C Thesis

E FFECT
OF CLINICAL
PATHWAY IMPLEMENTATION
AND PATIENTS
CHARACTERISTICS ON
OUTCOMES OF CORONARY
ARTERY BYPASS GRAFT
SURGERY
The studies in this thesis were financially supported by:

Scholarship from Sector of Cultural Affairs and Mission, Ministry of Higher
Education, Cairo, Egypt
Graduate School for Health Research (SHARE), University Medical Center
Groningen, Groningen, The Netherlands
University of Groningen, Groningen, The Netherlands
The printing of this thesis was financially supported by:

Scholarship from Sector of Cultural Affairs and Mission, Ministry of Higher
Education, Cairo, Egypt
Graduate School for Health Research (SHARE), University Medical Center
Groningen, Groningen, The Netherlands
University of Groningen, Groningen, The Netherlands
Colofon
Copyright: Noha El-Sayed Hussein El-Baz 2009
Lay-out and printing: M.H.W. Hooiveld, Groningen and Ipskamp Drukkers,
Enschede
Cover: Artist impression of a graphic artwork of El-Sayed Hussein El-Baz
ISBN: 9789077113967
All rights reserved. No part of this publication may be reproduced, stored in a

retrieval system, or transmitted, in any form or by any means, electronically,
mechanically, by photocopying, recording or otherwise, without prior written
permission of the author.
RIJKSUNIVERSITEIT GRONINGEN
Effect of clinical pathway implementation and

patients characteristics on outcomes of
coronary artery bypass graft surgery
Proefschrift
ter verkrijging van het doctoraat in de

Medische Wetenschappen
aan de Rijksuniversiteit Groningen
op gezag van de
Rector Magnificus, dr. F. Zwarts,
in het openbaar te verdedigen op
maandag 8 juni 2009
om 16.15 uur
door
Noha El-Sayed Hussein El-Baz

geboren op 10 november 1973
te Alexandria, Egypte
Promotor
Prof.dr. S.A. Reijneveld
Rijksuniversiteit Groningen
Copromotores
Dr. L.J. Middel

Dr. J.P. van Dijk
Dr. P.W. Boonstra
Medisch Centrum Leeuwarden
Prof.dr. K. van der Meer

Prof.dr. J.J.L. van der Klink
Prof.dr. J.L. Hillege
Beoordelingscommissie:
To the memory of my Uncle Professor Samir Mustafa

I miss you very much
To the memory of my God mother Iris Marini
Non dimenticher mai
Paranimfen:
Klaske Wynia
Nehad El-Sayed Hussein El-Baz
List of contents
List of contents
Chapter one
General Introduction
Page
Chapter two
Are the outcomes of clinical pathways evidence-based? A critical appraisal
of clinical pathway evaluation research
Published in Journal of Evaluation in Clinical Practice, 2007; 13(6):920929
39
Chapter three
Coronary artery bypass graft surgery patients in a clinical pathway
gained less in health-related quality of life as compared to patients who
undergo CABG in a conventional care plan
Accepted by Journal of Evaluation in Clinical Practice July 2008
65
Chapter four
EuroSCORE predicts poor health related physical functioning six months
post-coronary artery bypass graft surgery
Published in Journal of Cardiovascular Surgery, 2008;49(5):663-672
83
Chapter five
The impact of Type D personality on deterioration in health-related
quality of life after coronary artery bypass graft surgery is mediated by
changes in anxiety and depression
Submitted
103
Chapter six
Low positive affect is associated with more health complaints in younger
bypass patients
Submitted
125
Chapter seven
General Discussion and Conclusion
143
Summary
177
Samenvatting
185
Acknowledgements
197
Appendices
203
About the author
251
Graduate School for Health Research SHARE

and previous dissertations
255
C HAPTER 1
I NTRODUCTION
Introduction
10
Chapter 1
C HAPTER 1
I NTRODUCTION
General introduction, aims and outline

Coronary artery bypass graft (CABG) surgery is one of the most frequently
performed cardiac surgical procedures with unquestionable benefits, aimed at
relieving anginal symptoms and improving health related quality of life
(HRQoL). In the past decades, there has been a great development in the
methods of delivering care to CABG patients, one of which was the introduction
of a clinical pathway. A clinical pathway (CP) is a method of delivering care that
was developed in the 1980s in the United States and since then it has been
widely used in other parts of the world. Recently, the use of CP as a method of
delivering care was initiated and introduced at the University Medical Center
Groningen (UMCG) in the Netherlands,
where the Thoracic Surgery
department, UMCG, implemented a clinical pathway for patients undergoing

CABG.
This study was undertaken to investigate the effect of CABG pathway on the
patients outcomes. The outcomes investigated were length of stay (LOS),
readmission and complications and outcomes that were rarely examined when
evaluating the effects of CABG pathways, such as health-related quality of life
(HRQoL) and psychological distress (PD), i.e. anxiety and depression.
Existing studies evaluating the effect of clinical pathways on outcomes of
patients were mainly of poor methodological quality1. These studies also
concentrated on evaluating organization related outcomes, e.g. LOS and costs,
and few articles investigated the effect of CPs on patients related outcomes, like
complications, HRQoL, and psychological distress1. Therefore, the aim of our
study was to investigate the effect of implementing the CABG pathway plan on
patient related outcomes compared to patients in a conventional care plan. The
significance of the current study lies in the fact that it is a controlled study and
we investigated patients outcomes that were mainly rarely addressed
by
studies evaluating the effect of pathways, e.g. HRQoL and psychological

distress. Furthermore, this study also reports on the role played by the
EuroSCORE on predicting outcomes other than mortality, e.g. functional status,
LOS, and postoperative complications. Moreover, we are presenting the effect of
other patients characteristics that can affect the desired outcomes of CABG
surgery as Type-D personality, and psychological distress (anxiety and
depression), and lastly the effect of positive affectivity on cardiac related health
complaints after CABG.
In this chapter, we also present an overview of the epidemiology and
pathophysiology of coronary artery disease (CAD) in order to present an outline
of the disease process and the development of anginal symptoms which in turn
11
Introduction
affect patients functional abilities. In addition, this introductory chapter

presents the significance of HRQoL measurements in patients undergoing
critical procedures, i.e. CABG, and reviews the process of development and
evaluation of clinical pathways. Finally, at the end of this introductory chapter
we present a conceptual model that we developed based on the conceptual model
of Wilson and Cleary in 19952, which provided the basis for the research
questions and the aims formulated.
1.1 Coronary artery disease
1.1.1 Epidemiological data
Coronary artery disease (CAD) is a leading cause of mortality and morbidity in
the developed world. It involves the narrowing or total occlusion of the arteries
that provide oxygenated blood and nutrients to the cells of the heart as a result
of plaque forming on the lining of the arteries by the atherosclerotic process3. In
the Netherlands, according to the Dutch Heart Foundation, the incidence of
cardiac infarction in 2004 in men was 32.000 and in women 36.000.
Furthermore, it was found that the prevalence of ischemic heart diseases in both
men and women
55 years was 277.300 in 2004, while mortality due to ischemic
heart disease constituted 32,5% among the other diseases causing mortality in
20034.
The concept of burden of disease combines mortality and morbidity into a single
indicator denoted as the Disability Adjusted Life Years (DALYs). According to
the Atlas of heart disease and stroke5. The disability-adjusted life years lost, can
be thought of as healthy years lost to a disease, and they indicate the total
burden of disease as opposed to simply the resulting deaths. By comparing the
data from the Netherlands with Egypt regarding DALYs, we may conclude that
the burden of CAD in Egypt is three times higher compared to the Netherlands6.
1.1.2 Pathophysiology
CAD is a chronic process that begins early in life, particularly during
adolescence, and slowly progresses throughout life7. The main cause of CAD is
the development of atherosclerosis. The word Atherosclerosis originates from the
Greek words athera meaning gruel or paste or porridge and sclerosis meaning
hardness. Risk factors of CAD include: older age, male gender, family history of
premature coronary artery diseases, cigarette smoking, diabetes mellitus,
hypertension, hyperlipidemia, inactive lifestyle, obesity and as well as stressed
personality behavior8. These risk factors accelerate a complex and chronic
inflammatory process that manifests as fibrous atherosclerotic plaque7,9.
Recently, psychological distress presented in depression and anxiety10,11 were
12
Chapter 1
also proven to be risk factors for the development of CAD, and poor
prognosis12,13.
1.2 Types of CAD
Coronary artery diseases can be classified into angina pectoris, myocardial
infarction (MI) and acute coronary syndrome (ACS).
1.2.1 Angina pectoris
The word angina comes from the Latin word meaning to choke14. Angina
pectoris, however, is the term used to describe chest pain or discomfort that
results from CAD. The patient may describe the sensation as pressure, fullness,
squeezing, heaviness or pain15.
Angina can be classified into16:
1. Angina pectoris: which is an uncomfortable sensation in the chest and
neighboring anatomic structures produced by myocardial ischemia. Angina
pectoris is caused by temporary, reversible myocardial ischemia induced by an
imbalance between myocardial oxygen demand and myocardial oxygen supply,
which occurs as a result of atherosclerotic narrowing, arterial inflammation, and
obstruction resulting from intense focal spasm of the coronary arteries. Other
causes of unstable angina are fever, tachycardia and thyrotoxicosis leading to
increased oxygen demand.
2. Stable angina which is a chronic pattern of transient angina pectoris,
precipitated by physical activity or emotional upset, relieved by rest within a
few minutes. Episodes are associated with temporary depression of ST segment,
but it does not result in permanent myocardial damage.
3. Variant angina or angina inversa is a typical angina discomfort, usually at
rest, that occurs in cycles and develops because of coronary artery spasm rather
than an increase of myocardial oxygen demands. It is usually associated with ST
segment elevation.
4. Unstable angina is a pattern of increased frequency and duration of angina
episodes produced by less exertion or at rest, there is also a high risk of
progression to myocardial infarction if untreated16.
The severity of anginal symptoms can be classified either by New York Heart
Association Functional Classification17 or Canadian Cardiovascular Society
Functional Classification18.
The New York Heart Association (NYHA) Functional Classification places
patients in one of four categories based on how much they are limited during
physical activity; the limitations/symptoms are in regards to normal breathing
13
Introduction
and varying degrees in shortness of breath and or angina pain. NYHA Class
Symptoms are classified into: Class (I) No symptoms and no limitation in
ordinary physical activity; Class (II) Mild symptoms (mild shortness of breath
and/or angina) and slight limitation during ordinary activity; Class (III) Marked
limitation in activity due to symptoms, even during less-than-ordinary activity,
e.g. walking short distances (20-100 m), and comfortable only at rest; Class (IV)
Severe limitations: experiences symptoms even while at rest; mostly bedbound
patients.
Furthermore, the Canadian Cardiovascular Society Angina Grading Scale is also
commonly used for the classification of severity of angina and it is classified as
follows: Class (I) Angina only during strenuous or prolonged physical activity;
Class (II) Slight limitation, with angina only during vigorous physical activity;
Class (III) Symptoms with everyday living activities, i.e. moderate limitation;
and Class (IV) Inability to perform any activity without angina or angina at
rest, i.e. severe limitation.
1.2.2 Myocardial infarction
Myocardial infarction (MI) is the rapid development of myocardial necrosis
caused by a critical imbalance between oxygen supply and demand of the
myocardium. This usually results from plaque rupture with thrombus formation
in a coronary vessel, resulting in an acute reduction of blood supply to a portion
of the myocardium19.
The size of the infarction is determined by factors such as extent, severity and
duration of ischemia, the size of the vessel affected and amount of collateral
circulation, the status of intrinsic fibrinolytic system, vascular tone, and
metabolic demands of the myocardium at time of event.
MI mostly results in damage of the left ventricle, leading to compromise of left
ventricular function. MI can also occur in the right ventricle or both ventricles.
When all the tissues of the layers of the myocardium are necrotic it is called
transmural infarction. As a result the pumping effect of the heart is affected
which compromises cardiac output20.
Signs and symptoms of MI: the onset of symptoms in MI is usually gradual,
lasting several minutes, and rarely instantaneous. Chest pain is the most
common symptom of acute myocardial infarction and is often described as a
sensation of tightness, pressure, or squeezing. Pain radiates most often to the
left arm, but may also radiate to the lower jaw, neck, right arm, back, and
epigastrium, where it may mimic heartburn. Levine's sign, in which the patient
localizes his chest pain by clenching his fist over the sternum, has classically
been thought to be predictive of cardiac chest pain, although a prospective
observational study showed that it had a poor positive predictive value21.
14
Chapter 1
Shortness of breath (dyspnea) occurs when the damage to the heart limits the
output of the left ventricle, causing left ventricular failure and consequent
pulmonary edema. Other symptoms include diaphoresis (an excessive form of
sweating), weakness, light-headedness, nausea, vomiting, and palpitations.
These symptoms are likely induced by a massive surge of catecholamine from
the sympathetic nervous system which occurs in response to pain and the
hemodynamic abnormalities that result from cardiac dysfunction. Loss of
consciousness (due to inadequate cerebral perfusion and cardiogenic shock) and
even sudden death (frequently due to the development of ventricular fibrillation)
can occur in myocardial infarctions. Complications that may arise include:
recurrent MI, cardiogenic shock, ventricular septal wall rupture, left ventricular
wall rupture, pericarditis, thromboembolism, dysrhythmias, and conduction
disturbances caused by affection of sinoatrial (SA) and atrioventricular (AV)
nodes.
1.2.3 Acute coronary syndrome
The terminology acute coronary syndrome (Figure 1.) is used to describe clinical
symptoms compatible with acute myocardial ischemia and includes unstable
angina and acute MI. Unstable angina refers to unexpected chest pain or
discomfort that occurs at rest. Patients with MI are either those with ST
segment elevation MI or non-ST segment elevation MI22.
Figure 1. Clinical classification of acute coronary syndromes23

N QMI = non-Q - wave myocardial infarction; NSTEMI = non-ST elevation myocardial infarction;
Q wave MI = Q wave myocardial infarction; ST = ST segment of ECG tracing
15
Introduction
1.3 Treatment of CAD

The aim of therapy in patients with angina is to restore the balance between
oxygen supply and oxygen demand. This can be achieved by modification of risk
factors, pharmacological therapy or invasive therapy.
Pharmacological therapy includes nitroglycerin, morphine, beta blockers,
calcium antagonists and anti-platelets therapy24. In case of MI, the medical
therapy includes: thrombolytic therapy, oxygen therapy, nitroglycerine and
morphine
sulfate.
Invasive
treatment
includes
percutaneous
coronary
intervention (PCI) or (CABG).

Cardiac rehabilitation: one of the important aspects of treating MI is cardiac
rehabilitation. The rehabilitation program begins by preparing patients for
discharge following the initial treatment through education about the program
which includes exercise, smoking cessation, lipid management, weight control,
psychological intervention, blood pressure control and return to work. Family
members are also included in the program, so they can learn about heart
diseases and help achieve the goals of the program.
1.3.1 Non invasive treatment
Non invasive treatment of CAD is aimed at controlling symptoms and slowing or
stopping the progression of disease. The method of treatment is based on many
factors determined by symptoms, a physical exam and diagnostic testing. In
many cases, if the blockage is less than 70 percent, medications may be the first
line of treatment. Treatment includes modification of risk factors and
medication. Risk factors of CAD are either modifiable e.g. smoking, stress,
obesity, high blood cholesterol, high blood pressure, physical inactivity, diabetes
mellitus, alcohol and high fat diet or non modifiable, e.g. increased age, male sex
and heredity factors (including race)15,19.
The medications used to treat CAD include: anticoagulants, which help in
decreasing the clotting (coagulating) ability of the blood, help to prevent harmful
clots from forming in the blood vessels and may prevent the clots from becoming
larger and causing more serious problems. Antiplatelet agents most commonly
prescribed is Aspirin which keeps blood clots from forming by preventing blood
platelets from sticking together in patients who have had a heart attack,
unstable angina, ischemic strokes, or transient ischemic attacks. Angiotensin II
Receptor Blockers (or Inhibitors) prevent this angiotensin from having any
effects on the heart and blood vessels, and prevent rise in blood pressure.
Moreover, Beta Blockers which act to decrease the heart rate and cardiac
output, subsequently lowering the blood pressure and making the heart beat at
a slower rate and with reduced force, Calcium Channel Blockers interrupt the
movement of calcium into the cells of the heart and blood vessels, which
16
Chapter 1
decreases the hearts pumping strength and relaxes blood vessels, thus lowering
the blood pressure and chest pain related to reduced blood supply. Diuretics help
the body to rid itself of excess fluids and sodium through urination, which
relieves the heart's workload, decrease blood pressure and edema. Vasodilators
relax blood vessels and increase the supply of blood and oxygen to the heart,
while reducing its workload leading to relief of chest pain. Digitalis increases
the force of the heart's contractions, which can be beneficial in case of heart
failure and for irregular heart beats. Finally, statins are also prescribed to
lower blood cholesterol level15,19,25.
1.3.2 Invasive treatment of CAD
1.3.2.1 Types of Invasive treatment
Treatment generally aims to reduce cardiac workload, improve coronary artery
blood flow, and, over the long term, slow down and reverse the atherosclerotic
process. Coronary blood flow can be improved by PCI or CABG, our main
concern in this study is CABG surgery.
Coronary artery bypass graft surgery
The indications of CABG are listed in Table 1. according to the guidelines
established by the 2004 American College of Cardiology (ACC) and American
Heart Association (AHA).
In CABG, native vessels or conduits are harvested during the initial phase of
surgery to reroute or bypass blood flow past diseases areas of coronary arteries.
The first saphenous vein aortocoronary bypass graft was performed in 1964.
Since then, the use of CABG has become an acceptable treatment for CAD.
Selection of the graft or conduit depends on the diameter similar to coronary
arteries, absence of disease or wall abnormalities, and adequate length. The
commonly used grafts are saphenous vein grafts, internal mammary artery
grafts, radial artery, and right gastroepiploic artery. After one year, about 85%
of the venous bypass grafts are patent, but after ten years, as many as 97% of
the internal mammary artery grafts are patent. Arteries show hypertrophy to
accommodate the increased blood flow, where veins do not.
CABG has proved to be effective in relieving angina and improving exercise
tolerance, and it prolongs life in patients with left main CAD and three vessels
disease with poor left ventricular function. To decrease mortality associated
with bypass surgery, it is necessary to consider several factors: urgency of
operation, age, previous heart surgery, sex, left ventricular ejection fraction,
percentage of stenosis of the left main coronary artery, and the number of major
17
Introduction
18
Chapter 1
19
Introduction
coronary arteries with greater than 70% stenosis.

Complications of CABG
CABG is typically performed during cardiopulmonary bypass with the heart
stopped; a heart lung machine pumps the blood, removes carbon dioxide (CO2)
and oxygenates the blood. The main risks of the procedure include stroke and
MI. For patients with a normal-sized heart, no history of MI, good ventricular
function, and no additional risk factors, risk is < 5% for peri-operative MI, 2 to
3% for stroke, and
1% for mortality; risk increases with age and presence of
underlying disease. Operative mortality rate is 3 to 5 times higher for a second

bypass than for the first; thus, timing of the first bypass should be optimal.
After cardiopulmonary bypass, about 25 to 30% of patients develop cognitive
dysfunction, possibly caused by micro-emboli originating in the bypass machine.
Dysfunction ranges from mild to severe and may persist for weeks to years. To
minimize this risk, some centers use a beating heart technique (i.e., no
cardiopulmonary bypass), in which a device mechanically stabilizes the part of
the heart upon which the surgeon is working.
Prognosis of CABG
CAD may progress despite bypass surgery. Postoperatively, the rate of proximal
obstruction of bypassed vessels increases. Vein grafts become obstructed early if
thrombi form and later (several years) if atherosclerosis causes slow
degeneration of the intima and media. Aspirin prolongs vein graft patency.
Continued smoking has a profound adverse effect on patency.
1.4 The role of nursing care in CABG surgery
The nursing care of patients is not limited to the postoperative period, but
nurses are responsible for patients care during preoperative and postoperative
phases. The main focus during preoperative phase involves: history recording,
physical examination, diagnostic procedures, preoperative teaching, including
operative procedure, intensive care unit (ICU), invasive lines and recovery
period. Postoperative care mainly includes transporting the patients to ICU,
where they will recover from anesthesia and may remain for up to 24 hours after
surgery.
This phase involves monitoring of vital signs, cardiac output, connection to
mechanical ventilator, measuring end-tidal CO2, SpO2, peripheral pulses and
perfusion signs, output of chest tubes and body temperature to prevent
hypothermia. Once the patient is hemodynamically stable, urine output is
measured and assessed, clinical data are obtained, chest radiograph, 12 lead
ECG, routine blood work, assessment of neurological status and pacemaker
20
Chapter 1
function. Furthermore, the patient is closely monitored for systematic

inflammatory responses, severity and control of pain and prevention of
complications.
The achievement of optimum patient outcomes following CABG surgery is the
aim of health care providers involved in patient care, especially critical care
nurses. In the past decades there has been a great focus on the use of managed
care, due to increased costs and demand for high quality care. This presented a
unique challenge for critical care nurses to integrate theoretical knowledge,
assessment skills, and problem solving ability to provide optimal, high quality
nursing care15,27.
1.5 Outcomes of coronary artery bypass graft surgery
CABG is an established treatment procedure with clear benefits, including
symptom relief, prolonged survival and improved health related quality of life.
Studies evaluating the effect of CABG primarily concentrated on mortality
rates, occurrence of complications and length of stay in the health care facility.
In the past decades there has been a great interest in the effect of both CABG
the factors affecting HRQoL before and after the operation. Several studies were
conducted to examine whether patient related factors28-36, such as: (i) age, (ii)
sex, (iii) educational level, (iv) type of work, (v) marital status and (vi) social
support, or clinical variables such as: (vii) severity of illness, (viii) left
ventricular ejection fraction (LVEF), (ix) multiple vessels diseases
28,30,33,35,37
and
recently the role of (x) psychological distress (anxiety and depression)31, and (xi)
type of personality38-40 affect the HRQoL of patients after CABG.
1.5.1 HRQoL in relation to critical illness
Over the last decades quality of life (QoL) has become an increasingly important
concept in evaluating healthcare outcomes in several fields of critical care,
including open heart surgery, which is considered a major surgery and the first
few months after surgery are considered a critical and crucial period.
Nevertheless, some clinicians disregard HRQoL measures as they perceive them
as soft or not as scientific as physiological measures41. However, health care
personnel working in any critical or intensive care setting recognizes that a
patients physical status at discharge is only a preliminary measure of success of
therapeutic outcomes. Short term outcomes include changes in clinical status
and improvement or relief of symptoms, while long term outcomes take into
consideration the impact of hospitalization, undergoing a critical procedure (e.g.
open heart surgery), and the nature of care the patient receives following
surgery in ICU or intermediate care units on his HRQoL after discharge.
21
Introduction
There is a need for longer period of assessment to evaluate the meaningful

effects of the treatment received. In order to assure that clinical protocols have
resulted in the required outcomes, symptoms relief and return to normal
functioning. More importantly, a patients perception of his health is unique and
the main factor in explaining and predicting outcomes. Thus, HRQoL measures
should be advocated in critical care research42. Currently, there has been a great
interest in the effect of critical care and treatment on HRQoL. Several studies
have attempted to address this issue and came up with the conclusion that
HRQoL measurement is an important aspect of patient care, evaluation and
follow-up43-49.
1.5.2 CABG, HRQoL and related factors
Several studies28,29,31-35,50,51 investigated the effect of CABG surgery on HRQoL
and also factors affecting HRQoL after CABG. Their findings were mainly that
CABG improved HRQoL in the majority of patients and there were several
factors that affected this outcome.
These factors can be classified into patients related characteristics, e.g. age,
female gender, marital status, type of work, personality trait, smoking habits,
high alcohol intake and high socioeconomic deprivation28-35,52, and biological and
medical factors, such as diabetes mellitus, a body mass index of >35kg/m2,
chronic obstructive pulmonary disease, peripheral vascular disease, NYHA class
at baseline, gastrointestinal problems, congestive heart failure, decreased forced
expiratory pressure, LVEF, elevated serum creatinine53, and health status at
baseline54, sleep problems, hypertension, infection55, history of psychiatric
diseases, postoperative events, like hospital readmission, and not following a
rehabilitation program after CABG. Furthermore, mood disturbances and
psychological aspects, like depression and anxiety, were also found to play a
major role in affecting patients HRQoL undergoing CABG56-58,59. It was reported
that a higher score of depression at baseline has been shown to predict
deterioration in mental HRQoL60.
Risk stratification models for cardiac surgery, like the Parsonnet score61,62 and
Cleveland Clinic score63, were developed over the last few decades mainly to
predict operative mortality. Currently, the European System of CardiacOperative Risk Evaluation score (EuroSCORE) is a widely used operative riskprediction tool, that has been shown to be a valuable measure for prediction of
operative mortality related to adult cardiac surgery 64,65. Higher levels of
EuroSCORE were associated with increased in-hospital and thirty-day
mortality, longer stay in the ICU and more frequent readmission. However, very
few studies attempted to investigate whether risk stratification models,
specifically EuroSCORE, can predict postoperative HRQoL66-68.
22
Chapter 1
1.6 The clinical pathway experience

The following section presents the history of CPs development and the use of CP
in the UMCG, in addition to the process of designing, implementing and
evaluating a CPs.
1.6.1 Early phases of CP development
In the early 1980s critical pathways were developed in The New England
Medical center in Boston, Massachusetts in the United States of America. CPs
are also referred to as clinical pathway, integrated care pathway, care map, and
multidisciplinary action plan. CPs have been developed in health care as
multidisciplinary care plans that outline the sequence and timing of actions,
necessary for achieving expected patient outcomes and organizational goals,
regarding quality, costs, patient satisfaction and efficiency.
The concept of CPs refers to specific guidelines for care that describe patient
treatment goals and define a sequence and timing of intervention for meeting
those goals efficiently. They can also be defined as care plans that detail
essential steps in patient care with a view to describing the expected progress of
the patient69. The use of CPs has become very popular in the past decades in a
lot of diseases and surgical procedures. CABG pathway as designed contained
the following components: assessment, consultations, rehabilitation, tests,
treatments, activities, diet and nutrition, elimination, medications, education
and counseling of patients and their families, and preparation for discharge.
The efficacy of CPs designed for patients undergoing CABG were mainly
described in studies without randomized clinical trial design or did not use
(matched) control groups70,71. Studies that compared CP with standard care only
evaluated the success of the pathway on decreasing length of stay and costs72,73,
but recently studies have shifted to evaluate the effects of CPs on other
outcomes like readmission, complications, patients satisfaction, and quality of
life74-76. In a recent review article we recommended that more (randomized)
controlled studies should be conducted in which patients are randomly assigned
to the condition of either a pathway or conventional care, and that standardized
tools should be used to measure important outcomes, like HRQoL, cardiac
related complaints, anxiety and depression.
1.6.2 Clinical pathways in the UMCG
The department of Thoracic Surgery in the UMCG decided in the spring of 2004
to implement a CP for patients undergoing CABG surgery. Collaboration was
started between the former Care Sciences Department at the Medical Faculty
and the department of Thoracic Surgery to evaluate the effect of the clinical
pathway on patient outcomes, including: physical and mental functioning
23
Introduction
(overall HRQoL), quality of care, LOS, hospital waiting time till surgery,
psychological stress, use of health services, patient expectation of care and staff
job satisfaction. The process of developing, implementing and evaluating the
clinical pathway is presented in Figure 2.
The Steering Committee
The formulation of the CP was overseen by a Steering Committee (stuurgroep)
that planned the designing, and implementation of the CP. The Steering
Committee consisted of: the head of the Thoracic Surgery Department, the
nursing care manager of the Thoracic Center, the head of Anesthesiology and
the coordinator of Thoracic Anesthesia.
The Committee provided support to determine what is needed to initiate the
pathway, determine the needed resources, and direct all disciplines involved in
the pathway. The Committee conducted a review of literature to evaluate
existing LOS in the UMCG and also determined the best practice available.
Next, the committee facilitated the setting of the actual team that developed the
pathway and assisted the team in overcoming any difficulties. The project team
included the head nurse of Thoracic Surgery, acute care nurse practitioner, staff
nurse, physiotherapist, social worker and dietician. The Committee also
determined that 8 days-CP was suitable for the patient population at the
UMCG.
Furthermore, the latest patient care evidence based guidelines were revised. All
the current protocols were also revised and updated, and new protocols
regarding sternal wound infection control, nutrition and pain control were
added.
Development of the pathway
The pathway team, which included all disciplines involved in patient care,
determines the type and sequence of care that will be provided to the patient, in
addition to the daily goals that must be achieved in order to reach the clinical
outcomes expected by the time of discharge. The pathway comprised of 8 days
template and comprised of the following elements: general assessment,
circulation, respiration, intake and output balance, pain relief, neurological,
nutrition/metabolism,
physiotherapy,
activity/movement,
and
patient
information/education.
Education of the staff
The development and implementation of CP require changes and modifications
in clinical practice, and patient care in the Thoracic Surgery unit. Thus, the staff
24
Chapter 1
members of different disciplines involved in patient care received educational

sessions about the components of the pathway before the implementation.
Patient interactive educational sessions
During the pre-operative period, patients who were visiting the out-patient
clinic were invited to join interactive education sessions. Patients were also
informed about what to expect during the immediate preoperative, postoperative
periods till discharge (in the pathway), and were invited to express their feelings
of anxiety and their concerns about surgery and recovery. Furthermore, patients
were provided with booklets with information regarding surgery and expected
outcomes.
Tracking of variances (Appendix II.)
Variances occur when the patient does not follow the plan and sequence outlined
in the CP. Variances can be classified into patient or family, care provider or
clinician, hospital or system, or community. Patient variances occur when a
patient develops a complication or is unable to reach a goal set in the pathway
plan. Care provider variance is when a staff member or clinician does not carry
out the task that is crucial for a patient to be discharged on the preset time.
Hospital or system variance is due to inefficiencies such as not scheduling a test
on time. Finally, community variances occur when discharge is postponed,
because the patient needs further care that can not be arranged after discharge.
Tracking and analyzing variances facilitates the patients progress along the CP.
When the CP fails to meet 70% of the patients needs, the pathway should be
reevaluated. Variance data are collected every few months and analyzed for
repeating trends or patterns. It is recommended that the pathway be evaluated
every six months. Tracking of variances was performed by a nursing director at
the UMCG and a full variance analyses report was presented to the Thoracic
Surgery Department
Outcome evaluation
The efficacy of the pathway is determined by measuring patient outcomes.
Outcomes measured include: LOS (meeting discharge date), readmission rate,
morbidity, mortality and patient satisfaction. In this study we also measure
HRQoL, health complaints, anxiety and depression.
25
Introduction
Figure 2. The process of designing, implementing and evaluating the clinical

pathway
1.7 The conceptual model

The central concepts of this study are introduced in a conceptual model (Figure
3.) based on a model developed by Wilson and Cleary, 199577, and the
modifications of Spertus et al,. 200278, and Rumsfeld, 200241. The Wilson and
Cleary model has been used in several publications investigating the factors
affecting HRQoL33,79-83.
Wilson and Cleary proposed a valuable framework for classifying predictors of
HRQoL.
They
distinguished
physiological/biological
factors,
symptoms
(including emotional and cognitive variables), individual patient characteristics,

such as gender or age51,54 and environmental characteristics, such as provision of
services, e.g. cardiac rehabilitation84.
The biological/physiological or medical characteristics that have been constantly
related to poor HRQoL outcomes after CABG include the New York Heart
Association (NYHA) classification of dyspnoea, current smoking, poor left
ventricular ejection fraction, presence of a chronic disease, such as diabetes, or
pulmonary disease as chronic obstructive pulmonary disease (COPD), operative
related variables, such as complications arising from the surgery that may well
also affect HRQoL after surgery28,30,50,51,54,85,86. In our model we also added the
EuroSCORE as variable affecting HRQoL. Recently, there has been an interest
in whether there is an association between the EuroSCORE and HRQoL66,68,87,88
(Figure 3).
26
Chapter 1
Furthermore, the model includes symptoms of depression and anxiety that have
an effect on mental HRQoL and worse outcomes after CABG. It is of note that in
patients scheduled for CABG the prevalence of depressive symptoms is high89.
Preoperative anxiety and depression has been known to predict the incidence of
adverse symptoms or psychopathology following surgery13,90-94. A study by Hfer
and colleagues31 found that depression has the main indirect effect on HRQoL in
CAD patients. Thus, we included in our model psychological factors (anxiety and
depression) in addition to positive and negative affectivity95-99.
Moreover, We included patients characteristics that have been linked to poor
HRQoL outcomes after coronary procedure, such as age and gender. Younger
patients30,100 have reported more physical improvement in HRQoL compared to
older patients30,50. The findings regarding the influence of gender, reported that
women benefit less from CABG in relation to HRQoL30,80,101,102. Other
socioeconomic data, such as marital status or having a partner85,103 working or
not33, have been associated with poor HRQoL. We also took into account the type
of personality (Type-D personality), which has been found to affect HRQoL after
cardiac related intervention39,104-106.
In relation to environmental influence on HRQoL outcomes used cardiac
rehabilitation (CR) program attendance is one of the factors affecting HRQol
84,107.
In our model, we further added the effect of method of care provided, i.e.
care in a CP plan to determine its effect on HRQoL and psychological distress.

Other outcomes we included were the effects of these variables on cardiac
related complaints after CABG, which we measured using the
health
complaints scales (HCS)108. Thus, it is theorized here that physiological,

psychological, and environmental variables influence symptom status, which in
turn affects functional health and general health perceptions, which influences
overall HRQoL. Furthermore, we are addressing the issue of the discrepancy
between the expected effect of surgery, which is an improvement in cardiac
function and which is the main focus of clinicians, versus patient focus, which is
mainly concerned with the interpretation of this improvement into a meaningful
change in his functional status and HRQoL. In light of this proposed model we
formulated our research questions.
27
Introduction
28
Chapter 1
1.8 Research questions

Finally, we present the research questions of this thesis, which were developed
based on the presented conceptual model.
1. Are the outcomes of CPs really evidence-based given the methodological and
statistical conclusion validity?
2. What is the difference between the CP group and the conventional care group
in relation to LOS, complications, readmission, HRQoL and psychological
distress? Does a CP contribute towards an improved HRQoL six months after
CABGas compared to a conventional care trajectory?
3. Does physical and mental HRQoL assessed with self-reported SF-36 differ
across classes of the EuroSCORE before and six months after CABG? Is the
EuroSCORE a predictor of physical and mental domains of HRQoL six months
after CABG?
4. What are the predictors of deterioration HRQoL six months following CABG?
Do anxiety and depression mediate the effect of type D personality on
deterioration in HRQoL using structural equation modeling?
5. What is the impact of positive affectivity on cardiac-related health complaints
in CABG surgery patients?
1.9 Outline of the thesis
Following this introductory chapter, Chapter 2 is a systematic review
addressing the question whether the outcomes of CPs are evidence-based and
provides a critical appraisal of the evaluation studies that examined the effects
of clinical pathways. Chapter 3 presents the effect of implementing a CABG
pathway on patients outcomes in comparison with conventional care. It
addresses short term outcomes like: LOS, hospital delay, readmission and
complications, and long term outcomes, like HRQoL and psychological distress.
The focus is mainly the question regarding whether pathway patients gained
more in their HRQoL compared to patients who received conventional care.
Chapter 4 reports on the use of EuroSCORE as a predictor of health related
physical functioning six months after CABG and highlights the association
between EuroSCORE and physical functioning before and after CABG, in
addition to the association between EuroSCORE and LOS, and number of
complications.
29
Introduction
Chapter 5 is addressing the important topic of factors associated with

deterioration in health after CABG. In this chapter we present the results of a
regression model and a structural equation model that highlights the role played
by PD, i.e. anxiety and depression and Type D personality in deterioration of
patients HRQoL six months after CABG. Whilst Chapter 6 is mainly presenting
the results of investigating the impact of positive affectivity and age on cardiac
related health complaints measured by health complaints scales in CABG
surgery. Chapter 7 summarizes the main results of the thesis, general
conclusion concerning the main objectives of the thesis are formulated and
discussed, and finally, implications for future research and clinical practice
discussed and formulated.
30
Chapter 1
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37
Introduction
38
C HAPTER 2
A RE THE
OUTCOMES OF CLINICAL
PATHWAYS EVIDENCE - BASED ?
A CRITICAL
APPRAISAL OF
CLINICAL PATHWAY
EVALUATION RESEARCH
Noha El Baz MSc, Berrie Middel PhD, Jitse P. van Dijk MD PhD,
Andre Oosterhof RN MBA, Piet W. Boonstra MD PhD and Sijmen
A. Reijneveld MD PhD
Published in Journal of Evaluation in Clinical Practice 2007
December; 13(6):920 - 929
Are the outcomes of clinical pathways evidence-based?
40
Chapter 2
Chapter 2
Are the outcomes of clinical pathways
evidence-based?
A critical appraisal of clinical pathway evaluation
research
A BSTRACT
Aim and objective
To evaluate the validity of study outcomes of published papers that report the
effects of clinical pathways (CPs).
Method
Systematic review based on two search strategies, including searching Medline,
CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of
KnowledgeSM. We included randomized controlled or quasi-experimental
studies evaluating the efficacy of clinical pathway application. Assessment of the
methodological quality of the studies included randomization, power analysis,
selection bias, validity of outcome indicators, appropriateness of statistical tests,
direct (matching) and indirect (statistical) control for confounders. Outcomes
included length of stay, costs, readmission rate and complications. Two
reviewers independently assessed the methodological quality of the selected
papers and recorded the findings with an evaluation tool developed from a set of
items for quality assessment derived from the Cochrane Library and other
publications.
Results
The study sample comprised of 115 publications. A total of 91.3% of the studies
comprised of retrospective studies and 8.7% were randomized controlled studies.
Using a quality-scoring assessment tool, 33% of the papers were classified as of
good quality, whereas 67% were classified as of low quality. Of the studies,
10.4% controlled for confounding by matching and 59.1% adopted parametric
statistical tests without testing variables on normal distribution. Differences in
outcomes were not always statistically tested.
Conclusion
Readers should be cautious when interpreting the results of clinical pathway
evaluation studies because of the confounding factors and sources of
contamination affecting the evidence-based validity of the outcomes.
41
2.1 Introduction
Clinical pathways have been developed in health care as multidisciplinary care
plans that outline the sequence and timing of actions necessary for achieving
expected patient outcomes and organizational goals regarding quality, costs,
patient satisfaction and efficiency. The concept of clinical pathways (CPs) refers
to specific guidelines for care that describe patient treatment goals and define a
sequence and timing of intervention for meeting those goals efficiently1. They
can also be defined as care plans that detail essential steps in patient care with
a view to describing the expected progress of the patient2. They are also known
as critical pathways, integrated care pathway, critical path, care maps and
care paths and they are being embraced in many systems.
In an attempt to evaluate the efficacy of integrated care pathways, Campbell et
al. posed the question Are clinical pathways effective in improving patient
care?3. They used the results of a comprehensive review performed by the
National Health Service in Wales in 1996, which was comprised of
approximately 4000 references to integrated care pathways and related topics
worldwide. The studies that were found mainly described benefits that were
experienced and addressed concerns associated with the use of pathways or
practical barriers to implementation. Most of the studies they found were
uncontrolled beforeafter studies and no randomized controlled studies were
found. The authors came to the conclusion that these reports do not provide
reliable evidence and publication bias is highly likely, favoring publications
reporting favorable experience.
Every et al. reported that in cardiovascular medicine, although the studies they
evaluated were somewhat under-powered, the overall experience had been
promising1. CPs applied to patients with a cardiovascular disease showed a
tendency towards a decreased treatment variation, improved guideline
compliance and reduced costs. However, the evidence of the effectiveness of CPs
in cardiovascular medicine cannot be generalized because of the insufficient
number of controlled studies. Renholm et al. concluded in a review article that
clinical pathways had positive effects on patient-care outcome, although some
studies did suggest that the use of CPs had no influence on patient-care
outcomes, while by the same token they also stated that there was no evidence
at all that they had any negative effect2.
Similarly, Van Herck et al. concluded that CPs did have a positive effect on
patient outcome, but they did not take methodological weaknesses into
consideration, because they analysed most of the manuscripts (55.5%) by means
of abstracts4. Additionally, they expressed their concerns about publication bias
since clinical pathways with no, few, or even negative results hardly ever get
published.
42
Chapter 2
Kim et al. conducted a systematic review which focused on the effectiveness of

CPs for total knee and total hip arthroplasty5. They included 11 papers and
identified only one randomized controlled study. They reported a decrease in
length of stay (LOS) and in costs with either reduced or unchanged rates of
complications and either improvement or no change in patient-reported
outcomes. Furthermore, they concluded that, although the data in their review
supported the effectiveness of CPs, definitive conclusions cannot be made
because of methodological limitations.
Another systematic review was conducted by Kwan et al. regarding CPs for
stroke patients6,7. They included both randomized and non-randomized studies
and found no evidence that CPs provided any significant additional benefit over
standard medical care in terms of major clinical outcomes (death or discharge
destination). Moreover, they concluded that stroke patients in CP groups were
more dependent on discharge, while the effect on LOS and hospitalization costs
remained unclear.
Despite these uncertainties, CPs have been widely used in many institutions
throughout the United States, the United Kingdom and some parts of Europe for
patients undergoing various treatments, surgeries or diagnostic procedures.
According to the results of the majority of publications in which clinical
pathways were compared with standard care, there is an overall tendency to
come to the conclusion that CPs are effective in reducing LOS, costs,
complication rates and readmissions. On the other hand, CPs may positively
affect patients health-related functioning, quality of life or patient satisfaction.
However, some critical studies1,4,5,8 have introduced serious doubts about the
amount of the evidence and this criticism stimulated us to undertake this study.
The purpose of this study was to appraise the methodological qualities of clinical
pathway (CP) evaluation studies in order to evaluate the validity of the evidence
for the efficacy CPs and to suggest improvements in future study design.
Methodological quality was defined through a set of parameters related to the
design and conduct of the study that determines the internal and external
validity of the study912.
2.2 Methods
Two search strategies were employed to find published studies on the efficacy of
CPs. The first strategy involved computerized database searches using Medline,
CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005. Studies were
identified by a broad range of keywords: clinical pathways, critical pathway,
clinical paths and integrated care pathway, effect, adults, paediatric diseases,
patient satisfaction, length of stay, complications, readmission, quality of care,
quality of life, costs, longitudinal studies, experimental studies, randomized
43
controlled studies, cohort studies, double-blind methods, systematic review,

evaluation and comparative studies.
The second strategy concerned a snowball sampling method using the databases
of ISI Web of KnowledgeSM. We identified studies that were cited retrospectively
in a publication on the effectiveness of CPs, as well as studies that cited the
selected papers in the years following their publication.
2.2.1 Inclusion and exclusion of publications
Information from abstracts and titles of the papers that were detected using
both search strategies was used to include or exclude manuscripts. Papers were
excluded if they were:
Manuscripts that addressed the noun pathway, but were not related to
studies investigating the efficacy of a CPs in terms of specified guidelines or
outlines for care that describe patient-treatment goals and define a sequence
and timing of interventions to meet those goals efficiently;
Manuscripts concerning our definition of a CPs which did not provide
empirical quantitative results, such as letters to the editor, brief reports, case
studies, qualitative designs, opinions of experts, etc..
After exclusion of inappropriate manuscripts, two of the investigators (NEB and
BM) independently assessed the remaining publications in full text against two
criteria:
1. The study evaluated the efficacy of a CPs by means of quantitative methods
(e.g. a meta-analysis or systematic review).
2. The design of the effect study included a CPs group and a control group.
Papers were included if one or both investigators unequivocally considered the
publication as appropriate for analysis. Differences were resolved through
discussion
with
reference
to
third
reviewer
(JPvD),
if
necessary.
Methodological appraisal included papers that satisfied both criteria.

2.2.2 Assessment of methodological quality
Two reviewers (NEB and BM) independently assessed the methodological
quality of the selected papers and recorded their findings with an evaluation tool
or scoring system comprising of a set of items for quality assessment from the
Cochrane Library and from other publications on quality assessment of studies
911,13.
The quality score was based on eight items that evaluated the following
methodological characteristics of individual studies as presented in Table 1.
44
Chapter 2
The appraisal of the overall methodological quality was based on a weighted

score in which the similarity of groups at baseline, randomization and adequate
statistical methods were assigned three points; the use of power analysis and
control of confounders were assigned two points; and assessment by a medical
ethics committee, unbiased outcome measure and eligibility criteria were
assigned one point. We calculated overall quality scores for each study by
summing up the score-weighted yes scores.
We established the cut-off point between high and low quality studies by
following the method developed by Verhagen et al.12. They set the cut-off point at
50% of the maximum achievable score of 16 points, meaning high-quality studies
scored
8.0 and low-quality studies scored
7.0 points. In addition to this
dichotomous scale, we arranged the quality scale scores into the following
ordinal categories: invalid studies (scores 03), weak to medium quality (scores
47), good quality (scores 811) and high quality (scores 1216).
2.3 Analysis
Analyses were performed using SPSS version 12.0.1 (SPSS Inc., Chicago, IL,
USA) and for all tests P < 0.05 was considered significant. We calculated 95%
confidence intervals for the differences in proportions 14. Chi-square and
Fishers exact tests were used for associations between categorical variables.
Apart from the methodological parameters in Table 1., outcomes such as
decrease in LOS, costs, readmission and complications and their statistical
significance were observed.
45
2.4 Results
Of the 556 publications that were analysed, 310 papers (55.7%) were not related
to our definition of a CPs at all as they addressed either metabolic, molecular or
genetic pathways, letters to the editor and editorials or investigated the effect of
a pharmacological therapy, or aspects of surgical techniques. Of the remaining
sample of 246 publications, 131 manuscripts were excluded because they either
did not meet the inclusion criterion regarding required study design (74 papers
contained no evaluation study, 52 papers addressed the definition or phases of
development of CPs and five were not in English). A total of 115 studies out of
556 investigated the efficacy of CPs according to our definition of CPs and these
were used for the assessment of methodological quality (see Figure 1.).
Figure 1. Flowchart describing study selection and excluded studies
2.4.1 Disease treatments

In the period between 1995 and 2005, 246 publications addressed relevant
aspects of CPs in terms of our definition. In Table 2., these publications are
shown sorted by disease or intervention category. The most often studied
46
Chapter 2
category was in the field of cardiovascular surgery and diseases in both the
gross sample and study sample (21.5% and 17.4%, respectively). Twenty
publications evaluating cardiovascular clinical pathways were included in the
study sample1534. The relative number (%) of publications included in the study
sample varied between 5% and 16% in the following domains: (1) respiratory
diseases, therapy and thoracic surgery28,3551; (2) gastrointestinal surgery,
endoscopic surgery and diseases5270; (3) orthopedic surgery and multiple
trauma7183; (4) oncological diseases and surgery8492; (5) neurological trauma,
disorders, diseases and pain management93100; (6) vascular surgery15,19,101105;
and (7) gynaecological diseases, surgery and maternity care106111.
Categories of diseases or treatment, which represent less than 5% of the study
sample, comprised studies on urological diseases, surgery and procedure112116;
psychological disturbances and mental health117,118; metabolic diseases119;
paediatric conditions120122; burn and skin reconstructive surgery123,124; and head
and neck surgery125,126.
We tested whether selection bias affected the sample of manuscripts used for
methodological analysis with 95% confidence intervals for differences in
proportions. The differences between the proportion of papers addressing the
effects of CPs on job satisfaction and papers not in English showed underrepresentation in the final sample (used in the current study) as compared with
the total sample of CPs -related publications. The study sample of papers shows
a similar distribution across diseases as compared with the gross sample,
indicating a good representation of the population of studies published between
1995 and 2005.
2.4.2 Designs
Of the 246 papers, 131 were excluded because of the fact that they were
descriptive studies or review articles and only the remaining 115 publications
were included based on the criteria of study design. Ten randomized controlled
studies were found and the majority (n=105) were comprised of studies with a
retrospective comparative research design or were cross-sectional retrospective
studies that compared the differences in patient outcome during a period before
and after implementation of CPs. The following retrospective designs were used:
1. A majority of these studies (n=96) used a historical control group and were
conducted at the same hospital (beforeafter design).
2. Three studies were conducted with a historical control group from a different
hospital and at different time periods.
3. Six studies were conducted using concurrent control and experimental groups
either in the same hospital, though using separate wards, or in different
hospitals.
47
Ten studies, labeled as randomized controlled studies, comprised studies that

randomly selected hospitals45,127 where a pathway was implemented or that
assigned patients randomly to either pathway care or standard care.
48
Chapter 2
These randomized controlled studies followed up patients after discharge for

outcomes like quality of life, pain, readmission, mortality and complications.
One paper assessed patients at baseline, 3, 6 and 12 months117, and another
measured patients 1 week after assignment to CP or conventional care and then
at 4, 12 and up to 26 weeks9698. The remaining papers followed up patients after
discharge from the health care facility at a time ranging from 10 days up to 12
weeks42,45,56,72,127,128.
2.4.3 Randomization and matching
We detected 12 retrospective studies (10.4%) that controlled for confounding
through matching, of which three studies used a random sample from a CP
group which was matched with controls from the pre-pathway period25,30,
48,50,58,79,81,107,110,111,122,129.
Furthermore, 10 randomized controlled studies were
found, of which two studies randomly assigned hospitals either to implement a

CP or to remain on standard care45,127. Eight studies randomly assigned patients
to either a CP or standard care42,56,72,9698,117,128.
2.4.4 Power analysis
The question of what sample size to use constitutes a crucial part of any
research proposal. However, only 16.5% (n=19) of the studies conducted a power
analysis to determine in advance the required number of observations which
would be sufficient to provide the required precision of results. Among the 115
studies, 25% of the samples were very small (n<50), 25% ranged from 51 to 100
patients, 25% ranged from 100 to 200 patients and 25% had samples greater
than 200 patients in either the CP or the control group. No statistically
significant association was found between sample size (n<100 vs. n>100) and
performance for a statistical power analysis (Chi-square, P=0.56).
2.4.5 Control for confounding
In less than half of the studies (42.1%), the authors did pay attention to the
problem of controlling for potential confounders and either applied direct control
with randomization or matching (17.5%), and/or used a control for confounders
(e.g. co-morbidity, age and gender) in regression models (24.6%). The other
(57.9%) did not take the potential risk of confounders into account at all.
Selection bias may occur when inclusion and exclusion criteria are obscure. In
57 of the studies that were appraised (49.6%), misleading conclusions were
prone to arise based on the fact that patients in experimental groups differed
from the control group patients regarding characteristics such as differences in
49
age, gender, disease severity or co-morbidity. The other half of the studies
meticulously described criteria for inclusion and exclusion.
2.4.6 Accuracy and validity of outcome measures
Length of stay was evaluated in 108 publications (93.3%). However, more than a
quarter (28.1%) of these studies gave no accurate or meticulous description of its
operationalization or a clear description of the way it was assessed. Costs and
hospital charges were assessed in 73 papers (63.5%), among which 62 (53.9%)
stated a clear description of the charges and costs calculated.
Readmission rates were calculated in 53 papers (46.1%), of which 50 (43.5%)
precisely defined readmission within a time frame.
Complications were evaluated in 70 papers (60.9%), of which 64 (55.6%)
defined and clearly stated the complications.
Quality of life was assessed in 10 (8.7%) of the studies with a validated
measure. Functional health-related functioning was measured in six (5.2%)
studies, and both quality of life and health status were measured in two papers.
Three studies (2.6%) assessed psychological distress (anxiety and depression).
However, only two studies used a validated measure: the Hospital and Anxiety
and Depression Scale48,98.
Patient satisfaction was assessed in 15 studies (13.0%), but was measured
with a multi-item tool in 13 studies (11.3%). Work satisfaction was evaluated in
four (3.5%) of the studies, and three studies presented an accurate description of
this construct. Clinical quality-of-care indicators were evaluated in 57 (49.6%)
papers and were accurately defined in all cases.
2.4.7 Appropriateness of statistical methods
More than half (59.1%) of the studies adopted parametric statistical tests
without question, but the rest (40.9%) tested variables over normal distribution
and, depending on the outcome, used non-parametric tests. Reduction of LOS,
costs, readmission rates and number of complications belong to the most
relevant targets for implementing CPs.
However, decreases in LOS, costs, readmission rates and number of
complications were not statistically tested in 12.3%, 28.8%, 20.8% and 27.1% of
the
113,120.
studies,
respectively1619,22,23,2528,32,33,3638,42,4447,49,53,61,75,85,88,91,92,99103,105,110,
There were studies that used a statistical test to decide whether a
difference between a CP group and a control group was due to sample

fluctuation, but they also reported other differences without this test. For the
main outcome parameters, LOS, readmission rates, costs and number of
complications (65%) of the studies tested for each outcome (23%) did not test for
50
Chapter 2
all differences between CPs and controls, while (12%) did not apply any test at
all.
2.4.8 Quality of studies related to statistically significant outcomes
We found 92 publications that reported a decrease in LOS and 60 that reported
a decrease in costs. All the good-quality studies reported a statistically
significant result in both LOS and costs. However, among the low-quality
studies (84%) of the papers reported a reduction in LOS that was statistically
significant, and only 68% of the publications reported a decrease in costs which
was
statistically
significant
(Fishers
exact
test,
P=0.02
and
P=0.03,
respectively). There was no association between quality of the studies and the
statistical significance of the reduction in complications and in readmission
rates (see Table 3).
2.4.9 Overall quality related to other study characteristics

According to the dichotomous threshold of Verhagen et al.12, one-third of the
papers (33%) analysed were classified as high-quality papers, while 67% were
classified as studies of low quality. However, the ordinal quality scale showed
that 35.7% of the studies reflected low quality, that is, invalid studies (31.1%)
were appraised as weak- to medium-quality studies, and 24.3% as good-quality
studies. Finally, 8.7% of the sample reflected very good quality.
No statistically significant associations were found between the quality of the
studies and the sample size (MannWhitney U-test/Wilcoxon W-test, Z= 0.48,
P=0.63). Across the diseases shown in Table 1., the differences between
proportions of low- or high-quality studies were not statistically significant.
Furthermore, the quality of the studies was not associated with treatment in
terms of surgery versus non-surgery (Fishers exact test, P=0.31).
51
Data extracted from hospital records were used in 81% of the studies and 19%
used self-reported questionnaires or interviews in combination with data from
the hospital records.
Both dichotomous and ordinal categorization confirmed that studies which
qualified as good quality were more likely to use patient record information in
combination with self-report questionnaires or interviews (Fishers exact test,
P=0.01). Because of the fact that the majority of studies (91.3%) used electronic
databases, the question of whether dropouts were analysed appropriately did
not play a significant role in our analysis. A significant association was found
between the quality of the study and its design. Only 27% of the studies with a
retrospective design were classified as of good quality (Fishers exact test,
P=0.0001), whereas all randomized controlled studies were of high quality.
2.5 discussion
The majority of the publications on CP we analysed were classified as studies of
low quality (67%), which raise questions about the validity of the evidence for
the implementation of CP in the last decade.
The methodology of studies assessing the efficacy of CPs has been criticized in
regard to their research designs, poor reporting of the methodology and underpowered sample sizes1,3,58. Therefore, we performed an appraisal and analysis of
the methodological qualities of a large number of CP evaluation studies in order
to investigate the validity of their outcomes.
In relation to the internal and external validity of the studies in the sample, our
analysis revealed several factors that influenced the quality of CP evaluation.
Most studies in our sample concerned non-randomly selected small patient
populations without a power analysis19,23,25,36,52,54,56,58,59,61,76,81,8688,91,99,107,111,118,122,
123,126,128.
Furthermore, in many studies selection bias has occurred. Patients selected for
a CP were likely to differ from patients managed with standard care using
characteristics known to be associated with LOS and hospital delay, and
consequently included costs such as age and co-morbidity. In half of the study
sample (49.6%), the inclusion and exclusion criteria of patients were obscure and
difficult to relate to the populations characteristics. According to our findings,
only 12 retrospective studies (10.4%) controlled for selection bias by matching,
out of which three studies matched a random sample from a CP group with
controls from the pre-pathway period group 25,30,48,50,58,79,81,107,110,111,122,129.
In regard to the outcomes measured, our analysis also revealed that most
studies focused on cost issues and reductions in LOS. However, clinically
relevant outcomes such as mortality, discharge disposition, quality of care as
seen through the eyes of the patient, psychological distress (anxiety), care
52
Chapter 2
dependency and use of health services after discharge were largely ignored. A
few
studies
focused
on
outcome
in
terms
of:
(1)
destination
of
discharge21,24,69,72,78,98,101,104,122; (2) delay44,109; (3) patient education32,124; (4) quality

of care22,74; and (5) psychological distress48,98.
In relation to the use of appropriate statistical tests, more than half (59.1%) of
the studies adopted parametric statistical tests without question, but 40.9%
tested variables on normal distribution and, depending on the outcome, used
non-parametric tests. Beforeafter differences in frequently measured outcomes
such as LOS, costs, readmission and complications were statistically tested in
few of the studies. Other studies used statistical tests to decide whether
differences between groups were related to sample fluctuations, while also
reporting other differences without statistical tests. After reviewing all papers
included, it was clear that there was an inevitable risk of misrepresentation of
the true costs.
Reduced LOS in the hospital may lead to admission to another health care
facility, for example, a rehabilitation unit or extended care facility. Although
costs related to these services are not considered as a part of hospital charges,
they still add to direct health care costs and may also lead to out-of-pocket
expenses for the patient. Furthermore, studies that report reduction in both
LOS and costs do not take into consideration that both are interrelated, which
leads to contamination in statistical analysis.
Moreover, from a methodological point of view both the investigators (who
assessed the outcomes) and the health care providers should have been blinded
to the use of a CP since this might have biased their observations and
assignment procedure.
In the light of these findings, it can be concluded that readers must be extremely
cautious when interpreting the results of CP evaluation studies because of the
confounding factors and the sources of contamination affecting the internal and
external validity of most of the published studies.
2.6 Recommendations for future research
After reviewing a large number of CP evaluation studies and having stated our
conclusions, we recommend that:
1. More (randomized) controlled studies should be conducted, in which patients
are randomly assigned to the condition of either a pathway or standard should
be conducted. However, such randomized controlled studies in the same hospital
invite contamination, because many of the same doctors, as well as care staff,
are involved in treating the same population of patients. To avoid such
Hawthorne
effects,
we
suggest
establishing
multi-centre
trials
with
randomization after pre-stratification of confounding factors (e.g. gender, co-
53
morbidity) with a clearly defined method of randomization, concealment of

allocation or blinding with the appropriate balancing method 130.
2. Standardization of the total direct costs is specified by clearly defined cost
components and a standardized operational definition of LOS. LOS should not
be confined to the hospital setting, but should be extended to include whether
patients are discharged home or to an extended health care facility, and should
include whether this is a permanent or temporary arrangement. An accurate
calculation in this case will reflect the true effect of CPs on LOS and subsequent
related costs.
3. More attention should be paid to measuring relevant patient outcomes such
as quality of life, hospital anxiety, patient expectations and satisfaction with
standardized validated tools, which reflect the true effect with use of
appropriate statistical methods.
Until the results of good-quality research are more widely available, CPs should
be considered as a potentially effective (but not evidence-based) practice to
improve patient care.
54
Chapter 2
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64
C HAPTER 3
C ORONARY
ARTERY BYPASS GRAFT

SURGERY PATIENTS IN A
CLINICAL PATHWAY GAINED
LESS IN HEALTH - RELATED
QUALITY OF LIFE AS
COMPARED TO PATIENTS WHO
UNDERGO
CABG
IN A
CONVENTIONAL CARE PLAN
Noha El Baz, MSc, Berrie Middel, PhD, Jitse P. van Dijk, MD, PhD, Piet W.
Boonstra, MD, PhD, Sijmen A. Reijneveld, MD, PhD. Accepted for publishing
by Journal of evaluation in clinical practice in July 2008
Coronary artery bypass graft surgery patients in a clinical pathway...
66
Chapter 3
Chapter 3
Coronary artery bypass graft surgery
patients in a clinical pathway gained less in healthrelated quality of life as compared to patients who
undergo CABG in a conventional care plan
A BSTRACT
Aims and objectives
the aim of this study is to determine the difference between clinical pathway (CP) and
conventional care in terms of length of stay, readmission, complications, HRQoL domains,
depression and anxiety, as well as to determine the relative contribution of CP towards an
improved HRQoL after CABG.
Method
A longitudinal quasi-experimental pre-test/post-test design was used to study and compare
clinical outcome, HRQoL depression, and anxiety for CP versus conventional care patients
after CABG. HRQoL was measured using SF-36, whilst depression and anxiety were
measured using Hospital anxiety and depression scale. Length of stay and patient
complications were derived from the hospital database.
Results
We found that implementing a clinical pathway decreased hospital delay from 2.50 (7.19)
to 1.80 (1.60), which was statistically significant p=.002.. We also found that patients in
the conventional care plan improved more than patients in the CP in HRQoL. Outcomes in
favor of patients in the conventional care trajectory were based on the difference between
small ES ( .20 < .50) for pathway patients and moderate ES ( .50 < .80) for conventional
care patients, except for the domain of physical functioning and physical component
summary, where the ES for conventional care was large (> .80).
Conclusion
The aim of designing and implementing pathways is to decrease LOS, and costs, while
maintaining quality of care and improving patient outcomes. Our findings suggest that
these aims were not fulfilled in this CABG pathway. We recommend that, when designing a
clinical pathway, all patient-related characteristics, risk indicators, along with physiological
status, be taken into consideration.
67
3.1 Introduction
Nowadays, health-care professionals are faced with the challenge of providing high quality
patient care, while simultaneously cutting costs and decreasing in-hospital length of stay
(LOS). This challenge has made the use of clinical pathways very appealing, both as a tool
for improving outcomes and for decreasing costs during a specific length of stay1,2. Clinical
pathways (CPs) are multidisciplinary management plans that display goals for patients and
provide the corresponding ideal sequence and timing for staff action to achieve those goals
with optimal efficiency3,4.
Clinical pathways, when applied to health care, have raised obvious concerns, however, as
there are individual patient factors that may contribute to deviations from crucial elements
in the pathway plan, and so have an effect on the outcome expected. Factors, such as
these, cannot be controlled by the pathway guidelines and so need to be considered when
modeling the care process. Pathway designers tend to address the ideal patient without
comorbidities or complications and so they do not control for such confounding patient
characteristics before assignment to the pathway5,6. Thus, the heterogeneity of the effects
of CP, as compared to conventional care, may be due to lack of attention to confounders.
Differences in the methodological quality of study designs may further add to this
heterogeneity7,8.
According to our findings in an earlier systematic review7 on the efficacy of CPs, only twelve
out of the 115 studies (10.4%) controlled for selection bias by means of matching. Out of
these, three studies matched a random sample from a CP group with controls from a prepathway period group. Furthermore, most of these studies focused on cost issues and
reductions in LOS, while clinically relevant outcomes such as discharge disposition, healthrelated quality of life (HRQoL), depression, anxiety, and care dependency were largely
ignored. Because there was a tendency to report only the positive or neutral effects of CPs,
the negative effects of pathways were rarely reported. However, a systematic review
addressing in-hospital care pathways for stroke patients has concluded that patient
satisfaction and quality of life can be significantly lower in the care pathway group, while at
the same time there was no significant difference in LOS between the two groups9,10.
This same trend has emerged in the past decade in relation to evaluating CABG pathways,
ever since more comparative cohort studies were conducted to detect the effect of CABG
pathways. It has been concluded that CABG pathways did decrease LOS, costs11-15 and
complications16, but none of these studies provided any evidence regarding quality of life
(QoL) or depression, and anxiety.
This stated, few investigators have used health-related functioning or QoL measures as
outcomes in order to detect differences between pathway and conventional care patients,
and have ended up finding that there is no difference between the two groups in relation to
HRQoL17-19.
Generally speaking, it would appear to be difficult to detect statistically significant and
clinically relevant differences in trials that evaluate care interventions such as nurse-led
68
Chapter 3
disease management, case management and clinical pathways20,21 in coronary artery

diseases (CAD), COPD and CABG19. This is largely because the main effects are induced by
(medical) treatments in both control and experimental groups.
In light of these findings, the aim of this study is to determine the difference between CP
and conventional care in terms of HRQoL domains, depression and anxiety, as well as to
determine the relative contribution of CP towards an improved HRQoL six months after
CABG.
3.2 Material and method
3.2.1 Study Design
A longitudinal quasi-experimental pre-test/post-test design was used to study and compare
clinical outcome, HRQoL, depression and anxiety for CP versus conventional-care patients
six months after CABG. A conventional randomization procedure was considered
inappropriate. Randomizing individual patients (or surgeons) to either a clinical pathway or
conventional care within the same hospital invites contamination, because many of the
same doctors, as well as care staff, are involved in treating the same population of patients.
Nevertheless, the assessment of patients outcomes was done in ignorance of the method
of care they were receiving. We therefore used a pre-pathway control group and applied
the CONSORT criteria22 for the reporting of randomized controlled trials, finding this the
best way to obtain information from this study.
After inclusion, patients received a mailed questionnaire before surgery, accompanied by
an informed consent form. Follow-up questionnaires were sent out six months after the
CABG intervention was executed. The questionnaires, once filled out, were checked for
completeness at baseline as well as at follow-up. If a page was not filled in, a copy was sent
with a request to please complete the questions or, if it concerned one or fewer questions,
patients were interviewed by telephone. Because the completeness of the questionnaire
was monitored by a computer program both at baseline and follow-up, we effectively
reduced the non-response on questions and, consequently, on scales.
3.2.2 Patient selection
Consecutive patients, who were scheduled for CABG following a Coronary Angiography
(CAG), were recruited from October 2004 till March 2005, and these constituted the control
group receiving conventional care. Patients scheduled for CABG with the application of the
CP were recruited from April 2005 till January 2006, from both the University Medical
Center Groningen (UMCG) in Groningen and the HAGA Hospital in The Hague, both in the
Netherlands. Patients with other incapacitating diseases, cognitive impairments, admitted
for emergent/urgent CABG, aged 80 and older, or who did not speak Dutch were excluded.
Ethical approval was obtained from each participating hospitals ethics committee.
An overview of patient selection for the current study is presented in Figure 1.
69
A postal follow-up survey was sent out to 256 patients, both at baseline and six months
after CABG. The response rate at baseline was 77.3% (198/256). When comparing included
patients with non-responders, no differences were found between either group except with
regard to gender ( 2=4.85, df=1; p=.03), with 33.3% vs. 21.2 % females, respectively.
Compared with the study baseline sample, dropouts at follow-up did not differ
systematically for gender ( 2=1.63, df=1; p=.20) and marital status ( 2=1.81, df=1; p=.18),
nor for mean differences in age (66.1 10.09 vs. 64.59 9.95; df =196; p=.45). Given that
we used a prospective design that included only patients with complete questionnaire data
at baseline and six-month follow-up, our analyses were finally based on 168 patients.
Figure 1. Overview of patient selection for the current study
3.2.3 Procedure
3.2.3.1 The clinical pathway
The pathway targeted a maximum LOS of eight days. Patients followed the pathway
designed from admission till discharge; the pathway did not extend after discharge and did
not include a follow-up program. In the preoperative period patients participated in an
interactive educational session where they were informed about their preparation for
surgery by the cardiothoracic surgeon, the anesthesiologist and the nurse practitioner.
Patients were also informed about what to expect during the preoperative and
postoperative periods, and were invited to express their feelings of anxiety and their
concerns about surgery and recovery. Furthermore, the nurse practitioner and the
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Chapter 3
physiotherapist prepared patients for discharge by providing education about wound care,
the occurrence of complications, physical rehabilitation and exercises, blood sugar and
weight control. Patients who underwent CABG in the control group followed the
conventional trajectory without structural educational sessions and without controlling for
length of stay.
3.2.4 Measures
3.2.4.1 Demographic variables
We obtained data on patient characteristics and medical status at baseline. Age and gender
were used as reported by patients in the questionnaire. Being married, living with a partner
or being a widower were all classified as (1) living with a partner; divorced or living alone
were classified as (2) living alone. Educational status was defined as (1) elementary
schooling, (2) secondary schooling, (3) higher professional training and (4) college
education/university, based on the highest degree obtained. Work status was defined as (0)
working and (1) not working (with housewives classified as working). Smoking was recorded
as (0) not smoking and (1) smoking. Type D personality was recorded as (0) type D and (1)
non-type D.
3.2.4.2 Medical variables and number of perioperative complications
The Risk stratification model EuroSCORE was used to calculate patients risk levels and
patients were later classified into three risk groups: (1) low (additive score of 0-2), (2)
medium (scores 3-5) and (3) high risk (scores 3-5)23-27. Data on preoperative and
postoperative medical and clinical characteristics, such as NYHA, angina, and myocardial
infarction, LVEF, chronic pulmonary disease, renal diseases, diabetes, as well as
postoperative events such as atrial or ventricular arrhythmia, use of inotropes, reexploration for bleeding or tamponade, sternal re-suturing, time spent on mechanical
ventilation, were all retrieved from the registry database, medical notes, outpatient notes
and intensive therapy unit (ITU) charts.
3.2.4.3 Type D personality
We used the Type D Scale (DS14) to assess the distressed (type D) personality28. This scale
consists of fourteen items that are answered on a five-point Likert scale from 0 (false) to 4
(true). Seven items tap negative affectivity, and seven items tap social inhibition (score
range, 028 for each subscale). Type D caseness is defined by a high score on both
subscales, as determined by a standardized cut-off score 1028. The DS14 is a valid and
reliable scale with Cronbachs alpha =.88/.86, and three-month test-retest reliability
(r)=.72/.82 for the negative affectivity and social inhibition subscales, respectively 28. Type D
personality is more than just negative affect, since it also encompasses how patients deal
71
with this affect through the inclusion of the social inhibition component28. The DS14 was
administered at baseline.
3.2.4.4 SF-36 (health-related quality of life)
The SF-36 was sent to patients preoperatively after they were scheduled for CABG, and
postoperatively six months after CABG. The SF-36 is a generic measure that assesses eight
HRQoL domains, i.e., physical functioning, role physical functioning, role emotional
functioning, mental health, vitality, social functioning, bodily pain and general health29.
Scale scores are obtained by summing the items together within a domain, dividing this
outcome by the range of scores and then transforming these raw scores to a scale from 0 to
100. A higher score on the SF-36 sub-domains represents better functioning, with a high
score on the bodily pain scale indicating freedom from pain. The scale has good reliability
with Cronbachs alpha ranging from .65 to .96 for all subscales30. Later, the sub-domains of
the SF-36 were dichotomized, with the lowest tertile indicating impaired health status31-33.
3.2.4.5 HADS Anxiety and depression
Anxiety and depressive symptoms were assessed at six months post-CABG using the sevenitem anxiety subscale and the seven-item depression subscale from the Hospital Anxiety
and Depression Scale (HADS)34. Responses to both subscales are indicated on a four-point
Likert Scale from 0 to 3 (score range 0 21). A cut-off score 8 was used for both subscales
to identify patients with anxiety and depressive symptoms. This cut-off has been shown to
balance sensitivity and specificity optimally35. The HADS has been shown to be a valid and
reliable instrument35,36 and to predict mortality in patients referred for exercise testing37.
3.2.4.6 Hospital length of stay, readmission and discharge destination
LOS was calculated for each patient in three time intervals: (1) days between date of
admission and date of discharge, (2) days between date of admission and date of operation,
and (3) days between date of operation and discharge. Destination after discharge was
recorded and was defined as (0) home or (1) other (including extended health-care facility,
and nursing homes, or hospitals). Readmission after operation due to cardiac-related
complaints was assessed six months after CABG.
3.3 Analysis
Discrete variables were compared using the chi-square test (Fishers exact test, when
appropriate, and difference-of-proportions test)38, and were presented as numbers and
percentages. Continuous variables were normally distributed (Shapiro Wilk, p>0.05) and
were therefore compared with the Student T-test, and are here presented as means SD.
All statistical tests were two-tailed. A value of p<0.05 was used for all tests to indicate
statistical significance.
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Chapter 3
First, CP and conventional care groups were compared at baseline for sociodemographic
and clinical characteristics, and the effect sizes (ES) were calculated only for statistically
significant results, since differences between groups due to sample fluctuation had no
clinical relevance. Cohens ES d for unrelated samples was used to estimate the magnitude
of the statistically significant differences between CP and conventional care groups (mean
difference score/the pooled standard deviation). According to Cohens thresholds, an ES of
<0.20 indicates a trivial difference, an ES of 0.20 to <0.50 a small difference, an ES of 0.50
to <0.80 a moderate one, and ES 0.80 a substantial difference. For differences in
proportions between CP and conventional care, Cohens effect size statistic w was used
with a threshold of <.10 for trivial, >.10 - <.30 for small, >.30 <.50 for medium, and >.50 for
large differences39.
Second, we estimated the amount of change between baseline and follow-up for HRQoL,
depression, and anxiety across the CP and conventional care groups. The magnitude of
change for each scale of the SF-36 and HADS was estimated independently both in the CP
group and the control group with a standardized response mean (SRM)40, and relative
validity methodology41,42 was used to compare these effect sizes across both groups.
Relative efficacy index (RE) coefficients estimate how much groups differ in size of
improvement, relative to the most improved group on that health-status measure.
In order to estimate the difference in change that may have contributed to the differences
in postoperative care methods (in the current study, clinical pathway vs. conventional care)
we have used the (RE).
RE
ES Pathway
ES most
ES Controls
x100
improved
All statistical analyses were performed using SPSS 13.0.1 for Windows.
3.4 Results
3.4.1 Patient characteristics
Differences between the pathway and conventional care groups, in relation to patient
demographics and treatment-related characteristics, were analyzed in Table 1.. The two
groups differed in terms of marital status, level of education, receiving inotropic support
and hours on mechanical ventilation. According to Cohens effect size w for difference in
proportions, these differences were small39.
3.4.2 Length of stay, discharge destination and readmission
73
As regards LOS and waiting time till surgery, we found that implementing a CP decreased
hospital delay (number of days the patient spent in the hospital from admission to
operation) from 2.50 (7.19) to 1.80 (1.60), which was statistically significant p=.002.
However, according to the thresholds of Cohens effect size d (ES), this difference has to be
considered trivial (ES=.15)39. Moreover, there was no statistically significant difference
between both groups in relation to the number of patients exceeding eight days of stay in
the hospital. The number of patients in the pathway group who exceeded the eight days
LOS (fell off the pathway) was 64 (57.1%), while in the conventional care group 39 (52.7%)
of the patients exceeded eight days.
Furthermore, there was no statistically significant difference between the two groups in
relation to discharge destination (i.e., discharge to home or to extended care facility),
attending a rehabilitation program after surgery, or readmission rate, in addition, all
readmissions were to the hospital where patients had surgery.
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Chapter 3
75
3.4.3 Differences in improved HRQoL across CP and conventional care

patients six months after CABG
Treatment-related improvements in both CP and conventional care groups were statistically
significant, and these effects indicate clinically relevant change43 in HRQoL and anxiety.
However, patients in the clinical pathway improved relatively less than did patients in
conventional care in terms of HRQoL for the six domains of physical and mental HRQoL: 1)
physical functioning, 2) social functioning, 3) physical role functioning, 4) mental
functioning, 5) vitality and 6) bodily pain as presented in Table 2. Regarding both physical
and mental component scores, conventional care patients gained relatively more than
pathway patients.
In contrast to these comparisons, patients in the CP improved substantially more in terms
of emotional role functioning, which yielded the highest RE, and in general health. No
differences were found in the magnitude of decreased depression, but the level of anxiety
decreased more in conventional care patients than in CP patients. It was also found that, in
relation to pain, both groups improved equally with moderate effect sizes.
Outcomes in favor of patients in the conventional care trajectory were based on the
difference between small ES ( .20 <.50) for pathway patients and moderate
76
Chapter 3
77
ES ( .50 <.80) for conventional care patients, except for the domain of physical functioning
and physical component summary, where the ES for conventional care was large (>.80).
3.5 Discussion
To our knowledge this is the first controlled study to investigate the effect of being in a
pathway for CABG patient outcomes. We controlled for variations by matching patients
based on age, gender and EuroSCORE. Although the main goal of implementing clinical
pathways is to decrease LOS, being in a pathway did not decrease LOS in the current study.
Moreover, there was no statistically significant difference between the conventional care
group and the pathway group regarding readmission rates. Patients in the pathway group,
however, had a decreased admission-operation delay (days in hospital between admission
and operation). Improvement in HRQoL after CABG was realized in both groups (also for
patients who had, according to our cut-off criterion, poor health status). We found,
however, that patients receiving conventional care improved relatively more, as compared
to pathway patients, for the six sub-domains of SF-36, but not for the domains of emotional
role functioning and general health. In addition, the conventional care group improved
more on both the physical and mental component summary.
Regarding depression and anxiety, there was no difference between groups in relation to
depression levels, but patients in the conventional care group decreased in anxiety
relatively more when compared to the pathway-group patients. Other studies that
investigated the effect of the CABG pathway on HRFS found no differences between either
group18,19.
Our findings confirm that confounding individual characteristics and differences must be
taken into consideration in designing the pathways. Factors such as ethnicity, comorbidity,
personality traits, risk indicators, and occurrence of perioperative incidences affect
patients perceived health status. Do clinical pathways account for these differences? Few
authors posed the same questions and investigated whether pathways should be based on
the acuity of patient conditions44, or the presence of preoperative risk factors and
perioperative incidences45. Yet they come to the same conclusion, and that was when
designing a pathway, all these factors need to be taken into consideration.
A systematic review by Dy and colleagues46, focused on determining the effectiveness of
CP, concluded that CPs tended to be effective when applied to procedures with lower
complexity/severity of illness. They also stated that because pathways tend to be
relatively inflexible and oriented toward patients with predictable course of care, they may
not work well when care is more variable as in intensive care unit.
3.6 Strengths and limitations
The strength of this study lies in the fact that we compared outcomes of a CP with a control
group under conventional care, and controlled for potential confounders, namely, age,
gender and EuroSCORE through matching. The limitations of the study lie in the fact that (1)
randomizing individual patients (or surgeons) to a CP or conventional care in the same
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Chapter 3
hospital was inappropriate as this would induce contamination bias; (2) at the start of the
current study there was no controlled study that evaluated the effects of CP on HRFS, which
therefore made it impossible to perform a power analysis; and that (3), although reminders
were sent at baseline for non responders and at follow-up for dropouts, 23% of patients
declined to participate at baseline and 12% dropped out at follow-up.
3.7 Conclusion
In conclusion, the aim of designing and implementing pathways is to decrease LOS and
subsequently decrease costs, while at the same time maintaining quality of care and
improving patient outcomes. Our findings suggest that these aims were not fulfilled in the
CABG pathway. It has been argued that clinical pathways address the ideal patient47,
which we tend to agree with, and thus in light of these findings, we recommend that when
designing a clinical pathway, all patient-related characteristics, risk indicators, along with
physiological status, be taken into consideration.
Likewise, pathways should be designed and length of stay set based on patients acuity of
illness and a follow-up period should be added for these patients in order to ensure
optimum outcome. We also recommend incorporating HRQoL measurement as part of a
routine assessment of patient health, both pre- and postoperative, since this will provide a
clear view of the patients perception of his physical functioning and mental health, which
will, in turn, have a great impact on planning care and counseling patients. Further research
is needed to evaluate the effects of CP when designed in such a way.
79
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82
C HAPTER 4
PREDICTS
E URO SCORE
POOR HEALTH -
RELATED PHYSICAL
FUNCTIONING SIX MONTHS
POST - CORONARY ARTERY
BYPASS GRAFT SURGERY
Noha El Baz, MSc, Berrie Middel, PhD, Jitse P. van Dijk, MD,
PhD, Daniele C.M. Wesselman, RN, Piet W. Boonstra, MD, PhD,
Sijmen A. Reijneveld, MD, PhD.
Published in Journal of Cardiovascular Surgery, October 2008,
49(5):663-672.
EuroSCORE predicts poor health-related physical functioning six months post-CABG surgery
84
Chapter 4
Chapter 4
EuroSCORE predicts poor health-related
physical functioning six months post-coronary artery

bypass graft surgery
A BSTRACT
Background
The objectives of this study are to test whether EuroSCORE is associated with
pre-operative health-related quality of life (HRQoL), length of stay and number
of post-operative complications, and whether it is a predictor of mental and
physical health-related quality of life six months after CABG.
Methods
We conducted a longitudinal observational study among 181 patients who
underwent CABG. Physical and mental domains of quality of life (QoL) were
measured using SF-36 and risk stratification was estimated using the
EuroSCORE. A post hoc test (with Bonferroni correction) was used to determine
whether EuroSCORE was associated with preoperative HRQoL, LOS and
postoperative rate of complications. Hierarchical regression analysis was
performed to explore the associations between EuroSCORE, postoperative
events and postoperative health-related quality of life.
Results
We found that EuroSCORE is associated with physical functioning before and
after CABG and a higher EuroSCORE is a predictor of poor physical functioning
and not a predictor of the mental domains of QoL, while smoking predicted
bodily pain after CABG. Furthermore, readmission within six weeks after
discharge was a predictor of poor physical functioning, physical role and general
health. Moreover, post hoc tests showed statistically significant and clinically
relevant differences in physical functioning between low-risk and high-risk
EuroSCORE classes, and between medium and high classes at baseline and six
months after CABG. High-risk patients had more peri-operative complications
and longer lengths of stay, as compared to low-risk patients.
Conclusions
EuroSCORE is a predictor of poor self-reported physical functioning six months
after CABG and is not a predictor of mental functioning.
85
4.1 Introduction
Coronary artery disease (CAD) is a major source of mortality and morbidity in
developed countries, for which CABG has been a primary treatment option for
more than 25 years1. Early reports on the benefits of CABG have focused on
survival rates, adverse cardiac events and other objective biomedical parameters
such as left ventricular ejection fraction (LVEF), morbidity and mortality in
cardiac surgical patients. In recent decades attention has shifted towards
investigating the impact of CABG surgery on post-operative subjective health
outcomes in terms of functional status, activity level, resumption of daily living
activities, return to work, perceived psychological well-being and self-reported
health-related functional status. Functional status refers to the ability to
perform those tasks of daily life in the physical, emotional and social domains
that determine the patients subjective experience of HRQoL.
Recent studies have posed the question of whether clinical indicators and
patients individual characteristics can predict postoperative HRQoL, which is a
patient-centered outcome; subsets of patients are known to prefer improvement
in health status over prolonged survival2.
Generic measures such as the SF-36 and disease-specific measures such as the
Minnesota Living with Heart Failure questionnaire (MLHF) are usually
composed of physical, emotional and mental health status components, as well
as a social functioning component, as relevant determinants of HRQoL3. Several
clinical and patient characteristics that predict physical HRQoL after cardiac
surgery were identified: gastrointestinal problems, congestive heart failure4,
current smoking, decreased forced expiratory pressure, LVEF, female gender,
elevated serum creatinine5, diabetes mellitus, chronic obstructive pulmonary
diseases (COPD) and health status at baseline6, sleep problems, hypertension,
hospital readmission, and not following a rehabilitation program after CABG7.
On the other hand, regarding mental health status following cardiac surgery,
the predictors identified were peripheral vascular diseases, infection, and a type
D personality4 history of psychiatric diseases, COPD, current smoking, older age
and higher NYHA classes5,6.
Furthermore, risk stratification models have been developed over the last few
decades to correct for differences between populations and to allow for a
comparison of the actual outcome with the predicted outcome8. These models are
used to investigate patient outcomes in relation to preoperative patient and
disease characteristics in order to estimate coefficients for each risk factor of
mortality, which are then translated into risk scores. The scores assigned to
each risk factor are then added to calculate the overall risk score of mortality for
a patient and to construct clinical risk groups. Reference to these groups can be
86
Chapter 4
made in order to adapt clinical decisions to individual patients, to compare

surgical performances, and for patient counseling9.
The European system of cardiac-operative risk evaluation score (EuroSCORE) is
a widely used operative risk-prediction tool, which was developed between 1995
and 1999, and it has been shown to be a valuable measure for prediction of
operative mortality related to adult cardiac surgery 10,11. Higher levels of
EuroSCORE were associated with increased in-hospital and thirty-day
mortality, longer stay in the ICU, and readmission11. Moreover, EuroSCORE can
be used to accurately predict prolonged length of stay and specific postoperative
complications such as renal failure, endocartitis, and/or sepsis after CABG12.
However, to our knowledge, the association between EuroSCORE and
preoperative HRQoL was not taken into consideration and EuroSCORE was not
investigated as a predictor of postoperative self-reported HRQoL in cardiac
surgery patients. In light of these conclusions the aim of our study was:
To determine whether EuroSCORE is associated with self-reported physical
and mental HRQoL before and six months after CABG
To determine whether EuroSCORE is a predictor of physical and mental
domains of HRQoL six months after CABG
4.2 Material and Methods
4.2.1 Design
A two-center longitudinal observational study.
4.2.2 Patients
Consecutive patients, who, following a coronary angiography (CAG), were
scheduled for CABG, were recruited from January to December 2006 from the
University Medical Center Groningen (UMCG) in Groningen and the HAGA
Hospital in The Hague, both in the Netherlands. Patients with incapacitating
diseases, cognitive impairments, aged 80 or older, their operation was cancelled
or who did not speak Dutch, were excluded. Ethical approval was obtained from
the hospitalsEthics Committee.
4.2.3 Procedure
After inclusion, before surgery patients received a mailed questionnaire
accompanied by an informed consent form. Follow-up questionnaires were sent
six months after the CABG intervention was executed. After the questionnaires
were received, they were checked for completeness at baseline, as well as at
follow-up. If a page had not been filled in, a copy was sent with a request to
87
complete the questions or, if it concerned one or only a few questions, patients
were interviewed by telephone.
4.2.4 Measures
Patient demographics including age, gender, marital status, education, working
status,
and
smoking
(current
smoking)
were
derived
from
patients
questionnaires.
4.2.4.2 Medical variables and number of peri-operative complications
The collected preoperative data and medical variables such as angina,
myocardial infarction, hypertension, diabetes, mild renal insufficiency, LVEF,
chronic pulmonary disease and postoperative events, such as use of inotropes
(inotropes commenced on leaving theater or in the ICU>3 g/kg/min), atrial
arrythmias (all atrial tachycardias or fibrillation requiring treatment) or
ventricular arrhythmia (ventricular tachycardias or fibrillation requiring
treatment), sternal resuturing (for any reason: technical failure or infection), reexploration for bleeding (bleeding/tamponade, that required surgical reexploration after initial departure from the operating theater or exploration for
other reasons, e.g., cardiac arrest or additional grafting) and time spent on
mechanical ventilation, were retrieved from the registry database, medical
notes, outpatient notes and intensive therapy unit (ITU) charts.
4.2.4.3 Hospital length of stay and readmission
Hospital length of stay was calculated for each patient. Readmission within four
to six weeks after operation due to cardiac-related complaints was recorded six
months after CABG.
4.2.4. 4 SF-36 (health-related quality of life)
The Short Form Health Survey (SF-36) was sent to patients preoperatively after
they were scheduled for CABG and postoperatively six months after CABG. The
SF-36 is a generic measure that assesses physical and mental health status
domains. A higher score on the SF-36 sub-domains represents better
functioning, with a high score on the bodily pain scale indicating freedom from
pain. The scale has good reliability, based on Cronbachs alpha, ranging from .65
to .96 for all subscales3.
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Chapter 4
4.2.4. 5 EuroSCORE
In this study, EuroSCORE was calculated for all patients, based on patient and
disease characteristics according to the standard additive EuroSCORE model.
Furthermore, the added scores were classified into three risk groups: (1) low
(additive score of 0-2), (2) medium (scores 3-5) and (3) high risk (scores >6)13,14.
4.3 Analysis
First, discrete variables were compared using the chi-square test (Fishers exact
test when appropriate), and are presented as numbers and percentages.
Continuous variables were normally distributed (Shapiro Wilk, p>0.05) and
were therefore compared with the Student T-test; they are presented as means
SD. Effect sizes (ES) were calculated only for the statistically significant
results, since differences between groups that are due to sample fluctuation
have no clinical relevance. Cohens ES d for an unrelated sample was used to
estimate the magnitude of the difference between two groups (mean difference
score/the pooled standard deviation).
Next, Cohens thresholds for effect size were used: an ES of <0.20 indicates a
trivial difference, an ES of 0.20 to <0.50 a small difference, an ES of 0.50 to
<0.80 a moderate and ES
0.80 a substantial difference15. A formula for
calculating the 95% confidence interval (CI) for an effect size (95% CI for ES) is
given by Hedges and Olkin16, Middel et al.17 showed that ES reflects clinical
relevance using a global-rating scale of perceived change in functioning as
external criterion. Therefore, in the current study, an ES 0.20 was considered
to be a clinically relevant difference between groups.
Finally, hierarchical regression analysis was performed to explore the
associations
between
baseline
EuroSCORE,
immediate
postoperative
complications, and physical and mental health-related quality of life (HRQoL)

six months after CABG. All statistical tests were two-tailed. A value of p<0.05
was used for all tests to indicate statistical significance and all analyses were
performed using SPSS 13.0.1 for Windows.
4.4 Results
4.4.1 Response rate
At baseline 198 patients filled out the questionnaires and 168 at follow-up. An
overview of the patient selection for the current study is presented in Figure 1.
The postal follow-up survey was sent out at baseline and six months after CABG
to 256 patients. The response rate at baseline was 77.3% (N=198). When
comparing included patients with non-responders, no differences were found
89
between both groups other than with regard to gender ( 2=4.85, df=1, p=.03),
with 33.3% and 21.2% females, respectively.
Figure. 1. Overview of patient selection for the current study
Compared to the study baseline sample, drop-outs at follow-up did not differ for
gender ( 2=1.63, df=1, p=.20) and marital status ( 2=1.81, df=1, p=.18), and no
statistically significant difference (df=196; p=.45) was found for age (mean age
drop-outs 66.1 10.09; mean age participants 64.59 9.95).
4.4.2 Sample description
Differences between the EuroSCORE classes in relation to patient demographics
and treatment-related characteristics were analyzed, and presented in Table 1..
There was no statistically significant difference between low, medium and high
EuroSCORE in relation to marital status, educational level and admission to a
university or peripheral hospital, but age, gender, work status and LOS were
statistically significantly associated with EuroSCORE classes.
Patients with a high-risk EuroSCORE class were found to be significantly older
and also had a longer length of stay. Furthermore, the percentage of females in
the high-risk class was 34.7%, which is more than the number of females in lowrisk (7.8%) and medium-risk (25%) classes. It was also found that 85.7% of
patients in the high-risk class were not working, as compared to 53% in the low90
Chapter 4
risk class, which can be explained by the fact that patients in the high-risk class
had a mean age of 71.33 8.26 years.
91
In relation to coronary history, there was no statistical significance with regard

to MI, unstable angina, previous cardiac surgery and pulmonary hypertension,
but there was an expected statistically significant difference between the
EuroSCORE and NYHA classes. It was found that 81.7% of the high-risk
EuroSCORE class were patients with NYHA classes III & IV, as compared to
60% in both medium and low-risk classes, with differences that were
statistically significant (95% CI 4.5 to 35.9% and 95% CI 3.7 to 35.5%,
respectively).
4.4.3 EuroSCORE and preoperative self-reported physical HRQoL
Post hoc analysis with Bonferroni correction against capitalization on chance
showed that a statistically significant difference between EuroSCORE classes
was found in self-reported physical functioning at baseline as shown in Figure 2.
and 3.. Higher-risk patients had worse physical functioning at baseline and six
months after CABG, as compared to medium and low-risk patients. Patients
with a higher EuroSCORE had a longer hospital stay (admission to discharge
and operation to discharge), and a higher number of perioperative complications,
as compared to low-risk patients.
Figure 2. Mean scores with p-values and effect sizes for differences between
low and high risk EuroSCORE in physical functioning at baseline and 6
months after CABG
92
Chapter 4
medium and high risk EuroSCORE in physical functioning at baseline and 6
months after CABG
Post hoc tests showed that high-risk patients had a statistically significant and
clinically relevant lower score on the physical functioning scale at beforesurgery, as compared to low-risk (P<0.01; ES=0.70) and medium-risk (P<0.01;
ES=0.62) patients. Despite the fact that all patients improved on average in
physical functioning six months after CABG, it was found that high-risk
patients had significant and clinically relevant lower scores for physical
functioning, as compared to low-risk (P<0.01; ES=0.82) and medium-risk
patients (P<0.05; ES=0.52).
4.4.4 EuroSCORE and perioperative complications
Between high-risk and low-risk classes of EuroSCORE a significant and
relevant difference in perioperative complications was found: P<0.05; ES=0.50.
Only comparisons between low and high classes of EuroSCORE revealed
statistically significant and clinically relevant differences in the average number
of days between admission and discharge P<0.05; ES=0.50, and between
operation and discharge, P<0.01; ES= 0.58 as displayed in Figure 4..
93
low and high risk EuroSCORE in length of stay and number of perioperative
complications
4.4.5 EuroSCORE and postoperative self-reported physical and mental

HRQoL
Tables 2. and 3. show the results of a hierarchical regression analysis designed
to ascertain the relative contribution of the EuroSCORE, NYHA class, smoking,
immediate postoperative complications, readmission, and LOS in the prediction
of self-reported physical and mental HRQoL six months after CABG, controlling
for marital status, level of education and working status. In each model,
analyses were adjusted for baseline scores of respective HRQoL domains. Since
age and gender are used as weights in the algorithm of the EuroSCORE, these
characteristics were not used in the multivariable regression analysis in order to
avoid contamination bias.
Poor post-CABG physical functioning was significantly predicted by a higher
EurosSCORE (= -.191, p=.009), by readmission to the hospital six weeks after
CABG (= -.158, p=.018), and by higher NYHA (= -.150 , p=.025). The adjusted
R2 indicated that the variables in the model contributed towards a relevant and
unique part (27.4%) of the explained variance in physical functioning.
Poor physical role was predicted by readmission (= -.217, p=.003) and longer
LOS (= -.140, p =.046). Moreover, the adjusted R2 signified that these variables
94
Chapter 4
95
96
Chapter 4
in the model explained approximately 14.2% of physical role functioning six

months after CABG.
Smoking was a predictor of increased bodily pain CABG (= - .168, p=.019), as
was history of renal insufficiency (= -.161, p=.025); this variable in the model
contributed to 18.6% of the explained variance in physical pain. Finally, the
variable predicting general physical health was readmission to the hospital six
weeks after CABG (= -.173, p=.014 ), and the adjusted R2 indicated that the
variables in this model explained approximately 21.5% of the variance in
general physical health six months after CABG.
In relation to mental HRQoL, it was found that EuroSCORE was not associated
with any of the four mental components of the SF-36, but our results did show
that poor social role was associated with readmission (= -.225* p=.001) and
longer LOS (= -.160* p =.015). The adjusted R2 signified that the model
explained 26.1% of the poor social role six months after CABG. As regards
emotional role, it was found that current smoking was associated with poor
emotional role (= -.174* p=.023), and the adjusted R2 explained only 7.4% of the
variance in emotional role. Moreover, in relation to mental health it was found
that patients who had undergone a re-exploration for tamponade or bleeding (=
-.206* p=.003), along with patients who had undergone sternal resuturing (=
-.142 p=.036), experienced poor mental health. In addition, our results showed
that readmission was also associated with poor mental health (= -.185*
p=.003), while, on the other hand, patients with a history of angina had better
mental health six months after CABG (= .128, p=.043). The adjusted R2 of this
model explained 36.2% of the variance in mental health for patients six months
after CABG.
Poor vitality was associated with re-exploration surgery during the immediate
postoperative period (= -.170* p=.024) and with readmission to the hospital
after discharge (= -.218 * p=.002), and the adjusted R2 explained 24.1% of the
variance in vitality six months after CABG.
4.5 Comments
To our knowledge, this is one of the first studies that has found that the
EuroSCORE is associated with self-reported physical functioning before and
after CABG, and that EuroSCORE predicts poor physical HRQoL six months
following CABG surgery (adjusted for baseline physical HRQoL).
We used the SF-36 components as an indicator of patient-perceived physical and
mental quality of life. Poor physical functioning is a reflection of perceived
limitation in performing all physical activities, such as having difficulties
bending, stooping or lifting light objects, lifting heavy objects, climbing stairs,
walking a (long) distance, bathing or dressing. Such a finding has an implication
97
for clinical practice and for the role of health care personnel including
cardiologists, cardiac surgeons and nurse practitioners. This is because,
although the development of risk models has led to the appropriate selection of
patients for CABG, there are limited data available to help clinicians predict
which patients will experience an improved HRQoL after CABG. Risk
stratification is an essential component of optimizing care in terms of
recommending the most appropriate treatment strategy, along with efficient
patient and family counseling18. Counseling patients on the level of their
physical functioning after CABG will help give the patients a clear overview of
the improvement they can expect and the limitations in daily-living activities, as
well as the extent of rehabilitation needed.
Furthermore, EuroSCORE was able to discriminate between physical healthrelated quality of life at baseline and follow-up. It can be seen that patients in a
high-risk EuroSCORE class had poorer health at baseline and, despite their
improvement after CABG, they still had poor physical health at follow-up, as
compared to low-risk and medium-risk patients. This is in line with the findings
of a recent study by Colak et al.19, where they found that high-risk EuroSCORE
patients were likely to have significant improvement in HRQoL following CABG,
as compared to low-risk and medium-risk groups. Moreover, EuroSCORE was
able to detect statistically significant and clinically important differences
between low-risk and medium-risk vs. high patient-risk classes in average
number of LOS from admission to discharge, from operation to discharge, and in
number of perioperative complications.
In this study, we also found that poor physical and mental HRQoL was
associated with several variables such as higher NYHA classes, readmission
after six weeks of discharge, longer LOS, current smoking, history of renal
insufficiency, re-exploration for bleeding and sternal resuturing. These findings
are in line with the findings of other researchers4,5,7,20.
Higher NYHA class was found to be associated with poor physical functioning,
which is also in accordance with the findings of other researchers4,20.
Furthermore, increased bodily pain was found to be associated with a history of
renal insufficiency and current smoking. Current smoking was also a
determinant of poor mental health status after CABG5. Smoking increases
myocardial oxygen demand and may cause an inappropriate decrease in
coronary blood flow and myocardial oxygen supply. Smoking has also been
linked to prolonged mechanical ventilation, respiratory complications after
cardiac surgery21, a significant increase in mortality, as well as an increased
need to repeat the revascularization procedure22.
In this study, we found that readmission within six weeks after CABG was a
predictor of poor physical functioning, physical role, general health, social role,
98
Chapter 4
mental health and vitality after surgery. Readmission to the intensive care unit4
and re-hospitalization after discharge were found to be associated with poor
physical and mental health scores7. Some studies investigated the predictors for
thirty-day readmission, and it was found that female gender, older age, a history
of diabetes, MI, COPD, wound infection and immediate postoperative atrial
fibrillation were highly associated with readmission23,24. We also found that
longer LOS was associated with poor physical and social role. Length of stay
longer than seven days was found to be associated with low scores in physical
health-related
status4.
Immediate
postoperative
complications
like
re-
exploration for bleeding and sternal re-suturing were found to be associated

with poor mental health and vitality.
Despite of sending reminders the none response rate at baseline was
approximately 23% and compared to the study sample, non-responders differed
for gender since more females declined to accept the invitation to participate,
which may have led to an under-representation of females. The strengths of the
study lie in the fact that non-responders and excluded patients (excluded due to
age over 80) did not differ from responders in their demographic and clinical
baseline characteristics. Moreover, during follow-up, as compared to the study
sample, dropouts did not differ for age, gender or marital status. In addition to
this fact, we used the standardized SF-36 questionnaire, which is an established
measure to assess HRQoL.
Health related quality of life measures have become an important aspect of
patients evaluation, but clinicians tend to disregard them, and the reason was
explicitly stated by Rumsfeld an important barrier to the acceptance and use of
surveys like the SF-36 and Seattle Angina Questionnaire (SAQ) by clinicians in
the perception that health status measures are soft or not as scientific as
physiological measures like treadmill testing25.
In conclusion, it is evident that EuroSCORE is a predictor of self-reported
physical functioning after CABG. Physical functioning is an important
component of the SF-36, which reflects the persons ability to perform a wide
range of daily-living activities. The ability of the EuroSCORE as a risk
stratification model to predict health-related physical functioning provides an
opportunity to consult patients regarding their expectations of improvement,
and the need for further preparation, rehabilitation and support following
CABG, subsequently improving their HRQoL.
In light of these findings, we recommend that in order to provide patientcentered care with effective counseling, self-reported HRQoL must be considered
as part of and integrated into the process of diagnosis and management of the
99
patients illness. It should be feasible to include the assessment of HRQoL in

research protocols and clinical practice. Future studies that replicate these
findings are warranted, given that few studies have examined the impact of
EuroSCORE on patients after CABG.
100
Chapter 4
4.7 Reference List

1. Hunt JO, Hendrata MV, Myles PS. Quality of life 12 months after coronary artery
bypass graft surgery. Heart Lung 2000; 29(6):401-411.
2. Lenzen MJ, Reimer WJMS, Pedersen SS, Boersma E, Maier W, Widimsky P et al. The
additional value of patient-reported health status in predicting 1-year mortality after
invasive coronary procedures: a report from the Euro Heart Survey on Coronary
Revascularisation. Heart 2007; 93(3):339-344.
Predictors of health-related quality of life after coronary artery bypass surgery. Ann
Thorac Surg 2004; 77(5):1508-1513.
7. Simchen E, Galai N, Braun D, Zitser-Gurevich Y, Shabtai E, Naveh I.
coronary bypass operations: The Israeli Coronary Artery Bypass Study (ISCAB). J
Thorac Cardiovasc Surg 2001; 121(5):909-919.
8. Nilsson J, Algotsson L, Hoglund P, Luhrs C, Brandt J. Comparison of 19 pre-operative
risk stratification models in open-heart surgery. Eur Heart J 2006; 27(7):867-874.
9. Kolh P. Importance of risk stratification models in cardiac surgery. Eur Heart J 2006;
27(7):768-769.
Ann Thorac Surg 2006; 82(1):57-61.
12. Toumpoulis IK, Anagnostopoulos CE, Derose JJ, Swistel DG. Does EuroSCORE
predict length of stay and specific postoperative complications after coronary artery
bypass grafting? Int J Cardiol 2005; 105(1):19-25.
European system for cardiac operative risk evaluation (EuroSCORE). Eur J
Cardiothorac Surg 1999; 16(1):9-13.
multinational database of 19030 patients. Eur J Cardiothorac Surg 1999; 15(6):816-822.
15. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ:
Lawrence Earlbaum Associates; 1988.
101
16. Hedges L, Olkin I. Statistical Methods for Meta-Analysis. New York: Academic
Press; 1985.
a global question rating? J Eval Clin Pract 2001; 7(4):399-410.
18. Holmes J. Risk Stratification and Interventional Cardiology: Robert L. Frye Lecture.
Mayo Clin Proc 2003; 78(12):1507-1518.
19. Colak Z, Segotic I, Uzun S, Mazar M, Ivancan V, Majeric-Kogler V. Health related
quality of life following cardiac surgery - correlation with EuroSCORE. Eur J
Cardiothorac Surg 2008; 33(1):72-76.
surgery: One-year self-assessment of quality of life and functional outcome. Ann Thorac
Surg 2003; 76(5):1598-1604.
21. Ngaage DL, Martins E, Orkell E, Griffin S, Cale ARJ, Cowen ME et al. The impact of
the duration of mechanical ventilation on the respiratory outcome in smokers
undergoing cardiac surgery. Cardiovasc Surg 2002; 10(4):345-350.
22. Papathanasiou A, Milionis H, Toumpoulis I, Kalantzi K, Katsouras C, Pappas K et
al. Smoking cessation is associated with reduced long-term mortality and the need for
repeat interventions after coronary artery bypass grafting. Eur J Cardiovasc Prev
Rehabil 2007; 14(3):448-450.
23. Beggs VL, V. Factors related to rehospitalization within thirty days of discharge
after coronary artery bypass grafting. Best Pract Benchmark Healthc 1996; 1(4):180186.
24. Stewart R, Campos C, Jennings B, Lollis SS, Levitsky S, Lahey S. Predictors of 30day hospital readmission after coronary artery bypass. Ann Thorac Surg 2000;
70(1):169-174.
25. Rumsfeld JS. Health status and clinical practice - When will they meet? Circulation
2002; 106(1):5-7.
102
C HAPTER 5 T HE IMPACT OF
T YPE D PERSONALITY ON
DETERIORATION IN
PERCEIVED HEALTH STATUS IS
MEDIATED BY INCREASED
LEVELS OF ANXIETY AFTER
CORONARY ARTERY BYPASS
GRAFT SURGERY
Noha El Baz, MSc, Berrie Middel, PhD, Susanne S. Pedersen, PhD,

Jitse P. van Dijk, MD,PhD, Sijmen A. Reijneveld, MD,PhD
Submitted
The impact of Type D personality on deterioration in perceived health status is mediated by
104
Chapter 5
Chapter 5
The impact of Type D personality on
deterioration in perceived health status is mediated by

increased levels of anxiety after coronary artery bypass
graft surgery
A BSTRACT
Objectives
The objective of this study is to determine predictors of deterioration in health
related functional status (HRFS) six months after CABG and test a
hypothesized model of the role played by Type D personality, increased levels of
anxiety and depression in predicting deterioration in HRFS using a structural
equation model (SEM).
Methods
We used multivariate logistic regression to examine the association between
patient
demographic
charcteristics,
medical
history,
clinical
variables
postoperative complications, psychological distress and HRFS. Then, we

employed the SEM to test the tenability of a priori hypothesized model of the
role played by Type D personality, increased anxiety and depression in
predicting treatment-related longitudinal change in physical and mental HRFS.
Results
Regression analysis revealed that angina, increased anxiety and depression, but
not Type D were independent predictors of deterioration in HRFS. The SEM
results showed that increased anxiety and depression mediated the relationship
between Type D and deterioration in HRFS after CABG. Type D, anxiety and
depression explained 65% of the variance in mental HRFS change, and 25% of
the variance in physical HRFS change.
Conclusions
Our findings showed that despite the fact that the majority of patients
experienced improvement in their HRFS after CABG, some patients experienced
no change or deterioration, and this deterioration was associated with a history
of angina, and increased levels of anxiety and depression. Our results outlined
the role played by personality Type D, anxiety and depression in predicting
deterioration after CABG.
105
5.1 Introduction
Coronary artery bypass grafting (CABG) is an established treatment procedure
with unequivocal benefits that include symptom relief1, improved health-related
functional status (HRFS)2 and prolonged survival1-4. However, this improvement
is not realized in all patients; approximately 20-30% of patients experience no
change or a deterioration in HRFS or quality of life5-7.
Few studies have investigated predictors of deterioration in HRFS after CABG.
One study by Lindsey et al. reported that patients, who had poor HRFS
preoperatively, were less likely to experience improvement after surgery and
found that patient-related factors, such as diabetes mellitus, smoking, younger
age, high alcohol intake and high socioeconomic deprivation, were associated
with a decline in HRFS8. Welke and colleagues found that a body mass index of
> 35kg/m2, and co-morbidity of a chronic obstructive pulmonary disease, and a
peripheral vascular disease were associated with deterioration in HRFS after
CABG9. Another study found that being male and being classified in a higher
NYHA class at baseline gained more in HRFS after CABG2.
In the past decade, it has become obvious that psychological distress, i.e. anxiety
and particularly depression, are risk factors of CAD10 and determinants of the
recovery process after myocardial infarction (MI)11, in addition both, are
considered to affect HRFS in patients with CAD5,12-17.
A recent study by Lee18 found that Preoperative angina scores and at follow-up,
co-morbid illness, anxiety and depressive symptoms, and physical activity
accounted for 37% of PCS variance. Preoperative anxiety, interim myocardial
infarction and age, diet scores, and anxiety and depression symptoms (at followup) accounted for 60% of MCS variance.
Of note is the fact that depressive symptoms seem to have a greater impact on
HRFS than objective measurements of disease severity, such as ejection fraction
and ischemia17. A study by Mallik et al.19 found that depressive symptoms at the
time of CABG surgery, particularly at the level of severe depressive symptoms,
are associated with a lack of functional benefits 6 months after operation.
Furthermore, a higher score of depression at baseline has been shown to predict
deterioration in mental HRFS6, while changes in depression and anxiety scores
accounted for most of the change in HRFS post treatment. In a prospective
study, where they investigated the effect of invasive treatment of CAD on
HRFS, Hfer et al.14 showed that change in anxiety explained 37% of the total
variance in the SF-36 physical component summary change scores and 64% of
the variance in the mental component summary change score. Which indicate
that changes in subjective HRFS after treatments in patients with CAD may be
highly influenced by mood disturbance than by treatment methods, rather than
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Chapter 5
objective biomedical variables such as left ventricular ejection fraction or degree

of angina14,17.
Remarkably, the majority of longitudinal studies examining changes in HRFS
after
CABG
primarily
deteriorations2,5,8,9,12,20-23,
seem
to
report
improvements
rather
than
which was a principal motive for the conducting of this
study, as since CABG has become an established intervention with strong

evidence of improving physical and mental health status suppressed the fact
that there are patients who perceive their health status as unchanged or
deteriorated19,20. Two main factors may explain why subjects deteriorate after an
effective CABG:
1. A subtraction of baseline scores from post-CABG scores, results in a positive
mean change score, indicating improvement, since the majority of change scores
are, as expected, on the positive side of the distribution. As a consequence, the
minority of observations found in the distribution of change scores that are zero
or negative is likely to be neglected.
2. Patients who, during the control visits after CABG complaint that they still
have no energy, feel fatigued or have the idea that they do not improve may
have higher levels depression and, more symptoms of anxiety6,14,19. In studies
among patients with cardiovascular disease of heart failure, it has become
evident that these symptoms of psychological distress are associated by
personality traits, such as Type D24,25. Lately, the effect of Type D personality26
on outcomes of patients with CAD or undergoing invasive cardiovascular
procedures has drawn a lot of attention. Several studies were conducted to
investigate Type D personality trait and it is evident that it is associated with
poor outcomes after invasive cardiovascular procedures25-32 and CAD24.
There are various methods available33,34 for identifying the magnitude of
improvement and of deterioration by standardized intra-individual change in
HRFS that fall into the category of distribution-based methods5. The most
common distribution-based statistical methods are effect size statistics, which
are independent of measurement units and allow for comparing different
outcomes35; they can be applied both to group data and to the data from
individual patients in study samples36-38.
The objectives of the current study is to test an a priori hypothesized model of
the predictors of non- improvement and deterioration in HRFS after CABG with
a structural equation modeling technique.
107
5.2 Methods
5.2.1 Patients and design
Two hundred and fifty six patients scheduled for CABG following coronary
angiography (CAG) were recruited from January to December 2006 from the
University Medical Center Groningen (UMCG) and the HAGA Hospital in The
Hague, the Netherlands, and were followed after CABG for six months. Patients
with chronic diseases, cognitive impairments, aged 80 or older, or who did not
speak Dutch were excluded. Ethical approval was obtained from the respective
hospitals medical ethics committees.
5.2.2 Procedure
Prior to surgery, patients were approached for participation in the study. If they
agreed, they signed an informed consent form and completed a set of
standardized and validated self-report questionnaires. Follow-up questionnaires
were sent to patients six months post CABG. Researchers checked the
questionnaires for completeness upon receipt. If a page had not been filled in, a
copy was sent to the patient with a request to complete the questions or, if it
concerned one or only a few questions, patients were interviewed by telephone.
5.2.3 Measures
Patient demographics, including age, gender, marital status, education, working
status and current smoking were derived from patients questionnaires. The
collected pre-operative data and medical variables, such as angina, myocardial
infarction (MI), hypertension, diabetes, mild renal insufficiency, left ventricular
ejection fraction (LVEF) and chronic pulmonary disease were retrieved from a
registry database, medical notes, outpatient notes or intensive therapy unit
(ITU) charts. Postoperative events, including use of inotropes (inotropes
commenced on leaving theater or in the ICU >3 g/kg/min), atrial arrythmias (all
atrial
tachycardias
or
fibrillation
requiring
treatment)
or
ventricular
arrhythmia (ventricular tachycardias or fibrillation requiring treatment),

sternal re-suturing (for any reason, e.g., technical failure or infection), reexploration for bleeding (bleeding/ tamponade that required surgical reexploration after initial departure from the operating theater or exploration for
other reasons, e.g., cardiac arrest or additional grafting) and time spent on
mechanical ventilation were also retrieved from these same sources.
108
Chapter 5
5.2.3.2 Health-related functional status

The Short Form Health Survey 36 (SF-36) is a valid, reliable and widely used
generic measure of HRFS that has been used in a myriad of studies
investigating the impact of cardiac and non-cardiac diseases on HRFS. It is
comprised of 36 items contributing to eight scales: physical functioning, role
physical functioning, bodily pain, general health, vitality, social functioning, role
emotional functioning and mental health39,40. These scales are standardized to a
score from 0 (poor) to 100 (high) and can be combined into two component
summary scores (i.e., physical component summary (PCS) and mental
component summary (MCS)). The SF-36 has yielded good reliability estimates,
with Cronbachs alpha ranging from .65 to .96 for all subscales41. The SF-36 was
administered both prior to surgery and at six-month follow-up.
We used the Type D Scale (DS14) to assess the distressed (Type D) personality26.
This scale consists of 14 items that are answered on a five-point Likert scale
from 0 (false) to 4 (true). Seven items tap negative affectivity and seven items
social inhibition (score range: 028 for each subscale). Type D caseness is
defined by a high score on both subscales, as determined by a standardized cutoff score 10 31. The DS14 is a valid and reliable scale with Cronbachs alpha
=.88/.86 and three-month testretest reliability (r)=.72/.82 for the negative
affectivity and social inhibition subscales26, respectively. Type D personality is
not only defined in terms of negative affect, as it also takes into account how
patients deal with this affect through the inclusion of the social inhibition
component. The DS14 was administered at baseline.
5.2.3.4 HADS Anxiety and depression
Anxiety and depressive symptoms were assessed six months post CABG using
the seven-item anxiety subscale and the seven-item depression subscale of the
Hospital Anxiety and Depression Scale (HADS)42. Responses to both subscales
are indicated on a four-point Likert Scale from 0 to 3 (score range 0 21). A cutoff score
8 was used for both subscales to identify patients with probable
clinical levels of anxiety and depression. This cut-off has been shown to balance
sensitivity and specificity optimally43. The HADS has been shown to be a valid
and reliable instrument43,44 and to predict mortality in patients referred for
exercise testing45.
5.2.3.5 Statistical methods
First, discrete variables were compared using the Chi-square test (Fishers exact
test when appropriate) and are presented as numbers and percentages.
109
Continuous variables were compared with the Student T-test and are presented
as means SD.
Then, we calculated changes in HRFS by subtracting individual baseline scores
from individual follow-up scores. Scores with a negative sign indicated
deterioration in SF-36 scales. A decrease, or improvement, in the number of
symptoms of anxiety and depression, as measured by the HADS, scores with
negative signs indicated improvement.
We assessed HRFS with the generic SF-36 and classified subjects as
deteriorated, improved or stable using intra-individual effect sizes only when
longitudinal change was statistically significant at group level. Such an
approach has been advocated by others46, since examining changes in mean
scores masks changes in individual patients.
Middel et al. showed that ES
.20 reflects clinical relevance according to an
external criterion by which CAD patients were classified as stable, deteriorated

and improved subjects35-37. Therefore, an ES 0.20 was considered to be a cut off
for estimating the prevalence of clinically relevant change in patients. Patients
were classified as deteriorated if their change score for the PCS and MCS,
indicated a decline >.20 ES. Patients were classified as stayed the same if their
change score was in the range -.20 to +.20, and were classified as better if their
change score improved >.20 ES. To determine the factors affecting adverse
impact on HRFS after CABG, we merged patients who had no change in their
scores with patients who had worsened, considering both as a negative outcome.
Patients who had ES .20 were classified as improved9,23.
Next, in order to determine the factors predicting deterioration in HRFS, we
performed a logistic regression analysis in which we included type D
personality, deterioration in anxiety, depression and HRFS, including the
covariates age, gender, marital status, work, NYHA class, LVEF and angina.
Finally, we used structural equation model to determine the relationship
between possessing a type D personality trait, and increased level of anxiety and
depression and it's association to deterioration and no change in HRFS.
SEM is a multivariate technique for testing the tenability of this model and is
an elaboration of regression analysis. However, to test this model with LISREL
two criteria must be met, namely (i) that a causal relationship between
variables is known on the basis of previous research or assumed on theoretical
considerations and that (ii) recursive relationships or feedback loops can be
tested. In this study, we used change in anxiety and depression between
baseline and follow-up after CABG as predictors of treatment-related change in
HRFS. We also used longitudinal change in anxiety and depression as a
mediator the relationship between personality Type-D and treatment-related
change in HRFS.
110
Chapter 5
Path analysis was used to test this hypothesized model in which (i) factors
considered as precursors to declined levels of CABG-related change in mental
and physical HRFS (enhanced levels of depression and anxiety) directly
predicted a stable or decreased extent of physical and psychological functioning
and (ii) Type D influenced changes in mental and physical HRFS directly and
indirectly through its effect on the precursor factors. Within the structural
model, longitudinal change was estimated from these outcomes at follow-up
through the latent variables representing the subtraction of physical and mental
functioning, and anxiety and depression at baseline from these outcomes at
follow-up. Therefore, to estimate the differences between baseline and follow-up,
the path coefficients were fixed at 1 and -137. The latent construct Type D
personality was estimated with the indicators of negative affectivity (NA), while
social inhibition (SI) was estimated with a latent Type D personality disposition
indicating simultaneously high scores on both subscales26. Patients who were
neither anxious nor depressed at baseline or at follow-up were removed from the
variance-covariance matrices in all of the LISREL analyses. To allow for mutual
comparisons between the path coefficients, the completely standardized solution
was used. For judging the model fit, we used multiple criteria as suggested by
Bentler and Bonett47. These criteria were (a) non-significant
, indicating that a
non-significant amount of variance in the data remains unexplained (a ratio of

2
to the degrees of freedom less than three generally indicates a good model
fit48);
(b) the root mean square error of approximation (RMSEA) <0.06,
indicating a good fit to the data49 (c) the standardized root mean square residual
(SRMR) <.05, indicating good model fit50-52; (d) comparative fit index (CFI),
indicating good fit with a value >.97 (and according to Hu and Bentler (1999)
this criterion is more appropriate than the >.95 criterion, as the large number of
severely miss-specified models is unacceptable53); and (e) the Adjusted Goodness
of Fit Index (AGFI) >.95, indicating51 good fit. Both CFI and RMSEA were used,
because it has been argued that they provide more stable and accurate
estimates than several of the other fit indices53,54. Given their complementary
features, we used all five indices to evaluate the model. All bivariate and
multivariable statistical analyses were performed using SPSS 15 for Windows
5.3 Results
5.3.1 Selection bias
An overview of patient selection for the current study is presented in Figure 1..
A postal follow-up survey was sent out to 256 patients, both at baseline and six
months after CABG. The response rate at baseline was 77.3% (198/256). When
comparing included patients with non-responders, no differences were found
111
between either group except with regard to gender ( 2= 4.85, df=1; p=.03), with
33.3% vs. 21.2 % females, respectively. Compared with the study baseline
sample, dropouts at follow-up did not differ systematically for gender ( 2=1.63,
df=1; p=.20) and marital status ( 2=1.81, df=1; p=.18), nor for mean differences
in age (66.1 10.09 vs. 64.59 9.95; df =196; p=.45). Given that we used a
prospective design that included only patients with complete questionnaire data
at baseline and six-month follow-up, our analyses were finally based on 168
patients.
Figure 1. Overview of patient selection for the current study
5.3.2 Baseline characteristics

Table 1. presents the demographic characteristics, preoperative medical
variables and postoperative events of the study sample. The mean age of the
study sample was 64.89 9.95, 79.3% were males, 79.3% were married or living
with a partner, 61.9% had elementary schooling, and 72.2% were not working.
Of all patients, 11.6% had a Type D personality and 7.3% were smokers. In
relation to clinical characteristics, 27.1% were high-risk patients according to
the EuroSCORE, 67.7% had an NYHA class of III or IV, and 58.1% had a history
of angina. Concerning postoperative events, 32.6% of patients had developed
atrial arrhythmias and 32% needed inotropic support.
112
Chapter 5
113
5.3.3 Proportions of deteriorated, stable and improved subject 6 months

after CABG
The percentages of patients experiencing deterioration, no change, or
improvement in HRFS, along with anxiety and depression, are presented in
Table 2.. Generally, a large proportion of patients improved in all domains of
HRFS, and in anxiety and depression between baseline and the six-month
follow-up. In relation to physical role functioning it is notable that 37.3% of
patients experienced no change while 14.5% deteriorated. As regard to role
emotional
functioning,
48.2%
also
experienced
no
change
and
15.7%
deteriorated, for social functioning, 28% remained the same and 19.3%
deteriorated. To prepare this studys structural equation measurement model we
performed a multivariable logistic regression. The results showed that patients
who did not improve in physical HRFS following CABG were more likely to have
a history of angina, while patients who reported higher levels of anxiety and
depression experienced deterioration/no change in both physical and mental
HRFS. These findings were in line with the findings of other studies14,17 as they
found that increased levels of anxiety and depression were predictors of
deterioration in HRFS rather than other known variables such age, sex, or
degree of ischemia. Furthermore, it is of note that Type D personality was not
associated with deterioration/no change in HRFS using logistic regression
analyses
114
Chapter 5
5.3.4 Structural Equation Model (SEM)

This model was evaluated by examining the parameter estimates and by using
the indices of overall fit provided by LISREL. Residual correlations between NA
and SI, changes in anxiety and depression, and changes in physical and mental
HRFS were allowed, as they belonged to the same measure and were assessed
simultaneously. All model parameters met the criteria for model fit. For this
model, the Chi-square statistic (5.79, p=0.45) indicated that a non-significant
amount of variance in the data remained unexplained and, relative to degrees of
freedom (6), was less than two. The RMSEA indicated a good fit <0.06 (0.003), as
was the SRMR <0.05 (0.039). The CFI value of 1.00 exceeded the .97 value and
the AGFI index was >.95. Taken together, these results suggest a model with a
good fit.
Figure 1. depicts the results of the path analysis, showing the direct and
mediated paths between Type D personality, change in anxiety and depression
after CABG, and CABG-related changes in mental and physical HRFS. As
proposed in our hypothesized model, direct paths from changes in anxiety to
changes in physical and psychological functioning were significant, with
negative betas indicating that no change/deterioration in anxiety and depression
predicted levels of no change/deterioration in mental and physical HRFS. As can
be seen in Figure 1., increased levels of anxiety and depression mediated the
relationship between Type D personality and deterioration/no change in both
mental and physical HRFS six months after CABG. Moreover, Type D directly
increased the likelihood of deterioration/no change in MCS (= -.16, p<0.01),
while the pathway coefficient from Type D to PCS change was not significant.
Regarding change in mental and physical HRFS, it can be seen that stable or
increased levels of anxiety largely explained no change/deterioration in mental
HRFS (direct effect = -.58**), while stable/increased levels of depression,
mostly explained no change/deterioration in physical HRFS (= -.55**).
Furthermore,
stable/increased
levels
of
depression
explained
no
change/deterioration in HRFS (= -.38**) and stable/increased levels of anxiety

explained no change/deterioration in physical HRFS (= -.33**). It is evident in
the model that Type D personality accounted for a significant change in
depression (= -.23**) and anxiety (= -.21**). Type D personality and no
change/deterioration in anxiety and depression explained 65% of the variance in
mental HRFS change, while 25% explained the variance of the change in
physical HRFS. These results appear to provide evidence to support the
hypothesized role of levels of no change/deterioration in anxiety and depression
as precursors of deterioration/no change in HRFS. They also serve to support the
mediating
role
of
personality
in
115
the
relationship
between
no
change/deterioration in psychological distress and no change/deterioration in

HRFS in cardiac patients.
Figure 2. A path model of type-d as predictor of poor change in anxiety and

depression as precursors of change in mental and physical HRQoL 6 months
after CABG. Depicted coefficients are all statistically significant at P=0.05
level, N=166,
2=5.79,
df=6, P=0.45, AGFI= 0.96, CFI=1.00, SRMR=0.039,
RMSEA=0.003
5.4 Discussion
In the current study, the majority of patients improved in their HRFS and
experienced a decrease in psychological distress between baseline (before CABG)
and six-month follow-up (after CABG), which is in line with the majority of
evaluation studies of CABG. Nevertheless, 20-30% of patients experienced no
improvement in HRFS following CABG5-7. The findings of the regression
analysis indicated that history of angina, increased level of anxiety and
depression were predictors of deteriorated HRFS18, although we expected other
variables like type D personality trait to be one the predictors, as it has been
pointed out in several studies to be associated to adverse cardiac events and
poor HRQoL following cardiac procedures27-30.
These findings lead us to using structural equation modeling to investigate an a
priori hypothesized model which posits that certain inherent traits (i.e.,
personality characteristics or temperament) predispose individuals to greater
severity
of
medical-psychiatric
morbidity
and
adverse
outcomes.
Deterioration/no change in anxiety and depression further mediated the

relationship between Type D personality and deterioration/no change in both
mental and physical HRFS six months after CABG. However, Type D was also
116
Chapter 5
directly associated with deterioration/no change in anxiety, depression and

mental, though not physical, HRFS.
Anxiety and especially depression are well-known CAD risk factors10 and
predictors of the course of the recovery process after MI56. Both indicators of
psychological distress are considered to have a negative effect on HRFS in
patients with CAD13,15-17, with depressive symptoms having a greater influence
compared to ejection fraction and ischemia17.
In CABG patients, others have also found that higher scores for depression were
predictors of no improvement in MCS6. In addition, depressive symptoms have
been shown to have a negative effect on HRFS regardless of successful medical
and surgical treatment55. Hfer et al.56 used structural equation modeling to test
a conceptual model of HRFS in coronary artery diseases. This conceptual model
was originally developed in 1995 by Wilson and Cleary 57, who proposed a
relationship between biomedical, individual and environmental factors and
HRFS. After testing the model, Hfer et al. found that depression and anxiety
symptoms exerted the most significant effect on HRFS. Others using
preoperative distress also found that the most predominant predictor of
deterioration in HRFS was distress levels prior to surgery22,58.
The results of the structural equation model, which was based on the model
presented by Hfer and colleagues56, shed further light on this inconsistency due
to our inclusion of personality factors. This showed that the relationship
between Type D and deterioration/no change in HRFS was in part mediated by
deterioration/no change in anxiety and depression, although Type D also had a
direct relationship to deterioration/no change in mental, though not physical,
HRFS. These findings add to our knowledge of the role of Type D personality in
patient-centered outcomes. There is now the likelihood that inclusion of both
Type D and its mediators (i.e., anxiety and depression) as potential predictors
will lead to Type D no longer being associated with outcome due to the fact that
mediators are also in the analysis30. In addition, these findings are inline with
the findings of other studies that found that Type D personality trait have an
effect on outcomes and HRFSs of patients with CAD or undergoing invasive
cardiovascular procedures25,27-32.
The results of the current study have some implications for research and clinical
practice. First of all, they show that despite the majority of patients
experiencing benefits in HRFS following CABG, a subgroup reports a
deterioration/no change over a six-month period. Patients at risk for
deterioration/no change in HRFS were not only those with angina and
deterioration/no change in psychological distress levels, but also those with a
Type D personality disposition. This subgroup is unlikely to have been identified
by traditional methods, such as looking at changes in mean scores over time.
117
Such an approach would mask intra-individual changes, whereas the approach

used in the current study (i.e., the effect size statistics) is independent of
measurement units and allows for comparing different outcomes35. In addition,
they can be applied both to group data and to those from a single patient36-38.
Others have used a different approach. For example, Mueller and colleagues21
simply tag negative signs of the change scores as indicators of deterioration,
while not taking into account that these negative scores may comprise trivial
changes (i.e., change found by random variation). In CAD patients, Hawkes et
al.5, as suggested by the SF-36 scoring manual, simply took for granted that an
individual five-point change over time in the eight subscales was clinically and
socially relevant. This was done despite the fact that (1) this five-point criterion
was based on an American sample assessed some thirteen years ago, that (2)
these five points were based on no clear definition of what constitutes a
clinically meaningful change and that (3) these five points were likely to be
biased by cultural and semantic differences between the original and translated
SF-3659,60.
The limitations of the study arise mainly from the fact that we lost
approximately 15% of the study sample at follow-up. A longer follow-up of up to
one year would have provided more information on the progression of
psychological distress and HRFS14,56.
The external validity of the study was not severely biased as no statistically
significant difference (p=.15, df=286) between the study sample and nonresponders was found with regard to age (mean age sample 64.8 9.96; mean
age non-responders 66.7 11.22). However, compared to the study sample, nonresponders differed on gender ( 2= 4.85, df=1, p=.03), with 33.3% female
patients who did not respond to the invitation to the study as compared to 21.2%
females who did respond. Compared to the study sample, dropouts at follow-up
did not differ on gender ( 2= 1.63, df=1, p=.20) and marital status ( 2=1.81, df=1,
p=.18), and no statistically significant difference (df=196; p=.45) was found on
age (mean age dropouts 66.1 10.09; mean age participants 64.59 9.95). The
strengths of the study come from the fact that we used standardized mean
differences between baseline and follow-up to classify subjects as stable,
improved or deteriorated and that we used widely accepted thresholds for effect
size.
In conclusion, our findings showed that, despite the majority of patients
experiencing improvements in HRFS following CABG, 20-30% of patients
experienced no benefits. These patients were more likely to have a history of
angina and to report deterioration/no improvement in levels of anxiety and
118
Chapter 5
depression post CABG. Knowledge of the predictors of deterioration/no change

in patient-centered outcomes such as HRFS, is important in order to optimize
care and the medical management of these patients, since poor HRFS has also
been associated with increased risk of mortality and morbidity in CAD
patients61,62. These patients should be identified at an early stage. This would
enable health care professionals to provide them with more emotional and
psychological support before and after surgery, and help them cope with the
postoperative period and improve their HRFS
119
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of health-related quality of life in coronary artery disease patients: a prospective study
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123
124
C HAPTER 6 L OW P OSITIVE
A FFECT I S A SSOCIATED WITH
M ORE H EALTH C OMPLAINTS
IN Y OUNGER B YPASS
P ATIENTS
Susanne S Pedersen PhD, Noha El Baz MSc, Berrie Middel PhD

Submitted
Low Positive Affect Is Associated with More Health Complaints in Younger Bypass Patients
126
Chapter 6
Chapter 6
Low Positive Affect Is Associated with More
Health Complaints in Younger Bypass Patients

A BSTRACT
Purpose
We examined the impact of positive affect (PA) and age on health complaints in
coronary artery bypass graft (CABG) surgery patients, using a prospective
design.
Methods
Consecutive CABG patients (n=161), completed the PA Global Mood subscale at
baseline and the Health Complaints Scale (HCS) at baseline and 6 months.
Results
Cognitive and somatic complaints (ps<.001) decreased over time. None of the
interaction effects for time x age, time x PA, or time x age x PA were significant
(ps>.05). Patients with low PA reported more cognitive complaints (p<.001), and
there was a trend for younger patients reporting more symptoms (p=.08). There
was also a significant interaction effect for age x PA (p=.02), with younger
patients with low PA scoring highest on cognitive complaints. Patients with low
PA also reported significantly more somatic complaints (p<.001); neither the
main effect for age (p=.17) nor the interaction effect for PA x age was significant
(p=.44). These results remained in adjusted analysis.
Conclusions
Low PA was associated with more complaints, with younger patients with low
PA reporting more cognitive complaints. Cardiac rehabilitation should not only
target negative emotions but also seek to increase PA, as poor self-reported
health is a predictor of adverse prognosis.
127
6.1 Introduction
Negative emotions have been shown to play an important role in the
pathogenesis of coronary artery disease (CAD), with the majority of research
having been devoted to the studying of the influence of depression. In patients
treated with CABG surgery, depression has been associated with reduced
improvement in health status following surgery1, less likelihood of returning to
work2, and increased risk of mortality and other cardiac events, including
readmissions3,4.
By contrast, little is known about the influence of positive affect in the context of
CAD, although a recent study of patients treated with percutaneous coronary
intervention (PCI) shows that reduced positive affect is an independent
predictor of adverse clinical events, with increased positive affect exerting a
strong protective effect5. Positive affect refers to feelings of joy and
cheerfulness6, and is not merely the opposite of negative affect, as people can
feel happy and sad at the same time7. Previously, positive affect has also been
related to cardiovascular disease-related pathways, including inflammation and
hypercortisolemia, in healthy subjects8,9. The studying of positive affect is
potentially important not only because positive affect may be protective of
adverse health outcomes, but also because patients are unlikely to recognize
themselves in terms of negative emotions alone. Hence, it may also be
worthwhile including a positive affect measure when evaluating the effects of
medical and behavioral interventions in cardiac patients rather than focusing on
a reduction in psychological distress alone10.
However, the effects of positive affect on health outcomes may be moderated by
age, such that positive affect may be more important in younger than in older
patients, given that they are faced with different life issues. Evidence from
studies of CABG patients suggests that younger patients may be more anxious
prior to CABG surgery and at higher risk of developing clinical depression
following surgery11-13. For the clinical management of CABG patients,
knowledge of the potentially moderating effect of age is important, given that
patients undergoing CABG surgery nowadays are generally older compared to a
decade ago14. Moreover, with the ageing of the population and more patients
surviving acute cardiac events, such as myocardial infarction (MI), the number
of older patients receiving a CABG procedure is likely to increase in the future15.
Hence, in the current study, we examined the impact of positive affect and age
on health complaints in CABG patients, using a prospective study design.
128
Chapter 6
6.2 Methods
6.2.1 Study population and design
Consecutive patients, undergoing CABG surgery (n=161; 80% males; mean (SD)
age=64.49 (10.09)), between April 2005 till September 2006 at the University
Medical Center Groningen and the HAGA Hospital in The Hague, The
Netherlands, comprised the study population for the current study. Patients
with other incapacitating diseases, cognitive impairments, aged 80 and older, or
who were not sufficiently proficient in Dutch to complete psychological
questionnaires were excluded.
An overview of patient selection for the current study is presented in Figure 1..
A postal survey was sent out at baseline (i.e., prior to surgery) and 6 months
after CABG to 256 patients. The response rate at baseline was 77.3% (198/256).
By comparing included patients with non-responders, no differences were found
between both groups except with regard to gender (
= 4.85, df=1; p=.03) with
33.3% vs. 21.2 % females, respectively. Compared with the study baseline
sample, drop-outs at follow-up did not differ systematically on gender ( 2=1.63,
df=1; p=.20) and marital status ( 2=1.81, df=1; p=.18) nor on mean differences
on age (66.1 10.09 vs. 64.59 9.95; df =196; p=.45). Given that we used a
prospective design, including only patients with complete questionnaire data at
both baseline and 6 months follow-up, analyses are based on 161 patients.
Ethical approval was obtained from the ethics committee of each participating
hospital. The study was conducted according to the Declaration of Helsinki, and
every patient provided written informed consent.
6.2.2 Measures
Information on demographic variables (i.e. age, sex, marital status, and
education) and smoking was obtained through purpose-designed questionnaires.
6.2.2.2 Clinical variables
Clinical variables comprised data on pre-operative and post-operative medical
and clinical characteristics, including NYHA class, unstable angina, recent
myocardial
infarction
(MI),
left
ventricular
ejection
fraction
(LVEF),
hypertension, chronic obstructive pulmonary disease (COPD), intermittent

claudication, renal disease, diabetes, neurological dysfunction, and length of
hospital stay. This information was retrieved from a registry database and used
for denoting a risk score according to the European System for Cardiac Risk
129
Figure 1. Flowchart of patient selection
Evaluation (EuroSCORE) additive model, with patients being categorized into

three risk groups: (1) low (additive score of 0-2), (2) medium (scores 3-5), and (3)
high risk (scores 3-5). The EuroSCORE is used for risk stratification purposes
and predicts early mortality in cardiac surgical patients16-18.
6.2.2.3 Positive affect
The positive affect subscale of the Global Mood Scale was administered prior to
surgery19. The 10-item subscale contains positive affect terms (e.g. Selfconfident and Hard-working) that are rated on a 5-point Likert scale ranging
from 0 (not at all) to 4 (extremely), with a score range from 0 to 40. A higher
score reflects more positive affect. The positive affect subscale is internally
consistent, with Cronbachs
ranging from .85-.9119-21. In addition, the GMS has
been shown to be sensitive to tap treatment-related changes in negative affect

and positive affect in cardiac patients21 and to be associated with stress,
depression, fatigue and quality of life in a working population22.
The Type D Scale (DS14) was administered prior to surgery to assess the
distressed (Type D) personality23. The DS14 is comprised of two normal and
stable personality traits, negative affectivity (e.g. I often feel unhappy; 7 items)
130
Chapter 6
and social inhibition (e.g. I am a closed kind of person; 7 items). Items are
answered on a 5-point Likert scale ranging from 0 (false) to 4 (true), with a score
range from 0-28 for both subscales. Type D caseness is determined by means of a
standardized cut-off 10 on both subscales23. The DS14 was developed in cardiac
patients and is a valid and reliable measure, with Cronbachs alpha of .88/.86
and 3-month test-retest reliability r=.72/.82 for the negative affectivity and
social inhibition subscales, respectively 23. A recent study in a large sample of MI
patients showed that Type D is a stable measure over an 18-month period, and
is not confounded by cardiac disease severity and measures of anxiety and
depression24.
6.2.2.5 Health complaints
The Health Complaints Scale (HCS) was administered twice, namely prior to
surgery and at 6 months follow-up25. The scale is a disease-specific measure
developed in cardiac patients, with the 12-item cognitive complaints subscale
representing health worry and illness disruption (e.g. The idea that I have a
serious illness) and the 12-item somatic complaints subscale representing
cardiopulmonary, fatigue and sleep problems (e.g. Tightness of the chest)25.
Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely),
yielding a score range from 0-48 for each subscale. A higher score reflects more
health complaints. The HCS has been shown to be a valid and reliable measure
both in Belgian and Danish cardiac patients, with Cronbachs alpha >.89 for
both subscales25, 26. The HCS is also a sensitive outcome measures for tapping
treatment and cardiac rehabilitation related changes27.
6.3 Statistical analysis
Prior to statistical analyses, we divided patients into two age groups, that is
young ( 70 years; n=105) vs. ( 71 years; n=56), as done by others28, using age as
a between-subjects variable for the analyses. Positive affect (PA) was also
dichotomized, using the lowest tertile to indicate low positive. Baseline
characteristics stratified by age were compared with the Chi-square test
(Fischers exact test when appropriate) for nominal variables and Students ttest for independent samples for continuous variables. Analysis of variance
(ANOVA) with repeated measures was used to examine changes in health
complaints, the effects of age, low PA and their interaction term over the 6month follow-up period. Analysis of covariance (ANCOVA) with repeated
measures was performed to adjust for potential confounders, entering the main
effects for age and PA, and the interaction effect for age x PA, and the covariates
gender1,29, having a partner13, education13, COPD1,28, angina pectoris (NYHA
class I-II vs. III-IV)30, length of hospital stay28, and smoking28 being selected as
131
covariates a priori on the basis of the literature. In addition, we included LVEF

50% vs. >50%) as a covariate to adjust for a measure of disease severity and
Type D personality to adjust for personality factors. In order to avoid duplication
of covariates in the adjusted analyses and given that analyses were stratified by
age and PA, we chose not to adjust for the EuroSCORE, since age and LVEF
both contribute to this risk score. A p-value of <.05 was used to indicate
statistical significance. All analyses were performed using SPSS 14.0 for
Windows (SPSS Inc., Chicago, Illinois, USA).
6.4 Results
6.4.1 Baseline characteristics stratified by age
Demographic and clinical baseline characteristics stratified by age are shown in
Table 1. Younger patients ( 70 years) were less likely to have COPD (6.8% vs.
18.2%; p<.03) and angina class III-IV (58.3% vs. 83.9%; p=.002), but more likely
to have a shorter hospital stay in connection with their CABG surgery (mean
9.33.7 vs. 11.57.4; p=.04) compared to older patients ( 71 years). As expected
given that age is used as a weight in the EuroSCORE, and hence that the
comparison
of
younger
versus older
patients
on the
EuroSCORE
is
contaminated by age, patients with high risk were more prevalent among older
patients ( 71 years) (53.6% vs. 12.4%; 95% CI: 26.7-55.7), whereas patients with
low risk were more prevalent among younger patients ( 70 years) (53.3% vs.
3.6%; 95% CI: 39.1-60.5). Age was not associated with medium risk (34.3% vs.
42.95; 95% CI: -24.4-7.3). No other systematic differences were found between
the two groups on baseline characteristics.
6.4.2
Effects
of
positive
affect
and
age
on
health
complaints
(unadjusted)
There was a significant decrease in cognitive complaints (F(1,157)=76.561;
p<.001) during the 6-month follow-up period. None of the interaction effects for
time x age, time x PA or time x age x PA were significant (all ps>.05). Patients
with low PA reported significantly more cognitive complaints than high PA
patients (Baseline: mean (SD)=22.80 (12.74) vs. 13.63 (9.46); 6 months: mean
(SD)=13.96 (11.42) vs. 6.66 (7.55); F(1,157)=21.729; p<0.001), and there was a
trend for age, with younger patients reporting more symptoms than older
patients (Baseline: mean (SD)=16.90 (11.87) vs. 15.52 (10.34); 6 months: mean
(SD)=9.42 (10.33) vs. 7.88 (7.63); F(1,157)=3.150; p=.08). The interaction effect
for age x PA was also significant (F(1,157)=5.520; p=.02), with younger patients
with low PA scoring highest on cognitive complaints (Figure 2a).
132
Chapter 6
There was also a significant decrease in somatic complaints (F(1,157)=52.452;

p<.001) during the 6-month follow-up period. None of the interaction effects for
time x age, time x PA or time x age x PA were significant (all ps>.05). Patients
with low PA also reported significantly more somatic complaints at both time
points (Baseline: mean (SD)=19.96 (11.39) vs. 12.06 (9.68); 6 months: mean
133
Figure 2. Cognitive complaints and somatic complaints stratified by age and

positive affect (unadjusted)
Figure 2a. Cognitive complaints
Figure 2b. Somatic complaints

134
Chapter 6
(SD)=12.22 (9.76) vs. 7.46 (6.81); F(1,157)=16.850; p<.001) compared to high PA

patients, but neither the main effect for age (p=.17) nor the interaction effect for
PA x age was significant (p=.44).
6.4.3 Effects of positive affect and age on health complaints (adjusted)
In order to ascertain that the influence of age and PA on health complaints
could not be attributed to demographic and clinical confounders and personality
factors, we ran ANCOVAs, entering age, PA, and the interaction effect age x PA,
gender, having a partner, education, COPD, angina pectoris, LVEF, smoking,
length of hospital stay, and Type D personality in the analyses.
In adjusted analysis, the results remained the same for cognitive complaints for
the within-subjects effects, with a significant decrease in complaints over time
(F(1,139)=4.993; p=.027) and with no significant interaction effects for neither
time x age, time x PA, time x age x PA nor any of the time x covariate
interaction effects (all ps>.05). The between-subjects effect for low PA
(F(1,139)=9.844; p=.002) and the age x PA interaction (F(1,139)=4.281; p=.04)
were still statistically significant. Other significant covariates were poor LVEF
(p=.002) and gender (p=.046).
For somatic complaints, the results related to all the within-subjects effect
remained unchanged compared to unadjusted analysis, with a significant effect
for time (F(1,139)=10.051; p=.002) and with no significant interaction effects for
neither time x age, time x PA, time x age x PA nor for any of the time x covariate
interaction effects (all ps>.05) apart for time x gender (F(1,139)=4.133; p=.044).
The between-subjects effect for low PA was still significant (F(1,139)=5.692;
p=.005), whereas age was now also statistically significant (F(1,139)=5.692;
p=.018) and the covariate gender (F(1,139)=8.927; p=.003). Poor LVEF was not
associated with somatic complaints (p=.30).
6.5 Discussion
To our knowledge, this is the first study to examine the role of positive affect on
health complaints in patients with CAD in general and in CABG patients in
particular. Results of our study show that patients experienced a general
improvement in self-reported health, as indicated by a decrease in both cognitive
and somatic health complaints at 6 months compared to prior to CABG surgery.
There were no statistically significant differences in complaints by age group,
but patients with low positive affect reported both more cognitive and somatic
complaints than patients with high positive affect. Younger patients with low
positive affect were particularly prone to report more cognitive complaints but
not somatic complaints compared to older patients with low positive affect. This
135
relationship was not found for somatic complaints. In addition, poor LVEF was
associated with increased cognitive complaints but not somatic complaints.
The studying of positive affect has generally been neglected in CAD, with the
primary focus being on negative emotions, in particular depression, and their
influence on health outcomes1-4. Preliminary evidence on positive affect in both
clinical and non-clinical samples suggest that positive affect may be protective of
adverse health outcomes, including mortality5 and poor quality of life31, and be
related to cardiovascular disease-related pathways, including inflammation and
hypercortisolemia7,8. To our knowledge, this is the first study to look at the
influence of positive affect in CABG patients. We found that low positive affect
was associated with both more self-reported cognitive and somatic health
complaints, adjusting for demographic and clinical characteristics, including left
ventricular dysfunction as a measure of disease severity, and Type D
personality. More importantly, positive affect was shown to moderate the effect
of age on cognitive complaints, with younger patients with low positive affect
scoring highest on cognitive complaints. This suggests that positive affect may
be particularly important in younger patients, perhaps since they are faced with
different life issues, including returning to work and having to support their
family. Younger patients have also been reported to be more anxious prior to
CABG surgery compared to older patients11.
In the current study, patients experienced an improvement in their symptom
profile following CABG, as indicated by a reduction in both cognitive and
somatic health complaints. This finding is consistent with the general CABG
literature, showing that patients experience a reduction in health complaints
and emotional distress and improvement in quality of life post CABG11,32-34.
These improvements seem to occur irrespective of age32,35, as also found in the
current study, although recovery may occur more slowly in older patients11,32 and
older patients may experience more complications leading to death and
disability32,36. In the current study, older patients also had a higher risk score,
as measured by the EuroSCORE compared to younger patients.
In clinical research and practice, adoption of a positive affect approach in
addition to studying the role of negative emotions is not only important because
positive affect may be protective of adverse health outcomes, as shown in this
and other studies5,31, but also because patients are less likely to recognize
themselves in terms of negative emotions alone10. Hence, including positive
affect in psychosomatic research may increase the study compliance rate, simply
because patients can identify with the questions being asked. Similarly, cardiac
rehabilitation should not only target negative emotions but also seek to increase
positive affect, as poor self-reported health is a predictor of adverse prognosis
and rehospitalization in patients with CAD and chronic heart failure but also in
136
Chapter 6
CABG patients37,38. If rehabilitation can enhance positive affect, this may lead to
a reduction in health complaints and improvement in quality of life and
subsequent prolonged survival. Importantly, our results show that enhancing
positive affect in younger patients may be particularly important, as they may
comprise high-risk patients for impaired quality of life despite having a better
clinical risk profile, as evidenced by a lower EuroSCORE in the current study.
For the clinical management of CABG patients, knowledge of their clinical risk
profile may therefore not be sufficient to identify high-risk patients, with
psychosocial factors including positive affect likely having added value. This
recommendation has also been posited by others4.
The results of the current study should be interpreted with some caution. First
of all, although reminders were sent at baseline for non-responders and at
follow-up for drop-outs, 23% of patients declined to participate at baseline and
12% dropped out during follow-up. Second, the sample comprised patients from
both a university and a peripheral hospital; since university hospitals might
serve different patient groups compared to peripheral hospitals, differences in
patient characteristics may have occurred after sampling. Therefore, differences
between
the
two
hospital
settings
in
patient
and
treatment-related
characteristics were analyzed. No statistically significant differences between

the two groups were found on demographic characteristics and the EuroSCORE.
Regarding postoperative events, there was a higher prevalence of re-exploration
for bleeding in the university hospital sample and a longer length of stay in
hospital following surgery. Third, we had no information on medication (both
cardiac and psychotropic) nor participation in cardiac rehabilitation and
whether patients were being treated by a psychologist or a psychiatrist, which
may serve as potential confounders on outcome. Fourth, clinical data were only
collected prior to surgery and not during the follow-up period. Therefore, we
were not able to examine the potential influence of changes in cardiac symptoms
during the follow-up period on health complaints at 6 months. Fifth, the followup period was relatively short, extending to only 6 months. Hence, the results of
this study should be replicated using a longer follow-up period. Finally, Type D
personality was not significantly related to health complaints in adjusted
analyses, which is contrary to the bulk of research on Type D as a risk indicator
for adverse health outcomes39. Part of the explanation may be attributed to the
low prevalence of Type D personality in the current study of only 11.8%, which
is far below that found in a larger study of CABG patients and in other studies
of patients with ischemic heart disease39.
However, this study also has some strengths, including its focus on positive
affect, which is novel in the context of CAD, its prospective design, the use of a
137
disease-specific outcome measure (i.e. the HCS), and the adjustment for
potential confounders both of a demographic, clinical, and psychological nature.
In conclusion, we found that low positive affect was associated with both
increased cognitive and somatic complaints in patients undergoing CABG
surgery, with particularly young patients with low positive affect reporting more
cognitive health complaints, despite younger patients compared to older patients
in general having a better clinical risk profile, as indicated by a lower
EuroSCORE. Since this is one of few studies having examined the influence of
positive affect in CAD patients in general and the first in CABG patients in
particular, future studies are warranted to confirm these findings. For now, the
findings suggest that adoption of a positive affect approach in research and
clinical practice may be worthwhile, in addition to focusing on negative
emotions, as positive affect seems to have added health benefits. In cardiac
rehabilitation, it may be particularly important to identify young patients with
low positive affect, as they reported more complaints than older patients or
younger patients with high positive affect. Given that negative affect and
positive affect seem to be independent constructs, with the possibility of both
emotions occurring at the same time within individuals6,7, it would be
inappropriate to assume that a reduction in negative emotions, which is one of
the primary targets of rehabilitation, necessarily would lead to increased
positive affect. Hence, particular focus on enhancing positive affect is required.
138
Chapter 6
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141
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C HAPTER 7
D ISCUSSION
General discussion
144
Chapter 7
Chapter 7
General discussion
In this final chapter the main results of the thesis are presented, followed by a
general discussion concerning the main objectives of the thesis and finally,
implications for practice, policy and further research are stated.
7.1 Research questions and main findings
7.1.1 Are the outcomes of CPs really evidence-based given the
methodological and statistical conclusion validity?
In Chapter 2 we report the results of a systematic review where we assessed the
methodological quality of 115 studies evaluating the outcomes of clinical
pathways. In that review we used an evaluation tool that we had developed
based on the Cochrane Library and other publications on quality assessment of
studies1-4. In relation to the main question, whether the outcomes of CPs can be
denoted as evidence-based practice, we found that the majority of the
publications on CP were classified as studies of low quality (67%). Regarding the
internal and external validity of the studies in this larger sample of articles,
most studies concerned non-randomly selected small patient populations
without using a power analysis5-21. Additionally, in half of the study sample
(49.6%), the inclusion and exclusion criteria of patients were obscure and
difficult to relate to the populations characteristics. Furthermore, only 12
retrospective studies (10.4%) controlled for selection bias by matching, out of
which three studies matched a random sample from a CP group with controls
from the pre-pathway period group17,19,22-31. Regarding the outcomes measured,
our analysis also revealed that most studies focused on cost issues and
reductions in Length of Stay (LOS), which were treated as independent
outcomes although they are strongly interrelated. In relation to the use of
appropriate statistical tests, more than half (59.1%) of the studies adopted
parametric statistical tests without question, but 40.9% tested variables on
normal distribution and, depending on the non normal distribution of the
outcome, used non-parametric tests. Beforeafter differences in frequently
measured outcomes such as LOS, costs, readmission and complications were
statistically tested in few of the studies. These studies used bivariate statistical
tests or multivariable techniques to decide whether differences between CP and
control groups were due to sample fluctuations, while other studies reported
differences without statistical tests.
145
General discussion
7.1.2 What is the difference between the CP group and the conventional
care group in relation to LOS, complications, readmission, HRQoL and
psychological distress?
In Chapter 3 we focused on the difference between the CP group and the
conventional care group in relation to LOS, complications, readmission, HRQoL
and, psychological distress. We also investigated the contribution of a CP
towards an improved HRQoL six months after CABG as compared to a
conventional care trajectory.
In the current study, we found that being in a pathway did not decrease LOS,
which subsequently led to no decrease in hospital costs, although patients in the
pathway group experienced a statistically significant reduction in hospital delay
(time between admission and operation). We also found that there was no
statistically significant difference between both groups in relation to the number
of patients exceeding eight days of stay in the hospital. Moreover, there was no
statistically significant difference between the two groups in relation to
discharge destination (i.e. discharge to home or to extended care facility),
attending a rehabilitation program after surgery, or readmission rate, in
addition, all readmissions were to the hospital where patients had surgery.
Improvement in HRQoL after CABG was realized in both groups (also for
patients, who had poor health status according to our cut-off criterion). We
found, however, that patients receiving conventional care improved relatively
more, as compared to pathway patients, for six of the eight sub-domains of SF36, but not for the domains of emotional role functioning and general health.
Accordingly, the conventional care group improved more on both the physical
and mental component summary. Regarding symptoms of depression, and
anxiety, there was no difference between groups in relation to depression levels,
but patients in the conventional care group decreased in anxiety relatively more
when compared to the pathway-group patients.
7.1.3 Does physical and mental HRQoL differ across classes of the
EuroSCORE assessed with self-reported SF-36 before and six months
after CABG and is the EuroSCORE a predictor of physical and mental
domains of HRQoL six after CABG?
In Chapter 4 the association between the EuroSCORE with self-reported
physical and mental HRQoL before and six months after CABG is described. We
posed the questions whether physical and mental HRQoL differ across classes of
the EuroSCORE, assessed with self-reported SF-36 before and six months after
CABG, and whether the EuroSCORE is a predictor of physical and mental
domains of HRQoL six months after CABG.
146
Chapter 7
Our main findings were that EuroSCORE was able to discriminate between
physical HRQoL at baseline and at follow-up. It was also found that patients in
a high-risk EuroSCORE class had poorer health at baseline and, despite their
improvement after CABG, they still had poor physical health at follow-up, as
compared to low-risk and medium-risk patients. Moreover, EuroSCORE was
able to detect statistically significant and clinically important differences
between low-risk and medium-risk vs. high patient-risk classes in: 1) the
average number of LOS from admission to discharge, and from operation to
discharge, and 2) in the number of perioperative complications.
In this study, we also found EuroSCORE predicted poor physical functioning,
but not poor mental functioning. Likewise, poor physical and mental HRQoL
was associated with several variables such as higher NYHA classes, readmission
after six weeks of discharge, longer LOS, current smoking, history of renal
insufficiency, re-exploration for bleeding and sternal re-suturing32-35.
7.1.4 What are the predictors of deterioration in HRQoL six months
following CABG and do symptoms of anxiety and depression mediate
the effect of type D personality on deterioration in HRQoL?
Despite the fact that the aim of CABG is to relief angina and improve HRQoL,
some patients do not experience this improvement in multi-item domains of
physical and mental HRQoL. Several studies investigated HRQoL after CABG,
and
most
of these
studies
reported
results
which
were
denoted as
improvement36-40. However, very few studies investigated no changes or

deterioration between baseline and follow-up41-43. This skewness may be
attributed to CABG being an effective treatment option for the majority of
patients. A subtraction of mean baseline scores from post-intervention scores
results in positive change scores, since the majority of change scores are on the
improvement side of the distribution. As a consequence, the minority of
observations found in the distribution of change scores, that are stable or have
deteriorated, is likely to be neglected.
Accordingly, Chapter 5 focuses on the predictors of deterioration in HRQoL six
months following CABG and whether anxiety and depression mediated the
effect of type D on deterioration in HRQoL using structural equation modeling
(SEM).
The main findings were that the majority of patients improved in their HRQoL
and experienced a decrease in psychological distress between baseline (before
CABG) and six-month follow-up (after CABG). Nevertheless, 20-30% of patients
experienced no improvement or deteriorated in HRQoL following CABG41-43.
The results of logistic regression showed that deterioration/no change in
Physical components summary (PCS) was associated with a history of angina
147
General discussion
and that patients with increased levels of anxiety and depression had a higher
risk of deterioration in physical and mental HRQoL. The SEM showed that
increased levels of anxiety and depression mediated the relationship between
Type D personality and deterioration/no change in both mental and physical
HRQoL six months after CABG. Type D personality and increased anxiety and
depression explained 65% of the variance in mental HRQoL change, and 25% of
the variance for change in physical HRQoL.
7.1.5 What is the impact of positive affectivity on cardiac-related health
complaints in CABG patients?
Our final research question is focusing on the impact of positive and negative
affectivity on cardiac-related health complaints in CABG surgery patients. We
examined the impact of positive affect (PA)44 and age on health complaints. Our
main findings were that cognitive and somatic complaints (p<.001) decreased
over time (the period between the point at preoperative assessment till 6 months
after surgery). None of the interaction effects for time x age, time x PA, or time x
age x PA were significant (p>.05). Patients with low PA reported more cognitive
complaints (p<.001), and there was a trend for younger patients reporting more
symptoms (p=.08). There was also a significant interaction effect for age x PA
(p=.02), with younger patients with low PA scoring highest on cognitive
complaints. Patients with low PA also reported significantly more somatic
complaints (p<.001); neither the main effect for age (p=.17) nor the interaction
effect for PA x age was significant (p=.44).
7.2 Discussion, methodological considerations, implications for practice
and research
The following section discusses the results of the five research questions
presented in this thesis concerning: (1) the methodological quality of CP
evaluation study (2) the effect of implementing CP for CABG patients, (2)
EuroSCORE as a predictor of poor HRQoL, (3) the factors contributing to
deterioration in HRQoL after CABG and (4), finally, the effect of positive
affectivity on cardiac related health complaints. We will also present the
strengths and limitations of the studies and the implications the findings have
regarding practice, and future research
7.2.1 Efficacy of clinical pathway
7.2.1.1 Discussion
The finding of our systematic review Chapter 2, showed that the main aim of
designing and implementing CPs is to decrease LOS and costs, whilst at the
148
Chapter 7
same time maintaining quality of care and improving patient outcomes such as
HRQoL. However, the findings of our controlled longitudinal study suggest that
these aims were not reached, as we found that there was no difference between
both groups in relation to LOS, complications, readmission, attending a
rehabilitation program and discharge destination.
As was demonstrated in many studies, improvement in HRQoL and
psychological distress is mainly due to CABG, and it was expected that the
implementation of the CP with all the included updated care protocols,
guidelines, and interactive patient education would further improve patients
health and satisfaction. However, in this is study our findings were not in line
with these expectations.
Recently, a study by Deyirmenjian and associates45 demonstrated that patient
education before CABG contributed to an increased level of anxiety, which is in
line with our results, since we found that the level of anxiety decreased more in
conventional care patients than in CP patients who received an interactive
educational session before surgery.
To further investigate whether there were new findings supporting our results,
we searched following the publication of our paper for the latest studies
investigating the effect of CP implementations. It is evident that little has
changed since we performed our review article46. From 2006 to 2008, the articles
investigating the effect of CP were mainly descriptive or pre-post studies in
different medical and surgical fields 47-64. Only three RCTs were found, one
evaluating a CP targeted at care of patients with pneumonia in nursing homes65,
the second investigating whether implementing a pathway decreases post
operative lung surgery complications54, while the third was investigating a
pathway designed for children with asthma/wheezes attending the hospital66.
Ironically, only the study of the CP in nursing homes investigated the effect on
patient related outcome, i.e. HRQoL and functional status, and found no
difference between patients who followed a conventional plan or CP regarding
LOS, readmissions, mortality rate, and costs also not regarding HRQoL and
functional status. These findings are in line with our longitudinal study of the
CABG pathways, as there was no difference between both groups regarding
LOS, discharge destination, complications and readmission, although we found
that patients in the conventional care plan gained more in their HRQoL. Our
results are also in line with the results of other controlled studies investigating
the effect of CP, which found that there was no difference between both groups
in relation to LOS, discharge destination67, and that patients in the conventional
care plan had a better HRQoL68.
More importantly, in our search we also found that in relation to cardiovascular
diseases, surgery and PCI, the studies that were recently conducted were cross
149
General discussion
sectional
studies,
conducted
with
independent
samples
before
CP
implementation and after50,53,56,58 or descriptive studies without control group

59;60,
and the outcomes mainly concerned LOS, costs ,readmission and patient
satisfaction. It is clear that there is a lack of randomized controlled studies that

evaluate intervention-related CPs longitudinally (comparing subjects after
CABG with their baseline status). Therefore, it was hard to compare our results
to other studies evaluating the effect of pathways, since these studies were
either descriptive studies59,60,69,70 or comparative studies, that lacked a control
for confounders18,71-75 or used no repeated measurement design.
7.2.2 The use of risk stratification model EuroSCORE
The risk stratification model EuroSCORE has been widely used76-78 to predict
mortality, morbidity, LOS, costs and complications after cardiac surgery. To our
knowledge, however, our study is one of the first few studies79-81 to investigate
the relation between EuroSCORE and HRQoL. Our main findings were that
EuroSCORE was able to discriminate between physical HRQoL at baseline and
follow-up. It was also found that patients in a high-risk EuroSCORE class had
poorer health at baseline and, despite their improvement after CABG; they still
had poor physical health at follow-up, as compared to low-risk and medium-risk
patients.
In the current study, we established that EuroSCORE was able to detect
statistically significant and clinically important differences between low-risk
and medium-risk vs. high patient-risk classes in average number of LOS from
admission to discharge, from operation to discharge, and in number of
perioperative complication. Most importantly, EuroSCORE was a predictor of
poor physical functioning six months after CABG.
To our knowledge, only three studies investigated the relationship between
EuroSCORE and HRQoL. In 2005 Peric and associates81 conducted a study to
determine the relationship between EuroSCORE and QoL changes six months
after CABG. They used the Nottingham Health Profile Questionnaire (NHP)
part 1 as the model for assessing HRQoL. They found a small statistically
significant correlation between EuroSCORE and the change in HRQoL only in
the section of energy (r=.27) which explained only 7% of the variance.
Additionally, they found, six months after CABG, that patients with a higher
EuroSCORE had higher improvement scores of HRQoL in the NHP-section of
energy. Finally, they concluded that EuroSCORE showed excellent results in the
early mortality prediction after CABG76-78,82, but it was obvious that
EuroSCORE
was
not
predictor
of
HRQoL
changes
after
CABG81.
Nevertheless, it is difficult to compare our findings with the findings of this
150
Chapter 7
study since they used a different measure with different components to measure
HRQoL.
Another study was conducted by Colak and colleagues79 in 2007, where they
studied the differences in HRQOL of patients before and after cardiac surgery,
and correlated the results with values of EuroSCORE. They used the Short
Form SF-36 health survey before surgery and 1 year after discharge, to assess
changes in QoL.
They found that the high-risk group of patients (EuroSCORE 6) were likely to
have a significant improvement in a greater number of health domains following
surgery than the low- and medium-risk group (EuroSCORE <6).
Finally, a study conducted by Loponen et al. in 200880 investigated whether
EuroSCORE is a predictor of HRQoL at six, eighteen and thirty six months after
CABG. They used the 15D, a non-disease-specific measure, to assess HRQoL83.
They used both logistic and additive EuroSCORE scoring methods, and found
that both the additive EuroSCORE and logistic EuroSCORE correlated
significantly with HRQoL at 6, 18, and 36- month, but were predictors of 15 D
only at 36 months follow-up. Furthermore, there was a similar clinically
significant increase in the 15D score among the risk groups at 6 and 18 months,
but tended to decrease towards 36 months in the medium- and the high risk
group. Regarding the predictive power of the EuroSCORE, they found that
EuroSCORE was associated with longer ICU stay, longer total hospitalization
and more complications.
Despite the fact that it is hard to compare the findings of these studies to our
study, because of different designs and tools that were used to measure HRQoL,
the previous findings only confirm our findings regarding the ability of
EuroSCORE to discriminate between low, medium and high risk classes
regarding LOS and number complications. Yet, we also add to the knowledge
that EuroSCORE is a predictor of physical functioning, but not of poor mental
functioning.
7.2.3 Predictors of deterioration after CABG
Our findings showed that, even though the majority of patients experienced
improvements in HRQoL, also referred to as health related functional status
(HRFS), following CABG, 20-30% of patients experienced no benefits in HRQoL,
which is in line with the findings of some other studies41-43. Currently, it is still
evident that, so far, little attention has been paid to deterioration, as after
performing a search for the latest articles relating to deterioration in HRQoL in
2007-2008, we found that a small number of articles mentioned the issue of
deterioration in HRQoL after CABG84-86. The study by Merkouris and colleagues,
used the MacNew Heart disease questionnaire to measure HRQoL at 4 and 12
151
General discussion
months post CABG and they found that around 19.6% of their sample
experienced deterioration. The second article by Charlson and associates85
evaluated patients using the SF-36 and found that functional deterioration
ranged between 31.6% and 29.6% in both the study groups undergoing cardiac
surgery.
Kapetanakis and associates84 used the SF-36 to assess HRQoL at 6 months after
on pump and off pump CABG, and found that 13.8% of patients in the off pump
method reported a decrease in their physical scores in comparison to 17.3% in
the on-pump CABG group. Regarding postoperative change in mental scores, 10.
3 % in the off-pump patients reported deterioration compared to 9.3%, reporting
deterioration in the on pump group.
Likewise, they found that hypertension and multivessel CAD were independent
predictors of worse physical scores, whilst diabetes was associated with an
improved sum physical component score after CABG regardless of the surgical
approach.
In our study, patients reporting deterioration in HRQoL were more likely to
have a history of angina and these patients also reported deterioration in levels
of anxiety and depression post CABG. Anxiety and especially depression are
well-known CAD risk factors87 and predictors of the course of the recovery
process after MI88. Both indicators of psychological distress are considered to
have a negative effect on HRQoL in patients with CAD89-92, with depressive
symptoms having a greater influence compared to ejection fraction and
ischemia92. In CABG patients others have also found that increased symptoms of
depression were predictors of no improvement in mental sum scores of the SF3642. In addition, depressive symptoms have been shown to have a negative
effect on HRQoL regardless of successful medical and surgical treatment93.
The results of the structural equation model highlighted the role played by the
Type D personality and the effect of anxiety and depression. The model showed
that the relationship between Type D and deterioration/no change in HRQoL
was mediated by deterioration/no change in anxiety and depression.
We also found that Type D had a direct relationship to deterioration/no change
only in mental and not physical HRQoL, but unexpectedly the results of the
multivariable logistic regression analysis showed that Type D personality was
not an independent predictor of deterioration/no change in HRQoL. This finding
is contradictory to previous studies of CABG patients and patients treated with
percutaneous coronary intervention (PCI) or an implantable cardioverter32,94,95
that identified Type D as an independent predictor of poor HRQoL.
However, the introduction of Type D personality to our model shed a light on the
interceding
effect
of
anxiety
and
depression
between
Type
and
deterioration/no change in HRQoL. This adds to our knowledge of the role of
152
Chapter 7
Type D personality and psychological distress as determinants of deterioration

in HRQoL as a patient-centered outcome.
It is also worthy to mention that in this study we used standardized mean
differences or effect sizes (ES) in case of statistical significance differences over
time between baseline and follow-up to classify subjects as stable, improved or
deteriorated and that we used widely accepted thresholds for effect size. The
later subgroup of deteriorated patients was unlikely to have been identified by
traditional methods, such as looking at changes in mean scores over time. Such
an approach would mask intra-individual changes, whereas the approach used
in the current study (i.e. the effect size statistics) is independent of
measurement units and allows for comparing different outcomes96. In addition,
ES can be applied both to group data and to those from a single patient97-99.
There have been other methods used to detect change, that are different from
our approach, as an example in the study of Mueller and colleagues100 showed,
where they simply tagged negative signs of the change scores as indicators of
deterioration, while not taking into account that these negative scores may
comprise trivial changes (i.e. change found by random variation).
In addition, a study by Hawkes et al., determining deterioration in CAD
patients41, used the suggestion of the SF-36 scoring manual, that an individual
five-point change over time in the eight subscales was clinically and socially
relevant. This was done despite the fact that (1) this five-point criterion was
based on an American sample assessed some thirteen years ago, that (2) these
five points were based on no clear definition of what constitutes a clinically
meaningful change and that (3) these five points were likely to be biased by
cultural and semantic differences between the original and translated SF-36101102.
7.2.4 Effect of positive affectivity on cardiac related health complaints

after CABG
This study was conducted to examine the role of positive affectivity (PA) on
health complaints in patients with CAD in general and in CABG patients in
particular. The study of PA has generally been neglected in CAD with the
primary focus being on negative emotions, in particular depression, and their
influence on health outcomes103-106.
As a consequence, little is known about the influence of positive affect in the
case of CAD. Although earlier PA has been related to cardiovascular diseaserelated pathways, including inflammation and hypercortisolemia, in healthy
subjects107,108. Currently, few articles addressed this issue109,110, for example the
role of positive affectivity was presented in a recent study of patients treated
153
General discussion
with PCI where decreased PA was found to be an independent predictor of

adverse clinical events, with increased PA exerting a strong protective effect110.
In our study, we found that low PA was associated with both increased cognitive
and somatic complaints in patients undergoing CABG surgery, with particularly
young patients with low PA reporting more cognitive health complaints, despite
younger patients compared to older patients in general having a better clinical
risk profile, as indicated by a lower EuroSCORE. These findings highlight the
effect of positive affectivity and age on cardiac related health complaints in
CABG patients; they show the importance of assessing positive and negative
affectivity of patients before surgery.
7.3 General methodological considerations
Several methodological issues relating to the studies presented in this thesis
merit further discussion and clarification including: the study sample, the
design, the assessment point and other general considerations.
7.3.1. Selection bias
Participants in this study were consecutive patients, undergoing CABG surgery
(n=168; 80% males; mean (SD) age=64.49 (10.09)), between April 2005 till
September 2006 at the University Medical Center Groningen (UMCG) and
HAGA Hospital in The Hague, The Netherlands. The criteria for exclusion were
incapacitating diseases, cognitive impairments, aged 80 and older, or
insufficient proficiency of Dutch language.
Thus, we included patients from both a university hospital (UMCG) and a
peripheral hospital (HAGA), which might have aroused questions regarding the
differences between the two populations. We tested for differences between both
groups and we found that no statistically significant differences between the two
groups on e.g. age, sex, and the EuroSCORE, but regarding postoperative
events, there was a higher prevalence of re-exploration for bleeding in the
university hospital sample and a longer LOS following surgery (Chapter 3 and
5).
At baseline, the pathway and conventional care group differed in terms of
marital status, level of education, receiving inotropic support and hours on
mechanical ventilation postoperatively. According to Cohens effect size w for
difference in proportions, these differences were small111. However, later we
matched CP and conventional care patients on EuroSCORE, age and sex at
group level.
Furthermore, (in Chapter 4) we used a regression analysis and included being in
a UMCG or a peripheral hospital as an independent determinant of HRQoL, and
we found that being a patient in the HAGA hospital or the UMCG was not a
154
Chapter 7
predictor of HRQoL. Additionally, we found that re-exploration for bleeding and

LOS were not found to predictors of HRQoL (physical component summary and
mental component summary of the SF-36), yet, re-exploration for tamponade or
bleeding was associated with vitality and mental health, which are two of the
components of the mental scale of the SF-36.
The response rate at baseline was 77.3% (198/256), and by comparing included
patients with non-responders, no differences were found between both groups
except with regard to gender ( 2=4.85, df=1; p=.03) with 33.3% vs. 21.2 %
females, respectively. Compared with the study baseline sample, drop-outs at
follow-up did not differ systematically on gender ( 2=1.63, df=1; p=.20) and
marital status ( 2=1.81, df=1; p=.18) nor on mean differences on age (66.1
10.09 vs. 64.59 9.95; df =196; p=.45).
7.3.2. The study design and assessment points
We used a longitudinal, quasi-experimental pre-test/post-test design to study
and compare clinical outcome, HRQoL, depression and anxiety for CP patients
versus conventional-care patients six months after CABG. A conventional
randomization procedure was considered inappropriate. Randomizing individual
patients (or surgeons) to either a CP or conventional care within the same
hospital invites contamination, because many of the same doctors, as well as
care staff, are involved in treating the same population of patients, which also
made blinding impossible.
Nevertheless, the assessment of patients outcomes was done in ignorance of the
method of care they were receiving. We therefore used a pre-pathway
implementation control group and applied the CONSORT criteria112-114 for the
reporting of randomized controlled trials finding this the best way to obtain
information from this study.
On the other hand, given that we used a prospective design, which is strongly
recommended for questions regarding prognosis, or etiology and harm115, we
only included patients with complete questionnaires at both baseline and 6
months follow-up. Thus, analyses were based on 168 patients.
Evaluating outcomes at six months time interval post CABG is criticized and
considered some what controversial and labeled as early phase116-118, however,
this criticism is mainly for detecting mortality and not HRQoL, as several
studies have evaluated HRQoL at six months and three months and detected
significant results40,119-125.
Regarding the study of deterioration and assessment of change, it is vital to
mention that in this study we used standardized mean differences or effect sizes
(ES) between baseline and follow-up to classify subjects as stable, improved or
deteriorated and that we used widely accepted thresholds for effect size, and
155
General discussion
only statistical significant changes overtime were expressed in standardized

mean differences and trivial scores of -.20 to .20 were classified as unchanged
after CABG.
Other studies used different methods100, where they simply tagged negative
signs of the change scores as indicators of deterioration, while not taking into
account that these negative scores may comprise trivial changes (i.e., change
found by random variation), or just used the suggestion of the SF-36 scoring
manual, that an individual five-point change over time in the eight subscales
was clinically and socially relevant41, but the limitation here was that a longer
follow-up of up to one year would have provided more information on the longterm progression of psychological distress and HRQoL126,127.
7.3.2.2. Information bias of tools and measures
With regards to the postal survey, we sent out at baseline (i.e., prior to surgery)
and 6 months after CABG to 256 patients, we were able to minimize nonresponse rate and missing values of scales by monitoring the completeness of the
questionnaires by checking that all the questions were answered at baseline as
well as at follow-up. If a page was not filled in, a copy was sent with a request to
please complete the questions or, if it concerned one or fewer questions, patients
were interviewed by telephone. Because the completeness of the questionnaire
was monitored by a computer program both at baseline and follow-up, we
effectively reduced the non-response on questions and, consequently, on scales.
The tools used in our study to assess different outcomes of patients have been
widely used and validated in several studies. The patients in our study were
classified as low, medium or high risk with the EuroSCORE (1) low (additive
score of 0-2), (2) medium (scores 3-5), and (3) high risk (scores 3-5). The
EuroSCORE have received some criticism about its validity in predicting
mortality, but it has been validated as risk stratification model that predicts
early76-78, and late mortality128-131, in addition to other related outcomes like
LOS, and complications132,133, costs134, and, recently, HRQoL79,81,135 in cardiac
surgical patients, and has been validated in different populations77,82,136,137 and
several studies80,128,130,138-148.
For evaluating QoL (also referred to as functional status), we used a generic
HRQoL measure (SF-36), which is also a valid, reliable and widely used generic
measure of HRQoL, that has been used in a myriad of studies investigating the
impact of CABG on HRQoL40,42,72,79,84,94,95,122,124,127,149. On the other hand, the
question may arise concerning the use of other disease specific tool, like the
Seattle angina questionnaire or The MacNew Heart Disease HRQoL
instrument, as they are more sensitive than generic tools150, but, unfortunately,
by the time we started our research, there was no validated Dutch version of
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these tools, but later the MacNew questionnaire was validated in the Dutch
population151.
As regards PD (anxiety and depression) we used the Hospital Anxiety and
Depression Scale (HADS)152. This measure of PD has been evaluated on its
psychometric quality in many (international study populations). The HADS is a
reliable and valid questionnaire, that performs well in screening for the separate
dimensions of anxiety and depression153, and has been used in several studies
investigating outcomes of CAD and CABG127,154-157.
Moreover, Type D Scale (DS14) was also administered prior to surgery to assess
the distressed (Type D) personality158. The DS14 is comprised of two normal and
stable personality traits, negative affectivity (e.g. I often feel unhappy; 7 items)
and social inhibition (e.g. I am a closed kind of person; 7 items). This measure
of psychological distress has been evaluated on its psychometric quality in
different populations including Danish and Dutch cardiac patient samples. A
recent study in a large sample of MI patients showed that Type D is a stable
measure over an 18-month period and is not confounded by cardiac disease
severity and measures of anxiety and depression159. Recently, the effect of Type
D on outcomes of CAD, PCI and CABG has been established in a number of
articles94,156,160,161.
Furthermore, PA was measured using the positive affect subscale of the Global
Mood Scale (GMS)44, which was administered prior to surgery. The GMS has
been shown to be sensitive to treatment-related changes in both negative and
positive affect in cardiac patients162 and to be associated with stress, depression,
fatigue and quality of life in a working population109, although is has been
neglected as a contributing factor that might be a factor associated with adverse
effects related to CAD or cardiovascular invasive procedures109,110 .
Lastly, the Health Complaints Scale (HCS), which is a disease specific measure
pertaining to cardiac complaints, was administered twice, namely prior to
surgery and at 6 months follow-up163. The scale is a disease-specific measure
developed in cardiac patients, with the 12-item cognitive complaints subscale
representing health worry and illness disruption (e.g. The idea that I have a
serious illness) and the 12-item somatic complaints subscale representing
cardiopulmonary, fatigue and sleep problems (e.g. Tightness of the chest)163.
The HCS has been shown to be a valid and reliable measure both in Belgian and
Danish cardiac patients163,164. The HCS is also a sensitive outcome measures for
tapping treatment and cardiac rehabilitation related changes155.
157
General discussion
7.4. Strengths and limitations

Each presented chapter had strengths and limitations, which we summarize in
this section.
In Chapter 3, the strength of this study lies in the fact that we compared
outcomes of a CP with a control group under conventional care and controlled
for potential confounders, namely age, gender and EuroSCORE, through
matching at group level. The limitations of the study lie in the fact that (1)
randomizing individual patients (or surgeons) to a CP or conventional care in
the same hospital was inappropriate, as this would induce contamination bias;
(2) at the start of the current study there was no controlled study that evaluated
the effects of CP on HRFS, which therefore made it impossible to perform a
power analysis.
In Chapter 4, where we investigative whether EuroSCORE was a predictor of
HRQoL after CABG. Despite of sending reminders the non-response rate at
baseline was approximately 23%, and compared to the study sample, nonresponders differed for gender, since more females declined to accept the
invitation to participate, which may have led to an under-representation of
females. The strengths of the study lie in the fact that non-responders and
excluded patients (excluded due to age over 80) did not differ from responders in
their demographic and clinical baseline characteristics. Moreover, during followup, as compared to the study sample, dropouts did not differ for age, gender or
marital status. In addition, we used the standardized SF-36 questionnaire,
which is an established measure to assess HRQoL
In Chapter 5, which addressed the predictors of deterioration in HRQoL, the
strength of the study is that we used standardized mean differences (ES)
between baseline and follow-up to classify subjects as stable, improved or
deteriorated with widely accepted thresholds for effect size, but the limitation
lies in the fact that a longer follow-up of up to one year would have provided
more information on the long-term progression of psychological distress and
HRQoL126,127.
In Chapter 6 concerning the role played by positive affectivity, although no
statistically significant differences between the two groups were found on
demographic characteristics and the EuroSCORE, in postoperative events, there
was a higher prevalence of re-exploration for bleeding in the university hospital
sample and a longer LOS in hospital following surgery. Furthermore, we had no
information regarding medication (both cardiac and psychotropic), nor
knowledge concerning participation in cardiac rehabilitation and whether
patients were being treated by a psychologist or a psychiatrist, which may serve
as potential confounders on outcome. Also, clinical data were only collected prior
to surgery and not during the follow-up period. Therefore, we were not able to
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examine the potential influence of changes in cardiac symptoms during the

follow-up period on health complaints at 6 months. Moreover, the follow-up
period was relatively short, extending to only 6 months. Hence, the results of
this study should be replicated using a longer follow-up period. Yet, this study
also has some strengths, including its focus on positive affect, which is new in
the field of CAD, its prospective design, the use of a disease-specific outcome
measure (i.e. the HCS), and the adjustment for potential confounders both of a
demographic, clinical, and psychological nature.
7.5 Implications for practice and research.
The findings of this thesis have implications for both practice and research
7.5.1 Implications for clinical and nursing practice
Due to the multidisciplinary nature of CPs the results of this study have
implications for policy, practice and health care personnel involved in health
care planning, coordination and delivery, i.e. cardiac surgeons, case managers,
critical care/cardiothoracic surgery nurses, and cardiologists. The designing and
implementation of CPs is carried out by the multidisciplinary team, but nurses
play a major role in implementing the pathway, delivering patient education
and preparing patients for discharge. In addition, nursing case managers are
responsible for coordinating the planning and designing of pathways. It is
particularly of importance for nurses and health care personnel, involved in
delivering care to CABG surgery patients, to recognize the factors affecting the
outcomes of these patients. Therefore, we recommend that implementations of
pathways should not be for the sole purpose of decreasing LOS and costs, but
rather focus on improving quality of care by designing the pathways to be based
on acuity of illness, i.e. different pathways for low, and high risk patients, as it
was found that pathways are more successful in younger patients with lower
severity of illness50,165-167.
We previously stated that pathways were judged to be mainly addressing the
ideal patient46,168, who would fit perfectly into the plan and reach the designed
goals without deviation. Thus, we agree with the view pointing out that
pathways are more expected to be useful when implemented in areas of lower
severity/complexity of illness, or patients who are not psychologically stressed,
because pathways tend to be somewhat nonflexible and leaning toward patients
with the expected course of care i.e. the ideal patient, they may not work well
where care is more variable, and challenging setting as the Intensive care unit,
or an emergency unit46,165,167.
Moreover, patient-related characteristics and psychological status should be
taken into consideration, which may require a health-psychologist to become a
159
General discussion
routine member of the pathway team and incorporate protocols, that tend to
manage anxiety and/or depression related to illness or pending surgery.
Another issue that is worthy to mention is that the educational material and
patient education program or interactive sessions should take into consideration
patients level of education, socioeconomic status and anxiety level, as in our
study there was over-representation of patients with elementary schooling
compared to patients in the conventional care groups, which might explain why
patients in the pathway group experienced higher anxiety levels than patients
in the conventional care group45.
EuroSCORE and HRQoL
The significance of our findings in Chapter 4 lie in the fact that poor physical
functioning is a reflection of perceived limitation in performing all physical
activities, such as having difficulties bending, stooping or lifting light objects,
lifting heavy objects, climbing stairs, walking a (long) distance, bathing or
dressing. Such a finding has an implication for clinical practice and for the role
of health care personnel, including cardiologists, cardiac surgeons and nurse
practitioners. This is because, although the development of risk models has led
to the appropriate selection of patients for CABG, there are limited data
available to help clinicians to predict which patients will experience an
improved HRQoL after CABG. The findings of our study indicate that
EuroSCORE can be used to predict health status after CABG, which will help
communicate to patients what level of improvement can be expected after
surgery. Risk stratification is an essential component of optimizing care in
terms of recommending the most appropriate treatment strategy along with
efficient patient and family counseling169. It should be feasible to include the
assessment of HRQoL in clinical practice, and we recommend that, in order to
provide patient-centered care with effective counseling, self-reported HRQoL
must be considered as part of, and integrated into, the process of diagnosis and
management of the patients illness.
Predictors of deterioration
These findings have a significance to practice, as the knowledge of the predictors
of deterioration/no change in patient-centered outcomes, such as HRQoL, and
the role played by anxiety, depression and Type D personality is important in
order to optimize care and the medical management of these patients. Poor
HRQoL has also been associated with increased risk of mortality and morbidity
in CAD patients170,171. These patients should be identified at an early stage. This
would enable health care professionals to provide them with more emotional and
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psychological support before and after surgery, and help them cope adequately
with the postoperative period and improve their HRQoL.
Positive affectivity and health complaints
The findings of this study have implications for practice as cardiac rehabilitation
should not only target negative emotions, but also seek to increase positive
affect, as poor self-reported health is a predictor of adverse prognosis and rehospitalization in patients with CAD. If rehabilitation can enhance positive
affect, this may lead to a reduction in health complaints and improvement in
QoL and subsequent prolonged survival.
7.5.2 Implications for future research
Clinical pathways evaluation
In relation to future research there is a great need for more multicenter RCTs,
since it is evident that the increased trend of using pathways is still disputed as
very little controlled data confirmed their efficiency. Moreover, it is of
importance to incorporate important outcomes as HRQoL, functional status and
psychological distress as part of the pathway evaluation.
Incorporating HRQoL and psychological distress measurement, as part of a
routine assessment of patient health, both pre- and postoperative, which can be
easily done by cardiothoracic surgery nurse, will provide a clear view of the
patients perception of his physical functioning and mental health, which will, in
turn, have a great impact on planning care before and after surgery, which
might, subsequently, improve HRQoL.
EuroSCORE and HRQoL
Future research is required with a larger sample and there is a need to assess
the difference between a disease-specific measure, e.g. The cardiac Health
Complaints Scale (HCS), and a generic measure, e.g. SF-36 or Nottingham
health profile, in predicting QoL of CABG patients stratified by risk-class, in
order to compare the relative validity of these measures150.
Deterioration after CABG
In relation to future research, more studies with a longer follow-up are required
to investigate the role played by PD and Type D personality and their effect on
HRQoL of CABG patients.
161
General discussion
Positive affectivity and health complaints

Regarding future research, clinical data should be collected prior surgery and
during the follow-up period, in order to examine the potential influence of
changes in cardiac symptoms during the follow-up period on health complaints
and we also recommend a longer follow-up period. It is also important to adopt a
PA approach in clinical research and practice, and not just study the role of
negative emotions, because patients are less likely to recognize themselves in
terms of negative emotions alone. Thus, including PA in psychosomatic research
may increase the study compliance rate, simply because patients can identify
with the questions being asked.
7.6. General conclusion
This thesis is aimed at presenting the different factors affecting HRQoL after
CABG in the frame of the conceptual model based on the model of Wilson and
Cleary and the modifications of Spertus172 and Rumsfeld173. We presented the
effect of an environmental factor, i.e. care in the hospital setting in Chapter 3,
which was mainly concerned with the effect of implementing the CP. Then, the
effect of risk factors and clinical variables were shown in Chapter 4, while the
effect of personality traits and PD were presented in Chapter 5 and, finally, we
investigated the effect of PA on cardiac specific health complaints Chapter 6.
Regarding the use of risk stratification models, it is clear that they can be used
to predict other outcomes of patients and not just mortality, and that using risk
stratifications models to predict HRQoL should become incorporated in the
routine preoperative assessment of patients. Furthermore, attention should be
paid to all the factors associated with deterioration in HRQoL, including factors
that were ot fully investigated, as anxiety, depression, personality traits Type D,
positive and negative affectivity, using disease-specific measures, such as
cardiac-related health complaints scale.
The main issue is that pathways were originally designed to decrease LOS in
order to decrease the costs associated with hospital stay, but it was not the case
here; LOS did not decrease and the causes can be attributed to patients
(occurrence of complications) or can be attributed to organizational factors as
the health insurance system in the Netherlands is different from the US, and
the way that health insurance companies reimburse health care facilities is also
somewhat different, and that might be a reason why the decrease in LOS could
not be detected.
On the other hand, the CP system might be successfully implemented in
Egyptian governmental, university and health insurance hospitals, where
CABG is performed, as it is a very expensive procedure, as the government
covers the costs of surgery and patient care. It is obvious that more controlled
162
Chapter 7
studies with a larger sample is needed to detect the effect of CP on

organizational and economical outcomes.
Finally, self reported HRQoL measures are strong and valuable outcome, that
reflect and evaluate the effect of CABG and methods of care delivery, and we
strongly recommend that it should be incorporated in the routine assessment of
patients before and after surgery, as it is a reflection of patients perception of
their own health. Such research is needed specially in the field of critical care
nursing, as it is beneficial in detecting the effect of critical illness, complicated
procedures and care on outcomes of critically ill patients.
163
General discussion
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General discussion
176
S UMMARY
Summary
178
Summary
Summary
This thesis reports on the evaluation of the effect of implementing a coronary
artery bypass graft (CABG) clinical pathway (CP) on various patients outcomes,
including length of stay (LOS), readmission, complications, health-related
quality of life (HRQoL) and psychological distress (PD). This study also reports
on the role played by the EuroSCORE in discriminating between low, medium
and high risk patients in relation to physical functioning, LOS, and number of
complications. In addition, we present in this study the predictors of
deterioration in HRQoL after CBAG and the role played by Type D personality
and the mediating effect of change in anxiety and depression, leading to a
deterioration in HRQoL. Finally, this study depicts the impact of positive
affectivity and age on cardiac-related health complaints in CABG surgery
patients.
Chapter 1 is a general introduction, presenting an overview of the current
study which reports on the aspects that affect the outcome of CABG,
particularly those patients undergoing care in a CP. The outcomes investigated
are LOS, readmission and complications and outcomes that were rarely
examined, when evaluating the effects of CABG pathways, like HRQoL and PD,
i.e. anxiety and depression.
In Chapter 1, the central concepts of this study are introduced based on a
conceptual model of Wilson and Cleary, 1995, and the modifications of Spertus et
al., 2002 and Rumsfeld, 2002. Within the framework of this study the model
depicts the factors that affect the outcome of CABG, namely HRQoL and
Cardiac health complaints. These factors were identified as individual and
demographic characteristics, personality traits, psychological status, positive
affectivity, clinical variable and environmental factors, i.e. care in a pathway
program.
Over the last few decades, HRQoL has become increasingly important in
evaluating healthcare outcomes. This thesis had therefore the following
objectives:
To perform a systematic review in order to analyze the main effects of
implementation of clinical pathways and to evaluate the validity of study
outcomes of published papers that report effects of CPs.
To determine the difference between CP and conventional care in terms of
patient related outcome, as well as to determine the relative contribution of CP
towards an improved HRQoL and psychological distress after CABG.
179
Summary
To determine whether the EuroSCORE is associated with patients outcomes

before and six months after CABG and whether EuroSCORE is a predictor of
HRQoL six months after CABG.
To identify predictors of deterioration in HRQoL six months following CABG
and to test a hypothesized model of the determinants of no change/deterioration
in HRQoL using structural equation modeling.
To examine the impact of positive affectivity on cardiac related health
complaints in CABG surgery patients.
Chapter 2 reported on the validity of study outcomes of published papers that
report effects of CPs. We performed a systematic review based on two search
strategies, including searching Medline, CINAHL, Embase, Psychinfo and
Picarta from 1995 till 2005 and ISI Web of KnowledgeSM. We also included
randomized controlled or quasi-experimental studies evaluating the efficacy of
CP application. Assessment of the methodological quality of the studies included
the utilization of: randomization, power analysis, selection bias, validity of
outcome indicators, appropriateness of statistical tests, and indirect (statistical)
control for confounders. Outcomes included LOS, costs, readmission rate and
complications. Two reviewers independently assessed the methodological quality
of the selected papers and recorded the findings with an evaluation tool
developed from a set of items for quality assessment derived from the Cochrane
Library and other publications. The study sample comprised of 115 publications
out of 556 publications after applying inclusion and exclusion criteria. A total of
91.3% of the studies comprised of retrospective studies and 8.7% were
randomized controlled studies. Using a quality-scoring assessment tool, 33% of
the papers were classified as of good quality, whereas 67% were classified as of
low quality. Of the studies, 10.4% controlled for confounding by matching and
59.1% adopted parametric statistical tests without testing variables on normal
distribution. Differences in outcomes were not always statistically tested. Our
main conclusion is that researchers and health care professionals should be
cautious when interpreting the results of CP evaluation studies, because of the
confounding factors and sources of contamination affecting the evidence-based
validity of the outcomes.
Chapter 3 depicts the difference between CP and conventional care in terms of
clinical outcomes, HRQoL domains, depression, and anxiety, as well as to
determine the relative contribution of CP towards an improved HRQoL after
CABG. We conducted a longitudinal quasi-experimental using a pre-test/posttest design to study and compare clinical outcome, HRQoL, depression, and
anxiety for CP versus conventional care patients after CABG. HRQoL was
180
Summary
measured using SF-36, whilst depression and anxiety were measured using
Hospital anxiety and depression scale. LOS and patient complications were
derived from the hospital database. We found that implementing a CP
significantly decreased hospital delay, but did not decrease neither overall LOS
nor readmission rates. We also found that patients in the conventional care plan
improved more than patients in the CP in HRQoL. Outcomes in favor of patients
in the conventional care trajectory were based on the difference between small
ES ( .20 <.50) for pathway patients and moderate ES ( .50 <.80) for
conventional care patients, except for the domain of physical functioning and
physical component summary, where the ES for conventional care was large
(>.80). Our main conclusion was that, despite the fact that the aim of designing
and implementing pathways is to decrease LOS, and costs, while maintaining
quality of care and improving patient outcomes, our findings suggest that these
aims were not fulfilled in this CABG pathway. We recommend that, when
designing a CP, the multidisciplinary team including nurses and nurse case
managers, responsible for coordination and implementation, should take into
consideration all patient-related characteristics, risk indicators, along with
physiological status.
Chapter 4 presented whether EuroSCORE as a risk indicator is associated with
pre-operative HRQoL, and whether it is a predictor of mental and physical
HRQoL six months after CABG. We conducted a longitudinal observational
study among 181 patients who underwent CABG. Physical and mental domains
of HRQoL were measured using SF-36 and risk stratification was estimated
using the EuroSCORE. A post hoc test (with Bonferroni correction) was used to
determine whether EuroSCORE was associated with preoperative HRQoL, LOS
and postoperative rate of complications. Hierarchical regression analysis was
performed to explore the associations between EuroSCORE, postoperative
events and postoperative HRQoL. We found that EuroSCORE is associated with
physical functioning before and after CABG and a higher EuroSCORE is a
predictor of poor physical functioning and not a predictor of the mental domains
of quality of life, while smoking predicted bodily pain after CABG. Furthermore,
readmission within six weeks after discharge was a predictor of poor physical
functioning, physical role and general health. Moreover, post hoc tests showed
statistically significant and clinically relevant differences in physical functioning
between low-risk and high-risk EuroSCORE classes, and between medium and
high classes at baseline and six months after CABG. High-risk patients had
more peri-operative complications and longer lengths of stay, as compared to
low-risk patients. Our main conclusion is that EuroSCORE can discriminate
between low, medium and high risk classes regarding LOS, physical functioning
181
Summary
and number of complications. Furthermore, EuroSCORE is a predictor of poor

self-reported physical functioning six months after CABG and is not a predictor
of mental functioning.
Chapter 5 reported on the predictors of deterioration in HRQoL six months
following CABG and the test of a hypothesized model of the determinants of no
change and deterioration in HRQoL using structural equation modeling. We
used a multivariable logistic regression analyses to examine the association
between patient demographic characteristics, medical history, clinical data,
psychological distress and HRQoL. We used the structural equation modeling
(SEM) technique with LISREL to test the tenability of this model, as well as an
elaboration of regression analysis. The model used change in anxiety and
depression as predictors of change in HRQoL, as well as the role Type D plays in
this change.
The results of logistic regression showed that deterioration/no change in PCS
was associated with a history of angina and that patients with increased levels
of anxiety and depression had a higher risk of deterioration in physical and
mental HRQoL. The SEM showed that increased levels of anxiety and
depression mediated the relationship between Type D personality and
deterioration/no change in both mental and physical HRQoL six months after
CABG. Type D personality and increased anxiety and depression explained 65%
of the variance in mental HRQoL change, and 25% of the variance for change in
physical HRQoL. Our main conclusion is that, despite the fact that the majority
of patients experienced improvement in HRQoL following CABG, some patients
experienced no change or deterioration in their HRQoL. Our results outlined the
role played by personality Type D, anxiety and depression in predicting
deterioration in HRQoL six months after CABG.
Chapter 6 presented the impact of positive affect (PA) and age on health
complaints in CABG surgery patients, using a prospective design. We included
consecutive CABG patients (n=161), completed the PA items of the Global Mood
subscale at baseline and the Health Complaints Scale at baseline and 6 months.
The main findings of this chapter are that cognitive and somatic complaints
decreased over time. Patients with low PA reported more cognitive complaints,
and there was a trend for younger patients reporting more symptoms. There was
also a significant interaction effect for age x PA with younger patients with low
PA scoring highest on cognitive complaints. Patients with low PA also reported
significantly more somatic complaints; neither the main effect for age nor the
interaction effect for PA x age was significant. These results remained in the
adjusted analysis. Our main conclusion is that low PA was associated with more
complaints, with younger patients with low PA reporting more cognitive
182
Summary
complaints. Cardiac rehabilitation should not only target negative emotions but
also seek to increase PA, as poor self-reported health is a predictor of adverse
prognosis.
Implications for clinical and nursing practice
This study has implications for policy, practice and health care personnel
involved in planning, coordination and delivery of care, i.e. cardiac surgeons,
case managers, critical care/cardiothoracic surgery nurses and cardiologists. The
designing and implementation of CPs is carried out by the multidisciplinary
team, but nurses play a major role in implementing the pathway, patient
education and preparing patients for discharge. In addition, case managers are
responsible for coordinating the planning and designing of pathways. It is
particularly of importance for nurses and health care personnel, involved in
delivering care to CABG surgery patients, to recognize the factors affecting the
outcomes of these patients and incorporate quality of life and psychological
distress measures into the routine patient assessment protocols.
Recommendations for practice and research
1. More (randomized) controlled studies should be conducted, in which patients
are randomly assigned to the condition of either a pathway or standard
procedure. However, such randomized controlled studies in the same hospital
invite contamination, because many of the same doctors, as well as care staff,
are involved in treating the same population of patients. To avoid such
Hawthorne
effects,
we
suggest
establishing
multi-centre
trials
with
randomization after pre-stratification of confounding factors (e.g. gender, comorbidity) with a clearly defined method of randomization, concealment of
allocation or blinding with the appropriate balancing method.
2. Standardization of the total direct costs is specified by clearly defined cost
components and a standardized operational definition of LOS. LOS should not
be confined to the hospital setting, but should be extended to include whether
patients are discharged home or to an extended health care facility, and should
include whether this is a permanent or temporary arrangement. An accurate
calculation in this case will reflect the true effect of clinical pathways on LOS
and subsequent related costs
3. More attention should be paid to measuring relevant patient outcomes, such
as quality of life, hospital anxiety, patient expectations and satisfaction with
standardized validated tools, which reflect the true effect with use of
appropriate statistical methods.
4. When designing a clinical pathway, all patient-related characteristics, risk
indicators, along with physiological status, be taken into consideration.
183
Summary
5. Pathways should be designed and length of stay set based on patients acuity
of illness and a follow-up period should be added for these patients in order to
ensure optimum outcome.
6. Incorporating HRQoL and psychological distress measurement as part of a
routine assessment of patient health, both pre- and postoperative, which can be
easily done by cardiothoracic surgery nurse, since this will provide a clear view
of the patients perception of his physical functioning and mental health, which
will, in turn, have a great impact on planning care.
7. More research is needed with larger number of patients to examine the
relationship between EuroSCORE, health related quality of life and other
clinical outcomes, which will help provide patient-centered care with effective
counseling, regarding patient expectations after surgery.
8. Further research is required regarding the role played by psychological
distress and Type D personality and there effect on the HRQoL of CABG
patients.
9. In future research clinical data should be collected not just prior surgery, but
also during the follow-up period, in order to be able to examine the potential
influence of changes in cardiac symptoms during the follow-up period on health
complaints, and we also recommend a longer follow-up period.
10. Adoption of a positive affect approach clinical research and practice, and
studying the role of negative emotions, because patients are less likely to
recognize themselves in terms of negative emotions alone. Thus, including
positive affect in psychosomatic research may increase the study compliance
rate, simply because patients can identify with the questions being asked.
11. Cardiac rehabilitation should not only target negative emotions, but also
seek to increase positive affect, as poor self-reported health is a predictor of
adverse prognosis and re-hospitalization in patients with CAD. If rehabilitation
can enhance positive affect, this may lead to a reduction in health complaints
and improvement in quality of life and subsequent prolonged survival.
184
S AMENVATTING
Samenvatting
186
Samenvatting
Samenvatting
Dit proefschrift doet verslag van de evaluatie van de effecten van implementatie
van een clinical pathway of een klinisch pad voor patinten, die een coronary
artery bypass graft (CABG) ondergaan. Ook worden de effecten van een CABG
onderzocht zonder rekening te houden met het ingerichte klinische pad. Bij de
evaluatie van het klinische pad staan als uitkomstmaten opnameduur,
heropname, complicaties, symptomen van angst en depressie en de ervaren
lichamelijke en mentale gezondheidstoestand centraal. Bij de bestudering van
de longitudinale effecten van CABG op de ervaren gezondheidstoestand wordt
de rol van persoonlijkheid in relatie tot angst en depressie geanalyseerd. Deze
studie doet ook verslag van de predictieve waarde, die de risicofactor, gemeten
met de EuroSCORE, heeft op het fysiek functioneren na de CABG, op de
opnameduur en op het aantal complicaties. In aanvulling daarop is onderzocht
of verandering in symptomen van angst en depressie op baseline en 6 maanden
na CABG voorspellers zijn van verslechtering in ervaren gezondheidstoestand
en welke rol type D persoonlijkheid hierin speelt. Tenslotte beschrijft dit
proefschrift de impact van positieve en negatieve affectiviteit op cardiaalgerelateerde gezondheidsklachten bij CABG-chirurgie patinten.
Hoofdstuk 1
Hoofdstuk 1, een algemene introductie van dit proefschrift, geeft een uitgebreid
overzicht van het theoretische kader, de gemeten concepten en klinische
variabelen, die toegepast zijn in deze studie. Dit hoofdstuk gaat in op aspecten,
die van invloed zijn op de uitkomst van een CABG-behandeling, in het bijzonder
bij patinten, die verzorgd zijn binnen het klinische pad (KP). De onderzochte
uitkomstvariabelen in relatie tot de effecten van het KP waren opnameduur,
heropname en operatie-gerelateerde complicaties, alsook uitkomstvariabelen,
die slechts zelden werden onderzocht bij de evaluatie van de effecten van een
CABG-pad, zoals ervaren lichamelijke en mentale gezondheidstoestand en
symptomen van angst en depressie.
In hoofdstuk 1 worden deze centrale concepten van de studie gentroduceerd,
mede gebaseerd op het conceptuele model van Wilson and Cleary, 1995, en de
aanpassingen daarop van Spertus et al., 2002, en Rumsfeld, 2002. Binnen het
kader van deze studie beschrijft het model factoren, die van invloed zijn op de
uitkomst
van
een
CABG-behandeling,
namelijk
fysieke
en
mentale
gezondheidstoestand, zoals gemeten met de SF-36 en cardiaal-gerelateerde

gezondheidsklachten, gemeten door de thoraxchirurg. Daarnaast werden
factoren in het model opgenomen als individuele en demografische kenmerken
(geslacht, leeftijd, opleidingsniveau), persoonlijkheidskenmerken (Type-D),
187
Samenvatting
psychologische status, w.o. angst en depressie (HADS), en vitale uitputting

(Maastrichtse Vragenlijst Vitale Uitputting), positieve en negatieve affectiviteit
en global mood.
Dit proefschrift had daarom de volgende doelstellingen:
Uitvoeren van een systematische review om de belangrijkste effecten van de
implementatie van klinisch paden te analyseren en het evalueren van de
validiteit van de uitkomsten van gepubliceerde studies, die rapporteren over
effecten van klinische paden.
Vaststellen van verschillen tussen patinten, die een CABG in een KP en in
een traject van conventionele zorg ondergingen, met betrekking tot verschillende
domeinen
van
lichamelijke
en
mentale
gezondheidstoestand,
alsmede
symptomen van angst en depressie. Tevens werd de relatieve bijdrage van een
KP geschat ten opzicht van de bijdrage van het conventionele CABG-traject.
Hiertoe werden van de statistisch significante verschillen tussen baseline en
follow-up effect sizes berekend als indicator van de omvang van de verbetering
in ervaren gezondheid en symptomen van angst en depressie.
Vaststellen of de EuroSCORE is geassocieerd met patintenuitkomsten. Zowel
vr als zes maanden na CABG en werd onderzocht of de EuroSCORE een
voorspeller is van de ervaren lichamelijke en mentale gezondheidstoestand zes
maanden na CABG.
Identificeren van voorspellers van de niet-beoogde uitkomst van CABG,
namelijk gelijkblijvende ervaren gezondheidstoestand of een verslechtering
hierin zes maanden na CABG en toetsen van een hypothetisch model van de
determinanten van deze uitkomst met behulp van structural equation modeling
(LISREL).
Bestuderen van de impact van positieve affectiviteit op cardiaal-gerelateerde
gezondheidsklachten bij CABG-chirurgie patinten.
Hoofdstuk 2
Hoofdstuk 2 beschrijft een systematische review, waarin verslag wordt gedaan
van de validiteit van onderzoeksresultaten van gepubliceerde artikelen, die
rapporteren over effecten van KP.
Deze
systematische
literatuurstudie
is
uitgevoerd
op
basis
van
twee
zoekstrategien, waaronder het zoeken in Medline, CINAHL, Embase, Psychinfo

en Picarta van 1995 tot 2005 en ISI Web of KnowledgeSM. Wij includeerden
daarbij zowel gerandomiseerde experimentele (randomized controled trials) of
quasi-experimentele studies, die de werkzaamheid van een CP evalueerden. De
beoordeling van de methodologische kwaliteit van de studies omvatte het
gebruik van: randomisatie, poweranalyse, selectiebias, betrouwbaarheid en
validiteit van de uitkomstindicatoren, geschiktheid van de statistische testen, en
188
Samenvatting
indirecte
(statistische)
controle
op
confounders.
Resultaten
omvatten
opnameduur, kosten, aantal heropnames en klinische complicaties. Twee

reviewers beoordeelden onafhankelijk de methodologische kwaliteit van de
geselecteerde artikelen en legden hun bevindingen vast met behulp van een
evaluatie-instrument, dat was samengesteld uit onderwerpen voor beoordeling
van methodologische kwaliteit zoals toegepast door de Cochrane Library en
gepubliceerd in andere publicaties. De studie omvatte, na toepassing van de
inclusie- en exclusiecriteria, een selectie van 115 publicaties uit een totaal van
556 publicaties. 91.3% van de studies omvatte retrospectieve studies en 8.7%
waren gerandomiseerd, gecontroleerde studies. Met behulp van het kwaliteitsbeoordelingsinstrument kon 33% van de artikelen geclassificeerd worden als van
goede methodologische kwaliteit, terwijl 67% kon worden geclassificeerd als van
slechte methodologische kwaliteit. In 10.4% van deze studies werd voor
confounding gecontroleerd door matching en in 59.1% werden parametrische
statistische toetsen gebruikt zonder controle op een normale verdeling van de
scores. Verschillen in uitkomsten tussen de KP groep en de controlegroep
werden niet altijd statistisch getoetst. Onze belangrijkste conclusie is dat
onderzoekers en gezondheidszorgprofessionals voorzichtig moeten zijn bij het
interpreteren van resultaten van evaluatiestudie over KPs vanwege het niet
voldoende controleren van niet in het experiment betrokken factoren, die de
zuiverheid van het gevonden verschil vertekenen en daarmee de evidence-based
validiteit van de uitkomsten ernstig kunnen verzwakken.
Hoofdstuk 3
In Hoofdstuk 3 wordt verslag gedaan van het verschil tussen KP en
conventionele zorg in termen van klinische uitkomsten, domeinen van ervaren
lichamelijke en mentale gezondheidstoestand, symptomen van depressie en
angst, alsook het vaststellen van de relatieve bijdrage van een KP in termen van
een verbeterde ervaren gezondheidstoestand na CABG in vergelijking tot de
bijdrage
van
het
conventionele
behandelingstraject.
Wij
voerden
een
longitudinaal, quasi-experimentele pre-test/post-test onderzoek uit om klinische

uitkomsten, ervaren gezondheidstoestand, depressie and angst voor KP te
bestuderen en te vergelijken ten opzichte van conventionele zorgpatinten na
CABG. Hiertoe werden van de statistisch significante verschillen tussen
baseline en follow-up effect sizes berekend als indicator van de omvang van de
verbetering in ervaren gezondheid en symptomen van angst en depressie. Om
het relatieve verschil in effectgrootte te bepalen in de vergelijking tussen CABG
in een KP en CABG in een conventioneel traject is de relative efficacy index
gebruikt.
189
Samenvatting
Lichamelijk en mentale gezondheidstoestand werd gemeten door gebruik te

maken van SF-36, terwijl depressie en angst werden gemeten door gebruik te
maken
van
Hospital
anxiety
and
depression-schaal.
Opnameduur
en
complicaties bij patinten werden verzameld uit de database van het ziekenhuis.
Wij vonden dat implementatie van een KP de opnameduur tussen opname en
operatie significant verlaagde, maar dat de totale tijdsduur tussen opname en
ontslag niet verlaagd werd. Ook was er geen verschil in heropname tussen het
ondergaan van een CABG in een KP en in een conventioneel CABG traject. Wij
vonden ook dat patinten in het conventionele zorgtraject relatief sterker
verbeterden dan de patinten in het KP met betrekking tot zes domeinen van
lichamelijk en mentaal functioneren: lichamelijk, sociaal, en lichamelijk
rolfunctioneren, mentaal functioneren, vitaliteit en ervaren pijn. Deze bevinding
werd bevestigd door de gesommeerde componenten van mentaal en lichamelijk
functioneren. Uitkomsten in het voordeel van patinten in het conventionele
zorgtraject waren gebaseerd op het verschil tussen kleine effectgrootte (effect
size) ( .20 <.50) voor patinten in het KP en medium effect size ( .50 <.80) voor
conventionele zorgpatinten, uitgezonderd voor de subschaal lichamelijk
functioneren en totale, gesommeerde, component lichamelijk functioneren,
waarvoor de ES in de conventionele zorg groep groot was (>.80) in tegenstelling
tot de KP groep (ES .61). Onze belangrijkste conclusie was dat, ondanks het feit
dat de doelstelling van het ontwikkelen en implementeren van klinische paden
is om de opnameduur en kosten te verlagen, waarbij de kwaliteit van de zorg
behouden blijft en de uitkomsten voor de patint verbeteren, deze doelstellingen
niet werden bereikt in dit klinisch pad voor CABG. Wij bevelen daarom aan dat
wanneer bij inclusie of exclusie in de toewijzing aan een klinisch zorgpad voor
CABG risico-indicatoren, de psychologische status van de patint (symptomen
van angst, depressie, vitale uitputting) eveneens in overweging wordt genomen.
Hoofdstuk 4
In Hoofdstuk 4 worden de resultaten gepresenteerd van de analyses, waarin
wordt nagegaan of de EuroSCORE als risico-indicator is geassocieerd met
preoperatieve ervaren gezondheidstoestand, en of de EuroSCORE een
voorspeller is voor mentale en fysieke gezondheidstoestand zes maanden na
CABG. Wij voerden een longitudinaal-observationele studie uit onder 181
patinten, die een CABG ondergingen. Fysieke en mentale domeinen van
ervaren gezondheidstoestand werden gemeten met behulp van SF-36 en de
risicostratificatie werd bepaald door gebruik te maken van de EuroSCORE. Een
post hoc test (met Bonferroni-correctie) werd gebruikt om te bepalen of
EuroSCORE geassocieerd was met preoperatieve Health Related Quality of Life
(HRQoL), opnameduur en het aantal postoperatieve complicaties. Hirarchische
190
Samenvatting
regressie analyse werd uitgevoerd om de samenhang
tussen EuroSCORE,
postoperatieve events en postoperatieve HRQoL te onderzoeken. Wij vonden

dat EuroSCORE geassocieerd is met fysiek functioneren voor en na CABG en
een hogere EuroSCORE is een voorspeller voor slecht fysiek functioneren en
geen voorspeller voor de mentale domeinen van HRQoL, terwijl roken
lichaamspijn (bodily pain) na CABG voorspelde. Daarnaast was heropname
binnen zes weken na ontslag een voorspeller voor slecht lichamelijk
rolfunctioneren en algemene gezondheid. Tevens werden met ANOVA post hoc
toetsen statistisch significante en klinisch relevante verschillen in lichamelijk
functioneren tussen patinten, die met de EuroSCORE als laagrisico en medium
risico waren geclassificeerd, en patinten, die als hoogrisico geclassificeerd
waren. Hoogrisico patinten hadden meer peri-operatieve complicaties en een
langere
opnameduur
in
vergelijking
met
laagrisico
patinten.
Onze
belangrijkste conclusie is dat EuroSCORE onderscheid kan maken tussen laag-,

medium- en hoogrisico klassen met betrekking tot opnameduur, lichamelijk
functioneren en het aantal complicaties. Daarnaast is EuroSCORE een
voorspeller voor een als slecht ervaren mate van lichamelijk functioneren zes
maanden na CABG maar is geen voorspeller voor mentaal functioneren.
Hoofdstuk 5
In Hoofdstuk 5 wordt verslag gedaan van de voorspellers van verslechtering in
ervaren gezondheidstoestand zes maanden na CABG door middel van het
toetsen van een a priori model van de determinanten van een niet beoogde
behandelingsuitkomst van CABG, namelijk geen verandering of verslechtering
in de ervaren lichamelijke en mentale gezondheidstoestand. In eerst instantie
werd logistische regressie analyse toegepast om, multivariaat, de samenhang te
onderzoeken tussen demografische kenmerken van patinten en klinische data
met
verbetering
symptomen
van
versus
angst
geen
en
verandering/verslechtering
depressie
en
componenten
enerzijds
van
en
ervaren
gezondheidstoestand (mentaal en lichamelijk functioneren) anderzijds. Het

gespecificeerde model werd getoetst met de techniek van structural equation
modelling (SEM). In het model wordt verondersteld dat de (reeds bekende)
samenhang tussen persoonlijkheidstype D en slechtere gezondheidstoestand bij
CABG patienten wordt gemedieerd door symptomen van angst en depressie.
Het model getoetst met SEM liet zien dat verhoogde niveaus van angst en
depressie
de
relatie
medieerde
tussen
type
persoonlijkheid
en
verslechtering/geen verandering in zowel mentale als fysieke HRQoL zes

maanden na CABG. Type D persoonlijkheid en verhoogde angst en depressie
verklaarde 65% van de variantie in de verandering van de ervaren mentale
gezondheid, en 25% van de variantie in de verandering in lichamelijke
191
Samenvatting
gezondheid. Onze belangrijkste conclusie is dat, ondanks het feit dat bij de
meerderheid van de patinten na CABG een verbetering in lichamelijke en
mentale gezondheid is gemeten, er onder patinten ook geen verandering of
verslechtering in hun ervaren gezondheidstoestand is vastgesteld. Onze
resultaten lieten zien wat de rol is, die gespeeld wordt door type D
persoonlijkheid in relatie tot angst en depressie bij het voorspellen van
verslechtering in HRQoL zes maanden na CABG.
Hoofdstuk 6
In Hoofdstuk 6 wordt verslag gedaan van de impact van positieve affectiviteit
(PA) en leeftijd op ziekte-specifieke gezondheidsklachten bij CABG-chirurgie
patinten. In dit deel van het proefschrift onderzoek is gebruik gemaakt van de
Health
Complaints
Scale
waarmee
somatische
en
cognitieve
gezondheidsproblemen worden gemeten. De belangrijkste bevindingen van dit

hoofdstuk zijn dat cognitieve en somatische klachten tussen baseline en 6
maanden follow-up afnamen. Patinten met een lage PA rapporteerden meer
cognitieve klachten en er was een trend waar te nemen waarbij jongere
patinten meer symptomen rapporteerden. Er was ook een significant
interactie-effect voor leeftijd x PA, waarbij jongere patinten met een lage PA
het
hoogst
scoorden
op
cognitieve
klachten.
Patinten
met
lage
PA
rapporteerden ook significant meer somatische klachten; noch het belangrijke

effect voor leeftijd noch het interactie-effect voor PA x leeftijd was significant.
Deze resultaten bleven na gecorrigeerde analyse. Onze belangrijkste conclusie is
dat lage PA geassocieerd is met meer klachten, waarbij jonge patinten met een
lage PA meer cognitieve klachten rapporteerden.
Hoofdstuk 7
In dit laatste hoofdstuk worden de belangrijkste resultaten van dit proefschrift
samengevat, gevolgd door een reflectie op de methodologische validiteit van het
uitgevoerde onderzoek.
Onze studie toonde aan dat veel evaluaties van klinische paden methodologische
tekortkomingen hebben en dat patinten in het klinisch pad, dat wij hebben
bestudeerd, relatief minder geprofiteerd hebben in termen van ervaren
gezondheidstoestand. De uitgebreide voorlichting in het klinisch pad heeft
misschien geleid tot een verhoogd risico om meer symptomen van angst en
depressie te ontwikkelen. Daarnaast toonden we aan dat een risicoprofiel
(EuroSCORE) opgebouwd uit objectieve waarnemingen een goede voorspeller is
van subjectief ervaren gezondheid na een CABG. Dat persoonlijkheid (type D)
als ook symptomen van angst en depressie voorspellers zijn van een slechtere
mentale en lichamelijke gezondheid was bekend, maar dat angst en depressie de
192
Samenvatting
invloed van type-D persoonlijkheid, op post-operatieve gezondheidsgerelateerde

kwaliteit van leven, mederen, was een nieuw gegeven.
Een aantal bedreigingen van de interne en externe validiteit van het onderzoek
zijn gevalueerd. Het onderzoek vond plaats in een universitair en een perifeer
ziekenhuis met thoraxchirurgie werkend met eenzelfde klinisch pad voor CABG.
De beide ziekenhuizen verschilden niet m.b.t. de demografische kenmerken van
de patinten (geslacht, leeftijd, opleidingsniveau) en niet m.b.t het risicoprofiel
(EuroSCORE). Wel verbleven de patinten vanaf de operatie gemiddeld langer
in het UMCG en was de prevalentie van een post-operatieve bloeding hoger. Op
de belangrijkste kenmerken waren er geen verschillen tussen deelnemers en
weigeraars bij aanvang van het onderzoek. Ook was er geen systematische
uitval van drop-outs voor de post-CABG meting. Door een historische
controlegroep te creren voor de implementatie van het klinisch pad is gepoogd
contaminatie bias te verminderen (contaminatie door in hetzelfde tijdvak in
hetzelfde ziekenhuis patinten toe te wijzen aan een klinisch pad of aan het
conventionele traject). Om de invloed van potentile confounders uit te sluiten in
de vergelijking tussen CABG in het klinische pad en in een conventioneel
operatietraject
zijn
beide
groepen
gematched
op
geslacht,
leeftijd
en
EuroSCORE. Een tekortkoming is dat de effecten beschouwd moeten worden als

korte termijn (6 maanden) effecten van CABG.
Implicaties voor de klinische en verpleegkundige praktijk
Deze studie heeft implicaties voor beleid, praktijk en gezondheidszorgpersoneel
zoals
bijvoorbeeld
hartchirurgen,
intensive
care/cardiothoracale-
chirurgieverpleegkundigen en cardiologen betrokken bij planning en cordinatie

van het proces van zorg bij een CABG. Het ontwerpen en implementeren van
een klinische pad wordt uitgevoerd door een multidisciplinair team, maar
verpleegkundigen spelen een belangrijke rol bij (i) de implementatie van een
dergelijke interventie, (ii) het voorlichten van de patint en (iii) het voorbereiden
van de patint voor het ontslag. Het is met name van belang voor
verpleegkundigen en andere professionele behandelaars en zorgverleners, die
betrokken zijn bij het verlenen van zorg aan CABG chirurgie-patinten, met
name die factoren te herkennen, die van invloed zijn op de post-operatieve
gezondheid en kwaliteit van leven van deze patinten, waarbij verandering in
het aantal symptomen van angst en/of depressie een significante rol spelen. Dit
pleit er voor om met korte versies van meetinstrumenten de ervaren
gezondheid/gezondheidsgerelateerde kwaliteit van leven, angst en depressie op
te nemen in de routinematig toegepaste protocollen.
193
Samenvatting
Aanbevelingen voor de praktijk en onderzoek

1. Meer (gerandomiseerd) gecontroleerde studies, ook bekend als randomized
controlled trial (RCT) zouden moeten worden uitgevoerd, waarin patinten at
random toegewezen aan zorg georganiseerd in een klinisch pad of worden
toegewezen aan de standaard behandeling. Echter, indien dergelijk RCTs
uitgevoerd worden in hetzelfde ziekenhuis leidt dit tot contaminatie bias,
omdat het merendeel van de afdelingsartsen, alsook zorgstaf zowel betrokken is
bij de behandeling patinten in het KP als bij patinten behandeld in het
standaard behandelingings- en zorgtraject. Om een dergelijk zgn. Hawthorneeffect te voorkomen, stellen wij voor om de effectiviteit van een klinisch pad te
bepalen in een multi-centre trial met, na pre-stratificatie van confounding
factoren (bijvoorbeeld geslacht, EuroSCORE), random toewijzing aan een
ziekenhuis werkend met een KP of aan een ziekenhuis werkend met een
standaardtraject.
2. Standaardisatie van de uitkomstmaten m.n. de directe kosten, door duidelijk
en precies gedefinieerde kostencomponenten en een gestandaardiseerde, en een
nauwkeurige operationele definitie van de opnameduur. De opname- of
verblijfsduur dient o.i. niet beperkt te worden tot de ziekenhuis-setting, maar
zou moeten worden uitgebreid indien de patint na ontslag elders opgenomen
wordt. Een accurate berekening zal dan meer zuiver het effect van klinische
paden weerspiegelen. Daarbij dient men rekening te houden met het risico van
contaminatie tussen de opnameduur en de (in)directe kosten.
3. Bij de evaluatie van een KP zou meer aandacht besteed moeten worden aan
het meten van gezondheidsgerelateerde kwaliteit van leven, symptomen van
angst
en
depressie
met
betrouwbare
en
(internationaal)
gevalideerde
vragenlijsten c.q. meetinstrumenten.

4. Bij het ontwikkelen van een klinische pad dient men niet de ideale patient
voor ogen te hebben, maar rekening te houden met die demografische
kenmerken, risico-indicatoren, en aanwezigheid van symptomen van angst en
depressie,
waarvan
bekend
is
dat
ze
het
behandelresultaat
kunnen
verminderen.
5. Korte vragenlijsten van kwaliteit van leven, symptomen van angst en
depressie als onderdeel van een routinematige beoordeling van de gezondheid
van de patint, zowel pre- en postoperatief, kunnen gemakkelijk worden
uitgevoerd door een cardiothoracale-chirurgieverpleegkundigen. Daarmee wordt
een betrouwbaar en valide beeld verkregen van de perceptie van de patint met
betrekking tot zijn fysieke functioneren en geestelijke gezondheid, waarmee in
de klinische besluitvorming rekening kan worden gehouden.
6.
194
Samenvatting
7. Meer onderzoek is nodig met een groter aantal patinten om de relatie tussen
EuroSCORE, HRQoL en andere klinische resultaten te onderzoeken, die zullen
helpen bij patint-georinteerde zorg met effectieve counseling met betrekking
tot verwachtingen bij de patint na operatie/behandeling.
8. Verder onderzoek is nodig met betrekking tot de rol die het persoonlijkheid
(o.a. Type-D) speelt bij de invloed van angst en depressie op kwaliteit van leven
na een (medische) interventie.
9. Bij toekomstig onderzoek dienen klinische gegevens zowel vr CABG
verzameld te worden als tijdens de follow-up periode om de mogelijke invloed
van veranderingen in de cardiale symptomen op post-operatieve kwaliteit van
leven en psychologische status te kunnen bestuderen.
195
Samenvatting
196
A CKNOWLEDGEMENTS
Acknowledgements
198
Acknowledgements
Acknowledgements
First of all, I Thank God for giving me the ability to finish this thesis. Then, I
would like to thank my country Egypt, as I was able to come here on a
Scholarship sponsored by the Egyptian government to obtain my PhD. I also
would like to thank the entire sector of cultural affairs and mission, and general
administration of missions and cultural affairs in Cairo and the Egyptian
cultural Office in Berlin for their effort, and moral and financial support
throughout my scholarship and study period.
This has been a long Journey that lasted for almost 5 years, a lot has happened,
things were lost and things were gained, it was a journey of self development,
and growth. Now I have reached the end of a phase in life and starting a totally
new phase with a lot of open doors and opportunities, but all what is
accomplished is owed to the support and help of several people in my life,
including family, colleagues and friends, whom I would like to thank.
During the past 5 years, I was blessed with a lot of people, who helped me to
start and finish this PhD project. No matter how many words I type or say will
never express the gratitude and appreciation that I really feel.
Berry, when you replied my letter that it was possible to come to Groningen to
get my PhD, I never ever thought that I would meet such a kind, supportive,
brilliant and understanding person. A true Vater Doktor. I would also like to
thank Elka for her warm welcome, friendliness and the motherly feeling, I
always felt, when I met you.
Jitse, your help, caring support and sincere advice are the corner stones for my
success. Thank you very much!
Menno, thank you for listening to my ideas and for your supervision, which
helped to improve my work and took me this far.
Susan, it was a pleasure sharing a paper with you and I really learned a lot.
Piet, you have been so encouraging and stimulating. I really appreciated your
support.
Klaske, I really appreciate your support and help. You have been a true friend
since I arrived here and you really impressed me with your kind nature. Thanks
for being my paranimf.
Danielle and Andre, I could not have done it without you.
I would also like to thank the members of the reading committee prof.dr. K. van
der Meer, prof.dr. J.J.L. van der Klink and prof.dr. J.L. Hillege.
199
Acknowledgements
My professors and colleagues at the faculty of nursing in Alexandria, Egypt, who

supported and helped me before I arrived to the Netherlands.
Prof.Dr. Nadia Taha, I will never forget your kindness and support and how you
helped me a lot to put things into perspective and how to be in control of things.
Thank you.
Prof.dr. Azza El-Soussi, I really cannot find the correct words to express what I
want to say, but all I can say is that you are a role model, that I look up to and I
hope that I will always measure up to your expectations.
Prof.dr. Fatma El Sharkawy, thank you for your help during the preparation of
the protocol of my doctoral thesis and the references and material you provided
me with. Also thank you for your support and encouraging words.
Prof.dr. Amal Kadry, I really valued you genuine concern during the 5 years I
was away from home and I learned great deal from you, including precision and
accuracy. Prof.dr. Nagwa Reda, we worked together very close during my
master thesis and I appreciate all the clues and tips you taught me about
scientific writing as they set the basis for work here. My Colleagues and
teachers, dr. Sahar and dr. Nesrine, I really appreciate everything I have
learned from you. Thank you.
To my wonderful parents Yousreya and Esmat, who shaped my personality and
the way I look at things in life. They taught me that with hard work, honesty,
persistence and Gods will nothing is impossible.
Harry en Paula, ik heb een vader en een moeder in Nederland. Ik zal nooit
vergeten hoe Paula de hele nacht bij mij heeft doorgebracht tijdens het meest
bijzondere moment in mijn leven. Bedankt!
My late uncle Samir and my beloved tante Hanaa, by listening to you I was able
to learn about ambition, scientific research and how to be proud and sure of
myself. I will always remember what you told me. It is not important to do what
you love, but to love what you do.
Mam Iris, I miss you so much, you taught me selfconfidence, unconditional love,
patience, persistence and the importance of mastering more than one language.
Nehad, dear brother, your emotional and moral support, when I was down,
made a big difference to me. Thank you.
Nihal and sweet Nour, Ayten and Emad. Dear sister, your words always made
me feel stronger and enabled me to go on.
Peter, Paul, Sonja, Karin, Robin en Tobias, jullie geven mij allemaal het gevoel
familie te zijn. Bedankt voor jullie hulp en ondersteuning.
Nazek, I would like to thank you very much for your encouragement and
support, and I cherish your friendship a lot.
Amany, Eman, and Samah, my dear honest, true friends and who were always
there for me. Thank you.
200
Acknowledgements
Michiel, jij bent mijn beste vriend. Ik heb veel aan je te danken. Mijn
gemoedsrust, mijn geluk en al het mooie in mijn leven. Bedankt voor je steun, je
hulp, je aanmoedigingen, het luisteren naar mijn frustraties, het drogen van
mijn tranen en mij altijd het gevoel te geven speciaal te zijn. Je hebt mij geleerd
om meer geduld te hebben, meer vasthoudend te zijn if you do not ask, you will
never get, om backupplannen te maken, maar bovenal heb je mij geleerd dat,
ondanks alles, ik tijd vrij moet maken om te genieten van het leven.
Bram Youssef, je bent het mooiste cadeautje in mijn leven. Je lach en de blik in
je ogen geven mij het gevoel, dat ik de hele wereld aankan. Jij hebt mij de
energie gegeven om dit proefschrift af te kunnen ronden.
201
Acknowledgements
202
A PPENDICES
203
Appendices
204
Appendices
Appendix 1
205
Appendices
206
Appendices
1. EuroSCORE
Patient-related factors
Score
Age
(per 5 years or part thereof over 60 years)
Sex
female
Chronic pulmonary
disease
longterm use of bronchodilators or steroids for

lung disease
Extracardiac arteriopathy
any one or more of the following: claudication,

carotid occlusion or >50% stenosis, previous or
planned intervention on the abdominal
aorta,limb arteries or carotids
Neurological dysfunction
disease
severely affecting ambulation or day-to-day

functioning
Previous cardiac surgery
requiring opening of the pericardium
Serum creatinine
>200m micromol/L preoperatively
Active endocarditis
patient still under antibiotic treatment for

endocarditis at the time of surgery
Critical preoperative state
any one or more of the following: ventricular

tachycardia or fibrillation or aborted sudden
death, preoperative cardiac massage,
preoperative ventilation before arrival in the
anaesthetic room,preoperative inotropic
support, intraaortic balloon counterpulsation or
preoperative acute renal failure (anuria or
oliguria<10 ml/hour)
Cardiac-related factors
Score
Unstable angina
rest angina requiring iv nitrates until arrival in

the anaesthetic room
LV dysfunction
moderate or LVEF30-50%
poor or LVEF <30
Recent myocardial infarct
(<90 days)
Pulmonary hypertension
Systolic PA pressure>60 mmHg
Operation-related
factors
Score
Emergency
carried out on referral before the beginning of

the next working day
Other than isolated

CABG
major cardiac procedure other than or in

addition to CABG
Surgery on thoracic aorta
for disorder of ascending, arch or descending

aorta
Postinfarct septal rupture
207
Appendices
208
Appendices
2. Perioperative and Postoperative events

Type of operation performed:
ECC:
Yes
No
Date of surgery:
Number of days in the ICU:
Date of discharge or deceased:
Discharged to:
- Home
- Other hospital
- Not applicable
Use of inotropes
Yes
No
Postoperative intra-aortic balloon pump
Yes
No
AF/ SVT
Yes
No
VT/ VF
Yes
No
Permanent pacing after surgery
Yes
No
Re-exploration for bleeding
Yes
No
Sternal resuturing
Yes
No
Re-intubation
Yes
No
(Indicate if inotropes commenced on leaving theatre or in the ICU

Exclude <3 ug/kg/min Dopamine)
Is used at any stage of the postoperative period
Atrial tachycardias or fibrillation requiring treatment

ventricular tachycardias or fibrillation requiring treatment
(bleesing/ tamponade that required surgical re-exploration after

initial departure from the operating theatre or exploration of other
reasons e.g. cardiac arrest, additional grafting, etc.)
(for any reason- technical failure or infection)
(patient re-intubated at any stage of the postoperative course)
Duration on mechanical ventilation
(note the duration of mechanical ventilation in hours)
0-6
6-12
12-24
>24
Full tracheostomy
Yes
No
Pulmonary embolism
Yes
No
Transient stroke / neurological deficit
Yes
No
Permanent stroke
Yes
No
Documented myocardial infarction
Yes
No
Infected sternotomy
Yes
No
Septicaemia
(from any source, known or unknown)
Gastrointestinal haemorrhage
Yes
No
Yes
No
Peptic Ulceration
Yes
No
Pancreatitis
Yes
No
(either surgical or percutaneous)

(documented pulmonary embolism)
(neurological deficit, which has fully recovered by the time of
discharge from the hospital)
(persisting neurological deficit at time of discharge from hospital)
( requiring debridement or suture)
(proven peptic ulceration causing pain or perforation)

(amylase >1500 iu)
209
Appendices
Mild /moderate renal failure
Yes
No
CVVH
Yes
No
Patient deceased
Yes
No
(postoperative creatinine > 200 mmol/L)

(Hemodialysis required)
(at time of discharge)
Cause of death
- Not applicable
- Cardiac
- Neurological
- Pulmonary
- Carcinoma
- Multisystem failure
- Other
- unknown
210
Appendices
3. SF-36 QUESTIONNAIRE ITEMS

1. In general, would you say your health is:
(Circle One Number)
Excellent
Very good
Good
Fair
Poor
2. Compared to one year ago, how would you rate

your health in general now?
(Circle One Number)
Much better now than one year ago
Somewhat better now than one year ago
About the same
Somewhat worse now than one year ago
Much worse now than one year ago
The following items are about activities you might do during a typical day. Does
your health now limit you in these activities? If so, how much?
(Circle One Number on Each Line)
Yes,
Limited
a Lot
Yes,
Limited
a Little
No,
Not Limited,
at All
4. Moderate activities, such as moving

a table, pushing a vacuum cleaner,
bowling, or playing golf
5. Lifting or carrying groceries
6. Climbing several flights of stairs
7. Climbing one flight of stairs
8. Bending, kneeling, or stooping
9. Walking more than a mile
10. Walking several blocks
11. Walking one block
12.Bathing or dressing yourself
3. Vigorous activities, such as running,

lifting heavy objects, participating in
strenuous sports
211
Appendices
During the past 4 weeks, have you had any of the following problems with your
work or other regular daily activities as a result of your physical health?
Yes
No
13. Cut down the amount of time you
1
2
spent on work or other activities
14. Accomplished less than you
1
2
would like
15. Were limited in the kind of work
1
2
or other activities
16. Had difficulty performing the
1
2
work or other activities
(for example, it took extra effort)
During the past 4 weeks, have you had any of the following problems with your
work or other regular daily activities as a result of any emotional problems
(such as feeling depressed or anxious)?
Yes
No
17. Cut down the amount of time you
1
2
spent on work or other activities
18. Accomplished less than you
1
2
would like
19. Didnt do work or other activities
1
2
as carefully as usual
20. During the past 4 weeks, to what extent has your physical health or
emotional problems interfered with your normal social activities with family,
friends, neighbors, or groups?
(Circle One Number)
Not at all
1
Slightly
2
Moderately
3
Quite a bit
4
Extremely
5
21. How much bodily pain have you had during the past 4 weeks?
(Circle One Number)
None
1
Very mild
2
Mild
3
Moderate
4
Severe
5
Very severe
6
212
Appendices
22. During the past 4 weeks, how much did pain interfere with your normal
work (including both work outside the home and housework)?
(Circle One Number)
Not at all
1
A little bit
2
Moderately
3
Quite a bit
4
Extremely
5
These questions are about how you feel and how things have been with
you during the past 4 weeks. For each question, please give the one answer
that comes closest to the way you have been feeling.
How much of the time during the past 4 weeks
23. Did you feel full of pep?

24. Have you been a very
nervous person?
25. Have you felt so down in
the dumps that nothing
could cheer you up?
26. Have you felt calm and
peaceful?
27. Did you have a lot of
energy?
28. Have you felt
downhearted and blue?
29. Did you feel worn out?
30. Have you been a happy
person?
31. Did you feel tired?
All
of the
Time
Most
of the
Time
A Good
Bit
of the
Time
Some
of the
Time
A Little
of the
Time
None
of the
Time
1
1
2
2
3
3
4
4
5
5
6
6
1
1
2
2
3
3
4
4
5
5
6
6
32. During the past 4 weeks, how much of the time has your physical health
or emotional problems interfered with your social activities (like visiting with
friends, relatives, etc.)?
(Circle One Number)
All of the time
1
Most of the time
2
Some of the time
3
A little of the time
4
None of the time
5
213
Appendices
How TRUE or FALSE is each of the following statements for you.

Definitely Mostly Dont Mostly Definitely
True
True
Know
False
False
33. I seem to get sick a little
1
2
3
4
5
easier than other people
34. I am as healthy as
1
2
3
4
5
anybody I know
35. I expect my health to get
1
2
3
4
5
worse
36. My health is excellent
1
2
3
4
5
214
Appendices
4. HADS
Patients are asked to choose one response from the four given for each interview. They
should give an immediate response and be dissuaded from thinking too long about their
answers. The questions relating to anxiety are marked A, and to depression D. The
score for each answer is given in the right column. Instruct the patient to answer how it
currently describes their feelings.
Anxiety
I feel tense or wound-up
Most of the time
A lot of the time
From time to time, occasionally
Not at all
I get a sort of frightened feeling as if something awful is about to happen

Very definitely and quite badly
Yes, but not too badly
A little, but it doesn't worry me
Not at all
Worrying thoughts go through my mind

A great deal of the time
A lot of the time
From time to time, but not too often
Only occasionally
I can sit at ease and feel relaxed

Definitely
Usually
Not Often
Not at all
I get a sort of frightened feeling like butterflies in the stomach

Not at all
Occasionally
Quite Often
Very Often
I feel restless as if I have to be on the move

Very much indeed
Quite a lot
Not very much
Not at all
I get sudden feelings of panic

Very often indeed
Quite often
Not very often
Not at all
0
215
Appendices
Depression
I still enjoy the things I used to enjoy
Definitely as much
Not quite so much
Only a little
Hardly at all
I can laugh and see the funny side of things

As much as I always could
Not quite so much now
Definitely not so much now
Not at all
I feel cheerful
Not at all
Not often
Sometimes
Most of the time
I feel as if I am slowed down

Nearly all the time
Very often
Sometimes
Not at all
I have lost interest in my appearance

Definitely
I don't take as much care as I should
I may not take quite as much care
I take just as much care as ever
I look forward with enjoyment to things

As much as I ever did
Rather less than I used to
Definitely less than I used to
Hardly at all
I can enjoy a good book or radio or television program

Often
Sometimes
Not often
Very seldom
The norms below will give you an idea of the level of Anxiety and Depression.
0-7 = Normal
8-10 = Borderline abnormal
11-21 = Abnormal
Reference: Zigmond and Snaith (1983)
216
Appendices
5. Type D personality
0 = false 1 = rather false 2 = neutral 3 = rather true 4 = true
1. I make contact easily when I meet people
2. I often make a fuss about unimportant things
3. I often talk to strangers
4. I often feel unhappy
5. I am often irritated
6. I often feel inhibited in social interactions
7. I take a gloomy view of things
8. I find it hard to start a conversation
9. I am often in a bad mood
10. I am a closed kind of person
11. I would rather keep other people at a distance
12. I often find myself worrying about something
13. I am often down in the dumps
14. When socializing, I dont find the right things

to talk about
217
Appendices
218
Appendices
6. HCS
Name:
Sex:
Age:
Date:
Below are a number of problems and complaints that ill people often have.
Please read each item carefully and then circle the appropriate number
next to that problem. Indicate how much each problem has bothered you
lately. Please use the following scale to record your answers.
0=NOT AT ALL 1=A LITTLE BIT 2=MODERATELY 3=QUITE A BIT 4=EXTREMELY

Lately, how much were you bothered Lately, how much were you bothered
by the following specific problems: by the following general problems:
Somatic complaints
A1. Sleep that is restless or disturbed
A2. Tightness of the chest
A3. Feeling that you are not rested
A4. Fatigue
A5. Trouble falling asleep
A6. Inability to take a deep breath
A7. Stabbing pain in heart or chest
A8. Feeling exhausted without any reason
A9. Shortness of breath
A10. Pain in heart or chest
A11. Feeling weak
A12. Feeling you cant sleep
B1. The idea that bad health is the biggest problem in

life
B2. Not being able to work fluently
B3. Being afraid of illness
B4. The idea that you were able to take on much more
work formerly
B5. Feeling blocked in getting things done
B6. The idea that you have a serious illness
B7. Feeling you are not able to do much
B8. Something serious is wrong with body
B9. Feeling you are no longer worth as much as used to

be
B10. Feeling despondent
B11. Worrying about your health
B12. Thinking that all your worries would be over if

you are physically healthy
Cognitive complaints
219
Appendices
220
Appendices
7. GMS
Name:
Sex:
Age:
Date:
Below are a number of words that describe different feelings and emotions.
Please read each item carefully and then circle the appropriate number
next to that word. Indicate to what extent you have felt this way lately.
Please use the following scale to record your answers.
0=NOT AT ALL 1=A LITTLE BIT 2=MODERATELY 3=QUITE A BIT 4=EXTREMELY

To what extent have you felt this way lately :
1. Wearied
11. Listless
2. Active
12. Tired
3. Worn out
13. Enterprising
4. Dynamic
14. Relaxed
5. Bright
15. Insecure
6. Helpless
16. Sociable
7. Hard-working
17. Cheerful
8. Feeble
18. Fatigued
9. Lively
19. Weakened
10. Physically weak
20. Self-confident
221
Appendices
222
Appendices
Appendix 2
223
Appendices
224
Appendices
1. KLINISCH ZORGPAD CABG 2005, UMCG

Naam:
Kamernummer:
Datum:
OK gepland als:
Preoperatief CABG (met/zonder hart-longmachine)
!! nd invullen als pat als 1e voor OK gaat !!
Spreekuurpatint
AC
Algemeen
Anamnese is gecheckt/aangevuld
v.A09
v.A02
Mvk is uitgewerkt
- patint is op de hoogte van de
voorbereidingen pre-ok
v.A04
v.A06
v.A07
v.B07
v.B08
v.B09
Respiratie
ADL
dd
v.A01
v.A03
Circulatie
Interventies
v.C01
v.J03
v.J04
v.J05
v.J06
- patint is op de hoogte van het

ok-programma
- patint heeft rondleiding op
afdeling gehad
Patint is gescreend voor de
nazorg
Is aangemeld bij liaisonvpk
(indien nodig)
Patint heeft
opnameonderzoeken gehad
- X-thorax
- ECG
- lab
- urinesediment
Prothese uit / sieraden af / OKpak aan / laten uitplassen
Vpk dossier / medische status /
ponsplaatje / mvk /
anesthesielijst / evt. X-thorax
mee naar OK
Hartfrequentie is binnen de
normale grenswaarden van de
patint
Patint is koortsvrij
Bloeddruk is binnen de normale
grenswaarden van de patint
Saturaties zijn binnen de
patint
Patint heeft zich gedoucht/
gewassen met hibischrub
Patint is geschoren m.b.v
clipper
Patint heeft neuspenselen
uitgevoerd met chloorhexidine
neuszalf
Patint heeft premedicatie
volgens anesthesielijst gehad
225
procedure
procedure
protocol
procedure
procedure
procedure
ld
nd
Va
Appendices
Vervolg stap spreekuurpatint

AC
Interventies
dd
Pijnbestrijding
v.E01
Patint begrijpt de uitleg van

de pijnscorelijst m.b.v. meetlat
Voeding +
Stofwisseling
v.G03
Patint is aangemeld bij

DROP+ waaknaald is gegeven
(indien diabeet)
v.G08
ld
nd
Va
protocol
in
wording
procedure
Dagcurve is geprikt + beleid

vlgs. DROP is uitgevoerd (indien
diabeet)
- 6 uur blds prikken en meegeven naar OK
v.G04
v.G05
v.G06
v.G07
Patint is gescreend a.d.h.v.

stroomschema voedingsbeleid
Opnamegewicht + lengte is
genoteerd
Patint is nuchter volgens
anesthesielijst
Decubitusscorelijst is ingevuld
(bij verhoogd risicopatint)
Uitscheiding
Fysiotherapie
v.K02
Patint heeft ontlasting gehad
v.I01
Voorlichting
v.H02
Patint heeft een preoperatief

gesprek met de fysiotherapeut
gehad
Patint heeft preoperatief
gesprek met de chirurg gehad
Patint is in staat zijn angsten
te benoemen en voelt zich
hierin ondersteund
Patint en sociaal netwerk
geven aan tevreden te zijn over
de psychosociale begeleiding
v.H04
v.H01
procedure
procedure
procedure
procedure
Beoogd resultaat: Patint is volledig genformeerd, op de hoogte van de

procedure en voorbereid voor de operatie
Naam dagdienst
Naam fysiotherapeut
Naam late dienst
Klinisch zorgpad CABG 2005, UMCG

Gewijzigd: 18-10-2005
Eigenaar: prof.dr. P. Boonstra; beheerder: A.A.Oosterhof
226
Naam nachtdienst
Appendices

Naam:
Kamernummer:
Datum:
OK gepland als:
!! nd invullen als pat als 1e voor OK gaat !!
AC
Algemeen
Interventies
dd
v.A01
Anamnese is afgenomen
v.A09
v.A02
Mvk is uitgewerkt
voorbereidingen pre-ok
- patint is op de hoogte van het
ok-programma
bezoektijden
- patint is geinformeerd over de
ic-periode
v.A03
v.A04
v.A05
v.A06
v.A07
Circulatie
v.B07
- patint heeft rondleiding over

afdeling gehad
Patint is gescreend voor de
nazorg
Is aangemeld bij liaisonvpk
(indien nodig)
Opname + lichamelijk onderzoek
door arts-assistent of nursepractitioner
Patint heeft opnameonderzoeken gehad
- X-thorax
- ECG
- lab
- urinesediment
Prothese uit / sieraden af / OKpak aan / laten uitplassen
procedure
procedure
procedure

ponsplaatje/ mvk/ anesthesielijst
/ evt. X-thorax mee naar OK
Hartfrequentie zijn binnen de
patint
v.B08
v.B09
v.B04
Telemetrie nr.
+ waaknaald
Respiratie
v.C01
Saturaties zijn binnen de normale grenswaarden van de patint
ADL
v.J03
Patint heeft zich gedoucht /

gewassen met hibischrub
procedure
v.J04
Patint is geschoren m.b.v.

clipper
procedure
procedure
227
protocol
ld
nd
Va
Appendices
Vervolg stap preoperatief

Interventies
Pijnbestrijding
Voeding +
Stofwisseling
dd
v.J05
Patint heeft neuspenselen uitgevoerd met chloorhexidinezalf
v.J06
Patint heeft premedicatie

volgens anesthesielijst gehad
v.E01
Patint begrijpt de uitleg van de

pijnscorelijst m.b.v meetlat
Patint is aangemeld bij DROP +
waaknaald is gegeven
v.G03
(indien diabeet)
Dagcurve is geprikt + beleid vlgs

DROP uitgevoerd (indien diabeet)
v.G08
- 6 uur blds prikken & meegeven naar OK
v.G04
Patint is gescreend a.d.h.v.

stroomschema voedingsbeleid
v.G05
Opnamegewicht + lengte is
genoteerd
anesthesielijst
v.G06
v.G07
Uitscheiding
Fysiotherapie
Voorlichting
Decubitusscorelijst is ingevuld
(bij verhoogd risicopatint)
Patint heeft ontlasting gehad
v.K02
v.I01
Patint heeft preoperatief gesprek met fysiotherapeut gehad

Patint heeft preoperatief gesprek met de anesthesist gehad
v.H03
v.H02
ld
nd
Va
procedure
Protocol in
wording
procedure
procedure
procedure
procedure
procedure
procedure
Patint heeft preoperatief

gesprek met de chirurg gehad
te benoemen en voelt zich hierin
ondersteund
Patint en sociaal netwerk geven
aan tevreden te zijn over de
psychosociale begeleiding
v.H04
v.H01
Beoogd resultaat: Patint is volledig genformeerd, op de hoogte van de

procedure en voorbereid voor de operatie.
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

228
Naam nachtdienst
Appendices
3. Klinisch zorgpad CABG 2005, UMCG

Naam:
Kamernummer:
Datum:
Standaardligdag formulier
OK datum:
OK gepland als:
AC
Circulatie
v.B01
dd
v.B04
Hartfrequentie zijn binnen de

patint
-8/20 uur
-8/20 uur
-8/20 uur
Telemetrie nr. + waaknaald
v.B05
Patint heeft geen AP- klachten
v.B06
Patint heeft een stabiel gewicht

in relatie met het
opnamegewicht
Patint geeft aan niet benauwd
te zijn
Patint is ADL zelfstandig
v.B02
v.B03
Respiratie
v.C01
ADL
v.J01
v.J02
Voeding
+
Stofwisseling
v.G01
Uitscheiding
v.B22
v.G02
v.K03
Voorlichting
Interventies
v.H04
v.H01
Patint geeft aan acceptabel te

hebben geslapen
Patint is in staat voldoende
intake tot zich te nemen passend
bij lichaamsbehoefte
Diabeten zie diabetenboek
Patient heeft voldoende urineuitscheiding in relatie tot de
vochtopname
Patint heeft een voor hem aanvaardbaar ontlastingspatroon
te benoemen en voelt zich hierin
ondersteund
Patint en sociaal netwerk geven
ld
nd
procedure
procedure
procedure
Beoogd resultaat: Patint heeft stabiele vitale functies en is koortsvrij.

Naam dagdienst
Naam late dienst

Gewijzigd: 06-01-06
229
Naam nachtdienst
Va
Appendices
230
Appendices

Naam:
Kamernummer:
Datum:
Preoperatief CABG (met/zonder hart-longmachine), OK-dag
Stap 1
!! dd ALLN invullen als pat als 2e voor OK gaat!!
AC
Algemeen
v.A06
Interventies
dd
Protheses uit / sieraden af / okpak aan / laten uitplassen
v.A07

ponsplaatje / mvk / anesthesielijst /
evt. X-thorax mee naar ok
Circulatie
v.B08
ADL
v.J03
Patint heeft zich

gedoucht/gewassen met hibischrub
v.J07
procedure
Patint heeft 1 keer neuspenselen

uitgevoerd met chloorhexidine
neuszalf
v.J06
procedure
Patint heeft premedicatie volgens

anesthesielijst gehad
Voeding
v.G06
Stof-

anesthesielijst
+
v.G08
wisseling
procedure
Bij diabeten is dagcurve geprikt +

beleid volgens DROP uitgevoerd
- 6 uur blds prikken om 7 uur 2
liter gl 5% infuus + aangegeven
hoeveelheid insuline volgens
DROP
procedure
Beoogd resultaat: Patint is gereed voor de operatie en koortsvrij.

Naam dagdienst

Gewijzigd: 18-10-05
231
Va
Appendices
232
Appendices

Naam:
Kamernummer:
Datum:
Postoperatief CABG (met/zonder hart-longmachine), Van IC naar verpleegafdeling
Stap 2
Van IC terug om .uur
AC
Algemeen
v.A08
Interventies
dd
Overdracht van IC-vpk naar afdelingsvpk

- ingreep
- varianties
v.A09
Vpk dossier is bijgewerkt

- groene lijst / mvk uitwerken
- voorblad bijwerken a.d.h.v. Ok-verslag
- controle/ vochtlijst bijwerken
Circulatie
v.B09
procedure
Hartfrequentie is binnen de normale

1e 6 uur a 1 uur meten daarna a 3 uur
v.B10
- 6/14/20 uur
v.B11

1e 6 uur a 1 uur meten daarna a 3 uur
v.B12
Vochtbeperking 1750 cc all in
v.B13
Patint heeft een evenwichtige

vochtbalans
Tussenbalans a 12 uur
v.B14
Infuus 1/2 liter glucose 5%/24 uur + 15

mmol MgSo4
v.B15
Patint heeft voldoende urineuitscheiding in relatie tot de vochtopname

CAD ieder uur hevelen
Minimale productie 30-40 cc per uur <=arts
bellen
v.B16
Thoraxdrain produceert <25-30cc per uur

Vertoont geen luchtlekkage, beginnend
sereus van kleur&substantie
Max productie 25-30cc per uur >= arts bellen
v.B17
Redondrain (arm/been) produceert < 5-10

cc per uur
Max prod 5-10cc per uur >= arts bellen
Respiratie
v.C02
Patint geeft aan niet benauwd te zijn,

saturaties zijn binnen de normale
- 4 uur na ontslag IC sat meten, indien sat
93% afbouwen met 1 liter
- daarna a3 uur sat meten en afbouwen tot 0
- 3 uur na stoppen o2, nog 1x sat meten
v.C04
Patint heeft zijn hoestkussen binnen

handbereik
233
protocol
ld
nd Va
Appendices
Vervolg stap 2
AC
ADL
Pijnbestrijding
interventies
v.J08
Patint krijgt volledige hulp bij ADL
v.J09
v.G11
Patint geeft aan acceptabel te

hebben geslapen
Patint kan m.b.v. pijnscorelijst
aangeven dat de pijn < 4 is
Patint geeft aan voldoende te hebben
aan de standaard pijnmedicatie
Patint is in staat om smiddags
helder vloeibaar drinken tot zich te
nemen
Patint is in staat om savonds
vloeibaar/licht verteerbaar eten tot
zich te nemen
Patint geeft aan niet misselijk te zijn
v.G12
Controle van de bloedsuikers
v.E02
v.E03
Voeding
+
Stofwisseling
dd
v.G09
v.G10
- bij niet diabeten; actrapidpomp stoppen,

bloedsuikercontrole tot 2x <10, anders
aanmelden DROP
- bij diabeten; actrapidpomp vervolgen + 4
uur bloedsuikercontrole, patint is aangemeld
bij DROP
v.G13
Wonden lekken niet door
v.G14
Geen tekenen van decubitus zichtbaar

Bed staat in fowlerstand
Patint heeft darmperistaltiek
Maagslang verwijderen
Patint geeft aan voldoende te
kunnen ventileren en de hoestkracht
is voldoende om evt aanwezig sputum
zelfstandig te kunnen klaren
Uitscheiding
Fysiotherapie
v.K03
Voorlichting
v.H04
v.I02
ld
nd Va
Protocol in
wording
procedure
procedure
procedure
procedure
protocol
procedure
Patint is in staat zijn angsten te

benoemen en voelt zich hierin
ondersteund
Patint en sociaal netwerk geven aan
tevreden te zijn over de psychosociale
begeleiding
v.H01
Beoogd resultaat: Patint heeft stabiele vitale functies, vertoont geen tekenen
van infectie en begrijpt de noodzaak van goed doorademenm / ophoesten en is
in staat dit uit te voeren.
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

234
Naam nachtdienst
Appendices

Naam:
Kamernummer:
Datum:
Postoperatief CABG (met hart-longmachine)
Stap 3
AC
Algemeen
Interventies
dd
v.A10 Routine onderzoeken dag 2 zijn

verricht
- X thorax op zaal
- ECG
- lab
Circulatie
procedure
v.B18 Hartfrequentie is binnen de

patint
- 8/14/20/0 uur
v.B10 Patint is koortsvrij

- 8/14/20 uur
v.B19 Bloeddruk is binnen de normale

- 8/14/20/0 uur
v.B12 Vochtbeperking max. 1750 cc per

24hr
v.B06 Patint heeft een stabiel gewicht
in relatie met het opnamegewicht
procedure
v.B13 Patint heeft een evenwichtige

vochtbalans
tussenbalans a 12 uur
v.B21 Patint heeft een gereguleerde
vochthuishouding, HB is > 5
Infuus verwijderen
v.B23 Thoraxdrain heeft < 150 cc over
de nacht geproduceerd, vertoont
geen luchtlekkage
wordt verwijderd door arts/ np'er
v.B24 Redondrain arm / been heeft < 10
cc over de nacht geproduceerd
wordt verwijderd
Respiratie
ADL
v.C01 Patint geeft aan niet benauwd te

zijn
v.J08 Patint krijgt volledige hulp bij
ADL
v.J11 Patint is in staat 2 keer 20 min
in de stoel te zitten
protocol
protocol
protocol
procedure
v.J12 Patint is in staat om onder

begeleiding naar toilet te lopen
procedure
v.J13 Patint begrijpt het belang van de

steunkous is aangemeten &
aan/uit gedaan (bij vene)
v.J09 Patint geeft aan acceptabel te
hebben geslapen
235
ld
nd
Va
Appendices
Vervolg
stap 3
Pijnbestrijding
AC
Interventies
dd
v.E02 Patint kan m.b.v. pijnscorelijst

aangeven dat de pijnscore < 4 is
v.E03 Patint geeft aan voldoende te
hebben aan de standaard
pijnbestrijding
Voeding
+
Stofwisseling
v.G15 Patint is in staat voldoende

volwaardige voeding tot zich te
nemen passend bij zijn
lichaamsbehoefte
v.G12 Controle van de bloedsuikers
- 2x <10 stop bloedsuikercontrole
- bij diabeten; actrapidpomp i.o.m.
DROP
stoppen, bloedsuikerdagcurve
v.G13 Wonden laten geen tekenen van
roodheid, zwelling of overmatig
lekken zien
v.G14 Geen tekenen van decubitus
zichtbaar
Bed in fowlerstand
Uitscheiding
v.B22 CAD verwijderen om 8 uur

Patint heeft spontane diurese
binnen 6 uur
Protocol in
wording
procedure
procedure
procedure
procedure
protocol
v.K03 Patint heeft een voor hem

aanvaardbaar ontlastingspatroon
bij geen def-> start lactulose 1 keer dd
Fysiotherapie
v.I02
Patint geeft aan voldoende te

kunnen ventileren en de
hoestkracht is voldoende om evt
aanwezig sputum zelfstandig te
kunnen klaren
v.I03
Patint is op de hoogte van het

behandelplan van de fysiotherapie
v.I04
Patint kan met begeleiding van

een hulpverlener een transfer
maken naar de stoel
procedure
procedure
236
procedure
ld
nd
Va
Appendices
Vervolg
stap 3
Voorlichting
AC
Interventies
dd
ld
nd
Va
v.H04 Patint is in staat zijn angsten te

ondersteund
v.H01 Patint en sociaal netwerk geven
v.H11 Patint geeft op vraag aan
overgeplaatst te willen worden
naar een ander ziekenhuis
procedure
Beoogd resultaat: Patint heeft stabiele vitale functies, vertoont geen tekenen
van infectie, kan met hulp uit bed komen en korte tijd opzitten, is in staat
voldoende voeding/vocht tot zich te nemen, controle onderzoeken zijn verricht;
resultaten binnen acceptabele grenzen.
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

237
Naam nachtdienst
Appendices
238
Appendices

Naam:
Kamernummer:
Datum:
Stap 4
AC
Circulatie
Interventies
dd
v.B25

- 8/14/20 uur
v.B10
- 8/14/20 uur
v.B26

- 8/14/20 uur
v.B27
Patint is in staat om minimaal 1500

cc vocht per 24 uur tot zich te nemen
Vochtintake bijhouden
v.B06
Patint heeft een stabiel gewicht in

relatie met het opnamegewicht
procedure
Respiratie
v.C01
Patint geeft aan niet benauwd te zijn
ADL
v.J10
Patint is in staat zich gedeeltelijk

zelfstandig te wassen ( rand van het
bed)
v.J15
Patint is in staat om 3 keer 30 min in

de stoel te zitten en zelfstandig te
lopen op de kamer
procedure
v.J16
v.J09
Pijnbestrijding
v.E04
Patint is in staat gedeeltelijk

zelfstandig steukous aan/uit te
trekken ( bij vene)
Patint geeft aan acceptabel te hebben
geslapen
protocol
in
wording
v.E03

aan de standaard pijnbestrijding
procedure
239
ld
nd
Va
Appendices
Voeding
+
Stofwisseling
AC Interventies
volwaardige voeding tot zich te
lichaamsbehoefte
v.G16 Diabeten zie diabetenboek
lekken zien
Uitscheiding
Fysiotherapie
v.G14 Geen tekenen van decubitus

zichtbaar
v.B22 Patint heeft voldoende urineuitscheiding in relatie tot de
vochtopname
Bij geen def -> microlax / klysma
geven
v.I04
Patint kan zelfstandig of met

enige hulp een stukje lopen op de
afdeling.
v.I05
Patint is op de hoogte van

fysiologische reacties van het
lichaam op inspanning
v.I02
Patint kan voldoende ventileren

en de hoestkracht is voldoende om
evt aanwezig sputum zelfstandig
te kunnen klaren
dd
ld
nd
Va
procedure
procedure
procedure
protocol
procedure
procedure
procedure
Voorlichting
v.H05 Patint geeft toestemming tot

schrijven van een overdracht,
(indien patint wordt
overgeplaatst, datum noteren op
voorblad)
procedure

ondersteunt
Beoogd resultaat: Patint is koortsvrij met stabiele vitale functies,verricht ADL
grotendeels zelfstandig, is mobiel op kamer, mobiliseert op de afdeling met fysio
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

Gewijzigd: 02-01-06
240
Naam nachtdienst
Appendices

Naam:
Kamernummer:
Datum:
Stap 5
AC
Interventies
dd
Circulatie

patint
- 8/20 uur
- 8/20 uur
- 8/20 uur
Respiratie

zijn
v.J14 Patint is in staat zich grotendeels
zelfstandig te wassen ( wastafel)
v.J15 Patint is in staat zelfstandig te
mobiliseren en kan min 3 keer 30
min in de stoel zitten
procedure
ADL
procedure
Pijnbestrijding
v.J16 Patint kan grotendeels

zelfstandig steunkous
aan/uittrekken (bij vene)
hebben geslapen
Protocol in
wording

pijnbestrijding
Voeding
+
Stofwisseling

volwaardige intake tot zich te
lichaamsbehoefte
procedure
procedure

lekken zien
protocol
Uitscheiding

vochtopname
241
ld
nd
Va
Appendices
Vervolg stap 5
AC
Fysiotherapie
Interventies
dd
v.I05
Patint is in staat om onder

begeleiding te kunnen traplopen,
(indien dit is vastgesteld in het
behandelplan van de patint)
v.I06
Patint is aangemeld voor

screening hartrevalidatie, (indien
dit van toepassing is)
ld
nd
Va
procedure
procedure
Voorlichting
v.H06 Ontslagboek is gegeven,

Patint begrijpt het belang van
het ontslagboek,
(ontslag noteren op voorblad)
ondersteund
v.H07 Ontslagdatum is doorgegeven aan
liaisonvpk (indien patint is
aangemeld)
procedure
Beoogd resultaat: Patint is koortsvrij met stabiele vitale functies, kan traplopen onder
begeleiding
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

Eigenaar: prof.dr. P. Boonstra; beheerder: hv A.A.Oosterhof
242
Naam nachtdienst
Appendices

Naam:
Kamernummer:
Datum:
Stap 6
AC
Circulatie
Interventies
dd

patint
- 8/20 uur

- 8/20 uur

- 8/20 uur
Respiratie
ADL
Pijnbestrijding
Voeding
+
Stofwisseling
Uitscheiding
Fysiotherapie

zijn
v.J16 Patint is in staat om zelfstandig
de steunkous aan/uit te trekken
(bij vene)
v.J17 Patint geeft aan de A.D.L.
zelfstandig te verrichten (douchen)
v.J18 Patint is zoveel mogelijk uit bed
hebben geslapen
pijnbestrijding
volwaardige intake tot zich te
lichaamsbehoefte
lekken zien
vochtopname
v.I07 Patint is in staat een inspanning
te leveren op de fiets,
v.I08
procedure
protocol in
wording
procedure
procedure
protocol
(indien dit in het behandelplan is

geformuleerd)
procedure
- belasting / belastbaarheid
- inspannen / ontspannen
- hartrevalidatie
- ontslagboekje
- ADL-activiteiten
procedure
Patint heeft afsluitend gesprek

gehad met de fysiotherapeut,
waarin de volgende onderwerpen
zijn besproken:
Vervolg stap 6
243
ld
nd
Va
Appendices
AC
Voorlichting
Interventies
dd

ondersteund
v.H08 Ontslagboek is besproken met de
patint en sociaal netwerk ,
hebben geen vragen meer t.a.v.
ontslag
v.H09 Patint is aangemeld bij
verpleegkundig spreekuur (indien
dit van toepassing is)
ld
nd
Va
procedure
procedure
Beoogd resultaat: Patint is koortsvrij met stabiele vitale functies, is

genformeerd over ontslag, nazorg, leefregels, activiteiten en rust, heeft gefietst
met de fysio
Naam dagdienst
Naam fysiotherapeut
Naam late dienst

Gewijzigd: 06-01-06
Eigenaar: prof.dr. P. Boonstra; beheerder: hv A.A.Oosterhof
244
Naam nachtdienst
Appendices

Naam:
Kamernummer:
Datum:
Stap 7
Algemeen
AC
v.A11
Interventies
Routine onderzoeken dag 6 zijn
verricht
- X thorax
- ECG
- lab
Circulatie
v.B01

- 8/20 uur
v.B02
v.B03
- 8/20 uur
- 8/20 uur
v.B06
Patint heeft een stabiel gewicht in

relatie met het opnamegewicht
v.C01
v.J17

Patint is in staat de ADL zelfstandig
te verrichten (douchen)
Patint is in staat zelfstandig
steunkous aan/ uit te doen (bij vene)
Patint geeft aan acceptabel te hebben
geslapen
aangeven dat de pijnscore< 2 is
Respiratie
ADL
v.J16
v.J09
Pijnbestrijding
Voeding
+
Stofwisseling
v.E04
v.E03

aan de standaard pijnbestrijding
v.G15
Patint is in staat voldoende

volwaardige intake tot zich te nemen
passend bij zijn lichaamsbehoefte
Diabeten zie diabetenboek
v.G16
v.G13
Uitschei-ding v.B22
v.K03
Voor-lichting v.H04
v.H01
Wonden laten geen tekenen van

roodheid, zwelling of overmatig lekken
zien
Patint heeft voldoende urineuitscheiding in relatie tot de
vochtopname
Patint heeft een voor hem
Patint is in staat zijn angsten te
ondersteund
Patint en sociaal netwerk geven aan
tevreden te zijn over de psychosociale
begeleiding
dd
ld
nd
procedure
procedure
Protocol in
wording
procedure
procedure
protocol
Beoogd resultaat: Patint is koortsvrij met stabiele vitale functies, controle

onderzoeken zijn verricht: resultaten zijn binnen acceptabele grenswaarden
Naam dagdienst
Naam late dienst

Gewijzigd: 06-01-06
245
Naam nachtdienst
Va
Appendices
246
Appendices

Naam:
Kamernummer:
Datum:
Postoperatief CABG (met hart-longmachine), dag van ontslag
Stap 8
Circulatie
AC
v.B07
v.B08
v.B09
v.B20
Respiratie
ADL
v.C01
v.J17
v.J16
Pijnbestrijding
Voeding
+
Stofwisseling
v.E04
Patint geeft aan voldoende te hebben aan de

standaard pijnbestrijding
v.G15
Patint is in staat voldoende volwaardige intake

tot zich te nemen passend bij zijn
lichaamsbehoefte
Patint krijgt diabetesmedicatie volgens
voorschrift DROP (indien diabeet)
v.G13
Wonden laten geen tekenen van roodheid,

zwelling of overmatig lekken zien
(zonodig agravetang meegeven)
v.B22
Patint heeft voldoende urine-uitscheiding in

relatie tot de vochtopname
Patint heeft een voor hem aanvaardbaar
ontlastingspatroon
Meegeven bij ontslag;
brief huisarts
medicijnkaart
afspraken polikliniekbezoek
brief telefonisch spreekuur
v.K03
Voorlichting
AC
v.J17
v.G17
v.I08
v.H08

Patint is in staat de ADL zelfstandig te
verrichten ( douchen)
Patint is in staat zelfstandig steunkous aan te
trekken ( bij vene)
Patint kan m.b.v. pijnscorelijst aangeven dat de
pijnscore <2 is
v.E03
v.G16
Uitscheiding
Interventies
- 8 uur
- 8 uur
Bloeddruk is binnen de normale grenswaarden
van de patint
- 8 uur
Patint heeft een stabiel gewicht in relatie met
het opnamegewicht
v.H10
dd
procedure
Protocol in
wording
procedure
procedure
protocol
Ontslagcriteria
dd
Patint is ADL- zelfstandig; zo niet dan is hiervoor thuiszorg geregeld
Wonden laten geen tekenen van roodheid, zwelling of overmatig lekken zien
Patint heeft het mobilisatieschema van de fysiotherapeut afgewerkt
Patint heeft afrondend gesprek gehad met verpleegkundige over ontslagboekje
Beoogd resultaat: Patint gaat met ontslag.

Naam dagdienst

Gewijzigd: 06-01-06
247
Va
Va
Appendices
248
Appendices
249
Appendices
250
A BOUT
THE
A UTHOR
About the author
252
About the author
About the author

Noha El Baz was born in the cosmopolitan Mediterranean city of Alexandria on
10th of November 1973. She was educated at the Scottish school, currently
known as El Manar English school for girls, from 1977 till 1991. In 1991, she
joined the Faculty of Nursing at the Alexandria University, where she obtained
a bachelor degree with Honors in 1995 and did a one-year internship in the
Intensive Care Units of the Alexandria University hospitals. In 1996, she
volunteered as clinical demonstrator at the Critical Care Nursing department of
the Faculty of Nursing at the Alexandria University. In 1997, she was appointed
as a full-time demonstrator and later, in June 2002, obtained her masters in
Critical Care Nursing with a thesis titled The effect of two methods of
intermittent enteral feeding on outcomes of critically ill patients. In August
2002, Noha was appointed assistant-lecturer in the same department, organized
and participated in several training courses, workshops and international
conferences, in addition to her participation in preparing and editing the Critical
Care Cursing procedure manual at the Critical Care Nursing department. In
2004, Noha was awarded a full scholarship by the Egyptian government to
pursue a PhD in the Netherlands. The project titled The effect of clinical
pathways on outcomes of CABG was a collaboration between the Health
Sciences department and the Thoracic Surgery department at the UMCG,
Groningen, and the Thoracic Surgery department at HAGA hospital in The
Hague.
Her research interests are in Cardiovascular Research, Critical Care and
General Clinical Research.
253
About the author
Publications
El Baz N, Middel B, van Dijk J, Oosterhof A, Boonstra P, Reijneveld S. Are the
outcomes of clinical pathways evidence-based?A critical appraisal of clinical
pathway evaluation research. Journal of Evaluation in Clinical Practice 2007; 13
(6):920-929.
El Baz N, Middel B, Van Dijk J P, Wesselman D C M, Boonstra P W,
Reijneveld S A. EuroSCORE predicts poor health-related physical functioning
six month postcoronary artery bypass graft surgery. J Cardiovasc Surg 2008 ;49
(5):663-72
El Baz N, Middel B, van Dijk J, Boonstra P, Reijneveld S. Coronary artery
bypass graft (CABG) surgery patients in a clinical pathway gained less in
health-related quality of life as compared with patients who undergo CABG in a
conventional-care plan. (Accepted for publication, July 2008, Journal of
Evaluation in Clinical Practice)
Pedersen, S.S , El Baz, N, Middel, B. Low Positive Affect Is Associated with
More Health Complaints in Younger Bypass Patients. (Submitted).
El Baz N, Middel B., Pedersen S.S, Van Dijk J.P, Reijneveld S.A. The impact
of Type D personality on deterioration in health-related quality of life after
coronary artery bypass graft surgery is mediated by changes in anxiety and
depression. (Submitted)
El-Baz N Reda NA, El Soussi A. Bolus versus slow gravity drip enteral
feeding. 19th International Conference in Anesthesia and Intensive Care,
ALEX AIC 2003
El-Baz, N. Clinical pathways, what, how and why? at the Cardio Alex 2003
Congress, June 25th-27th, Alexandria, Egypt
El-Baz, N.
Meta Analysis on nursing researches in cardiology at the
DeltaCardio2004 annual international conference, February 24th 27th,

Alexandria, Egypt.
254
G RADUATE S CHOOL FOR

H EALTH R ESEARCH SHARE
AND
PREVIOUS DISSERTATIONS
Graduate School for Health Research SHARE and previous dissertations
256
Graduate School for Health Research SHARE

This thesis is published within the research program Public Health and
Health Services Research of the Graduate School for Health Research
SHARE. More information regarding the institute and its research can be
obtained from our internetsite: www.rug.nl/share
Previous dissertations from the program Public Health and Public Health
Services Research
Santvoort, MM van (2009) Disability in Europe; policy, social participation and
subjective well-being
Supervisor: prof dr WJA van den Heuvel
Co-supervisors: dr JP van Dijk, dr LJ Middel
Stewart RE (2009) A multilevel perspective of patients and general practitioners
Supervisors: prof dr B Meyboom-de Jong, prof dr TAB Snijders, prof dr FM
Haaijer-Ruskamp
Jong J de (2009) The GALM effect study; changes in physical activity, health and
fitness of sedentary and underactive older adults aged 55-65
Supervisor: prof dr EJA Scherder
Co-supervisors: dr KAPM Lemmink, dr M Stevens
Buist I (2008) The GronoRun study; incidence, risk factors, and prevention of
injuries in novice and recreational runners
Supervisors: prof dr RL Diercks, prof dr W van Mechelen
Co-supervisor: dr KAPM Lemmink
kodov Z (2008) Coronary heart disease from a psychosocial perspective:
socioeconomic and ethnic inequalities among Slovak patients
Supervisor: prof dr SA Reijneveld
Co-supervisors: dr JP van Dijk, dr I Nagyov, dr LJ Middel, dr M Studencan
Havlkov E (2008) Fatigue, mood disorders and sleep problems in patients with
Parkinson's disease
Supervisor: prof dr JW Groothoff
Co-supervisors: dr JP van Dijk, dr J Rosenberger, dr Z Gdovinov, dr LJ Middel
Bos EH (2008) Evaluation of a preventive intervention among hospital workers to
reduce physical load
Supervisor: prof dr JW Groothoff
Co-supervisor: dr B Krol
Wagenmakers R (2008) Physical activity after total hip arthroplasty
Supervisors: prof dr S Bulstra, prof dr JW Groothoff
257
Co-supervisors: dr M Stevens, dr W Zijlstra

Zuurmond RG (2008) The bridging nail in periprosthetic fractures of the hip;
incidence, biomechanics, histology and clinical outcomes
Supervisor: prof dr SK Bulstra
Co-supervisors: dr AD Verburg, dr P Pilot
Wynia K (2008) The Multiple Sclerosis Impact Profile (MSIP), an ICF-based
outcome measure for disability and disability perception in MS: development and
psychometric testing
Supervisors: prof dr SA Reijneveld, prof dr JHA De Keyser
Co-supervisor: dr LJ Middel
Leeuwen RR van (2008) Towards nursing competencies in spiritual care
Supervisors: prof dr D Post, prof dr H Jochemsen
Co-supervisor: dr LJ Tiesinga
Vogels AGC (2008) The identification by Dutch preventive child health care of
children with psychosocial problems : do short questionnaires help?
Supervisors: prof dr SA Reijneveld, prof dr SP Verloove-Vanhorick
Kort NP (2007) Unicompartmental knee arthroplasty
Supervisor: prof dr SK Bulstra
Co-supervisors: dr JJAM van Raay, dr AD Verburg
Van den Akker-Scheek I (2007) Recovery after short-stay total hip and knee
arthroplasty; evaluation of a support program and outcome determination
Supervisors: prof dr JW Groothoff, prof dr SK Bulstra
Co-supervisors: dr M Stevens, dr W Zijlstra
Van der Mei SF (2007) Social participation after kidney transplantation
Supervisors: prof dr WJA van den Heuvel, prof dr JW Groothoff, prof dr PE de
Jong
Co-supervisor: dr WJ van Son
Khan MM (2007) Health policy analysis: the case of Pakistan
Supervisors: prof dr WJA van den Heuvel, prof dr JW Groothoff
Co-supervisor: dr JP van Dijk
Rosenberger J (2006) Perceived health status after kidney transplantation
Supervisors: prof dr JW Groothoff, prof dr WJA van den Heuvel
Co-supervisors: dr JP van Dijk, dr R Roland
lkova M (2006) Unemployment and the health of Slovak adolescents
Supervisors: prof dr SA Reijneveld, prof dr JW Groothoff
Co-supervisors: dr JP van Dijk, dr A Madarasova-Geckova
258

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Effect of clinical pathway implementation and

ter verkrijging van het doctoraat in de

Noha El-Sayed Hussein El-Baz

Prof.dr. S.A. Reijneveld

Dr. L.J. Middel

Prof.dr. K. van der Meer

To the memory of my Uncle Professor Samir Mustafa

About the author

Graduate School for Health Research SHARE

Noha El-Sayed Hussein El-Baz

General introduction, aims and outline

where the Thoracic Surgery

department, UMCG, implemented a clinical pathway for patients undergoing

studies evaluating the effect of pathways, e.g. HRQoL and psychological

affect patients functional abilities. In addition, this introductory chapter

55 years was 277.300 in 2004, while mortality due to ischemic

Figure 1. Clinical classification of acute coronary syndromes23

1.3 Treatment of CAD

intervention (PCI) or (CABG).

coronary arteries with greater than 70% stenosis.

1% for mortality; risk increases with age and presence of

underlying disease. Operative mortality rate is 3 to 5 times higher for a second

function. Furthermore, the patient is closely monitored for systematic

There is a need for longer period of assessment to evaluate the meaningful

1.6 The clinical pathway experience

members of different disciplines involved in patient care received educational

Figure 2. The process of designing, implementing and evaluating the clinical

1.7 The conceptual model

(including emotional and cognitive variables), individual patient characteristics,

care in a CP plan to determine its effect on HRQoL and psychological distress.

complaints scales (HCS)108. Thus, it is theorized here that physiological,

1.8 Research questions

Chapter 5 is addressing the important topic of factors associated with

1.10 Reference List

18. Campeau L. Letter: Grading of angina pectoris. Circulation 1976; 54(3):522-523.

32. Jarvinen O, Saarinen T, Julkunen J, Laurikka J, Huhtala H, Tarkka MR. Improved

48. Grady KL, Meyer P, Mattea A, Dressler D, Ormaza S, White-Williams C et al.

Are the outcomes of clinical pathways evidence-based?

Are the outcomes of clinical pathways

Are the outcomes of clinical pathways evidence-based?

Kim et al. conducted a systematic review which focused on the effectiveness of

Are the outcomes of clinical pathways evidence-based?

controlled studies, cohort studies, double-blind methods, systematic review,

Methodological appraisal included papers that satisfied both criteria.

methodological characteristics of individual studies as presented in Table 1.

The appraisal of the overall methodological quality was based on a weighted

8.0 and low-quality studies scored

7.0 points. In addition to this

Are the outcomes of clinical pathways evidence-based?

Figure 1. Flowchart describing study selection and excluded studies

2.4.1 Disease treatments

Are the outcomes of clinical pathways evidence-based?

Ten studies, labeled as randomized controlled studies, comprised studies that

These randomized controlled studies followed up patients after discharge for

Furthermore, 10 randomized controlled studies were

found, of which two studies randomly assigned hospitals either to implement a

Are the outcomes of clinical pathways evidence-based?

There were studies that used a statistical test to decide whether a

difference between a CP group and a control group was due to sample