A PREOPERATIVE EDUCATION INTERVENTION TO REDUCE ANXIETY

AND IMPROVE RECOVERY AMONG CHINESE CARDIAC PATIENTS:

A RANDOMISED CONTROLLED TRIAL

Ping Guo MSc

Thesis submitted to the University of Nottingham for the degree of

Doctor of Philosophy

May 2012
 ABSTRACT

Background: Patients awaiting cardiac surgery typically experience

physical and psychological stress. Although there is evidence that
preoperative education can improve postoperative outcomes among
general surgical patients, less is known about preoperative education for
patients undergoing cardiac surgery, particularly in the context of
healthcare delivered in China.

Aim: The aim of this study was to evaluate whether a preoperative

education intervention designed for Chinese cardiac patients could reduce
anxiety and improve recovery.

Methods: A randomised controlled trial was conducted between December

2009 and May 2010 at two public hospitals in Luoyang, China. Adult
patients undergoing cardiac surgery were randomly allocated to usual care
or preoperative education that included usual care plus an information
leaflet and verbal advice. All outcomes were recorded at seven days
following surgery. The primary outcome was change in anxiety measured
by the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes
were change in depression (HADS), change in pain as measured by the
Brief Pain Inventory short form (BPI-sf), length of ICU stay and
postoperative hospital stay. A qualitative evaluation was carried out with a
sample of 20 trial participants (ten from each group) to explore their views
on preoperative education and their experiences of taking part in the trial.

Results: A total of 153 patients were recruited to the trial, 77 of which

were randomly allocated to usual care and 76 to preoperative education. Of
these, 135 (88.2%) completed the trial. The participants who received
preoperative education experienced a greater decrease in anxiety score
(mean difference -3.6 points, 95% CI -4.62 to -2.57; P<0.001) and a
greater decrease in depression score (mean difference -2.1 points, 95% CI
-3.19 to -0.92; P<0.001) compared with those who did not. There was no
difference between groups in average pain, current pain, and interference
in general activity, mood and walking ability. Patients in the preoperative
education group reported less interference from pain in sleeping (mean
difference -0.9 points, 95% CI -1.63 to -0.16; P=0.02). There was
borderline evidence to suggest a reduced number of hours spent in the ICU
among preoperative education patients (P=0.05) but no difference in
length of postoperative hospital stay (P=0.17).

Eleven themes were generated from the qualitative interviews. These were
collapsed into three categories: the process and context of information
giving and trial experience. Most interview participants commented that
communication between patients and healthcare providers was limited,
reactive and rarely interactive. Those who received the preoperative
education intervention reported that they valued both the written and
verbal information. Participants welcomed the opportunity to engage with
the trial, and made suggestions concerning future preoperative education.

Conclusions: This form of preoperative education is effective in reducing

anxiety and depression among Chinese cardiac patients. Preoperative
education should be incorporated into routine practice to prepare Chinese
cardiac patients for surgery. More trials of complex interventions delivered
in China are needed to provide evidence for Chinese healthcare.

Trial registration: Current controlled trials ISRCTN87451169.

i
 LIST OF OUTPUTS

Guo, P., East, L. & Arthur, A. (2012) A preoperative education intervention

to reduce anxiety and improve recovery among Chinese cardiac patients: a
randomized controlled trial. International Journal of Nursing Studies 49 (2):
129-137. (Appendix 11)

Guo, P. (2010) Preoperative education among Chinese cardiac patients: a

randomised controlled trial. The Doctoral Student Forum of U21 Health
Sciences Meeting. Monterrey, Mexico.

ii
 ACKNOWLEDGEMENTS

I would like to thank my supervisors, Dr Antony Arthur for his wise

guidance and clarity of thought and Dr Linda East for her inspiring feedback
and advice. Their wonderful combination of supervision style always made
me feel motivated, excited and active throughout my study. The process of
working with them was a very enjoyable and unforgettable journey. Their
insightful and constructive comments on an earlier draft of this thesis were
greatly appreciated. Their patience and encouragement kept me going to
the very end. I am extremely fortunate to have been supervised by both
of them.

I would also like to thank Chaojuan Wang, Li Li, Xin Tian, Quanxing Cao,
and Jing Wang for their input to the design and assessment of my patient
information leaflet. I am particularly grateful to the managers of the
hospitals Xiaoshan Feng, Yawei, Li, and Xingpeng Chen who allowed this
study to take place.

The study would not have been possible without the ongoing interest and
support of all my colleagues at the First Affiliated Hospital of Henan
University of Science and Technology and staff in the cardiac surgery ward
of Luoyang Central Hospital. I would like to thank the patients and their
families for participating in my study.

My thanks to the School of Nursing, Midwifery and Physiotherapy, at the

University of Nottingham for funding my study through a PhD studentship
and helping me grow in my nursing career. I am also grateful to Dr Catrin
Evans who helped me to develop my research interests in preoperative
education for Chinese patients undergoing cardiac surgery and provided me
with unending help, support, patience and understanding.

Finally, my special thanks to my parents in China for their unconditional

love and great support in keeping my self-confidence, strength and
passion, especially when I was facing difficulties or challenges. My thanks
to all of my friends across the world for their friendship and support in
facilitating the fulfilment of this study.

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 TABLE OF CONTENTS

ABSTRACT ........................................................................................ i
LIST OF OUTPUTS .............................................................................ii
ACKNOWLEDGEMENTS ...................................................................... iii
LIST OF TABLES ............................................................................. viii
LIST OF FIGURES ............................................................................. ix
LIST OF ABBREVIATIONS .................................................................. x

CHAPTER ONE INTRODUCTION AND OVERVIEW ............................. 1

1.1 Significance of the study .............................................................. 1
1.2 Conventions and terminology used in the thesis ............................. 4
1.3 Structure of the thesis ................................................................. 5

CHAPTER TWO ANXIETY AND DEPRESSION AMONG CARDIAC

SURGERY PATIENTS AND PREOPERATIVE PATIENT EDUCATION .... 8
2.1 Introduction ............................................................................... 8
2.2 The epidemiology of cardiovascular disease ................................... 8
2.2.1 Mortality associated with cardiovascular disease ..................... 8
2.2.2 The global burden of cardiovascular disease .........................13
2.2.3 Management of cardiovascular disease: cardiac surgery .........15
2.3 Anxiety and depression among cardiac surgery patients .................17
2.3.1 Anxiety and depressive symptoms .......................................17
2.3.2 Preoperative anxiety causing poor cardiac surgical outcomes ..21
2.3.3 Anxiety relief interventions .................................................22
2.4 Preoperative education ...............................................................25
2.4.1 Importance of preoperative education ..................................26
2.4.2 Theories of preoperative education ......................................26
2.4.3 Components of preoperative education ................................28
2.4.4 Methods of preoperative education ......................................29
2.5 Effects of preoperative education in general surgery ......................31
2.6 Patients’ experience of preoperative patient education ...................34
2.7 Summary..................................................................................37

CHAPTER THREE EVIDENCE FROM RANDOMISED CONTROLLED

TRIALS OF PREOPERATIVE EDUCATION INTERVENTIONS FOR
CARDIAC SURGERY PATIENTS ...................................................... 38
3.1 Introduction ..............................................................................38
3.2 Moving from a narrative review to a systematic review ...................38
3.3 Aim of the review and selection criteria ........................................40
3.4 Search strategy .........................................................................40
3.5 Studies identified .......................................................................41
3.6 Assessing methodological quality of the trials ................................42
3.7 Interventions tested ...................................................................44
3.8 Outcome measures ....................................................................48
3.8.1 Psychological outcomes ......................................................49
3.8.2 Physiological outcomes ......................................................52
3.8.3 Length of stay ...................................................................52
3.8.4 Other outcomes ................................................................53
3.9 The use of qualitative data within trials ........................................54
3.10 Gaps and application of existing evidence ...................................56

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CHAPTER FOUR THE CONTEXT OF CARDIAC PREOPERATIVE
EDUCATION IN CHINA .................................................................. 59
4.1 Introduction ..............................................................................59
4.2 Healthcare in China ....................................................................59
4.3 The patients’ journey from admission to discharge when undergoing
cardiac surgery ...............................................................................63
4.4 Preoperative education for cardiac patients at study hospitals .........67
4.4.1 Information needs and lack of communication .......................67
4.4.2 Cardiac preoperative education in nursing practice ................69
4.4.3 Preoperative teaching resources and interventions ................71
4.5 Research aim and objectives .......................................................73
CHAPTER FIVE METHODS .............................................................. 74
5.1 Introduction ..............................................................................74
5.2 Study design .............................................................................74
5.3 Settings ....................................................................................77
5.4 Participants ...............................................................................80
5.4.1 Inclusion criteria ...............................................................80
5.4.2 Initial approach and informed consent..................................80
5.5 Baseline assessment ..................................................................81
5.5.1 Patient characteristics ........................................................82
5.5.2 Anxiety and depression ......................................................82
5.5.3 Pain .................................................................................83
5.6 Randomisation and blinding ........................................................84
5.7 Interventions ............................................................................85
5.7.1 Usual care ........................................................................85
5.7.2 Preoperative education .......................................................86
5.8 Outcome measures ....................................................................90
5.9 Sample size and statistical analysis ..............................................92
5.9.1 Sample size ......................................................................92
5.9.2 Data management .............................................................92
5.9.3 Data analysis ....................................................................93
5.10 Qualitative evaluation ...............................................................94
5.11 Interview participant selection ...................................................96
5.12 Qualitative data collection .........................................................96
5.13 Qualitative data analysis ...........................................................97
5.14 Being an ‘insider’ ................................................................... 100
5.15 Ethical considerations ............................................................. 102
5.16 Summary .............................................................................. 104

CHAPTER SIX TRIAL RESULTS ..................................................... 106

6.1 Introduction ............................................................................ 106
6.2 Recruitment and participant flow ............................................... 106
6.3 Baseline characteristics ............................................................ 107
6.4 Uptake of and adherence to the interventions.............................. 110
6.5 Follow-up................................................................................ 110
6.6 Primary outcome - anxiety ........................................................ 111
6.7 Secondary outcomes - depression and pain ................................. 114
6.7.1 Depression ..................................................................... 114
6.7.2 Pain ............................................................................... 115
6.8 Length of stay outcomes ........................................................... 116

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 6.9 Summary................................................................................ 117

CHAPTER SEVEN QUALITATIVE EVALUATION – FINDINGS.......... 118

7.1 Introduction ............................................................................ 118
7.2 Characteristics of the interview participants ................................ 118
7.3 Categories and themes ............................................................. 119
7.4 Process of information giving..................................................... 120
7.4.1 Reputation and hierarchy ................................................. 120
7.4.2 Understanding risk .......................................................... 121
7.4.3 Role models .................................................................... 123
7.4.4 Communication ............................................................... 124
7.4.5 Views on the intervention ................................................. 129
7.5 The context of information giving............................................... 133
7.5.1 Illness and help seeking behaviour .................................... 133
7.5.2 Strength from knowledge ................................................. 136
7.5.3 Information as a low priority ............................................. 139
7.5.4 A perception of paternalism .............................................. 140
7.6 Trial experience ....................................................................... 141
7.6.1 Motivations to participate ................................................. 141
7.6.2 Understanding of randomisation ........................................ 143
7.7 Summary................................................................................ 145

CHAPTER EIGHT DISCUSSION..................................................... 147

8.1 Introduction ............................................................................ 147
8.2 Overview of the main findings ................................................... 147
8.3 Strengths and limitations of the study ........................................ 148
8.3.1 Study design................................................................... 148
8.3.2 Recruitment and follow up ................................................ 151
8.3.3 Randomisation, blinding, and contamination ....................... 152
8.3.4 Data analysis .................................................................. 154
8.4 Comparison with other studies .................................................. 156
8.4.1 Effect on psychological health outcomes ............................. 156
8.4.2 Effect on length of stay and other outcomes ....................... 158
8.4.3 Factors influencing preoperative education in routine practice
............................................................................................. 160
8.5 Summary................................................................................ 166

CHAPTER NINE RECOMMENDATIONS AND CONCLUSIONS .......... 167

9.1 Introduction ............................................................................ 167
9.2 Implications for nurse training in preoperative education .............. 167
9.3 Implications for preoperative education practice .......................... 169
9.3.1 Multidisciplinary preoperative education ............................. 169
9.3.2 Patient involvement and social support .............................. 170
9.4 Implications for policy .............................................................. 171
9.5 Implications for future research ................................................. 174
9.5.1 Effectiveness or efficacy? .................................................. 174
9.5.2 Research priorities ........................................................... 175
9.6 Conclusions ............................................................................. 177

REFERENCES ............................................................................... 179

APPENDICES ............................................................................... 211
Appendix 1 Participant information sheet.......................................... 212

vi
Appendix 2 Consent form ............................................................... 213
Appendix 3 Patient characteristics form ............................................ 214
Appendix 4 Hospital anxiety and depression scale ............................. 215
Appendix 5 Brief pain inventory short form ....................................... 216
Appendix 6 Preoperative information leaflet - ‘your heart surgery’ ....... 217
Appendix 7 Contact letter ............................................................... 218
Appendix 8 Leaflet evaluation form .................................................. 219
Appendix 9 Interview schedule........................................................ 220
Appendix 10 Approval letters .......................................................... 221
Appendix 11 Publication ................................................................. 222

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 LIST OF TABLES

Table 2.1 Coronary heart diseases: male deaths 2010 in selected countries
(Number per 100,000 inhabitants) ......................................................11
Table 2.2 Global costs attributable to cardiovascular disease, and
cardiovascular disease incidence (in 1000s) between 2010 and 2030 from
Bloom et al. (2011) ...........................................................................14
Table 3.1 Search terms used ..............................................................41
Table 3.2 Checklist for assessing validity of randomised controlled trials
(from the Centre for Review and Dissemination) ...................................43
Table 3.3 Quality assessment of the randomised controlled trials ............44
Table 3.4 Summary of the reviewed randomised controlled trials (n=6) ...46
Table 3.5 Outcomes of preoperative education interventions among cardiac
patients ...........................................................................................50
Table 5.1 Contents of baseline assessment ..........................................81
Table 5.2 Components of the preoperative education intervention ...........88
Table 5.3 The features of usual care and preoperative education ............90
Table 6.1 Baseline characteristics of participants (n=153) randomised to
the usual care or preoperative education group .................................. 108
Table 6.2 Primary outcome - anxiety scores on the HADS for usual care
group and preoperative education group ............................................ 113
Table 6.3 Secondary outcomes - depression and pain for usual care group
and preoperative education group ..................................................... 113
Table 6.4 Length of stay outcomes for usual care group and preoperative
education group.............................................................................. 117
Table 7.1 Characteristics of the interview participants ......................... 119
Table 7.2 Categories and themes ...................................................... 119

viii
 LIST OF FIGURES

Figure 2.1 Causes of global deaths ....................................................... 9

Figure 3.1 Flow diagram of study selection process ...............................42
Figure 4.1 Chinese health services ......................................................62
Figure 4.2 Typical journey of a cardiac surgery patient from hospital
admission to discharge ......................................................................65
Figure 5.1 The design of the cardiac preoperative education intervention
study ..............................................................................................77
Figure 5.2 Locations of Henan province and Luoyang .............................79
Figure 5.3 Administration map of Luoyang ...........................................79
Figure 6.1 Flow diagram of the progress through the phases (enrolment,
intervention allocation, follow-up and data analysis) of the trial of two
groups ........................................................................................... 107
Figure 6.2 Change in anxiety scores by study groups .......................... 112

ix
 LIST OF ABBREVIATIONS

BAI Beck Anxiety Inventory

BHIS Urban Employee Basic Health Insurance Scheme
BPI-sf Brief Pain Inventory - short form
CABG Coronary Artery Bypass Grafting

CHD Coronary Heart Disease

CI Confidence Interval
CONSORT Consolidated Standards of Reporting Trials
COREQ Consolidated Criteria For Reporting Qualitative Research
CROQ Coronary Revascularisation Outcome Questionnaire
CT Computerised Tomography
GDP Gross Domestic Products

HADS Hospital Anxiety and Depression Scale

ICU Intensive Care Unit

LDL Low Density Lipoprotein
MOH Ministry of Health
MRI Magnetic Resonance Imaging
NICE National Institute for Health and Clinical Excellence
NRCMS New Rural Cooperative Medical System
PCI Percutaneous Coronary Intervention Procedures
PE Preoperative Education
QOL Quality of Life
RCT Randomised Controlled Trial
SD Standard Deviation
STAI Self-Evaluation Questionnaire for State Anxiety Inventory
UC Usual Care
VAS Visual Analogue Scale
WHO World Health Organisation

x
 CHAPTER ONE

INTRODUCTION AND OVERVIEW

1.1 Significance of the study

Undergoing cardiac surgery can be physically and psychologically stressful

for patients and their families. Patients awaiting cardiac surgery may

experience high levels of anxiety and significant symptoms of depression

due to fears, worries, and uncertainties about surgery (Fitzsimons et al.,

2000, Gallagher and McKinley, 2007). These can exacerbate symptoms of

existing cardiovascular disease, adversely affect physiological parameters

before and during anaesthesia, and can result in prolonged recovery

(Andrew et al., 2000, Pignay-Demaria et al., 2003, Duits et al., 1997).

Preoperative education has been used to improve patients’ experiences by

providing health care relevant information, coping skills, and psychosocial

support before surgery (Kruzik, 2009, Scott, 2004). Compared to usual

care, preoperative education can promote positive postoperative outcomes

in mixed groups of surgical patients (Shuldham, 1999a, Shuldham, 1999b).

Although there is evidence to support the use of preoperative education in

reducing anxiety and enhancing postoperative outcomes for surgical

patients, specific evidence for its effectiveness among cardiac surgery

patients remains inconclusive. Previous studies have reported conflicting

findings. Some studies have highlighted the effects of preoperative

education on improving physical recovery (McHugh et al., 2001) and

psychosocial recovery for coronary artery bypass surgery (McHugh et al.,

2001, Sørlie et al., 2007, Shelley and Pakenham, 2007) while other studies

found no evidence that cardiac patients’ anxiety is reduced (Shuldham et

al., 2002, Arthur et al., 2000, Goodman et al., 2008, Asilioglu and Celik,

2004) or of any effect on pain (Shuldham et al., 2002, Watt-Watson et al.,

2004) or hospital stay (Shuldham et al., 2002, Sørlie et al., 2007, Watt-

1
Watson et al., 2004). Among various forms of preoperative education

interventions designed for cardiac surgery patients, few attempts have

been made to evaluate the effectiveness of verbal communication assisted

with the use of written information. Furthermore, most studies were

undertaken in western countries. Evidence generated from these studies

cannot be directly transferred to a Chinese context without a more critical

and context specific investigation as there is evidence to suggest that

cultural factors may influence patients’ responses to such interventions

(Cheung et al., 2003).

In China, a country with a rapidly growing economy and sophisticated

technologic advances in medicine today, the culture of healthcare delivery

does not prioritise the provision of preoperative education for patients. A

lack of communication and interaction between healthcare providers and

patients in Chinese hospitals is of key concern (Henderson and Chien,

2004). One possible explanation for the inadequate provision of

preoperative information is a lack of current guidelines from Chinese

national health organisations addressing the preoperative information

needs for patients. Good communication between healthcare providers and

patients is essential. In the UK, offering surgical patients (or, as

appropriate, their carer and/or family) verbal and evidence-based written

information about treatment and care has been emphasised within NICE

guidelines (National Clinical Guideline Centre, 2011, National Institute for

Clinical Exellence, 2003, National Collaborating Centre for Women's and

Children's Health, 2008). These guidelines promote the provision of

information tailored to patients’ needs and covering such topics as

diagnosis, choice of anaesthesia, choice of analgesia and other

medications, surgical procedures, possible complications, postoperative

2
care, rehabilitation programme, long-term outcomes and healthcare

professionals involved.

Based on adult learning theory, a preoperative education intervention was

specially designed for Chinese cardiac surgery patients aimed at reducing

their anxiety and improving postoperative outcomes. This intervention

included verbal communication assisted with the use of a patient

information leaflet ‘Your Heart Surgery’. A randomised controlled trial was

conducted at two public hospitals in Luoyang, China to investigate the

effect of the intervention on health outcomes among Chinese patients

undergoing cardiac surgery. The primary interest of this trial was to

determine whether providing such an intervention could reduce anxiety

among Chinese cardiac patients. This trial also aimed to evaluate whether

this form of preoperative education intervention could reduce symptoms of

depression, decrease perceived pain, and shorten length of Intensive Care

Unit stay and postoperative hospital stay.

To get a broader understanding of why this preoperative education

intervention might succeed or fail and how it might be optimised, a

qualitative evaluation was also conducted with a sample of trial participants

through individual in-depth interviews before hospital discharge.

Specifically, this qualitative evaluation aimed to explore patients’

perceptions of preoperative information giving, their feelings about the

preoperative education intervention and their experiences of taking part in

the trial.

The results from this study not only generated evidence of the effect of this

preoperative education intervention on Chinese cardiac patients’ anxiety,

but also provided greater insights into the contents and process of the

3
intervention implemented and the context in which the intervention was

delivered. It is hoped that this study can help healthcare providers in China

to make evidence based decisions regarding whether or not this form of

preoperative education should be incorporated into routine practice to

prepare Chinese cardiac patients for surgery.

1.2 Conventions and terminology used in the thesis

Where the term ‘developed countries’ is used in the thesis, it refers to

those regions or areas which are more economically developed such as

Canada and the United States in Northern America, Europe, Japan in Asia,

and Australia and New Zealand in Oceania (United Nations Statistics

Division, 2011). China is widely regarded as a ‘developing country’

although it became the world’s second largest economy in 2010 and

increasingly, is playing an important and influential role in the global

economy. According to the World Bank Report (World Bank, 2011), China

is classified as an upper middle-income country and ranks 120th in the

world with a per capita gross national income of about $4,260 in 2010,

compared with the UK’s $38,560 (ranking 31st), Japan’ $42,130 (27th) and

the US’ $47,240 (16th) .

The term ‘cardiac surgery’ refers to any types of open heart surgery

performed to replace and/or repair diseased valves, to bypass blocked

vessels, to correct acquired or congenital defects, and to graft a prosthesis

or transplants. During open cardiac surgery, the thoracic cavity is opened

to expose the heart and the blood is recirculated and oxygenated by a

heart-lung machine. Heart prosthesis and heart transplantation are not

performed at the two hospitals where the study took place.

4
The terms ‘anxiety’ and ‘depression’, throughout the thesis, refer to

symptoms of anxiety and symptoms of depression reported by the patient

or observed by health care providers, which are generally considered as

distinct from a diagnosis of clinical anxiety and depression. These

symptoms are situational and reactive and associated with grief, loss or a

major social transition and can last for at least two weeks and interfere

with everyday life of patients.

The term ‘I’ is used in the thesis to make it clear to the reader where I was

responsible in taking particular actions in conducting the study. This has

avoided the necessity of writing in the third person which I believe would

have the effect of distancing myself from the work. I hope that choosing

such a style has added clarity to my writing.

1.3 Structure of the thesis

The purpose of this thesis is to present my doctoral work which set out to

evaluate the effect of a preoperative education intervention to reduce

anxiety and improve recovery among cardiac patients in China. To help

orientate the reader, the structure of the thesis is described here. The first

chapter introduces the area of study, some of the key terms used in the

thesis, and the structure of the thesis. It provides an overview of the study

and sets the scene for the thesis.

To understand the context of the study, the relevant literature is reviewed

in Chapters Two, Three and Four. Chapter Two describes the epidemiology

of cardiovascular disease and covers the areas of prevalence, risk factors,

currently available treatment options, and patients’ negative experiences

associated with surgical treatment. Preoperative education interventions

based on adult learning theory are described as a way of improving

5
patients’ experiences in this chapter. Chapter Three reviews the literature

concerned with the effect of preoperative educations for cardiac patients

through a systematic approach. The review critically appraises available

evidence reported in randomised controlled trials using a two group

comparison design. Chapter Four introduces the Chinese health care

system and preoperative education practice for cardiac patients at the two

study hospitals in Luoyang. It highlights the unique Chinese context in

which the study was undertaken. Chapter Four ends with a statement of

the aims of the study (the trial and qualitative evaluation) reported in the

remainder of the thesis.

Chapter Five describes the methodology and methods of the study.

Rationale for the design of the study is discussed. Participants’ recruitment,

baseline measures, the process of randomisation and the preoperative

education intervention, and follow-up measures are explained for the trial.

With regard to the qualitative evaluation, the access and sampling of

interview participants is explained and the methods of data collection and

data analysis are described. This chapter discusses the ethical

considerations made in connection to the design and implementation of the

study.

The results of the trial and qualitative evaluation are reported in Chapters

Six and Seven respectively. Chapter Six describes the recruitment and

participant flow for the trial, baseline characteristics of the two study

groups, uptake and adherence of the interventions, and presents the

difference between groups in terms of primary, secondary and other

outcomes. Chapter Seven presents the categories and themes generated

from the analysis of the interview data.

6
Finally in Chapter Eight, the methodological strengths and limitations of the

study are discussed. The results of the study are compared with other

studies in this field. Chapter Nine, the last chapter of the thesis, brings the

findings from the trial and qualitative evaluation together to examine the

implications for practice, education and policy making. Based on the

lessons learnt from carrying out the study, this chapter also provides

recommendations for the possible directions of future research.

7
 CHAPTER TWO

ANXIETY AND DEPRESSION AMONG CARDIAC SURGERY PATIENTS

AND PREOPERATIVE PATIENT EDUCATION

2.1 Introduction

The aim of this chapter is to provide the reader with the background

information necessary to understand the significant symptoms of anxiety

and depression among cardiac surgery patients and the importance of

preoperative patient education as an intervention to alleviate these

symptoms and improve patients’ recovery. This chapter describes the

epidemiology of cardiovascular disease and covers the areas of mortality

associated with cardiovascular disease, economic burden and increasing

need for surgical treatment. The psychological burden placed on patients in

the preoperative period is significant. This chapter discusses anxiety and

depressive symptoms, the impact of preoperative anxiety on patient

surgical outcomes, and possible methods of alleviating these symptoms.

The concept of preoperative education and its intended effects on various

groups of surgical patients are demonstrated. Finally, this chapter explores

the literature concerning patients’ experience of preoperative education

and factors influencing the delivery of preoperative education in nursing

practice.

2.2 The epidemiology of cardiovascular disease

2.2.1 Mortality associated with cardiovascular disease

Cardiovascular disease is an overarching term that refers to a group of

disorders involving the heart or blood vessels. It includes coronary heart

disease, stroke, peripheral arterial disease, rheumatic heart disease,

congenital heart disease and heart failure. Cardiovascular disease is the

leading cause of mortality worldwide, with a rising incidence in both the

developed part of the world and in developing countries (Lee and

8
Carrington, 2007, Waldman and Terzic, 2011). In 2008, an estimated 17.3

million people died from cardiovascular disease, which accounted for 30%

of all global deaths. Of these deaths, 7.3 million were due to coronary

heart disease and 6.2 million were due to stroke (Figure 2.1) (World Health

Organisation, 2011a). Coronary heart disease can present with symptoms

such as chest pain and breathlessness. The main forms of coronary heart

disease are acute myocardial infarction and angina.

Figure 2.1 Causes of global deaths

Source: WHO. Cardiovascular diseases.

http://www.who.int/cardiovascular_diseases/en/index.html.

The major risk factors associated with most deaths in cardiovascular

disease are tobacco use, elevated blood cholesterol, hypertension, diabetes,

obesity, physical inactivity, unhealthy diet, increased level of anxiety and

depression, and alcohol use (Scholte op Reimer et al., 2006, Health

Development Agency, 2001, Yusuf et al., 2004). A large proportion of

cardiovascular disease can be prevented through adopting a healthier

lifestyle such as stopping tobacco use, improving diet and nutrition,

avoiding stress and depression, and engaging in regular physical activity

(Haskell, 2003, Graham et al., 2007). In the National Institute for Health

and Clinical Excellence (NICE) guidance on prevention of cardiovascular

disease at population level (National Institute for Health and Clinical

9
Exellence, 2010), 12 policies were recommended to reduce the incidence

and mortality of cardiovascular disease. A major element of the guidance

was an assessment of the key risk factors for cardiovascular disease and

the potential impact which changes in risk behaviour could deliver.

Some studies have shown nurse-led or nurse-coordinated cardiovascular

disease secondary prevention programmes to be effective and feasible in

managing patient risk factors (Wood et al., 2008a, Murchie et al., 2003,

Campbell et al., 1998). In the Randomised Evaluation of Secondary

Prevention by Outpatient Nurse SpEcialists (RESPONSE) trial (Deaton,

2010), 754 patients discharged from 11 medical centres in the Netherlands

within eight weeks of their acute coronary syndromes were randomised to

usual care or usual care plus a nurse-led prevention programme involving

four half-hour-long nurse visits over six months. The RESPONSE trial found

that patients in the intervention group had a 17% relative risk reduction in

10-year mortality compared with those in the usual care group. In addition,

the intervention patients had better results for systolic blood pressure, low

density lipoprotein (LDL) cholesterol, physical activity and a healthy diet

compared with usual care. These results suggest that this type of nurse-led

intervention is an effective means of improving secondary prevention and

could be widely implemented across Europe.

There is evidence highlighting the relationship between socioeconomic

deprivation and the prevalence and incidence of cardiovascular disease

(Lee and Carrington, 2007). Low socioeconomic status is associated with

an increased prevalence and incidence of heart failure (Philbin et al., 2001,

Stewart et al., 2006, Rosengren et al., 2009) and a higher mortality rate

from myocardial infarction (Chang et al., 2007, Donyavi et al., 2011,

Macintyre et al., 2001, Murphy et al., 2006). According to the World Health

10
Organisation report (2011), the mortality of cardiovascular disease

increases with age and affects men and women equally. Over 80% of the

global deaths from cardiovascular disease take place in low- and middle-

income countries where the resources for surveillance, prevention, and

treatment are severely limited, and people are more exposed to the risk

factors for cardiovascular disease and have less access to effective disease

prevention and healthcare services (Gaziano et al., 2010). Table 2.1

reports the male death rate from coronary heart disease across the world

in 2010 (Euromonitor International, 2011).

Table 2.1 Coronary heart diseases: male deaths 2010 in selected

countries (Number per 100,000 inhabitants)

Rank Country Male deaths Rank Country Male deaths

1 Ukraine 665.12 29 China 130.08

3 Russia 445.25 30 Pakistan 128.88

13 Finland 228.39 31 Australia 125.30

14 Nigeria 215.14 35 India 116.34

16 Sweden 185.49 38 Denmark 94.02

18 Germany 166.96 49 France 73.17

21 USA 158.19 50 Japan 72.32

22 United Kingdom 156.53 51 Jordan 71.93

23 New Zealand 148.85 52 Saudi Arabia 70.12

26 Italy 134.38 56 Chile 62.53

27 Canada 133.62 60 Brazil 54.03

Source: World Health Databook 2011.

Annually in the United Kingdom, there are 200,000 deaths from

cardiovascular disease (60,000 premature deaths with health and social

costs exceeding 30 billion) (World Health Organisation, 2003). In 2007,

coronary heart disease caused around 91,000 deaths in the UK, compared

to around 34,500 deaths from lung cancer, just over 16,000 deaths from

colo-rectal cancer, and almost 12,000 deaths from breast cancer. In 2007,

11
141,000 people suffered from a myocardial infarction and 720,000 had

heart failure (British Heart Foundation, 2010).

Within a country with high population growth and a rapidly expanding

economy, cardiovascular disease has increased in China and become one of

the leading causes of death among Chinese adults due in part to changing

health behaviours and dietary habits (Critchley et al., 2004). Over three

million Chinese people die of cardiovascular disease each year which

accounts for approximately 33% of all deaths in rural areas and 39% of

deaths in urban areas (Wu et al., 2011).

Risk factors of cardiovascular disease for Chinese people are similar to

those factors affecting the wider global population. Liu (2007) reported that,

according to the World Health Organization, the death rate for

cardiovascular disease attributable to tobacco was 6.0% worldwide and 9.2%

in China in 1990 projected to reach 16.6% by 2020. The number of

Chinese people defined as overweight and obese has increased by 39%

and 82% respectively in the past decade. The prevalence of hypertension

and diabetes mellitus in China, the two key risk factors of cardiovascular

disease, has also increased significantly in the past 20 years (Liu, 2009).

An integrated management of comprehensive risk factors is urgently

required to address China’s increasing cardiovascular disease burden (Liu,

2007).

It is estimated that, by 2030, almost 23.6 million people will die from

cardiovascular disease globally and the largest increase in number of

deaths will occur in South-East Asia. Although the mortality rate of

cardiovascular disease and prevalence of major cardiovascular risk factors

has generally decreased in economically developed countries, the

12
corresponding mortality rate and risk prevalence of the disease has

substantially increased in China (Sanderson et al., 2007, He et al., 2005,

Gu et al., 2007, Sun et al., 2010). Cardiovascular diseases are projected to

remain the single leading cause of death (World Health Organisation, 2011).

As part of the WHO global strategy, effective interventions and

programmes have been developed in order to reduce major risk factors for

cardiovascular disease throughout the entire population, to monitor and

treat individuals at high risk or with established cardiovascular disease, and

ultimately to reduce global morbidity, disability and mortality due to

cardiovascular disease.

2.2.2 The global burden of cardiovascular disease

Cardiovascular disease has become a major public health issue worldwide

(Deaton et al., 2011). It not only affects individuals’ physical and

psychosocial function, health-related quality of life as well as symptom

management, but places a heavy economic burden on both families and

societies across the world (Deaton and Grady, 2004, Deaton and

Namasivayam, 2004). People with established cardiovascular disease are at

greatly increased risk for developing further cardiovascular events and

deaths. They are targeted in the National Service Framework for Coronary

Heart Disease as a high risk group in whom risk factor modification and

treatment with aspirin and statins should be highlighted (Lawlor et al.,

2003, Department of Health, 2000).

The health care provided for people with cardiovascular conditions is costly

and prolonged, which involves primary prevention through hypertension

and cholesterol management and screening, medical and surgical

treatment through hospitalisation, and need for follow-up clinical care. The

indirect costs of cardiovascular disease mainly encompass productivity loss

13
owing to either significant morbidity or premature mortality (Yusuf et al.,

2001). Cardiovascular disease disrupts the future of individuals and

families by affecting their health adversely during their peak mid-life years,

and therefore undermining the development of nations by depriving

valuable human resources at a time of life when they are likely to be most

productive (Yusuf et al., 2004, Clarke et al., 2009).

The total economic burden of cardiovascular disease has been estimated

between 2010 and 2030 on a global scale (Gaziano et al., 2009, Lloyd-

Jones et al., 2009, World Health Organisation, 2005). According to a report

by the World Economic Forum and the Harvard School of Public Health

(Bloom et al., 2011), in 2010, the global cost of cardiovascular disease was

estimated at US$863 billion (an average per capita cost of US$125), of

which about US$474 billion (55%) was due to direct healthcare costs and

the remaining 45% to productivity loss, or time loss from work because of

illness or the need to seek care. The cost of cardiovascular disease is

estimated to rise by 22% to US$1,044 billion in 2030. The incidence of

coronary heart disease is estimated to increase from 24 million in 2010 to

over 32 million in 2030. During the 20-year period, the overall cost of

cardiovascular disease could be as high as US$20 trillion (Table 2.2).

Table 2.2 Global costs attributable to cardiovascular disease, and

cardiovascular disease incidence (in 1000s) between 2010 and
2030 from Bloom et al. (2011)

Year Total cost Congestive heart Coronary heart Stroke

(billions of failure incidence disease incidence incidence
US$) (in 1000s) (in 1000s) (in 1000s)

2010 863 10,072 24,167 28,299

2015 906 10,821 25,933 30,370
2020 957 11,830 28,284 33,122
2025 1,002 12,754 30,369 35,571
2030 1,044 13,637 32,339 37,886
Total, 20,032
2010-2030

14
2.2.3 Management of cardiovascular disease: cardiac surgery

Coronary heart disease is among the major causes for hospitalisation and

mortality across the world. The prevalence of coronary heart disease in

some countries such as the United Kingdom appears to be rising, especially

for men aged 75 years and older (Scarborough et al., 2010). However,

with the improvement of prevention and diagnostics, the introduction of

new medications, and advanced surgical technologies, there has been a

significant decline in mortality associated with coronary heart disease

(Deaton and Namasivayam, 2004) and total cardiovascular disease over

the past two decades worldwide (Capewell and O’Flaherty, 2008). Since the

1980s, mortality rates from coronary heart disease have fallen in many

developed countries such as Australia, Canada, the United Kingdom, France

and the United States (Tunstall-Pedoe et al., 1999, Scarborough et al.,

2010, Okrainec et al., 2004).

Effective and inexpensive medication is available to treat nearly all

cardiovascular diseases. When the symptoms of these diseases cannot be

controlled by pharmacologic treatment, increased awareness on the

benefits of surgical treatment is needed in disease management. Cardiac

surgery is typically the treatment of choice for many congenital or acquired

heart conditions. It includes coronary artery bypass grafting (CABG) to

treat coronary heart disease, valve surgery to repair or replace damaged

heart valves from rheumatic fever, and congenital surgery to correct

malformations of heart structure existing at birth such as arterial and

ventricular septal defect.

Coronary heart disease occurs when the walls of the coronary arteries

which supply oxygen and nutrients to the heart become narrowed or

blocked by a gradual build-up of fatty material called atheroma. CABG

15
surgery is a widely used method to bypass or get around the narrowed part

of the coronary arteries and improve the blood supply to the heart, which

effectively relieves signs and symptoms of angina and increases life

expectancy (Eisenberg et al., 2005). CABG is particularly common in

developed countries having annual procedure rates of more than 515,000

in the United States. In 2007, an estimated 1,178,000 percutaneous

coronary intervention procedures (PCI), 408,000 bypass procedures, and

1,061,000 diagnostic cardiac catheterisations were performed for inpatients

in the United States. The estimated direct and indirect cost of heart disease

in the same year was $177.5 billion (American Heart Association, 2011).

Although surgical treatment has shown its superiority to medical treatment

with great advances in surgical techniques and care in the past decade

(Martens et al., 2006), cardiac surgery is still classified as high risk

because of its complexity. It has higher risks of death and postoperative

complications and takes longer recovery time, as compared to other

minimally invasive cardiac procedures like balloon angioplasty and stenting

(Granton and Cheng, 2008). A wide number of risk stratification models for

cardiac surgery have been developed and used as tools to help to

preoperatively predict the incidence of mortality and morbidity (Nilsson et

al., 2006). However, the outcomes of cardiac surgery are difficult to predict

as some of these models cannot account for factors such as skill and

experience of the surgeons and health care providers as well as other

resources within the institutions where the surgery is performed (Granton

and Cheng, 2008). Undergoing cardiac surgery is a challenging and

distressing event for patients and families and can trigger negative

emotional, physiological and cognitive responses (Screeche-Powell and

Owen, 2003, Fitzsimons et al., 2003, Koivula et al., 2002). Vingerhoets

argued (1998) that surgery with an uncertain outcome produces more

16
psychological problems than surgery with relative little ambiguity about the

course and outcomes of events.

2.3 Anxiety and depression among cardiac surgery patients

Cardiac surgery patients are confronted with the risk of death from surgery

and the risk of complications such as postoperative atrial fibrillation, graft

failure, myocardial infarction, stroke, pneumonia, renal failure, serious

bleeding and wound infection which may lead to a longer hospital stay, a

blood transfusion, dialysis, further surgery or even loss of life (Karlsson,

2008). Being faced with the risks of death and complications from surgery,

however small, has a direct impact on patient well-being. When confronted

with the news about the need to undergo cardiac surgery, patients are

likely to have concerns regarding how his or her disease and its treatment

will affect life, work and relationships with others. These concerns can

stimulate patients to ask questions about treatment and care and seek help

from health care providers. However, a qualitative study interviewing

twenty male cardiac surgery patients found that when patients’ concerns

could not be dealt with appropriately by health care providers, preoperative

anxiety and symptoms of depression are increased (Vargas et al., 2006).

2.3.1 Anxiety and depressive symptoms

Anxiety is a vague and disturbing feeling of discomfort or fear that affects

cardiac surgery patients psychologically and physically. In a prospective

cohort study 55.8% patients who were admitted for elective cardiac

surgery reported preoperative state anxiety (Detroyer et al., 2008).

Anxiety is a common emotional response to situations and threats

perceived to be uncontrollable or unavoidable. It is a sign that heightens

awareness of an imminent danger, accompanied by an automatic reply

(Ohman, 2000).

17
Fear and worry are the primary psychological symptoms of anxiety (Barlow,

2004). There are many possible reasons for developing anxiety before

surgery. The heart problem itself that needs surgical treatment is often one

of the most significant causes of anxiety. Being in hospital can be another.

People may be consumed by fear of being uncertain, and lack of control

and by worrying about the recovery process (Fitzsimons et al., 2000,

Gallagher and McKinley, 2007). Typically patients awaiting cardiac surgery

experience an increased level of anxiety related to surgery itself, surgical

outcomes, and any complications following surgery, pain or discomfort, and

their ability to return to normal life and work. In addition, preoperative

anxiety can be caused by a fear of unfamiliar procedures during their

hospital admission, preoperative preparation, surgery, and postoperative

care in hospital (Fitzsimons et al., 2003). A survey showed that many

patients expressed fear and apprehension towards the need for myocardial

revascularisation surgery. These feelings were even more pronounced

among individuals who were undergoing a surgical procedure for the first

time (Lindsay et al., 2000).

Anxiety may trigger activation of the sympathetic nervous system and the

hypothalamic-pituitary-adrenal axis. This activation produces a variety of

physiological responses such as increased oxygen consumption, reduced

immune response, and altered coagulation and autonomic tone (Frazier et

al., 2002). Regarding cardiac reactivity to psychological stressors, many

studies have shown that anxiety affects autonomic nervous system

regulation, platelet activation, activity of the hypothalamo-pituitary-adrenal

axis and myocardial effusion which in turn cause increased blood pressure,

heart rate, and cardiac output (Thomas et al., 2008, Tsigos and Chrousos,

2002). In the meantime gastrointestinal activity is inhibited and immune

18
function is decreased (Marieb, 2006, Roth-Isigkeit et al., 2002, Macleod et

al., 2002).

Cardiac patients with a high level of anxiety can experience physical

symptoms including headache, dizziness, nausea, muscle weakness,

fatigue, sweating, and difficulty falling asleep, or even more intense

symptoms such as chest pain, palpitations, shortness of breath. Chest pain

is a common symptom of anxiety and may take the form of a sharp pain or

a feeling of visceral tightness that lasts greater than half an hour. It could

also indicate the possibility of a fatal heart attack (Braunwald et al., 2005).

Previous studies have suggested a robust relationship between

psychological factors and the development of hypertension (Rutledge and

Hogan, 2002), and the influence of psychological factors in the incidence

and progress of cardiovascular diseases (Hamer et al., 2008, May et al.,

2002, Stansfeld et al., 2002, Franco et al., 2003), or in morbidity and

mortality among patients with acute myocardial infarction and heart failure

(Frazier et al., 2002, Robinson et al., 2004, Yasuda et al., 2002).

In a sample of patients awaiting coronary artery bypass grafting, 43% had

significant symptoms of depression before surgery (Pirraglia et al., 1999).

Stroobant and Vingerhoets’s follow-up study (2008) indicated that one-

third of the patients undergoing CABG showed mild to moderate cognitive-

affective symptoms of depression before surgery and patients with

preoperative moderate cognitive-affective depression could be at risk for

sustained feelings of depression for up to five years following surgery. The

presence of depression has been associated with an increased risk of

developing coronary heart disease and an increased risk of morbidity and

mortality from established coronary heart disease (Malhotra et al., 2000,

Sharpe, 2003, Rumsfeld and Ho, 2005) and to be an important predictor of

19
returning to work after coronary heart disease events (Söderman et al.,

2003).

The degree or amount of anxiety or depression is influenced not only by

the complexity and severity of the disease and surgery but also by many

other factors such as age and gender (Naqvi et al., 2005, Vaccarino et al.,

2003, Detroyer et al., 2008). Other aggravating factors can lead to anxiety

and depression such as poor social support, low standard of education, and

moderate or severe dyspnoea (Karlsson, 2008). Shen et al. (2008)

conducted a study with 735 older men (mean age 60 years) without a

history of coronary disease or diabetes at baseline to investigate whether

anxiety characteristics independently predicted the onset of MI over 12

years and whether this relationship was independent of other psychological

variables and risk factors. Anxiety characteristics were assessed with four

scales (psychasthenia, social introversion, phobia, and manifest anxiety)

and an overall anxiety factor derived from these scales. They concluded

from their study that anxiety characteristics independently and

prospectively predicted MI incidence and anxiety-prone dispositions

appeared to be a robust and independent risk factor of MI among older

men with coronary heart disease.

Vanhout et al. (2004) observed that there was a gender difference in the

association between anxiety and mortality in a large, community-based

random sample (n=3107) of older men and women (55–85 years) in The

Netherlands. They concluded that men with anxiety disorders had 87%

higher risk of mortality over 7 years of follow-up but in women with anxiety

disorders no association was found with subsequent mortality. Koivula et

al.’s study (2001b) with 207 patients scheduled for coronary artery bypass

grafting surgery concluded that patients' fears differed with respect to their

20
objects and intensity, with women reporting more intense fears. Men also

had fears, but the objects of fear differed from those in women. Apart from

gender, the intensity of fear was associated with physical exercise,

emotional problems and depression. They suggested that nursing

interventions could be developed to meet the different needs for

information and support, especially among women but also among men, to

help relieve their fears during the wait for bypass surgery. This provides

the foundation and serves as impetus for developing and evaluating a

preoperative education intervention for patients awaiting cardiac surgery in

the present study.

2.3.2 Preoperative anxiety causing poor cardiac surgical outcomes

Underlying psychological problems, particularly panic disorder, anxiety and

depression can not only independently increase the risk of cardiovascular

disease, exacerbate symptoms of the existing disease, but can also

adversely affect physiological parameters before and during anaesthesia,

and result in the possibility of prolonged recovery from surgery (Duits et al.,

1997, Andrew et al., 2000, Pignay-Demaria et al., 2003). Preoperative

anxiety was found to contribute to delayed wound healing, decreased

immune response, fluid and electrolyte imbalance, increased rate of

infection, and abnormal vital signs and was also associated with increased

postoperative pain (Scott, 2004, Vaughn et al., 2007).

Such psychological problems risk compromising the rehabilitation process,

which could eventually result in poor health related quality of life,

considerable health expenditure, and ongoing mortality and morbidity

(Szekely et al., 2007, Mayou et al., 2000). Anxiety disorder, present

preoperatively, was found to be associated with increased risk of cardiac

mortality (Tully et al., 2008, Hemingway et al., 2001, Roest et al., 2010).

21
Shibeshi et al. (2007) and Rosenbloom et al. (2009) found that following a

diagnosis of coronary artery disease, a high level of anxiety increases the

risk of MI or sudden cardiac death among patients with coronary artery

disease.

Many recent studies have demonstrated a link between preoperative

anxiety or depressive symptoms and postoperative psychological status

(Rymaszewska et al., 2003). Duits et al. (1997) reviewed 17 prospective

studies between 1986 and 1996 and suggested that preoperative anxiety

and depression were strong predictors of psychological problems that occur

after CABG. Another study by Douki et al. (2011) showed significant

positive association between preoperative state anxiety and postoperative

state anxiety. They concluded that identifying patients likely to experience

anxiety before CABG and to highlight risk groups would enable health

providers to design specific interventions that predominantly focus on

reducing patients’ anxiety and improving their quality of life. Recently

anxiety and depression screening questionnaires such as the Generalised

Anxiety Disorder (GAD) and Primary Care Evaluation of Mental Disorders 9-

item Patient Health Questionnaire (PHQ) have been developed and

validated, which are easy to administer and take less than five minutes for

patients to complete (Rumsfeld and Ho, 2005, Spitzer et al., 2006). Once

significant symptoms of anxiety and depression are identified, establishing

appropriate interventions to relieve symptoms is essential.

2.3.3 Anxiety relief interventions

Anxiety is a normal human response particularly when people are facing a

serious situation or a life-threatening procedure like cardiac surgery.

Koivula et al. (2001a) suggested that the uncertainty and waiting for CABG

disturbed many patients more than their chest pain. A long wait for CABG

22
can result in deterioration of patients’ emotional state and physical activity.

During this time, patients’ ability to cope with anxiety and depression may

depend on support from family, friends, and health care providers.

Although individuals may have their own coping approaches, patients and

their families and friends may require special care and additional support

from professionals. Health care providers have a role in monitoring

patients’ anxiety, identifying what causes their anxiety, and then

determining possible solutions to preventing or decreasing it and helping

them prepare for the surgery (Frazier et al., 2002).

Although anxiolytic or antidepressant medications can help with relieving

severe anxiety, they carry risks of potential side effects, dependence and

withdrawal. Various distraction or relaxation techniques such as yoga-

based interventions and therapeutic massage are considered to be

important complementary and alternative medical treatments for anxiety

reduction by keeping patients’ attention away from fearful thoughts and

increasing their calmness (Subramanya and Telles, 2009, Sherman et al.,

2010). Manzoni et al. (2008) undertook a meta-analysis of 27 studies

published between 1997 and 2007 (including randomised controlled trials,

observational and without control group studies) which evaluated the

efficacy of a variety of relaxation techniques for anxiety problems and

disorders including Jacobson's progressive relaxation, autogenic training,

applied relaxation and meditation. The results showed consistent and

significant efficacy of relaxation techniques in the treatment of anxiety. In

addition, meditation proved to be most effective in reducing anxiety

compared to other techniques. This meta-analysis provided a better

understanding of the variability and clinical significance of anxiety

improvement subsequent to relaxation techniques. However, it may

significantly overestimate the effect being examined as previous work

23
suggests that there is a tendency for the inclusion of non-randomised

controlled trials within a meta-analysis to yield greater treatment effects

than when the included studies are restricted to those where treatments

have been randomly allocated (Schulz et al., 1995, Wood et al., 2008b,

Kunz and Oxman, 1998).

In the surgical field, from the last two decades, guided imagery has played

an important role not only in reducing preoperative anxiety but also

reducing postoperative pain in patients undergoing same-day surgical

procedures (Gonzales et al., 2010) and in patients having cardiac surgery

(Halpin et al., 2002). Some recent studies also found that music therapy

had a positive effect on patients’ pain intensity and anxiety for cardiac

surgery patients by creating calm, relaxing atmosphere geared towards

reducing anxiety (Kshettry et al., 2006, Sendelbach et al., 2006, Twiss et

al., 2006). However, in a review (Pittman and Kridli, 2011) synthesising

the data from 11 articles to assess the efficacy of music intervention in

reducing preoperative anxiety in adults, they concluded that there was

inconsistent evidence regarding the effectiveness of music in lowering

blood pressure, heart rate and respirations in anxious patients.

Information may be beneficial in reducing patients’ anxiety and improving

their experience of hospitalisation (Bailey, 2010). Patients who perceived

they had less control developed higher levels of anxiety and experienced

more complications (Moser et al., 2007). Patients’ information needs are

likely to be greater in the run up to cardiac surgery. They are dependent on

health care providers to explain their current heart condition, procedures

and future surgery. Although there is no universal agreement regarding

what works best or how its effects can be measured, most researchers

consider that timely preoperative education may be an important

24
intervention to lessen fear of the unknown and make patients feel more

control over their situation.

2.4 Preoperative education

The presence of anxiety and depression before cardiac surgery leads to

poor surgical outcomes. There is a need for health care providers to find

ways to respond to and manage these psychological problems patients

experience preoperatively and prepare them for surgery in order to reduce

mortality and hasten postoperative recovery (Vargas et al., 2006). In

recent years there has been increasing emphasis placed on informed

consent for both treatment and research globally. The basic requirements

of informed consent focus on patients’ access to information, competence

to make a decision, and involvement in health care (Gammelgaard et al.,

2004).

In terms of informed consent for surgical treatment, patients need to be

provided with adequate information to understand the risks, benefits, and

alternatives available in order to make the right decisions and engage in

their health care (Angelos et al., 2003). Preoperative education has been

considered as an interactive process of providing information and

explanations about surgical procedures, expected patient behaviours and

anticipated sensations as well as providing appropriate reassurance and

psychosocial support to patients who are about to undergo surgery. The

main aim of preoperative education is to prepare patients for surgery and

to facilitate their recovery after surgery by helping them understand their

health and care and implement the information provided to achieve better

health outcomes (Bernier et al., 2003).

25
2.4.1 Importance of preoperative education

The concept of preoperative education originated in the 1950s.

Preoperative education has become increasingly viewed as an important

and complex intervention in surgical nursing (Johansson et al., 2005). It is

designed to help patients obtain information on their operation and after-

care (Leino-Kilpi et al., 1998, Poskiparta et al., 2001), reduce anxiety and

experience a shorter length of stay (Cashman, 2001). It may also help

patients play a more active role in the management of their own situation

(Anderson and Sharpe, 1991, Anderson, 1995, Leino-Kilpi et al., 1999).

Additionally it also enables nurses to acquire the necessary information

about patients such as mobility difficulties and psychological problems and

decide whether they can successfully adapt to, or cope with, their current

situation, and, if not, what might be done to assist them (Johnson and

Anderson, 2007).

Most importantly, preoperative education may reduce anxiety by making

the unknown familiar. According to Spalding’s study with patients awaiting

a total hip replacement surgery (2003), such familiarity can be achieved in

three ways by (1) providing an understanding of the experiences patients

will encounter during and after surgery; (2) giving opportunity to meet the

staff that will be caring for them; and (3) familiarising patients with the

environments they will meet when in hospital. Preoperative education not

only provides specific information about what to expect during the

preoperative and postoperative period but also influences the attitudes and

behaviours of patients with respect to their health and care.

2.4.2 Theories of preoperative education

The most widely applied theories in preoperative education are stress, self-

efficacy and adult learning. In stress theory, psychological stress has a

26
deleterious impact on patients’ health leading to anxiety. Teaching patients

about their forthcoming surgery can increase their ability to cope with

stress and influence their behaviour in managing their surgery (Cupples,

1991, LeRoy et al., 2003). This overlaps with the theory of self-efficacy,

which refers to people’s sense of confidence in their ability to take control

of their lives and to perform a certain behaviour (Bailey, 2010, Wong et al.,

2010). The underlying assumption of self-efficacy theory is that the greater

their confidence, the more likely it is that people will initiate behavioural

change and persist in that particular behaviour (Bandura, 1986, Bandura,

1997). Self-efficacy is considered to be the mediator between knowledge

and action. Enhancing patient preoperative education may provide them

with knowledge and skill to cope with the anticipation of surgery and

decrease their anxiety. Self-efficacy theory is commonly used to underpin

the educational intervention for orthopaedic patients (Pellino et al., 1998,

Yeh et al., 2005, Heye et al., 2002).

Some studies in preoperative education were based on the theories of adult

education or learning, emphasising that education can be designed to

assist patients in meeting their needs to care for themselves and

consequently patient can learn to perform particular behaviours with an

improvement in well-being (Stolic, 2004, Shuldham, 1999a, Walsh and

Shaw, 2000). Education aims to remove irrational beliefs, influence

behaviours and enhance patient empowerment by providing or receiving

accurate information and advice on how the patient can best engage in his

or her own health and care (Dixon-Woods, 2001). To some extent these

educational theories rely on the concept of cognitive reappraisal which has

an impact on emotion and well-being (Heikkinen et al., 2008, Callaghan

and Li, 2002, Persson and Lilja, 2001).

27
2.4.3 Components of preoperative education

Traditionally information given to patients during preoperative education to

provide an understanding of the experiences patients will encounter during,

and after surgery falls into three categories: procedural, sensory, and

coping information. Procedural information relates to the explanation of

medical events such as the reason and consequences of surgery, specific

surgical procedures, behavioural instructions during the postoperative

period, and discharge from the hospital. Sensory information addresses the

sensations that patients can feel during or after the procedure such as pain

and discomfort. Finally coping information includes areas like deep

breathing and cough exercises to minimise complications and increase

postoperative function (Suhonen and Leino-Kilpi, 2006).

It is important to provide an appropriate amount of information to patients

undergoing surgery. But patients vary considerably in the amount of

information they feel comfortable with or are able to assimilate (Bernier et

al., 2003). This variation is not only between individuals but even in the

same individual at different times and depending on the specific context.

Preoperative education should be tailored according to individual needs at a

particular point in time to provide a proper balance between enough and

too much information (Lilja et al., 1998). There is controversy around

providing information regarding risk and complications of surgery prior to

the procedure. Some studies have assumed that unnecessary anxiety

develops if excessive detailed information regarding the risks and

complications are given to the patients (Mitchell, 2000) but elsewhere it

has been observed that explicit information which successfully increased

knowledge about the risk of anaesthesia did not increase anxiety in a group

of patients awaiting cardiac surgery (Garden et al., 1996).

28
2.4.4 Methods of preoperative education

Preoperative education has been administered in various approaches and

formats including written materials, audio-visual presentations, oral

information in the form of one-to-one counselling or group discussion, or

combinations of some or all of these. Previous studies have shown that

each approach has both advantages and limitations (Lithner, 2000).

Fitzpatrick and Hyde (2005) interviewed twelve experienced surgical nurses

in Ireland regarding how preoperative education is practised in clinical

contexts. The results suggested that the quality of preoperative education

depended largely upon the individual nurse caring for the patient. Her or

his choice about delivery methods depended on the availability and

accessibility of teaching tools or materials. If educational resources are

unavailable, oral explanation would be the only way for nurses to deliver

information to their patients.

However, oral explanations can be forgotten or misunderstood. One study

showed that, on average, adult patients forget approximately half of what

they had been told within five minutes of leaving the consultation (Kenny

et al., 1998). In general, people may only retain about 20% of what they

hear but this may increase to 50% if there is additional visual or written

input (Kenny et al., 1998). Additionally, due to an increasing trend toward

shorter times between hospital admission and surgery, there has been

limited time that nurses can spend with patients before surgery. Thus

reliance on verbal information giving alone may not always be effective.

The use of media such as leaflets (van Zuuren et al., 2006) and videos

(Roth-Isigkeit et al., 2002) can help to deliver information in a potentially

more efficient and interesting way. A systematic review of randomised

controlled trials concluded that the use of video and printed information

about the general process and risks of anaesthesia for preoperative

29
education has a positive impact on anxiety and knowledge (Lee et al.,

2003).

It is argued that written information offers many advantages over other

teaching media as it is reusable and readable at any time as well as easy to

reproduce and distribute. Research-based disease-specific written

information can be developed to reinforce and assist with verbal

communication (Walsh and Shaw, 2000, Lewis and Newton, 2006). Patient

information leaflets, as an important source of health information for

patients, have a long history in health care and are the most cost-effective

and time-efficient means of communicating health messages (Semple and

McGowan, 2002). Traditionally they were seen as a way of giving

information to a passive recipient but more recently as part of patient

empowerment (Dixon-Woods, 2001). Written information should be short

and presented in simple language avoiding jargons or any difficult medical

terms. A study concluded that a one page information handout would be a

low-cost and efficient way of measurably reducing the anxiety and fears

that a significant number of patients have about anaesthesia and surgery

(Fitzgerald and Elder, 2008).

Many studies have demonstrated a positive effect of written information

provided preoperatively and have shown surgical patients’ better

understanding of their condition and treatment (Ivarsson et al., 2005a,

Ferrús-Torres et al., 2011). It has been observed that written information

helps patient recall and that patients find written information easier to

discuss with family and friends. The use of information leaflets is strongly

recommended in emergency care settings to improve patient satisfaction

(Arnold et al., 2009). But Johansson et al.’ (2005) in their systematic

review of 11 trials involving 1044 adult orthopaedic patients, investigating

30
the effect of preoperative nursing patient education reported that leaflets

alone will not have beneficial effect unless they are given with oral

information. Without oral explanation, patients find the written materials

complex to understand and difficult to remember. The provision of written

materials, in combination with oral information to patients may be one of

the more effective methods in preoperative education (Stern and

Lockwood, 2005, Hodgkinson et al., 2000).

2.5 Effects of preoperative education in general surgery

Preoperative education has been used in an attempt to improve patients’

experiences by providing relevant information about health care and coping

skills (Kruzik, 2009, Scott, 2004). Several meta-analyses (Hathaway, 1986,

Devine and Cook, 1986, Devine, 1992) and reviews (Shuldham, 1999b,

Oshodi, 2007) of preoperative information provision have been conducted.

All of these have shown that compared with usual care, preoperative

information is generally beneficial to adult surgical patients.

Hathaway (1986) reviewed 68 experimental studies and concluded that

patients having some form of preoperative instruction, particularly those

receiving instruction containing psychological and mixed forms of content,

helped to improve adult surgical patients’ welfare and postoperative

outcomes. The meta-analysis found that the greatest effects were achieved

with patients who had high levels of fear and anxiety. The meta-analysis of

Devine and Cook (1986) included 102 studies and found a positive effect of

psycho-educational interventions on pain, psychological well-being and

satisfaction with care outcomes. Subsequently, Devine’s updated review

(1992) synthesised 191 studies of any form of psycho-educational care, of

which 69% used random assignment to treatment condition. This meta-

analysis confirmed earlier findings but also found pre-surgical psycho-

31
educational interventions produced small to medium effects on length of

hospital stay, medical complications, respiratory function and resumption

of activities. Devine stated that the overall efficacy of psycho-educational

care provided to adult surgical patients found in this review was reliable

and could not be attributed to the biases associated with the decision to

publish, low internal validity, measurement subjectivity, or Hawthorne

effects.

However, the latest meta-analysis above is now nearly twenty years old

and surgical practices, patterns of hospitalisation and nursing as well as

patients’ knowledge and expectations have changed substantially.

Shuldham (1999b) reviewed more recent studies in this field and

demonstrated that preoperative education for patients about what to

expect before major surgery had a beneficial impact on a variety of patient

outcomes. These included objective measures such as length of hospital

stay as well as subjective measures such as anxiety, pain, and satisfaction.

Although many questions remain unanswered about the effect of

preoperative information on patients’ outcomes, none of the meta-analyses

and reviews raised concerns that the information itself increased anxiety.

The effects of preoperative education may differ according to type of

surgery. With reference to patients undergoing orthopedic surgery, the

meta-analysis of Johansson et al. (2005) found that preoperative education

can improve patients’ anxiety and knowledge. A Cochrane review

undertaken by McDonald et al. (2004) concluded that there was evidence

of a modest beneficial effect of preoperative education on preoperative

anxiety among patients undergoing hip or knee replacement surgery. But

little evidence was found to support the effect of preoperative education on

postoperative outcomes, such as pain, functioning and length of hospital

32
stay. These reviewers suggested that there might be beneficial effects

when preoperative education was tailored according to anxiety, or targeted

at those most in need of support (e.g. those who are particularly disabled,

or have limited social support structures).

Some trials or quasi-experimental studies have shown that preoperative

information of various types and in different forms appear to have positive

effects on the ability of patients to cope with and recover physically and

psychologically from their planned surgery (Wong et al., 2010). A

randomised controlled trial (Pager, 2005) demonstrated that preoperative

information by the use of video-tapes showing patients what to expect

from cataract surgery resulted in less anxiety, and greater understanding

of, and satisfaction with, their treatment. This finding was supported by

Zieren et al.’s trial (2007) showing that an informative video before

inguinal hernia surgical repair can lead to better quality of life

postoperatively.

Another randomised controlled trial conducted by Lin and Wang in Taiwan

(2005) found that a preoperative nursing intervention for pain through oral

explanation had a positive effect on anxiety and pain for patients

undergoing abdominal surgery. In Blay and Donoghue’s trial (2005), pre-

admission education intervention with the use of verbal and written

information on pain management, wound care, diet and elimination helped

reduce pain following laparoscopic cholecystectomy and significantly

increased patients’ knowledge of self-care and complication management.

Studies of preoperative education are characterised by poor design in

terms of patient assignment, blinding of participants and researchers,

follow-up procedures and statistical analyses (Shuldham, 1999a). There is

33
considerable space for improvement in trial design as a basis for promoting

evidence based nursing. In addition although there are a relatively large

number of studies on preoperative education and some evidence to show

its value on patients undergoing minor surgeries, for some major areas of

health care such as heart disease, sufficient evidence does not yet exist to

enable firm conclusions to be drawn (Shuldham, 1999b).

More specifically, there is a lack of information on the needs of patients

who are undergoing cardiac surgery. It has been observed that cardiac

surgery can cause more anxiety and can create negative physiological,

psychological, and social health changes in patients as compared to other

minor surgeries (Fitzsimons et al., 2003, Screeche-Powell and Owen,

2003). This group may therefore be in greater need of information to

support their understanding about their health and preoperative

preparation. Evidence of the effectiveness of preoperative education

interventions for patients undergoing general surgery may not be

transferable to those who are undergoing cardiac surgery.

2.6 Patients’ experience of preoperative patient education

Preoperative patient education is important for patients awaiting surgery

who become vulnerable and anxious before surgery (Aquilina and

Baldacchino, 2007, Moene et al., 2006). They depend on health care

providers to communicate with them about useful information and advice

to help them prepare for their surgery. Chan et al. (2012) systematically

reviewed eleven qualitative studies (six were conducted in the UK and

others in Sweden, the USA, Canada, Ireland and Malta) on patients’

experiences of preoperative communication. They found that patients

showed different needs and desire for the content, form and sources of

preoperative information. Most surgical patients prefer to receive extensive

34
information preoperatively in order to meet their need for control over their

care of disease and surgery (Hall et al., 2008). Patients report being

irritated by not being given sufficient or clear information or being given

inconsistent information by different health care providers (Gilmartin and

Wright, 2008). More importantly, the review also showed that patients

were sensitive to the attitude of health care providers. A caring, respective

and empathic attitude shown by health care providers determined patients’

levels of satisfaction and confidence as well as their overall impressions of

the health care team. However, not all health care providers demonstrated

such a positive attitude (Mottram, 2009).

As nurses have a fundamental role in delivering preoperative education,

they need to be able to identify and meet patients’ needs for preoperative

education. However, providing patients with adequate preoperative

information is challenging in nursing practice (Fitzpatrick and Hyde, 2005,

Fitzpatrick and Hyde, 2006, Suhonen and Leino-Kilpi, 2006). In Fitzpatrick

and Hyde’s study (2006), a sample of 12 experienced surgical nurses was

interviewed in depth aiming to explore the factors relating to nurses that

influence the delivery of preoperative patient education in everyday

surgical clinical contexts in Ireland. Findings indicated that nurses’ different

understanding of the importance of preoperative education and views

about what preoperative education should be led to inconsistency in

preoperative care across patients. The majority of participants believed

that nurses’ knowledge, skills and experience of preoperative education

and communication influenced the standard of preoperative education

delivered to patients. Lack of confidence due to less knowledge and skill

and inexperience was seen to result in limiting the opportunity for patients

and their families to ask questions or avoiding communication and

engagement with patients and families.

35
Other related factors identified from the interview data included the

content of materials delivered in the preoperative education process and

the form of preoperative education as well as wider structural components

of the learning environment. Fitzpatrick and Hyde (2006) argued that

organisational investment in the area of preoperative education is

essential, which requires a clear conceptualisation of this aspect of patient

care and the development and evaluation of preoperative education

materials and interventions which are patient centred. In addition, nurses

face the challenge of having to deliver preoperative education within a

confined time frame. In the context of shortened length of hospital stays,

especially preoperatively, the optimal form and process by which

preoperative education can be delivered effectively and efficiently needs to

be determined (Fitzpatrick and Hyde, 2006, Ong et al., 2009).

Sub-optimal provision of information has been attributed to health care

providers' misunderstanding of the information patients prefer (Mordiffi et

al., 2003). In other words, preoperative information is often based on what

health care providers perceive is important for patients. However, this can

be quite different to patients’ actual needs. Keulers et al. (2008) found that

surgeons thought that their patients desired more extensive information on

cause, effect, and prognosis of the disease itself. However, in contrast,

patients demonstrated their need for receiving more specific information

regarding the preoperative period, anaesthesia, operation, postoperative

period, self-care, and general hospital information. The study concluded

that surgeons generally underestimate their patients’ desire for

preoperative information.

36
2.7 Summary

Cardiovascular disease is the leading cause of morbidity and mortality

worldwide, with economic effects at the levels of both the individual and

society. Cardiac surgery is associated with a range of unintended negative

physical, psychological and social health changes. Patients awaiting cardiac

surgery can experience physical and psychological stress, including anxiety

and depression due to fears, worries, and uncertainties about surgery.

These can exacerbate symptoms of the existing disease, adversely affect

physiological parameters before and during anaesthesia, and can result in

prolonged recovery from surgery.

Previous studies have shown that preoperative education, as a nursing

intervention, can reduce anxiety and improve postoperative outcomes in

various groups of surgical patients. Patients’ experience of preoperative

education is varied but most surgical patients prefer to receive extensive

information preoperatively in order to maintain some control over their

health. Factors influencing the quality of preoperative patient education

include the value placed on preoperative education by nurses, nurses’

knowledge of and skills in the delivery of preoperative education, content

and form of preoperative education, and organisational investment in this

aspect of care. Previous randomised controlled trials evaluating the effects

of preoperative education interventions for patients undergoing cardiac

surgery are critically reviewed in the following chapter.

37
 CHAPTER THREE

EVIDENCE FROM RANDOMISED CONTROLLED TRIALS OF

PREOPERATIVE EDUCATION INTERVENTIONS FOR CARDIAC
SURGERY PATIENTS

3.1 Introduction

This chapter presents a detailed review of the effects of preoperative

education among cardiac patients from previously published randomised

controlled trials. Although there is evidence that preoperative education

interventions can lead to positive postoperative outcomes for surgical

patients in general, less is known about their effectiveness for patients

undergoing cardiac surgery. This review critically appraises available

evidence reported in recent randomised controlled trials with two group

comparison design.

3.2 Moving from a narrative review to a systematic review

A previous review has demonstrated the impact of preoperative education

on a variety of outcomes including both objective measures such as length

of hospital stay as well as subjective parameters such as anxiety, pain and

satisfaction among a mix of general surgical patients (Shuldham, 1999b).

However the review concluded that it was difficult to apply the findings to a

particular group of patients undergoing surgery such as for cancer or heart

disease. Shuldham (2001) therefore carried out a narrative review of ten

studies evaluating preoperative education for those undergoing cardiac

surgery. It suggested that there was limited evidence to support the

positive impact of preoperative education on patients’ recovery from

cardiac surgery.

The effect of preoperative education for cardiac surgery patients is far from

clear. In the review by Shuldham (2001), only one of the ten studies

included was a randomised controlled trial in which random allocation of

38
patients to intervention and control groups was handled effectively

(Anderson, 1987). The remaining studies were either descriptive (Recker,

1994, Grady et al., 1988) or random assignment was not explicit (Cupples,

1991, Lamarche et al., 1998, Mahler and Kulik, 1998, Rice et al., 1992). In

addition, the review is now ten years old and the studies included were

published between the years of 1978 and 1998. Preoperative waiting time,

cardiac surgical practices, and preoperative and postoperative care as well

as patients’ knowledge and expectations have changed substantially during

the last decade.

Another review is called for to look at more recent studies in this field with

robust study designs. In contrast to a narrative review, a systematic review

limits bias by using explicit and transparent methods to search, critically

appraise and systematically synthesise the studies addressing specific

clinical questions (Satya-Murti, 2000, Sackett et al., 2000, Akobeng,

2005c). Systematic reviews have increasingly replaced traditional narrative

reviews as a way of summarising research evidence for effectiveness of

diagnostic and treatment interventions and for the outcomes of natural and

therapeutic exposures, including adverse events and costs (Collins and

Fauser, 2005). Systematic reviews of randomised controlled trials (RCTs)

are considered to be evidence of the highest level in the hierarchy of

research designs evaluating effectiveness of interventions (Akobeng, 2005c,

Evans, 2003). A systematic review of recent randomised controlled trials

examining the effectiveness of preoperative education interventions for

cardiac surgery patients was carried out. The process for conducting the

systematic review included clear and reproducible eligibility criteria for

selection of studies, a comprehensive search for relevant studies that met

the eligibility criteria, critical appraisal of the quality of included studies,

and synthesis of results.

39
3.3 Aim of the review and selection criteria

The aim of this review was to update evidence regarding whether

preoperative education interventions have effects on a range of health

outcomes of patients undergoing cardiac surgery and to identify the

outcomes affected. Secondly, the review sought to specify the contents and

forms of preoperative education interventions for patients undergoing

cardiac surgery. Studies were included in the systematic review if they met

the following selection criteria: (1) the studies were published in English

between 2000 and 2011; (2) the studies involved adult patients (aged 18

and over) undergoing cardiac surgery; (3) the studies compared any form

of preoperative education interventions to usual care; (4) studies evaluated

the effect of preoperative education on one or more outcomes including

biological, psychological, length of stay, the utilisation of service and cost

outcomes; (5) the studies were randomised controlled trials.

3.4 Search strategy

A comprehensive search strategy was developed to obtain all relevant

studies. Electronic databases including the Cochrane Central Register of

Controlled Trials from the Cochrane Library, MEDLINE, CINAHL, PsycINFO,

EMBASE, and Web of Science were searched. The following subject

headings or key words used in the search were: cardiac surgery,

preoperative education, anxiety, and recovery (Table 3.1). Searches were

limited to adult population, English language, and 2000 to 2011 periods. As

randomised controlled trial is the most appropriate research design for

evaluating an intervention (Moher et al., 2010), ‘randomised controlled trial’

was used as a keyword to map to the title, abstract and full text for

identifying the best quantitative evidence. All searches were screened and

duplicated studies were discarded. Reference lists of all retrieved articles

40
were followed up for additional studies that investigated the effect of

preoperative education for cardiac patients.

Table 3.1 Search terms used

Key Concepts Keywords

Cardiac surgery ‘Cardiac surg*’, ‘cardiac oper*’, ‘open heart’.

Preoperative education ‘Patient education’, ‘patient counsel*’, ‘patient teach*’, ‘patient

learn*’, ‘patient inform*’, preoperative & preadmission.

Anxiety or postoperative Anxiety, depression, stress, pain, knowledge, length of stay,

recovery recovery.

Research methodology Randomised controlled trial.

3.5 Studies identified

After filtering out duplicate studies retrieved from the databases, 266

potentially relevant studies were assessed. The full texts of 35 studies were

obtained through the search strategy and reviewed in further detail. Of

these, 29 articles were excluded because they did not meet the inclusion

criteria (Figure 3.1). Reasons for exclusion fell into the following

categories: (1) the studies were non randomised controlled trials (n=5) or

uncontrolled studies or qualitative designs (n=12); (2) the studies involved

only surgical procedures but not open heart surgery (n=3); (3) focus of

interventions was not preoperative education (n=6); (4) usual care was

not used as control group (n=3).

41
 Potentially relevant citations of studies
identified after searching electronic
databases, duplicates removed (n=266)

Obviously irrelevant studies

excluded (n=176)

Abstracts of studies retrieved for

detailed evaluation (n=90)

Studies excluded after

evaluation of abstracts (n=55)

Full text of studies obtained for

evaluation (n=35)
Studies excluded after full
text evaluation with reasons
(n=29)

Relevant studies included in the

systematic review (n=6)

Figure 3.1 Flow diagram of study selection process

Consequently, a total of six randomised controlled trials were included in

the review. Three studies were carried out in the UK (Goodman et al., 2008,

McHugh et al., 2001, Shuldham et al., 2002), two in Canada (Arthur et al.,

2000, Watt-Watson et al., 2004), and one in Norway (Sørlie et al., 2007).

As the individual trials differed considerably in interventions and outcome

measures, it was decided not to pool results but synthesise them

descriptively. Data were synthesised in terms of methodological quality

assessment, intervention characteristics, outcomes and reported qualitative

evaluation of the interventions.

3.6 Assessing methodological quality of the trials

All of the six trials were critically evaluated based on a checklist

recommended by the Centre for Review and Dissemination (Table 3.2)

(Centre for Review and Dissemination, 2009). The quality of the six trials

42
varied (Table 3.3), although in general, design, conduct, and reporting

were better in randomised controlled trials published after the adoption of

the first Consolidated Standards of Reporting Trials (CONSORT) statement

in 1996 (Kane et al., 2007, Schulz et al., 2010). The sample sizes ranged

from 98 (McHugh et al., 2001) to 406 (Watt-Watson et al., 2004). Random

allocation was performed effectively in all six trials reviewed.

Table 3.2 Checklist for assessing validity of randomised controlled

trials (from the Centre for Review and Dissemination)

Item No. Topic Checklist item

1 Randomisation Was the assignment to the treatment groups really

random?

2 Blinding of participants Was the randomisation of participants blinded?

3 Follow-up Was relatively complete follow-up achieved?
4 Analysis of withdrawal Were the outcomes of people who withdrew described
and included in the analysis?

5 Blinding of outcome Were those assessing outcomes blind to the

assessors treatment allocation?

6 Baseline Were the control and treatment groups comparable at

entry?

7 Identical except Were the groups treated identically other than for the
intervention named interventions?

Patients in the trials were generally not blind to the intervention though

this was not explicitly stated in three of the six trials. Given the nature of

the preoperative education interventions and the requirements of patient

informed consent, it is probably unrealistic to expect blinding of

participants though this raises the issue of potential bias in participant

responses to self-report questionnaires. Of the six trials, only two of them

reported that blinding of the outcome assessors was accomplished

(Shuldham et al., 2002, Watt-Watson et al., 2004) and the remainder did

not make it clear who acted as outcome assessors and whether they were

blinded or not.

43
Table 3.3 Quality assessment of the randomised controlled trials

Studies Random Blinding Complete Analysis of Blinding Groups Equivalent

allocation of follow-up withdrawal of comparable treatment
patients assessor at baseline other than
interventions
Arthur Yes No No No Not No, gender Not clear
et al. stated & peak
oxygen use
Goodman Yes Not Yes No Not Yes Not clear
et al. stated stated
McHugh Yes Not No No Not Yes No
et al. stated stated

Shuldham Yes No Yes Yes Yes No, marital Yes

et al. & length of
wait
Sørlie Yes No No Yes Not Yes Yes
et al. stated

Watt- Yes Not Yes No Yes Yes Yes

Watson stated
et al.

Not all study reports accounted for all participants lost to follow-up. Sørlie

et al.’s (2007) and Shuldham et al.’s (2002) trials included all participants

randomised to the intervention or control group in the analysis. However

the use of a strict intention to treat analysis was impossible in cases of

missing data such as loss to follow-up, any withdrawals or non-compliers.

Four trials did not use strict ‘intention to treat’ analysis and did not further

explain how missing data and/or deviation from protocol were dealt with,

although they provided information about the characteristics and reasons

for withdrawals (Arthur et al., 2000, Goodman et al., 2008, McHugh et al.,

2001, Watt-Watson et al., 2004). Exclusion of any withdrawn participants

who have sustained severe side effects to the intervention will affect the

results of a trial (Abraha and Montedori, 2010, Unnebrink and Windeler,

2001, Touloumi et al., 2001).

3.7 Interventions tested

A full description of the reviewed trials including the interventions and

outcomes are detailed in Table 3.4 below. Broadly speaking, the content of

preoperative education interventions in most trials was similar. The

44
education interventions covered comprehensive preoperative information

on a range of topics including procedures, surgery preparation,

postoperative progress, psychological support and coping skills. The

exception is Watt-Watson et al. (2004), who focused mainly on the

importance of pain relief for recovery and pain relief methods. In three

trials, the preoperative education intervention emphasised the provision of

individualised information whereby patients were encouraged to express

their questions and worries (Arthur et al., 2000, McHugh et al., 2001,

Sørlie et al., 2007).

Most of the trials used media based educational interventions combined

with verbal explanations. Written materials were used in the form of

manual or booklet or package in three trials (Goodman et al., 2008, Watt-

Watson et al., 2004, Shuldham et al., 2002). In Goodman et al.’s and

Watt-Watson et al.’s trials, nurses guided the participants in the

intervention group to read the written material through, discussed

important points contained in the written materials, and answered patient

questions. One trial used a 12 minute video combined with 40 minute

patient-centred information session delivered by specially trained nurses.

The video was shown twice: preoperatively and again during the session at

admission (Sørlie et al., 2007).

In Arthur et al.’s trial (2000), the intervention group received an 8 week

multidimensional preoperative education involving individualised,

prescribed exercise training twice per week in a supervised environment,

with education and reinforcement during the waiting period. Additionally,

monthly nurse-initiated telephone calls, as another important component of

45
Table 3.4 Summary of the reviewed randomised controlled trials (n=6)

Author/Setting Population Interventions Outcome measures Results

Arthur et al. 249 patients Intervention group (n=123): exercise Primary:
(2000) awaiting training; education & reinforcement; Postoperative length of hospital stay. 1 less day for intervention group* & less time in ICU*
Canada elective CABG monthly telephone calls.
Secondary:
Usual care group (n=123): followed by Health-related quality of life (QOL SF-36). SF-36 physical/mental: positive effect/no difference.
primary care physicians, cardiologists or Anxiety (STAI). Anxiety: no difference.
surgeons. Peak exercise performance, social support Other outcomes: no difference.
& utilization of health care services.

Goodman et al. 188 patients Intervention group (n=94): a cardiac risk Primary:
(2008) awaiting assessment, monthly lifestyle counselling Anxiety & depression (HADS). Anxiety & depression: no difference.
UK cardiac & preparation; the manual & nurses’ Length of stay. Median length of stay: no difference.
surgery explanation. Change in blood pressure (BP). BP and total cholesterol: no difference.
Body Mass Index & Serum Cholesterol. BMI or HDL cholesterol: no change.
Control group (n=94): standard care
consisting of the hospital helpline Secondary:
telephone numbers and a pre-surgery Change in smoking rate (by self-report). Numbers of smokers too small for analyses.
information day. Blood glucose (by the Trust laboratories). Change in glucose levels: no difference.
Quality of life (CROQ & SF-36). QOL: no difference except for physical QOL on SF-36*.
Postoperative complications (medical and Post-operative complications: no difference.
nursing notes). Cost analysis: less in intervention group*.

McHugh et al. 98 patients Nurse led shared care group (n=49): Risk factors:
(2001) awaiting health education & motivational interviews Smoking status. Higher cessation rate in intervention*.
UK elective CABG monthly. Obesity. Intervention patients more likely to reduce obesity*.
Physical activity. Time spent being physically active*.
Control group (n=49): usual care.
Blood pressure. Systolic/diastolic BP: decreased in intervention group*.
Plasma cholesterol. Patients’ proportion with cholesterol exceeding target
values: no difference.

General health (SF-36). SF-36: improved in intervention group*.

Anxiety & depression (HADS). Anxiety & depression: improved*.
Patient satisfaction (questionnaire). Patients were satisfied with the service.

46
Shuldham et al. 356 elective Experimental group (n=188): Anxiety & depression (HADS). HADS: no difference 6 month after surgery.
(2002) CABG patients a day of preadmission education by
UK multidisciplinary members plus usual care. Well-being (General Well-Being Wellbeing: no difference 6 month after surgery.
questionnaire).
Control group (n=168): usual care
involving individual teaching on admission Pain (VAS). Pain: no difference 6 month after surgery.
by staff complemented by information
sessions on the ward. Length of hospital stay. Significant difference with the experimental group
having the longer hospital stay.

Sørlie et al. 109 elective Intervention group (n=55): video Anxiety (BAI). Less anxiety in intervention group at discharge* & up
(2007) CABG patients combined with individualised information to 1year*.
Norway sessions by nurses at admission and at Subjective health (SF-36). Better subjective health in intervention group at
hospital discharge. discharge* and during 2 years*.
Depression (Zung self-rating scale). Depression: no difference at discharge but less in the
Control group (n=54): standardised intervention during 2 years*.
information but no video. Length of postoperative stay. Mean length of postoperative stay: no difference.

Watt-Watson et 406 CABG Pain education group (n=202): a booklet Primary outcome:
al. (2004) patients plus standard care. Pain-related interference (BPI-I). Pain-related interference: no difference.
Canada
Standard care group (n=204): a booklet & Secondary outcome:
a video including general procedural Postoperative pain (McGill Questionnaire). Postoperative pain: no difference.
information. Analgesic use (patient’s charts). Analgesics: no difference.
Concerns about taking analgesia (subscale Fewer concerns about analgesic in intervention group
from Barriers Questionnaire). on day 5 after surgery*.
Satisfaction (American Pain Society). Satisfaction: no difference.
Impact of gender. Women: greater interference due to pain in overall
activities*.
Hospital stay (patients’ charts). Length of stay: no difference.

BAI: Beck Anxiety Inventory BPI: Brief Pain Inventory

CROQ: Coronary Revascularisation Outcome Questionnaire HADS: The Hospital Anxiety and Depression Scale
QOL SF-36: Quality of Life Short Form-36 STAI: Self-Evaluation Questionnaire for State Anxiety Inventory
VAS: Visual Analogue Scale * P<0.05

47
the intervention, were used to answer questions and provide reassurance

for patients.

The trial by Shuldham et al. (2002) involved a more comprehensive

intervention than any of the other trials. The intervention was given in the

form of a day of education by trained multidisciplinary health care

professionals prior to admission for surgery. This one day education

programme provided information on coronary artery disease, hospital stay,

medical care, and rehabilitation. It was informal, with questions and

discussion encouraged, and family members were welcome to attend.

Videos were used and a package of written information was given to each

participant randomised to the intervention group. Also an optional visit to

the wards and ICU was arranged. This preoperative intervention involved

members of a number of health care professions (nurses, physiotherapists,

and doctors). But a lack of evidence for a benefit from this form of

preoperative education suggested that future research might use

alternative methods such as CD-ROM or the internet.

In reports of various preoperative education interventions in the six trials,

little attention was paid to the underlying theoretical basis of the

intervention being tested. Two trials lacked detail about the ‘normal’ or

‘usual’ care given to patients (Arthur et al., 2000, McHugh et al., 2001).

Even if the other trials included some description, control ‘treatment’

tended to be unmonitored so it is unclear how consistently it was delivered

and whether its content changed during the trial.

3.8 Outcome measures

Each of the trials included in the review measured a variety of outcomes.

Anxiety and depression, quality of life, patient satisfaction and length of

48
hospital stay were the most common. The majority of outcome measures

heavily relied on self-report by the participants in the trials. Various

measurement tools were utilised including generic or cardiac disease

specific questionnaires.

Although some of the included trials focused more on psychological

outcomes, others were interested in the efficacy of preoperative education

on making changes to patients’ lifestyle and modifying risk factors of heart

disease before or after cardiac surgery and whether or not preoperative

education might contribute effectively to postoperative recovery by

increasing patients’ knowledge about physiotherapy, exercises and deep

breathing. Table 3.5 summarises the data on the outcomes of these trials

into four categories: psychological, physiological, length of stay, and other

outcomes.

3.8.1 Psychological outcomes

Of the trials included in the review, five of them measured anxiety except

one (Watt-Watson et al., 2004) which focused on pain related outcomes.

Individual trials have produced varied findings. Both Sørlie et al. (2007)

and McHugh et al. (2001) showed a significant effect of preoperative

education on anxiety whereas three trials did not demonstrate difference in

anxiety scores between the invention and control groups (Arthur et al.,

2000, Shuldham et al., 2002, Goodman et al., 2008). Caution should be

applied when comparing results across trials as different tools were used.

In three trials using the Hospital Anxiety and Depression scale (HADs)

(Shuldham et al., 2002, Goodman et al., 2008, McHugh et al., 2001), only

McHugh et al.’s trial reported a significant reduction in anxiety levels in

patients receiving the intervention. Arthur et al. used the Self-Evaluation

49
Questionnaire for State Anxiety Inventory (STAI) and Sørlie et al. used

Beck Anxiety Inventory (BAI) to measure anxiety.

Table 3.5 Outcomes of preoperative education interventions among

cardiac patients

Studies Arthur Shuldham Goodman Sørlie McHugh Watt-Watson

et al. et al. et al. et al. et al. et al.
(2000) (2002) (2008) (2007) (2001) (2004)
Outcomes n=249 n=356 n=188 n=109 n=98 n=406

Psychological
Anxiety = = =

Depression = =

Pain = =

Quality of life = =

Patient
satisfaction
Physiological
Modifiable risk
factors
Blood pressure =

Total =
cholesterol
Recoveries & =
postoperative
hypertension
Exercise =
performance
Length of stay
Hospital stay = =

ICU stay

Postoperative =
stay
Other
Costs

Use of services =
&social support

=: No difference between two groups

: Significant decrease with intervention group
: Significant increase with intervention group

Four trials measured depression, of which three used the HADs (Shuldham

et al., 2002, Goodman et al., 2008, McHugh et al., 2001). Of these only

McHugh et al. found a positive effect of preoperative education on

50
symptoms of depression. Although McHugh et al.’s trial did show positive

results in depression for the intervention group, the trial had a small

sample size (n=98), compared to the other two with relatively large

samples (n=356 and n=188). One trial by Sørlie et al. (2007) used the

Zung self-rating scale as the measurement tool for depression and

reported that patients who received the intervention had significantly

reduced depression levels at six months and two years, but no differences

were found between groups at discharge.

Pain was measured in two trials (Watt-Watson et al., 2004, Shuldham et

al., 2002), of which neither demonstrated a significant difference between

the two groups. Watt-Watson et al. randomly assigned 406 CABG patients

to a ‘standard care’ or ‘standard care plus pain booklet’ group in order to

test the effectiveness of a preadmission education intervention designed to

reduce pain and related activity interference after CABG surgery. Results

showed no evidence of a clinically significant improvement for the

intervention group in pain management outcomes in terms of

postoperative pain, pain-related interference, and analgesic use.

Quality of life was measured in three trials (Goodman et al., 2008, McHugh

et al., 2001, Arthur et al., 2000) using the SF-36 questionnaire, a generic

tool. Goodman et al. not only used the SF-36 but also a cardiac specific

quality of life measurement tool, the Coronary Revascularisation Outcome

Questionnaire (CROQ). There was no evidence of an effect of the

intervention on quality of life scores as measured by both the SF-36 and

CROQ, except for a statistically borderline improvement on the physical

composite summary score of the SF-36 for those allocated in the

intervention group. Similarly, Arthur et al.’s trial also found that patients in

the intervention group showed statistically borderline improvement on the

51
SF-36 physical composite summary score, but no evidence of an effect of

the intervention on mental composite summary score of the SF-36.

However, McHugh et al. found that compared with patients who received

usual care, those in the intervention group had a greater improvement in

general health status scores across all eight domains of the SF-36.

Two trials examined the effect of preoperative education on patient

satisfaction (McHugh et al., 2001, Watt-Watson et al., 2004). McHugh et al.

reported that patients were satisfied with the service, which improved

information about CABG and was supportive in making lifestyle changes

and helped reduce anxiety for themselves and their family. Also in Watt-

Watson et al.’s trial, patients were very satisfied with their overall care and

health care providers’ responses to their reports of pain. The booklet was

rated as helpful, particularly by female trial participants.

3.8.2 Physiological outcomes

Three of the six trials included the effect of preoperative education on

measures of physiological outcomes. Only one trial (McHugh et al., 2001)

found that a nurse led preoperative intervention had a positive effect on

modifiable risk factors. Specifically, the intervention participants were more

likely to stop smoking and to reduce obesity and blood pressure. By

contrast, in the other two trials, no evidence was demonstrated of the

effect of the intervention on physiological outcomes such as blood pressure,

total cholesterol, and physical recovery (Arthur et al., 2000, Goodman et

al., 2008).

3.8.3 Length of stay

Five of the six trials included length of stay outcomes with the exception of

McHugh et al. (2001). Arthur et al. (2000) found that patients in the

52
intervention group spent less time in ICU, and one less day in overall

hospital stay and postoperative hospital stay than their counterparts in the

control group. Goodman et al. (2008) and Watt-Watson et al. (2004) failed

to detect a difference in the median length of hospital stay between groups.

Sørlie et al. (2007) found no differences in mean length of postoperative

stay between groups. Nevertheless, Shuldham et al. (2002) showed that

there was a significant difference in length of hospital stay with the

intervention group having the longer stay. They considered that the

possible factors that might have led to one day longer stay in the

intervention group were the severity of heart disease, length of time on

cardiopulmonary bypass, number of grafts and intraoperative blood loss.

3.8.4 Other outcomes

Out of the six trials, only one trial (Goodman et al., 2008) conducted cost

minimisation analysis and showed that the total costs were less in the

intervention group due to fewer readmissions. Arthur et al. (2000)

examined utilisation of health services and social support but found that

the two groups did not differ. However, although not statistically signficant,

more patients in the intervention group chose to participate in

postoperative cardiac rehabilitation and the intervention group reported

more support six months after surgery.

There is no clear and consistent pattern with regard to the outcomes of the

six trials reviewed. One study did not show any effect of the preoperative

education intervention on any of the measured outcomes, namely patients’

anxiety, depression, pain and wellbeing. Further it reported that there was

a significant difference in the length of hospital stay favouring the control

participants although this result was not explicable and represented less

than one extra day in the intervention group compared to the mean nine

53
days seen in the control group (Shuldham et al., 2002). All other trials

reported the positive effects of preoperative education on one or more

outcomes.

3.9 The use of qualitative data within trials

Only one of the six trials included in the review (Goodman et al., 2008)

reported the use of qualitative semi-structured interviews and focus groups

to explore patients’ and nurses’ perspectives of the nurse-led education

and support intervention for patients awaiting coronary artery bypass

surgery in London (Goodman et al., 2009). The trial failed to show that the

intervention could affect anxiety and depression, quality of life, length of

hospital stay, risk factors or postoperative fitness but might have an effect

on total costs through fewer readmissions in the intervention group. Their

qualitative study aimed to add to the evaluation of the intervention by

exploring the patients’ experience of waiting for surgery while taking part

in the trial as well as exploring staff views of both the intervention and the

patients’ descriptions of their experience.

In the qualitative study, a purposive sample of 19 patients was selected

from both intervention and control groups to be interviewed three months

after discharge with interview transcriptions read back to staff during focus

groups. The staff discussed what they had learned from the patients’

experience and their own experience of the intervention. The findings

showed that the patients appreciated the physical preparation and

psychological support for surgery from the nurses. However, the patients

varied in their understanding of the intervention and their degree of

motivation to improve their health. The staff reported varying in their

approach to preparing patients for surgery. It was suggested that engaging

patients fully with the intervention, tailoring information according to

54
individual needs, perceptions of staff competence in performing physical

assessment, and giving medical advice or referring back to the medical

team were important factors in how patients received the intervention.

These findings suggest a need for staff to improve communication both

between themselves and with their patients.

The data from the qualitative study provide insight into the process and

context of the intervention while the trial itself focused on the outcomes of

the intervention. Patients’ spontaneous responses and original comments

might be limited or missed by the use of structured quesionnaires in the

trial. Qualitative data are often used to explore the subjective meanings

behind survey responses and to develop quantitative measures and scales

which are more sensitive to respondents' meanings and interpretations

(Coyle and Williams, 2000). Some have suggested that evaluating the

context and process of the intervention should be considered as equally

important as the outcomes (Clarke, 2001, Warburton and Black, 2002).

Goodman et al.’s qualitative study exploring patients’ own views,

experiences or perceptions of the intervention implemented in the trial

through face-to-face interviews generated ideas for the development of a

qualitative evaluation in the present study. Recently, it has been

increasingly recognised that combining qualitative and quantitative

methods in health research can help understand more fully the world of

research subjects and capitalise on the strengths of different methods

(Coyle and Williams, 2000, Sale et al., 2002). Additionally, the issues

addressed in this qualitative study recommended several areas important

to explore for future research with cardiac surgery patients from different

cultural backgrounds, such as patients’ attitudes towards their health,

understanding of healthcare services, views on information provision, and

55
patients’ experience of taking part in a trial. They served as the basis for

fomulating the questions discussed during the interviews in the present

study.

3.10 Gaps and application of existing evidence

There is evidence that preoperative education interventions can lead to

positive postoperative outcomes for surgical patients in general, but less is

known about their effectiveness for patients undergoing cardiac surgery. A

review of randomised controlled trials published between 2000 and 2011

was conducted in order to analyse the existing evidence concerning the

effect of preoperative education among cardiac surgery patients. A total of

six randomised controlled trials were identified. The preoperative education

interventions in these trials were designed with a range of topic areas,

duration and frequency to compare with usual care. Among various forms

of preoperative education interventions designed for cardiac surgery

patients, few attempts have been made to evaluate the effectiveness of

verbal communication assisted with the use of written information.

The trials included in the review have produced conflicting findings about

the effectiveness of preoperative education for patients undergoing cardiac

surgery. Some trials have demonstrated the effects of preoperative

education on improving physical (McHugh et al., 2001) and psychosocial

recovery of cardiac patients (McHugh et al., 2001, Sørlie et al., 2007) while

others found no evidence that patients’ anxiety is reduced (Shuldham et

al., 2002, Arthur et al., 2000, Goodman et al., 2008) or of any effect on

pain (Shuldham et al., 2002, Watt-Watson et al., 2004) or hospital stay

(Shuldham et al., 2002, Sørlie et al., 2007, Watt-Watson et al., 2004).

Evidence of the effect of preoperative education among cardiac surgery

patients is inconclusive.

56
Most studies are conducted in Western countries. To date, no evaluation of

preoperative education interventions has been performed among Chinese

cardiac patients. Evidence generated from these existing studies cannot be

directly transferred to the Chinese context of healthcare delivery without a

more critical and context specific investigation as cultural and social factors

may influence patients’ responses to such interventions (Cheung et al.,

2003).

Evidence based practice can improve clinical decision making and quality of

patient care and treatment through the integration of best research

evidence with clinical expertise, patient preferences and resource

considerations (DiCenso et al., 2005, Akobeng, 2005a, MacPhee and Pratt,

2005). Decisions that are based on scientific clinical research, patient and

family preferences and clinical expertise instead of purely experiential

knowledge and intuition are considered to increase effectiveness, to

minimise the possibility of error and to standardise practice (Rashotte and

Carnevale, 2004, Parahoo, 2006). Despite the fact that clinical expertise,

patient preferences and specific contexts and situations have been

incorporated in the definition of evidence based practice, it appears that

best research evidence remains the core element of evidence based

practice (Mantzoukas, 2008). In defining the validity of evidence,

randomised controlled trials and systematic reviews of randomised

controlled trials are in essence the corner stone or the gold standard for

the evidence based practice movement (Walker, 2003, Rycroft-Malone,

2006, Berwick, 2005, Franks, 2004).

Given the conflicting results from the previous trials included in the review

and the inappropriateness of direct application of the existing evidence to a

57
Chinese context, there is a definite need for conducting well-designed trials

at Chinese hospitals to provide an evidence base of whether or not newly

developed preoperative education interventions are effective in reducing

anxiety and improving recovery among Chinese cardiac surgery patients.

In addition, the review has shown a lack of qualitative evaluation of cardiac

preoperative education interventions.

58
 CHAPTER FOUR

THE CONTEXT OF CARDIAC PREOPERATIVE EDUCATION IN CHINA

4.1 Introduction

The aim of this chapter is to provide the context, in particular that of the

delivery of preoperative education in China, within which this study has

taken place. The literature relating to patient education in Europe shows

that patient education seems to be mainly influenced by the characteristics

of the health care system (Albada et al., 2007, Visser et al., 2001).

Therefore this chapter starts with presenting an overview of the Chinese

healthcare system. This chapter moves on to describe how preoperative

education for cardiac surgery patients is delivered in Chinese hospitals.

Finally, the aim and objectives of the study are stated.

4.2 Healthcare in China

In the 1990s, China shifted away from the communist-model of free

healthcare system to a more capitalistic, entrepreneurial era and put most

of the financial burden to households and hospitals (Gao, 2005). Currently,

revenue from the sale of medicine is closely linked to the income of

hospitals and often the salaries of health care providers. Doctors therefore

have a financial incentive to prescribe medicines. Consequently, some

essential medicines, which are always affordable like penicillin antibiotics to

treat the basic healthcare needs of the population, have become replaced

by newer generation of cephalosporins due to low profitability of the former

drugs.

In the Chinese healthcare system, the increasing cost of medicines and the

limited availability of some essential medicines are preventing some people

from seeking medical help (Yang et al., 2010, Chen et al., 2010). The

Chinese Ministry of Health (Ministry of Health, 2004) conducted the third

59
National Health Service survey in 2003 and found that 48.9% of

respondents had not seen a doctor and 29.6% reported not being admitted

to hospital due to cost concerns. It is apparent that more than 500 million

Chinese will continue to find medical treatment out of their reach due to its

high cost (Ministry of Health, 2004). In response to this situation, the

Minister of Health - Gao Qiang (2005) pointed out that “The gap between

the need for healthcare services and the capabilities of current Chinese

health insurance and delivery system is still immense…Development of the

healthcare sector should depend on the government as well as the

market…”.

The Government is committed to increase healthcare spending and to

implement health reform in order to provide affordable, efficient, and high-

quality healthcare for hundreds of millions of Chinese, especially in rural

areas. Healthcare expenditures have been increasing in China, but still

remain low when compared to developed countries and even some other

developing countries. For instance, in 2009 China spent 4.6% of its gross

domestic product (GDP) on health with a total per capita expenditure on

health of about $309, compared with the UK’s 9.3% of GDP with total

health expenditure of $3,399 per capita in the same year (World Health

Organisation, 2011b). China having the largest population in the world

(over 1.3 billion) has a low total per capita healthcare spend.

Various forms of health insurance have been introduced to widen coverage

of health insurance in China such as Urban Employee Basic Health

Insurance Scheme (BHIS), New Rural Cooperative Medical System

(NRCMS), commercial and non-commercial forms of insurance. By the end

of 2004, BHIS covered more than 124 million people including employees

and retirees, and 34.1% of the employed population in the urban areas.

60
But vulnerable groups such as women, people on low income, employees

with short-term contracts, and rural-urban migrant workers may be left out

(Xu et al., 2007). The Chinese government initiated the NRCMS in 2003

aiming to reduce the financial burden on rural residents, which is a

government run, voluntary participation, community-based, and cost-

sharing medical insurance program (Shi et al., 2010, Dib et al., 2008). Shi

et al. concluded that the coverage of NRCMS was high but it was not

adequate to improve access to in-patient care and protect against financial

catastrophe and household impoverishment due to health payment,

especially for the poor and the chronically ill. Although to some extent

these health insurance schemes can enhance the access to and use of

health services, it is estimated that over half of healthcare costs in China

are paid by consumers’ out-of-pocket, which prevents people from seeking

medical care (Yuanli, 2002, Gao et al., 2001)

In China, the Ministry of Health (MOH) is responsible for making healthcare

laws, regulations and policies, adjusting the distribution of resources, and

enacting standards for professions as well as medical service quality. Local

Health Bureaus of provincial governments, city governments, and county

governments play an important role in the delivery and management of

medical services belonging to their own region. Broadly speaking, the

Chinese medical service system is complex and can be classified into the

following four kinds: outpatient clinics, community health centres, hospitals

and other (Ministry of Health, 2009, Technomic Asia, 2011).

There were nearly 289,000 medical facilities in China in 2008, of which

19,700 (7%) were hospitals (Figure 4.1), 25% were community health

centres, 66% outpatient clinics, and 2% other services. The latter included

the health and anti-epidemic stations under the leadership of the Ministry

61
of Health or Health Bureaus of local governments at provincial, city, or

county level as well as small sized medical stations. Community health

centres can perform limited diagnosis or testing while clinics provide basic

outpatient services. Hospitals provide a wide range of medical services and

include general hospitals, Chinese traditional medicine hospitals, and

specialist hospitals (e.g., maternity and child hospitals, cardiac surgery

hospitals, eye hospitals, or cancer hospitals) at provincial, city, or county

level (MOH, 2009, Technomic Asia, 2011).

Chinese Health Services

7% 2%
Outpatient Clinics

Community Health
25% Centres
Hospitals
66%

Other

Figure 4.1 Chinese health services

More than 90% of Chinese hospitals are government owned or socially

owned non-profit hospitals such as military hospitals, hospitals funded by

ministries, and university hospitals. Less than 10% of medical services are

privately owned or foreign invested health facilities (Ministry of Health,

2009). Those private profit medical centres and foreign hospitals play a

supplemental role and are guided by different policies (Liu, 2005). Their

target patient group is people from overseas or wealthy Chinese people.

The structures and quality of care between these medical services vary

greatly across the country due to different administrative management

according to their locations, grades and ownership.

62
4.3 The patients’ journey from admission to discharge when
undergoing cardiac surgery

With the rapid increase of cardiovascular disease in China, the Chinese

Government and Ministries of Health need to take national action to

increase financial resources for prevention and management of

cardiovascular disease and support the education and training of healthcare

providers in health promotion and risk reduction. Apart from disease

prevention, it is estimated that over 8 million Chinese are in need of

cardiac surgery with over 74,000 cardiac operations taking place in Chinese

hospitals each year (Pezzella, 2006, Zhang and Chen, 2007).

In order to explore how the usual preoperative education is practiced at the

cardiac surgical wards of the two study hospitals, it is important to have a

broad understanding of what processes people need to go through in China

after their heart problems occur. The journey a patient undergoing cardiac

surgery will typically face in China is different from that of many western

countries due to different health care systems. In China, individuals are not

registered with a general practitioner and there is little in the way of

appointment systems in Chinese hospitals. If people feel sick or have chest

pain, they will directly go to the outpatient department in the nearest

hospital where a nurse is responsible for deciding which specialist at the

outpatient department is appropriate for onward referral according to their

presenting symptoms.

After consulting with the specialist on the same day, the heart problems

might be identified and then possible treatment options would be

suggested. If the complex or serious heart problems could not be treated in

the local hospital, the specialist would refer them to other hospitals. If the

63
specialist considers that the patient needs to be hospitalised for further

observation or surgical procedures, the patient will be advised to directly

contact the cardiac ward in the inpatient department and arrange the

hospital admission as soon as possible. The outpatient service normally

ends at this point when patients decide whether they go ahead with the

specialist’s advice or not. The majority of patients visit the ward and talk

with the doctor on the ward before being admitted.

The admission process to Chinese hospitals is as quick and efficient as

possible and can take place on the same day of the initial consultation. As

patients have a choice as to which hospital they will receive treatment

from, they may wish to visit other hospitals at this point. Generally

speaking, the date and time of admission mainly depends on the

availability of the ward beds, patients’ requirements and preference as well

as the doctor’s recommendation. Emergency admissions normally come

through the emergency department and allow for little planning, with a

swift admission process and prompt in-patient assessment and treatment.

The doctor at the emergency department will inform the relevant ward in

order that preparations can be made and the appropriate tests can be

organised for the patient’s arrival.

Almost 75% of cardiac surgery patients have had some related

consultations and basic examinations from other hospitals before they are

admitted to the First Affiliated Hospital of Henan University of Science and

Technology and Luoyang Central Hospital which constitute the research

setting for the present study (First Affiliated Hospital of Henan University of

Science and Technology Records, 2009, Luoyang Central Hospital, 2009).

The journey taken by cardiac surgery patients from hospital admission to

discharge at the two study hospitals is illustrated in Figure 4.2. After

64
admission, the patient will be directed by the staff at the main reception of

the hospital to the cardiac surgery ward area if he or she is unfamiliar with

the hospital. Once arriving at the ward, a nurse will meet and greet the

patient and take them to their allocated bed. An introduction to the ward

layout, its facilities and routine will be explained by a nurse.

75% patients referred from other hospitals

25% from the hospital

outpatient department

Day 1: Admitted into the cardiac surgery ward

Day 1-10: Preoperative period for tests & preparation

(Normally 7- 10 days of hospital stay)

Visit from the surgeon &

anaesthetist 1 day before surgery

Day 11: Cardiac surgery (Normally 2-3 hours)

Day 11-12: ICU stay (Normally 24 hours)

Day 12-22: Return to the cardiac surgery ward

(Normally 7-14 days stay in hospital)

Day 23: Discharge from hospital

Full recovery at home

Figure 4.2 Typical journey of a cardiac surgery patient from

hospital admission to discharge

Each cardiac surgery ward accommodates about 60 patients. There is a

doctor available at all times and five to six nurses on duty in the daytime

and one nurse during the night. The duty doctor is in charge of all patients

and present on the ward. That is the first person for nurses and patients to

65
contact when needed. In addition, a routine morning meeting provides the

chance for all of the doctors and nurses to discuss each patient’s condition,

treatment and care. All patients, and where appropriate their relatives and

friends, are involved in the care process from the moment they are

admitted to the hospital. They are informed to contact nurses at the

nursing station whenever they want.

The patient may choose their own doctor. Otherwise the duty doctor on

admission will be allocated to him or her. The patient’s doctor will be

informed of the patient’s arrival on the ward as soon as possible, to allow

for prompt assessment, clinical examination and the ordering of any

relevant tests. All patients usually undergo cardio-coloured ultrasound and

if necessary, cardiac catheterisation, Computerised Tomography (CT), or

Magnetic Resonance Imaging (MRI). If the need for cardiac surgery is

indicated after these tests and examination, the doctor then discusses the

surgical procedures with the patient and their family and schedules a

surgery date with the operation theatre. The patient’s doctor may not

necessarily be the chief surgeon. The chief surgeon can be nominated by

the patient’s doctor or the patient. At the two study hospitals, it typically

takes around seven to ten days between the date of hospital admission and

surgery. Patients are required to stay in the hospital during this

preoperative period in order for them to be closely observed and prepared

for cardiac surgery. This potentially increases the risk of raised anxiety

during this extended preoperative period.

Once the surgery date is confirmed by the operation theatre, the surgeon

and anaesthetist will separately visit the patient one day before surgery.

These visits allow them to have a final assessment of the patient, inform

the patient about the surgery, discuss any questions the patient and family

66
members have, and obtain consent. At the two study hospitals, cardiac

surgery is normally performed in the morning, so skin and bowel

preparation will be made by the nurse the night before surgery. After that,

the nurse reminds the patient of the need for fasting for at least six to

eight hours before surgery.

After two or three hours of surgery, the patient will be transferred to the

Intensive Care Unit and stay normally 24 hours in the ICU before they can

return to the cardiac surgery ward. The doctor and nurses on the ward

continue to monitor the patient and help the patient to recover from

surgery until the doctor is satisfied with progress and the patient is

discharged. The majority of patients are discharged between seven and

fourteen days after surgery. Patients are reminded to return for regular

assessments if necessary, for instance monitoring and guidance of

medication dosages. Apart from that, the two study hospitals do not

provide cardiac rehabilitation programmes and subsequent care after

hospital discharge for their patients. After discharge from the hospital,

patients are left very much to their own care at home or are referred to the

local hospitals or outpatient clinics for wound care.

4.4 Preoperative education for cardiac patients at study hospitals

4.4.1 Information needs and lack of communication

With the improvement in health care in China, meeting the individual

patient’s needs and delivering patient centred care is recognised as

important aspects of nursing practice. A descriptive study of the

information needs of 83 Hong Kong Chinese patients undergoing surgery

emphasises that although there are social and cultural differences between

Chinese and western countries and different traditions regarding the

delivery of information and education, patients’ desire and needs for

67
information about surgery was fairly consistent (Henderson and Chien,

2004). Preoperative education providing preoperative information and

emotional support for Chinese cardiac surgery patients can help them

become more aware of what is going on in their overall treatment and

care. It can minimise physical, psychological and social factors that impact

on an individual and prepare them for surgery and postoperative recovery

(Liou et al., 2008).

Although the need for patient education prior to cardiac surgery is clear,

there are no current guidelines from Chinese national health organisations

regarding preoperative information needs for this group of patients. This

leads to more difficulties for health care providers to deliver preoperative

education for their patients at Chinese hospitals. Contemporary health care

in many western countries aims to reinforce the rights of patients to

information about their condition and treatment through the establishment

of the Patients’ Charters and other guidelines (Schmidt, 2007). Compared

with the United Kingdom, the United States, and other European countries,

the culture of healthcare delivery does not prioritise the provision of

preoperative education for patients in China. A lack of communication and

interaction between health care providers and patients in Chinese hospitals

is of key concern (Henderson and Chien, 2004).

My experience of working in the cardiac surgery ward at the First Affiliated

Hospital of Henan University of Science and Technology has indicated that

many cardiac surgery patients tend to be poorly informed about their

condition and surgery process prior to surgery. Patients undergoing cardiac

surgery are often fearful, anxious and feel stress during their preoperative

period, and require preoperative information and emotional support. Many

patients have impoverished financial conditions and in comparison to the

68
way cardiac surgical patients are managed in countries such as the UK, a

relatively long preoperative hospital stay may create new stressors and add

to their worries about existing disease and surgery. Preoperative education

is under developed in cardiac surgical care at Chinese hospitals. Cardiac

nurses have an important role in providing preoperative information, advice

and guidance to reduce patients’ anxiety and fears about surgery. How to

deliver preoperative information for their patients undergoing cardiac

surgery is a great challenge for nurses. The actual preoperative information

giving in current practice is usually given responsively, with relatively little

interaction between patients and cardiac nurses, and information rarely

supported by written information. It is not uncommon that patients

increasingly become anxious.

4.4.2 Cardiac preoperative education in nursing practice

Usually cardiac nurses at the two Chinese study hospitals do not provide

complete preoperative information for their patients. They place a low

priority on providing preoperative information compared to other clinical

duties, especially when faced with issues of time availability and heavy

workloads. Although patients normally stay more than one week in the

hospital before cardiac surgery, there is limited time for nurses to spend

with each patient on carrying out teaching activities due to the nursing

shortage in both hospitals. Limited time has been identified as the main

impediment to patient education in previous studies (Turner et al., 1999,

Tse and So, 2008, Marcum et al., 2002). Tse and So (2008) conducted a

descriptive cross-sectional study in 2005 to examine 91 nurses’ perceptions

of the importance of preoperative education for ambulatory surgical

patients in two public hospitals in Hong Kong. They found that 65.9% of

the nurses said that they did not often tell patients everything needed to

69
know and 81.7% ranked time availability as the most influential factor

affecting the amount of information provided to patients.

Although it is acknowledged that Hong Kong appears to be within a largely

western health care system, the mostly Chinese population creates a

strong traditional Chinese identity. The findings from Tse and So’s study in

Hong Kong (2008) shed light on current practice in the provision of

preoperative education at Chinese hospitals and the factors that affect

nurses’ provision of such teaching. In their study, approximately 60% of

the nurses thought that doctors were responsible for giving preoperative

information to patients. At two study hospitals, routinely the surgeon and

anaesthetist separately visit the patient before cardiac surgery. Nurses

may be uncertain about the contents of preoperative information that have

already been given or will be given by doctors, surgeons and anaesthetists.

Often they may assume that patients have already received sufficient

information from other health care providers if they do not ask. Thus

cardiac nurses tend not to give further information to patients unless they

raise questions and there is relatively little interaction between cardiac

nurses and patients. Turner et al.’s study of registered nurses’ perceptions

of teaching (1999) also found that nurses had difficulties in embracing the

role of patient educator and they often expressed confusion over their

responsibility for delivering education to patients.

The preoperative information given at present is often based on what the

health care providers feel the patients need and want to know rather than

exploring the patients’ perspective on what their information needs are for

the preoperative period. Evidence from Mordiffi et al.’s study (2003) of

information provided versus information needed by surgical patients and

two case studies of current preoperative teaching practice in a surgical

70
ward in Hong Kong (Lee and Lee, 2000, Lee and Chien, 2002) suggest a

lack of congruence between nurses’ perceptions of patients’ preoperative

needs and actual need. At two study hospitals, it is also recognised that the

preoperative information routinely given may not address individual

patients’ needs. A gap may exist between what surgical patients want to

know of their condition or treatment and what their doctors or nurses think

they should know, as health care providers tend to underestimate patients’

desire for information (Keulers et al., 2008). Thus health care providers

should not assume patients’ information needs have been met and

patients’ perspective of preoperative education and information needs

should be explored (Goodman et al., 2009, Ivarsson et al., 2007, Attree,

2001).

4.4.3 Preoperative teaching resources and interventions

The cardiac surgery wards of two study hospitals have limited teaching

resources to assist health care providers for preoperative education. The

resources available include wall posters and heart models to help doctors

to explain the function of heart and the risks and effects of cardiac surgery,

but there are no leaflets, booklets or videos explaining what to expect once

patients are admitted to the hospital and how to prepare for surgery.

Verbal communication is the most common method and perhaps is the only

way for nurses to deliver information to their patients in current practice. A

study interviewing twelve experienced surgical nurses about how the usual

preoperative education is practised at one particular hospital in Ireland

(Fitzpatrick and Hyde, 2005) revealed that the use of teaching tools

depends on their availability and the practice of individual nurses. In line

with the findings reported by Tse and So (2008), 91% of the nurses

preferred to use face-to-face oral explanations as a method of information

delivery and seldom used other teaching methods, suggesting that limited

71
teaching resources may have affected the amount of information delivery

and hence the quality of care.

Verbal communication combined with other teaching resources such as

written materials or videos can assist Chinese cardiac surgery patients in

understanding the surgical preparation, postoperative care in hospital and

subsequent post-discharge care. In a study by Liou et al. (2008), 91 adult

patients preparing for coronary artery bypass grafting surgery in Taiwan

were randomly allocated to a video-tape viewing group or to a teaching

booklet group. Each form of preoperative education was followed by an oral

explanation of respiratory and leg exercises, pain management, and early

ambulation. The study demonstrated that preoperative instruction with

video-tape was similarly effective as teaching booklets on patients’

perceived stress, perceived helpfulness and recovery.

There is a need to increase health care providers’ motivation to develop

cardiac specific teaching resources and try structured preoperative

education interventions through the use of these resources for cardiac

patients at Chinese hospitals. It is essential that health care providers can

demonstrate evidence about the effectiveness of these newly developed

resources or interventions through rigorous research in order to identify

the best way of providing preoperative education in improving quality of

care.

In summary, patients undergoing cardiac surgery are often fearful, anxious

and under stress during their preoperative period, and desire preoperative

information. However, under the unique characteristics of health care

system and health services in China, the culture of healthcare delivery does

not prioritise the provision of preoperative education for patients. The

72
actual preoperative information giving in current practice is limited, with

relatively little interaction between patients and cardiac nurses, and

information rarely supported by written information. To improve the quality

of preoperative education for Chinese cardiac patients in nursing practice,

the development and evaluation of new cardiac specific teaching resources

and interventions is called for.

4.5 Research aim and objectives

This study aimed to evaluate the effects of a preoperative education

intervention designed for Chinese cardiac surgery patients on anxiety and

recovery. More specifically, the objectives of the study were

(1) to determine whether provision of a preoperative education intervention

comprising an information leaflet and verbal advice could reduce

anxiety among Chinese patients undergoing cardiac surgery.

(2) to assess whether this form of preoperative education could reduce

symptoms of depression, decrease perceived pain, and shorten the

length of ICU and postoperative hospital stay.

(3) to explore patients’ perceptions of and attitudes towards preoperative

education and experiences of participating in the study.

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 CHAPTER FIVE

METHODS

5.1 Introduction

This chapter describes the methods of the Cardiac Preoperative Education

Intervention Study. This was a randomised controlled trial to test the

effectiveness of a preoperative education intervention (comprising an

information leaflet and verbal advice) in reducing anxiety and improving

postoperative recovery among Chinese patients undergoing cardiac surgery

at two public hospitals in Luoyang, China. Qualitative interviews were also

conducted to explore patients’ attitudes towards preoperative education

and experiences of taking part in the trial.

The following sections describe the study design and report the eligibility

criteria for entry into the trial, the process of identifying, recruiting and

consenting participants and recording baseline measures. The process of

randomisation and the components of the intervention are described, and

the follow-up process to endpoint of the trial is explained. The qualitative

evaluation is described including the access to, and sampling of

participants, the methods of interview data collection and data analysis are

provided. The last section of this chapter discusses the ethical

considerations made in connection to the design and implementation of the

study.

5.2 Study design

A randomised controlled trial was considered to be the most appropriate

way to evaluate the effectiveness of a new intervention. This Cardiac

Preoperative Education Intervention Study was a two-centre randomised

controlled trial. In this trial, participants in each centre were individually

randomised to one of two ‘parallel’ groups. Randomisation is the most

74
robust method of preventing selection bias, and adjusting for known

confounders such as age, sex, and stage of disease, as well as unknown

confounding factors. The two groups were treated and observed identically

apart from the intervention received, so that any differences detected in

outcomes might be explained only by the intervention (Akobeng, 2005b).

The aim of the trial was to compare usual care alone with usual care plus a

preoperative education intervention comprising an information leaflet and

verbal advice among Chinese patients undergoing cardiac surgery. More

specifically, the objectives of this trial were to determine whether providing

this form of preoperative education to cardiac surgery patients reduces

anxiety, depression, pain, and accelerates postoperative recovery.

Randomised controlled trials are considered to represent the ‘gold standard’

or the most valid evidence on the effectiveness of interventions or

treatments (Mantzoukas, 2008, Benton and Craib, 2001). This is achieved

by applying strict methodological rules of objectivity and control of

contextual variables such as objective observation and precise

measurement (Weaver and Olson, 2006). The findings generated by

properly conducted randomised controlled trials are likely to be closer to

the true effect than the findings from other research methods (Evans, 2003,

Craig and Smyth, 2002).

In a positivist world view, there should be strong associations between

paradigm, methodology and methods, consequently such a view considers

different methodologies and methods as incompatible and their

combination logically impossible (Bazeley, 2004). However, randomised

controlled trials cannot explain the complexity of daily practice and provide

answers on why and how interventions work by understanding individual

patient perceptions and experiences of specific interventions (Rolfe and

75
Gardner, 2006). The reality of practice appears to be much closer to the

interpretive or constructive and postmodern paradigms which focus on

meaning and understanding the phenomenon and at the same time

acknowledge the influences of the researcher and the research process and

context on the subject being studied (De Simone, 2006, Coyle and Williams,

2000).

While the trial investigated the outcomes affected by the intervention, a

qualitative evaluation was included to probe deeper to make sense of

findings generated by the quantitative data. The evaluation explored

patients’ views on preoperative education, emotional responses to heart

disease and surgery, and experiences of taking part in the trial through

interviews. It is emphasised that philosophically the qualitative and

quantitative paradigms are not as diverse or mutually incompatible as

often conveyed (Clark, 1998, Gillies, 2002, Burnard and Hannigan, 2000).

Each method may have placed a different emphasis on the relative merits

of the different approaches but quantitative and qualitative methodologies

study different phenomena and encourage or allow expression of different

facets of knowledge. If one takes this view then both can be combined in a

single study for seeking complementarity which is considered both

philosophically and practically sound (Sale et al., 2002, Fraenkel and

Wallen, 2006, Burnard and Hannigan, 2000).

From a pragmatist’s point of view, the diversity of truths is reachable

through different forms of inquiry and a plurality of methods (Bryman,

2001, McCready, 2010). The inability to definitively exclude one approach

from another has implications for the acceptability of mixing qualitative and

quantitative research methods, although paradigmatic debates continue to

exist (Bazeley, 2004, Johnson and Onwuegbuzie, 2004). As Burnard and

76
Hannigan (2000) suggested, perhaps the debate should not be about the

primacy of one research method over another but that methods are chosen

according to the questions addressed.

Combining qualitative and quantitative methods is often considered to be in

an attempt to serve the dual purpose of generalisation and in-depth

understanding – to gain an overview of social realities (Bazeley, 2004).

Having adopted a pragmatic approach, the design of the Cardiac

Preoperative Education Intervention Study is illustrated in Figure 5.1.

Eligibility assessment by doctors

Initial approach and informed consent by PG

Baseline assessment by PG

Randomisation by PG

Preoperative education by PG Usual care by ward nurses

Cardiac surgery

Follow-up measures by ward nurses

Qualitative interviews by PG

PG: Ping Guo

Figure 5.1 The design of the cardiac preoperative education

intervention study

5.3 Settings

The study took place in the cardiac surgical wards of two public hospitals in

my home city Luoyang, Henan province, China: the First Affiliated Hospital

of Henan University of Science and Technology and Luoyang Central

Hospital. Both hospitals are tertiary health care and urban teaching

77
hospitals with 1200 beds each. At each hospital approximately 300 cardiac

surgical procedures are performed each year. I obtained access to each

hospital by initially telephoning the hospital manager and director of

nursing as a preliminary notification to explain about the overall research

project and then emailing them to state the research aim and objectives,

proposed methods and potential contribution from the research.

China is one of the world’s largest countries with 9.6 million square

kilometres and a population of about 1.37 billion in 2010. Henan province

is located in eastern central China, on the plain between the Yellow and

Huaihe rivers and includes 18 cities (Figure 5.2). It covers an area of

167,000 square kilometres and is similar to the size of England, Wales, and

Northern Ireland together. According to Henan government statistics

(2009), Henan has the largest population of the 22 Chinese provinces. At

the end of 2007 its total population stood at 98.69 million (the population

of the UK was estimated to be 60.98 million in July of 2007 according to

National Statistics).

Henan is the 5th largest provincial economy of China and the largest

among inland provinces in 2009 with its nominal GDP of about 2.29 trillion

RMB (US$339 billion), although it ranks nineteen in terms of GDP per

capita of the 22 Chinese provinces (Wikipedia, 2011). In relation to public

health, at the end of 2005, there were a total of 14,536 medical and

healthcare centres equipped with 212,000 beds and staffed with 287,000

medical professionals and technicians in Henan province. In addition, there

were 184 centres for disease control and prevention, staffed with 14,000

professionals and technicians (Henan Government, 2009).

78
Luoyang, where the study setting is located, is the second largest city in

Henan province, with a population of 6.46 million at the end of 2006. It

covers 15,208 square kilometres and is slightly bigger than Northern

Ireland. Luoyang borders the provincial capital of Zhengzhou to the east

and administers six districts of Luoyang city, one county-level city and

eight counties (Figure 5.3). Luoyang is one of the Eight Great Ancient

Capitals of China, having more than three thousand years history. It is a

major industrial city in China and also plays an important role in history,

culture, and scientific knowledge (Luoyang Government, 2009). The two

study hospitals are located close to the city centre and provide

comprehensive health care services mainly for the residents of Luoyang.

Henan Luoyang Zhengzhou

Figure 5.2 Locations of Henan province and Luoyang

Mengjin county

Xin’an county 6 districts of Luoyang city

Yiyang county 1 County-level city: Yanshi

Luoning county Yichuan county

Song county Ruyang county

Luanchuan county

Figure 5.3 Administration map of Luoyang

79
5.4 Participants

5.4.1 Inclusion criteria

All adult patients (18 years old or above) undergoing any type of elective

cardiac surgery were eligible for the trial if they were able to speak, read,

and write Chinese. For the purposes of the trial, ‘cardiac surgery’ was

defined as including coronary artery bypass grafting, valve surgery,

congenital and other open heart surgery. Heart transplants are not

performed at the two hospitals where the study took place. Patients who

fell into the category of emergency cases and those who had undergone

cardiac surgery on a previous occasion were excluded from the study.

5.4.2 Initial approach and informed consent

Typically, patients who require cardiac surgery are admitted seven days

prior to the surgery to facilitate nursing and medical assessments, tests,

and preparations. Patients eligible to participate in this trial were identified

by the duty doctor responsible for providing diagnostic assessment. I

contacted potentially eligible patients to confirm whether or not they met

the inclusion criteria and then invited them to participate in the trial

typically on the second or third day following hospital admission.

During this initial approach, I distributed an information sheet (Appendix 1)

to the patient and the study was explained verbally in order to ensure that

the patient received and understood the salient information at this point.

Each patient was explicitly advised that inclusion in the study would not

alter their treatment or duration of preoperative hospital stay, and that if

they decided to participate they could freely withdraw from the study at

any time.

80
Following the explanation of the purpose of the study and process of study

involvement, patients were asked if they would consent to participate. I

then asked those patients willing to take part in the study to sign a written

consent (Appendix 2). Patients were not asked to give consent in the initial

approach as it was considered important to make sure that patients had

enough time to read the information sheet, think about participation, and

discuss it with their family members or friends if they wish.

5.5 Baseline assessment

Once written consent was obtained, I carried out baseline assessments.

The contents of the baseline assessment included patient socio-

demographics, presence or absence of co-morbidities, type of surgery,

previous hospitalisation, blood pressure, heart rate, anxiety, depression,

and pain (Table 5.1). Firstly I conducted a face-to-face interview with each

participant to obtain the participant’s characteristics. The participant was

then asked to self-complete the HADS and BPI questionnaires to avoid

interviewer bias. An envelope was provided for the participant to return the

questionnaires, thereby ensuring privacy and confidentiality. In this trial,

the questionnaires were distributed by hand to reduce cost and improve

the response rate.

Table 5.1 Contents of baseline assessment

Contents Questionnaires Number Mode Completed

of items of completion by

Patient Demographic information 6 Face to face interview PG

characteristics Clinical information 4 Face to face interview
Physical assessment 5 Medical records
Anxiety & HADS: Self-completed Participant
depression Anxiety subscale 7
Depression subscale 7
Perceived pain BPI: Self-completed Participant
Pain severity subscale 4
Pain interference subscale 7

PG: Ping Guo

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5.5.1 Patient characteristics

Participants’ characteristics (Appendix 3) were gathered by asking a list of

questions involving socio-demographic information (such as age, gender,

marital and living status, education level, employment) and clinical

information (such as type of surgery, co-morbidities, and any previous

hospitalisation or operation history). In addition, the participant’s physical

assessment at admission including systolic blood pressure, diastolic blood

pressure, heart rate, height, and weight was obtained by reviewing the

individual medical records.

5.5.2 Anxiety and depression

Anxiety and depression was measured by using the Hospital Anxiety and

Depression Scale (HADS), a self-reported instrument developed by

Zigmond and Snaith. It was initially validated against formal psychiatric

interviews in hospital out-patients (Zigmond and Snaith, 1983). HADS

consists of 14 questions, seven relating to anxiety (anxiety subscale) and

seven to depression (depression subscale). Each question has four

response categories, with a possible score of 0-3, and the HADS produces

scores on each subscale ranging from 0 to 21, with higher scores indicating

a greater degree of anxiety and depression (Appendix 4).

The HADS has been found to be a reliable and valid instrument in previous

studies, not only for detecting states of anxiety and depression in the

setting of a hospital medical out-patients clinic but also for detecting and

managing patients’ emotional problems in medical and surgical

departments (Shuldham et al., 1995, Snaith, 2003, Zigmond and Snaith,

1983). In addition, the HADS has been validated for use in native Chinese

patients in general hospitals. The Chinese-Cantonese version of it was

found to have good internal consistency and external validity, with

82
favourable sensitivity and specificity for screening for psychiatric disorders

(Leung et al., 1999, Lam et al., 1995).

5.5.3 Pain

Perceived pain was measured with the Brief Pain Inventory-short form

(BPI-sf) (Cleeland, 1989). It is a 11-item questionnaire that consists of a

pain severity subscale to rate pain severity in four domains (worst, least,

average and right now) and a pain interference subscale to measure the

perceived degree to which pain interferes with daily activities in seven

functional domains (general activity, mood, walking ability, work, relations

with others, sleep, enjoyment of life) (Appendix 5). Each item is rated with

a 10cm visual analogue scale, where ‘0’ indicates ‘none’ and ‘10’ indicates

‘worst imaginable’. Patients were asked to rate their pain by circling the

one number that best describes pain at its worst and least in the past 24

hours as well as on the average and right now, and to circle the one

number that describes how, during the past 24 hours, pain has interfered

with for example, their general activity.

The BPI-sf has been used to quantify the burden of painful diabetic

peripheral neuropathy in previous studies in the USA (Gore et al., 2005,

Zelman et al., 2005b, Zelman et al., 2005a) and in Asia, Latin America,

and the Middle East (Hoffman et al., 2009). The Chinese version of the

BPI-sf is a reliable and valid measure of pain among patients with cancer

(Ger et al., 1999, Wang et al., 1996). The intraclass correlation coefficient

for the test-retest reliability was 0.79 for the pain severity subscale and

0.81 for the pain interference subscale. The coefficient alpha for the

internal reliability was 0.81 for the pain severity subscale and 0.89 for the

pain interference subscale (Ger et al., 1999).

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5.6 Randomisation and blinding

After baseline assessment, participants were randomly allocated to one of

the two arms of the trial, usual care or usual care plus preoperative

education. Allocation was determined by a stratified block randomisation,

with random block size and stratified by the two study hospitals. To ensure

there was distance between the preparation of the randomisation list and

the actual random assignment of participants, the randomisation list was

generated by my supervisor (AA) who had no contact with study

participants. Stratified block randomisation was used to assign participants

to either preoperative education group or usual care group. The two strata

were the First Affiliated Hospital of Henan University of Science and

Technology and Luoyang Central Hospital. The ‘ralloc’ command in Stata

version 9.2 was used to assign randomly allocated treatments in block

sizes of 2, 4, 6, 8 and 10. The size of each block was determined randomly

and in unequal proportions to elements of Pascal’s triangle (1:4:6:4:1).

This prevented too great an imbalance in the number of participants

allocated to each arm and avoided the risk of being able to predict the

allocation in advance (Pocock, 1983).

Randomisation was implemented using a series of consecutively numbered,

opaque, sealed envelopes. Each envelope contained a study number and

the arm of the trial to which the participant was to be allocated. The

envelope was opened in the presence of the participant after baseline

assessment was completed. Participants had an equal chance of being

randomised into the preoperative education or the usual care arm of the

trial. Following the assignment to study group, it was explained to the

participant in greater detail what would be expected of them.

84
It was not possible for participants to be blind to their allocation. The

baseline data were collected by me who was also aware of each individual

allocation. However, taking baseline measures prior to randomisation and

having no role in determining the patients’ readiness for discharge from the

ICU or from the hospital would reduce my potential bias. The surgeons and

nurses involved in the care of the patients who participated and therefore

able to influence outcomes were not made aware of the group the

participant had been randomly assigned to. However it was possible that

the participant may have brought it up in conversation that she or he had

been given the preoperative education intervention. In order to minimise

this influence, participants in the preoperative education group were asked

not to inform clinical staff about their allocation during the trial.

5.7 Interventions

5.7.1 Usual care

Both study hospitals are teaching hospitals and care provided in the two

cardiac surgical wards was similar. All participants in the trial received

usual care. It consisted of two separate visits from the surgeon and

anaesthetist one day before surgery. These visits constituted the main

opportunity whereby patients and family members could gain information

related to the general process and risks of their surgery and anaesthesia,

the use of analgesia and/or pain management. During these visits, the

surgeon and anaesthetist would respond to specific concerns of the patient

or their family and obtain informed consent for the proposed surgery and

general anaesthesia. Additional information was available from the ward-

based cardiac nurses though this tended to be responsive rather than

proactive. No written materials were available for patients’ use, nor were

there any guidelines for nurses to standardise the information given to

patients.

85
5.7.2 Preoperative education

For patients randomly allocated to the preoperative education intervention

group, I delivered the preoperative education intervention. This

intervention took place in a quiet area on the ward where patients were

unlikely to be disturbed following randomisation (at least two to three days

before surgery). It comprised an information leaflet ‘Your Heart Surgery’

written in Chinese (Appendix 6) together with approximately 15 to 20

minutes of verbal advice.

Creating written preoperative education materials for cardiac surgery

patients, like other aspect of nursing work, should be guided by evidence. I

designed this leaflet specifically for Chinese cardiac pre-surgical patients,

their family and friends after reviewing previous literature around patient

information leaflet development (Walsh and Shaw, 2000, Dixon-Woods,

2001, Mancunian Health Promotion Specialist Service, 1997). Ivnik and Jett

(2008) suggest the basic principles which are an adequate staring point in

the process of developing a new leaflet or handbook such as considering

who needs to be involved (collaboration), why is the leaflet needed

(purpose), what messages need to be conveyed (content), and how will it

look (design).

The final version was reviewed using a leaflet evaluation checklist by ten

representatives of Chinese cardiac surgery patients and five clinical experts

regarding its content, technical characteristics and practicability (Appendix

7 and 8). These patients and experts thought that the leaflet was suitable

for Chinese patients undergoing cardiac surgery and it covered useful and

relevant information that patients would want to know. In particular, all ten

cardiac patient representatives found that the style of language was

86
appropriate and the words used in the leaflet could be easily understood.

Some patients suggested that a little red heart symbol could be used at the

beginning of every paragraph to make the leaflet easy to read and more

attractive, and that more content was needed relating to recovery at home.

According to their feedback, the leaflet was then edited before use within

the trial.

The leaflet was in the form of a double-sided A4 page, formatted so that it

could be gate-folded into three to allow ease of use and printed in colour.

Illustrations were used to improve clarity and understanding. The contents

of the leaflet included pertinent procedural, sensory temporal and

instructional information throughout the patients’ journey from the

preoperative phase until discharge (St. Mary's General Hospital Regional

Cardiac Care Centre, 2003, Johnston and Charboneau, 2000, Margereson

and Riley, 2003). It was divided into several short sections under the

headings: preoperative tests and preparation; the stay in the Intensive

Care Unit (ICU) after surgery; returning to the cardiac surgical ward; and

recovery at home. The leaflet also provided a contact number to call for

further help after discharge from hospital if required. It was designed to be

short, simple, and suitable for application by clinical staff (Huebler, 2007).

The exact timing for the delivery of the intervention was arranged so that

family members and friends could be present if desired by the patient. The

intervention began with me welcoming the participant and (where present)

family members, and giving them the information leaflet. The participant

was given time to browse the leaflet. Then each section of the leaflet was

explained in turn, practical advice was offered and any questions the

participant had were discussed. The components of the preoperative

education intervention are summarised in Table 5.2.

87
Table 5.2 Components of the preoperative education intervention

Discussion of topics Information covered

Introduction Welcome the participant and their family members.

Distribute the leaflet and allow a few minutes to read it through.
Start to talk through the sections of the leaflet.

Patients’ journey Explain the process from admission, preoperative care, operation time,
(Diagram) postoperative recovery, discharge, and full recovery after discharge.

Preoperative Demonstrate preoperative procedure including

preparation a) Blood and urine analysis, chest X-ray, and electrocardiography;
(Diagram) b) Visit from the surgeon and anaesthetist;
c) Preparations a night before the surgery (gastrointestinal tract &
skin);
d) Preparations in the morning of the surgery (removing jewelry or
prostheses, donning a hospital gown, and giving medications);
e) Transporting to operation room, administration of anesthesia.

Postoperative Introduce ICU environment and explain about

expectation a) Uncomfortable feelings;
b) Equipment used such as cardiac monitors, different catheters, chest
tubes, and ventilator;
c) Communications with clinical staff within patients’ limitations;
d) Advice regarding pain management and early mobilization, diet, deep
breathing, coughing and leg exercises;
e) Discharge, rehabilitation and medication after discharge, lifestyle
change, and general check-up;
f) Contact details.

Further advice Answer any queries about the information provided.

Encourage to reread the leaflet afterwards and to ask for clarification or
seek further information about any of the content of the leaflet when
necessary.
Remind the participant to put the leaflet back in the envelope after use
and not to pass it to others.
Inform the follow-up measure will be taken on the postoperative 7th
day.

Concluding remarks Thanks for attending.

Express best wishes for the forthcoming surgery.

The design of the intervention administered in the trial was underpinned by

adult learning theory. It was underpinned by the following elements: (1)

supplementing usual care with written information; (2) structured oral

preoperative education using the leaflet as a way of facilitating this; (3)

explaining the process of being hospitalised at the cardiac surgery unit and

preparation for the operation; (4) discussing uncomfortable feelings likely

to occur after the operation; (5) encouraging the expression of feelings and

concerns the participant deemed important and answering questions; and

(6) developing a trusting relationship and mutual respect during the

process of the preoperative education intervention.

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Adult learning theory refers to a collection of several concepts and theories

that explain how adults learn such as social (cognitive) learning theory,

transformational learning theory and self-directed learning theory. Adult

learning has been considered as a process that adults engage in, which

results in a relatively long-term change in the domains of attitude,

knowledge, and behaviour (Smith, 2002a, Yannacci et al., 2006, Yang,

2004). Based on adult learning theory, the intention of the intervention

was to reduce patients’ anxiety and improve recovery, and enhance

patients’ self-regulation and capacity for cooperation with healthcare

providers through active involvement in their own health management and

care.

In order to minimise possible contamination between the two arms of the

trial, a copy of the leaflet was put into an envelope for the participant to

take away. Each participant was asked not to share it with other patients

on the ward. The features of usual care and preoperative education

intervention are described in Table 5.3. It provided a clear comparison

between usual care and preoperative education regarding the general

description, form, key content, use of written materials, mode and timing

of delivery (Smith et al., 2010, Glasziou et al., 2010).

89
Table 5.3 The features of usual care and preoperative education

Element Usual care Preoperative education

General description Unstructured verbal Leaflet based advice, explanation

information only and discussion
Form Two separate visits from the Distribution of an information
surgeon and anaesthetist leaflet ‘Your Heart Surgery’ and
Responsive information from provision of 15-20 minute verbal
the cardiac nurses on the ward advice

Key content General information about the Specifically tailored procedural and
surgery and anaesthesia instructional information
throughout cardiac surgery
patients’ journey from admission,
preoperative tests and
preparation, postoperative ICU
and ward stages, till recovery after
discharge from hospital.

Use of written None The information leaflet with simple

materials texts and diagrams handy for
quick reference

Mode of delivery Different staff members Specialist cardiac nurse

Timing One day before surgery At least two to three days before
surgery

5.8 Outcome measures

Three commonly used outcomes for evaluating the effectiveness of

preoperative education interventions among cardiac patients were

consistently used in the trials reviewed (Goodman et al., 2008, McHugh et

al., 2001, Shuldham et al., 2002, Sørlie et al., 2007, Arthur et al., 2000,

Watt-Watson et al., 2004). They included (1) psychological distress

measured by medication use and/or stated anxiety levels; (2)

postoperative pain measured by analgesic use and/or pain-rating scales;

and (3) the rate of recovery measured by the length of stay and/or rate of

postoperative complications. However, the findings were conflicting.

Therefore these outcomes were re-examined in the present trial.

Follow-up measures were assessed on the seventh day after surgery by a

cardiac nurse who was blinded to group assignment. The primary outcome

was change in anxiety as measured by the anxiety subscale of the HADS

between baseline and follow-up. As the intervention was designed to

90
decrease psychological stress for cardiac surgery patients through the form

of preoperative education, anxiety as a measure of psychological health

became the main focus of the trial. The secondary outcomes were change

in symptoms of depression measured using the depression subscale of the

HADS, change in pain as measured by the BPI-sf, length of ICU stay and

postoperative hospital stay. A range of secondary outcome measures were

chosen in recognition of the complex nature of the preoperative education

intervention. Follow-up measures consisted of issuing the same

questionnaires of HADS and BPI-sf to the participants from both arms of

the trial seven days after open cardiac surgery (the endpoint of the trial).

Data gathering on this occasion was undertaken by a nurse who was

blinded to group assignment, as my physical presence may have affected

responses from the participant.

The time point of the seventh postoperative day was chosen since

determining whether the preoperative education intervention had any

ongoing effectiveness was considered to be more important than assessing

the effects of the intervention immediately after its completion. In addition,

this allowed patients to have recovered sufficiently from surgery to be able

to concentrate on the questionnaires and for the experience to be fresh in

their mind. In cases where the participant was still in the intensive care

unit at seven days after surgery then these questionnaires were given

three days after transfer to the ward. For participants who were discharged

without surgery, had care transferred, or died prior to their follow-up

measures, then the date of leaving from the ward or the date of death was

treated as the endpoint.

Data for the length of Intensive Care Unit (ICU) stay and postoperative

hospital stay were obtained from the individual medical records at

91
discharge. The ICU stay was the actual number of hours the participant

spent in the Intensive Care Unit and postoperative hospital stay was

calculated from the day of surgery until hospital discharge. Because the

disparity in the length of wait for operation in hospital varied largely,

postoperative hospital stay was considered more accurate and appropriate

to show the speed of recovery.

5.9 Sample size and statistical analysis

5.9.1 Sample size

A power calculation was based on the primary outcome of anxiety score on

the HADS. Other studies (Arnold et al., 2009) have demonstrated that a

difference of two points on the HADS anxiety score between trial arms

constitutes a clinically meaningful change in anxiety. Assuming a standard

deviation of four points as observed in previous studies (Arnold et al.,

2009), it was calculated that 63 participants were needed in each arm to

have 80% power at a significance level of 0.05. Therefore it was planned to

recruit a total of 148 participants in order to allow for a 15% attrition rate.

5.9.2 Data management

Data from the trial were entered into an Access database and checked,

blind to the participant’s group. Firstly, each questionnaire was examined

for missing responses. The HADS produced one overall summative score

for anxiety and another for depression, while the BPI-sf comprised of a

series of domains that did not produce one overall summative score and

are presented separately.

It is acknowledged that multiple testing, where a set, or family, of

statistical inferences is considered simultaneously, can create problems of

artificially increasing the chance of a significant finding (type I error). In

92
order to prevent this from happening, an a priori approach was taken for

the analysis of the pain outcome. It involved analysing six selected

domains on the BPI-sf which were identified to be most relevant (average

pain and current pain on pain severity subscale, and general activity,

mood, walking ability, and sleep on pain interference subscale).

5.9.3 Data analysis

Analyses were carried out blind, with the groups known as ‘arm 1’ and ‘arm

2’. The use of a strict intention to treat analysis is impossible in cases of

missing data such as loss to follow-up (Abraha and Montedori, 2010). All

participants who completed follow-up were analysed as part of the group to

which they were randomised and those lost to follow-up were excluded

from analyses.

Descriptive statistics were used to summarise baseline characteristics

including demographic and clinical information including age, gender,

marital status, employment status, education level, and type of surgery

(Rugg, 2007). Categorical variables are presented using frequencies and

proportions, and continuous variables using means and standard deviations

(SD). Independent-samples t-tests were used for anxiety, depression, pain

outcomes, and non-parametric Mann-Whitney U tests for length of stay

outcomes.

Linear regression models were used to compare anxiety, symptoms of

depression, and pain scores between the two groups at follow-up after

adjusting for baseline score, age, gender, education level, and surgery type.

Taking anxiety (the primary outcome) as an example, a linear regression

model was performed whereby anxiety score on the HADS at seven days

after surgery was the dependent variable, and baseline anxiety score, age,

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gender, education level, surgery type, and treatment group were used as

independent covariates. These covariates were chosen a priori to avoid

‘data dredging’.

Data were checked to ensure that they met the assumptions required for

linear regression analysis. Both adjusted and unadjusted results are

reported (Petrie and Sabin, 2000). All reported P values are two-tailed,

with P<0.05 considered as significant. The analyses were performed using

SPSS version 16 (Bryman and Cramer, 2005).

5.10 Qualitative evaluation

If the trial provided evidence of the effect of the cardiac preoperative

education intervention on a range of health outcomes, it would be of

limited value to know that the intervention was successful without knowing

why and how this particular intervention ‘worked’. The qualitative

evaluation aimed to add a qualitative perspective to the trial by exploring

patients’ thoughts and feelings about preoperative information and

education and their experience of taking part in the trial. It was hoped that

through the qualitative evaluation, an in-depth understanding of the

intervention might be obtained and factors potentially influencing

intervention outcomes explored. As suggested, qualitative evaluations can

help to understand ‘why an intervention fails or has unexpected

consequences, or why a successful intervention works and how it can be

optimised’ (Craig et al., 2008).

In the Cardiac Preoperative Education Intervention Study, while the trial

generated quantifiable data on the outcomes of the intervention,

qualitative interviews were conducted to provide valuable insight into the

content, process and context of the intervention implemented and enrich

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understanding of patients’ experience of taking part in the trial by listening

to what patients said they desired, wanted and needed and drawing

together descriptions of their experience of illness and treatment (Oakley

et al., 2006, Gillies, 2002, Holloway and Wheeler, 2002). The qualitative

evaluation was crucial for truly understanding the context and possible

reasons for the outcomes of the intervention obtained from the trial and

promoting evidence-based decision making about the improvement of

practice in preoperative education in China.

It is recognised that qualitative research is able to capture the patient

perspective of healthcare by insightful interpretations and to enable health

care providers to understand how patients perceive health services

(Bryman, 2001). As a result, qualitative approaches have been increasingly

used in health care research to complement or expand the knowledge base

of health care obtained from quantitative methods, to influence health

policy at a local, national and international level, and to help to improve

patient care (Warburton and Black, 2002). Philosophically, although there

is the ongoing argument that qualitative and quantitative methodologies

come from different philosophical backgrounds and researchers should stay

within one paradigm, many researchers including nurses and doctors tend

to take a more pragmatic view and carry out mixing research methods

across paradigms (Miller and Fredericks, 2006, Johnson and Onwuegbuzie,

2004, Chatterji, 2004).

The existing literature has indicated a lack of knowledge concerning cardiac

patients and their experience of preoperative education. In such

circumstances, in-depth interviews were considered as an essential means

of developing the knowledge base on a relatively unexplored phenomenon

(Holloway and Wheeler, 2010). Specifically, the purpose of gathering data

95
by means of interview was to capture the thoughts and feelings of the

participants, and to document in their words their health care experience.

An inductive research approach was used to conduct semi-structured

interviews with patients before discharge.

5.11 Interview participant selection

All trial participants consented to be interviewed as part of the qualitative

evaluation. A purposive sample of 20 trial participants (ten from the

preoperative education group and ten from the usual care group) were

approached before discharge from hospital to arrange an individual

interview. A purposive sampling approach was to ensure that interviewees

were invited not only from both arms of the trial but also from both

genders, different types of cardiac surgery, and a range of age groups

(Green and Thorogood, 2004).

5.12 Qualitative data collection

I carried out the interviews in a quiet area either in the patient’s room or

an office on the cardiac surgical ward which was convenient for the

participants (Hansen, 2006). Family members and friends were also invited

to contribute to the interviews. There was no time limit for interviews, and

the majority lasted between 40 and 60 minutes. The interviews were semi-

structured. An interview schedule with open questions was developed to

guide the conversation in each interview (Appendix 9). Questions asked

during the interview were formulated based on a literature review of

surgical patients’ information needs, their perception of the provision of

information and the effect of individualized information (Suhonen and

Leino-Kilpi, 2006) and a qualitative study exploring cardiac patients’

experiences of a nurse-led preoperative education intervention (Goodman

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et al., 2009). A digital audio recorder was used during each interview with

the participant’s consent.

During each interview, the participant was asked to express their thoughts

and opinions about information needs, how preoperative information was

usually delivered and could be improved in future practice, and to talk

through their feelings about the illness, surgery, the preoperative

education intervention, and taking part in the trial. Examples of such

questions included: Can you describe the first experience of your heart

problem? Tell me how you felt at the time when you were told you needed

cardiac surgery. How did you find the preoperative information you

received before surgery? What did you expect when you decided to

participate in the study? If participants had their own questions relating to

their health or treatment, these were dealt with as appropriate at the end

of the interview and referred where necessary to their chief doctor. As data

from the first interviews were gathered, their content provided direction for

subsequent interviews in keeping with an inductive approach.

5.13 Qualitative data analysis

All interviews were carried out in Chinese. The interviews were transcribed

verbatim by me, and repeatedly listened to in order to check and confirm

accuracy. The transcribed data were then coded and thematically analysed

in QSR NVivo 8 with a focus on the content, process and context of the

intervention and the experience of taking part in the trial (de Laine, 2000).

Transcribing and analysing the data in Chinese occurred simultaneously as

the data collection was proceeding. Due to time limitations, transcripts

were not returned to participants for comment and/or correction.

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Interviewees’ accounts were categorised and compared enabling

identification of the themes that were common in the dataset. When a list

of themes and subthemes had evolved, this was examined for overlapping

themes merged under one descriptive label and spurious themes

containing few quotations. Then the transcripts were revisited to determine

if analysis of that theme had been applied to all transcripts. If not, they

were re-examined for that theme, with attention being paid to indicate

contradictory accounts or unusual cases. Throughout this process, the data

were consistently analysed in order to gain insight to relationships between

themes. The findings were interpreted within the context of the existing

literature.

Barbour (2001) argues that the question is no longer whether qualitative

research methods are valuable but how rigour can be assured or enhanced.

Checklists of qualitative research design and data analysis (Pope et al.,

2000, Greenhalgh and Taylor, 1997) and consolidated criteria for reporting

qualitative research (COREQ) (Tong et al., 2007) have been introduced in

an attempt to improve the rigour of qualitative research. Green and

Thorogood (2004) suggest a number of features of rigorous qualitative

analysis, which include transparency, providing a clear account of the

procedures used, the analysis of the whole dataset including deviant cases

and disconfirming data, using more than one analyst, providing simple

frequency counts of key themes, comparing findings to other studies, and

accounting for the role of the researcher in the research.

All of the principles outlined above were applied to the analysis of this

qualitative evaluation, with the exception of the use of more than one

analyst. Due to resources and time limitations, it was not possible to have

more than one analyst to independently code and analyse the data.

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However, I translated seven written transcripts (one third of the interviews)

from Chinese to English in full and the rest for relevant codes. These

translated transcripts were reviewed by my supervisors and checks were

made on the interpretation of data.

Reflecting on the translation, it was a challenging process as not only the

literal meaning of the words used by participants needed translation but

also the contextual information such as humorous use of words and

phrases, sarcasm and use of metaphors (Green and Thorogood, 2009,

Chen and Boore, 2010). Some concepts in one language may be

understood differently in another (Jagosh and Boudreau, 2009) and

metaphors vary from culture to culture (van Nes et al., 2010). For example,

qi (气 in simplified Chinese) is the central underlying principle in traditional

Chinese medicine and martial arts. ‘Qi’ could be literally translated as

breath, air, or gas. ‘Qi’ could mean life energy or energy flow. When

combining it with the Chinese word for blood (making 血气, xue-qi, blood

and breath), the concept could be used to account for motivational

characteristics. So it is difficult to find an equivalent word in English. In

order to preserve the cultural meanings and nuances of the original, having

a good understanding of Chinese culture and being able to find an

equivalent in English were key concerns (Chen and Boore, 2010).

However, translation between languages might hinder the interpretation of

meaning of participants’ experience and result in loss of meaning of

participants’ actual words which decreases the overall rigor of the

qualitative study (van Nes et al., 2010). Back-translation is translating

from the target language (English) back to the original source language

(Chinese) and the equivalence between two language versions can be

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evaluated. It may be considered as the most common and rigorous

procedure to validate the conceptual equivalence of the translation (Lopez

et al., 2008). But the back-translation approach has been criticised by

some for its basis in positivism such that ‘research is language free and

that the same meaning in the source language can be found in the target

languages’ (Larkin et al., 2007, p.469). Others argue that its focus on

linguistic equivalence rather than conceptual equivalence can be

problematic (Jagosh and Boudreau, 2009). Squires (2008) argues that

back-translation does not necessarily enhance the trustworthiness of

reported findings any more than an independently critical review by a

bilingual competent individual.

Time and financial constraints prevented either back-translation or an

independent review by a bilingual individual in this study. All translations

were undertaken by me, which had the advantage of translation

consistency and improved conceptual congruency. Maintaining conceptual

equivalence of participant views was the most important consideration in

the translation process, as the quality of translation can considerably affect

data analysis and findings (Squires, 2009).

5.14 Being an ‘insider’

The study was conducted in my home city and one of the study hospitals

was the hospital where I am employed. This was advantageous in that the

study setting was familiar to me both culturally and contextually.

Importantly I was able to easily develop rapport with patients and gain

their trust with the continuous help and support from my colleagues. Such

an insider perspective gives an awareness of current issues in the

organisation (DeLyser, 2001, Galea, 2009). However, insider research has

its disadvantages. It was acknowledged that my previous knowledge and

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personal experience of nursing within the organisation meant that ‘taken

for granted’ assumptions could limit the ability to probe for deeper

meaning or understanding of the phenomenon under study and might lead

to some important issues overlooked in the interview data analysis (Asselin,

2003). Awareness of these advantages and disadvantages can, to some

extent, help minimise the potential side effect of being an ‘insider’, better

understand individual experiences within a specific context, and enhance

the trustworthiness or credibility of the qualitative evaluation (van Heugten,

2004).

It was important that participants were able to describe their feelings from

their own perspective in the context of their culture as well as their own

characteristics and background. During each interview, I tried to make the

participant feel more comfortable about our conversation and encouraged

the participant to talk freely and openly to me about their feelings of

preoperative education and experiences of participating in the study.

However, participants knowing that this study was designed and conducted

for my PhD work at a British university and becoming familiar with me

could influence some participants’ perceptions or expectations of me and

my study. The majority of the participants valued the UK higher education

system I was studying within and this allowed me to gain credibility with

them. Eventually they considered me as their friend. As a result,

participants’ accounts may have been affected in a subtle way.

From my perspective, I viewed my prior knowledge and preconceived ideas

about the study settings and friendship with the participants as an

advantage rather than a disadvantage. Finding ways to use my ‘insider’

status to help but not hinder insights was a key concern. I have attempted

to separate my own experiences and prior assumptions from the

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description of participants’ experience and perceptions in the process of

data collection and subsequent analyses. I took account of the influence

my connection with the culture and study settings has on the findings and

reported and interpreted the findings in a transparent way.

5.15 Ethical considerations

Ethical approval for this study was granted by the First Affiliated Hospital of

Henan University of Science and Technology Teaching and Research Ethics

Committee and the Luoyang Central Hospital Research Ethics Committee

(Appendix 10). The study was registered by Current Controlled Trials

(ISRCTN87451169) in November 2009 before the recruitment began. As

this Cardiac Preoperative Education Intervention Study involves patients,

the following ethical issues were carefully considered in designing and

conducting the study.

A starting point was the question of equipoise. The concept of equipoise

has been represented as a central ethical principle of human

experimentation and requires that a patient should be ethically enrolled

into a randomised controlled trial only when there is substantial uncertainty

about which of the trial arms would most likely benefit him or her (Fries

and Krishnan, 2004, Ashcroft, 2004, Miller and Veatch, 2007). Djulbegovic

et al. (2000) suggested that, in the context of randomised controlled trials,

equipoise means that participants will not suffer relative harm from random

assignment to a particular treatment arm.

In this study, the participants from both groups received the same usual

care as delivered by ward staff. Apart from the intervention itself, those in

the control group did not have any aspect of care withheld from them that

was of known benefit. Although a body of work has demonstrated the

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positive effects of preoperative education on anxiety and postoperative

recovery in many types of elective surgery, there are contradictory views

of the role of preoperative education among cardiac surgery patients.

Equipoise is dependent on the existence of uncertainty about the relative

value of two treatments being compared. If there were no uncertainty,

then trials would be both unnecessary and unethical (Djulbegovic et al.,

2000, Felson and Glantz, 2004). To this extent, equipoise did exist in this

study as the previous trials reviewed have not been able to provide

conclusive evidence that preoperative education is superior to the usual

care among cardiac surgery patients.

Secondly, the study did not involve any invasive procedures in the

technical sense, so the risk of harm is low. However, effort and

commitment were required from the participants when benefits could not

be guaranteed. A range of questions were asked in the qualitative

interviews, some of which were quite personal and might trigger anxiety or

distress (Richards and Schwartz, 2002), such as patients’ experiences of

disease and seeking medical help and their perceptions of information they

received. Therefore it was essential to be careful not to coerce people to

take part. In view of this, all eligible patients were fully informed through

the information sheets and verbal explanation on the aims and methods of

the study and procedures that might be involved. Participation was entirely

voluntary. Even though participants had given written consent to take part,

it was made clear that they were still free to withdraw from the research at

any time without having to give a reason and without their medical care

being affected in any way (Gregory, 2003).

Informed consent from study participants is fundamental in undertaking

ethical health research (Taljaard et al., 2011, Iphofen, 2005). In this study,

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significant challenges were experienced in ensuring practical requirements

for informed consent to be met. These challenges were partly attributable

to differences in the understanding of research concepts and processes

between patients due to gaps in access to resources, literacy levels, and

perceptions of health and illness and information needs. When orally

explaining the aim and process of the study to each patient, these

differences between patients were considered so that simple language

combined with a patient attitude help ensure every patient fully understood

the information conveyed.

Finally, in order to ensure that the participants did not receive too great a

burden from the study, the intervention was kept simple and the

questionnaires were short. In addition, confidentiality and anonymity were

considered throughout the study from data collection and analysis to

publication, and ensured by appropriate use and storage of data through a

password protected database and by nondisclosure of personal identifiable

information such as participants’ name and address (Gregory, 2003, Oliver,

2003).

5.16 Summary

The study on which this thesis is based was a randomised controlled trial

evaluating the effects of a preoperative education intervention on anxiety

and postoperative recovery among Chinese cardiac patients. The

preoperative education intervention was specially designed and

implemented for cardiac surgery patients to potentially reduce their anxiety

and improve postoperative outcomes. This intervention included the

development of preoperative information in the format of a patient leaflet

‘Your Heart Surgery’. The initial idea was that it would be useful to put

together a page of information which the patients and their family could

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refer to whenever they want and which could provide specific information

for verbal advice.

Adult patients undergoing elective cardiac surgery were randomised to one

of two arms of the trial. The preoperative education group received a 15-20

minute leaflet-based preoperative education intervention, while all

participants received usual care. The primary outcome measure was

change in anxiety score on the HADS. Secondary outcomes were change in

depression score on the HADS, perceived pain measured by the BPI-sf, and

length of ICU stay and postoperative hospital stay. Measurement occurred

at baseline (on the second or third day after admission) and follow-up (on

the seventh day after the operation).

A qualitative evaluation was also conducted to gain a deeper insight into

the process and outcomes of the intervention. Interviews were followed

with a sample of trial participants before hospital discharge to add a

qualitative perspective to the evaluation by exploring patients’ perceptions

of preoperative education and their experience of taking part in the study.

The results of the trial and qualitative interviews are reported separately in

the next two chapters.

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 CHAPTER SIX

TRIAL RESULTS

6.1 Introduction

This chapter reports the results of the Cardiac Preoperative Education

Intervention Trial. The recruitment and participant flow for the trial is

described in the next section. The third section focuses on baseline

characteristics of the two study groups. The fourth section looks at the

period between randomisation and follow-up and reports on uptake and

adherence of the interventions. The fifth section describes the follow-up of

the participants at seven days after their surgery. Then the difference

between groups in terms of primary, secondary and other outcomes is

presented in the sixth, seventh, and eighth sections respectively.

6.2 Recruitment and participant flow

The period of recruitment for the trial was between 1st December 2009 and

17th March 2010. A total of 245 patients were admitted into the Cardiac

Surgery Ward of the two study hospitals during this period, of which 89

(36.3%) were excluded on the basis of age (being less than 18 years,

n=82), four because they were emergency cases and three patients

excluded because they were undergoing cardiac surgery for the second

time. Of the remaining 156 patients who were eligible, two decided not to

participate and one decided to leave the hospital shortly after admission

giving an uptake rate of 98.1%. The trial ended when 153 patients were

recruited. Participant flow through the trial is illustrated in Figure 6.1.

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 Assessed for eligibility (n=245)

Excluded (n=92):
Did not meet inclusion criteria (n=89)
Declined to participate (n=2)
Other reasons (n=1)

Informed consent and baseline data (n=153)

(n=153)

Randomised (n=153)

Allocated to preoperative education (n=76): Allocated to usual care (n=77):

Received allocated intervention (n=76) Received usual care (n=77)

Loss to follow-up (n=8): Loss to follow-up (n=10):

Discharged without surgery (n=6) Discharged without surgery (n=8)
Care transferred (n=2) Died after surgery (n=2)

Analysed available data (n=68) Analysed available data (n=67)

Figure 6.1 Flow diagram of the progress through the phases (enrolment,
intervention allocation, follow-up and data analysis) of the trial of two groups

6.3 Baseline characteristics

Baseline data were collected from all 153 recruited participants before they

were randomly allocated to either the usual care group (n=77) or

preoperative education group (n=76). Table 6.1 presents a comparison of

the two groups in terms of these demographic and clinical characteristics at

baseline.

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Table 6.1 Baseline characteristics of participants (n=153)
randomised to the usual care or preoperative education group.
Values are numbers (percentages) unless stated otherwise

Usual care Preoperative education

Variables (N=77) (N=76)
Mean (SD) age in years 52.3 (15.99) 52.0 (16.12)
Gender
Male 40 (51.9) 44 (57.9)
Female 37 (48.1) 32 (42.1)
Marital status
Married 66 (85.7) 59 (77.6)
Widowed, separated, divorced 4 (5.2) 7 (9.2)
Single 7 (9.1) 10 (13.2)
Education
a
≤9 years 56 (72.7) 56 (73.7)
>9 years 21 (27.3) 20 (26.4)
Living alone 4 (5.2) 2 (2.6)
Employment status
Employed 19 (24.7) 16 (21.1)
Unemployed 38 (49.4) 41 (53.9)
Retired 20 (26.0) 19 (25.0)
Type of surgery
Coronary artery bypass grafting 33 (42.9) 37 (48.7)
Valve surgery 28 (36.4) 24 (31.6)
Congenital & others 16 (20.8) 15 (19.8)
Co-morbidities
None 54 (70.1) 48 (63.2)
Hypertension 16 (20.8) 18 (23.7)
Diabetes 1 (1.3) 6 (7.9)
Others 6 (7.8) 4 (5.2)
Previous hospitalisation 6 (7.8) 9 (11.8)
Previous operations 6 (7.8) 9 (11.8)
Physical assessment mean (SD)
Heart rate (beats/min) 76.3 (7.67) 78.9 (8.85)
Systolic pressure (mmHg) 116.8(14.15) 113.8 (11.78)
Diastolic pressure (mmHg) 72.1 (9.58) 71.0 (8.76)
Height (Cm) 165.2 (6.00) 165.4 (7.29)
Weight (Kg) 64.7 (12.51) 64.5 (13.04)
Anxiety and depression mean (SD)
HADS anxiety subscale 7.3 (4.33) 6.0 (3.59)
HADS depression subscale 5.9 (4.35) 4.8 (3.17)
Pain measures mean (SD)
BPI-sf pain severity items
Average pain 1.1 (1.65) 0.8 (1.33)
Current pain 0.4 (1.00) 0.2 (0.66)
BPI-sf pain interference items
General activity 1.6 (2.59) 1.3 (2.28)
Mood 1.8 (2.60) 1.6 (2.29)
Walking ability 2.3 (3.20) 2.1 (2.74)
Sleep 1.5 (2.72) 1.2 (2.38)

a
Nine-years of compulsory education from elementary to junior high school.

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There was no difference in the mean age of the two randomised groups

(52.3 years for the usual care and 52.0 for the preoperative education) but

slightly more men were allocated to the preoperative education group

(44/76) than to the usual care group (40/77). Both groups were similar at

baseline in terms of education level, marital, living and employment status,

although the preoperative education group had a slightly higher proportion

of coronary artery bypass grafting (37/76) than the usual care group

(33/77) and more participants with diabetes were randomised to the

preoperative education group (6/76 versus 1/77). There was no difference

in previous hospitalisation, operation history or physical assessment (heart

rate, blood pressure, height and weight) between the two groups.

However, the most important baseline difference between the two groups

was mean anxiety and depression summary HADS scores. The mean HADS

anxiety score was 1.3 points higher in the usual care group than in the

preoperative education group (7.3 compared with 6.0). The mean HADS

depression score was 1.1 points higher in the usual care group (5.9

compared with 4.8). This suggests there was a greater degree of anxiety

and depression at baseline among the usual care group. Both groups had

similar mean scores at baseline regarding all domains of pain severity

subscale and pain interference subscale on the BPI-sf.

In summary, the two groups were broadly similar in terms of socio-

demographic profile, the presence of co-morbidities, type of surgery,

previous hospitalisation and operation history, physical attributes and pain,

however those participants in the preoperative education group at the point

of recruitment were slightly more likely to be male, be admitted for

coronary artery bypass grafting, and have diabetes. There was a small

difference between the groups in HADS score with the preoperative

109
education group appearing to be less anxious and with fewer depressive

symptoms.

6.4 Uptake of and adherence to the interventions

The randomisation process took place as soon as baseline data were

collected from each participant. The 153 randomised participants received

usual preoperative care delivered by ward staff. All of the 76 participants

randomised to the intervention arm of the trial received the preoperative

education. As planned, the preoperative education occurred immediately

after randomisation. Each session lasted only 15 to 20 minutes, which

helped to ensure a 100% uptake rate of the intervention.

6.5 Follow-up

Out of the 153 participants, 135 (88.2%) in the trial were successfully

followed up at seven days after surgery. There were a total of 18 losses to

follow-up during the study period (eight from the preoperative education

group and 10 from the usual care). Follow-up data were collected from 68

(89.5%) of those who had been allocated to the preoperative education

group (n=76) and 67 (87.0%) of those who had been allocated to the

usual care group (n=77).

The reasons for the 18 participants being lost to follow-up were various.

Eight in the usual care group had to be withdrawn before undergoing

cardiac surgery as half of those decided to leave the hospital without

surgery due to unspecified reasons (perhaps financial or other family

problems). The other half experienced an acute exacerbation of their illness

so that doctors considered them unsuitable for surgery at that time. Two

participants in the usual care group died after surgery when they were in

the ICU and cause of death for both was recorded as acute cardiac failure.

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The main reasons for drop-out in the intervention group were categorised

in three ways: five were discharged without surgery due to unspecified

reasons; one was considered not suitable for surgery; two participants’

care was transferred to other hospitals before surgery.

Neither intervention nor usual care processes involved any invasive

procedures in the technical sense and the risks and harms associated with

them were low. Between the start of recruitment and the end of follow-up,

no adverse events or side effects were noted for either group. Reasons for

attrition did not appear to differ between those randomly allocated to the

preoperative education group and those randomly allocated to the usual

care group. Of the 135 who completed the trial, complete data were

available for all outcomes with 100% item response for outcome scales.

6.6 Primary outcome - anxiety

The main outcome measure for the trial was change in HADS anxiety score

between baseline and follow-up. As described in the previous chapter, the

modified intention to treat was carried out not only for analysis of the

primary outcome but also secondary and other outcomes. It involved

analysing all participants as originally allocated except the 18 cases of

unavailable data at follow-up of seven days after surgery. Their drop-out or

withdrawal at some point in the trial (through leaving before surgery,

death or care transfer) meant they were not assessed at follow-up. Finally

135 participants (preoperative education group n=68; usual care group

n=67) were included in the analyses.

There was some imbalance in the two groups at baseline as reported

earlier in this chapter. This was addressed by conducting prespecified

adjusted analysis in which a linear regression model was used to control for

111
some baseline variables (HADS anxiety score at baseline, age, sex,

education level, and types of surgery). An association between the

preoperative education and clinical outcomes could be confounded by

baseline score and participants’ characteristics such as age, sex, education

level and types of surgery. All of these potential confounding factors were

taken into account. Both unadjusted and adjusted analyses are reported in

Table 6.2 and a comparison of the two groups is described here.

Both groups had reduced anxiety scores at follow-up, but those

randomised to the preoperative education group had a mean decrease in

anxiety score of 3.5 points (Standard Deviation=4.50) between baseline

and follow-up. By contrast, the mean change among the participants in the

usual care group was a reduction of 0.7 points (SD=4.95). Figure 6.2

presents the distribution of change in anxiety scores by two groups. This

comparison of the two groups was statistically significant and those in the

preoperative education group experienced a more significant decrease in

anxiety than those in the control group (mean difference -2.7; 95%

Confidence Interval -4.35 to -1.13; t= 3.37; P=0.001).

Figure 6.2 Change in anxiety scores by study groups

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Table 6.2 Primary outcome - anxiety scores on the HADS for usual care group and preoperative education group

Outcome Usual care Preoperative Unadjusteda Adjustedb

education
Mean difference (95%CI) P value Mean difference (95%CI) P value
Mean (SD) anxiety score

At baseline (n=153) 7.3 (4.33) 6.0 (3.59)

At follow-up (n=135) 6.1 (2.87) 2.5 (3.10)

Mean change (SD) from baseline -0.7 (4.95) -3.5 (4.50) -2.7 (-4.35 to -1.13) 0.001 -3.6 (-4.62 to -2.57) <0.001
a
Independent-samples t-test.
b
Linear regression: controlling for baseline anxiety score, age, gender, education level, and types of surgery.

Table 6.3 Secondary outcomes - depression and pain for usual care group and preoperative education group

Outcomes Usual care Preoperative Unadjusteda Adjustedb

education
(n=67) (n=68) Mean difference (95%CI) P value Mean difference (95%CI) P value
Depression subscale
Mean change (SD) from baseline -0.6 (4.94) -2.3 (4.41) -1.6 (-3.23 to -0.04) 0.04 -2.1 (-3.19 to -0.92) <0.001

Pain intensity items

Mean change (SD) from baseline
Average pain 1.1 (2.23) 0.7 (1.94) -0.4 (-1.07 to 0.36) 0.33 -0.4 (-0.96 to 0.13) 0.13
Current pain 0.8 (1.63) 0.6 (1.28) -0.2 (-0.66 to 0.34) 0.53 -0.3 (-0.72 to 0.11) 0.14

Pain interference items

Mean change (SD) from baseline
General activity 1.6 (3.21) 1.4 (2.74) -0.2 (-1.20 to 0.83) 0.72 -0.2 (-0.95 to 0.62) 0.67
Mood 0.7 (3.25) -0.0 (2.86) -0.8 (-1.83 to 0.25) 0.14 -0.8 (-1.60 to 0.02) 0.06
Walking ability 1.1 (3.77) 0.4 (3.03) -0.7 (-1.87 to 0.46) 0.23 -0.6 (-1.43 to 0.14) 0.10
Sleep 0.9 (3.10) -0.1 (2.77) -1.0 (-2.03 to -0.03) 0.04 -0.9 (-1.63 to -0.16) 0.02

a
Independent-samples t-test.
b
Linear regression: controlling for baseline score, age, gender, education level, and types of surgery.

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When adjustment was made for five baseline variables (baseline anxiety

score, age, gender, education level, and type of surgery), it appeared to

widen the difference between the two groups, with the preoperative

education group having significantly lower HADS anxiety score at follow-up

when compared to the usual care group (mean difference -3.6; 95% CI -

4.62 to -2.57; P<0.001). Regardless of the method of analysis used, the

participants in the preoperative education group appeared to have a

greater reduction in anxiety than those in the usual care group.

6.7 Secondary outcomes - depression and pain

The secondary outcomes for the trial were change in depression score on

the HADS between baseline and follow-up, and change in pain measured

by the BPI-sf. Table 6.3 presents the unadjusted and adjusted analysis of

the secondary outcomes.

6.7.1 Depression

Both groups had lower depression scores at follow-up: a mean reduction of

2.3 points (SD=4.41) was observed in the preoperative education groups

compared with 0.6 points (SD=4.94) in the usual care group. There was a

greater reduction in depression from baseline to seven postoperative days

among the participants in the preoperative education group than those in

the usual care group (mean difference -1.6; 95% CI -3.23 to -0.04;

P=0.04).

When adjustments were made, there were some changes in the estimated

mean difference between the two groups for certain secondary outcomes

including depression. The mean difference in depression scores of the two

groups, estimated from the linear regression model, was -2.1 points (95%

CI -3.19 to -0.92; P<0.001). In both the unadjusted and adjusted

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analyses, participants in the preoperative education group had significantly

lower scores for depression than the usual care group.

6.7.2 Pain

At follow-up, both groups had higher scores for the majority of domains of

pain measures indicating the participants had reported worse pain and

increased pain interference at seven days after surgery, compared to

baseline. However, mean changes from baseline to follow-up were greater

in the usual care group for all these six tested domains of pain. According

to the unadjusted analyses, there was no evidence that the preoperative

education intervention was associated with any change in the five domains

apart from sleep, demonstrated in findings from the adjusted analyses.

In the adjusted analyses, there was no difference between the two groups

in the severity of average pain experienced and current pain experienced.

Scores for average pain increased by a mean of 0.7 points in the

preoperative education group and 1.1 points in the usual care group (mean

difference -0.4; 95% CI -0.96 to 0.13; P=0.13). Mean scores for current

pain increased 0.6 in the preoperative education group and 0.8 points in

the usual care group (mean difference -0.3; 95% CI -0.72 to 0.11;

P=0.14).

There was also no evidence of a difference between groups in the amount

of general activity, mood, and walking ability interfered by pain. Mean

change in general activity was very similar in the two groups at 1.4 points

for the preoperative education group compared with 1.6 points for the

usual care group (mean difference -0.2; 95% CI -0.95 to 0.62; P=0.67).

Between the two groups, there was no difference in mood interference

from pain (mean difference -0.8; 95% CI -1.60 to 0.02; P=0.06) and in

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walking ability interference from pain (mean difference -0.6; 95% CI -1.43

to 0.14; P=0.10).

In terms of the domain of pain interference with sleep, mean change

between baseline and follow-up was -0.1 in the preoperative education

group compared with 0.9 in the usual care group. This means that at

follow-up, the participants in the preoperative education group had less

pain interference with sleep, while those in the usual care group reported

worse sleep due to pain from baseline. In the independent samples t test,

two groups had a difference of 1.0 points (95% CI -2.03 to -0.03; P=0.04).

After adjusting for the potential confounders, the mean difference in sleep

scores of the groups, calculated from the linear regression model, was -0.9

(95% CI -1.63 to -0.16; P=0.02), indicating that there was a difference

between groups in sleep interference from pain.

6.8 Length of stay outcomes

In addition to the primary outcome of change in HADS anxiety score and

secondary outcomes of depression and pain, other data for the length of

stay outcomes were available from medical notes. Both actual hours

participants spent in the ICU and days in the hospital after surgery were

recorded at discharge in order to compare the preoperative education and

usual care groups. Analysis was carried out as before, comparing groups

according to a modified intention-to-treat approach, but this time the

nonparametric Mann-Whitney U test was used instead of parametric t test

due to the violation of the assumption of distribution normality and equality

of variance. Table 6.4 presents a comparison of the two groups on the

length of stay outcomes.

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Table 6.4 Length of stay outcomes for usual care group and
preoperative education group

Length of stay Median (interquartile range) P valuea

Usual care (n=67) Preoperative education (n=68)

Hours in ICU 48.0 (39.0 to 77.0) 44.0 (23.3 to 67.0) 0.05

Days in hospital 12.0 (10.0 to 17.0) 14.0 (9.3 to 19.8) 0.17

after surgery
a
Mann-Whitney U test

Participants receiving the preoperative education intervention spent four

hours less in the ICU than participants receiving the usual care only

(median 44 hours versus 48 hours). Borderline statistical significance was

noted for the preoperative education group (P=0.05). However, no

significant difference was found in length of postoperative hospital stay:

the preoperative education group stayed 14 days in hospital after surgery

compared with 12 days for the usual care group (P=0.17).

6.9 Summary

Of the 153 participants, 135 (preoperative education group n=68; usual

care group n=67) completed all outcome measures. Based on the analyses

of these available data, the preoperative education intervention group had

a greater decrease in anxiety and depression scores although both groups

had lower anxiety and depression scores at the follow-up of seven days

after surgery. The intervention had no significant effect on average and

current pain intensity as well as pain interference in the domains of general

activity, mood and walking ability except sleep. The intervention seemed to

affect the time spent in the ICU but not the length of postoperative hospital

stay. The findings of the post-trial qualitative interviews are reported in the

next chapter.

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 CHAPTER SEVEN

QUALITATIVE EVALUATION – FINDINGS

7.1 Introduction

Semi-structured interviews were conducted with 20 trial participants.

During each interview, the participant was asked to express what they felt

they needed to know (retrospectively and in advance of their surgery), to

comment on the care they received (whether that be usual care and/or the

preoperative education intervention), to explain what worked well for them

and what could be improved, and to talk through their experiences of

taking part in the trial. This chapter presents the findings generated from

the analysis of the interview data. The characteristics of the interview

participants are summarised in the next section. The third section outlines

the categories and themes generating from the interview data. In the

subsequent sections the interview results are reported.

7.2 Characteristics of the interview participants

Twenty participants, ten from each arm of the trial, were purposefully

selected to capture variation in age, gender, education level, and types of

surgery. Table 7.1 shows a summary of the interview participants’

characteristics. Of the 20 interview participants, 12 were male and eight

were female. Eleven interview participants were aged 50 years old or

younger and nine were over 50 years old. The youngest interview

participant was 23 years old and the oldest was 74. Seven of the 20

interview participants had received more than nine years of education. In

terms of types of surgery, seven had undergone coronary artery bypass

grafting, seven valve surgery, and six congenital or other kinds of cardiac

surgery.

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Table 7.1 Characteristics of the interview participants

Characteristics Preoperative Education Usual Care

(n=10) (n=10)
Gender
Male 8 4
Female 2 6
Age in years
18-30 2 0
31-50 3 6
51 & older 5 4
Education
≤9 years 6 7
>9 years 4 3
Surgery type
Coronary artery bypass grafting 5 2
Valve surgery 3 4
Congenital & Others 2 4

7.3 Categories and themes

A total of eleven main themes were generated from the related codes of

the 20 interviews and named according to their content. These were

collapsed into three categories: the process of information giving, context

of information giving, and trial experience. Table 7.2 provides an overview

of the categories and themes. To prevent the interview participants being

identifiable, the sources of direct quotations refer to the trial entry number

with either PE representing the preoperative education group or UC usual

care group. Furthermore, where a quote is used, a brief description of the

participant characteristics is included.

Table 7.2 Categories and themes

Categories Themes
1. Process of information giving 1. Reputation and hierarchy
2. Understanding risk
3. Role models
4. Communication
5. Views on the intervention
2. Context of information giving 1. Illness and help seeking behaviour
2. Strength from knowledge
3. Information as a low priority
4. A perception of paternalism
3. Trial experience 1. Motivations to participate
2. Understanding of randomisation

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7.4 Process of information giving

The main findings regarding the process of providing preoperative

information were in relation to reputation and hierarchy, understanding risk

information, role models, patients’ experiences of preoperative

communication with health care providers, and views on the intervention.

These themes were elicited from the interview participants in both the

preoperative education and usual care groups. Views on the intervention

were obtained from preoperative education group participants only.

7.4.1 Reputation and hierarchy

Several participants reported that prior to their surgery they were

predominantly concerned with who would be performing the surgery and

wanted more information about the reputation of their surgeon (e.g.,

203PE and 6UC). Having more information related to their surgeon, they

explained, would give them a sense of security, give them more confidence

in the success of their surgery and ultimately reduce their preoperative

anxiety.

Some interview participants explained that many staff tried to minimise the

conversation with patients and their families before surgery. They believed

that this was in order to avoid taking responsibility,

They were afraid of telling you too much before surgery. I guess it

may be because they were cautious. They were afraid to say

something which might cause disputes or trouble afterwards in case

the consequence of surgery was not good. (11PE)

One participant (6UC) had similar feelings in this regard and said that she

preferred to ask the director of the ward - a cardiac surgeon in the hospital

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rather than other staff. She believed that the director must have more

knowledge, skills, and authority than others and was therefore the most

trustworthy person to talk to on the ward. These participants reported that

limited information received could be caused partially by some staff

members’ lack of knowledge about heart disease and surgery or skills of

communication. In addition, they found that some junior staff and nurse

students were not confident in delivering preoperative information. Some

participants also said that they preferred doctors to deliver information

rather than nurses (1PE, 18PE and 203PE). Their accounts suggested that

position in the perceived hierarchy of hospital staff was important to these

patients and information was judged on the basis of its source within the

hierarchy and the reputation of the individual conveying the information.

7.4.2 Understanding risk

Although some participants felt that information about possible adverse

events and complications from their treatment might make them anxious,

others expressed a wish to discuss it with ward staff. A number of

participants felt that they received very limited information about such

risks prior to surgery giving little knowledge of the nature and likelihood of

these problems. This kind of information was available from their doctors if

they asked for it but not offered routinely.

Normally staff preferred to discuss this risk related information with family

members rather than directly with patients as they thought this

information would increase patients’ anxiety (6UC, 27UC, 58UC, 11PE and

248PE). However, data from interviews suggested that patients were keen

to access this type of information and understood that any surgery entailed

some risk (1PE, 248PE and 39UC). One participant (248PE) said that ‘Of

course, I am also anxious for it but it is just a small part of my concern.

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Sometimes I think there must be the risk no matter what kind of

operations…’ Another woman, though concerned about risks, appeared

keen to be fully informed:

The day before surgery when doctors came to ask my husband to

sign the consent form for surgery, I was a bit scared. He said

theoretically the success rate for this surgery was 98% but after all

there were still the risk of 2%. He told us that we should have some

preparation for all possible results. I considered that if any problems

happened after surgery, how would the whole family stand and go

through… Anyway I think I can understand. Such a big operation, it

is impossible without risks. (39UC)

Many participants had a similar understanding of risk information. They

considered lack of success as equivalent to death. Thus they had a lot of

worries about the threat their heart surgery posed to both their own and

their family members’ lives. For most of them, surgery was the primary

source of anxiety, although other factors contributed to it, such as financial

and family concerns. They mentioned that the process of providing

information about risk could be improved by checking patients’

understanding and reiterating information when necessary.

All open heart procedures carry risks related to the use of cardiopulmonary

bypass. More recently, there has been a greater awareness of not only the

mortality risk associated with cardiac surgery but also on the incidence of

morbidity including renal failure, infection, prolonged ventilation,

neurologic deficit and bleeding after surgery. However, the safety of

cardiac surgery has improved significantly over the years and major

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postoperative complications are now exceedingly rare (Granton and Cheng,

2008).

7.4.3 Role models

Being able to see other patients’ improvement and recovery over time was

a factor that the participants from both arms of the study cited as a form of

helpful encouragement to continue with the process of undergoing surgery.

One participant emphasised this by saying that ‘… Before surgery I really

saw a lot of patients undergoing heart surgery, some were very weak at

the beginning, but they all healthily walked out of the hospital after

surgery. These real cases also educated me, so that I do not feel the

pressure, and really went into the operating room with ease. (248PE)’ In

particular, when they witnessed the recovery process of those whose

health conditions were considered to be poorer than theirs, they became

more confident about their own forthcoming surgery. One 38 year old

woman commented,

…Not afraid now. At first I was very afraid. After coming here, I saw

other patients were experiencing the same as my situation and even

worse than mine. You see that little child next room who had

congenital heart surgery before. This time he had to do it for the

second time… He is so little but has experienced so much. Heart

surgery, twice? When thinking about that child and myself, I asked

myself 'what I am still afraid of'. I was really not afraid the day

before surgery. (273UC)

Some interview participants found that they did not experience much

contact with other patients, so opportunities to gain support from others

were limited. They strongly believed that there was a need for mutual

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learning and peer encouragement as it helped to develop a sense of shared

experience and brought comfort from the feeling that they were not alone.

These participants suggested that the hospital could formally invite

patients who had experienced cardiac surgery recently to be part of a

group discussion with current patients and their families. This form of

information sharing was believed to encourage people to actively

participate in the discussion and eventually save staff time spent on

patients’ preoperative education (18PE and 63UC). One participant pointed

out,

… it can make preoperative patients realise that so many people like

themselves suffering the heart problems underwent successful

surgery, and recovered so quickly, which can greatly enhance their

confidence of overcoming disease and surgery. (254UC)

Patients wanted to listen to and see the benefit of surgery, know about

possible skills of coping with anxiety and pain, and learn ways to overcome

any difficulties from previous successful cases. Because the individuals in

the group had all been treated with open heart surgery, they could feel

some degree of shared experience and communicate easily with each other.

Those who did manage to obtain information from others’ stories found this

peer support very helpful and expressed that they would like to share their

own experience with future patients (11PE and 54PE).

7.4.4 Communication

Some participants explained that they gathered information from a range

of sources including friends, newspapers, books, television, radio and the

internet. However, when they were admitted for surgery, they started to

heavily rely on hospital staff to give information or advice as they

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considered that information from other sources might be incorrect or

misleading and potentially cause harm to them (60UC, 286UC and 54PE).

During the interviews, all participants were given the opportunity to reflect

on their experiences of preoperative communication between them and the

ward staff and to make suggestions for improvements to the delivery of

preoperative information for future patients.

7.4.4.1 Communication as a unidirectional and reactive process

Some participants’ reflection on preoperative communication was positive

though individuals’ enthusiasm varied. In particular, they valued the

friendliness and courtesy shown by some ward staff, which projected

feelings of encouragement, confidence, respect and care in patients (60UC,

214PE, 216PE and 254UC). Some participants mentioned that they

appreciated instructional information from the ward staff such as balloon

blow training, deep breathing and cough practice (273UC and 286UC).

Most of this information could be understood because it was given in plain

language and in a straightforward manner (203PE, 254UC and 255PE).

However, other participants noted that information giving was often ‘one-

way’ whereby the information was predominantly from staff to patients and

reactive whereby staff only gave the information when patients asked for it.

The participants felt a lack of engagement with the way information was

given (6UC, 248PE, 27UC and 254UC). Patients often attributed this to the

ward staff’s heavy workload. As one female participant put it,

They always seemed extremely busy. Sometimes I would like to ask

something, their response was very short. In fact, I did not quite

understand what they said, so felt embarrassed to ask again for

clarification. (6UC)

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In the two study hospitals, shortage of staff was a real problem. The staff

members were tied up with routine medical tasks. Some participants

seemed to accept that the busy working environment did not allow the

staff to spend much time on providing patients with information or

psychological support. They felt that they could only get information from

the staff when asking for it. However, the majority suggested that they

were too shy to ask because they thought the staff did not have the time

nor assigned responsibility to give them this basic information. One

participant described it by saying,

They are experts but I am an amateur, so I do not want others to

laugh at me. I'll give you an example. I once asked the Director if

my body had adjusted to the optimum for operation because I have

been here for long time. He told me that all of things look fine but

only the EF value was still too low. I did not know what the EF value

is and do not dare to ask about it... (248PE)

7.4.4.2 Limited communication and information giving

There was considerable variability in the amount or level of preoperative

information interview participants desired. A few participants were

confident that the ward staff would have provided the information they

needed to know before surgery, and assumed that whatever information

was not provided was unimportant and unnecessary. They were happy to

leave it in the hands of experts. However many participants (27UC, 53PE,

216PE and 254UC) expressed that information was insufficient particularly

in relation to pain relief and wound care, medications, rehabilitation and

living a healthy lifestyle.

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A number of interview participants commented on the value of face-to-face

communication between patients and ward staff. They believed that it was

not only the most direct way to share information and the quickest way to

get a response, but could also help enhance patient-staff relationships. One

interviewee (1PE) indicated that before surgery she ‘just want to have

someone to sit with, like friends. If staff could speak to us like this way, I

think we would not only get knowledge, but would also receive timely

psychological comfort.’

However eleven out of 20 interview participants indicated that there was

very limited contact and communication with the ward staff. One

participant (53PE) reported, ‘I would say it was nothing. What I mean by

that is basically there was no communication and information exchange. I

learned a lot by reading the posters on the wall by myself.’ He went on to

say, ‘I am still not clear about what coronary heart disease is and whether

all of coronary heart disease must do bypass surgery etc. etc. I had a lot of

questions in my mind…I had such a major operation, what a shame that at

the end, I still do not understand why I needed surgery, which blood

vessels got a problem...’

Patients in China are increasingly aware of their rights for information

about treatment and care. These participants observed that until discharge,

they still had a number of unanswered questions and unresolved concerns.

They even argued for the need for a new role of a full time cardiac surgery

consultant on the ward with a specific responsibility to spend time talking

with patients and their families, and gain a greater understanding. In

addition, participants suggested that written or audio-visual materials could

be used as complementary tools to facilitate verbal communication (286UC,

27UC, 53PE and 216PE). Some highlighted the need for handbooks or

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leaflets focusing on different aspects of care which could be referred to at

any time. Two participants (248PE and 255PE) suggested that a

combination of different ways of conveying information might be more

appropriate, particularly when giving information to those patients from

rural areas with often lower levels of education. Both participants explained

that different ways could complement each other to achieve a better and

more thorough understanding.

7.4.4.3 Preference for individualised information and optimal timing

An issue identified from interview participants was that the information

available was not specific enough (58UC and 286UC). One participant

(58UC) said that ‘staff should select the most appropriate information for

different individuals according to their personality. They should pay

attention to how much, how deep, and how detailed information to give for

each individual. If they could not get it right, it certainly may increase

worry’. General information might not be appropriate in meeting the

detailed information needs of all patients. Some tailored and individualised

information was also needed.

Half of the twenty interview participants stated ‘the sooner, the better’ to

summarise their views on when best to receive preoperative information.

Two participants (286UC and 216PE) noted that it was not considered to be

the best time to receive information when getting closer to surgery as they

felt that the provision of information when they were at their most anxious

could increase their anxiety and fear. They needed enough time not only to

digest the information they were given, but also alleviate some of the

worry through communication with family members.

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7.4.5 Views on the intervention

Each participant in the intervention group received preoperative education

including a patient information leaflet and verbal explanation. These

participants were asked for their views on the intervention in order to help

understand the way the intervention might ‘work’ as a part of routine care.

Analysis of the interview data suggested that participants’ feelings about

the preoperative education intervention varied considerably.

7.4.5.1 Leaflet

The majority of those who had received the intervention (six out of ten)

commented positively on the design of the leaflet. They felt it was clear

and straightforward and provided the right amount of information. The

leaflet was used as a helpful and handy tool for quick reference (1PE, 11PE,

18PE, 53PE, 54PE and 203PE). Three participants commented that their

family had found it helpful to read and that their friends wanted a copy

(11PE, 18PE and 53PE). They liked the coloured headings separating

sections and the graphics which they found made complex medical

procedures simple. One person explicitly stated that the layout of the

leaflet helped his understanding,

…Every time I read your leaflet, I learned something from it. It is

very clear, one point by one point, about what I shall do in this step

and what I shall feel the next step. You categorised it into several

sections … and also illustrated and explained in a very simple

diagram. I like it very much… I often read it through, especially at

the preoperative stage… (18PE)

However, for some interview participants, the amount of information in the

leaflet was perceived as insufficient for their needs and they would have

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liked more information in areas such as normal range of body temperature

after surgery, use of medicine at home and precautions after discharge,

although most of the patients mentioned that having this leaflet was better

than nothing (203PE, 216PE, 248PE and 255PE). One interviewee (248PE)

noted that the leaflet seemed ‘so basic’ and he could memorise all the

information it contained after his first reading. He implicitly suggested that

its design and the limited depth and breadth of its content would be

unlikely to motivate some patients to reuse the leaflet.

7.4.5.2 Verbal explanation

The information that the leaflet provided formed the basis of the discussion

with those allocated to preoperative education group during the 15-20

minute contacts. Several interview participants reported finding the

discussion interesting, enjoyable and rewarding. They expressed that being

able to obtain accurate information prior to surgery was something that

fulfilled a need unmet by ward staff. As one participant said,

In the ICU I always recalled what you told me. I realised you gave

the accurate information. What I was experiencing in there was

exactly what you explained to me before surgery. I had a tube

inserted through mouth and had very dry mouth and lips. I really

could not be able to speak like you have told me. (11PE)

7.4.5.3 Leaflet combined with verbal explanation

When asked to summarise experiences of the leaflet along with verbal

explanation and to evaluate its potential impact, eight out of the ten

interview participants from the preoperative education group were mostly

enthusiastic. This positive reaction to the intervention was related to a

sense of control over the situation. They viewed in retrospect that the

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intervention improved their understanding about their cardiac surgery and

at the same time helped to relieve unnecessary worries and anxiety,

highlighted by the following extracts.

What you delivered is exactly what I need and desire to get, so

when you talked to me about the brochure I listened very carefully.

(248PE)

If only giving me the leaflet to read by myself, it would be very

intuitive, abstract and boring. I would not take it seriously. After

reading it, I still did not know how to breathe and how to cough and

so on. But after your thorough explanation, I was pretty sure about

it. (53PE)

They indicated that both the written information and verbal explanation

could be effective in improving people’s confidence and should be

combined to maximise the benefits. A leaflet on its own might be easily

ignored without verbal explanation. Another participant (255PE) was

concerned about older patients who might not see and understand the

leaflet properly. Therefore, the opportunity for a face-to-face explanation

was viewed as a helpful alternative way to obtain the information.

However, the reaction of two of the interview participants was less

enthusiastic (214PE and 248PE). Although both expressed some surprise at

their raised awareness of information needs, they still considered physical

health as a priority when they were uncertain about whether they could

survive from surgery, as illustrated by the following quote.

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 The physical aspects of health are the most basic. If physiological

needs still could not be guaranteed, what is the point talking about

other things? Cardiac surgery patients are just like walking on the

boundary of life and death. (214PE)

No one commented that the intervention was too burdensome. All

participants in the preoperative education group had consistently

completed and followed the intervention. No one reported that the

information given in the intervention was a repetition of information that

they had already received by other ward staff. One interview participant

commented that,

If you did not tell me, I really did not get any information. No other

doctors or nurses came to me to talk with me about that… Language

is very easy to understand, the entire process is explained very

clearly. Your explanation was fantastic and let me know clearly what

was going on now and what would the next step… I got very familiar

with that procedure, so I was well prepared. (53PE)

A proportion of the interview participants from this group who identified the

intervention as a useful tool to get them relaxed commented that they

believed it had been too short and would have liked it on more than one

occasion (11PE, 53PE, 216PE and 203PE). However, they understood that a

one-off preoperative education intervention was part of the trial protocol.

They considered it important that in addition to providing accurate

information, reinforcement was needed as some patients might have not

completely absorbed what they were told or might have forgotten the

information they had been given. This was similarly pointed out by some of

the interview participants from the usual care group (58UC, 63UC and

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282UC). The participants suggested that it would be preferable if patients

could be given introductory information on admission and then this

information be ‘re-enforced’ at a later point in their hospital stay.

7.5 The context of information giving

The interview participants’ accounts provided insight into the context within

which the intervention was being delivered. Themes relating to this

category were illness and help seeking behaviour, strength from

knowledge, information as a low priority, and a perception of paternalism.

7.5.1 Illness and help seeking behaviour

Notwithstanding the considerable variations in patients’ experiences of

seeking and receiving information relevant to their illness, most interview

participants discussed the role of information and their specific information

needs in remarkably similar ways. One 44 year old man, who underwent

valve replacement, emphasised his inclination toward pharmacological

treatment when he was first diagnosed with rheumatic heart disease in

1993.

…the symptoms were mild. Doctors did not recommend immediate

surgery. They said a bit narrow but my own valve could still be used

for eight or ten years. So I tried both western medicine and

traditional medicine for two to three months. My symptoms were

basically controlled… (282UC)

This participant further noted that he was not being treated medically since

then but his disease had subsequently progressed to the stage where he

needed surgery. In fact, acting on the information from doctors did prolong

the life of his natural valve for about 17 years. He was satisfied with the

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information he received and his decision to not have surgery at that early

time.

Many interview participants talked of being reluctant to undergo cardiac

surgery unless suggested by a doctor that they had no other choice (e.g.,

54PE). Although these interview participants ultimately consented to

undergo cardiac surgery, all of them thought about alternative methods of

treatment. Information the doctor explained regarding why they believed

surgery was necessary helped them make a final decision. As a 67 year old

woman recalled:

Yes. The same thing happened two years ago. Doctors said to me

that I had heart disease and I had to receive a bypass surgery. At

that time I only could accept stent placement but not surgery. I

understood that surgery was not a small thing. But referring to the

result from angiogram, doctor told me that it was not suitable to do

stent. The only way was to have an open heart surgery… (254UC)

In both cases, doctors played an important role in giving accurate

information before the surgery actually took place. The participants felt

that such honest and straightforward information about treatment

alternatives enabled them to weigh risks and benefits of each alternative

and helped them make the right decision. Another 41 year old woman

explained her story of seeking help in this way:

… When it came to winter, the weather was getting cold, I started

feeling uncomfortable. The symptoms this time clearly was worse.

Chest pain started to bother me a lot… My sister introduced me to

see an old traditional Chinese doctor. He gave me some Chinese

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 herb medicine to take and acupuncture treatment once a day to go

with. These treatments lasted for a month but did not make me feel

any better. In December last year, I caught a bad cold and always

found rapid breaths. The doctor in a county hospital took X-ray on

my chest and then I was diagnosed with heart disease again. He

suggested me to come here for further investigation and

treatment… (6UC)

The participant 6UC was diagnosed with heart disease by different doctors

more than once but still kept a hope that the heart disease could probably

be cured by Chinese herb and acupuncture rather than surgery. Once

cardiac surgery was considered essential, patients would need to make a

decision on which hospital they wished to be treated at. One 42 year old

man explained:

… I actually visited several other hospitals. What I was particularly

looking at was staff profiles on the wall and health care facilities. I

did not ask any doctors and nurses. I regarded myself as an

observer from outside. Finally I made decision after having carefully

observed every hospital. I think I was very confident about my

surgery because of my careful observation, comparison, and

evaluation. (286UC)

Throughout his account above, he recalled that his decisions were not

based on what he was told or recommended but the information he

gathered through his observations. For this patient, seeing was believing.

Cardiac surgery, as these interview participants said, is not a small

operation. Therefore it is hard to make a decision on whether to have it or

not. Patients normally experienced a transition from being reluctant,

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hesitant, and frustrated, to making a decision. Their decisions were largely

driven by the information they had gathered from various sources before

surgery, with doctors having the final influence.

7.5.2 Strength from knowledge

When asked how they felt about cardiac surgery, most interview

participants discussed their experience of fears and worries between

admission and surgery. One of the most predominant feelings expressed by

participants was anxiety. One 52 year old woman talked of her story, after

hospital admission,

I really started to worry a lot… What if I could not get out of the

operating room? Yes, I really could not express myself how scared I

got at that time (weeping)… Before surgery I was in bad mood. I

had increased pressure when getting closer to surgery. I even

started not to sleep a few days before the date of my surgery.

(58UC)

Some interview participants recalled similar preoperative feelings. These

emotional feelings were from male and female participants alike. They

emphasised that when they thought about how during surgery their chest

would be opened and their heart would stop beating, they became

extremely scared and anxious (273UC female; 214PE female; 216PE male).

They also expressed their worries about family members if they died. This

illustrates the potentially considerable psychosocial impact of cardiac

surgery.

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In contrast, some interview participants pointed out that their

psychological state before surgery was relatively stable and they were not

that anxious. Their explanations gave insights into the source of their inner

strength. One male participant said,

… I was not full of worries. First, I believe the world's great progress

in medical technology, the second is the belief in the good

reputation of the hospital, the third, I trust in the level of health

care in our ward… I have experienced everything in my 74 years,

and should not have any fear. (248PE)

Quite a few interview participants specifically commented that having

knowledge about the recently rapid improvement of surgical technology,

reputation of the hospital and cardiac surgical ward made them feel secure

and calm (e.g., 286UC and 54PE). 11PE and 60UC also similarly stated that

they did not worry too much about the result of surgery as much as

younger patients did. They believed that death was a point everybody

would come to at the end, so they should not be scared.

The majority of interview participants stated either explicitly or implicitly

that they did experience various degrees of anxiety prior to the surgery.

They described how information could to some extent help the gradual

building up of their inner strength to mentally cope. A 42 year old man

summarised, ‘the more I know, the less anxious I feel’ (286UC):

Yes, I did not have any worries preoperatively… I was equipped

myself with the knowledge. By searching relevant information

online, I became more confident on my illness and surgery. I think

that I will be all right… (286UC)

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This interview participant emphasised the importance of prior knowledge

and individual engagement into health care. One 69 year old man without

computer skills reported that his children had helped him to search for

information on the internet and even went to hospitals to gather

information on his behalf (54PE). One woman who felt highly anxious said

repeatedly that she wished that she had made every effort to gather all

information and knowledge she needed before surgery (58UC). Their

different level of prior knowledge may explain why some interview

participants felt cardiac surgery to be a source of anxiety while others did

not report feeling particularly anxious.

With increasing expectation among Chinese people of a good quality of life,

patients and their families become more and more active in seeking health-

related information. They are keen to learn more about any aspects of their

healthcare. Preoperative information was viewed as very important for

them to gain strength and confidence, as most participants stated during

the interview. Some articulated what information they particularly wanted

and needed before surgery (203PE and 6UC).

In the preoperative stage, surgery was the first thing, of course. So

I wanted to know all the information relevant to my surgery, such

as who would be my surgeon, how long a heart surgery generally

lasts, when patients would be awake from anaesthesia etc., followed

by the prognosis, for instance, when to get out of bed, how long the

patient can be discharged and would the surgery bring a lot of

pain?... (6UC)

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Interestingly, there was a tendency for the interview participants to deny

experiencing anxiety regarding their surgery in the early stages of their

interview, particularly for male participants. As the interview continued,

participants were more willing to acknowledge feelings of panic and

anxiety. One man (53PE) said ‘I did not feel it. No, I never... Well, it is not

possible for a person who is not having any fear of the surgery, right?...

When the operating room's door was about to close, at that particular time,

I was so afraid indeed.’ Those who did experience anxiety might feel it

shameful to speak out because it is sometimes seen as an indication of

weakness. His account implied that the preoperative education intervention

he had received might reduce but not remove anxiety. Of the twelve male

participants, six referred to being anxious but only two in the first half of

the interview (282UC and 54PE).

7.5.3 Information as a low priority

Three interview participants explained that they felt that in Chinese

hospitals, information and emotional support was a generally ignored

aspect in patient preoperative care (58UC, 227UC and 53PE). As one 50

year old man put it,

Certainly I have learned a lot of knowledge through taking part in

your research. I have realised patients' mental health is important

and psychological care for patients should be stressed in hospitals.

But in our healthcare system, this part is far behind western

countries like the UK where provision of patient information and

support have been well developed. In China, no one is responsible

for giving you information and helping you release anxiety and

stress. We definitely lack this aspect of care. (53PE)

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These participants considered themselves vulnerable during the

preoperative period. They believed that they should have been equipped

with more knowledge about their health and care. However some

participants (214PE and 248PE) explained that they placed their attention

on physical health rather than information needs and psychological

concerns. They doubted the effect of information and psychological care on

health outcomes and thought that sometimes information could create

anxiety. A participant (214PE) said ‘information and psychological care

cannot treat my heart disease. I don’t want information because getting to

know more about my condition can bring more worries to me and my

family. I only want to get my surgery successfully done’. Traditionally in

China, provision of information and psychological support has been

considered as a lower priority by both hospital staff and patients, compared

to other treatment and care.

7.5.4 A perception of paternalism

Some interview participants indicated that ward staff only talked about

heart disease and surgery with their family members particularly the

severity of their health condition and possible risk of surgery but did not

inform them before their surgery took place (6UC, 27UC, 58UC, 11PE and

248PE).

To be honest, very few doctors or nurses came to talk with us. Only

the day before surgery the doctor and anaesthetist came to ask for

some signatures. I think they were related to legal and medical

responsibility that sort of thing. No one informed me about things

like heart disease, preoperative preparation, and postoperative care

and so on. Sometimes when I encountered any doubt I even did not

know who to turn to. (27UC)

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The participants were not given full information and others often made

decisions for them. In China, hospital staff considered family members to

be in the best position to judge whether to pass the information onto

patients or not. In fact, family members normally chose to tell patients

about the severity of their conditions after surgery rather than prior to

surgery. As a result, patients did not know what was going on before

surgery in spite of being keen to be informed. It implies that information

giving is often based on what health care providers or others perceive are

the patients’ needs. However this can be quite different to what patients

themselves identify as their needs.

When ward staff informed the patient, they tried not to scare patients but

convey a feeling of trust, safety and confidence. Sometimes they thought

that it would be better for patients not to know, which could be seen as a

way of protecting patients. In fact, it is a form of paternalism (Cody, 2003,

p288). To be able to help patients make decision and involve them in

health care, it is necessary to provide them with full information about

disease and treatments.

7.6 Trial experience

Interview participants were encouraged to talk about their own ideas or

expectations about any aspect of the study. The majority expressed their

motivations and appreciation towards the participation in the study and

some of them spoke of their understanding of random allocation.

7.6.1 Motivations to participate

Interview participants found the questionnaires simple to understand and

that completing the questionnaires was neither inconvenient nor

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burdensome. After knowing what would be required of them in both groups

they felt that joining the study was not difficult nor time consuming (203PE

and 227UC). Throughout the trial, no one postponed or refused to

complete the questionnaires, which was another indicator that the study

was not perceived as too burdensome.

More than half of the interview participants spoke about their intention to

take part in the study, that is, they expected the study could, to some

extent, help them learn more about their surgery and health and think in a

positive way (203PE and 58UC). In addition, some participants mentioned

that they were keen to help with the study as they hoped that their

participation could improve current services, so that other patients and

their families would get better treatment and care (203PE, 248PE and

282UC). They showed their care and concerns about others and felt good

when they could offer help to others. A 74 year old man told me during his

interview that ‘I have gone through some tortuous paths, and I do not

want other patients to go, like me, again’ (248PE). From their account of

motivation, participating in the study, in their view was beneficial to

themselves and to others.

Several interview participants emphasised that their motivation was

because of curiosity about getting involved in a clinical study. One 63 year

old male participant who had his bypass surgery stated,

Your study was really good. The first time I heard from you about it,

I feel it should be a good study. So I must attend…I know that

many things may seem very common in foreign countries, but for

our country, are totally new. For example, it is the first time that I

had the honour to participate in medical research. This experience

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 makes me feel very curious and excited. I had never come across it

or even heard of it. (60UC)

For two participants (214PE and 227UC), the study taking place had added

to their good impression of the hospital and trust in the overall quality of

care of the hospital. A 39 year old man explained that it was his doctor

who recommended the study and he found that there would be a need for

more clinical studies,

I felt our hospital should have more studies like this. First of all, we

can understand more necessary knowledge, and secondly our

voices, to a certain extent, can be reflected upward to the

management team and eventually it will help improve patient

satisfaction and our overall service level of the hospital. (216PE)

7.6.2 Understanding of randomisation

Interview participants had different levels of understanding about the

concept of randomisation and what would be involved in the randomisation

process, although it had been explained to them before asking for their

consent about participation. Some participants had clearly understood that

they were randomly assigned to one of the trial arms and the meaning of

using this approach. Others were less clear in their understanding of it.

The 52 year old female participant who had nine years of education level

reported how she understood randomisation: ‘Randomisation is something

to be done in random order ... For example input all of patients' names into

a computer and ask computer to randomly assign them into groups... It is

a bit like gambling or lottery. You have no idea who will be in which group,

isn't it?’ She further summarised that, ‘Random, in fact, means no law to

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follow and is entirely accidental’ (58UC). Although she was in the usual

care group and did not get the leaflet she wanted, she believed

randomisation could ensure the participants’ allocation to be fair because

that who was in which group was not decided by someone but a

computerised process.

Some participants held similar views about randomisation as something

beyond human control (203PE, 214PE and 60UC). They believed that it was

arranged by fate as to whether they would be allocated to the preoperative

education group or not, and that the possibility of getting into any group

for everybody was equal. One 23 year old man (203PE) put his explanation

of the randomisation process more simply by saying that, ‘I know I have a

50% probability to be assigned to either the control group or leaflet group.

I totally understand this is your study requirements.’ Not all patients

grasped the concept of randomisation. Several participants explicitly stated

that they were not quite clear about what it was. One male participant

(60UC) who got a bachelor degree said, ‘I knew a little. I was not clear

actually. But I knew randomisation must be a good way to do your

research.’

Only two interview participants explicitly stated that they would not mind

which group they would be allocated to (60UC and 214PE). The majority of

participants described their preference for being allocated to the

preoperative education group (254UC and 255PE) as they expected more

information and support in this group and desired to see the leaflet.

However, they further explained that although they had a preference they

would like to keep complying with the study because they understood

having two groups was a basic feature of the study design.

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All interview participants indicated that they understood what was required

of them in the study from the day they signed the consent form. The

participants from the preoperative education group stated they had not

shared the leaflet with others, while those allocated to the usual care group

denied having seen the leaflet. Only one man (53PE) from the preoperative

education group mentioned that he was given a leaflet after he had read it

from another patient in the same room. From his story, it was apparent

there was some contamination between the two groups.

Interview participants felt lucky and pleased to be involved in the study.

Most participants, when asked if they would change any decisions they

made in relation to the participation, stated that there was nothing they

would change and furthermore they would like to recommend joining the

study to other patients.

7.7 Summary

The qualitative evaluation provided valuable insights into the content,

process and context of the intervention implemented and a deep

understanding of patients’ experience of taking part in the trial. It helped

to answer the questions regarding why and how the preoperative education

intervention worked or not and how it could be improved. Regarding the

process of information giving, participants spoke about the hierarchy of

hospital staff and how information was judged on the basis of the

reputation of its source. A number of interview participants expressed their

wishes to get more information about possible risks and complications

before surgery to enable them to have a better understanding of cardiac

surgery. Role models were highlighted by some participants who

commented on the need for mutual learning and peer encouragement. This

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helped to develop a sense of a shared experience and brought comfort

from the feeling that participants were not alone.

Many participants noted that information giving by ward staff was generally

one way, reactive rather than proactive, and limited, and patients were not

fully engaged. This was often attributed to the staff’s heavy workload. The

majority of interview participants who had received the intervention felt

satisfied with it. Participants believed that the leaflet combined with verbal

explanation helped them remain calm, be better prepared for surgery and

take an active role in health care.

The context of information giving helped shed a light on possible factors

influencing the delivery of preoperative education. Reflecting patients’

increasing demand for information about health care, they had gathered

from various sources advice and support before surgery to help them make

important decisions. A few participants explained that they really have

understood the importance of information on building up their inner

strength to face surgery. Information giving and psychological support

were considered a low priority, compared to other treatment and care in

China. Some participants mentioned that they felt lack of knowledge before

surgery. As a way of protecting patients, sometimes family members were

informed but patients themselves were overlooked. All interview

participants appreciated being involved in the study and most showed a

level of understanding of the concept of randomisation. These findings are

discussed alongside the trial results in the next chapter.

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 CHAPTER EIGHT

DISCUSSION

8.1 Introduction

The aim of this study was to test the hypothesis that a preoperative

education intervention could reduce anxiety among cardiac surgery

patients in China. A secondary aim was to examine whether the

intervention could reduce depression and perceived pain, as well as length

of Intensive Care Unit stay and postoperative hospital stay. The trial was

carried out to test this, while a qualitative evaluation was conducted to

explore the perceptions and experiences of patients who took part in the

trial. In this chapter, the results and methodological strengths and

limitations of the study are discussed. The findings from the trial and

qualitative evaluation are integrated and discussed in the light of adult

learning theory and are critically assessed in comparison with those from

other studies.

8.2 Overview of the main findings

Among participants randomised to the preoperative education group, there

was a greater reduction in anxiety and depression and less pain

interference with sleep compared with those in the usual care group. In the

trial, there were no differences observed between the two groups in terms

of average pain, current pain, and interference from pain in general

activity, mood and walking ability. This suggests the education intervention

had a positive effect on patients’ psychological health. A lack of difference

between randomised groups in postoperative hospital stay and the

borderline evidence that the preoperative education intervention can

reduce hours spent in Intensive Care Unit suggests that any benefits to

physical recovery are likely to occur immediately after surgery rather than

in the longer-term.

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The three categories emerging from the qualitative evaluation were: the

process of information giving, context of information giving, and the

process of participating in the trial. Most interview participants commented

that preoperative communication between patients and health care

providers was limited and reactive and patients were not fully engaged.

The overall response to the preoperative education intervention was

positive. The participants in the preoperative education group valued both

the patient information leaflet and the verbal explanation.

The context of information giving provided insights into possible factors

influencing the delivery of preoperative education. There is evidence to

support the statement that during the preoperative phase, staff usually

intended not to provide full information to patients as a way of protecting

patients, especially when discussing the risks and complications of surgery.

All interview participants reported enjoying being part of the study and

made a number of helpful suggestions concerning preoperative education

in future practice.

8.3 Strengths and limitations of the study

8.3.1 Study design

To my knowledge, this was the first randomised controlled trial to assess

the effect of preoperative education among Chinese patients undergoing

cardiac surgery. The sample size of 153 is larger than most other trials of

preoperative education interventions that have been conducted in Norway

(Sørlie et al., 2007) and the United Kingdom (McHugh et al., 2001). Most

of the larger studies to look at the effect of preoperative information for

cardiac surgical patients are non-randomised in design (Ivarsson et al.,

2005a). A review of fundamental characteristics of interventional clinical

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trials registered in the ClinicalTrials.gov database found that most

interventional trials registered between 2007 and 2010 were small in terms

of numbers of participants, with 62% enrolling 100 or fewer participants.

The median number of participants per trial was 58 for completed trials and

70 for trials that have been registered but not completed (Califf et al.,

2012).

The study was conducted in two Chinese public hospitals where protocols

for usual care and preoperative education were the same. However

environmental factors such as ward staff and ward layout may have had an

effect on patients’ psychological health. Although randomisation was

stratified by hospital the trial was not powered sufficiently to test for an

interaction between study group and hospital. Utilisation of health services

and social support was not an outcome examined in the present study and

therefore it is not possible to draw conclusions about cost effectiveness.

In this study, an understanding of the participants’ perspective concerning

the cardiac preoperative education intervention and their experiences of

involvement in the trial was obtained through a series of individual, face-

to-face interviews. This qualitative evaluation provided greater insights into

the process of preoperative information giving. The underlying

considerations about the context in which preoperative information was

delivered for Chinese cardiac patients became clearer. The interview data

also helped uncover the possible motivations for the patients to take part

in the trial and their understanding of the concept of randomisation. The

qualitative evaluation can not only help explain the results of the trial but

can also inform the future design of preoperative education interventions

for cardiac patients.

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Although adding a qualitative perspective into the trial is a strength of this

study, there were considerable challenges throughout the research

process. Acting as the interviewer may have meant that interview

participants might have seen me as a connection or liaison between the

patients and hospital administration. Therefore, when they expressed their

feelings, concerns or frustrations I sometimes felt they expected me to

report to the administration board in order for these to be acted on.

However, it is important to acknowledge that the interview participants

might attempt to present themselves to the interviewer as playing an

appropriate social role, whereby they provided answers that placed them in

a positive light or that they believed the interviewer wanted to hear (van

Heugten, 2004, Asselin, 2003). For example, they might have been

reluctant to criticise the intervention delivered by the interviewer and to

talk about their real experience with the interviewer. Consequently their

accounts of both the intervention and trial experience could have been

influenced by my presence.

It is also recognised that the study participants might have felt

uncomfortable in expressing their negative feelings about the surgery or

psychological problems. Two case studies of psychosomatic symptoms in

China (one from Hong Kong and the other from Nanjing) cited by Helman

illustrated that in Chinese culture, the open expression of emotion is not

encouraged (Helman, 2007, p262). It is particularly true for males in

China, which was supported by the observation that some male interview

participants initially denied experiencing any anxiety before surgery but

admitted that their anxiety did exist as the interviews went further. This

aspect of Chinese culture could also influence patients’ response to the

Hospital Anxiety and Depression Scales.

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8.3.2 Recruitment and follow up

Recruitment to the study was highly successful, with only two patients

declining to take part. It was emphasised to patients that participation was

voluntary and although there was a relatively small window between

admission and surgery in which to inform, recruit and consent patients, all

were given at least a day to consider their participation. The successful

recruitment in the present study could be attributed to several factors

including giving a clear explanation of the study and building up the

rapport with patients during the first contact. Additionally, medical support

was crucial, in that the doctors on the ward recommended the study to

their patients.

The present study had a low attrition rate of 12% (18/153). The main

reason for loss to follow-up was being discharged without surgery (n = 14)

with the remaining attrition due to reasons of death, and transfer of care to

another hospital. In China, it is not unusual for patients to discharge

themselves prior to surgery. This may be due to the financial cost incurred

by the patient if the procedure is to go ahead. It cannot be ignored that

there was a possibility that a patient's decision to discharge themselves

before surgery was influenced by the preoperative education intervention.

However, this is an unlikely explanation given the similarity of attrition

between the two groups (six from the preoperative education group and

eight from the usual care group) and that this overall rate is similar to that

observed outside the trial period.

The other issue worthy of note is that all participants in the preoperative

education intervention group had consistently taken up and completed the

intervention. The qualitative evaluation provides a possible explanation.

During the interviews, no one reported that the information given in the

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intervention was a repetition of information that they had already received

from other ward staff. The interview data also suggested that participants’

curiosity about the trial may have encouraged those in the two groups to

maintain their involvement in the trial, thus contributing to the low attrition

rate in the study. Outcomes were observed at seven days following

surgery. It is not possible to infer from our study whether the positive

effects of the preoperative education intervention would persist beyond this

period.

8.3.3 Randomisation, blinding, and contamination

Although randomised controlled trials are the most rigorous type of

scientific evaluation, the reliability and validity of the evidence from a trial

has to rely on an appropriate procedure of random allocation (Kendall,

2003). Allocation in this study was determined by a stratified block

randomisation, with random block size and stratified by the two study

hospitals. This prevented too great an imbalance in the number of

participants allocated to each arm and avoided the risk of being able to

predict the allocation in advance.

Data from the qualitative interviews showed that patients’ understandings

of the design of the study and what procedures were involved in the study

were variable. This has become a widely acknowledged problem in any

randomised trial (Kerr et al., 2004, Ellis, 2000, Robinson et al., 2005).

Although considerable effort had been made to provide clear and accurate

information for patients’ consent in this study, doing so could not

guarantee their full understanding of it, especially some difficult concepts

such as randomisation. It suggests that more discussions and explanations

about the purpose of randomisation need to be available for patients in

order for investigators to be confident that consent given is fully informed.

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To avoid bias, randomised controlled trials should ideally be double blinded,

where the participants and those responsible for their treatment or the

evaluators are unaware of which treatment the participant is receiving

(Pocock, 1983, Schulz and Grimes, 2002). However, due to the nature of

the intervention participants could not be blinded to study group allocation.

There is the risk therefore that some of the differences observed at follow-

up may be due to social desirability bias. To counteract this potential

problem it was ensured that the nurse collecting follow-up self-completion

measures was unaware as to which group the participant had been

allocated and was not the one who delivered the preoperative education

intervention. Baseline measures were carried out prior to the random

allocation. In conducting the analysis I was blind to study group labels.

That some evidence of a difference in hours spent in ICU postoperatively

was found also suggests that the difference in outcomes observed were not

limited to self-reported outcomes.

Although the leaflet was kept in an envelope and patients allocated to

preoperative education were asked not to pass on the leaflet, the

possibility of contamination between the two groups cannot be excluded.

The resources were not available to cluster randomise so patients allocated

to different groups could, in theory, be cared for in the same preoperative

ward alongside each other. Even if the participants in the usual care group

could have been prevented from seeing the leaflet, it was impossible to

avoid those in the preoperative education group sharing the knowledge and

skills they had learned from the intervention by talking with those in the

usual care group. So the risk of information leakage from the intervention

group to the control group leading to contamination of the trial arms can

only be minimised but not be avoided. However, the effect of

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contamination is likely to have resulted in an underestimation rather than

an overestimation of differences between the two groups at follow-up, that

is, the point estimate of an intervention’s effectiveness can be reduced due

to contamination between the two trial arms (Winkens et al., 1997,

Torgerson, 2001, Keogh-Brown et al., 2007).

8.3.4 Data analysis

Intention to treat analysis is generally considered the most robust analysis

for randomised controlled trials because of the inclusion of patients not

receiving intervention despite being randomised to intervention group

(Pocock, 1983). However, the use of a strict intention to treat analysis was

impossible in cases of missing data such as loss to follow-up (Abraha and

Montedori, 2010). Per protocol analysis also did not seem to be an

appropriate label to describe data analysis reported in this trial as it implies

that any individual receiving a treatment they were not randomised to

would be analysed according to the treatment received rather than the

treatment randomly allocated (Sedgwick, 2011, Sedgwick, 2010, Shah,

2011).

In this trial, all participants who completed follow-up were analysed as a

part of the group to which they were randomised and those lost to follow-

up were excluded from analyses. The 14 participants who were lost to

follow-up become effectively ineligible for the study by not having the

surgery for which the intervention was designed and which would make the

outcomes meaningful. Therefore, although these individuals were ‘lost to

follow-up’ in the technical sense, an alternative way of dealing with them

would be to have excluded them on the basis of their subsequent

‘ineligibility’.

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For the trial, independent-samples t-tests were used for anxiety,

depression and pain. Differing effects of socio-demographic data such as

age, gender and type of cardiac surgery should be taken into account when

analysing the data. It seemed more appropriate to also report data analysis

from linear regression models, whereby anxiety, symptoms of depression,

and pain scores were compared between two groups at follow-up after

controlling for baseline score, age, gender, education level, and surgery

type.

The qualitative evaluation consisted of the rich descriptive narrative

derived from semi-structured interviews with a sample of trial participants.

By analysing interview participants’ own accounts, patients’ voices were

heard, and their views on preoperative education and experiences of the

intervention and the trial were therefore reflected. With regard to interview

data analysis, it is important to ensure that the interpretation of data is as

close to the actual meaning of participants’ accounts as possible

(Silverman, 2001, Green and Thorogood, 2009).

Respondent validation, whereby participants are provided with written

transcripts or data analysis to check and confirm whether they reflect

participants’ own experience, may contribute to the credibility and rigor of

findings (Mays and Pope, 2000, Barbour, 2001). However seeking

validation from participants can be problematic because views may change

over time. Researchers are then faced with dilemma when respondents

wish to change data (Johnson and Waterfield, 2004). Through respondent

validation, additional data are gathered and require further analysis

(Papadopoulos et al., 2002). This may lead to confusion rather than

confirmation. So the value of respondent validation may be questionable

(Cutcliffe and McKenna, 2002, Horsburgh, 2003). Since the interview

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transcripts were not reported back to the participants, it is acknowledged

that there may have been some meaning lost through interpretation and

translation in this study.

8.4 Comparison with other studies

Many health service activities such as preoperative education should be

considered as complex interventions which are built up from a number of

various components acting both independently and interdependently

(Campbell et al., 2007). The Medical Research Council framework was

designed for the development and evaluation of randomised controlled

trials for complex interventions to improve health care (Campbell et al.,

2000). However, there is no doubt that designing and evaluating

preoperative education interventions can pose a considerable challenge and

require a substantial investment of time and efforts. A low rate of refusal

and attrition in this study to some extent is evidence of the feasibility of

delivering the intervention and its acceptability to patients. Previous trials

on preoperative education for cardiac patients have provided conflicting

evidence. It is also difficult to compare our findings with trials where

preoperative education interventions are highly variable or poorly

described.

8.4.1 Effect on psychological health outcomes

The participants randomised to the preoperative education group showed a

greater decrease in anxiety score (mean difference -3.6 points) and a

greater decrease in depression score (mean difference -2.1 points)

compared with those in the usual care group after adjustment for baseline

differences. The preoperative education intervention appears to be

beneficial for these Chinese patients in relation to their psychological

health. This finding is consistent with a randomised controlled trial of 98

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patients on the waiting list for elective bypass surgery at Glasgow (McHugh

et al., 2001). That study concluded that a monthly nurse led programme of

shared care for patients consisting of health education and motivational

interviews according to individual need could effectively reduce levels of

anxiety and depression measured by the HADS. A smaller clinical trial of a

preoperative health education program with 70 coronary artery bypass

graft patients in Iran observed significant improvements between two

groups in emotional reaction as measured by the Nottingham Health Profile

(Babaee et al., 2007).

However, some studies have found no evidence of the effects of the

provision of preoperative information on postoperative anxiety and

depression (Goodman et al., 2008, Ivarsson et al., 2005a, Shuldham et al.,

2002). Goodman et al. (2008) replicated the Glasgow study (McHugh et

al., 2001) with a larger sample of 188 patients listed for bypass surgery in

London and did not observe a difference between groups in anxiety and

depression scores. The trial conducted by Shuldham et al. (2002)

randomised 356 patients to a day of education from members of a

multidisciplinary team before admission for bypass surgery and found no

difference between groups in anxiety and depression six months after

surgery.

Perhaps these findings relate to the setting of the study. If the study was

conducted in a setting where a relatively high standard of preoperative

education has been routinely delivered to patients, it would be more

difficult to detect the difference between the intervention and routine care.

In China, the relative lack of routine information giving in hospitals has led

to Chinese patients’ eagerness and desire to receive information. It could

explain why a structured preoperative education intervention in this trial

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had a greater impact on psychological health than similar interventions

delivered to cardiac surgery patients in western countries.

8.4.2 Effect on length of stay and other outcomes

A lack of difference between randomised groups in postoperative hospital

stay and the borderline evidence that the preoperative education

intervention can reduce hours spent in ICU suggests that any benefits to

physical recovery are likely to be in the immediate rather than the longer-

term. Arthur et al. (2000) in a larger randomised controlled trial of 249

patients in Canada found that patients who received preoperative

intervention involving exercise training twice a week, education and

monthly nurse-led phone calls spent one less day in the hospital after

surgery and two less hours in the ICU. Another study (Shuldham et al.,

2002) found that there was no difference between groups in relation to

their ICU stay but their preoperative intervention group spent one day

longer in hospital after surgery. In this study, there was borderline

evidence to show that preoperative education resulted in a reduction of

four hours in ICU stay. Although no statistically significant difference in

postoperative hospital stay was observed, the median length of stay was

two days greater in the preoperative education group compared with those

who received usual care only.

There are a number of possible explanations as to why, in this study, the

patients allocated to the preoperative education group spent two days

longer in the hospital after surgery. The finding could be due to chance.

Another possible explanation for this is the slightly higher proportion of

preoperative education group patients undergoing bypass surgery (48.7%

bypass surgery in the preoperative education group vs. 42.9% in the usual

care group). This also can partly be explained by characteristic differences

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at baseline whereby the preoperative education group tended to have more

patents categorised as single and widowed, separated, or divorced, more

patients unemployed, and a relatively higher proportion of patients with co-

morbidities and previous hospitalisation and operation experiences. All of

these differences can possibly result in the longer postoperative hospital

stay for the patients in the preoperative education group due to being less

well physically and with less family and social support.

This trial did not observe differences between the two groups in terms of

average pain, current pain, and interference from pain in general activity,

mood and walking ability. The participants randomised to the preoperative

education group showed less pain interference with sleep compared with

those in the usual care group. Our finding of relatively little impact on

postoperative pain is consistent with previous studies (Shuldham et al.,

2002, Watt-Watson et al., 2004). In the Canadian randomised controlled

trial (Watt-Watson et al., 2004) with 406 bypass surgery patients to

evaluate a preadmission pain education intervention, the patients in the

intervention group who received an additional pain booklet did not have

better pain management outcomes although they had some reduction in

pain-related interference in activities. On the other hand, a clinical trial

(Babaee et al., 2007) of a preoperative health education program with 70

Iranian bypass patients observed improvements in pain, sleep and physical

mobility as measured by the Nottingham Health Profile. However, the

results from Babaee et al.’s small trial are more likely to be biased by less

reliable methods, where randomisation was reported but the patients were

selected to be in the control group after all of the participants in the

intervention group had received the education intervention and been

discharged from the hospital.

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8.4.3 Factors influencing preoperative education in routine practice

Adult learning theory provided a foundation for the development and

delivery of the preoperative education intervention in this study. Adult

learning theory helps to understand how adults learn and provide some

guidance on how to structure and deliver new information for optimal

uptake and mastery (Smith, 2002a, Yannacci et al., 2006, Yang, 2004,

Kaufman, 2003). Among various psychological and educational models of

adult learning, Malcolm Knowles’s notion of andragogy has become the

most influential work and widely used as a distinctive conceptual basis for

adult education and learning. It emphasises six principles of adult learning:

an adult’s need to know; readiness to learn; motivation to learn; self-

concept; orientation to learning; and the role of the learner’s experiences

(Knowles et al., 1998, Smith, 2002b). Consideration of these principles of

adult learning contributed to the design of this preoperative education

intervention for cardiac patients in China in terms of the timing, content,

and format of the intervention. When adult learning theory was integrated

into the development and implementation of the intervention, the

intervention had the potential for not only meeting the information needs

of patients but also their special needs and requirements as adult learners.

The goal of the preoperative education intervention was to reduce patients’

anxiety and improve recovery by improving patients’ knowledge and

understanding of their disease process and surgical treatment that they

were about to experience and enhancing the level of engagement with their

health care. The trial examined the effect of the intervention on patients’

psychological health and length of stay. It was also considered important to

explore how preoperative education subsequently influenced patients’

attitude, behavioural performance and health changes in the qualitative

evaluation. As the interview participants who received the preoperative

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education intervention recalled, through the accessibility of preoperative

information, their anxiety was decreased and their feelings of strength,

confidence and control over the situation were improved. They valued both

the written and verbal information delivered during the intervention. The

interview participants reported that they were motivated by the

opportunity to engage with the trial, and made a number of helpful

suggestions or recommendations concerning future preoperative education

interventions.

The qualitative evaluation revealed that patients’ perceptions of the

reasons behind not getting sufficient and useful preoperative education fall

into three broad areas: the heavy workload of staff; a lack of knowledge

and skills among staff; and a scarcity of resources. Some interview

participants in this study identified information needs and felt that they

needed more or different information and should have been encouraged to

ask nurses more questions about unclear issues. The patients’ experiences

of gaps in cardiac preoperative education from ward nurses is consistent

with the findings in a literature review of adult surgical patients’ perception

of the provision of information by nurses (Suhonen and Leino-Kilpi, 2006)

and a study of education of surgical patients by hospital staff members in

the Netherlands (Breemhaar et al., 1996).

8.4.3.1 The heavy workload of staff

The inadequacies of preoperative education were mainly attributed to staff

nurses’ heavy workload. Each cardiac surgery ward in both study hospitals

accommodates about 60 patients. There are only five to six nurses on duty

in the daytime and one nurse on duty during the night. The low nurse-

patient ratio places considerable pressure on ward nurses. The situation

becomes even more problematic when extra removable beds are arranged

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on the corridor for patients to have a temporary stay if there is no patient

room available. Nurses are constantly busy with a large amount of routine

care and administration. This may be because in China, the nurse’s role

has traditionally and culturally been perceived as carrying out doctors’

orders and administering medication. Neither doctors nor patients consider

health education to be part of a nurse’s responsibility (Choi et al., 2010).

The associated lack of time staff nurses can spend with patients resulted in

minimal contact with patients and their families and a perceived lack of

individualised information and care. This is consistent with the findings

from previous studies in China (Wu et al., 2011, Chan et al., 2007), the

United States (Barber-Parker, 2002, Chobanian et al., 2003) and the

United Kingdom (Casey, 2007). If increasing the numbers of staff is not

possible, health care providers need to work together to seek ways to

deliver preoperative information more effectively and efficiently.

8.4.3.2 A lack of knowledge and skills among staff

Another commonly mentioned barrier was the perception of staff members’

lack of knowledge and skills and a lack of confidence in preoperative

information for cardiac patients. Patients in this study noticed that health

care providers often provided what they assumed to be important to their

patients, with no one taking the time to check that patients and their

families were given the information they themselves felt they needed. This

is consistent with previous studies describing patients’ experiences while

waiting for cardiac surgery (Ivarsson et al., 2004) and the experiences of

patients’ next of kin (Ivarsson et al., 2005b). It is important for health care

providers to avoid forms of paternalism wherein a treatment or service is

‘carried out intentionally on behalf of a person other than oneself, against

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that person’s wishes or without consent, with the explicit purpose of doing

good for, or avoiding harm to, that person’ (Cody, 2003, p288).

In China, more attention needs to be paid to patient-centred care and

enabling patients to make decisions on what and how much information

they want. Since there is considerable variability in the amount and content

of preoperative information that patients desire, providing the same level

of information may not meet the needs of a highly diverse group of people

(Screeche Powell, 2004). It is unrealistic to expect all cardiac patients to

want to receive and discuss the same information. Listening to patients and

identifying their individual information needs may be the first step in order

to provide appropriate and relevant information (Abela, 2009). Ongoing

patient assessment is an important skill for nurses to identify the level of

fear and anxiety and its sources, patients’ pre-knowledge and

understanding level and to individualise education topics according to their

specific circumstances (McHugh et al., 2001).

Patients’ individual preferences for preoperative information may vary,

especially for information regarding potential risks and postoperative

complications associated with cardiac surgery. Beresford et al. (2001)

demonstrate that it is important for health care providers to routinely

discuss with patients about their requirement and preferences. Patients can

be distressed by too detailed information about risk (Ivarsson et al., 2007,

Tobias and Souhami, 1993) and their preoperative anxiety can be

increased by inappropriate information (Gillies and Baldwin, 2001).

Previous research has also shown that an inaccurate and sometimes

irrational understanding of illness and treatment are frequent among

coronary patients, and the overestimation of risk is associated with higher

levels of anxiety (Broadbent et al., 2006). Cardiac nurses need to provide

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sufficient and accurate information relating to both the benefit of cardiac

surgery and risk and possible complications in a way that patients can

understand (Oates and Paasche-Orlow, 2009, Cheng et al., 2002).

Numerous strategies can be implemented to help patients understand the

information conveyed such as clear and simple explanations, interactive

communication, use of plain language and visual images, welcoming

patients’ feedback and questions, and a trusting patient-staff relationship

(Weiss, 2007, Rosser and Kasperski, 2001, Hall et al., 2001).

In addition, it was noted by the majority of participants that preoperative

communication between nurses and patients appeared to be unidirectional

and focused on patient teaching with the patient as a passive recipient of

information. More interactive discussion between staff nurses and patients

was appreciated. Previous studies have also demonstrated that patient

relationships with nurses appear to determine how satisfied patients are

with the amount of information they receive (Suhonen and Leino-Kilpi,

2006, Sørlie et al., 2000).

8.4.3.3 A scarcity of resources

There are limited resources for cardiac preoperative education at Chinese

hospitals. Most of the resources and guidelines which have been developed

in western countries cannot be directly transferred for use in a country like

China with such a different socio-cultural context. It is not only because

learning needs and preferences are very different from one cultural group

to another but also the whole healthcare systems are not comparable

(Suhonen and Leino-Kilpi, 2006). The participants described their

appreciation of getting specific information about average length of hospital

stay, and the tests and procedures likely to be undertaken during their

hospital stay. Under the unique characteristics of the Chinese healthcare

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system, this kind of information can be considerably different from western

countries.

In order to meet the needs of patients undergoing cardiac surgery in China,

more creative, and more creative use of teaching materials and practice

guidelines are needed, which can facilitate staff in the delivery of

preoperative education and eventually improve preoperative education in

practice. In cardiac preoperative education, there was an expressed need

for the development and use of leaflets or handbooks about rehabilitation

and care after hospital discharge. This suggestion was consistent with the

findings of a study which identified a need for providing patient specific

postoperative care and rehabilitation before patient undergo thoracic

surgery (Ong et al., 2009). The period following hospital discharge has

been found to be stressful for patients (Utriyaprasit et al., 2010). However,

currently in China, only a few hospitals provide patients with cardiac

rehabilitation services and in those nurses play a limited role (Thompson

and Yu, 2007) and in many Chinese hospitals cardiac rehabilitation

programmes do not exist (Wu et al., 2011). Cardiac rehabilitation services

are not provided in the two study hospitals. To ensure continuity of care,

preoperative information should cover what patients need to know about

their care after being discharged from the hospital.

As the impact of digital revolution on modern life is recognised, the

production and use of videotapes, audiotapes or computer assisted

preoperative education, offer the advantage of being interactive and

possibly more engaging to patients. Developing and using health education

materials deserves more attention as rapid turnover along with staff

shortages make it hard for nurses to deliver sufficient verbal information,

(Monsivais and Reynolds, 2003). But these education materials need to be

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tailored to match cardiac patients’ needs, characteristics and preferences.

Although developing these education materials involves the expenditure of

time and resources, the significant clinical impact of preoperative education

warrants the expenditure of time and resources (Oates and Paasche-Orlow,

2009).

8.5 Summary

This chapter discussed the methodological strengths and limitations of the

study in terms of study design, patients’ recruitment and follow up,

randomisation, blinding and contamination, and data analysis. The trial

results and qualitative findings were integrated and examined in

comparison with other studies. The trial has demonstrated that the

preoperative education intervention is effective in reducing anxiety and

depression among Chinese cardiac patients. It supports the importance of

preoperative education for the improvement of patients’ psychological

outcomes. The study was conducted in China where a relative lack of

routine information provided to Chinese patients has led to their eagerness

and desire to receive preoperative education. This could explain why the

structured preoperative education intervention in this trial had a greater

impact on psychological health than similar interventions delivered to

surgical patients in western countries.

The qualitative evaluation further explained that receiving preoperative

information could help decrease patients’ anxiety and improve their

feelings of strength, confidence and control over the situation. A number of

suggestions made by the interview participants helped to reveal several

factors influencing preoperative education for cardiac patients in practice in

China. The overall findings from this study can inform recommendations for

future practice and research, which are presented in the final chapter.

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 CHAPTER NINE

RECOMMENDATIONS AND CONCLUSIONS

9.1 Introduction

This form of preoperative education has been shown to be effective in

reducing anxiety and depression among Chinese cardiac patients. Based

upon existing evidence and international practice, preoperative education

should be incorporated into routine practice to prepare Chinese cardiac

patients for surgery. Improving preoperative education in future may be

achievable through changes in nurses’ attitudes, values, knowledge and

skills. It requires time and commitment, as well as support from individual,

professional and organisational levels. This chapter examines the

implications for nursing education, practice and policy making in relation to

the improvement of cardiac preoperative education in the context of health

care in China. Finally, the lessons learnt from carrying out the study and

how these can inform future research are presented.

9.2 Implications for nurse training in preoperative education

This preoperative education intervention comprising an information leaflet

and verbal advice was relatively simple to design and administer and

offered substantial gains for cardiac surgery patients. Despite Chinese

patients’ increasing demands for preoperative education, nurses focused on

medical tasks and collecting factual information and often failed to address

the patients’ fears and emotional issues, especially when those nurses were

facing heavy workloads and limited time. Thus it is recommended that this

area of care should receive attention.

The training of nurses in the importance of delivering this form of

preoperative education is a key recommendation if evidence from this

study is to be incorporated into routine practice. Clinical nurses, apart from

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undertaking clinical tasks, should have a role in, or responsibility for, giving

general information and supporting patients in relation to the reduction of

preoperative anxiety and depression (Sørlie et al., 2007, Bäckström et al.,

2006). Preoperative education is a well-recognised strategy by which

healthcare providers address patients’ fear and worries about their surgery

(Mooney et al., 2007). Evidence that clinical nurses are poorly prepared for

dealing with psychological health problems demonstrates a need for

greater education and training in this area (Bergvik et al., 2008). Perhaps a

first step is raising awareness among nurses of the potential for alleviating

symptoms of anxiety and depression among the patients in their care.

The knowledge and skills and experience of the individual staff influenced

the standard of preoperative information received by patients and patients’

confidence in individual members of staff. Nowadays, despite the

increasing morbidity and mortality due to cardiovascular disease in China,

a survey found that Chinese nurses lacked the knowledge to provide

guidance in cardiovascular disease prevention and treatment to patients

with, or at risk of, the disease (Wu et al., 2011).

As increasing attention is being paid to the evidence base for practice,

nurses need to be equipped with the knowledge and skills in critically

appraising and utilising evidence (Soltani, 2008). However, in China,

clinical nurses tend to take the view that practice should be underpinned by

convention and tradition. A possible reason for the failure of implementing

research evidence to inform nursing practice is nurses’ lack of research

related knowledge and skills. Nurses do not feel they are capable of

evaluating the quality of research and have enough authority to make

change in health care practice (Eddins et al., 2011, Chien, 2010). There is

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a need for a way to educate and empower nurses in order for them to

introduce evidence into their practice.

9.3 Implications for preoperative education practice

9.3.1 Multidisciplinary preoperative education

The complex relationship between the physical, psychological, and social

health of patients demands that health interventions for anxiety and

depression are delivered holistically and coherently (Rosenfeldt et al., 2011,

Martin and Turkelson, 2006). The importance of multidisciplinary

cooperation in patient education has been noted by others (Deccache and

van Ballekom, 2001, Fournier et al., 2001, Bensing et al., 2001), while the

role of nurses in patient education cannot be overlooked (Monsivais and

Reynolds, 2003).

Although interview data in the present study indicated that doctors played

an important role in giving information, providing patients with appropriate

preoperative information is not the prerogative of medical staff. As

preoperative education includes all aspects of patient health care, to deliver

the diverse contents of information may involve a wide range of

professionals including not only medical staff, but also nurses,

anaesthetists, psychologists, pharmacologists and physiotherapists. The

goal of preoperative education to prepare patients for surgery is perhaps

best reached through the collaborative efforts of the health care providers

involved in the patients’ care (Ong et al., 2009, Tse and So, 2008)

There is a need to call for a nurse-coordinated multidisciplinary

preoperative education in which different health care providers from across

disciplines work closely together to provide a more effective and efficient

service. The strength of multidisciplinary interventions lies in the breadth of

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skills and expertise that different disciplines bring. On the other hand,

inconsistencies, overlaps and gaps can be found when information is

supplied by different health workers (Van Weert et al., 2003). The

unambiguous delineation of responsibilities and tasks in information

provision, such as being clear about who is responsible for what kind of

information at what time, can help prevent this (Tromp et al., 2004).

9.3.2 Patient involvement and social support

The participants during the interview valued the involvement of role models

in preoperative education and wished they could get more contact with

previous patients and learn more from their stories. It is recommended

that ward staff help co-ordinate the process whereby patients who have

undergone cardiac surgery recently can talk with current patients about

their own experiences of surgery. Whyte and Grant (2005) suggested that

an eager and well-informed patient could participate in the process of

preoperative education. It is considered as a beneficial way to provide peer

support and encouragement through shared experience. Additionally,

patient feedback on the delivery of preoperative information should be

encouraged and taken into account. It can contribute to the development

and improvement of preoperative education interventions in the future

(Wensing et al., 2003, Kruzik, 2009). Areas in need of improvement can be

highlighted by patient feedback (Marshall et al., 2000, Tasa et al., 1996),

which often help to inform both practice and policy (Jamtvedt et al., 2006).

Social support not only facilitates recovery after coronary artery bypass

surgery (Hämäläinen et al., 2000), but it can also play an important role in

patient preoperative education. Family members play an important role in

providing social support, although health care providers can provide social

support through communication with patients (Rantanen et al., 2004,

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Martin and Turkelson, 2006). In the present study, nearly all of the

participants in the preoperative education group invited at least one of

their family members to attend the intervention. Perhaps this was because

the presence of family members enabled them to remember and reinforce

what had been discussed. A systematic review of patients’ experiences of

preoperative communication similarly showed that relatives were found to

be needed during the preoperative communication to help the patients

prepare better for the surgery (Chan et al., 2011). On the other hand,

involving family members in the process of preoperative education to

discuss questions they had helped family members become calmer about

the surgery (Martin and Turkelson, 2006).

9.4 Implications for policy

The provision of preoperative education has not received sufficient

attention in Chinese hospitals. One reason for this is a lack of policy and

financial support from the Chinese Department of Health in patient

preoperative education. Albada et al.’s research (2007) comparing patient

education in hospitals in the Netherlands, Flanders and England suggests

that where there is a stable organisation and delivery of patient education

in hospitals, it is mainly the result of government policy and subsidy. A lack

of national or regional policy of patient preoperative education results in a

lack of coherence in preoperative education practice at Chinese hospitals.

China having a relatively low total per capita healthcare spend limits

financial support which can be provided for patient education.

Evidence based government policies on patient preoperative education are

needed. They can trigger every hospital or institution in China to

acknowledge the importance of preoperative education in patient health by

outlining the minimum service in preoperative education hospitals should

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deliver to patients. Financial support from the national and regional

government as well as at hospital level is also essential for the

development of preoperative education materials to use in practice, cardiac

nurse training in the delivery of preoperative education and research in the

field of preoperative education.

Although the intervention in this study was designed to be simple, it would

take at least ten minutes for each patient from the nurses’ limited time if it

was to be implemented by clinical nurses on the cardiac surgical wards. It

is not impossible to incorporate into routine care but will inevitably increase

nurses’ workloads. Nurses working in specialist roles were seen to

contribute positively to preoperative patient education and their input

reduced the workload of ward based nurses (Fitzpatrick and Hyde, 2006).

In a qualitative study exploring the perceived role and impact of one nurse

consultant in rheumatology (Ryan et al., 2006), seven peers of the

consultant and five patients were interviewed and found the nurse

consultant role had an impact on service development, leadership and

education activities. The advanced nursing roles were found to have a

positive impact on patient outcomes and play an important role in

improving nursing quality in many areas including cardiac nursing (PEPLAU,

2003). The development of advanced nursing roles in cardiac surgery in

China could potentially contribute to optimising preoperative education

practice in terms of speed and efficiency.

Since there is a lack of research evaluating preoperative education for

cardiac patients in China, policy making in this area is more likely to be

based on international literature and international practice. Evidence

showed that patient education in one country may function as a mirror for

the quality improvement of patient education in other countries (Visser et

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al., 2001). Exploring and learning from experience with preoperative

education among cardiac patients in other countries can contribute to the

development of innovative education interventions and improvement of

health care services in China. While it is acknowledged that compared to

western countries, there may be different traditions regarding the delivery

of information and education in China, patients’ desire for information

about surgery and suggestions for improving the quality and effectiveness

of preoperative education seems fairly consistent (Henderson and Chien,

2004). Findings generated from other countries can enrich the

understanding of preoperative education interventions from a cross-cultural

perspective (Douglas et al., 2009, Hayman and Hughes, 2005).

However, it is unwise to directly apply preoperative education interventions

which have been effective in other countries into practice in China without

further investigation. These interventions have to be tailored to suit the

social, cultural and economic conditions in China. The intervention designed

in this study is likely to be applicable across different countries and cultures

by adjusting the method of implementation according to the specific

cultural and environmental contexts. As Pettigrew (1990) argued, when

any change process takes place, a comprehensive analysis of the cultural

and contextual influential factors is important such as exploring and

evaluating the underlying obstacles and available resources under the

given circumstances.

With the increasing incidence and substantial global burden of

cardiovascular disease, nursing care for this group of patients deserves

worldwide attention. Health inequalities do exist in prevention, diagnosis,

treatment, and follow-up of heart disease. The need for integrating cultural

competence into nursing education and practice becomes apparent when

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nursing’s global consciousness evolves further (de Leon Siantz and Meleis,

2007). In view of this, it is time for nurse leaders in China to acknowledge

the importance of engaging Chinese cardiac nurses along with

cardiovascular nurses and researchers from other countries to contribute to

prevention, treatment and care of people with cardiovascular disease and

people at high risk.

9.5 Implications for future research

9.5.1 Effectiveness or efficacy?

More research is needed that evaluates health care interventions applied

by health care providers rather than research teams. There has been a

tendency for researchers to underestimate both the ability of health

services staff, from across professional backgrounds, to work to research

protocols and their understanding of the importance of concepts of trial

design such as randomisation. However, researchers are often not directly

involved in clinical practice. Involving health care providers in research or

encourage them to carry out research can become a starting point

(Mantzoukas, 2008).

The health care providers in this study were not experienced researchers

but they maintained enthusiasm for the project throughout the study

period as this was the first time any of them had been involved in a

randomised controlled trial. Both the successful recruitment of participants

and completion of follow-up measures can be attributed to the significant

contribution made by doctors and nurses working at the cardiac surgical

wards of the two study hospitals.

Standardising and replicating a non-pharmacological intervention for other

settings is sometimes difficult as the intervention in a trial is usually

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conducted according to a highly specified protocol which may be

impractical when applied in practice (Campbell et al., 2007, Campbell et al.,

2000). Therefore, the importance of evaluating these interventions under

‘normal’ service conditions, or in other words, evaluating interventions as

they operate in the ‘real world’ is emphasised (Arthur et al., 2002, Cheater,

2003). Although in the present study my role was as a cardiac nurse to

carry out the preoperative education intervention, it is necessary to test

whether a similar effect can be found if the intervention was to be

delivered by the nurses on the wards.

9.5.2 Research priorities

Despite some methodological limitations of this study, the results suggest

that this simple low cost preoperative education intervention has beneficial

effects on cardiac patients’ psychological outcomes. This study could serve

as a basis for further research regarding preoperative education for cardiac

surgery patients. Further trials that deal with these methodological

problems should be undertaken, along with ones that replicate the study in

other settings such as in primary care and among people with significant

anxiety and impaired quality of life.

The preoperative education intervention was feasible and could safely be

used among patients who were undergoing various types of cardiac

surgery. Exploring possible ways in which the preoperative education

intervention could be incorporated into routine practice is a priority for

future research. There is a need for more research to determine the

optimal time for preoperative education and to examine the long term

effects of preoperative education. Future work is also needed to show

whether preoperative education interventions like this affect ‘hard’

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outcomes, such as physiological outcomes, utilisation of health services

and costs.

In China, the time from admission to surgery is typically one week

although there is an increasing trend toward shortening this period. This is

in contrast to cardiac surgery performed in western countries where

patients undergoing elective surgery are admitted on the day of the

procedure. There is evidence showing that the longer a patient stays on the

waiting list for cardiac surgery, the more likely they are to reduce their

leisure activities, causing them to experience anxiety, reduced physical and

social functioning, poorer vitality, and general health (Sampalis et al.,

2001). While longer preoperative hospital stay gives ample time for

preoperative intervention, it is possible that this partially accounts for a

relatively high level of baseline anxiety which has allowed the trial to

demonstrate such a large impact of preoperative education on patient

anxiety. The effect of decreasing preoperative hospitalisation on patient

anxiety and other postoperative outcomes is a subject suitable for future

research.

There is an increasing awareness in western countries of the costs

associated with poor health literacy (Eichler et al., 2009) but the concept of

health literacy has been given scant attention in China. Health literacy has

been defined as ‘the ability of individuals to understand and use text,

documents, and numbers pertinent to commonly encountered health care

situations. These situations included care of illness, dealing with preventive

care, and navigating the health care system’ (Weiss, 2007, p8). Health

literacy is critical to empowerment. Many factors are associated with poor

health literacy including an increasingly complex healthcare system,

difficulties accessing healthcare, limitations in patient-provider

176
communication, and the failure of health care providers to promote self-

management and recognise patient barriers to communication and

comprehension (Oates and Paasche-Orlow, 2009, Hironaka and Paasche-

Orlow, 2008). There is a need for observational studies to determine the

level and variation of health literacy among Chinese health care users, and

qualitative research to gain greater insights into how good health literacy is

achieved.

Future research should target the dearth of trials into complex

interventions delivered within the context of Chinese healthcare. Cardiac

rehabilitation interventions may be a fruitful subject for further exploration,

as the period following hospital discharge has been found to be stressful for

patients (Utriyaprasit et al., 2010). Complex interventions are context

specific (Craig et al., 2008) and it is unwise to assume that evidence from

western countries is directly transferable to Chinese healthcare settings

without further investigation.

9.6 Conclusions

This study provides empirical support for the hypothesis that a

preoperative education intervention involving an information leaflet

combined with verbal explanation can be effective in reducing anxiety

among Chinese patients undergoing cardiac surgery. The follow-up

qualitative evaluation exploring patients’ experience provided in depth

understanding of the context and process of the intervention implemented

and helped answer questions regarding why and how this intervention

works and can be improved. The acceptability of both the intervention and

the study was supported by the low attrition rate and data from the

qualitative evaluation. This type of intervention could be widely

implemented both across China and the world.

177
Cardiovascular diseases are increasing in China and have become one of

the leading causes of mortality among Chinese adults. Patients awaiting

cardiac surgery experience high levels of anxiety and significant symptoms

of depression due to fears, worries and uncertainties about surgery.

Findings from this study not only have important implications for hospital

staff who are looking for effective strategies to control patients’ elevated

anxiety in anticipation of cardiac surgery, but also help make

recommendations for quality improvement of preoperative education in

practice. More research is needed into possible ways to incorporate

preoperative education interventions into everyday nursing practice, the

optimal time and components of these interventions for sustained effect,

and patients’ health literacy within the context of Chinese health care.

178
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APPENDICES

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Appendix 1 Participant information sheet

English version

Chinese version

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Appendix 2 Consent form

English version

Chinese version

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Appendix 3 Patient characteristics form

English version

Chinese version

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Appendix 4 Hospital anxiety and depression scale

English version

Chinese version

215
Appendix 5 Brief pain inventory short form

English version

Chinese version

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Appendix 6 Preoperative information leaflet - ‘your heart surgery’

English version

Chinese version

217
Appendix 7 Contact letter

English version

Chinese version

218
Appendix 8 Leaflet evaluation form

English version

Chinese version

219
Appendix 9 Interview schedule

English version

Chinese version

220
Appendix 10 Approval letters

English version

Chinese version

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Appendix 11 Publication

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