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RUTH MAIR CLEMENT
ST08004858
CARDIFF SCHOOL OF
SPORT
UNIVERSITY OF WALES
INSTITUTE CARDIFF
‘HOW IN THE VIEW OF EXPERTS CAN
EXERCISE BE USED, IN COMBINATION WITH
EMERGING TECHNOLOGIES TO IMPROVE
THE QUALITY OF LIFE OF CHRONIC HEART
FAILURE SUFFERERS?’
TABLE OF CONTENT
ACKNOWLEDGEMENTS
I
ABSTRACT
II
CHAPTER I INTRODUCTION
1
1.1 Introduction
2
1.2 Aim of Thesis
2
CHAPTER II LITERATURE REVIEW
3
2.1 Introduction
4
2.2 Definition and Diagnosis of CHF
4
2.3 The Impact of CHF
5
2.4 The Benefits of Exercise on CHF
7
2.5 Current Treatments of CHF
2.5.1 Pharmacological Therapies
2.5.2 Surgery
2.5.3 Mechanical Support
9
9
11
12
2.6 Emerging Technologies for the Treatment of CHF
13
2.7 Rationale and Purpose of the Present Study
14
CHAPTER III METHODOLOGY
16
3.1 Introduction
17
3.2 Participants
18
3.3 The Approach
3.3.1 Interviews and the Interview Guide
3.3.2 The Focus Groups (Phases 2, 3 and 7)
3.3.3 The Pilot Study- Phase 3
19
19
21
21
3.4 Interview Procedure
24
3.5 Data Analysis, Reliability and Validity
25
CHAPTER IV RESULTS AND DISCUSSION
27
4.1 Introduction
28
4.2 Wales and Chronic Disease
29
4.3 Current Treatments of CHF
29
4.4 Exercise and CHF
31
4.5 Emerging Technologies and CHF
32
4.6 Combining Exercise and Emerging Technologies
36
4.7 Impact on QOL and the Future
39
4.8 Main Findings
43
4.9 Practical Implication
43
4.10 Strengths and Limitations
44
CHAPTER V CONCLUSIONS AND FUTURE WORK
45
5.1 Conclusion
46
5.2 Future Work
46
LIST OF REFERENCES
47
APPENDICES
64
LIST OF TABLES
4
TABLE 1: THE NYHA CLASSIFICATION OF HF.
TABLE 2: SIDE EFFECTS OF ACEI’S, DIURETICS AND BETA-BLOCKERS, AHA (2009B).
10
TABLE 3: CURRENT SURGICAL PROCEDURES FOR THE TREATMENT OF CHF (NHS
CHOICES, 2010 CLELAND).
11
TABLE 4: CURRENT MECHANICAL SUPPORT DEVICES FOR THE TREATMENT OF CHF
(EDUARDO AND FERREIRA, 2003).
12
TABLE 5: PARTICIPANTS USED IN THE RESEARCH STUDY.
19
TABLE 6: THEMES INCLUDED IN THE INTERVIEW GUIDE.
20
TABLE 7: MODIFICATIONS AND CHANGES MADE TO THE ORIGINAL INTERVIEW GUIDE. 23
TABLE 8: PROCEDURES AND STRATEGIES USED TO ENSURE AN EFFECTIVE INTERVIEW
(TAYLOR ET AL., 2006B).
24
LIST OF FIGURES
FIGURE 1: COMPARISON OF A HEALTHY HEART (LEFT) WITH AN ENLARGED HEART
(RIGHT), SHOWING A NOTICEABLE THINNING OF THE MUSCLE WALLS (CALON
CARDIO TECHNOLOGY, 2011).
5
FIGURE 2: EMERGING LVAD (CALON CARDIO, 2011).
13
FIGURE 3: PLAN ADOPTED FOR RESEARCH STUDY.
17
FIGURE 4: A TAG CLOUD OF ALL TRANSCRIBED INTERVIEWS, USED FOR ILLUSTRATED
PURPOSES ONLY (TAGXEDO, 2011)
28
ACKNOWLEDGEMENTS
It is a pleasure to thank those who made this thesis possible.
First of all, thank you to my supervisor Dr.Rich Neil for his guidance and support
throughout the course of the study.
Thank you also to Dr Mike Kiernan and Dr Daniele Doneddu for their
encouragement and support from the preliminary to the concluding end.
It is furthermore an honour and a pleasure to thank those who, so kindly, gave up
their time and effort to participate in this study.
And, last but certainly not least, thank you to my Mam and Dad for their love and
support, not only through this thesis, but through the three years at UWIC.
i
ABSTRACT
Wales has a high incidence of chronic disease and current indications suggest
that this is likely to increase. Chronic heart failure (CHF) is a problem that has a
direct impact on the quality of life (QOL), morbidity and mortality of the population
of Wales, the UK and globally. In Wales alone, 32,000 cases of CHF are
diagnosed each year. Current technology offers no cure for CHF; at best it slows
down the development and progression of the disease. Scientists are developing
new treatment modalities, which may cure CHF and improve the QOL of the
sufferer. Traditionally, individuals with CHF would be encouraged to rest but,
increasingly, researchers have observed that appropriate exercise can positively
affect the physiology and psychology of CHF patients.
This research seeks to answer the question ‘How in the view of experts can
exercise be used in combination with emerging technologies to improve the quality
of life of chronic heart failure sufferers?’ The research is a qualitative study which
interviews a range of experts in the field of CHF. It allows an understanding of how
experts perceive the efficacy of current treatments, the emerging treatment
candidates and how those new technologies maybe combined with exercise to
impact positively on the QOL of the suffers.
The ten experts interviewed were a combination of practicing clinicians,
technologists and research academics. Their views demonstrated a high degree of
unanimity, leading to the conclusion that ‘experts believe that exercise can be
used in combination with emerging technologies to improve the QOL of CHF
patients, through the use of left ventricular assist devices and stem cell therapy’.
However, the experts also held the unanimous view that a great deal of research
was needed in this field in order to define the correct exercise programme and
treatment in order to tailor to the need of individual circumstances. The project has
led one group of researchers to review their plans, and incorporate the findings of
this study into their future research programmes.
ii
“Don’t worry about your heart,
it will last you as long as you live”
W.C.Fields, 1880-1946
CHAPTER I
INTRODUCTION
1.1 Introduction
There is a reported high incidence of chronic disease within Wales, and
demographic trends suggest that these are likely to continue increasing in the
future (Pritchard et al., 2006). Consequently, the Royal Pharmaceutical Society of
Great Britain (RPSGB, 2008) stated that the burden placed upon the National
Health Service (NHS) is substantially growing and difficult to sustain, improving
the way in which chronic conditions are managed in Wales is therefore vital.
Among chronic disease, chronic heart failure (CHF) is a serious problem in Wales
with an estimated 32,000 cases of heart failure (HF) diagnosed each year and
96,000 sufferers in need of ongoing care (Blenkinsopp et al., 2004). Approximately
10,400 people in Wales and England die each year from the condition. Not only is
there a problem with morbidity rates, the annual cost of HF on the NHS, in the UK
exceeds £625 million (Petersen et al., 2002; RPSGB, 2008).
Several authors have highlighted the positive impact that an exercise regime could
have on both the prevention of chronic disease, and the quality of life (QOL) of the
chronic disease sufferers (Colberg and Grieco, 2009; Moy et al., 2009; Yung et al.,
2009). In addition, new technologies are emerging for the treatment of CHF, with
the aim to reduce symptoms, delay progression of the disease and extend and
improve the QOL of the sufferer (Petersen et al., 2002).
1.2 Aim of Thesis
Through the view of medical and technological experts, this project will investigate
whether these technologies will offer new opportunities for combining emerging
technologies
with
exercise
to
improve
2
the
QOL
of
CHF
sufferers.
CHAPTER II
LITERATURE
REVIEW
2.1 Introduction
The aim of this review is to critically analyse existing literature encompassing
exercise/physical activity (PA), emerging technologies/treatments and their effects
on the QOL of CHF patients. The chapter will be separated into six sections:
Definition and Diagnosis of CHF, the Impact of CHF, the Benefits of Exercise on
CHF, Current treatments of CHF, Emerging technologies for the Treatment of
CHF, and the Rationale and Purpose of the Present Study.
2.2 Definition and Diagnosis of CHF
Experts have defined CHF as a very complex and multi-dimensional clinical
syndrome (Mann, 2004). According to Pina et al. (2003, p.2) ‘heart failure may be
defined as the inability of the heart to meet the demands of the tissues, which
results in symptoms of fatigue or dyspnoea.’ CHF sufferers also experience the
loss of functional capacity, which is a very important marker of the prognosis. The
New York Heart Association (NYHA) classification is widely used by physicians to
determine the extent of this functional loss, and is also very useful in determining
the best course of therapy for the CHF patient (Raju, 2003). The NYHA classified
HF into four categories based upon the severity of the symptoms (see Table 1).
Table 1: The NYHA Classification of HF.
CLASSIFICATION PATIENT SYMPTOMS
Class I (Mild)
Class II (Mild)
Class III (Moderate)
No limitations of physical activity. Ordinary physical activity does not
cause undue fatigue, palpitations, or shortness of breath.
Slight limitation of physical activity. Comfortable at rest, but ordinary
physical activity results in fatigue, palpitations, or shortness of breath.
Marked limitations of physical activity. Comfortable at rest, but less than
ordinary activity causes fatigue, palpitations, or shortness of breath.
Unable to carry out any physical activity without discomfort. Symptoms
Class IV (Severe)
of cardiac insufficiency at rest. If any physical activity is undertaken,
discomfort is increased.
As indicated by the NYHA classifications, the inability to perform exercise without
discomfort maybe one of the first symptoms experienced by CHF sufferers, and
4
therefore exercise intolerance is directly linked to the diagnosis of the disease
(Pina et al., 2003). CHF is also characterised by symptoms such as anxiety,
shortness of breath, confusion, fatigue and signs of fluid retention such as ankle
swelling (Dickstein et al., 2008; Hwang et al., 2010). These symptoms are due to
the ventricle enlarging as a result of the strain put on the heart, with
accompanying thinning of the muscle walls and subsequent enlarging of the heart
(Braunwald, 2008). Figure 1 illustrates the difference between an enlarged,
congested heart (CHF) and a normal, healthy heart.
Figure 1: Comparison of a healthy heart (left) with an enlarged heart (right), showing a
noticeable thinning of the muscle walls (Calon Cardio Technology, 2011).
2.3 The Impact of CHF
CHF is the end result of many cardiovascular disorders with a poor prognosis.
This means that the disease is rapidly worsening, and the likelihood of the
patient’s life coming to an end is increased (Nicholson, 2007). Several authors
have reported that 30-40% of patients diagnosed with CHF die within a year, and
45-75% of individuals at 5 years are at an increased risk of sudden death (Cowie
5
et al., 2000; Marcolina, 2009; Selman et al., 2007). Dickstein et al. (2008) stated
that the lifetime risk of developing CHF is 1 in 5, with incidence increasing steeply
at the age of 75 years.
In addition to high mortality and morbidity rates, CHF patients have a seriously
impaired QOL as pain becomes an increasing and significant problem (Flynn et
al., 2009; Selman et al., 2007). According to the British Heart Foundation (BHF,
2004) the QOL of individuals with CHF is very poor compared with individuals
suffering from other chronic conditions. The BHF (2004) report also stated that
QOL in people with CHF decreases considerably as the severity of the disease
increases. Individuals cannot carry out simple activities due to the physical and
social limitation caused by the disease, resulting in hospital admission becoming
recurrent (Archanga and Gray, 2002).
Hospital admission is increasing among CHF patients and is predicted to rise by
as much as 50% over the next 25 years. The cost of CHF patient consultations
has been estimated at £45 million per year, accounting for a total of 1 million inpatient bed days (The National Collaborating Centre of Chronic Conditions, 2003).
Hospital and general practice (GP) visits mean that more CHF patients are absent
from work and are unlikely to be employed with resulting significant associated
costs to the UK economy (Petersen et al., 2002).
Hypertension, atrial fibrillation, obesity and diabetes are known to be some of the
more frequent aetiologies of CHF (Marcolina, 2009; Petersen et al., 2002).
According to Dickstein et al. (2008) coronary artery disease is also a very common
aetiology of HF, being the initiating cause in 70% of patients. In addition, many
studies have recognised a relationship between a high body mass index (BMI)
and the development of CHF. Horwich et al. (2001, p.789) highlighted a strong
relationship between BMI and HF, stating that ‘obesity is regarded as a significant
risk factor for cardiovascular disease and has also been linked to the development
of heart failure.’ This relationship was again acknowledged by Lavie et al. (2004)
and Poirier et al. (2006) who reported a close relationship between obesity and
the development of CHF. Specifically, they stated that obesity may have many
adverse effects on cardiac complications and function.
6
Patterns of today’s living have channelled Wales into an increasingly obese and
sedentary existence, and, physical inactivity is the most prevalent risk factor
(American College of Sports Medicine, 2006). Recent statistics from the Welsh
Health Survey (2008) show that 62% of men and 53% of women are classified as
being obese, with the magnitude increasing to 72% and 62% among 45 to 64 year
old individuals. Statistics for children are even more worrying, with the Health
Behaviour in School-aged Children Study (2006) and the Millenium Cohort Survey
finding that Welsh children have among the highest obesity levels in the
participating European and North American countries (Obesity Pathway, 2010).
As alluded to earlier, obesity significantly increases the risk of developing CHF
(Marcolina, 2009; Poirier et al., 2006; Wilmore et al., 2008). Obesity may
predispose the individual to CHF through different mechanisms that include:
increased total blood volume, increased cardiac output and left ventricular
hypertrophy (Poirier et al., 2010). With obesity levels in Wales being unacceptably
high, and the relationship between obesity and the development of CHF being so
close, it is thought that levels of HF will rise dramatically over the next 25 years
(Pritchard et al., 2006).
2.4 The Benefits of Exercise on CHF
Despite the documented relationship between obesity and the development of
CHF, it has been acknowledged that obesity, and the associated risk factors, can
be improved through physical activity (PA) and the pursuit of physical fitness
(Guilder et al., 2005). Studies of lifestyle interventions have found that combining
moderate weight loss with increased PA reduces the incidence of chronic
conditions by up to 50-58% (Obesity Pathway, 2010).
Traditionally, individuals suffering from CHF were recommended to rest due to
cardiac de-compensation (Hambrecht et al., 2000). This approach has however
been reviewed and reconsidered by scientists and medical practitioners over the
years. Guidelines developed by the American Heart Association (AHA, 2009a)
advise individuals with HF to perform thirty minutes of moderately-vigorous
exercise five or more times per week. There is an increasing consensus that
7
exercise training can improve the functional capacity, and improve the QOL of
CHF patients, with relatively few complications (McKelvie, 2008; O’Connor 2009).
Further studies have established that exercise is an effective part of CHF
management. Hambrecht et al. (2000) provided evidence that exercise training
has the potential to improve the QOL of CHF patients, they also suggested that
exercise has the potential to improve left ventricular stroke volume and reduce
cardiomegaly, ultimately decreasing the size of the heart. This view is supported
by a significant number of other researchers in the field (Chien et al., 2008;
Koukouvou et al., 2004; Smart and Warwick, 2004). McConnell et al. (2003) stated
that patients with HF respond positively to exercise, as it increases their
respiratory muscle endurance, and peak oxygen consumption (VO2peak). These
improvements are possibly related to increases in the blood flow through the
heart, in particular the ventricular chamber filling rate, and decreases in the
peripheral resistance. Findings from Pina et al. (2003) highlighted that exercise
training can improve VO2peak by as much as 12-31% by improving endothelial
function and oxygen extraction in the periphery. In addition to these findings,
Marcolina (2009) suggested that through exercise, HF patients can rely on
improvements in pulmonary-mediated oxygen functioning.
The potential influence of PA on the QOL of CHF patients was further examined
by Koukouvou et al. (2004) who showed that exercise training in patients with CHF
can diminish their depression and anxiety, improving QOL. The study highlighted
that gains in physiological response in trained patients showed a strong positive
correlation with initial levels of depression. McKelvie (2008, p.9) concluded that HF
patients can improve their symptoms, and hence QOL, through the physiological
effects of exercise, the authors state that through exercise; ‘there is reasonable
expectation that there will be a reduction in mortality and morbidity.’
The AHA recommends that people with HF should add resistance training to their
exercise program in order to improve cardiovascular health (Williams et al., 2007).
Studies have shown that resistance training can improve muscle strength and
VO2peak, which most importantly can improve the QOL of the patient by allowing
them to breathe freely (Levinger et al., 2005; Yeh et al., 2003). There is also some
evidence that a combination of strength and endurance training can improve
8
exercise tolerance, reverse skeletal muscle histochemical abnormalities, and
enhance blood flow, which may ultimately lead to an increased QOL for CHF
patients (Belardinelli et al., 1999; Coats et al., 1992; Degache et al., 2007).
While there is currently no cure for CHF, many studies arrive at a similar
conclusion, namely that exercise training is safe and deeply beneficial for the
treatment and QOL of the sufferers. Smart and Warwick (2004) agreed by
highlighting that exercise should be part of the standard treatment of HF patients.
Therefore, exercise may play a very important role in prevention, and improving
the QOL of the CHF patients as a secondary prevention.
2.5 Current Treatments of CHF
Improvements in QOL and the chance of recovery for CHF patients is not
something that is possible with exercise alone. Many treatments have been used
to manage CHF including: pharmacological therapies, surgical intervention and
mechanical support devices (Swedberg et al., 2005).
2.5.1 Pharmacological Therapies
The main pharmacological therapies used by physicians for the treatment of CHF
are angiotensin-converting enzyme inhibitors (ACEIs), diuretics and beta blockers
(Anderson, 2001). These drug therapies have been known to help both survival
and symptomatology by improving ventricular function, increasing survival rate
and reducing congestion (Dickstein et al., 2008). Findings from McAlister et al.
(2004) and Swedberg et al. (2005) highlighted that ACEIs improve exercise
performance, QOL, and reduce hospitalization in patients with HF. Trials
conducted by Degenais et al. (2006) showed a reduction in adverse outcomes
related to HF through the use of ACEIs. The trials also showed that ACEIs
lowered the risk of admission to hospital due to HF by as much as 14%.
As well as ACEIs, diuretics are thought to be just as essential for the treatment of
CHF. When an individual has CHF there is an increased risk of fluid overload, and
diuretics are vital for reducing this by increasing urination. The reduction in fluid
helps to relieve the hearts workload and decreases the build up of fluid in the
lungs, ankles and legs (NIH, 2011; Swedberg et al., 2005). According to Faris et
9
al. (2002) diuretics decrease the symptoms of CHF and signs of pulmonary and
systematic venous congestion, allowing the patient to feel slightly better.
Another drug therapy used to manage CHF is beta-blockers (Dickstein et al.,
2008). Beta-blockers block specific receptors, which reduce the heart’s tendency
to beat faster; this lowers blood pressure, and allows the heart to beat at a slower
rate (AHA, 2009b). Hjalmarson (1997) described how the drug therapy
significantly decreases the risk of sudden death, data from 24 post infarction
studies showed an average of 20% mortality reduction over two years.
Despite previous research suggesting that these pharmaceutical treatments are
beneficial for the treatment of CHF, other studies have acknowledged serious
problems originating from these drugs. O’Connor (2009) stated that individuals
taking these supplements may suffer from dyspnoea and fatigue, reducing their
QOL. Findings by McMurray et al. (2005) showed that ACEIs occasionally cause
worsening of the renal function, symptomatic hypotension, and cough, thus
confirming a previous study by Rocca et al. (1999) who stated that ACEIs may
reduce sympathetic activity. They also showed that the drug may lead to a
potentially life-threatening complication, increasing death rate by 0.1-0.2%. Betablockers have been shown to cause worsening of HF, increase insulin resistance
and predispose patients to diabetes (Bangalore et al., 2007; Dickstein et al.,
2008). A large clinical trial of subjects who did not have diabetes showed the risk
of new–onset diabetes in patients on beta-blockers and diuretics. (Elliott and
Meyer, 2007). Other side effects of these drug therapies are shown in Table 2.
Table 2: Side Effects of ACEI’s, Diuretics and Beta-blockers, AHA (2009b).
MEDICATION
REPORTED SIDE EFFECTS
Cough, Kidney problems, Weakness, Low blood pressure and
ACEI
dizziness, Skin rashes, Altered sense of taste, Nausea,
Headaches.
Diuretics
Low blood pressure and dizziness, Poor kidney function, Loss of
potassium from the body (causing the individual to feel weak).
Decrease amount of oxygen circulating body (people become less
Beta-blockers
able to handle physical activity), Nausea, Weakness, Low blood
pressure and dizziness, Headaches,
10
2.5.2 Surgery
Surgery is also considered a valuable option for the treatment of CHF (Conaway
et al., 2003; Vaduganathan et al., 2010). Table 3 illustrates some of the current
surgical procedures. However, the final fallback approach when dealing with a
heart that is beyond repair is transplantation.
Table 3: Current Surgical Procedures for the treatment of CHF (NHS Choices, 2010
cleland).
PROCEDURE
Coronary Artery Bypass Grafting
Aortic Valve Surgery
Mitral Valve Surgery
Cardiac Resynchronization
Therapy
Pacemakers
Implantable Cardioverter
Defibrillator
DESCRIPTION
Blocked arteries are bypassed using transplanted
arteries thereby improving the blood supply to the
myocardium.
The damaged aortic valve is either repaired or
replaced by an alternative healthy or mechanical
valve.
The damaged mitral valve is either repaired or
replaced by an alternative healthy or mechanical
valve.
Both the left and right heart walls are electrically
stimulated to ensure the correct timing of the heart
contraction.
The electrical activity of the heart muscles is
stimulated through the use of either an internal or
external pacemaker.
In cases where heart arrhythmia is common an
implantable cardioverter defibrillator detects
irregularities and uses electrical stimulation to
correct the abnormalities in the beat pattern.
Heart transplantation (HT) is a major surgical procedure known to increase
survival, QOL and exercise capacity (Dickstein et al., 2008; Slaughter et al., 2009;
Taylor et al., 2007). In patients with end-stage HF, HT is the only therapy proven
to provide survival benefits (Mehra et al., 2006). Survival rates of HT candidates
have significantly improved in recent times, and in selected individuals the
procedure maybe considered a life-saving operation (Lietz et al., 2007; Taylor et
al., 2006a).
However, recently the popularity of HT has declined dramatically due to QOL
problems in patients, the limited number of donors and long waiting list, which
severely limits the number of HTs carried out annually (Furukawa et al., 2005;
Kikugawa 2000). Lietz and Miller (2007, p. 1282) stated that ‘at the end of 2005,
48% of heart transplant candidates had spent more than 2 years on the waiting
11
list, compared with 17% in 1993.’ As of April the 1st, 2007 to March 31st 2008,
there were only 65 new adult and 5 new paediatric heart donors listed on the UK
donor registry (British Heart Association, 2008; NHS 2008). In 2010 there were
only a 112 heart transplants carried out in the UK (NHS Blood and Transplant,
2011). Comparison of these figures with the 10,400 people in England and Wales
each year dying from the disease shows the current inadequacy of the approach
of HT in tackling HF on a wider scale.
The limited number of heart donors is not the only problem surrounding HT. The
procedure is associated with a low QOL due to several problems such as cardiac
denervation which causes limited exercise capacity, right ventricular failure due to
elevated pulmonary resistance, atherosclerosis and drug toxicities (Fukamachi,
2004). Transplant rejection (which is a reaction to donor antigents and can result
in significant graft coronary artery disease) is also a major problem for the QOL of
HT patients, causing one in four patients to die within five years post operation
(Butler et al., 2009; Lindenfield et al., 2004; Usta et al., 2009).
2.5.3 Mechanical Support
Mechanical support is where the function of the heart, namely the circulation of
blood, is either aided or replaced by a mechanical device implanted into the
patient or external to the body (Furukawa et al, 2005; Maryland, 2001). The most
common mechanical support technologies currently employed are summarised in
Table 4. The mechanical devices described however, are only intended for short
term support of the heart function. The most exciting, and potentially revolutionary
development in mechanical support is the introduction of Left Ventricular Assist
Devices (LVADs) which have been widely used as a bridge to transplantation
(Lahpor et al., 2010). These devices are discussed in detail in the following
section.
Table 4: Current mechanical support devices for the treatment of CHF (Eduardo and
Ferreira, 2003).
DEVICE
Intra-aortic balloon pump
Heart-Lung machine
Total artificial heart
DESCRIPTION
An inflatable balloon positioned in the aorta that reduces the
stress on the heart.
An external device that provides circulation and oxygenation of
the blood bypassing the heart.
Commonly an electro mechanical device that replaces the
diseased heart providing complete circulatory function.
12
2.6 Emerging Technologies for the Treatment of CHF
In terms of mechanical support, the major advancement in the treatment of CHF is
the LVAD. LVADs are essentially small electro mechanical pumps that support the
hearts own circulatory function thereby both increasing the blood flow to the
periphery and reducing the stress on the already damaged heart (Calon Cardio,
2011). Since 2000, a number of studies have shown the clear benefits of LVADs
in both supporting the ‘bridge to transplant’ or in many cases, providing an
elongated life time (Bourque et al., 20020; Lahpor et al., 2010; Pagani et al., 2009;
Westaby, 2010). Figure 2 demonstrates an emerging LVAD currently under
development in Wales.
Figure 2: Emerging LVAD (Calon Cardio, 2011).
In those cases where the individual does not meet the inclusion criteria for HT the
use of an LVAD is the only alternative that can provide sufficient support to keep
the patient alive. The use of LVADs have been shown to provide both an
13
immediate and significant improvement in cardiac output and organ functioning
whilst alleviating the symptoms of CHF, thereby increasing QOL (Fukamachi,
2004; Slaughter et al., 2009). Rogers et al. (2010) showed that patients with
NYHA class IV symptoms at the time of implantation had significant QOL benefits
within the first month of LVAD support with between 47-59% of the patients
reverting to NYHA class I or II within six months. Fan et al. (2010) reported that
between 1999 and 2009, 56 paediatric patients were fitted with LVADs as a result
of CHF, 12 patients showed sufficient improvement to enable the LVAD to be
removed following complete recovery of the patient’s heart.
The NHS in the UK and, the Centre for Medicare and Medicaid Services (CMS) in
the US have both recognized the obvious clinical benefit of LVADs in providing
improved QOL for CHF patients. The NHS fitted 122 LVADs to patients in
2009/10, and the CMS has recently published its rules relating to payments for
LVAD implantation, essentially allowing the US government medical insurance to
pay for CHF patients to have LVAD support (CMS, 2010; NHS national reference
2010). In essence, there is an emerging body of evidence supporting the use of
LVADs for CHF patients. This evidence clearly shows the physical and QOL
benefits for CHF patients, and both the UK and US health care providers have
identified that LVADs are more likely to be an important tool for the long term
management of CHF.
2.7 Rationale and Purpose of the Present Study
The published literature leads to the conclusion that CHF is a serious and
problematic disease that limits people’s life expectancy and QOL. Many
researchers agree that exercise can play a vital and positive role in the treatment
and QOL of CHF patients. Others have agreed that emerging technologies have
also the potential to improve the QOL of CHF patients and also increase recovery.
There is limited work however that seeks to establish the impact of the optimal
combination of exercise and emerging technology on the QOL of CHF sufferers.
No research has considered the views of medical and technological experts in the
field of chronic disease and CHF to understand the interrelationship between
exercise and emerging technologies. This is important as it will give insight into
14
how this combination could deal with CHF in the context of an increasingly obese
and sedentary society, and improve the QOL of CHF patients.
The purpose of this study is to review the opinions of experts in the field of
medicine and healthcare innovation, with an eye to future trends, and particularly
how these may impact on issues relating to the QOL of CHF patients.
15
CHAPTER III
METHODOLOGY
3.1 Introduction
A qualitative approach was implemented in order to address the purpose of this
present study. The author’s intention was to understand and describe the views of
experts in the area of CHF. A qualitative approach would allow the researcher to
understand how experts interpret their experiences, how they construct their
worlds and what meaning they attribute to their experiences (Merriam, 2009). A
qualitative approach was deemed the most suitable (Kvale, 2007).
Further, the study adopted a grounded theory approach due to its novel insight.
Grounded theory involves ‘the inquirer generating a general explanation of a
process, action, or interaction shaped by the views of participants’ (Creswell,
2007, p.63). Figure 3 illustrates the plan adopted for this research study.
PHASE 1- Literature Review
PHASE 2- Focus Group 1
PHASE 3- Pilot Study
PHASE 4- Focus Group 2
PHASE 5- Semi-structured Interviews
PHASE 6 - Transcription and Preliminary
AnalysisSemi-structured Interviews
PHASE 7- Focus Group 3
PHASE 8- Analysis and Conclusion
Figure 3: Plan adopted for Research Study.
17
The following section will describe the participants, the approach, the procedure,
and nature of data analysis used within the research study.
3.2 Participants
Given that this research sought to establish the opinions of experts, the selection
of participants was paramount to ensuring the validity and reliability of the
research (Bryman, 2008). The following criteria were applied to the choice of
participants:
1. The range of participants needed to be a balance of medical
practitioners/clinicians and technologists in order to get a wide variety of
views and opinions.
2. Participants needed to be both experienced and expert in one or more
of the following fields:
a) Clinical care of chronic heart patients;
b) Research in a field related to CHF;
c) Technology development in a field related to CHF.
Participants included in this study were three females and twelve males, all with
significant experience, expertise and highly qualified in fields of direct relevance to
the study. Table 5 describes the experts used in each phase of the study. In
phases 2, 3, 4 and 7, the same group of experts were utilized, whereas a new
group of experts participated in phase 5. This allowed the formal interviews to be
conducted with a truly independent group of interviewees, thus increasing the
reliability and validity of the research (Bryman, 2008). A brief CV of each
participant is included in Appendix A and example of the participant consent form
is included in Appendix B.
18
Table 5: Participants used in the Research Study.
PHASES OF RESEARCH
NUMBER
PARTICIPANTS
Phase 2- Focus Group 1
5
Researcher Scientific A (BP)
Researcher Scientific B (CA)
Researcher Scientific C (PH)
Academic Statistician A (TR)
Clinician A (MC)
Phase 3- Pilot Study
2
Clinician A (MC)
Researcher Scientific A (BP)
Phase 4- Focus Group 2
5
Phase 5- Formal Interviews
10
Clinician B (AR)
Clinician C (CW)
Clinician D (JMH)
Clinician E (LJB)
Clinician F (MW)
Technologist A (DD)
Technologist B (GF)
Technologist C (KF)
Technologist D (MNK)
Technologist E (RMC)
Phase 7- Focus Group 3
3
Clinician A (MC)
Researcher Scientific B (CA)
Academic Statistician A (TR)
Researcher Scientific A
Researcher Scientific B
Researcher Scientific C
Academic Statistician A
Clinician A (MC)
(BP)
(CA)
(PH)
(TR)
3.3 The Approach
3.3.1 Interviews and the Interview Guide
Semi-structured interviews were selected as the approach of choice due to the
nature of the research question under investigation. Indeed, a fully structured
interview guide would not allow an individual to develop an argument and a view
of issues relating to the research question. Equally, an unstructured interview
would not extract facts and views directly related to the research question, both
decreasing the reliability and validity of the study (Roberts and Iiardi, 2003).
Bryman (2008) described semi-structured interviews as allowing necessary
flexibility, thus enabling the interviewee a greater deal of leeway in how to reply,
providing more in-depth answers. This approach also took into account the
19
inexperience of the researcher since it allowed for guidance and structure in the
context of interviewing the elite (Lodico et al., 2010).
The interviewer had a list of questions and specific themes to be covered, referred
to as the interview guide, which structured the course of the interview relatively
tightly, whilst allowing for the possible exploration of topics of relevance as they
might have been raised by the interviewees (Kvale and Brinkmann, 2009). The
themes included are illustrated in Table 6.
Table 6: Themes Included in the Interview Guide.
THEMES INCLUDED IN THE INTERVIEW GUIDE
1.General views surrounding the prevalence of chronic disease and CHF in Wales
2.Current treatments of CHF
3.The potential effect of emerging technologies for the treatment of CHF
4. The effect of exercise on CHF
5. The effect of a combination of exercise and emerging technology on the QOL of CHF
patients/NHS.
The interview guide was initially developed by information gained from the
literature review and focus group 1 (phases 1 and 2) which allowed for a
comprehensive analysis of the literature , encompassing exercise/physical activity,
emerging technology/treatments and their effects on the QOL of CHF patients
(e.g. Dickstein et al., 2008; McAlister et al., 2004; O’Connor 2010). There is limited
literature surrounding the impact of the combination of exercise and technology on
the QOL of CHF patients. This allowed the author to design an interview guide that
would explore new concepts and directions. The output of this process was then
shared with the academic supervisor at the School of Sport of University of Wales
Institute Cardiff (UWIC) who made valuable suggestions for improvement. The
refined guide was then tested in a series of pilot interviews leading to a second
focus group before fixing the guide and moving into the formal interviews.
Certain fundamental principals were applied to the design of the interview guide.
Although the subjects were elite, the interviewer’s questions were designed to be
brief and simple in order to gain a specific and honest answer (Kvale and
Brinkmann, 2009). Introductory questions were included to set the tone of the
interview and for the information to be collected in an effective manner (e.g. ‘how
long have you been in the field of chronic disease? And, what is your experience
20
in the field of chronic disease?’). This would allow the researcher to build a rapport
with the interviewee before asking more specific questions (e.g. can you give me
an example of how exercise and emerging technology could be combined?)
(Taylor et al., 2006b).
3.3.2 The Focus Groups (Phases 2, 3 and 7)
This project represents the first entry of the author into the research world.
Therefore, the design of the interview study was critical and needed careful
planning. Focus groups were not only used as a source of valuable research
information, but also as a resource of much needed advice, guidance and support
(Bryman, 2008).
The first focus group (containing five participants) was held prior to the
development of the interview guide. The purpose of this focus group was to
enable the author to gain a degree of knowledge surrounding emerging
technologies and CHF and to gain confidence in the content of the interview
guide. Opinions from the experts varied widely highlighting the innovative nature
of the study, thus demonstrating the non-trivial nature of the research question.
This led to the drafting of questions which were to be the subject of consultation
with the project supervisor, and subsequent testing via a small-scale pilot study.
Following the completion of the pilot study a refined interview guide was presented
to a second focus group of the same individuals as those involved in focus group
1. The outcome of this second focus group reassured the researcher regarding
the suitability of the interview guide. Following the formal interviews and analysis
of the results a third focus group was held to debate the outcomes of the research
in order to validate the findings of the study. In order to capture the content of the
focus groups appropriately, an audio recording device (iPad, from Apple, Inc.)
equipped with commercial recording software (IproRecorder) were used.
3.3.3 The Pilot Study- Phase 3
The interview guide was tested in a small-scale pilot study, before being applied in
the formal interviews. The pilot study would allow the interviewer to gain
confidence in an interviewing environment, establish effective communication and
21
practice building a rapport with the participants (Denzin and Lincoln, 2000). In
order to capture the interviews appropriately, the interviews were recorded and
subsequently transcribed. Conducting a pilot study was crucial to assess the
feasibility and effectiveness of the method, and in detecting any problems within
the interview guide (Mackey and Gass, 2005). Feedback was obtained from each
interviewee regarding their perception of the content of the interview guide.
Modifications were made, with some questions being rephrased and others being
added. Probes were also included in order to build a rapport and to gain further
knowledge from the interviewees (Bryman, 2008). Detecting problems early meant
that issues could be addressed before the conduct of the main study. Table 7
demonstrates the changes made to the original interview guide between focus
group 2 (phase 4) and the semi-structured interviews (phase 5). The final draft of
the interview guide is included in Appendix C.
22
Table 7: Modifications and changes made to the original Interview Guide.
FIRST DRAFT QUESTIONS
REFINED DRAFT QUESTIONS
How long have you been in this field and
what is your experience?
How long have you been in the field of
chronic disease?
What is your experience in the field of
chronic disease?
Do you think that Wales is a ‘hot spot’ for
chronic disease and what has led you to this
conclusion?
Do you think that Wales is a ‘hot spot’
for chronic disease? If yes what has lead
you to this conclusion? If not, why do
you think people have this perception?
Do you think that the people of Wales
exercise as much as the people of other
countries and what has led you to this
conclusion?
Do you think that the people of Wales
exercise as much as the people of other
countries? What has led you to this
conclusion?
What do you know about CHF and incidents
of CHF in Wales?
What do you know about CHF? What do
you know about the incidence of CHF in
Wales?
Are you involved in the treatment of CHF,
and if so what is being done to help the
patients?
Are you involved in the treatment of
CHF? If so, what is being done to help
the patients? If not, what do you know
about the treatment of CHF?
Do you think that current treatments of CHF
are adequate?
Do you think that current treatments of
CHF are adequate?
What has led you to this conclusion?
REASONS FOR
CHANGE
Questions needed to be
separated in order to gain
two answers and added
information. The ‘field’
needed to be defined.
Questions needed to be
separated so that
participants would provide
an answer to each one, also
a question needed to be
added in preparation for a
‘no’ response.
Questions needed to be
separated so that
participants would provide
two answers and added
information.
Questions needed to be
separated in order to get two
answers and added
information.
Questions needed to be
separated to get two
answers. A question needed
to be added in preparation
for a ‘no’ response.
A ‘why’ follow up question
was needed in order to fully
understand the opinion of
the interviewee.
Have you been involved in a project
combining treatment of chronic disease and
exercise?
Have you been involved in a project
combining treatment of chronic disease
and exercise? Can you elaborate on
that? Can you describe a little more
about this?
Probes where needed after
the question in order to fully
develop participant’s
responses.
What in your view are the emerging medical
technologies and therapies, and which of
these are relevant to the treatment of CHF?
What in your view are the emerging
medical technologies and therapies?
Which of these are relevant to the
treatment of CHF?
Questions needed to be
separate to get two answers
and added information.
Do you think that exercise has a role to play
in the prevention and treatment of CHF?
Do you think that exercise has a role to
play in the prevention of CHF?
Do you think that exercise has a role to
play in the treatment of CHF?
Questions needed to be
separated to get two
answers and added
information.
Do you think that combining current
treatment and exercise would be beneficial
for CHF patients?
Do you think that combining current
treatment and exercise would be
beneficial for CHF patients?
Can you give me an example of how a
combination of emerging technologies
and exercise could be combined?
Asking the interviewee for
an example of this
combination gave practical
merit to the findings of the
research.
What could the impact of the optimal
combination of treatment and exercise be on
the quality of life of CHF patients and the
health service?
What could the impact of the optimal
combination of treatment and exercise
be on the quality of life of CHF patient?
What could the impact of the optimal
combination of treatment and exercise
be on the health service?
Questions needed to be
separated to get two
answers and added
information.
How would you measure the impact of
treatment on CHF patients?
An additional question was
added in order to give
practical merit to the
research.
23
3.4 Interview Procedure
The author attempted to ensure that all interviews were as effective as possible by
addressing certain standard interview procedures and strategies (See Table 8).
Table 8: Procedures and strategies used to ensure an effective Interview (Taylor et al.,
2006b).
PROCEDURES
STRATEGIES
Provide a comfortable and quite
environment
Every interview took place in a comfortable and quiet
location (e.g. home, office) to ensure silence and
privacy. Mobile phones were switched off in order to
build a rapport with the individual.
Interview commenced with a briefing in which the
interviewer defined the situation for the subject. The
research study was something that had never been done
before and this gave much reason to participate in a new
and exciting project.
Gaining as much knowledge as possible in the field of
chronic disease, exercise and emerging technology
showed the interviewees that the researcher was taking
a genuine interest. Introductory questions allowed for a
rapport to be build.
Explain purposes of the research
and give the interviewee a reason to
participate
Show interest in the interviewee and
build a rapport
Great care was taken to thank the individuals who had
generously given up their time.
Ask questions in a predetermined
order and professional manner
Check with interviewee where you
have any doubt about a response
Each interviewee was debriefed and will be provided
with a copy of the ultimate conclusions of the study on a
later date.
The sequence of the questions were the same for
everyone, however at times the interviewee had a
chance to head in a new direction and a few extra
questions or probes would be included (e.g. can you
elaborate on that point please?)
Probes were added in case of any confusion about a
response (e.g. can you repeat that please?, or Can you
elaborate on that please?)
In this particular study the interviewees were experts in the field. Given that the
researcher was an undergraduate and therefore less qualified and experienced
than the participants being interviewed, there was a danger that the interviewees
would be too kind to the researcher and tolerate the potential naivety, thereby
reducing the research impact of the interview. Elite individuals are used to being
asked about their thoughts and opinions. This meant that there was a danger that
they would repeat the information contained in their normal day to day ‘talk tracks’.
24
The aim of the project was to produce a meaningful research output, and making
sure that the author gained as much knowledge as possible about the topic of
concern was vital. The knowledge developed through a literature review allowed
the interviewer to gain a sound knowledge which was used to gain the respect of
the interviewees and to follow up the arguments (Kvale and Brinkmann, 2009).
3.5 Data Analysis, Reliability and Validity
The transcribed interviews were printed and read multiple times in order to
become familiar with the content. As a grounded theory approach, open coding
was utilised to some extent. Open coding assumes no initial list of codes or
categories; it involves starting the analysis with an open mind and with only some
broad initial ideas of the main research theme (Gibbs, 2007). A software-based
approach would give researchers the advantage of saving time. However a paperbased approach was adopted, providing the researcher with an opportunity to
develop a robust methodology (Bryman, 2008).
The initial focus group (carried out in order to explore the field) benefited from the
open coding approach, as it allowed the identification of themes within the main
research question to be identified (e.g. CHF in Wales, CHF and exercise and
current treatments of CHF). Having identified these themes, a thematisation was
then used for the formal interviews. In this regard, the author used a hybrid
approach; initially open coding to identify the interview guide, followed by the
pursuit of themes in the interview process (Gibbs, 2007).
It is essential to provide validity and reliability in qualitative research (Creswell,
2007). Extracts from the interviews were compiled and common opinions
identified. There is always the risk that findings from qualitative research could
suffer from lack of robustness (Bryman, 2008). Indeed, as the research theme is of
novel nature, the lack of similar studies prevented the author from adopting a
cross-case analysis with comparable studies. In order to ensure reliability, a
number of techniques were used, namely transcription checking and an innovative
use of experts. Respondents were offered the opportunity to view the transcribed
25
interviews in order to provide confirmation that the transcription was faithful to their
views and experiences; this provided a means of checking the accuracy of the
transcription (Bryman 2008; Creswell, 2007). Focus groups served the dual
purpose of supplying authoritative feedback, and validation of the work. This
allowed a neutral and un-bias view of the research, and its dynamic findings. In
addition, internal reliability and credibility of the conclusions of the data was met by
a review from an external innovative expert (focus group 3).
Throughout the study, the principal of reflexivity has been applied. Given that the
researcher had no exposure to this field prior to the study, and taking into account
the limited experience in comparison to the experts, it is reasonable to state that
biasing approaches to research has been minimised (Suchan and Brewer, 2000).
26
CHAPTER IV
RESULTS AND
DISCUSSION
4.1 Introduction
The aim of this research study was to identify if a combination of exercise and
emerging technology could benefit the QOL of CHF patients. This was achieved
by interviewing ten experts in the field of chronic disease. The research outcomes
are detailed in the following chapter (sections 4.2 to 4.7) and these findings will be
discussed in relation to previous research. Finally, the strengths, weaknesses,
limitations, future directions and practical implications of the study will be provided.
Figure 4: A tag cloud of all transcribed interviews, used for illustrative purposes only
(Tagxedo, 2011)
28
4.2 Wales and Chronic Disease
In general all participants agreed that Wales is a ‘hot spot’ for chronic disease, a
clinician stated that, ‘if you look at the districts of Great Britain you’ll find that
Wales is there with parts of Northern England and Western Scotland with the
worst there is in Britain [for chronic disability in the chest].’ Some of the causes of
this ‘hot spot’ were described by a second clinician as, ‘obesity, lack of exercise,
smoking, poor diet…’
The views of the experts reflect the findings of Pritchard et al. (2006) who also
agreed that Wales is a ‘hot spot’ for chronic disease and Poirier et al. (2006) who
reported a close relationship between chronic disease and obesity.
4.3 Current Treatments of CHF
All ten participants were in agreement regarding current treatments of CHF being
inadequate. A clinician stated that, ‘current therapy for heart failure is not a
treatment because a treatment would be defined as something that would actually
have a permanent benefit, and all current therapies do is to reduce the decline in
heart function.’ A chest physician agreed by reflecting that:
For many patients [current treatments] can be [adequate], those people with
some left ventricle disorder, the results can be very good. …the prognosis
for people with severe heart failure remains awful …the likelihood of death
in the next two or three years is really high …there is room for other kinds of
treatment.
The technologists were also of a unanimous view, typical responses were, ‘I think
current treatments are targeting [and] managing the side effects, but do not target
reversing the problem. I think current technology is all about management rather
than cure’ and:
No, [they are] absolutely not [adequate]. You’re on long term drug therapy,
you’re on diaphoresis, your lifestyle is significantly curtailed, and if you’re
29
one of the lucky ones ...to get a heart transplant you get the extra life, but
it’s a very small percentage…
These finding were consistent with the published literature. Specifically, Cleland et
al. (1999) reported that whilst there was a slight improvement in survival rates with
improvement in treatment, the mortality rate in HF sufferers range from 41% to
66%. MacIntyre et al. (2000) agreed by reporting a median survival of 1.47 years
in men and 1.39 in women following a principle diagnosis of HF. Friedrich and
Bohm (2007, p.630) referred to the management of end-stage HF, they stated that
‘...the progressive course of heart failure leads to death and the treatment of end
stage heart failure leads palliation.’
In addition to the efficacy of current treatments, issues of finance and
practicalities also emerged. HT for example was viewed as being expensive and
complicated, one technologist when referring to HT commented:
Number one the expense, obviously we being a social state the
government funds the treatment...even if the numbers of donors do
increase, the government have to be willing to fund the additional
operations, which they just can’t.
The cost associated with HT is significant. In 2009/10 the basic cost of the
procedure itself was reported to be £22,500 without taking into account the
prolonged hospitalization and on-going medication required (NHS Choices, 2010).
Taking into account the relatively short survival rate reported by McIntyre et al.
(2000) and Lietz and Miller (2007) that almost half of HT candidates are on the
waiting list for more than two years, the likelihood of prolonged survival following
HF diagnosis is severely limited.
In conclusion, current treatments of CHF are limited to dealing with
symptoms rather than giving permanent relief. The costs and availability of HT
procedures prohibits their uptake, leading to high mortality rates. There is a need
for new treatments that are efficacious, cost effective and available to all.
30
4.4 Exercise and CHF
There was unanimity of opinion as to the preventative role of exercise in the
development of CHF with all interviewees concluding that it has a positive benefit.
A clinician stated:
Absolutely, I think there huge amounts of evidence that supports the fact
that exercise can have a very positive effect on heart function... Essentially
it trains the heart to better cope with under variability…
A GP provided a similar response:
…your heart is a muscle, a pump, you have to exercise the muscle to keep
it working as best as it can. Your heart muscle does not stop from the day
you are born until the time you die. Common sense tells you you’ve got to
keep it going..
The technologists also agreed with a typical response along the following lines:
There’s ample evidence to suggest that undertaking relatively modest levels
of exercise gives you an overall improvement in your circulation system, in
the performance of your heart…I think [exercise] is critical.
This view was similar to that of Kruk (2007) who concluded that there is evidence
that PA is associated with enhanced health and decreased risk of several chronic
diseases. Nusselder et al. (2009) showed that high levels of PA were associated
with approximately 3.5 years gain in life expectancy and up to 1.3 year delay in the
onset of cardiovascular disease.
The views regarding the role of exercise in the treatment of CHF were again
consistent amongst the interviewees. A cardiologist stated:
Groups…have studied skeletal muscle metabolism and blood flow in
patients with heart failure randomly allocated to exercise programs. It
appears that in heart failure the more you do physically, the more you
become able to do …for those who have moderate symptoms, physical
activity seems to improve the symptoms.
31
The response from a chest physician was ‘in terms of the exercise for people with
established heart failure …they’ve got real benefits to gain and I think there are
both physical and psychological benefits of major importance to be derived.’
Ironically, the one demurring opinion was that of a technologist who stated ‘difficult
to say [exercise is] probably not [beneficial]. Most ...people who have got chronic
heart failure are pretty ill...you have no aspirations to be training them up, your
pleased that their alive.’ This view was however an isolated opinion, with another
technologist stating:
I think [exercise] does [play a role in the treatment of CHF], but I think it has
to be personalised to the individual …I think every case has to be taken in
isolation, understand what the patient is going through, understand what the
treatment regime is and then prescribe the exercise programme in
combination with other factors.
Interestingly a GP suffering from CHF responded with a resounding ‘yes’ to both
questions, agreeing that exercise can play a role in both prevention and treatment
of CHF.
The experts views correlates to Koukouvou et al., (2004) who analysed
both the physical and psychosocial effects of exercising. They concluded that
there were gains in both physical and psychosocial wellbeing of the patients.
O’Connor et al. (2009) also showed that patients with CHF who participated in an
exercise programme had a modest reduction in hospitalization and cardiovascular
mortality.
In conclusion, exercise has a clear role to play in the prevention and
treatment of CHF. However, there is a need for further research, in particular the
nature of the exercise and the individuals need, which may result in a more
personalised and tailored treatment approach.
4.5 Emerging Technologies and CHF
The researcher investigated whether the NHS could cope with the stress put on it
by the prevalence of CHF in Wales. Consistent views on this matter were
32
expressed by the participants. A clinician felt that,’...unless there’s fantastic
preventive medicine around certain areas such as obesity, diabetes and heart
disease that the system will become…stretched.’ A technologist expressed a
similar view, ‘…[the health service has]been over stressed …but science has to
develop a way of dealing with issues such a chronic disease…’.
A technologist also stated that:
One of the things that National Service could do is to support more
developments of personalised treatments which are more tailored to
specific groups of people, genetic groups and therefore can be much more
specific. ...certainly it will play a big part in future developments and the way
we will benefit from the health service as well.
In conclusion, chronic disease in Wales, including CHF, is placing increasing
pressure on the NHS. New sciences and technology has to play its part in easing
this pressure. However, the process by which new technologies are taken up
within the NHS can be a barrier to adoption as it is a lengthy process. Take for
example the NICE (2007) guidelines on the use of Cardiac resynchronization
therapy for the treatment of HF. The process to approve this guideline included
both a full clinical and financial review of the treatment with numerous participants,
committee reviews, and input from both industry and professional organizations
over a period of two years.
The next question sought to identify what the emergent technologies might
be. Two generic technologies emerged from the discussions. Firstly the role of
mechanical devices, more specifically LVADs, and secondly stem cell technology.
A clinician stated:
…Is it possible that stem cell technology could develop in the next fifty
years to the point where you could make a heart in a laboratory? Make it
well enough that it could go in as a muscular pump with a blood supply …It
might be easy just to say I don’t believe it now, but it’s always a question of
who knows, we have been to the moon.
33
A technologist speculated ‘for Chronic Heart Disease its mechanical support
which is a miniature heart pump that sits inside the heart to provide blood
circulation.’ Continuing on the same theme another technologist stated:
We live in an age where devices are smaller than ever before…we live in
the world of …tailored treatments for the genetic makeup of the individual
and stem cells may well become very major sources of new treatments, and
prevention.
In conclusion, two novel approaches are emerging as candidate solutions
for the treatment of CHF. They are miniature implantable pumps (LVADs) and
stem cell therapy. The literature on the use of LVADs shows a benefit in both
physical function and QOL. Pagani et al. (2009) reported the findings from a study
on patients urgently requiring HT who were fitted with LVADs. Of the 281 patients
enrolled, 222 survived to HT over a period of up to 3.1 years on LVAD support. In
turn, there was a dramatic improvement in QOL of the patients. If, as this study
shows, and as reported earlier by MacIntyre et al. (2000) the period of life
expectancy for CHF patients can be increased with LVAD support, the probability
of surviving to HT is doubled.
Whilst there is ample evidence on the benefits of LVADs, the case to
support stem cell therapy is not so clear cut. Pre-clinical trials have shown positive
benefits in suitable models used to represent genetic HF (Yamada et al., 2008).
However, the clinical evidence is less than conclusive, a review by D’Alessandro
and Michler (2010) on stem cells highlighted limitations to date. They did however
conclude that there is evidence to support the basic safety and efficacy of stem
cell therapy.
With respect to timescales for implementation of these technologies there
was a general consensus as to the urgency required. With 96,000 people with
CHF needing on-going care in Wales the clinical need is urgent (Blenkinsopp et
al., 2004). A senior research academic noted that:
We are on the verge of seeing these treatments coming to the
market…medication is very rigorously regulated… it takes years to get that
medication approved maybe ten years. ...if you take your own biological
34
material, and you give your own biological material back to yourself then
that isn’t medication, that’s transplant…autologous treatments…the world of
devices [and]...stem cells were I’m involved, both can come to the market
much quicker.
A research professor took a slightly more pessimistic view stating, ‘implantable
pumps, I suppose at the right scale that would happen in the next five years. Stem
cells…I suppose there’s a potential in the next ten years’.
Therefore, implantable pumps (LVADs) for the treatment of CHF may be
established within a five year time scale. Sharples et al. (2006) evaluated the
financial impact of LVADs, however their use is still not approved under the
National Institute of Clinical Excellence (NICE) framework. Stem cells may take up
to ten years unless they are autologous, in which case time scales may be
significantly reduced. Morgan et al. (2010) quoted ‘the cost of drug development
would be in the order of $883.6 million’. Even if the optimum approach does focus
on autologous treatment there are still complex regulatory considerations to be
taken into account. Wilson-Kovacs et al. (2009) highlighted the variations is
regulatory approaches adopted by countries within Europe.
It was interesting to observe that the question ‘When do you think that these
therapies have an impact on the treatment of CHF?’ was interpreted differently
amongst the interviewees. Approximately half of the participants took this to mean
when these technologies would mature to be used in patients. The other half
interpreted the question as meaning when in the progression of the disease in the
individual patient would the intervention best be placed. Both interpretations gave
valuable information. The ambiguity had not been identified during the pilot phase
and the questions were left unchanged for the full interviews.
A GP stated, ‘well it would be nice if they started quite early on in heart
failure really so that you don’t get to that grade which is no quality [of life] at all.’ A
technologist agreed:
[The] earlier the better, once you get to chronic heart failure, there’s four
classifications. If you can get mechanical support when they’re class one
there’s a high probability that they will never ever get to class two, or revert
35
back to normal. If you take stress off the heart they may recover. …it’s
pointless waiting till the end before they die to put it in, you’ve got to attack
earlier.
A technologist specializing in cardiac devices stated that, 'a pump obviously, as
soon as you switch it on this person’s got their blood flow back, so the [pump is]
work straight away’. These views were confirmed by a third technologist who
stated ‘you could treat that patient at a stage were the damage is still very limited
and there would be potentially more chances for the patient to recover completely
or to a higher level at least’.
These findings were in agreement with the firm opinions of the leadership of
Calon Cardio (2011) who shortly before the completion of this work were awarded
the UKTI –IBIZ award for the best emerging technology of 2011. This is an
independent validation of the potential impact of LVADs in the field. It was
apparent that the sooner the future technologies are introduced to the treatment
protocol of the CHF patient the better. For the first time heart damage may be
reversible.
4.6 Combining Exercise and Emerging Technologies
Nine out of the ten interviewees were in agreement that combining current and
emerging technologies with exercise would be beneficial for CHF patients. A
technologist stated that:
…there are safety issues, there’s a need to make sure that the exercise is
tailored to the individual, and that the individual must be educated to watch
for irregular events …I think current technologies can be combined with
exercise to treat chronic heart failure.
This view was confirmed by a second technologist who commented:
Yes [this combination would be beneficial]. Exercise has such a benefit
overall in terms of weight loss, in terms of blood pressure, in terms of
stress on the heart, all of these factors will have an impact on the quality of
life, and obviously the length of life.
36
However, one technologist took a more pessimistic view regarding this
combination quoting that:
It’s all about prevention from the exercise point of view, it’s about preventing
the cardiovascular disease that then could go on to become heart
failure….but once someone’s developed heart failure I think forget it, you’re
just trying to keep them alive.
Therefore, combining exercise and emerging technologies can benefit CHF
patients. However, exercise must be tailored and personalised to each individual.
The participants came up with a variety of different ideas and suggestions
as to how emerging technologies and exercise could be combined. The response
from a clinician was:
…If a patient with serious heart failure was to get an implantable pump
what should result is a substantial increase or significant recent cardiac
output and then the potential for exercise tolerance. ...all of a sudden they
work hand in hand. As soon as that increase in cardiac output is achieved,
the possibilities of taking more exercise [is] there, and .benefits come from
that psychologically and then physically…as the heart improves and the
patient is able to take more exercise they become fitter in general, their
respiratory systems are in better shape, their muscles are in better shape…
A second clinician commented:
…I think that what you would do is treat the patient with our therapy (stem
cells) and then immediately as their heart begins to regenerate you would
take very strict control of their ...cardiovascular exercise ...I think you have
to be quite careful, what you’re looking for here is not exercise where your
taking the heart rate above 60% of the vo2 max ...what you want to do is to
do exercise with the patients in to range of about 60% of their peak [Vo2
max]. Essentially then you’d be looking at exercise for 45 or 35 minutes of
walking or very slow jogging….you’ve got an 84% benefit in that and then
you’ve also got a 13% reduction in mortality, it shows significant benefit.
A third clinician stated:
37
..by pumping blood back from the legs up in to the thorax, or by doing
something to the skeletal muscles it makes people who’s hearts are
ischemic, lacking in blood better. ...you’re doing something physical to the
patient’s legs that makes the heart better. That’s not like going to the gym,
but it wouldn’t be surprising if the same sort of thing happens when you do
go to the gym.
A technologist suggested that:
...if you can get class two heart failure patients, fit them with a device, they
can do the exercise, they can increase their overall level of health and who
knows three, six, nine months of a good physical regime …you could take
the heart device out …so if you can treat people with a pump, let them
exercise, take the pump back out, they may fully recover.
Another technologist came to a similar conclusion, stating that:
...a fitment of the pump …helps the heart to pump oxygenated blood around
the body. Providing your heart can take it, the combination of regular
exercise plus the pump has to be a good thing in theory. It should be done
and it’s been proven that we can do it, but the extent of how much exercise
I couldn’t comment on.
A third technologist described his suggestions on the combination:
...an example for me of how exercise could be combined, let us say that the
world of autologous stem cell treatment of heart failure emerges were if you
had heart failure you receive stem cells that are designed to correct that
heart failure, …which then has a direct impact on the activity of the heart,
which could have a direct impact on how stem cells imbed themselves in
the heart and how they grow in the heart. I think there is a lot to be learned
about how exercise and stem cell therapy link, and there’s a lot to be
learned about how to tailor the exercise to the specific case of the specific
individual.
In conclusion, exercise and emerging technologies could be combined in several
different ways. This study has shown that the two emerging candidate
38
technologies are implantable pumps (LVADS) and stem cell therapy. In the case of
LVADs, researchers have shown that resting the heart can result in an
improvement of the condition of the heart. Therefore, inserting a miniature LVAD in
a non-invasive approach, for a defined period can result in therapeutic benefits.
The vision for stem cell therapy is one were stem cells are extracted from the
patient and grown in a bio-incubator, cardio regenerative stem cell separated and
returned to the patient in an autologous approach. In principal this could lead to
improving, if not curing CHF.. Both of these approaches could benefit for being
combined with an exercise protocol. Emerging technologies offer additional
opportunity for combining exercise with the treatments of CHF delivering benefits
for the patient.
A third question was asked to all participants regarding the combination of
current and emerging technologies and exercise. As to whether or not the
development of emerging technologies would offer new opportunities for
combining treatment and exercise, all ten participants were in agreement. A
technologist stated, ‘…most definitely. Exercise does, I believe benefit the heart
and combining this with a pump or new technologies would only be beneficial for
all patients…’ This view was further extended by a clinician who stated:
There’s a very interesting study that was done at Harvard which showed
that exercise increases the body’s ability to produce stem cells… if you
exercise your body produces more stem cells, and therefore you can
regenerate your body better…we haven’t found it yet, but I think we’re going
to find that exercise increases the number of heart stem cells and as a
consequence you have better ability to regenerate the heart.
New technologies therefore, require different approaches for the combination of
exercise and treatment, and there is both a need and opportunity for further
research.
4.7 Impact on QOL and the Future
CHF has a dramatic negative impact on the QOL of a large number of patients
across Wales, the UK and indeed globally (Flynn et al., 2009; Selman et al., 2007).
39
It goes without saying that any new technology and treatment must have a
measurable and positive impact on that QOL. The final series of questions sought
to identify the potential impact of a combination of emerging technologies and
exercise on the QOL of CHF sufferers. A GP responded, ‘Well it could have an
amazing effect on the quality of life…it could be as normal. It’s important to the
person, if they can have a good quality of life, that’s the most important thing,
you’re health is number one.’ A clinician shared this view and added, ‘if you
include the psychological as well as the physical [the impact could be] really
substantial I think …and worthwhile pursuing.’ This view was reinforced by a
cardiologist who noted:
...you’ve got heart failure and you think bloody hell my life is over, failure,
it’s going to stop at any time. To show improvement in your condition, you
might have a heart that is failing, yet how can you’re exercise capacity be
improving, it can’t be that bad if you’re improving. You get peace of mind by
demonstrating what you can still do, and I think that awful feeling of lethargy
and tiredness might in some way improve, and if you can achieve those two
things you’ve done probably more than any tablet can do.
A technologist confirmed this conclusion with the statement:
Well heart failure has a dramatic impact on the quality of life of an individual
as your ability to breath freely…deteriorates and then your less… physically
active, you can less participate in activities and it becomes a downward
spiral. If you can slow down that progression, from phase one to...four, or
indeed reverse that, then you can reduce the discomfort, you can improve
the quality of life ...and you could actually force them up in a positive spiral.
I think it could have a dramatic effect on the physiological and psychological
wellbeing of individuals.
In conclusion, exercise can have a positive impact on the feeling of
wellbeing, hence the QOL of the CHF sufferer. In terms of how the health service
would adapt to the combination of emerging technologies and exercise, a
consultant clinician stated:
40
… the most important thing is that it will reduce the amount of cost the
health service would have because less people would have heart disease in
the first place. I think the value of public health measures is so profound
because it means that you can really start to see a massive return early
from your investment. The health service the more people you can prevent
from getting the disease in the first place, the better.
Again with a high degree of unanimity a technologist stated:
I think it could have a dramatic impact on the financial model of the health
service. If you can start to reduce the side effects, improve the quality of
life, and even partially or wholly cure some of these people, then the
financial impact and the reduction of burden on the health service could be
dramatic. Waiting times could be reduced, bed occupancy could be
reduced, but there are other impacts on the economy, impacts of lost time
in work…
A cardiologist agreed by stating:
…the impact might be positive in the sense that people can feel better and
less likely to go and see their doctors and use health service resources.
There’s a down side to all this, if by any chance it makes people live longer
that’s more years of tablets, more years of treatment, more cost…I think
most of us would say if you can make people feel better, and feel more
healthy then its worth some extra resource.
A clinician agreed adding that:
Its’ an interesting question and I think there might be two sides to it. First of
all I think it will demand more effort, more work, so you might say that’s
more of a burden on the NHS. If we get to the point afterwards that patients
are fitter, secondary prevention is more effective …prevention of further
events of the cardiovascular system like myocardial infarction in another
vessel. There should be gains in there for the health service,… your
spending and making the effort now to get people better and once they’re in
that better shape, they should be doing …better over that next set of years
in terms of the demand for admissions with worsening of the heart failure…
41
Therefore, the introduction of a combination of exercise and emerging technology
for CHF would introduce a new challenge for the NHS, but could deliver a
significant benefit to patient outcomes and service efficiency.
Finally, if these benefits are to be delivered then how could they be quantified in
easily measurable terms? The participants continued to come up with a variety of
different ideas with two clinicians stating, ‘I think I would do it through a quality of
life questionnaire’ and ‘by asking the patient how do they feel. That’s the most
important [thing] they will tell you straight; I feel great, I feel awful.’ A cardiologist
speculated:
I would do it by asking them generally to describe their life before the
diagnosis of heart failure, immediately after the diagnosis of heart failure,
before the exercise program and during or after it. I would want to ask their
partners ...the people that really know about their quality of life [are]…you
can have a person come back and say I’m doing a lot better, I feel
marvellous, and talk to the partner and they’ll say this person has become a
real pain to live with ... frankly he’s not the man I married. We’re not just
dealing with one person, we’re dealing with families.
A senior academic added:
You can measure their ability to undertake exercise, you can undertake
physical measurements you can scan the heart, you can measure blood
pressure, you can measure resting pulse, flow rates. But then there is a
whole spectrum of psychological benefits as well…state of mind, the
optimism, the happiness of these individuals…you can measure the impact
on their families. You must not forget that if a dear member of the family is
unwell, that has an impact on everybody in the family, and that in itself
could create a positive spiral of benefits.
The current common practice focuses the attention on the patient itself using
standardised QOL questionnaires such as EQ-5D and the Minnesota Living with
Heart Failure (Dyer et al., 2010; Calvert et al., 2005). However, neither of these
approaches take into account the impact of CHF on those close to the sufferer, as
42
suggested by the expert responses. Therefore, a holistic approach should be
taken to measure the impact of these treatments on the QOL of CHF patients.
4.8 Main Findings
The main findings of the study are:

Wales is a ‘hot spot’ for chronic disease and CHF;

Current treatments of CHF are inadequate;

Exercise can benefit the prevention and treatment of CHF;

Emerging technologies are developing for the treatment of CHF;

Exercise and emerging technologies could be combined for the treatment
of CHF, increasing the QOL of the patients.
Experts were in a high level of agreement on these five key findings, however they
were also of the view that there is a need for new research in this field, that
research should focus in particular on the tailoring on the exercise regime to match
the particular needs of the individuals and their treatment protocol.
4.9 Practical Implication
This research study is ambitious and carries great aspirations towards offering an
initial platform for further research and thinking, as it deals with issues that are of a
regional, national and global scale. CHF is a global problem, and a significant one
to the NHS in Wales. Although it seems, at first, to be difficult to imagine that an
undergraduate project could have any practical impact on future clinical, technical
and policy-related research directions, it has nevertheless vividly brought the topic
to the attention of international researchers and research-led organisations. As a
result of being exposed to this research topic in their capacity as participants, a
number of these research leaders, with associated teams, are now planning to
develop this project and incorporate it into their own research agendas. Therefore,
main practical implications can be identified in its faceted role as, but not limited to:
a trigger for further basic as well as applied research on the subject topic; an initial
43
tool to inform methodologies and design of related ‘mixed’ (combining technology
with medicine and exercise) clinical and non clinical trials. This is in accordance to
the identified need for developing new methodologies in health research, as
identified by the UK’s Medical Research Council (MRC, 2011); a basis upon which
to carry out further patient-focused qualitative research studies, for example on the
views of chronic disease sufferers towards, and experiences of, exercise and all
the related implications. Section 5.2 in chapter 5 will expand on future research
directions.
4.10 Strengths and Limitations
There are some inherent strengths to this study. Firstly, it gained access to true
experts, who were clinical practitioners, medical researchers and technologists,
and in many cases ‘world class’. This allowed reflection of the most recent thinking
in the field of emerging technology and captured rich insight into the field of CHF,
which allowed a multi and inter disciplinary context to be achieved.
The remit of this work was to serve as the final project for an undergraduate
degree and has therefore been limited by the resources available (research
budget), the length of the report required and the time available to be allocated on
the project. This piece of work can (in the view of the researcher) be expanded
and leveraged upon to serve as the basis for a further research work, by
expanding and focusing on a number of topics originating from it. In Chapter 5, a
number of these research strains are suggested.
44
CHAPTER V
CONCLUSIONS
AND FUTURE
WORK
5.1 Conclusion
The aim of this research study was to answer the question ‘How in the view of
experts can exercise be used in combination with emerging technologies to improve
the quality of life of chronic heart failure patients?’
The research question has been answered in large part, ‘experts believe that
exercise used in combination with emerging technologies will offer a significant
improvement to the QOL of CHF sufferers’. This view was held by the vast majority
of experts interviewed. However, the experts also held the unanimous view that a
great deal of research was needed in this field in order to define the correct
combination of exercise and treatment tailored to the need of individual
circumstances. Indeed, the project has led one group of researchers to review their
plans, and incorporate the findings of this study in their future research
programmes.
5.2 Future Work
As new technologies emerge for the treatment of CHF, combination of these new
approaches with an appropriate exercise regime could benefit QOL, morbidity and
mortality of sufferers. It is therefore critically important that researchers engage with
this agenda to insure optimal outcomes. Based on a fundamental understanding of
the impact of new treatments on the physiology, new exercise regimes must be
designed. These regimes should be tested in ethically approved, clinical studies.
Patient cohorts undergoing treatments combined with exercise should be compared
with similar cohorts experiencing treatment alone. Building on these results refined
exercise regimes should be tested in combination with treatment methods. This
reflects a comprehensive and resource intensive series of studies. However the
potential prize is great and every effort should be made to gain a deeper
understanding, thereby delivering benefits to the QOL of hundreds of thousands of
sufferers.
46
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63
APPENDICES
APPENDIX A – Participants’ Curricula Vitae
Participant
AR
Qualification:
Medical Doctor
MBA
PhD
Field:
Medicine and Surgery
Biotechnology Business
Medical Devices Business
Position:
CEO and Company Director
Entrepreneur
Experience:
10yr+ medicine and surgery
10yr Corporate business development
5yr Biotechnology business
2yr assistive medical device business
BP
Qualification:
Field:
Position:
Experience:
BSc (Biochemistry and Cell Biology)
Drug Development
Researcher
6yr cell biology
4yr pharmacokinetics, drug development
2yr personalised medicine and biotechnologies
CA
Qualification:
Field:
Position:
Experience:
BA (Product Design)
Personalised Medical Assistive devices
Researcher and Designer
2yr assistive technology product design
2yr User-centred design and ethnographic research
CW
Qualification:
Medical Doctor
PhD
Field:
Clinical medicine focussing on cardiology
65
Research on the care provided to patients during acute
coronary syndromes
Position:
Consultant Physician and cardiologist
Senior Academic
Experience:
30yr+ Medical Experience
15yr Clinical expertise in management of patients with heart
diseases
15yr+Cardiac Patients care
DD
Qualification:
MSc+ (Electronics Engineering)
PhD (medical device technology)
Field:
Medical Devices
Biotechnology business
Position:
Research Manager and Entrepreneur
Experience:
5yr Medical Technologies businesses
2yr Biotechnology and personalised medicine business
GF
Qualification:
Field:
Position:
Experience:
BSc (Mechanical Engineering)
Assistive Medical Devices
Technical Director
10yr+ in Mechanical Design
4yr+ medical devices
JMH
Qualification:
MB BCh , University of Wales, 1972
MRCP (UK), Royal College of Physicians, 1974
MSc (Human Genetics), University Edinburgh, 1978
MD (Wales) University of Wales, 1980
MA, University of Oxford, 1992
Field:
Position:
Experience:
Clinical and Experimental Medicine
Consultant Physician, Senior Academic (Professorial)
35yr+ in: Genetic epidemiology
Functional biology
Allergic diseases
Acute internal / emergency medicine
KF
Qualification:
HND
66
Field:
Position:
Experience:
Mechanical Engineering
Managing Director
25yr engineering
5yr medical devices business
LJB
Qualification:
Field:
Position:
Experience:
Medical Doctor
Medicine
General Practitioner
33yr medical experience
27yr general practitioner
MC
Qualification:
MSc+ Clinical Psychology
PhD Psychology
Field:
Position:
Experience:
Clinical Psychology
Researcher
7yr clinical psychology
3yr chronic fatigue research
2yr psychotherapy
MNK
Qualification:
Field:
Position:
PhD (medical device technology)
Medical device technologies
Company Director
Technologist and Entrepreneur
Experience:
20yr medical devices technologies, assistive devices
5 yr assistive medical technologies
5yr drug development and biotechnology businesses
MW
Qualification:
Field:
Position:
Experience:
Medical Doctor
General Medicine
General Practitioner
35yr medical experience
33yr general practitioner
67
PH
Qualification:
Field:
Position:
Experience:
MSc+ in Business, focus on Management and Applied
Microeconomics
Biotechnology business
Researcher
3yr Financial Management
2 yr+ commercial experience in Biotech and personalised
medicine businesses and Medical Device business
RMC
Qualification:
BSc (Physics)
PhD (Laser Physics)
Field:
Medical Devices Technologies
Biotechnology business
Position:
Entrepreneur
Company Director/Chair
Senior Academic (Professorial)
Experience:
25yr+ medical device technology
5yr pharmaceutical business
5yr Assistive medical devices business
TR
Qualification:
BSc (Business Administration, Industrial and Financial
Management)
MSc in Intellectual Capital Management
Field:
Position:
Experience:
Business and IP relating to Personalised Medicine and
Biotechnology
Researcher
2 yr in Biotechnology and Medical Devices business and IP
68
APPENDIX B – Participant Consent Form
UWIC PARTICIPANT CONSENT FORM
UWIC Ethics Reference Number:
Participant name or Study ID Number:
Title of Project: ‘How in the view of experts can exercise be used in combination with
emerging technologies to improve the quality of life of chronic heart sufferers?’
Name of Researcher: Ruth Mair Clement
Please initial each box.
1.
I confirm that I have read and understand the information sheet for the
above study. I have had the opportunity to consider the information,
ask questions and have had these answered satisfactorily.
2.
I understand that my participation is voluntary and that I am free to
withdraw at any time, without giving any reason.
3.
I agree to take part in the above study.
5. I agree to the interview / focus group / consultation being audio
recorded
6. I agree to the use of anonymised quotes in publications
Name of Participant
Date
Signature of Participant………………………………………….
Name of person taking consent…………………………………
Signature of person taking consent…………………………………
69
Date
APPENDIX C – Interview Guide
INTRODUCTORY/GENERIC QUESTIONS
1) How long have you been in the field of chronic disease?
2) What is your experience in the field of chronic disease?
3) Are you, or have you been involved in research or clinical study’s relating to
chronic disease?
4) Do you think that Wales is a hot spot for Chronic Disease?
5) If yes, what has led you to this conclusion?
6) What do you think are the causes of this hot spot?
7) If not why do you think that people have this perception?
8) Do you think that the people of Wales exercise as much as the people of other
countries?
9) What has led you to this conclusion?
10) Have you been involved in a project combining treatment of chronic disease
and exercise? Can you elaborate on that? Can you describe a little more about
this?
SPECIFIC QUESTIONS
11) What do you know about Chronic Heart Failure?
12) What do you know about the incidence of Chronic Heart Failure in Wales?
Can you describe a little more about this?
13) Are you involved in the treatment of Chronic Heart Failure?
14) If so, what is being done to help the patients? / If not what do you know about
the treatment of CHF?
15) Do you think that current treatments of CHF are adequate? Can you
elaborate on this please?
16) Do you think that a sedentary lifestyle combined with obesity is a factor in the
development of Chronic Heart Failure?
70
17) What has led you to this conclusion?
18) Why do you think that this is the case?
19) How could the health service improve its service using current and emerging
technologies and therapies? Can you elaborate on that point?
20) What in your view are the emerging medical technologies and therapies?
21) Which of the technologies that you know about are relevant to the treatment of
chronic heart failure?
22) When do you think that these therapies have an impact on the treatment of
chronic heart failure? Can you describe this a little more please?
23) Do you think that exercise has a role to play in the prevention of chronic heart
failure? Can you explain what you mean by this?
24) Do you think that exercise has a role to play in the treatment of chronic heart
failure? Can you elaborate on this point please?
25) Do you think that combining current treatments with exercise would be
beneficial for Chronic Heart Failure patients? Can you elaborate on this please?
26) Can you give me an example of how this combination of emerging
technologies and exercise could be combined? Can you describe a little more
about this..?
27) Do you think that emerging technologies might offer new opportunities for
combining treatment and exercise? Can you explain this a little more please?
28) What could the impact of the optimal combination of treatment and exercise be
on the quality of life of chronic heart failure patients? Can you elaborate on what
you said about this..?
29) What could the impact of the optimal combination of treatment and exercise be
on the health service? Can you describe a little more about this..?
30) How would you measure the impact of treatment on Chronic Heart Failure
Patients?
71