
as demonstrated in an analysis of HR-QOL studies by Shively, Fox, and Brass-Mynderse
(1996). They reviewed a large number of studies involving HR-QOL measures in
congestive heart failure patients and found that in the majority of cases the primary study
objective was the physiological changes affected by the medication interventions with
QOL only as a secondary analysis. The subjects in most of the studies were a majority
cohort of men, or gender was not recorded as being measured.

The lack of comparison between men and women, and exclusion of women with
heart failure in clinical drug trials is also supported through an analysis by Moser (1997).
Women are grossly underrepresented in the major clinical drug trials on heart failure
patients. There are multiple studies examining the QOL of CHF patients while
participating in clinical drug trials, but few women were included, or not compared with
men in these studies (VASODILATORS, the CONSENSUS Trial Study, V-HeFT II,
SOLVD, BETA-BLOCKERS CIBIS, US Carvedilol Heart Failure Study, and
DIGITALIS).

In a randomized double-blind parallel group-controlled trial of 51 patients
Sanderson et al., (1999) compared the effects of carvedilol and metoprolol on QOL.
Using the Minnesota Living with Heart Failure Questionnaire (LHFQ), quality of life was
measured, showing improvement with both the study groups. However, there were no

7

comparisons made between men and women, only 1 1 patients were women, and the
majority of the heart failure patients were in NYHA classification of III.

Hjalmarson et al. (2000) also used a randomized, double-blind controlled trial to
study the effects of controlled-released metoprolol and its effects on QOL. However, in
this sample size of 3991 patients, only 23% of the metoprolol group and only 22% of the
placebo group was female. No comparisons were made between the women and men in
regards to QOL.

Using the calcium channel blocker amlodipine in a randomized, double-blind,
placebo-controlled prospective design, Udelson et a1. (2000) studied the effects of
exercise tolerance and QOL. However, in this sample of 874 patients with CHF, only 204
were women, and the majority of the sample size was in NYHA classification of II and
III. Again, there were no comparisons between men and women.

This lack of comparison between men and women and exclusion of women
subjects has also been carried over to recent inotropic intravenous studies with heart
failure (Cesario, Clark, & Maisel, 1998; Oliva et al., 1999). In a quasi-experimental study
of the effects of a positive inotropic drug by Casario, Clark, and Maisel (1998), 10
subjects were studied, one of which was female. And in an experimental study by Oliva et
a1. (1999), only 7 women out of the 38 heart failure patients in NYHA classification of III
or IV, were in the study.

Quality of Life-Transplant Candidates

A significant amount of research measuring QOL has been conducted on heart
transplant candidates, but gender comparisons have also been excluded from these studies
of heart failure patients. Gender was reported as not being a significant contributor to

8

QOL, but only a small representation of women were included in the studies (Dracup,
Walden, Stevenson, & Brecht, 1992; Grady et al., 1995; Walden et al., 1989).

Dracup, Walden, Stevenson, and Brecht (1992), used a descriptive non-
experimental design to measure QOL in possible heart transplant patients, but only 17%
of the subjects were female. In a study by Grady et a1. (1995), a descriptive non-
experimental design was also used to study patients awaiting heart transplantation, but
again, only 17% of the subjects were women. And the majority of the 44 patients studied
by Walden et a1. (1989) in a quasi-experimental, between-subjects design of patients
being evaluated for heart transplantation, were men. The actual number of men and
women in the study was not recorded.

Quality of Life - Women with CHF

Studies of women with CHF are underrepresented in the literature. There are only
a few studies specifically addressing the population of women with congestive heart
failure. This is an important population of study, since recent research has shown heart
failure may impact women’s QOL differently than men (Bennett et al., 1998; Moser,
1997; Murberg et al., 1998).

Only three studies found in the review of literature specifically studied specifically
women with congestive heart failure (Riedinger et al., 2000; Bennett et al., 1998;
Friedman & King, 1995). Their findings demonstrated that the symptoms of fatigue and
dyspnea were particularly prevalent in this population (Riedinger et al., 2000; Bennett et

al., 1998; Friedman & King, 1995).

However, caution needs to be used with the interpretation of these results, based
on the relatively small sample size used in the studies of Bennett et al., and Friedman and
King; 30 women in Bennett, et al. (1998), and 57 women in Friedman and King (1995).

In a secondary analysis of the SOLVD trials, Riedinger et a1. (2000) studied
predictors of QOL of 691 women with CHF. The mean NYHA functional classification
for this cohort was 1.99. Since only 1.3% of the women were in NYHA class IV, classes
[11 and IV were combined for analysis. These results concurred with previous findings
that as the NYHA classification increased in severity, QOL scores decreased. However,
discretion needs to be used with the interpretation of these results since this was a
secondary analysis of this cohort, and was not a representative sample of all NYHA
classes.

These results demonstrate the need to perform gender specific comparison studies
of the responses of men and women with congestive heart failure in relation to their
perceived QOL (Moser, 1997).

Quality of Life - Men and Women Comparison

QOL research involving both men and women without connection to clinical drug
intervention trials or heart transplant candidates, have recently been reported. However,
studies specifically measuring gender differences with QOL are few (Chin & Goldman,
1998; Murberg et al., 1998), and can be divided into three categories: those that are
hospital based, those not including comparison analyses of men and women, and those
specifically looking at gender differences with QOL as their primary measurement of

study.

Candlish, Watts, Redman, Whyte, and Lowe (1998) examined QOL in men and
women aged 60 years and older in a prospective cohort study of hospitalized patients.
Measurement tools were used to measure the patient’s satisfaction with care and their
QOL. However, even with this equal representative sample of 75 elderly men and 73
elderly women with heart failure, no comparisons between these two cohorts were
performed.

A descriptive study by Wiklund, Lindvall, Swedberg, and Zupkis, (1987) was
done to assess the QOL of a sample of men and women with heart failure. A newly
developed self-assessment questionnaire measuring HR-QOL was used. Although 33 men
and 18 women were both included in this study, no gender comparison was done in this
study.

In only three studies were gender differences specifically studied, with results
revealing men and women responding differently to congestive heart failure, women
recording consistently a lower QOL than men (Steptoe et al., 2000; Chin & Goldman,
1998; Murberg et al., 1998). In a study of dilated cardiomyopathy patients, Steptoe et al.
(2000) measured HR-QOL on 99 patients. However, in this sample of 99 patients, only 20
were female and 92 of the subjects were in NYHA classification of l and 11. And of the 22
women in Murberg et al.’s (1998) study, had heart failure an average of 29.7 months
longer than the 59 men, which may be one contributing factors for the differences in
recorded QOL between men and women (Murberg et al., 1998). Although length of
disease was not controlled in the analysis by Chin and Goldman (1998), the 90 women

completing the surveys were an older cohort than the 89 men in the study. The extraneous

ll

variables of length of condition and age of cohort may explain the differences in the QOL
recorded by men and women of these studies.

A significant amount of research measuring QOL has been conducted on heart
transplant candidates. Findings have shown that the NYHA classification and self-
reported functional status was significantly correlated with patient’s psychosocial
adjustment. Those with a higher NYHA functional classification (class IV) had a poorer
life satisfaction than those with less symptom distress and better health perception (Grady
et al., 1995; Bennett et al., 1998). However, this exclusive population of persons with
heart failure may not be representative of the population of congestive heart failure
patients at large, secondary to the meticulous selection criteria of transplant candidates
(Bennett, Pressler, Hays, F irestine, & Huster, 1997).

Level of Severity

The New York Heart Association (NYHA) functional scale is a widely used
system to classify the severity of CHF. The grading system divides CHF into four classes
as follows: Class I - patients have impaired cardiac function, but do not display symptoms
and have no limitations with their activity. Class II - patients are classified at this level if
they become fatigued, short of breath, have anginal‘pain, or palpitations after moderate
activity. They are without symptoms at rest. Class 111- patients display significant
limitations in activity. Slight to moderate activities create symptoms of fatigue, shortness
of breath, anginal pain, or palpitations. Class IV - results when patients are unable to do
any physical activity without symptoms or discomfort. They display shortness of breath
and fatigue at rest (Konstam et al., 1994; Martensson, Karlsson, & Fridlund, 1997;
Murberg et al., 1998).

12

Ejection fraction (EF) is another widely used measurement tool for evaluation of
the severity of CHF. The EF is used in clinical practice for the evaluation ofleft
ventricular performance and is defined as the proportion of blood that is ejected during
each ventricular contraction compared with the total ventricular volume. Approximately
two-thirds of the end diastolic volume is ejected with each cardiac contraction, and is
considered a normal value in percentages of approximately 55%. However, this
measurement tool is very sensitive to the loading conditions present at the time of
measurement, and varies in values depending on the technique used for measurement.
Thus, the value can fluctuate based on the afterload present at the time of measurement.
Even with these known technical limitations, because of the clarity and ease of
measurement, the EF is widely used in practice to measure left ventricular performance
(Bellenger et al., 2000; Vera, Gardin, & Bok, 1995; Chatterjee et al., 1991).

The lack of representative studies including equal numbers of men and women
with heart failure, demonstrates the need for future studies measuring their QOL.
Comparison studies are needed between men and women to assess their perceived
symptoms. If men and women respond to heart failure differently, and if women with
CHF do indeed have a poorer QOL than men, then measuring their QOL is crucial to
testing therapeutic interventions designed specifically to meet their needs and improve
their QOL.

Generalization to women in the heart failure population needs careful attention,
and not extrapolated without further research. Representative samples of men and women

are needed to compare and contrast men and women’s perceived QOL.

l3

Theoretical Framework

The framework used to guide the development of this study and to define QOL is
the Wenger model (Wenger, 1989). The Wenger model is part of the framework used in
the development of the LHFQ (Rector, Kubo, & Cohn, 1987). In this model, Wenger
outlines three domains which should be examined when evaluating the HR-QOL of
patients with CHF. These domains include functional capacity, perceptions, and
symptoms and their consequences (Wenger, 1989). Figure l is a representation of the
impact of CHF on QOL across the NYHA classification for this study.

Wenger (1989) describes the first domain of HR-QOL, the functional capacity, as
“the patient’s ability to carry out the usual activities of day-to-day life” (p. 392). These
physical activities involve such things as self-care, intellectual, emotional functioning and
interactions with family, work and interpersonal actions (Wenger, 1989). Wenger further
describes the functional domain as involving activities which are necessary to perform the
activities of daily living which are essential to partake in both occupational and
recreational activities, as well as social and family relationships. The intellectual activities
are also a part of this domain and are described as the functions necessary to make
decisions, such as judgment, confidence, memory, alertness and the ability to
communicate (Wenger, 1989).

A second domain necessary to assess the HR-QOL of patients with CHF is the
patient’s perceptions (Wenger, 1989). This domain includes the patient’s perception of
their life satisfaction and health-related well-being and gives insight to the patient’s
beliefs, value systems and perceptions, including the patients’ assessment of their disease
and how it impacts their ability to function on a daily basis (Wenger, I989). Perceptions

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are included as a domain because research has shown that measuring perceived health is a
better indicator of work performance than actual functional measures of health (Wenger,
1989).

Symptoms are outlined as the third domain in assessing the QOL of patients with
CHF. According to Wenger (1989), symptoms may relate not only to the disease or
disorder, but also to the iatrogenic problems caused by treatment or comorbidities.
Wenger describes these symptoms as including but not limited to, dyspnea, exhaustion,
fatigue, insomnia, pain, dizziness, and side effects of medications. These symptoms may
in turn affect the other domains of functional capacity and perceptions as well (Wenger,
1989)

Examining these three domains when assessing QOL of patients with CHF may
be of added value over global or generic QOL measures (Wenger, 1989). Conservation of
patient’s fianctional capacity, autonomy, and self—care, are major goals of therapy for
patients with CHF (Wenger, 1989; Wenger, 1992). Therefore using these three domains
to assess QOL of men and women with CHF will help evaluate their perceived QOL with
CHF.

The research questions are as follows. Is there a difference between men and
women’s perceived QOL with CHF? Is there a difference in QOL across the NYHA
functional classifications without differentiation by gender? Is the QOL different for men
with CHF than women with CHF based on their NYHA functional classification?

Based on the research questions, it is hypothesized that the scores between men
and women with heart failure will be different based on their functional classification,
with women scoring lower in their perceived quality of life with CHF than men.

16

CHAPTER III
Methods and Procedures

A retrospective, non-experimental design using a between-subject comparison
was used in this study. Institutional review board (IRB) approval was applied for prior to
the retrospective study. Approval from Michigan State University Committee on
Research Involving Human Subjects (UCRIHS) and the Spectrum Health Research and
Human Rights Committee was granted. Confidentiality was insured to the fullest extent
as permitted by law.

The sample was drawn from a population followed by the outpatient Spectrum
Health Congestive Heart Failure Clinic, located in Grand Rapids, Michigan. Equal
numbers of men and women with each classification delineation were included until at
least 20 participants were in each cell. In order to increase the generalizability of the
sample, all subjects who were diagnosed with CHF and those who completed the
questionnaires during their routine clinical assessment were included in study. Persons
with CHF who were potential heart transplant candidates were excluded from this study
when known.

Review of the medical records by the investigator was done to collect
demographic data and to determine the NYHA functional classification. NYHA
classification was compared with their symptoms to ensure interrater reliability. Patient
demographics such as gender, age, employment status, socioeconomic factors, race,
comorbidities, number of medications, and marital status were collected from the

patient’s medical records. Ejection fraction (EF) was recorded as a percentage based on

17

echocardiogram reports done at the time of admission into the heart failure clinic. When
there were ranges for EF’s recorded in the chart, the data collector consistently recorded
the lower of the two numbers. For instance, if an EF was recorded as 25-30%, the
collector recorded 25% as their EF.

Participants currently are given the LHFQ upon the initial visit to the heart failure
clinic. Analysis of this previously collected data was done in this study. QOL scores were
derived from the LHF Q. The total score as well as the physical and the emotional
subscales were recorded for each subject. Mean scores and standard deviations were
recorded for the entire sample, and for each gender specific cohort, both with and without
the independent variable of the NYHA level of disease severity. These descriptive
statistics were done for the total LHFQ score and the physical and emotional subscales.
Questions that the subjects left blank on the questionnaires were recoded with the mean
scores. The highest possible score on the LHFQ was 105.

Measures

The disease specific Minnesota Living with Heart Failure Questionnaire (LHF Q)
was selected for use in this study to assess patient’s QOL with CHF. The LHFQ is a self-
administered questionnaire, which measures the patient’s perception of how CHF
symptoms have impacted their lives during the past month. The questionnaire is a 21 —item
instrument in which patients rate items on a 6-point response scale (0 = no, 1 = very little,
6 = very much). The items on the questionnaire ask patients to rate how CHF has
prevented them from living as they wanted during the past month (Rector & Cohn, 1992).

The LHF Q has two subscales which measure the physical (8 items) and emotional
(5 items) symptoms of CHF. The physical subscale consists of items related to the degree

18

of dyspnea and fatigue of CHF. The emotional subscale consists of items related to
feeling burdensome, feeling a loss of self-control, worry, difficulty concentrating, and
feeling depressed. The remaining 8 items do not fit in a specific subscale, but include
questions about the affects of CHF including earning a living, sexual activity, ankle
edema, diet, hospitalizations, medical costs, and side effects (Rector & Cohn, 1992).

Scoring of the LHF Q was computed by summating the responses of all 21
questions. A higher score indicates greater symptom impact, interfering with the person’s
ability to live the way they wanted during the past month. A lower score indicates better
HR-QOL. The physical and emotional subscales were computed by summating their
responses to the items to further examine the effect of CHF on a patient’s life (Rector &
Cohn, 1992).

Internal consistency reliability of the LHFQ has been well established in the use
with persons with CHF with a Chronbach’s alpha of at least 0.9 (Rector & Cohn, 1992;
Bennett et al., 1997; Gorkin et al., 1993; Bass, Fontana, & Bhat, 1997), and Chronbach’s
alpha of 0.87 (Bennett, Baker, & Huster, 1998) for the total LHFQ score. For this study, a
Chronbach’s alpha of 0.93 was found with the whole questionnaire, 0.95 for the physical
subscale, and 0.88 for the emotional subscale.

Content validity of the LHFQ has been established with the initial version of the
questionnaire. Patients were asked if there were any other emotional, physical, or social
issues which prevented them from living the way they desired, and no new limitations
were identified (Rector et al., 1987). Content validity has also been validated both in a

randomized, double—blind, placebo-controlled trial of pimobendan (Rector & Cohn,

l9

1992), as well as in the SOLVD Prevention Trial with enalapril verses placebo (Rector,
Kubo, & Cohn, 1993).

Construct validity has been established in a placebo-controlled trial with enalapril,
with patient’s baseline LHFQ scores significantly different at p<0.001 between
asymptomatic and symptomatic CHF patients (Rector et al., 1993). The LHFQ is a well
established instrument designed for specific use with CHF patients (Berry & McMurray,
I999; Ni et al., 2000). This questionnaire was developed using a cohort of men (Rector,
Kubo, & Cohn, 1987), but validated on women (Bennett et al., 1998). The scale,
however, has not been used to compare men and women in the same study.

A factor analysis was done for the LHF Q in this study to validate the items on the
subscales. An orthogonal transformation yielded two factors in this study, which
contained similar items to the physical and emotional subscales of the LHF Q.

The NYHA functional classification system was used as the criteria for classifying
heart failure patients into their level of severity. The New York Heart Association
(NYHA) functional scale is a widely used system to classify the severity of CHF. The
grading system divides CHF into four classes as follows: Class I - patients have impaired
cardiac function, but do not display symptoms and have no limitations with their activity.
Class II - patients are classified at this level if they become fatigued, short of breath, have
anginal pain, or palpitations after moderate activity. They are without symptoms at rest.
Class 111- patients display significant limitations in activity. Slight to moderate activities
create symptoms of fatigue, shortness of breath, anginal pain, or palpitations. Class IV -

results when patients are unable to do any physical activity without symptoms or

20

discomfort. They display shortness ofbreath and fatigue at rest (Konstam et al., 1994;
Martensson, Karlsson, & Fridlund, I997; Murberg et al., 1998).

Although the NYHA classification system is the most widely used system of
classification for CHF, it has received criticism for its lack of reliability, especially inter-
observer reliability (Konstam et al., 1994; Wenger, 1989; Bowling, 1995; Murberg et al.,
1998). While further clarity of this classification tool is desired to allow health care
providers to communicate CHF status more objectively, it is the most commonly used
and understood tool, and the criteria described above was used in this study to classify
CHF status.

Analysis

The descriptive statistics of means, standard deviations, and ranges for the scores
of the questionnaire were provided for gender differences, the physical subscale, the
emotional subscale, and level of disease severity. Extraneous demographic variables were
reported for men and women and by NYHA functional classification and analyzed for
differences using t-test or chi-square as appropriate.

Comparisons between men and women and across level of disease severity on
QOL were analyzed using factorial ANOVA with gender and NYHA classification as the
independent variable and QOL as the dependent variable. An alpha of .05 was used in this

study to determine statistical significance.

21

CHAPTER IV
Results

The sample size consisted of 184 subjects from the Spectrum Health Congestive
Heart Failure Clinic in Grand Rapids, Michigan. Data were analyzed using the SPSS and
SAS statistical software. Of these 184 subjects, 168 were Downtown Campus patients
and 16 were East Campus patients. The original intent was to collect data on subjects
only from the Downtown campus, however in order to have an equal number of men and
women in each NYHA classification, data on subjects from the East Campus was also
collected.

Subjects

The study sample consisted of 92 men and 92 women for a total of 184 subjects.
All attempts were made to include equal numbers of men and women in each NYHA
classification. However, since the heart failure clinic had so few patients in NYHA class
1, subjects in NYHA class I and II were grouped together for this analysis. Demographic
characteristics of the sample are presented in Tables 1 - 4.

Race was categorized into the following categories: White, Afiican American,
Hispanic, Asian, other, and unknown. Most of the subjects in this study were Caucasian.
Of the 184 subjects, 140 (76.1%) were white, 21 (l 1.4%) were African American, 2
(1.1%) were Hispanic, 1 (0.5%) were Asian, 1 (0.5%) were other, and 19 (10.3%) were
unknown. For the breakdown by gender, see Table l.

NYHA functional classification was recorded as being either labeled in the chart

or assigned by the data collector based on their symptoms recorded in the chart at the time

22

Table l.

 

 

 

 

 

 

Race
Men n=92 Women n=92

a % a 2/9
Caucasian 73 79.30 67 72.80
African American I l 12.00 10 10.90
Asian 1 1.10 0 0.00
Hispanic 0 0.00 2 2.20
Other 0 0.00 l 1.10
Unknown 7 7.60 12 13.00
Table 2.
Age

Men n=92 Women n=92

Standard Standard
fl Mean Deviation 11 Mean Deviation

Age 92 63.14 14.73 92 65.01 15.82
NYHA I and II 40 61.03 15.50 40 59.68 16.76
NYHA Ill 32 64.94 14.59 21 69.28 14.00
NYHA IV 20 64.50 13.49 20 68.85 14.03

 

23

Table 3.

Medications (#’s)

 

Men n=92
Mode Range

Women n=92
Mode Range

1:
ID

 

 

Medications 92 7 3-21 92 7 0-19
NYHA I and 11 40 7 3-13 40 7 0-15
NYHA III 32 7 3-21 32 7 4-15
NYHA IV 20 11 3-14 20 13 5-19
Table 4.

Ejection Fraction

 

 

Men n=92 Women n=92
Standard Standard
3 Mean Deviation 3 Mean Deviation
Ejection Fraction 91 26.31 14.02 90 29.43 16.37
NYHA I and II 40 26.25 12.30 39 28.26 14.08
NYHA 111 32 25.91 14.38 31 31.16 16.40
NYHA IV 19 27.1 1 17.27 20 29.05 20.65

 

24

of admission. Of the 184 subjects, 56 had NYHA class labeled in the medical record, and
the data collector assigned 128. The 92 men in this study ranged from 17 to 92 years of
age with a mean age of 63 years and a standard deviation of 14.73. There were 8 men in
NYHA class 1, 32 in class II, 32 in class III, and 20 in class IV. The 92 women in this
study ranged in age from 20 to 97 years with a mean age of 65 years and a standard
deviation of 15.82. There were 3 women in NYHA class I, 37 in class II, 32 in class III,
and 20 in class IV. Table 2 lists the mean ages and standard deviations for these groups
across the NYHA classification.

Medications were recorded by the number of pills taken daily and the drug family
classification. The number of medications taken by each individual ranged from 0 to 21
with the mode being 7. There were no statistically significant differences between men
and women with the number of medications taken. As disease severity increased, the
mean number of medications increased, but there was no statistically significant
differences with the QOL scores. Table 3 shows the medication numbers for the men and
women across the NYHA classifications. The most frequently prescribed medication was
diuretics followed by angiotensin converting enzyme inhibitors.

Medications were examined across NYHA classes and QOL scores. ANOVA did
not detect individual drug type differences or numbers between the men and women
across the NYHA. Having few subjects take a specific drug in each NYHA class, may
account for the lack of findings.

Comorbidities were recorded as hypertension (N: 93), diabetes (N: 64), chronic
obstructive pulmonary disease (N: 41), atrial fibrillation (N: 40), cancer (N= 22),
arthritis (N: 21), and none (N: 2). There were no significant differences recorded

25

between the groups in this study, due to the small numbers ofsubjccts with each disease
category in each NYHA classification.

However, when analyzing the 64 subjects with diabetes and their QOL scores
across the NYHA classification, there were statistically significant differences (F (2.183):
3.42, p = 0.0349) noted with NYHA classification and diabetes. Table 5 presents the
descriptive statistics for the QOL scores for those with diabetes and for those with other
comorbidities. Thus, showing that those with diabetes had lower QOL scores than the
subjects with other comorbidities.

Ejection fraction (EF) was recorded as a percentage based on echocardiogram
reports done at the time of admission into the heart failure clinic. The mean EF for the
subjects in NYHA class 1 and 11 combined was 27.24% with a standard deviation of
13.16. The mean EF for the subjects in NYHA class III was 28.49% with a standard
deviation of 15.51. The mean EF for the subjects in NYHA class IV was 28.10% with a
standard deviation of 18.85.

The mean ejection fraction for the men in this study was 26.31% with a standard
deviation of 14.02. One male subject did not have a recorded ejection fraction. The mean
EF for the men in NYHA class I and 11 combined was 26.25% with a standard deviation
of 12.30. The mean EF for the men in NYHA class III was 25.91% with a standard
deviation of 14.38. The mean EF for the men in NYHA class IV was 27.1 1% with a
standard deviation of 17.27.

The mean ejection fraction ofthe women in this study was 29.43% with a

standard deviation of 16.37. Two female subjects had medical records without a

26

Table 5.

Symptoms Reported as Most Severe

 

Symptoms Reported as Most Severe by Subjects (n=l84), as Measured by the LHFQ

 

 

 

 

 

 

Symptom Range Frequency M
0 1 2 3 4 4.5 5
Tiredness 0-5 13 7 20 27 35 l 81 3.68
Short of Breath 0-5 18 19 15 30 32 1 69 3.35
Difficulty Walking 0-5 27 12 17 26 30 2 70 3.28
Difficulty Working around Home 0-5 27 16 13 31 24 l 72 3.24
Eating Less 0-5 31 20 13 26 25 69 3.09
Resting Frequently 0—5 39 14 15 30 29 57 2.94
Difficulty w/ Recreational Activities 0-5 32 18 12 43 25 I 53 2.90
Difficulty Going Places 0-5 41 l3 16 38 29 2 45 2.77
Worry 0-5 34 26 18 31 27 48 2.73
Difficulty Relating to Family & Friends 0-5 36 20 17 41 3O 1 39 2.70
Symptoms Reported as Most Severe by Men (n=92), as Measured by the LHFQ
Smptom Range Frequency Mean
0 l 2 3 4 4.5 5

Tiredness 0-5 1 1 4 9 1 1 19 38 3.48
Shortness of Breath 0-5 I 1 9 9 15 18 l 29 3.19
Difficulty Walking 0-5 19 7 7 12 15 l 31 3.01
Difficulty w/ Recreational Activities 0-5 18 6 9 17 I4 28 2.94
Difficulty Working Around Home 0-5 19 8 8 16 8 33 2.92
Eating Less 0-5 18 13 5 16 8 32 2.86
Difficulty Sleeping 0-5 20 8 8 15 18 23 2.78
Resting Frequently 0-5 22 9 8 19 9 1 24 2.64
Difficulty Relating to Family & Friends 0-5 20 1 I 9 20 l3 19 2.56
Difficulty Going Places 0-5 26 6 7 19 l 1 1 22 2.56

 

Symptoms Reported as Most Severe by Women (11: 92), as Measured by the LHFQ

 

 

Smptom Range Frequency Mean
0 l 2 3 4 4.5 5
Tiredness 0-5 2 3 l l 16 16 l 43 3.88
Difficulty Working Around Home 0-5 8 8 5 15 16 1 39 3.55
Difficulty Walking 0-5 8 5 10 I4 15 l 39 3.55
Shortness of Breath 0-5 7 10 6 15 14 40 3.51
Eating Less 0-5 13 7 8 10 17 37 3.33
Resting Frequently 0-5 10 9 4 24 16 29 3.24
Wony 0-5 12 14 5 16 ll 34 3.11
Difficulty Going Places 0-5 15 7 9 19 18 l 23 2.97
Difficulty Relating to Family & Friends 0-5 16 9 8 21 17 1 20 2.83
Feelings of Depression 0-5 16 13 13 15 12 23 2.69

 

27

documented ejection fraction measurement. The mean EF for the women in NYHA class
I and 11 combined was 28.26% with a standard deviation of 14.08. The mean EF for the
women in NYHA class III was 31.16% with a standard deviation of 16.40. The mean EF
for the women in NYHA class IV was 29.05% with a standard deviation of 20.65.

When analyzing EF and the NYHA classification, with EF as the dependent
variable, there was no statistical significance between the means (F (2‘ ,8”, = 0.13, p =
0.8819). There also was no statistical significance with EF and gender (F (L I80) =1.65, p =
0.2002). And, there was no interaction found with EF across NYHA class and gender (F
(1,80) = 0.23, p = 0.7932).

Quality of Life and Gender

The entire sample of men and women together yielded a total mean LHFQ score
of 53.81 and a standard deviation of 25.83. The mean LHFQ score for the 92 men in this
study was 50.34 with a standard deviation of 26.32. And for the 92 women in the study,
the mean LHFQ score was 57.28 with a standard deviation of 25.00. Analyzing the men
and women’s LHFQ mean scores using ANOVA showed no statistically significant
differences between the genders (F o. m) = 2.24, p = 0.1363).

Looking at the two subscales in the LHF Q, the mean score for the physical
subscale (items 2, 3, 4, 5, 6, 7, 12, and 13) of the whole sample was 24.54 with a standard
deviation of 12.28. The mean score for the emotional subscale (items 17, 18, 19, 20, and
21) ofthe entire sample was 1 1.57 with a standard deviation of 7.58. Table 5 reports the
subscale scores for men and women in each NYHA class.

Examining the physical subscale scores between men and women yielded no
statistically significant difference (F ”m, = 1.16, p = 0.2824). However, when examining

28

the emotional subscale scores between the men and the women, the results showed
statistically significant results (F (1.183) = 5.75, p = 0.0175). Using Tukey’s post hoc to test
for statistical significance, resulted in difference between the men and women.

The ten items most frequently reported by both genders to impact QOL as
measured with the LHF Q are shown in Table 6. Table 6 also shows the ten items reported
most frequently as impacting the QOL of each gender. The minimum score for each
question in the subscales is 0 with a maximum score of 5.

Interestingly, when examining the relationship between EF and QOL for the entire
sample group no relationship was found (r = 0.076, p = 0.309). Similar gender specific
analysis also did not yield statistically significant relationships. Furthermore, when the
relationship between EF and QOL was examined for each NYHA classification
separately, no significant correlation was found [NYHA I & 11 (r = 0.0794, p = 0.4887);
NYHA 111 (r = 0.0772, p = 0.5475); NYHA IV (r = 0.0639, p = 06994)]. Analysis of
QOL and EF relationships for each of the subscales separately also did not find a
relationship. Even when a natural log linear transformation was used to correct for the
skewness in the data, no relationships were found in the results. Thus, there was no
relationship found between EF and QOL.

Quality of Life and NYHA Classification
Total scores

LHFQ scores were analyzed across the NYHA classifications to assess QOL for
the sample as a whole. Looking at the entire study group of NYHA classes I and 11
combined, the mean LHFQ score was 45.57 with a standard deviation of 28.28. For
NYHA class III the mean LHFQ was 55.24 with a standard deviation of22.83. The entire

29

Table 6.

 

 

 

 

LHFQ Scores
Total Sample Men Women
Standard Standard Standard
Mea_n Deviation M Deviation m Deviation
QOL Score
NYHA I and 11 45.57 28.28 38.93 27.69 52.22 27.61
NYHA 111 55.24 22.83 53.65 22.87 56.83 23.04
NYHA IV 68.00 17.83 67.87 16.53 68.12 19.59
Physical Subscale
NYHA l and 11 20.60 23.21 17.09 13.22 24.12 12.39
NYHA 111 24.89 10.92 24.84 10.27 24.94 1 1.71
NYHA IV 31.83 8.67 32.55 8.68 31.10 8.83
Emotional Subscale .
NYHA I and II 9.37 7.66 7.21 7.04 11.53 7.73
NYHA 111 12.04 7.53 10.95 7.34 13.12 7.67
NYHA IV 15.22 5.97 14.50 5.61 15.94 6.37
QOL Score with CHF
and Diabetes
NYHA I and 11 52.21 27.95 47.20 32.19 56.84 23.75
NYHA 111 48.65 19.28 52.77 20.79 42.66 15.87
NYHA IV 73.04 16.60 72.67 15.76 73.41 18.92
QOL Score with CHF
and Diabetes Excluded
NYHA I and 11 42.56 28.16 35.38 25.34 50.00 29.45
NYHA 111 60.05 24.23 54.53 25.43 64.26 22.98
NYHA IV 65.84 18.27 65.81 14.00 65.86 20.12

 

 

 

NYHA class IV yielded a mean LHFQ score of 68.00 with a standard deviation of 17.89.
Examining the classes using factorial ANOVA with NYHA as the independent variable
and QOL as the dependent variable, and controlling for the size differences in the classes,
a significant difference was noted (F (1,33) = 1 1.35, p = < 0.0001). Using Tukey’s post hoc
test to test for statistical significance between the NYHA classes, while controlling for the

differences in class size, resulted in statistically significant differences between the

30

NYHA classes I and 11 combined with class IV, and between NYHA class III and IV, with
a p value of < 0.0001. As disease severity increased there was a conversely significant
decrease in QOL.
Physical subscale scores

The LHFQ physical subscale mean score for the whole sample was 24.54 with a
standard deviation of 12.28. For the entire NYHA class I and 11 combined the mean score
was 20.60 with a standard deviation of 23.2 1. The physical subscale mean score for the
NYHA class III was 24.89 with a standard deviation of 10.92. The physical subscale
mean score for the entire NYHA class IV was 31.83 with a standard deviation of 8.67.

Analysis of both subscales was done to assess differences with NYHA class and
subscale scores. When analyzing the physical subscale as the dependent variable, and
NYHA class as the independent variable, there was statistically significant difference
found (F (2,183) = 12.91 , p = < .0001). Using Tukey’s post hoc test showed statistically
significant differences between NYHA classes I and 11 combined, with NYHA class IV,
and between NYHA class III and NYHA class IV.
Emotional subscale scores

The emotional subscale mean score for the whole sample was 11.57 with a
standard deviation of 7.58. For the NYHA class I and 11 combined, the emotional
subscale mean score was 9.37 with a standard deviation of 7.66. The emotional subscale
mean score for the NYHA class III was 12.04 with a standard deviation of 7.53. The
emotional subscale mean score for the NYHA class IV was 15.22 with a standard

deviation of 5.97.

31

Analysis ofthe emotional subscale produced similar results. Like the physical
subscale, the emotional subscale showed statistically a significant difference with the
NYHA classes (F (2,133) = 9.1 l, p = 0.0002). Using Tukey’s post hoc test to test for
statistically significance between the NYHA classes, while controlling for the differences
in class size, resulted in statistically significant differences between the NYHA classes I
and 11 combined and NYHA class IV.

Quality of Life - NYHA and Gender

Table 2 shows the descriptive statistics for the LHFQ scores of men and women.
For the men in the NYHA classes I and II combined, the mean LHFQ scores were 38.93
with a standard deviation of 27.69. The men in NYHA class 111 had mean LHFQ score
was 53.65 with a standard deviation of 22.87. For the men in NYHA class IV, the mean
LHFQ score was 67.87 with a standard deviation of 16.53.

The women in NYHA classes I and 11 combined yielded a mean LHF Q score of
52.22 with a standard deviation of 27.61. Women in NYHA class 111 had a mean LHFQ
score of 56.83 with a standard deviation of 23.04. For the women in NYHA class IV, the
mean LHFQ score was 68.12 with a standard deviation of 19.59.

While the mean scores for women with CHF appear lower than the men’s mean
scores for each NYHA class, analyzing this data did not find statistical significance.
Using factorial ANOVA and controlling for class size differences, there was no
significant interaction between gender with their LHF Q scores across the level of disease

severity (F (2‘ 133) = 1.26, p= 0.2870).

32

Physical subscale scores

The men in this study in NYHA classes I and 11 combined scored a mean physical
subscale score of 17.09 with a standard deviation of 13.22. For the men in NYHA class
III, the mean physical subscale score was 24.84 with a standard deviation of 10.27.
Examining the men in NYHA class IV, the mean physical subscale score was 32.55 with
a standard deviation of 8.68.

The women in this study in NYHA classes I and 11 combined had a mean physical
subscale score of24. 12 with a standard deviation of 12.39. For the women in NYHA
class III, the physical subscale mean score was 24.94 with a standard deviation of l 1.71.
The women in NYHA class IV had a mean physical subscale score of 3 l .10 with a
standard deviation of 8.83.

Gender specific inquiry with a two way ANOVA yielded no statistically
significant interactions between the men and women with their physical subscale scores
across the NYHA classes (F (2133, = 2.51, p = 0.0842).

Emotional subscale scores

The emotional subscale for the men in classes I and 11 combined had a mean score
of 7.21 with a standard deviation of 7.04. The emotional subscale for the men in NYHA
class III yielded a mean score of 10.95 with a standard deviation of 7.34. The mean
emotional subscale for the NYHA class IV men, were 14.50 with a standard deviation of
5.61.

The emotional subscale for the women of NYHA classes I and 11 combined had a
mean emotional subscale score of l 1.53 with a standard deviation of 7.73. The mean
emotional subscale for the women in class III was 13.12 with a standard deviation of

33

7.67. The mean emotional subscale score for the women in NYHA class IV were 15.94
with a standard deviation of6.37.

Again gender specific inquiry with a two way ANOVA yielded no statistically
significant interactions between the men and women with their emotional subscale scores

across the NYHA classes (F (2‘ .83) = 0.68, p= 0.5074).

34

CHAPTER V
Discussion

Summary of Results

The results of this study showed there were no differences in the total QOL scores
or their physical subscale scores between men and women. However, there were
statistically significant differences found between the men and women in their emotional
subscale scores. There were statistically significant differences found between the NYHA
classes with the overall QOL score and also with the physical and emotional subscale
scores across the NYHA classes. But when evaluating the NYHA across gender, there
were no statistically significant interactions found between the men and women across
the overall QOL score, or the physical and emotional subscales.

The results of this study support previous work in this area, that as the level of
disease severity with CHF progresses as measured by the NYHA classification, there is a
statistically significant decrease in the QOL (Riedinger et al., 2000; Bennett et al., 1998;
Grady et al., 1995; Schron et al., 1994; Gorkin et al., 1993). However, the results of this
study failed to support the hypothesis of the study, which stated that the QOL scores
between men and women with CHF would be different based on their functional
classification with women scoring lower than men in their perceived QOL.

Despite the fact that the mean scores for the men and women in each NYHA
classification varied, with women having a lower overall mean QOL score than the men
in this study, there were no statistically significant differences found. One possible

explanation for the differences in these findings might be the large standard deviations of

35

the mean scores for the LHF Q of both men and women. These study findings are in
contrast to the findings of others who reported women having a statistically significant
lower recorded QOL than men with CHF across the level of disease severity (Steptoe et
al., 2000; Chin & Goldman, 1998; Murberg et al., 1998).

However, care must be taken in the interpretation and comparison of this study’s
results with prior findings. The present findings may likely differ from prior research due
to differences in study designs. In the study of Steptoe et al., (2000) only 20 of the 99
subjects were women and 92 of the total sample were in the NYHA classifications I and
11. Because of the small number of women in an unequal disease severity distribution, the
Steptoe et al., (2000) study may have been sensitive to outliers which may explain the
differences with the results of this study.

Length of disease can potentially influence QOL with CHF, especially in light of
the high mortality rate of 62-75% within 5 years of diagnosis (Berry & McMurray, 1999;
Funk, 1993; Massie & Shah, 1997; Kannel & Belanger, 1991). Although length of disease
was unobtainable in the present study secondary to inconsistent recordings in the medical
records, Murberg et a1. (1998) measured disease length in a study with 22 women and 59
men. The women, who were found to have a lower QOL, had CHF 29.7 months longer
than the men. The present study’s sampling which obtained equal numbers of men and
women in each NYHA class, is likely to have resulted in similar lengths of disease in the
men and women and may explain the finding of similar QOL scores for men and women.

The age of the persons in study may also explain the differences in this study’s
results from prior study findings. In the study by Chin and Goldman (1998) an older
cohort of women was studied than the men. In the present study, the mean age for the 92

36

men was 63.4 years with a standard deviation of 17.73. The mean age for the 92 women
in this study was 65.01 years with a standard deviation of 15.82. This mainly Caucasian
study group in this study consisted of comparably matched groups of men and women
with both ages and range of age. The age difference between the men and women in the
study by Chin and Goldman (1998) could potentially explain the lower QOL for the
women in their study.

These study results support prior findings of women with CHF and their reported
symptoms. The symptoms of fatigue and dyspnea were also particularly prevalent in this
study which is consistent with previous research findings for patients with CHF
(Riedinger et al., 2000; Bennett et al., 1998; Friedman & King, 1995).

The overall mean QOL score for this entire study group as measured by the LHF Q
was 53.81, with a standard deviation of 25.83. Measured on a scale of 0-105 with a lower
score indicating a better HR-QOL, this study cohort appeared to report QOL scores
compared with other studies. The studies reporting worse QOL had patients primarily in
NYHA classes III and IV. Studies reporting better QOL had patients primarily in NYHA
classes I and II.

One particular issue with this study of patients with CHF was the scarcity of those
in NYHA class I found in this congestive heart failure clinic setting. The logical
explanation of this phenomenon may be due to their lack of symptoms, their undiagnosed
condition, lack of follow up with their care, or their treatment in the primary care setting
by their primary care provider. It can be difficult to fully compare the NYHA
classifications across all levels of disease severity due to the potential problem of access
to those with the diagnosis of NYHA class 1.

37

Interestingly, there was a statistically significant difference found between the
men and women with the emotional subscale of the LHF Q. However, this was not found
with the physical subscale. Perhaps women and men differ in these subscales with their
symptom complaints, as listed in Table 5. A couple of the symptoms that women
recorded more severe than men were that of worry and feelings of depression, which are
found solely in the emotional subscale. The symptoms that men recorded more severe
than women were that of difficulty with recreational activities and difficulty sleeping,
which are items found on the physical subscale. These findings suggest attention to
emotional and physical symptoms based on gender may be appropriate and important in
the care of patients with CHF.

Evaluating the theoretical framework as depicted in Figure 1, modifications need
to be made. With the representation of the staircase approach to CHF and QOL as
modified from Wenger’s (1989) model for this study, NYHA classes I and 11 need to be
combined onto one stair. This study did not differentiate between NYHA class I and II
and therefore inference as to QOL status cannot be extrapolated. Assessing the QOL of
patients with CHF as measured by the LHFQ, within the context of the three domains of
Wenger’s model, helps to evaluate the perceived HR-QOL of patients with CHF as
demonstrated in this study.

Discussion of Unexpected Findings

Interesting findings were discovered with this study between those with CHF and
diabetes, and those with CHF without diabetes. In this study, those with diabetes and
CHF had a statistically significant lower QOL than those subjects with other
comorbidities. However these results need to be interpreted with care. The number of

38

individuals with diabetes in this study was small (n=64), and there were a few extreme
outliers which skewed the results within this cohort of subjects. Extrapolation of these
finding must be with caution and must be done within this studies context. However,
these findings bear note of significance for future study. Perhaps this is a unique group of
patients that behave differently or experiences a different QOL than those without
diabetes.

Several medications have been touted to improve specific symptoms of CHF.
Analyzing the results of medications and QOL have shown some interesting secondary
results in this study. There were no individual drug interactions recorded between the
men and women across the NYHA classification. These findings may be related to the
variety of medications in each classification that were prescribed for this study group.
Having few subjects take a specific drug in each NYHA class, may account for the lack of
significant findings. Whether the negative side effects of certain medications outweigh
the benefits, or whether they impact the subject’s QOL, bears further investigation.

As a secondary analysis with this study, ejection fraction was found to have little
correlation with QOL or with the physical and emotional subscales. This is an interesting
finding and one that deserves additional exploration. Perhaps QOL cannot be measured
nor predicted by the functioning of the myocardium.

Ejection fraction and NYHA classification are different and separate ways to
characterize disease severity. NYHA classification relates to QOL, while EF did not
relate to QOL. The NYHA classification and the QOL measurements both use symptoms
in their classifications, while EF is based on physiological functioning of the heart. These
results question the significance of using EF to quantify the QOL in people with CHF.

39

Study Limitations

A major limitation in this study was the retrospective analysis design. The
retrospective examination was limited by the data available for analysis. Data was
collected from the information available in the medical charts, but cannot be construed as
inclusively allowing insight into the subject’s QOL with CHF. Incomplete LHFQ
questionnaires by study subjects also presented a limitation. Blank answers on the LHFQ
were recoded with the mean score of each question for the analysis. Mean scores were
used to replace blank questions to avoid an inadvertently false lowering of the total LHFQ
scores for those with missing items.

This study sample predominately consisted of a Caucasian representation. The
retrospective design limited the ability to control for ethnic representation consistent with
the community. Perhaps this congestive heart failure clinic, due to its location in the
community, caters to a primarily Caucasian ethnicity. Perhaps other ethnicities in the
community are more equally represented at other heart failure clinics or in the primary
care setting.

Although not a part of the study design, the underrepresentation of other ethnic
groups in this heart failure clinic may signify the need to address minority barriers to
healthcare access. Results of this study can not be extrapolated to the general population
or to other race categories, based on the exclusive Caucasian representation of this study.

Because of the retrospective design of this study, the measurement of QOL was
limited by the use of only one questionnaire. Using an additional tool to measure QOL in
conjunction with the LHF Q might add additional information for future research. A
prospective, longitudinal design using a representative sample of equal numbers of men

40

and women in each NYHA class would also yield more sensitive information to change
over time with QOL. Use of time as an additional variable may yield results in how QOL
is affected for men and women with CHF over time.

Implications for Education and Research

Future research should be aimed at a prospective longitudinal design with
representative samples of men and women in each NYHA firnctional classification,
including separation of NYHA classes I and 11. Women historically have been excluded
from many studies with CHF, until recently. Future research must include representative
study of both men and women with an ethnic mixture, across all levels of socioeconomic
status. Use of a longitudinal design might uncover gender or ethnic interactions over time
between CHF and QOL.

Additional studies should be designed to control for length of disease. Differing
length of diagnosis with CHF may show interactions between men and women in how
they perceive their QOL over time.

Highly reliable and valid measurement tools must be used for this population in
study which show subtle differences and which measure all aspects of QOL. Use of
multiple standardized measurements would facilitate comparisons among subjects in
different population groups. Measurement of QOL should be attempted with a battery
approach of questionnaires without undue burden on the respondents. Perhaps using a
battery approach study design including the LHFQ, subtle differences between men and
women may be discovered. Then interventions tailored to the needs of those with CHF
may continue to be developed to increase their QOL. Perhaps measuring QOL with more
than one measurement tool may further delineate previous findings that there are gender

41

differences in QOL with CHF. This would be consistent with other research findings
showing gender differences in QOL with CAD.

Another area, which bears further investigation, is the cohort of persons with both
CHF and diabetes. Perhaps this is a unique group of patients that behave differently or
experience a different QOL than those without diabetes. Future research should also
analyze this cohort to see if other study yields similar results. Using multiple standardized
measurements would facilitate and support other diabetic studies and comparisons across
comorbities.

An additional issue in need of investigation is the impact of caregivers on QOL.
This study did not show significant differences between the married and unmarried
individuals. Perhaps marital status is not a sensitive measurement as it does not include
significant others, other family members, or paid caregivers. A more inclusive inquiry
into caregiver status may uncover gender interactions related to CHF and should be built
in to future study designs.

Implications for Primary Care Practice

Future studies should be done using the primary care setting for the study sample.
Studying the population of patients with CHF in the primary care setting may yield
important information regarding practice patterns and treatment between those treated in
a heart failure clinic setting and those treated in primary care. Perhaps inquiry into the
primary care setting might yield crisis points of trajectory into care of the patient with
CHF.

QOL is a measurement based on a person’s perception of their condition and
symptoms. It is a highly subjective and multidimensional term, which cannot be directly

42

quantified. It can be indirectly measured with validated questionnaires to yield highly
reliable information (Martin & Stockler, 1998). With this study’s results of EF not
correlating with QOL, perhaps treatment should continue to be tailored towards symptom
alleviation with the CHF population, since QOL is a measurement of the patient’s
perceptions.

Studying men and women with CHF in the primary care setting might also help
further evaluate the reliability of the NYHA functional classification system. Further
clarity of this classification tool is desired to allow health care providers to communicate
CHF status more objectively. Perhaps studying this group of patients in the primary care
setting will stimulate inquiry into the classification of disease severity that is currently
used with CHF management.

Gender specific inquiry will further identify treatment aimed specifically at men
and women with CHF. Studying men and women in the primary care setting will further
test the use of the Wenger theoretical framework with this population. Perhaps due to the
methodological constraints of this study, the Wenger model had difficulty tapping into the
constructs with this sample. Perhaps further study within the primary care setting will
reveal clarity.

Patients with CHF regularly describe poor QOL, and the mortality from this
disease is staggering (Konstam et al., 1994; English & Mastrean, 1995). Increased
knowledge of gender specific QOL issues related to CHF impacts direct patient care. It is
imperative that as the number of people with CHF increase with our aging population,
continued inquiry into CHF is encouraged in order to mold our public policy of health
promotion and disease prevention to maximize the individuals QOL.

43

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