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Abstract of dissertation entitled
An evidence based guideline of pre and post operative oronasopharyngeal
care for cardiac patients
Submitted by
Leung Mei Ling
for the degree of Master of Nursing
at The University of Hong Kong
in August 2012
Background Nosocomial infection is a crucial problem and cause of
morbidity and mortality especially in cardiac surgery settings. The risk of
acquiring such infection is even higher because cardiac surgery patients require
intensive care postoperatively. The phenomenon is evidenced by longer length of
hospital stay and increased cost of care. Pneumonia and surgical site infections
were ranked among the top three most common hospital acquired infections. The
usual practice for mouth care is diluted thymol gargle solution for intubated
patients after cardiac surgery in Hong Kong. No local studies examine the effect
of oronasopharyngeal care on minimizing such infections. An evidence based
guideline in oral and nasopharyngeal nursing care is necessary to implement in
hospitals for improving patient surgical outcome.
Objective To develop an evidence based practice guideline for pre- and
postoperative oronasopharyngeal care of in-patients undergoing cardiac surgery
with implementation planning and discussion on evaluation.
Methods The most recent publications were searched till August 2011.
Randomized controlled trials with oropharyngeal and/ or nasopharyngeal care
with outcome measures on surgical site infection and/ or nosocomial pneumonia
were reviewed. Essential data were extracted with quality assessed
methodologically.
Results Six randomized controlled trials comparing oropharyngeal
and/ or nasopharyngeal care intervention with usual care were reviewed. The
studies mostly included middle-aged male patients undergoing cardiac surgery.
The results showed positively of interventions on nosocomial pneumonia and
surgical site infection when compared with usual care. In view of quality
assessments and statistically significant findings, the proposed change that could
improve surgical outcome of patients is to use chlorhexidine gluconate on
oronasopharyngeal care in the guideline. It mainly carries out in in-hospital
settings both by patients with education from nurses preoperatively, and by nurses
postoperatively.
Conclusion Reviewed evidence shown that the oronasopharyngeal care
interventions help effectively on minimizing the occurrence of nosocomial
pneumonia and surgical site infections for patients undergoing heart surgery. It
could be potentially adopted for nurses working in cardiac surgical ward and
cardiac intensive care unit.
An evidence based guideline of pre- and post operative
oronasopharyngeal care for cardiac patients
by
Leung Mei Ling
RN. H.K., BNurs. H.K.U.
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong
August 2012
Declaration
I declare that the dissertation and the research work thereof represents my own
work, except where due acknowledgement is made, and that it has not been
previously included in a thesis, dissertation or report submitted to this University
or to any other institution for a degree, diploma or other qualifications.
Signed ………………………………………………………….
Leung Mei Ling
i
Acknowledgements
I would like to express my most sincere thanks to my supervisor, Dr. Felix
Yuen, for his timely constructive feedback and guidance. His support of
innovative ideas affirms me to work hard on my goal. Without his guidance, I
could not have achieved this dissertation work.
Also thanks the help of my previous clinical instructor, Ms Veronica Lam,
and my superior, Ms Jackie Fung, for their support on my work and study, with
provision of timely response.
I would also like to take this chance to show my greatest gratitude to my
parents. I can’t imagine what I will be today without their unconditional love and
nurture.
Finally, another greatest applause will be given to God, the one who guides
me through the times of good and bad, and my friends, who accompany me
throughout those times.
ii
Contents
Declaration ……………………………………………………………… i
Acknowledgements ……………………………………………………….. ii
Table of Contents ………………………………………………………. iii
Lists of Appendices ………………………………………………………. v
Abbreviations ………………………………………………………………. vi
CHAPTER 1 INTRODUCTION
1.1 Background ……………………………………………… 1
1.1.1 Incidence of nosocomial infection
1.1.2 Prevalence
1.1.3 Lack of current practice in oral and nasal
pharyngeal care
1.2 Affirming needs ………………………………………… 3
1.2.1 Research done in foreign countries
1.2.2 Gaps on research knowledge
1.3 Aims and objectives …………………………………… 5
CHAPTER 2 REVIEW OF EVIDENCE
2.1 Search and appraisal strategies ………………………… 7
2.1.1 Criteria for selection of studies
2.1.2 Strategies for searching relevant studies
2.1.3 Methods used in performing quality assessments
2.1.4 Methods used for data extraction
2.2 Summary of the reviewed studies …………………… 12
2.2.1 Subjects characteristics
2.2.2 Screening and assessment
2.2.3 Treatment underwent in the intervention group
2.3 Quality assessment of the reviewed studies ………… 21
2.3.1 High quality studies
2.3.2 Medium quality studies
2.3.3 Low quality studies
2.4 Data synthesis from the studies reviewed ……………… 24
2.4.1 Efficacy of nasopharyngeal decontamination
iii
2.4.2 Oropharyngeal care interventions
CHAPTER 3 IMPLEMENTATION POTENTIAL
3.1 Target audience and setting ……………………………..… 28
3.2 Transferability of the findings ………………………..… 30
3.2.1 Setting similarity
3.2.2 Philosophy of care
3.2.3 Number of clients benefit from the innovation
3.2.4 Time for implementation and evaluation of the innovation
3.3 Feasibility …………………...…………………………. 35
3.3.1 Promoting factors
3.3.2 Inhibiting factors
3.4 Cost/ benefit ratio of the innovation …………………… 39
3.4.1 Cost-benefit ratio of hospitalized cardiac patients undergoing
cardiac surgery
3.4.2 Cost-benefit ratio of target department
CHAPTER 4 DEVELOPING AN EVIDENCE BASED PRACTICE
GUIDELINE
4.1 Objectives ……………………………………………… 44
4.2 Target population ………………………………………… 44
4.2.1 Target users
4.2.2 Target population
4.3 Rating scheme ………………………………………… 45
4.4 Recommendations ………………………………….……... 45
CHAPTER 5 IMPLEMENTATION PLAN
5.1 Communication plan …………………………………… 52
5.1.1 Communication plan before starting the change
5.1.2 Communication plan with managerial levels
5.1.3 Communication plan with nurses
5.1.4 Communication plan with inpatients
5.2 Pilot testing ……………………………………………… 56
5.2.1 Ethical aspect
5.2.2 Rate of surgical site infection and pneumonia
5.2.3 To measure the extent of protocol implemented by nurses
5.2.4 Reflection on the level of satisfaction of clients and nurses
5.2.5 Program utilization
CHAPTER 6 EVALUATION PLAN
6.1 Objectives and outcome measures …..……………….. 61
6.1.1 Patient outcome
6.1.2 Healthcare provider outcome
6.1.3 System outcome
6.2 Nature and number of clients involved ……………… 65
6.3 Types and timing of measurements …………………… 66
6.3.1 Ward round and documentation
6.3.2 Follow-up
6.3.3 Questionnaires and interviews
6.4 Data analysis ……………………………………….……… 68
6.4.1 Primary outcome
6.4.2 Secondary outcomes
6.5 Criteria of an effective guideline/ protocol ……………… 70
CHAPTER 7 CONCLUSION ………………………… 72
Appendices …………………………………………………… 78
References …………………………………………………… 114
iv
List of Appendices
Appendix 1
Search keywords ………………………………………… 78
Appendix 2
Search progress of databases ……………………………… 79
Appendix 3
The Scottish Intercollegiate Guideline Network (SIGN)
Guideline : methodological checklist for randomized
controlled trial ………………………………………… 84
Appendix 4
The Scottish Intercollegiate Guideline Network (SIGN)
grading system for determining level of evidence and
recommendations ………………………………………… 88
Appendix 5
Table of evidence ………………………………………… 89
Appendix 6
Table of quality assessment of reviewed studies ………… 95
Appendix 7
Flowchart of the nurse initiated guideline ……………… 107
Appendix 8
Timetable, proposed number and role of staffs ………… 108
Appendix 9
Questionnaire for evaluating level of satisfaction from
clients …………………………………………………… 109
Appendix 10
Questionnaire for evaluating level of satisfaction from
nurses …………………………………………………… 111
Appendix 11
Sample size calculation ……………………………… 113
v
Abbreviations and Symbols
Abbreviations
A&E Accident & Emergency Department
APN Advanced Practice Nurse
CABG Coronary Artery Bypass Grafting
CDC The Centers for Disease Control and Prevention
cm Centimeter
COS Chief Of Service
DOM Departmental Operations Manager
fl oz Fluid Ounce
FNA Fine Needle Aspirate
g Gram
ICU Intensive Care Unit
LOS Length Of Stay
LRTI Lower Respiratory Tract Infection
ml Milliliter
MRSA Methicillin Resistant Staphylococcus Aureus
NaCl Sodium Chloride
NG tube Nasogastric tube
NO Nursing Officer
OAH Old-aged home
RCT Randomized Controlled Trial
S. aureus Staphylococcus aureus
SSI Surgical Site Infection
URTI Upper Respiratory Tract Infection
USA The United States of America
UTI Urinary Tract Infection
VAP Ventilator Associated Pneumonia
WM Ward Manager
Symbols
% Percent
vi
1
CHAPTER 1
INTRODUCTION
1.1 Background
1.1.1 Incidence of nosocomial infections
Nosocomial infection is an infection acquired in hospitals or healthcare
facilities in which the patient is infected after the admission. That is, the infection
is not present prior to the hospitalization and is incubated upon patient’s
admission. It may also appear after discharge. The incidence of nosocomial
infections is particularly high among patients who require intensive care.
Nosocomial infections adversely affect patients’ quality of life (Segers,
Speekenbrink, Ubbink, van Ogtrop, & de Mol, 2006). In comparison to patients
without nosocomial infections, infected patients usually have longer length of
hospital stay and increased healthcare cost and that in turn affects human costs
and resources allocation. It is estimated that the treatment cost for patients with
sterna wound complications is 2.8 times higher than those with uncomplicated
postoperative courses (Ridderstolpe, 2001).
Among critically ill patients, ventilator-associated pneumonia is another
common and highly morbid condition. The Centers for Disease Control identified
four methods of inoculations that can cause nosocomial respiratory infections and
2
aspiration is regarded as the most important method. Therefore, in theory,
reducing the microbes/ flora in oropharyngeal area should positively affect
nosocomial respiratory infections (DeRiso, Ladowski, Dillon, Justice, & Peterson,
1996).
1.1.2 Prevalence
The Centre for Health Protection, Department of Health published a report
documenting a survey which examined the prevalence of infection among all
public hospitals in Hong Kong. The survey was conducted during July to
September 2010. According to the report, pneumonia and surgical site infections
are the top three most common hospital acquired infections. The prevalence of
pneumonia and surgical site infection was found to be 28.6% and 16%
respectively (Centre for Health Protection, 2011).
On the other hand, it is found that there were 7.4 to 67% nasal MRSA
carriers upon admission to the surgical department, whereas only 4.7 to 32% of
patients were found free of MRSA during hospitalization (Infection Control Team,
Queen Mary Hospital, 2012).
1.1.3 Lack of oral and nasopharyngeal care in the current practice
Modified nursing intervention, in addition to medical intervention, could
reduce nosocomial respiratory infections. However, because of inconclusive study
3
results and concerns about antimicrobial resistance, interventions such as
decontamination of digestive tract is not suggested to be used widely as a routine
prevention protocol (DeRiso, et al., 1996; Segers, et al., 2006). Therefore,
effective oral and nasal care interventions supported by evidence should be
developed. The best evidence can then be translated into practice to improve
patient care and reduce the emergence of antibiotic-resistant infections through
more effective infection control practice.
The pathogen species which have the potential to cause infectious respiratory
diseases are present in oropharyngeal and nasopharyngeal secretions (Okuda,
Kaneko, Ichinohe, Ishihara, & Okuda, 2003). It has been shown that the
pathogenesis of ventilator-associated pneumonia involves microaspiration of
oropharyngeal or gastric secretions contaminated with infectious organisms
(Collard, Saint, & Matthay, 2003). The microorganisms form biofilms which act
as reservoirs for respiratory pathogens and protect them from antibiotic and
chemical attack. The risk is especially high for patients with poor oral hygiene
(Okuda, et al., 2003).
1.2 Affirming needs
1.2.1 Research done in foreign countries
0.12% chlorhexidine gluconate oral rinse is commonly prescribed to treat
4
gingivitis. It is suggested that the oral rinse treatment can reduce oropharyngeal
flora in intubated patients by decreasing the temporary bacteremia caused by
mucosal damage during intubation, and in turn reduce the hematogenous bacterial
spread. This has been studied comprehensively and marked decrease in bacterial
load in the oral cavity for about 50% over 3 months has been demonstrated.
On the other hand, it is shown that nasal carriers of Staphylococcus aureus are at a
higher risk of infections after invasive procedures than the non-carriers. Carriers
were two to nine times more likely to be associated with surgical site infections
(Perl, Cullen, Wenzel, Zimmerman, Pfaller, Sheppard, Twombley, French &
Herwaldt, 2002).
1.2.2 Gaps in research knowledge
In intensive care units in Hong Kong, the usual practice for mouth care is
diluted thymol gargle solution for intubated patients after cardiac surgery. Only a
minority of patients who have undergone thoracic surgery requires intensive care.
There is lack of local study on the efficacy of the active ingredients of thymol
gargle solution or 0.12% chlorhexidine gluconate oral rinse to reduce the rate of
nosocomial infections. Moreover, whether and how ventilator-associated
pneumonia is preventable by thymol gargle solution remains unknown.
Furthermore, 2% mupirocin calcium ointment nasal decolonization is used in
5
patients requiring dialysis. The practice of applying the ointment preoperatively in
the surgical ward for patients who have undergone cardiothoracic surgery has
been carried out for a short period. However, the efficacy of mupirocin on
reducing SSI has not been studied.
Therefore, an evidence-based guideline in oral and nasopharyngeal nursing
care is established for exploration.
1.3 Aims and objectives
In view of the knowledge gap in the current practice, the aim of this
dissertation is to devise an effective evidence-based practice guideline for the pre-
and post-operative oral and nasopharyngeal care intervention for patients who
have undergone cardiac surgery.
The objectives are:
1. To review the current stage of knowledge regarding the effectiveness of
chlorhexidine gluconate oral rinse and 2% mupirocin nasal ointment for
patients who have undergone cardiac surgery systematically.
2. To summarize the relevant information from the selected studies into the table
of evidence and assess the quality of each study.
3. To assess the implementation potential of the evidence reviewed in terms of
the transferability, practicability and financial efficacy in the cardiothoracic
6
surgical department.
4. To summarize the study results and translate the evidence to develop an
evidence-based guideline about oral care intervention for patients who have
undergone cardiac surgery.
5. To synthesize an implementation plan and an evaluation plan for the
guideline.
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CHAPTER 2
REVIEW OF EVIDENCE
This chapter describes an evidence review on the effectiveness of oral and/ or
nasopharyngeal decontamination for patients who have undergone cardiothoracic
surgery and require intensive care afterwards. The review comprises the searching
and appraisal strategies, summary of the findings and quality assessment,
summary and synthesis of the available data. The research question in this
dissertation is: What is/ are the most effective oral and nasopharyngeal care
intervention(s) to minimize pneumonia and surgical site infections in patients who
have undergone cardiac surgery?
2.1 Search and appraisal strategies
2.1.1 Criteria for selection of studies
The inclusion criteria are based on study design, population, intervention and
outcome.
Study design: Only randomized controlled trials focusing on oropharyngeal
and/ or nasopharyngeal preparation in wards and intensive care units were
included to compare with the usual practice (control) and synthesize the best level
of evidence.
Population: Studies with the following patients’ characteristics were
8
included to align with the requirement of the guideline: (1) adult inpatients (aged
18 or above); (2) patients who have undergone single or a combination of surgical
procedures such as coronary artery bypass grafting, off-pump coronary artery
bypass, valve surgery and surgeries related to aorta; (3) patients with pulmonary
risk factors such as preoperative chronic obstructive pulmonary disease,
preoperative use of steroids, history of diabetes mellitus and history of smoking
were included. Studies were accepted if all of the above patient criteria were met.
Intervention: Studies with interventions on oral and/ or nasopharynx were
included. The intervention media could be mouthwash, ointment, gel or spray.
There is no limitation on how the interventions were delivered (by patients, by
nurses, reading leaflets or pamphlet, following the instructions from
manufacturers, educational program, video, return demonstration) and the
frequency of application.
Outcome: Outcome measure is defined as the overall reduction rate of
nosocomial pneumonia and/ or surgical site infections. The definition of infection
is defined by the Centers for Disease Control and Prevention (Horan TC, 2008).
Surgical site infection is defined clinically by purulent discharge or cellulitis
around wound sites or drain insertion sites. The depth of the infected surgical
wound (such as involvement of organ space) is defined individually. Nosocomial
9
pneumonia is defined by clinical and radiological criteria of new and progressive
radiological opacities of pulmonary parenchyma, purulent sputum with onset of
fever. These are non-specific criteria. More specific diagnosis is made by
obtaining samples from bronchoscopy.
2.1.2 Strategies for searching relevant studies
Four databases, namely CINAHL Plus, PUBMED, ScienceDirect and the
Cochrane library were used to search for suitable research papers. Only studies
written in English with full text available were included. There was no restriction
in terms of the year and types of publication. Google scholar was also used not
only as a database, but also as an adjunct when no full text was available but the
topic of the paper was relevant. Keywords stated on the paper were used in the
search and some studies were found from the reference list of the selected studies.
Keywords used are listed in appendix 1.
There were 7638 references retrieved on 27th
August, 2011 from the
databases. By applying the inclusion criteria, 7592 publications were excluded
due to unmatched type of publications such as letters, editorials and so on. The
remaining 46 papers were screened to exclude studies which were not randomized
controlled trials (28 papers). Twelve papers were further excluded because the
patients were not related to cardiothoracic surgery in the second screening.
10
Three of the remaining 8 studies were found to be duplicated in further
searching and/ or in different databases. One paper was found in the reference list
of the studies. Finally 6 studies were included in the review. The database search
process is shown in Appendix 2.
2.1.3 Methods used in performing quality assessments
Quality of all relevant studies was critiqued by a checklist developed by the
Scottish Intercollegiate Guideline Network (SIGN) (2008a). The checklist has
been widely used as a handy tool for guideline development since 90’s in different
countries. A variety of checklists is available for assessing different levels of
evidence. The adopted checklist is attached in appendix 3.
To sum up, the following areas of each study were assessed:
i. Appropriateness and clearness of the research question;
ii. Randomization;
iii. Adequacy of concealment method;
iv. Blinding;
v. Homogeneity of treatment and control groups at baseline;
vi. If the only difference is the treatment between the groups;
vii. Validity and reliability of the relevant outcome(s);
viii. Attrition rate comparison; and
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ix. Method(s) of data analysis.
Rating of each criterion was categorized as ‘well covered’, ‘adequately/
poorly/ not addressed’, ‘not reported’ and ‘not applicable’. ‘Not addressed’ means
such information is ignored or not mentioned, whereas ‘not reported’ means the
data mentioned is not sufficient for assessment. After assessing the internal
validity of each study, overall grading was given as 1++, 1+ or 1- for the
randomized controlled trial based on a grading system as attached in appendix 4.
Study bias, certainty of outcomes due to the study intervention and applicability
of the findings for guideline development were assessed. The quality assessment
of the studies will be summarized in later paragraphs.
2.1.4. Methods used for data extraction
To summarize the information of each study and extract the most relevant data
for producing a more comprehensive picture in translating for the guideline, the
following types of data are recorded in different columns of the table of evidence,
as attached in appendix 5:
i. Author(s), name of journal and year of publication;
ii. Study design and total number of participants;
iii. Subject characteristics such as age, gender, body mass index (BMI), surgical
procedure, smoking status, history of other illnesses, postoperative
12
characteristics as the baseline measurement;
iv. Details of the intervention delivery such as the materials and concentration
used, length of time, frequency and criteria to stop the intervention;
v. Treatments received for the control group compared to the treatment group;
vi. Follow-up methods;
vii. Primary and secondary outcome measures, if any;
viii. The effect size of each outcome measures, if any, denoting the confidence
interval and p-value.
2.2 Summary of the reviewed studies
The categories to be summarized in this review are the subjects’
characteristics, the treatments undergone in the intervention group and the control
group (routine, standard care or placebo), characteristics of the follow-up and the
outcome measures.
2.2.1 Subjects’ characteristics
Six randomized controlled trials were selected and included in this review.
Among the total of 7813 participants, 3343 were randomized to receive oral care
intervention or nasal care intervention. The settings were in hospitals, with the
majority in both ward and intensive care unit (DeRiso, et al., 1996; Houston et al.,
2002; Konvalinka, Errett, & Fong, 2006; Perl, et al., 2002; Segers, et al., 2006).
13
The interventions were taken place in the United States (DeRiso, et al., 1996;
Houston, et al., 2002; Perl, et al., 2002), the Netherlands (Koeman et al., 2006;
Segers, et al., 2006) and Canada (Konvalinka, et al., 2006). In all of the
participants, about 50% to 75% were men, aged 50 to 70 and with body mass
index of 16 to 39 (Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al., 2006).
Health status: In terms of pulmonary risk factors, 2% to 30% of the subjects
were with chronic obstructive pulmonary disease (DeRiso, et al., 1996; Houston,
et al., 2002; Konvalinka, et al., 2006; Segers, et al., 2006), 0.3% to 11% were
receiving immunosuppressive therapy such as steroid (DeRiso, et al., 1996; Perl,
et al., 2002), 9% to 28.5% were having diabetes mellitus (DeRiso, et al., 1996;
Houston, et al., 2002; Koeman, et al., 2006; Konvalinka, et al., 2006; Perl, et al.,
2002; Segers, et al., 2006) and 5.5% to 60% of patients were smokers (DeRiso, et
al., 1996; Houston, et al., 2002; Konvalinka, et al., 2006; Perl, et al., 2002; Segers,
et al., 2006).
About 23% of subjects were nasal carriers of Staphylococcus aureus
(Konvalinka, et al., 2006).
Information about the operation: Around 18.5% to 22% of the clients had
already stayed in the hospital before the operation, while 2.3% to 18.6% stayed
for more than 1 day before the surgery (Konvalinka, et al., 2006; Perl, et al., 2002).
14
In terms of the surgical procedure involved, 50% to 87% of the patients
underwent coronary artery bypass grafting, 10% to 22.2% were involved in valve
surgery (DeRiso, et al., 1996; Konvalinka, et al., 2006; Segers, et al., 2006), with
the procedure duration ranging from 140 minutes to 305 minutes.
Post-operative status: After the operations, 3.1% to 9.3% of the participants
needed reoperation/ re-exploration (Houston, et al., 2002; Konvalinka, et al., 2006;
Segers, et al., 2006); 1.5% to 3.8% acquired acute myocardial infarction; 3% to
20% required prolonged inotropic support for more than 24 hours, and the
duration of postoperative ventilation varied from 8.3 hours to 13.5 hours
(Konvalinka, et al., 2006; Segers, et al., 2006). 1.1% to 6% had renal failure
(Houston, et al., 2002; Segers, et al., 2006); about half of the participants required
blood transfusion and around 20% transfused more than 5 units of blood (Houston,
et al., 2002).
2.2.2 Screening and assessment
Four studies mentioned the assessment tools and screening methods used
(Koeman, et al., 2006; Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al.,
2006). The European System for Cardiac Operative Risk Evaluation
(EuroSCORE), which is used for prediction of cardiac surgery outcome (Segers,
et al., 2006), allocates 17 risk factors into incremental risk points to reflect the
15
operative mortality. Another tool is the clinical pulmonary infection scores (CPISs)
for post-operative patients (Koeman, et al., 2006). It is suggested to calculate the
score daily. Two studies had nasal culture done before operation to identify the
nasal carriers of S. aureus (Konvalinka, et al., 2006; Perl, et al., 2002).
2.2.3 Treatment underwent in the intervention group
Material: In the reviewed studies, 0.12% chlorhexidine gluconate was mostly
used (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al., 2006) while 2%
chlorhexidine and 2% chlorhexidine with colistin 2% were applied as the
intervention in one study (Koeman, et al., 2006). Another material used was 2%
mupirocin calcium (Konvalinka, et al., 2006; Perl, et al., 2002). No other
concentration was noted in the studies.
Quantity: 15 ml (Houston, et al., 2002) or 0.5 fl oz (DeRiso, et al., 1996) of
the material in the form of solution was used among the studies. In one study
approximately 2cm, 0.5g of paste was applied (Koeman, et al., 2006).
Texture: As for the texture of the medium, mouth rinse solutions were used
in half of the studies (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al.,
2006). Apart from solutions, the gel form nasal ointment (Koeman, et al., 2006;
Perl, et al., 2002; Segers, et al., 2006) and petroleum jelly (Konvalinka, et al.,
2006) were also used.
16
Timing: The frequency, timing and period of application varied among
different studies. The intervention was applied for 30 seconds for mouth rinse
(Segers, et al., 2006). The frequencies ranged from twice daily (DeRiso, et al.,
1996; Houston, et al., 2002; Konvalinka, et al., 2006; Perl, et al., 2002) to 4 times
daily (Koeman, et al., 2006; Segers, et al., 2006). The intervention started
immediately after hospitalization (Segers, et al., 2006), preoperatively (DeRiso, et
al., 1996; Houston, et al., 2002; Segers, et al., 2006), 5 days before operation (Perl,
et al., 2002) and 7 days before operation (Konvalinka, et al., 2006). After the
operation, the intervention continued until the NG tube was removed, which can
be the day after surgery (Segers, et al., 2006), until discharge from ICU (DeRiso,
et al., 1996), for 10 days postoperatively, until extubation, tracheostomy,
diagnosis of pneumonia or death (DeRiso, et al., 1996; Houston, et al., 2002).
Administration method: All of the studies explained in detail for the
administration methods of the medication. It was mostly administered by health
care workers (Houston, et al., 2002; Koeman, et al., 2006; Perl, et al., 2002;
Segers, et al., 2006) with the use of cotton swabs (Perl, et al., 2002), Q-tip cotton
applicator (Konvalinka, et al., 2006), or with sponge as an aid (Segers, et al.,
2006). Though not stated explicitly, some studies implied that the intervention
was administered by health care workers, since the patients were sedated until
17
extubation after operation (DeRiso, et al., 1996; Konvalinka, et al., 2006). Patients
were instructed to perform the intervention independently when they were capable
to do so (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al., 2006).
Site of application: The areas for application were at the pharyngeal, gingival
and tooth surfaces (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al.,
2006), tongue (Houston, et al., 2002), interior of each anterior naris (Perl, et al.,
2002), the vestibule to both nares (Konvalinka, et al., 2006), each side of the
buccal cavity (Koeman, et al., 2006) and both nostrils (Segers, et al., 2006).
Application instructions: Patients were instructed to rinse the application area
with the solution for 30 seconds with full strength to ensure adequate contact was
made with the area. In addition, ingestion of the agent, eating or drinking in 30
minutes after rinsing was prohibited (DeRiso, et al., 1996; Houston, et al., 2002).
Nursing staff was advised that after removing remnants of the previous dose
with a gauze moistened with saline (NaCl 0.9%), the paste was put on and
administered by a gloved fingertip so that the medication can be evenly
distributed (Koeman, et al., 2006). Another way was by swabbing the intubated
patient's oral cavity thoroughly (Houston, et al., 2002).
18
2.2.4 Intervention for the control group
Placebo with identical packaging, comparable color, taste and smell was used
(DeRiso, et al., 1996; Segers, et al., 2006); others such as Listerine (phenolic
mixture) (Houston, et al., 2002), placebo ointment with identical appearance with
the intervention medium (Konvalinka, et al., 2006; Perl, et al., 2002) and
petroleum jelly (Vaseline) (Koeman, et al., 2006) were used.
2.2.5 Follow-up and outcome measures
The mean follow-up period was 30 days after operation (Perl, et al., 2002).
Data was collected via contacting and visiting the cardiology department (Segers,
et al., 2006), reviewing medical records every 3 to 5 days (Koeman, et al., 2006;
Perl, et al., 2002; Segers, et al., 2006). Prospective wound surveillance was done
by a research assistant by reviewing the microbiology logs and nursing reports
biweekly (Perl, et al., 2002). Clinical pulmonary infection scores (CPISs) for all
patients were calculated daily (Koeman, et al., 2006).
Objective data were obtained by taking chest radiograph (DeRiso, et al.,
1996), oropharyngeal swabs daily (Koeman, et al., 2006), collecting sputum
samples when clinically indicated (DeRiso, et al., 1996) or during extubation
(Houston, et al., 2002) or every 48 hours (DeRiso, et al., 1996; Houston, et al.,
2002) then every 2 days (DeRiso, et al., 1996) if patients were not extubated
19
within 24 hours postoperatively until extubation or death (DeRiso, et al., 1996;
Houston, et al., 2002). It was done twice weekly if no clinical cultures were
obtained (Koeman, et al., 2006). Nasal cultures were obtained 2 weeks before the
surgery and at admission; wound cultures were collected for wounds with
drainage or debridement, and blood cultures were obtained for febrile and septic
patients (Konvalinka, et al., 2006). Additional cultures were obtained when
clinically necessary (DeRiso, et al., 1996).
Diagnosis of infection was done independently by physicians (Houston, et al.,
2002; Koeman, et al., 2006), infection control practitioners (Houston, et al., 2002)
and radiologists (DeRiso, et al., 1996), and was verified by three intensivists
(Koeman, et al., 2006).
After discharge, general practitioners (Konvalinka, et al., 2006) and patients
(Konvalinka, et al., 2006; Perl, et al., 2002) were telephoned weekly (Perl, et al.,
2002) or twice monthly (Konvalinka, et al., 2006) to determine any signs and
symptoms of infection. Patients were asked to phone back if signs and symptoms
of infection were developed. Surgeons completed a formal post-discharge
surveillance 6 to 8 weeks after surgery (Konvalinka, et al., 2006).
The primary outcome measures were the overall incidence of nosocomial
infection (DeRiso, et al., 1996; Segers, et al., 2006), pneumonia (Houston, et al.,
20
2002) as defined by the Centers for Disease Control and Prevention, rate of
surgical site S. aureus infections (Konvalinka, et al., 2006; Perl, et al., 2002) and
time to VAP (Koeman, et al., 2006). The incidence of the overall nosocomial
infection was significantly lower in the mouth rinse group than the control group.
(DeRiso, et al., 1996; Segers, et al., 2006), while the time to VAP was
significantly reduced in the chlorhexidine gel group (Koeman, et al., 2006).
Secondary outcomes included the incidence of URTI, LRTI (DeRiso, et al.,
1996; Segers, et al., 2006) and SSI, SSI among nasal carriers of S. aureus, UTI,
fungemias, wound infection rates, blood infection rates, other infections, line
sepsis rates, overall and site specific rates of nosocomial infection; S. aureus nasal
carriage and rate of nosocomial infections with S. aureus (Konvalinka, et al., 2006;
Perl, et al., 2002), oral colonization with gram-positive and gram-negative
microorganisms, endotracheal colonization, nonprophylactic antimicrobial use
(DeRiso, et al., 1996; Segers, et al., 2006), duration of hospital stay, in-hospital
mortality (DeRiso, et al., 1996; Koeman, et al., 2006; Segers, et al., 2006),
all-cause ICU mortality and complications due to infections, adverse effects of
trial medication, influence of the preoperative duration of trial medication on the
incidence of nosocomial infection; duration of intubation and the need for
reintubation (DeRiso, et al., 1996).
21
Similarly, statistically significant results was noted in the treatment groups
that received chlorhexidine in the form of mouth rinse, gel or ointment (DeRiso,
et al., 1996; Koeman, et al., 2006; Segers, et al., 2006).
2.3 Quality assessment of the reviewed studies
Appendix 6 summarizes the quality assessment of studies. In general, all the
studies have set an appropriate and clear research question, in which the subjects’
characteristics such as medical history, risk factors and infection status were
compared (DeRiso, et al., 1996; Houston, et al., 2002; Koeman, et al., 2006;
Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al., 2006). The only
difference between the treatment and control groups was chlorhexidine gluconate
(DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al., 2006) chlorhexidine
gluconate with colistin 2% (Koeman, et al., 2006) or mupirocin calcium
(Konvalinka, et al., 2006; Perl, et al., 2002). No statistically significant difference
was noted between the treatment group and the control group (DeRiso, et al.,
1996). In addition, all studies adopted intention to treat analysis as the method of
data analysis. Actual treatment analysis means re-analysis of patients in the
placebo group who have taken the intervention or vice versa (Konvalinka, et al.,
2006). The average attrition rate was low, with 3.93% among the studies (Houston,
et al., 2002; Koeman, et al., 2006; Konvalinka, et al., 2006; Perl, et al., 2002;
22
Segers, et al., 2006).
2.3.1 High quality studies
Three studies were rated as 1++ because of high quality, well done
randomization, allocation concealment and blinding process and clear definition
of outcome measures, which minimize the risk of bias and enhance generalization
of findings (DeRiso, et al., 1996; Konvalinka, et al., 2006; Segers, et al., 2006).
These studies carried out randomization through a computer-driven random
number generator after consent was obtained and the baseline characteristics
assessment, with 1:1 ratio for the treatment and control groups. Allocation
concealment was assured by the randomization being carried out by the pharmacy.
The randomization was independent and the pharmacy only involved dispensing
the active drug or placebo. Therefore, selection bias was minimized. Attrition rate
was about 2%, and the reasons of attrition included discontinuation of treatment,
patients received selective decontamination of digestive tract after recruited to the
trial and cancellation of surgery. The attrition rate was low as all subjects studied
were in-patients. Keeping telephone contact periodically could reduce attrition
after discharge (Konvalinka, et al., 2006; Perl, et al., 2002).
2.3.2 Medium quality studies
Among the studies, the study of Houston et al. (2002) was rated as 1+ level
23
of evidence because of the relatively higher risk of bias when compared with the
high quality studies although it was also a well conducted RCT. Patients were
randomized and assigned consecutively to the experimental or the control group
by medical record numbers. The method of randomization was not described in
detail. No evidence of blinding or allocation concealment was reported, which
increases selection bias. The attrition rate was also higher (6% on average).
2.3.3 Low quality studies
The remaining 2 RCTs were rated as 1- in level of evidence because the risk
of bias was the highest among all studies (Koeman, et al., 2006; Perl, et al., 2002).
No evidence of allocation concealment was reported in both studies, which
increases the selection bias. Furthermore, statistical difference was not presented
after comparing the baseline characteristics between the treatment and control
groups. In the study of (Koeman, et al., 2006), consensus in terms of the
interpretation of VAP diagnosis was reached through telephone conversations by
the intensivists, which affects transparency because the conversation was not
known by others. Also, the cases of consented patients withdrawn from the study
were still analyzed, which affects interpretation of the effects of the study
medication.
As for the study of (Perl, et al., 2002), the risk of attrition bias is high as the
24
attrition rate is more than 10%. The authors did not identify, justify or look into
the reason behind such high attrition rate. No baseline comparison was made
between the subjects completed the study and the subjects dropped out.
2.4 Data synthesis from the studies reviewed
2.4.1 Efficacy of nasopharyngeal decontamination
Nasal decontamination with mupirocin is not the first priority suggested
for nasopharyngeal care in reducing nosocomial pneumonia and/ or SSI. It is
because only one study found that the overall rate of nosocomial S. aureus
infections was reduced in the nasal carriers of S. aureus (Perl, et al.,
2002)(evidence level 1-).
2.4.2 Oropharyngeal care interventions
Agent: 0.12% chlorhexidine gluconate (DeRiso, et al., 1996; Houston, et al.,
2002; Segers, et al., 2006)(evidence level 1++, 1+ and 1++ respectively) and
chlorhexidine 2% (Koeman, et al., 2006) (evidence level 1-) are suggested.
Although the evidence level is 1-, higher concentration is recommended for
patients with higher risks of nosocomial pneumonia, that is, patients intubated for
more than 24 hours with heavy bacterial growth in the sputum samples (Houston,
et al., 2002) (evidence level 1+).
Quantity: 15 ml (Houston, et al., 2002) (evidence level 1+) or 0.5 fl oz
25
(DeRiso, et al., 1996) (evidence level 1++) of mouth rinse is suggested to be the
optimal amount of solution to ensure adequate contact of the solution with the
buccal, gingival, tongue, pharyngeal and teeth.
Texture: Mouth rinse (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et
al., 2006) (evidence level 1++, 1+ and 1++ respectively), nasal gel/ ointment
(Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al., 2006) (evidence level
1++, 1- and 1++ respectively) and petroleum jelly (Koeman, et al., 2006)
(evidence level 1-) are suggested as these textures do not interfere with the effect.
Timing: All studies recommended the mouth rinse to be applied for 30
seconds. The application frequency was suggested to be twice daily (DeRiso, et
al., 1996; Houston, et al., 2002; Konvalinka, et al., 2006; Perl, et al., 2002)
(evidence level 1++, 1+, 1++ and 1-) to 4 times daily (Koeman, et al., 2006;
Segers, et al., 2006) (evidence level 1- and 1++). It is suggested to start
immediately after hospitalization (Segers, et al., 2006) (evidence level 1++) or
before operation (DeRiso, et al., 1996; Houston, et al., 2002) (evidence level 1++
and 1+). If the patients wish to do so, it could be initiated 5 days to 7 days before
operation (Konvalinka, et al., 2006; Perl, et al., 2002). After the operation, the
intervention continued until the day after surgery (Segers, et al., 2006) (evidence
level 1++), or until extubation and discharge from ICU (DeRiso, et al., 1996)
26
(1++), or when the infection was diagnosed, because chlorhexidine has limited
therapeutic function as antiseptics or antimicrobial peptides but acts very well for
prevention. Thus, antimicrobial therapy should be initiated as soon as possible
(DeRiso, et al., 1996; Houston, et al., 2002; Koeman, et al., 2006; Konvalinka, et
al., 2006; Perl, et al., 2002; Segers, et al., 2006).
Administration method: The oral care could be done by patients who are
conscious and capable (DeRiso, et al., 1996; Houston, et al., 2002; Segers, et al.,
2006) (evidence level 1++, 1+ and 1++). It could be administered by health care
workers when patients are sedated or not able to perform the care (DeRiso, et al.,
1996; Houston, et al., 2002; Koeman, et al., 2006; Perl, et al., 2002) (evidence
level 1++, 1+, 1- and 1-).
Application instructions: Patients are instructed to rinse the oral cavity with
the solution for 30 seconds with full strength to ensure adequate contact with the
application area. Patients are taught not to eat or drink for half an hour after
rinsing. (DeRiso, et al., 1996; Houston, et al., 2002) (evidence level 1++ and 1+).
To provide oral care to patients, nurses could thoroughly swab the surfaces
of the intubated patient's oral cavity with the aid of cotton swabs (Houston, et al.,
2002), Q-tip cotton applicator (Konvalinka, et al., 2006), gloved fingertip
(Koeman, et al., 2006) or sponge (Segers, et al., 2006). Remnants of the previous
27
dose are advised to be removed with a gauze moistened with saline (NaCl 0.9%).
28
CHAPTER 3
IMPLEMENTATION POTENTIAL
After identifying and assessing the current stage of knowledge in view of
incidence, prevalence, current practice and research gap, an appraisal and
summary of the effectiveness of pre- and post-operative oronasopharyngeal care
intervention for hospitalized cardiac patients was come up from 6 randomized
controlled trials. An outline of the procedures of the intervention is included.
In this chapter, implementation potential of the proposed intervention is
assessed and discussed in terms of the target setting, the transferability of the
findings, the feasibility and the cost-benefit ratio of the intervention (Polit, 2012).
3.1 Target audience and setting
As no specific oronasopharyngeal care for patients undergoing heart surgery
is currently available, a clinical guideline for practice should be developed. The
guideline should be based on recommendations from this clinic area. It should be
tailored for hospitalized adult patients with cardiac disease who are eligible for
heart surgery.
The target setting of the interventions is 2 surgical wards and 1 adult ICU of
the department of cardiothoracic surgery, which locate within an acute public
29
hospital in Hong Kong. The total number of beds in the target setting is 64 and the
average rate of bed occupancy is 56.9% (Hospital Authority, 2010a). In general,
the targeted patients of the interventions should be diagnosed with hypertension,
chronic rheumatic heart disease, heart failure, aortic/ mitral and/ or tricuspid
insufficiency/ regurgitation, coronary heart disease. Their average length of stay is
7.5 days.
The target group of the proposed change is patients:
who age 18 years old or above;
are conscious upon admission;
are admitted for elective surgery, including single or a combination of
surgical procedures such as coronary artery bypass grafting, off-pump
coronary artery bypass, valve surgery and surgeries related to aorta.
In the proposed innovation, cooperation from various parties, such as
healthcare workers, pharmacists and patients, is essential and is the key to success.
Since frontline nurses in the ward and intensive care settings spend most of their
time with patients and they understand the patients’ needs and ways to
communicate with patients, they should take the lead to initiate the change.
30
3.2 Transferability of the findings
The following paragraphs describe the considerations in terms of the
similarity of the settings, philosophy of care, number of clients benefited from the
innovation, and the schedule of the implementation and evaluation of the
innovation.
3.2.1 Similarity of the settings
All studies included in the review were conducted in tertiary care hospitals.
One of the reviewed studies was conducted in university hospitals (Koeman et al.,
2006) and another was carried out in the cardiovascular ICU (DeRiso, Ladowski,
Dillon, Justice, & Peterson, 1996). One was conducted in mixed settings and
surgical ICUs (Koeman, et al., 2006) while one was in the setting of mixed
surgical setting (Perl et al., 2002). Although not explicitly stated, three studies had
similar settings for caring preoperative and postoperative cardiac patients
(Houston et al., 2002; Konvalinka, Errett, & Fong, 2006; Segers, Speekenbrink,
Ubbink, van Ogtrop, & de Mol, 2006). Among all studies, only two studies
reported the capacity. Specifically, one study mentioned that 1200 cardiac surgical
procedures were performed each year in a hospital with 480 beds (Segers, et al.,
2006) and another study stated that more than 1500 cardiac cases required
31
cardiopulmonary bypass were admitted annually (Houston, et al., 2002). The
capacity of the setting in other studies was not mentioned. Although the
nurse-to-patient ratio in ward and ICU was not stated in all studies, the burden and
transferability should not vary much because of the relative low level of bed
occupancy rate in the current setting.
Three of the six studies were conducted in the United States (DeRiso, et al.,
1996; Houston, et al., 2002; Perl, et al., 2002), while two were conducted in the
Netherlands (Koeman, et al., 2006; Segers, et al., 2006) and the remaining one
was performed in Canada (Konvalinka, et al., 2006). Although no similar study
has been conducted in Hong Kong, transferability of the results from these
reviewed studies into Hong Kong should still be high as the clinical settings in
Hong Kong are similar to those reported settings. Also, Hong Kong is an
international city with democratic stance. It integrates different cultural
perspectives and always adopts the good caring model from foreign countries.
Furthermore, oral hygiene in ICU is not new in nursing care and oral hygiene is
associated with VAP (Bergmans et al., 2001; Collard, Saint, & Matthay, 2003;
Kelleghan, 1993; Okuda, Kaneko, Ichinohe, Ishihara, & Okuda, 2003). The
current practice is thymol gargle cleansing and the frequency is according to
32
hospital protocol.
The characteristics of the subjects in this proposed innovation will be similar
to those mentioned in the reviewed studies. The majority of the subjects in the
reviewed studies were patients who underwent heart surgery (DeRiso, et al., 1996;
Houston, et al., 2002; Konvalinka, et al., 2006; Segers, et al., 2006), patients who
underwent surgery (Perl, et al., 2002) and patients who needed mechanical
ventilation (Koeman, et al., 2006). The subjects in all reviewed studies aged from
50 to 70 with 50% to 75% of them were men. Such aspect is similar to the current
setting. Meanwhile, similarity is also noted in diabetes and smoking status. About
9% to 25% of patients in the reviewed study were diagnosed with diabetes
mellitus (DeRiso, et al., 1996; Houston, et al., 2002; Koeman, et al., 2006;
Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al., 2006) and about 5.5% to
60% of patients were found to be smokers (DeRiso, et al., 1996; Houston, et al.,
2002; Konvalinka, et al., 2006; Perl, et al., 2002; Segers, et al., 2006). This is
similar to the current practice setting in which 20% of patients are diagnosed with
DM and around 15% are reported to be smokers.
Similarity is also identified for the LOS in hospital before surgery, type of
surgery involved and length of operation time. In some reviewed studies, less than
33
5% of patients stayed in hospital for more than 1 day before their operations
(Konvalinka, et al., 2006; Perl, et al., 2002). Also, in the reviewed studies,
approximately 50% of the patients had coronary artery bypass grafting and their
surgery procedures time lasted around 2 to 4 hours (DeRiso, et al., 1996;
Konvalinka, et al., 2006; Segers, et al., 2006).
3.2.2 Philosophy of care
The philosophy of care underlying the innovation is similar with that in the
practice setting. In particular, holistic and person-centered approach is adopted for
the innovation. Emphasis is placed on the right for patients to control their own
lifestyle. Therefore, it is vital to empower the patients for them to make informed
choices in their healthcare. Nurses’ assistance can help to achieve this goal with
clients by helping them to develop relevant knowledge and skills. The road
towards optimum health can be achieved by working in partnership by
incorporating with the significant others in the illness continuum. In the current
practice setting, cardiac nursing emphasis on knowledgeable practice and thus the
principles of cardiac nursing are evidence based and flexible in the meantime in
order to keep up with rapid advances in medicine (Hospital Authority, 2010b).
The proposed innovation recognizes the need of a multi-disciplinary team. To
34
enhance the quality of patient-centered nursing care for cardiac patients, nursing
practice must be developed continuously. In addition, in order to meet the needs,
reform and revise of the nursing care should be considered periodically.
Analyzing the problem, solving the problem and performing modification after
the evaluation are the essential elements for ensuring the success for the
innovation.
3.2.3 Number of clients will be benefited from the innovation
There are a sufficiently large number of clients who could be benefited from
the innovation in the practice setting. Since there are about 2 to 4 patients
undergoing cardiac surgery every day, with 5 weekdays, 780 patients will be
benefited from the proposed innovation in a year.
3.2.4 Time for the implementation and evaluation of the innovation
The duration for the implementation and evaluation of the innovation is
appropriate. The innovation starts right after patients’ admission and until the
patient is transferred back to ward after their condition is stabilized during the stay
in ICU. This implementation period will thus be lasted for around 3 days,
provided that no postoperative complications will occur. The evaluation period
will be continued for 1 month after the patients are discharged. This evaluation is
35
achievable since patients will come back to the specialty clinic for follow-up.
3.3 Feasibility
Feasibility of the proposed innovation is analyzed by two aspects: promoting
factors and inhibiting factors.
3.3.1 Promoting factors
Support from the Administration: Firstly, surgeons including the Chief of
Service conduct research and apply research findings in clinical setting. Some
examples of these include the application of pneumatic pump on lower limb for
patients after CABG, the use of mupirocin for nasal decontamination
preoperatively, and the selection of prophylactic antibiotics and administration
frequency. These examples demonstrate that there is a culture of research
utilization within the selected clinical setting and staffs are encouraged to follow
on research work.
Secondly, the administrators should support the innovation as it matches the
major initiatives of the targeted hospital, which is to provide better healthcare
service quality by promoting patient-centered care and continuous service
improvement (Hospital Authority, 2010c). Furthermore, as another initiative of
the Hospital Authority is to keep modernizing services by strengthening the
36
management structure (Hospital Authority, 2010d), the organizational climate will
become more conducive to research utilization.
Consensus and flexibility: There is a consensus among staffs and
administrators that the innovation could be beneficial to clients and therefore
should be tested. Discussion forums would be held to enhance communication and
understanding about the proposed innovation for both the management level and
the frontline staffs. Flexibility to carry out or terminate the innovation is allowed
for the sake of patients. That is, patients can refuse to participate in the innovation.
Also, once there is an unfavorable situation (e.g. allergy) occurs, the innovation
will be terminated. Healthcare professionals will meet the obligation of doing no
harm to patients (Henriksen K, 2005).
Resources: Support from the managerial level is the key for a successful
change. That is, Managers should take the lead to make changes. Where the
mangers demonstrate inadequate leadership, other staffs may have little drive to
make the necessary changes (Closs, Baum, Bryar, Griffiths, & Knight, 2000;
Sing-Ling, 2000). Support and cooperation outside the nursing department are
needed from other stakeholders such as COS, the pharmacy and finance
department for approval and resources. The need for staffs to attend extra practice
37
activities for learning the innovation is low since education can be conducted
internally by senior practicing nurse such as advanced practice nurse.
Measuring tools for clinical evaluation: Appropriate tools are readily
available for clinical evaluation of the innovation. As nasal culture is taken prior
to surgery, it serves as the baseline data for the examination of the relation and
comparison with postoperative infection status (Konvalinka, et al., 2006; Perl, et
al., 2002). In addition, the wound assessment chart, infection status monitoring
such as the clinical pulmonary infection scores (CPISs) (Koeman, et al., 2006)
will be used for assessing postoperative status.
3.3.2 Inhibiting factors
Resources: Consideration for resources should include time and cooperation
from colleagues. It is found that night nurses and older nurses encounter more
difficulties of research accessibility and have more negative view towards the
benefits of research practice. Incomprehensible analyses are the barriers for
initiating a change among staffs (Closs, et al., 2000). Such phenomenon is
probably due to the insufficient time to implement research findings, read research
articles and the lack of awareness of the beneficial research findings (Retsas &
Nolan, 1999).
38
Therefore, in order to solve this problem, communication between frontline
staffs and nurse leaders should be enhanced. Nurse leaders across all levels are
responsible for the comprehensive care for patients, meet patients’ needs and
resolve the encountered difficulties. It is problematic to acquire such information
without communicating with frontline staffs. Nurse leaders should clarify the
problems arose from the staff nurses since they are accountable for the quality of
patient care and the cost. Another vital reason for bridging the communication is
that, as stated by reports, nurses view pragmatism as the chief element for
assessing the usefulness of a new practice. Hence, communication can facilitate
staff nurses and mangers to analyze and compare the existing care with the
alternatives what are suggested in the research-based literature. From that, they
may come up with a practical protocol (Sing-Ling, 2000).
What the managers and the senior leaders can do are being the role models
by providing consultation, guidance and assistance. In order to narrow the gap
between knowledge and practice, managers should organize conference, and, by
the use of attendance, to support the participation form for improving practice.
University instructors serve as internal consultants to provide the necessary
guidance, participation and the utilization for practical problems.
39
As the rate of utilizing research findings is higher among degree nurses
(Parahoo, 1998) and they also have statistical and research training, it is suggested
to make use of this fact to form a peer support group. The use of a peer support
group can help the change to be carried out more clearly. Also, the group can help
to explain the change in detail in the form of statistics and that help to convince
the reluctant nurses (Closs, et al., 2000).
In the long run, for promoting evidence-based practice, fundamental changes
are necessary to be carried out within the education system, training and
managerial policy. Education on research utilization, acquisition of relevant skills
as well as support from the clinical areas are crucial, both for nursing students and
the clinical nurses within the healthcare system where nursing research is
expected to be utilized, so as to improve the ability of nurses to translate research
into practice (Parahoo, 1998; Retsas & Nolan, 1999).
3.4 Cost-benefit ratio of the innovation
The cost-benefit ratio is used to assess the potential benefits, risks and costs
on the implementation of the proposed innovation for the hospitalized cardiac
patients and the target setting.
40
3.4.1 The cost-benefit ratio of hospitalized cardiac patients undergoing
cardiac surgery
Material and nonmaterial costs: Table 3.1 and 3.2 below show the annual
cost expenditure of patients on implementing the program:
Table 3.1 Annual cost expenditure of 780 patients for the innovation
Costs Items Unit price
(HK$)
Estimated
Unit
Total price
(HK$)
Culture
swab stick
20 780 15600
Mouthwash 10 780 7800
Nasal
gel/ointment
5 260^ 1300
Petroleum
jelly
5 260^ 1300
Total 26000
Average cost for each
patient=$26000/780=$33
Table 3.2 Estimated additional expenses for treatment of each infected patient
Medical
services
Price/day
(HK$)
No. of
consultation
days *
Total
price
(HK$)
Note
Inpatient A&E 100 100
Inpatient 50(1st time)
100
1
29
2950
Total (HK$) 3050
Outpatient Specialty
clinic
100(1st time)
60
1
1
160
41
Drugs
from
clinic
10/drug 3x2 60 #
Outpatient
clinic
(dressing)
30 6 180
Total(HK$) 400
Note: *Predicted number of consultation; #Assuming 3 types of drugs dispensed
each consultation; ^Assuming one-third of the clients are at risk of VAP and nasal
carriers of S. aureus respectively.
The Cost-benefit ratio for the proposed innovation in terms of monetary values of
each patient is $33/$3050=1:91.5 (inpatient) and $33/$400=1:12 (outpatient)
respectively.
3.4.2 Cost-benefit ratio of target department
Manpower: Participants in this innovation consist of all frontline staffs
including registered nurses and enrolled nurses working in two cardiac surgical
wards and ICU, doctors in specialty outpatient clinic and nurses in outpatient
clinic. Laboratory technicians are also included. The number of staffs involved in
this innovation is estimated to be 70.
Material costs: Table 3.3 shows the annual running cost for the proposed
innovation.
42
Table 3.3 Annual running cost
Costs Items Unit price (HK$) Estimated
Unit
Total
price
(HK$)
Swab stick,
mouthwash,
nasal gel/
ointment
(As stated in table 3.1) 800 26000
Printing and
photocopying
Official
documents (eg.
Scale,
assessment
chart)
1 800 800
Total (HK$) 26800
Table 3.4 shows the extra cost for treating a SSI patient per year. As
mentioned in chapter 1, the prevalence of SSI is 16%.
Table 3.4 Extra costs for SSI patients per year
Costs Items Unit price
(HK$)^
Estimated
Unit**
Total price (HK$)
Antibiotics 390 39 15210
X-ray 3822 149058
Skilled
nursing
2028 79092
Durable
equipments
390 15210
Total (HK$) 258570
Note:^ Unit price with reference of a paper from USA (Perencevich et al, 2003),
price is converted to HK$; **Assume prevalence of SSI for cardiac cases only is
5%
43
The cost-benefit ratio for the proposed innovation in terms of monetary
values of the target department =$26800/$258570=1:9.6. The cost-benefit ratio
is even greater for pneumonia patients because of the higher prevalence rate
(Centre for Health Protection, 2011).
44
CHAPTER 4
DEVELOPING AN EVIDENCE BASED PRACTICE GUIDELINE
In this chapter, an evidence-based practice guideline is built according to the
evidence derived from the 6 RCTs. The objectives, target group, rating scheme
and content of the guideline are described respectively.
4.1 Objectives
Evidence-based recommendations are outlined in this guideline to:
Equip nurses with the best standardized practice on pre- and post-operative
oral and nasopharyngeal care intervention for patients who undergo cardiac
surgery;
Raise the awareness of research utilization;
Further reduce the incidence of SSI and VAP, which in turn affects staff
burden and working environment; and
Improve the quality of life of patients in the long run.
4.2 Target population
4.2.1 Target users
All nursing staffs working in the cardiac wards and ICU of a cardiothoracic
surgical department.
45
4.2.2 Target population
The target population of the proposed innovation is described in chapter 3.
4.3 Rating scheme
With reference to the ‘SIGN 50: A guideline developer’s handbook Annex B:
key to grades of recommendations’ (Scottish Intercollegiate Guideline Network,
2011b), grade of recommendations is assigned to each recommendation with
reference to the level of evidence from the RCTs (refer to Appendix 4).
4.4 Recommendations
4.4.1 Assessment
Recommendation 1.0 Assess for nasal S. aureus colonization
Patient should be assessed for S. aureus upon admission. Patients that are
found to be at risk will receive additional care (see Recommendations 2.4).
Supporting evidence:
Carriers of S. aureus are 2 to 9 times more likely than non-carriers to
acquire SSI (Perl et al, 2002)(1-).
S. aureus is the most common bacteria causing wound infections
(Konvalinka, 2006)(1++).
Colonization of the patient’s own flora is the primary source of
46
nosocomial infections (Segars, P., Speekenbrink, R.G.H., Ubbink,
D.T., van Ogtrop, M.L., de Mol, B.A.)(1+).
According to CDC, 4 possible mechanisms of nosocomial pneumonia
are: (a) oropharyngeal organisms aspiration; (b) inhalation of
contaminated aerosol; (c) hematogenous spread from distant body
sites and (d) bacterial translocation from the gastrointestinal tract
(Houston et al, 2002)(1+); (DeRiso II, A.J., Ladowski, J.S., Dillon,
T.A., Justice, J.W. & Peterson, A.C, 1996)(1++).
Recommendation 1.1 Assess for the level of risk of VAP
After operation, estimate the time of intubation. If it is equal to or longer than
48 hours, the concentration and agent for oronasopharyngeal care should be
changed (refer to recommendations 2.5).
Supporting evidence:
The effect of chlorhexidine gluconate has not been tested in
mechanically ventilated ICU patients with prolonged
intubation (Koeman et al, 2006)(1-).
4.4.2 Oronasopharyngeal care interventions
Recommendation 2.1
47
Perform oronasopharyngeal care at least twice a day preoperatively and
post-operatively.
Supporting evidence:
All studies performed the care twice a day as minimum
(Konvalinka, A., Errett, L., Fong, I.W., 2006; Segars, P.,
Speekenbrink, R.G.H., Ubbink,D.T., van Ogtrop, M.L., de
Mol, B.A., 2006; DeRiso II et al, 1996)(1++); (Houston, S. et
al, 2002)(1+); (Perl et al, 2002; Koeman et al, 2006)(1-).
Recommendation 2.2 Oronasopharyngeal care method
Nurses apply 0.12% chlorhexidine gluconate solution or nasal gel by using
cotton swabs, a Q-tip cotton applicator or sponge. Patients should be allowed to
perform the procedure by themselves when they are not sedated or after
instructions are given. (refer to recommendation 2.3).
Supporting evidences:
Studies mentioned the care was conducted by healthcare
workers (Houston, et al., 2002; Koeman, et al., 2006; Perl, et
al., 2002; Segers, et al., 2006)(1++) and 3 studies described
patients were instructed to perform the intervention
48
independently if they are capable to do so (DeRiso, et al.,
1996; Houston, et al., 2002; Segers, et al., 2006)(1++);
(Houston, et al., 2002)(1+).
The aid of cotton swabs (Perl, et al., 2002)(1-), a Q-tip cotton
applicator (Konvalinka, et al., 2006)(1++) or sponge (Segers,
et al., 2006)(1++) were mentioned respectively.
Studies have yet to compare the effectiveness between 0.12%
and 2% chlorhexidine gluconate.
One study used chlorhexidine gluconate in the form of nasal
gel and mouth rinse. However, comparison was not performed
to test the effect of the different textures.
Recommendation 2.3 Patient education
15ml of 0.12% chlorhexidine gluconate should be rinsed or applied for 30
seconds with full strength to ensure the agent is in contact with the pharyngeal,
gingival, tooth, tongue and each side of buccal cavity. Patients are reminded that
ingesting the agent, eating or drinking in 30 minutes after rinsing are prohibited.
Supporting evidence:
Applying 15ml of 0.12% chlorhexidine gluconate (Houston et al,
49
2002)(1+); (DeRiso et al, 1996)(1++) for 30 seconds (Segers et al,
2006)(1++) is regarded as enough for rinsing the oral cavity thoroughly.
The effect of agent will be affected when there is any activity in oral
cavity (Houston et al, 2002)(1+); (DeRiso et al, 1996)(1++).
Recommendation 2.4
For S. aureus carrying patients, 2% mupirocin calcium should be
applied to the inside of anterior naris for both nostrils in addition to the
recommendations of 2.1 to2.3.
Supporting evidence:
Prophylactic intranasal mupirocin administered to S. aureus
carriers significantly reduce the rate of all nosocomial S. aureus
infections (Perl et al, 2002)(1-); (Konvalinka, A., Errett, L.,
Fong, I.W., 2006)(1++).
A single, short course of mupirocin as preoperative prophylaxis
did not appear to select for mupirocin-resistant S. aureus isolates
(Perl, et al., 2002)(1-).
Recommendation 2.5
For patients with an increased risk of VAP, change the application agent
50
to 2% chlorhexidine and 2% colistin petroleum gel.
Supporting evidence:
The effect of chlorhexidine for long-term mechanically
ventilated ICU patients has not been evaluated (Koeman et al,
2006)(1-).
Chlorhexidine has a lower efficacy against gram-negative
microorganisms, whereas colistin is a polymyxin with high
activity against gram-positive and gram-negative
microorganisms. It has been applied in the topical and nebulized
form (Koeman et al, 2006)(1-).
Recommendation 2.6
Once the patients has presented symptoms of infection, stop the intervention
and consult medical treatment as soon as possible.
Suggested evidence:
All studies used the agent for prophylaxis only. It is not the
regime for infected patients (Konvalinka, A., Errett, L., Fong,
I.W., 2006; Segars, P., Speekenbrink, R.G.H., Ubbink,D.T.,
van Ogtrop, M.L., de Mol, B.A., 2006; DeRiso II et al,
51
1996)(1++); (Houston, S. et al, 2002)(1+); (Perl et al, 2002;
Koeman et al, 2006)(1-).
No study has applied the agent on infected patients.
A flowchart summarizing the guideline is shown in Appendix 7.
52
CHAPTER 5
IMPLEMENTATION PLAN
In the preceding chapter, an evidence-based guideline for oronasopharyngeal
care is constructed. A pilot test is necessary for testing the innovation. As this
relatively small-scale examination allows modification of the protocol and also
assess the implementation potential of the innovation, it helps the large-scale
generalization of the innovation in the future (Polit, 2012). The following sessions
describe the implementation plan in terms of communication plan with involved
personnel and pilot test, as well as an evaluation plan to measure the efficacy of
the guideline.
5.1 Communication plan
Communication plan is crucial for identifying and initiating conversation
with stakeholders. Such identification can also help to obtain approval for the
pilot testing and the implementation of the proposed guideline. The
communication starts from the managerial and administrative levels because their
support is crucial for initiating the change (Henriksen K, 2005). The objectives of
communication plan are:
(i) To promote the concept of the change as well as the change per se, as
planned;
53
(ii) To identify and analyze the methods to manage response and the resistance of
the change.
The Lewin’s Force-field Model is adopted for the communication plan. It
describes the factors in present (status quo) such as lack of skills among staffs and
inertia in nature form restraining forces and impede the change. On the other hand,
driving forces which facilitate the change, such as failure of old practice, move
personnel to the new practice in the future (Sullivan & Decker, 2005). All barriers
must be identified and tackled while facilitating factors should be reinforced in the
communication process.
5.1.1 Communication plan before the initiation of the change
The clinical problem is identified and discussed among frontline staffs. The
author, who acts as investigator, will deliver the idea and initiate a discussion with
Nursing Officers and Advanced Practice Nurses. After the extensive search of the
literature, randomized controlled trials were reviewed and critiqued and the
findings relating to the significance of infection control as well as the need for
change is provided. Feedbacks and implementation potential in view of feasibility
and cost are then considered.
5.1.2 Communication plan with managerial levels
Using the top down approach according to the Iowa model, two levels of
54
managers will be identified and contacted in the first week. Specifically, they are
the Chief of Service (COS) and the Departmental Operations Managers (DOMs)
of the Department of Cardiothoracic Surgery and that of the Department of
Specialist Outpatient Clinic, followed by the Ward Managers (WMs) of the
involved surgical ward, intensive care unit and outpatient clinic.
A proposal comprising the significance of the existing problem, research
findings stressing the need of oronasopharyngeal care (Chapter 1); summary of
guideline (Chapter 4), implementation potential, an outline of the budget, benefits
of the plan (Chapter 3, table 3.1-3.4), timetable, the proposed number and role of
staff involved will be demonstrated. The COS and DOMs will act as the
coordinators in which they will lead and coordinate different working units,
manage human and financial resources, identify barriers, and provide solutions in
meetings.
The Ward Managers will be invited to join the meetings with DOMs in order
to understand the importance of acting as an agent of change and familiarize with
the rundown of the program. The research problem base and research findings
(Chapter 1); summary of guideline (Chapter 4), timetable, the proposed number
and role of staff involved will be presented. The managers are responsible for
coaching, holding journal clubs and meetings with frontline staffs. The expected
55
time of communication with COS, DOMs and Ward Managers is about two
weeks.
5.1.3 Communication plan with nurses
Starting from the 3rd
week, three groups of nurses are responsible for the
delivery of the intervention and they will be communicated. These three groups of
nurses are ward nurses, nurses working in intensive care unit, and nurses working
in the specialty outpatient clinic. Promotional posters will be displayed in all
participating units starting from the third week. Four identical briefing sessions
will be held in the form of lunch seminars. All nurses are required to attend. The
information shown below will be introduced:
a. Introduction of the program and the role of staffs in different ranks;
b. Importance of carrying out the program;
c. Importance of the contribution of the staffs.
Questions will be welcomed at any time during the program via electronic
mail and telephone to the investigator (author) and to Advanced Practice Nurse or
Nursing Officer in person for problems that are encountered during the daily
operation. The communication with nurses is planned to be about four weeks.
Communication with nurses working in ward and intensive care unit:
In addition to the above information, instructions on how to carry out the
56
intervention will be given. Cue cards will be provided and return demonstration is
required for all staffs for carrying out the intervention.
5.1.4 Communication plan with inpatients
From the 7th
week, all patients eligible to participate in the program will be
contacted through telephone and will be asked to join the innovation. In particular,
the invitation will be performed when the patients are called for their admission
for operation or when the patients are admitted to surgical ward according to the
schedule. In order to draw patients’ interests, benefits of using mouthwash for free,
elimination of halitosis, improving oral/ nasal cavity hygiene and the possibility of
reducing post-operative complications and length of stay will be highlighted.
5.2 Pilot testing
After commencing the communication plan, which lasts for about six weeks,
a pilot study will begin to test the feasibility for generalizing the protocol to the
large scale implementation. The pilot test will be run for a month.
5.2.1 Ethical consideration
Before launching, approval of the pilot test has to be obtained from the
Hospital Ethics Committee. The decision of the approval is based on the weighing
between benefits, risks, rights, privacy and other ethical values of clients (Mino,
Copel, & Zucker, 2008; Zhou et al., 2009).
57
Upon admission, a Chinese or English version of consent form will be
presented to participants. Participants will also receive an explanatory information
sheet which clearly states the aim and the objectives, contraindications and risks
in taking part in the program, the right to refuse and withdraw to participate at any
time even after giving the consent, as well as the anonymity and confidentiality
issues. There is no new technique needed for frontline staffs to obtain consent as
such skill is the same for nurses to obtain consent from routine bedside care. The
investigator is kept blinded during data collection.
The objectives of the pilot test are:
To collect data on rate of surgical site infection and pneumonia;
To monitor nurses’ progress of the implementation of the protocol;
To observe clients’ and service providers’ level of satisfaction;
To identify and solve potential problems in order to estimate the feasibility of
implementing the protocol on a larger scale.
All nurses working in wards, intensive care unit and specialty outpatient
clinic will take part in this pilot test. This pilot study adopted a quasi-experimental
design with one study group.
All clients will be recruited from wards in cardiothoracic surgical department.
The targeted number of participants is based on the targeted sample size for the
58
large scale implementation of the program. The calculation of the sample size will
be shown in the subsequent session. Since the expected total number of clients to
be recruited into the program in a year is 175, the minimal number of clients
needs to be recruited in the pilot test is 15 (175/12 months= 15). As the expected
number of eligible clients attending to the targeted settings per day is 2 to 4, it is
assumed that a maximum of 60 clients can be recruited into the pilot study in each
month. Evaluation will be carried out after the recruitment phrase.
5.2.2 Rate of surgical site infection and pneumonia
The data on rate of infection will be compared with the statistics collected
before the implementation and also compared with the existing literature for
evaluating the effectiveness for proceeding to a larger setting.
5.2.3 To monitor nurses’ progress on implementing the protocol
The implementation of the protocol will be measured in two aspects, namely,
the procedure of enrolling participants and the carrying out of the care.
Procedure of enrolling participants: As all elective cases for operation are
admitted during the morning shift, a nurse in-charge during the daytime will
countercheck the eligibility of clients admitted to wards. For clients who refuse to
provide their consent for the new care plan or withdrawal during their
participation will be asked to write down the reasons for refusal. This procedure is
59
to let the clients think thoroughly before making their final decisions and to
prevent an increase in workload for staff nurses.
Carrying out the care: To assess staffs’ adherence towards the instructions of
the guideline, clients will be assessed on the procedures of performing the
mouthwash and will be requested for a practical demonstration. In addition,
auditing by Nursing Officers or Advanced Practice Nurse will be conducted.
5.2.4 Reflection on the level of satisfaction of clients and nurses
To measure clients’ level of satisfaction: After completing the pilot test, all
clients who have taken part in the program will be invited to fill-in a questionnaire.
The questionnaire comprises of 10 questions with rating scale concerning the
usefulness of interventions and the communication in service delivery. Open-end
questions will be used in the questionnaire to enquire potential areas of
improvement. The questionnaire is attached in Appendix 9. For clients who fail to
complete the questionnaire during follow-up or lost to follow-up, structured
telephone interview will be conducted. Clients will be called up to 3 times at
most.
To measure nurses’ level of satisfaction: At the end of the pilot study, nurses
working in wards and intensive care unit will be invited to join a focus group
interview. Areas on the framework of the guideline, means to promote change
60
such as lunch seminars, discussion, consultation hours and cue cards will be
explored. Comments on the facilitators and barriers encountered during the
implementation will be welcomed.
For all participating staffs, a questionnaire incorporating satisfaction of
training, usefulness and logistics of program, service delivery, difficulty of
adhering to the implementation, readiness to support the change will be assessed
by 20 questions in the format of Likert rating scale. Similar to collecting
comments from clients, suggestions for improvement will be enquired in
open-ended questions (Appendix 10). To promote comments giving and protect
staffs’ confidentiality, the questionnaire will be conducted in the computers and
thus no hand-writing is necessary. For staffs who do not favor the use of computer,
a sealed box for written comments will be placed in the eye-catching area in the
workplace.
5.2.5 Program utilization
To measure participation, the number of clients who provide consent will be
counted. The reasons related to their refusal will be collected and analyzed. The
necessary time for carrying out the protocol will be estimated by the frontline
staffs and will be compared with the original practice.
61
CHAPTER 6
EVALUATION PLAN
In the evaluation plan, outcome indicators for evaluation are identified and
are used to determine the number of clients involved, as derived from findings of
the selected randomized control trials. The evaluation is divided into two parts,
including the formative evaluation, which will be held at 1st, 3
rd, 6
th and 9
th month
for fine adjustments of the protocol, and the summative evaluation, which will be
carried out after the completion of the program at 12th
month. The outcome is
further divided into patient, healthcare provider and systems outcome. This
chapter outlines the objectives, outcome measures, instruments used for the
measurement, data analysis and criteria for determining the effectiveness of the
protocol.
6.1 Objectives and outcome measures
The objectives of the evaluation plan are (1) to assess the effectiveness of
encouraging staffs to promote a sustainable change and (2) to quantify the results
and present it to all stakeholders so they can understand the importance of the
continuation of the new implementation.
The primary outcome is the rate of total respiratory tract infection. In the six
selected randomized controlled trials, rate of respiratory infections was included
62
in all studies as primary outcome. When the rate of respiratory infections is found
to be reduced in this study, the guideline will be considered as effective. The
detected rate of respiratory infections recorded after the implementation will be
compared to those who have not participated in this program and the rate detected
before the implementation of the program.
The secondary outcomes are categorized into three aspects: patient outcome,
healthcare provider outcome, and systems outcome.
6.1.1 Patient outcome
1. To measure the acceptance of the new intervention;
2. To describe the baseline characteristics of patients in terms of:
A. Socio-demographic characteristics. Information such as age, gender,
education level and medical history will be recorded. Since none of the
randomized controlled trials was carried out in Hong Kong, obtaining
information on the patients’ characteristics in the hospital settings of
Hong Kong is worthwhile.
B. Objective physiological data: different pieces of information will be
collected from clients. Such information include their lung and renal
function, mobility, diabetes mellitus status, any extra cardiac
arteriopathy, cardiac related factors such as angina or recent myocardial
63
infarction, operation related factors such as type of intervention and so
on. Collecting this information can help to come up with the EuroScore
as stated in previous chapters for prediction of post-operative outcome,
which in turn can be used to examine whether there is a linkage with the
intervention;
3. To measure the patients’ rate and severity of surgical site infection (SSI)
during hospital stay, 1 week, and 1 month after discharge. The reason for
choosing such time period is because 12 to 84% of SSIs are detected after
patients discharge (Lee, 1997), while most SSIs become evident within 21
days post operatively (Sands, Gordon & Platt, 1996; Weigelt, Dryer & Haley,
1992). A pre and post, and with non participating group will be used for the
comparison;
4. To record the rate of infections, including: (i) total nosocomial infections, (ii)
urinary tract infections (UTI), (iii) bacteremias, both primary in origin and
secondary to endocarditis. In the selected studies, the rate of reduction after
intervention was found to be significant (p<=0.002), except the rate of UTI.
The findings can be used to compare with those in Hong Kong;
5. To record and compare factors other than infections, including: rate of use of
nonprophylactic antimicrobial agents, the mean and total length of stay in
64
hospital during the period of preoperative care, intensive care, after acquiring
nosocomial infection or surgical site infection; the number of readmissions
and deaths, if any; the mean days of using the intervention preoperatively;
6. To observe the potential adverse effects and its rate arising from the trial
medication;
7. To observe the temporal relationship between the application of trial
medication and incidence of infection.
6.1.2 Healthcare provider outcome
1. To illustrate the protocol implementation skills, teaching skills and
compliance of nurses on protocol utilization including assessment,
implementation and evaluation, as it is related to the level of confidence in
carrying out the protocol. Staffs may not adapt to the new implementation as
a start;
2. To identify healthcare providers’ level of satisfaction on the utilization of
protocol, communication of barriers and needs in the implementation process,
material and non-material support, as well as nursing care quality; To assess
staffs’ willingness of using the protocol; the questions raised during the
program will be grouped and form a ‘frequently asked questions’ page for
experience sharing and improving the innovation;
65
3. To find out the improvement in knowledge regarding the medication, the
protocol and research;
6.1.3 System outcome
1. To measure the utilization of the innovation by counting the number of clients
joining the program;
2. To examine the accessibility of the protocol, such as whether the content is
easy to fetch and comprehensible, the availability of help resource, number
and content of telephone consultation is noted;
3. To analyze the cost effectiveness of the program.
6.2 Nature and number of clients involved
As mentioned in previous chapters, the inclusion criteria of client selection is
identical with the target population of the protocol.
The sample size is calculated with reference to the primary outcome.
Reference information for sample size calculation was selected from two
reviewed studies as they used the rate of SSI for the comparison between the
chlorhexidine group and placebo. Details on the sample size calculation are shown
in Appendix 11. The average rate of total SSI is used for the sample size
calculation (Lenth, 2012-5). With the significance level set at the 0.05 level and
the statistical power level set at 80%, 170 clients should be recruited. Since clients
66
have the right to refuse the treatment at any time, the dropout rate and the use of
intention-to-treat approach need to be considered. Based on previous studies, the
dropout rate range from 1.51% (Segers, Speekenbrink, Ubbink, van Ogtrop, & de
Mol, 2006) to 1.56% (Koeman et al., 2006). Therefore, to take into account of the
possible dropout in this study, the final sample size is decided to be 175.
6.3 Types and timing of measurements
6.3.1 Ward round and documentation
Upon admission, patients’ background such as socio-demographic
characteristics, smoking and drinking history and medical history will be
documented. Routine skin condition assessment, physical examination and
laboratory tests for patients will be assessed and used as baseline information. A
simple graph is printed on skin assessment form for locating and describing the
wound/ skin condition. To avoid excessive manipulation to the wound(s) and add
unnecessary burden to staffs, wound(s) condition will be assessed as prescribed
and as clinical pathway as usual. Other data mentioned above will be reviewed
everyday during ward round by doctors. Grand round by all doctors of the
department will be carried out twice a week for the discussion of patients’
progress.
67
6.3.2 Follow-up
As part of the pre-discharge education, clients will be instructed to call the
investigator if there is any signs and symptoms of infection such as fever, redness,
swelling, increased temperature and pain around the wound area. Also, clients will
be contacted for follow-up in specialty outpatient clinic in one week and one
month after discharge. Wound conditions will be inspected by doctors and chest
X-ray will also be taken. A structured questionnaire will be given to patients
during one-month follow-up and quarterly by mail or electronic mail. The mailing
method also applies to clients who are lost to follow-up. If there is still no reply,
clients will be interviewed via phone contact. Patients who will be defined as
dropout case include those who are unable to be connected by phone for up to 5
times, certified dead, or being transferred out from the cardiothoracic surgical
department.
6.3.3 Questionnaires and interviews
In questionnaires, closed ended questions such as multiple choice questions
and open-ended questions will be deployed to clients asking for the adverse effect
related to the trial medications. Choices for instance the coloration of mouth,
irritation and allergic symptoms will be given; rating scales will be used for
measuring healthcare workers’ skills, compliance in carrying out the protocol as
68
well as satisfaction and accessibility of the program by patients/ healthcare
workers. Open-ended questions allowing flexibility for writing down areas of
improvement will be set for protocol consumers and users.
In the 4th
week of each month, two staffs from ward, ICU and specialty
outpatient clinic will be invited on a random basis to attend a formal interview to
give comments and verbalize the feelings about the program. The satisfaction,
advice for amendment and roadblocks in protocol operation will be assessed in
due course. In case there is shortage of time or difficult manpower arrangement
for formal interviews, the investigator will conduct informal assessment and
gather information by chatting with staffs during tea time or lunch time.
6.4 Data analysis
Data analysis of outcomes will be conducted by the analytical software
named SPSS. To take into account of the issues related to clients failing to
follow-up or discontinuing their participation during the program, an intention to
treat approach will be adopted for the analysis.
6.4.1 Primary outcome
The rate of total respiratory tract infections will be analyzed by using the two
tailed z-test testing one proportion. The intervention group will be compared to
two groups: (i) those not attending the program, and (ii) baseline data before the
69
program initiated.
6.4.2 Secondary outcomes
Rate of surgical site infection: Analysis for this outcome will be similar to
that for the primary outcome. In particular, it will be analyzed by the two tailed
z-test testing one proportion and will be compared to the baseline statistics and
clients not attending the program.
The baseline characteristics, acceptance of new intervention, adverse effect
experienced by patients, skills and compliance, satisfaction and improvement in
knowledge in healthcare workers outcome, utilization and accessibility of systems
outcome will be demonstrated by descriptive statistics such as mean, mode and
standard deviations.
One tailed analysis is used for the examination of the rate of other
nosocomial infections because currently there is no evidence to prove the
intervention is harmful. Previous studies have shown that the intervention of
chlorhexidine has an encouraging effect on the incidence of nosocomial infections
(Bergmans et al., 2001; DeRiso, Ladowski, Dillon, Justice, & Peterson, 1996;
Fourrier et al., 2000; Krueger & Unertl, 2002; Mojon, 2002). Other factors such as
rate of use of nonprophylactic antimicrobial agents, the number of readmissions
and deaths, the mean and total length of stay in hospital during the period of
70
preoperative care, intensive care, after acquiring nosocomial infection or surgical
site infection will be tested by two tailed analysis. The Kaplan Meier analysis will
be used for analyzing the days of use of the intervention and time of infections,
with estimation at 95% confidence interval for the median time to infection.
Cost effectiveness: all materials used will be recorded and calculated at the
end of the program. A summative cost including the cost of patient care
(antibiotics, cost of stay in ICU and so on) will be compared to the cost of patient
care before the commencement of the program.
6.5 Criteria of an effective guideline/ protocol
Using the reviewed RCTs as reference, the criteria of proving the
effectiveness of the guideline include the decrease in the total respiratory tract
infections, surgical site infections and patients’ length of stay in hospital caused
by nosocomial infections. Previous studies has shown that there are significant
difference between intervention groups and control group in the incidence of
lower respiratory infections with an effect size of -6.5% (p=0.002) (DeRiso, et al.,
1996; Segers, et al., 2006) and the deep surgical site infections with an effect size
of -3.2% (p=0.002) (DeRiso, et al., 1996; Koeman, et al., 2006; Perl et al., 2002).
Also, previous studies reported that the intervention shortened patients’ length of
stay by 6.9 days (p<0.001) (Segers, et al., 2006). All are measured with 95%
71
confidence interval.
72
CHAPTER 7
CONCLUSION
The oronasopharyngeal care interventions can effectively help to minimize
the occurrence of nosocomial pneumonia and surgical site infections for patients
who undergo heart surgery. The protocol is nurse initiated and the patient care is
conducted within the period of hospitalization. Assessment will be performed
prior to the selection of the most suitable intervention along with patient education.
The intervention has a preventive nature and cannot be used as a regime for
treating nosocomial infections. From the reviewed RCTs, a clinical guideline for
nurses on oronasopharyngeal care is established. The guideline is considered
feasible after the assessment of the implementation potential, transferability and
cost effectiveness of working in a surgical setting where cardiac patients undergo
surgery. Clinical indicators such as surgical site infection and respiratory tract
infection rate, and patients’ length of stay are the markers of an effective guideline.
The guideline can potentially be adopted by nurses working in cardiac surgical
ward and cardiac intensive care unit.
7.1 Limitations
There are limitations in this study. First, the prevalence of the problem is
general but not confined to the cardiothoracic department of the targeted hospital.
73
Also, since the guideline recommends to decontaminate the nose and oropharynx
at the same time, regions that lead to the decrease in nosocomial infection may not
be pinpointed as the decontaminated regions are not able to be separated (Segers,
et al., 2006). But the findings of pathogenic microorganisms located in nose and
mouth is associated with SSI and LRTI and will assist further studies in these
areas.
Another limitation is none of the studies was conducted in Hong Kong. This
affects the estimation of the target sample size. Based on the studies, it needs
175,000 subjects to participate in order to achieve a conclusive result if the
primary outcome is set as SSI. This finding is consistent with the low rate of S.
aureus infections at surgical site infections, in which 47.2% is associated with S.
aureus nasal carriers (Konvalinka, Errett, & Fong, 2006; Perl, et al., 2002).
Nosocomial infection still remains a diagnostic and therapeutic challenge in
the care of cardiac surgery patients. The diagnosis of nosocomial infection in this
patient population is sometimes difficult. It is because, apart from infection,
clinical and laboratory signs of inflammation can also be caused by, tissue injury
and the systemic inflammatory response syndrome (SIRS) associated with
cardiopulmonary bypass. Three risk factors have been found to be independently
associated with nosocomial infection after open heart surgery, namely: history of
74
immunosuppression, transfusion of more than five red blood cell units during the
first postoperative day in both operating room and ICU, and the development of
acute renal failure during the first two postoperative days. Recent report showed
that the use of cardiopulmonary bypass is associated with a significant increased
risk of acute renal failure following isolated coronary artery bypass surgery,
compared to off-pump myocardial revascularization (Stallwood, Grayson, Mills &
Scawn, 2004). All efforts are targeting to prevent the development of acute renal
failure by better protection of renal function perioperatively.
It has been supported that, apart from blood transfusion, other factors such as
general anesthesia, hemorrhage, surgical stress, low cardiac output syndrome
and/or temporary shock, and possibly systemic inflammatory response syndrome
may predispose the patient to immunosuppression and infection (Ulicny &
Hiratzka, 1991).
Prevention of nosocomial infections is of high priority in healthcare facilities.
Patients with nosocomial infections are reported to be resulted in higher mortality,
have longer durations of hospital stay, incur higher overall costs and require more
resources.
For cardiac surgical patients, the best infection control practice currently
include the use of prophylactic antibiotics around 30 to 60 minutes before incision
75
of skin, strict glycaemic management, no shaving or use of clippers rather than
razors during skin preparation, hand washing, and reduction of multiple blood
transfusions. Topical antiseptics, such as chlorhexidine gluconate, have been
shown to prevent ventilator-associated pneumonia.
The practice of decontamination of the nasopharynx and oropharynx with
chlorhexidine is associated with the reduced nosocomial infections in cardiac
surgical patients. It is a relatively inexpensive intervention and, in economic
perspective, the increase in nursing care time is more likely to be outweighed by
the reduction of nosocomial infections. It is necessary to further study the
economic benefits, while individual institutions should account for their own cost
structures when considering the economic benefits.
The selected randomized controlled trials have shown that the
implementation of this simple strategy by nurses is an effective method, both in
terms of practice and costs, for reducing nosocomial infection in cardiac surgery.
Consideration should be given to similar research for patients having other high
risk major surgical procedures, such as gastrointestinal surgery.
Most wound infections arise from skin organisms. The most commonly
involved organisms include Staphylococcus epidermidis, or Staphylococcus
aureus (Law, Mishriki & Jeffrey, 1990). Topical mupirocin has been shown to be
76
effective in eradication of S aureus among nasal carriers. The guidelines from the
Centers for Disease Control for prevention of surgical site infections have no
recommendation on the use of mupirocin in prevention against postoperative
infections (Centers for Disease Control and Prevention, 1999). In studies with
historic control subjects, universal preoperative mupirocin therapy reduced the
incidence of postoperative infection by more than a half (Kluytmans, Mouton,
VandenBergh, Manders, Maat, Wagenvoort, Michel & Verbrugh, 1996;
Cimochowski, Harostock, Brown, Bernardi, Alonzo, & Coyle, 2001). Yet, the
efficacy of such therapy still needs to be further examined by prospective, blinded
studies. Until such evidence is available, and even if such efficacy is demonstrated,
the ideal target for mupirocin use would be S aureus carriers. The major concern
about the indiscriminate use of mupirocin is the potential development of
resistance. Surveillance studies worldwide have shown that the prevalence of
high-level resistance to mupirocin is low (Schmitz, Lindenlauf, Hofmann, Fluit,
Verhoef, Heinz, & Jones, 1998; Watanabe, Masaki, Asoh, Watanabe, Oishi,
Furumoto, Kobayashi, Sato, Nagatake, 2001; Norazah, Koh, Ghani Kamel, Alias
& Lim, 2001). However, the possibility of the emergence of mupirocin resistant
strains of S aureus caused by long-term use of mupirocin still cannot be ruled out.
It was found that, prescribing the short and defined course of mupirocin, only one
77
among the four isolates that were mupirocin resistant identified was obtained from
patient treated with mupirocin (Perl et al, 2002). Although it is not clear whether
short-term therapy for the eradication of preoperative carriage leads to the
development of resistance, it is suggested to limit such use to patients with the
organism harbor in nares.
In summary, traditional prophylaxis against surgical-site infection has been
limited to topical preparatory scrub and intravenous antibiotics. These techniques
do not address the intranasal reservoir of S aureus that is found in approximately
one third of patients. Rapid detection and targeted therapy should become a part
of the routine protocol for surgical patients.
78
Appendix 1: Search keywords
Settings: heart surgery/ chest surgery/ mechanical ventilation;
Target group: cardiothoracic surgery;
Interventions: antiseptic mouthwash/ chlorhexidine gluconate 0.12%/
chlorhexidine gluconate 0.12% oral rinse/ oropharyngeal decontamination/
decontamination/ antibiotic use/ oral care;
Outcome: infection control/ nosocomial infection/ respiratory infection.
79
Appendix 2: Search progress of databases
Electronic engine: CINAHL Plus
# Keywords used Date Results
#1 antiseptic mouthwash and cardiothoracic surgery 0
#2 chlorhexidine gluconate 0.12% oral rinse 15/8 108 (4)
#3 heart surgery and infection control or
oropharyngeal decontamination 16/8 11 (1)
#4 find similar [2009 - Selective decontamination
of the digestive tract and selective oropharyngeal
decontamination reduced mortality in the ICU.
The article cites a study to find out whether
selective decontamination of the digestive tract
(SDD) or selective oropharyngeal
decontamination (SOD) reduce mortality in
patients in the intensive care unit (ICU). The
study was conducted in 13 ICUs in the
Netherlands on 5939 patients who were recently
admitted to the ICU. The study found that SDD
and SOD reduced mortality to a similar extent in
patients in the ICU. CRITICAL care medicine
RESEARCH INTENSIVE care units
ALIMENTARY canal ANTIBACTERIAL
agents PATHOGENIC microorganisms] 17/8 2543(4)
#5 #4 and oropharyngeal decontamination or
chlorhexidine gluconate 0.12% oral rinse 1
#6 antibiotic use and chlorhexidine gluconate 0.12% 0
#7 heart surgery and chlorhexidine gluconate 0.12% 18/8 2(0)
#8 heart surgery and infection control 0
#9 heart surgery and oral care 0
#10 heart surgery and mechanical ventilation 20/8 26(1)
#11 heart surgery and nosocomial infection 2(0)
#12 heart surgery and oropharyngeal decontamination 0
#13 heart surgery and respiratory infection 22/8 6(0)
#14 focus search on #4 23, 25/8 28
80
#15 reference list of record no. 4: effects of selective
Electronic engine: CINAHL Plus (Continued)
# Keywords used Date Results
decontamination of digestive tract on mortality
and acquisition of resistant bacteria in intensive
care: a randomized controlled trial 2
#16 related to oropharyngeal or gastric colonization
and nosocomial pneumonia in adult intensive
care unit patients 0
#17 articles related to
(1) oral decontamination for the prevention
of pneumonia in mechanically ventilated
adults: systematic review and meta-analysis
(2) Crit Care. 2006 Feb;10(1):R35. Effect of
oral decontamination with chlorhexidine on
the incidence of nosocomial pneumonia: a
meta-analysis. 0
#18 preop* and infection control 27/8 0
81
Electronic engine: PUBMED
# Keywords used Date Results
1 mesh terms oral rinse and heart surgery [MeSH
advanced search] 27/8 0
2 oral rinse and heart surgery 32(2)
3 related citations of [Prevention of nosocomial
infections after cardiac surgery by
decontamination of the nasopharynx and
oropharynx with chlorhexidine; a prospective,
randomised study]. [Article in Dutch] 773(25)
4 related review articles of Effects of topical
oral antiseptic rinses on bacterial counts of
saliva in healthy human subjects.
Balbuena L, Stambaugh KI, Ramirez SG,
Yeager C. Otolaryngol Head Neck Surg.
1998 May;118(5):625-9. 0
5 antiseptic mouthwash and cardiothoracic
surgery 5(2)
6 cardiothoracic surgery and topical chlorhexidine 0
7 heart surgery and topical chlorhexidine 5(0)
8 chlorhexidine gluconate 0.12% oral rinse 144
9 chlorhexidine gluconate 0.12% oral rinse
and cardiac surgery 4
10 chlorhexidine and chest surgery 32(0)
11 oral care and heart surgery 931(1)
12 mouthwash and heart surgery 0
13 decontamination and heart surgery 2
14 search all related articles of Chlorhexidine
gluconate 0.12% oral rinse reduces the
incidence of total nosocomial respiratory
infection and nonprophylactic systemic
antibiotic use in patients undergoing
heart surgery. 0
15 antiseptic mouthwash and cardiothoracic surgery
16 thoracic surgery and oral rinse 21(0)
17 thoracic surgery and oral decontamination 4(0)
82
Electronic engine: PUBMED (Continued)
# Keywords used Date Results
18 search articles related to Intranasal 0
mupirocin reduces sternal wound infection
after open heart surgery in diabetics and
nondiabetics.
19 cardiothoracic surgery and nosocomial
infection prevention 36(6)
83
Electronic engine: ScienceDirect
# Keywords used Date Results
1 heart surgery and oral rinse [Journals(Nursing
and Health Professions)] 27/8 106
2 reference list of review: Update:
Methicillin-Resistant Staphylococcus aureus
Screening and Decolonization in Cardiac
Surgery 0
3 oral rinse and heart surgery 106
4 antiseptic mouthwash and cardiothoracic surgery 1
5 cardiothoracic surgery and topical chlorhexidine 109
6 heart surgery and topical chlorhexidine 789
7 chlorhexidine gluconate 0.12% oral rinse and cardiac surgery 71
8 chlorhexidine and chest surgery 1171
Electronic engine: Cochrane library
# Keywords used Date Results
1 heart surgery and oral rinse 27/8 11
2 antiseptic mouthwash and cardiothoracic surgery 0
3 cardiothoracic surgery and topical chlorhexidine 1
4 heart surgery and topical chlorhexidine 0
5 chlorhexidine gluconate 0.12% oral rinse and
cardiac surgery 0
6 chlorhexidine and chest surgery 1
Electronic engine: Google Scholar
# Keywords used Date Results
1 antiseptic mouthwash and cardiothoracic surgery 27/8 562
2 cardiac surgery and oropharynx decontamination 0
Irrelevant studies/ duplicated records were found in ScienceDirect, Cochrane
Library and Google Scholar.
84
Appendix 3:
The Scottish Intercollegiate Guideline Network (SIGN) Guideline:
methodological checklist for randomized controlled trial
Study identification (Include author, title, year of publication, journal title, pages)
Guideline topic: Key Question No:
Before completing this checklist, consider:
Is the paper a randomized controlled trial or a controlled clinical trial? If in doubt, check the study design
algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial
questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison
Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: Reason for rejection: 1. Paper not relevant to key question □ 2. Other reason □ (please specify):
Checklist completed by:
Section 1: Internal validity
In a well conducted RCT study… In this study this criterion is:
1.1 The study addresses an appropriate and clearly focused
question.
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.2 The assignment of subjects to treatment groups is randomised Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.3 An adequate concealment method is used Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
85
1.5 The treatment and control groups are similar at the start of the
trial
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.6 The only difference between groups is the treatment under
investigation
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.7 All relevant outcomes are measured in a standard, valid and
reliable way
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was
completed?
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat
analysis)
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are
comparable for all sites
Well covered
Adequately
addressed
Poorly addressed
Not addressed
Not reported
Not applicable
Section 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or -
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
2.3 Are the results of this study directly applicable to the patient
group targeted by this guideline?
2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question.
The following section is provided for non-SIGN users of this checklist and is being developed to conform to the
standards set by the Guidelines International Network Evidence Tables Working Group.
Members of SIGN guideline groups do not need to complete this section.
86
Section 3: Description of the study
Please Print Clearly
3.1 Do we know who the study was funded by? □ Academic Institution □
Healthcare Industry
□ Government □ NGO □ Public
funds □ Other
3.2 How many centres are patients recruited from?
3.3 From which countries are patients selected? (Select all those
involved. Note additional countries after “Other”)
□ Scotland □ UK □ USA □
Canada
□ Australia □ New Zealand □
France □ Germany
□ Italy □ Netherlands □
Scandinavia □ Spain
□ Other:
3.4 What is the social setting (ie type of environment in which they
live) of patients in the study?
□ Urban □ Rural □ Mixed
3.5 What criteria are used to decide who should be INCLUDED in
the study?
3.6 What criteria are used to decide who should be EXCLUDED from
the study?
3.7 What intervention or risk factor is investigated in the study?
(Include dosage where appropriate)
3.8 What comparisons are made in the study (ie what alternative
treatments are used to compare the intervention with). Include
dosage where appropriate.
3.9 What methods were used to randomize patients, blind patients or
investigators, and to conceal the randomization process from
investigators?
3.10 How long did the active phase of the study last?
3.11 How long were patients followed-up for, during and after the
study?
3.12 List the key characteristics of the patient population. Note if there
are any significant differences between different arms of the trial.
87
3.13 Record the basic data for each arm of the study. If there are more than four arms, note data for
subsequent arms at the bottom of the page.
Arm 1:
Treatment:
Sample size:
No. analysed
With outcome:
Without outcome:
Arm 2:
Treatment:
Sample size:
No. analysed
With outcome:
Without
outcome>
Primary
outcome?
Arm 3:
Treatment:
Sample size:
No. analysed
With outcome:
Without outcome>
Primary outcome?
Arm 4:
Treatment:
Sample size:
No. analysed
With outcome:
Without outcome
Primary outcome?
3.14 Record the basic data for each IMPORTANT outcome in the study. If there are more than four, not data
for additional outcomes at the bottom of the page.
Outcome 1:
Value:
Measure:
P value
Upper CI
Lower CI
Primary outcome?
Outcome 2:
Value:
Measure:
P value
Upper CI
Lower CI
Primary
outcome?
Outcome 3:
Value:
Measure:
P value
Upper CI
Lower CI
Primary outcome?
Outcome 4:
Value:
Measure:
P value
Upper CI
Lower CI
Primary outcome?
3.15 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question. {Much of this is likely to be contributed by GDG
members).
88
Appendix 4
The Scottish Intercollegiate Guideline Network (SIGN) grading system for
determining level of evidence and recommendations
LEVELS OF EVIDENCE
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the
relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that
the relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is
not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
GRADES OF RECOMMENDATIONS
At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and
demonstrating overall consistency of results
A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 2++
Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
Good practice points
Recommended best practice based on the clinical experience of the guideline development group
Appendix 5
Table of evidence
89
Eff
ect
size
Sig
nif
ican
t dif
fere
nce
note
d;
1.I
nte
rven
tion
-co
ntr
ol=
-6.4
%
(95%
CI,
1.1
%-1
1.7
%;
p=
.002).
2.I
nte
rven
tion
-co
ntr
ol=
-6.5
%
(95%
CI,
2.3
%-1
0.7
%,
p=
.002);
dee
p S
SI:
inte
rven
tion
-co
ntr
ol=
-3.2
%(9
5
% C
I, 0
.9%
-5.5
%,
p=
.002).
3.
cult
ure
tak
en a
t su
rger
y-
cult
ure
tak
en a
t ad
mis
sion f
or
inte
rven
tion g
rou
p=
-37.5
%
(95%
CI,
27.7
%-4
7.3
%,
p<
.001).
4.i
nte
rven
tio
n-c
on
trol=
-7.9
%
(95%
CI,
7%
-10
%,
p=
.02).
5.
dura
tion o
f hosp
ital
izat
ion:
noso
com
ial
infe
cted
-non
-infe
cted
=6.9
day
s
(95%
CI,
12.3
-17.5
, p<
.001);
mea
n i
nte
nsi
ve
care
unit
sta
y:
noso
com
ial
infe
cted
-non
-infe
cted
=0.4
day
s
(95%
CI,
0.2
6-0
.61,
p<
.001)
Ou
tco
me
mea
sure
s
1.
Ov
eral
l in
ciden
ce o
f
no
soco
mia
l in
fect
ion
as d
efin
ed b
y t
he
Cen
ters
fo
r D
isea
se
Con
tro
l an
d
Pre
ven
tion
.
2.
Sec
ond
ary
ou
tco
me
mea
sure
s in
clud
ed t
he
inci
den
ce o
f L
RT
I an
d
SS
I,
3.
S a
ure
us
nas
al
carr
iag
e,
4. no
np
roph
yla
ctic
anti
mic
robia
l u
se,
5. du
rati
on
of
ho
spit
al
stay
,
6. in
-ho
spit
al
mo
rtal
ity,
7. tr
ial
med
icat
ion
adv
erse
eff
ects
,
8. if
th
e p
reop
erat
ive
du
rati
on
of
tria
l
med
icat
ion
in
fluen
ce
the
inci
den
ce o
f
no
soco
mia
l in
fect
ion
Fo
llo
w-u
p
-Co
mp
lete
d b
y
con
tact
ing a
nd
vis
itin
g t
he
refe
rrin
g
card
iolo
gy
dep
artm
ent.
-Med
ical
rec
ord
s
of
all
pat
ien
ts
wer
e re
vie
wed
.
Con
tro
l
-Tre
atm
ent
pro
toco
l sa
me
as
inte
rven
tion
gro
up
exce
pt
exp
erim
enta
l d
rug
was
rep
lace
d w
ith
pla
cebo
(n=
491
)
Inte
rven
tion
-0.1
2%
ch
lorh
exid
ine
glu
con
ate
as:
(a)
solu
tio
n a
s m
outh
rin
se
and
app
lied
fo
r 30
s 4
tim
es
dai
ly
(b)
gel
as
nas
al o
intm
ent
app
lied
4 t
imes
dai
ly
-Th
e in
terv
enti
on c
onti
nu
ed
fro
m d
irec
tly
aft
er
ho
spit
aliz
atio
n u
nti
l N
G t
ub
e
rem
ov
ed (
the
day
aft
er
surg
ery
)
(n=
500
)
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
CA
BG
: co
ron
ary
art
ery
byp
ass
gra
ftin
g
DM
: dia
bet
es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
NG
tub
e: n
asog
astr
ic t
ube
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
ion
SS
I: s
urg
ical
sit
e in
fect
ion
Su
bje
ct
Char
acte
rist
ics
-Pat
ients
und
ergo
ing
CA
BG
/ val
ve/
aort
ic/
com
bin
ed
surg
ery
-+/-
His
tory
of
DM
-+/-
His
tory
of
CO
PD
-so
me
are
smok
ing
-+/-
imm
uno
supp
ress
iv
e dis
ease
Stu
dy D
esig
n
RC
T
(n=
991
)
Bib
liog
rap
hic
cit
atio
n
Seg
ers,
P.,
Sp
eek
enb
rin
k, R
. G
.
H.,
Ubbin
k,
D.
T.,
van
Og
tro
p,
M. L
.,
& d
e M
ol,
B. A
.
JAM
A, 2
006
.
Appendix 5
Table of evidence
90
Eff
ect
size
Sig
nif
ican
t dif
fere
nce
in:
1.
Ov
eral
l no
soco
mia
l
infe
ctio
n r
ate
Inte
rven
tion
-con
tro
l=-8
.7%
(95%
CI,
p<
.01
)
2.
Inci
den
ce o
f to
tal
resp
irat
ory
tra
ct
infe
ctio
n
Inte
rven
tion
-con
tro
l=-6
.6%
(95%
CI,
p<
.05
)
3.
Use
of
nonp
rop
hyla
ctic
anti
bio
tic
Inte
rven
tion
-con
tro
l=-1
0%
(95%
CI,
p<
.05
)
Ou
tco
me
mea
sure
s
1.
Ov
eral
l no
soco
mia
l
infe
ctio
n r
ates
2.
Upp
er a
nd
lo
wer
resp
irat
ory
tra
ct
infe
ctio
n r
ates
3.
Uri
nar
y t
ract
in
fect
ion
rate
s
4.
Fun
gem
ias,
lin
e
sep
sis
rate
s
5. W
ound
in
fect
ion
rat
es
6. B
loo
d i
nfe
ctio
n r
ates
7.
Oth
er i
nfe
ctio
ns
8.N
onp
roph
yla
ctic
IV
anti
bio
tic
use
9. L
OS
in
ho
spit
al
10.
Du
rati
on
of
intu
bat
ion
11
. N
eed
fo
r
rein
tubat
ion
12.
In-h
osp
ital
mo
rtal
ity
Fo
llo
w-u
p
-A d
aily
ch
est
rad
iog
rap
h w
as
per
form
ed o
n
intu
bat
ed p
atie
nts
and
was
rev
iew
ed
by r
adio
logis
ts.
-Pat
ients
wh
o
fail
ed e
arly
extu
bat
ion
rece
ived
tra
chea
l
aspir
ate
cult
ure
anal
ysi
s at
48h
and
then
ev
ery
2
day
s u
nti
l
dis
char
ged
fro
m
the
ICU
or
dea
th.
Ad
dit
ion
al
cult
ure
s w
ere
obta
ined
as
clin
ical
ly
ind
icat
ed.
Con
tro
l
-Tre
atm
ent
pro
toco
l sa
me
as
inte
rven
tion
gro
up e
xce
pt
exp
erim
enta
l d
rug
was
rep
lace
d w
ith
pla
cebo
(n=
180
)
Inte
rven
tion
-0.1
2%
ch
lorh
exid
ine
glu
conat
e
ora
l ri
nse
adm
inis
tere
d
pre
oper
ativ
ely
and
on
a b
id
sched
ule
po
sto
per
ativ
ely
un
til
dis
char
ge
fro
m I
CU
/ dea
th
(n=
173
)
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
CA
BG
: co
ron
ary
art
ery
byp
ass
gra
ftin
g
DM
: dia
bet
es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
NG
tub
e: n
asog
astr
ic t
ube
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
ion
SS
I: s
urg
ical
sit
e in
fect
ion
ICU
: in
ten
siv
e ca
re u
nit
IV:
intr
aven
ou
s
LO
S:
length
of
stay
Su
bje
ct C
har
acte
rist
ics
-Pat
ients
und
ergo
ing
CA
BG
/ val
ve
surg
ery
-+/-
pulm
on
ary
ris
k f
acto
rs
such
as
CO
PD
, u
se o
f
ster
oid
s, h
isto
ry o
f d
iabet
es
and
/ o
r sm
ok
ing
Stu
dy D
esig
n
RC
T
(n=
353
)
Bib
liog
rap
hic
cit
atio
n
DeR
iso
II,
A.
J.,
Lad
ow
ski,
J.
S.,
Dil
lon
, T
. A
.,
Just
ice,
J.
W., &
Pet
erso
n,
A. C
.
Ches
t, 1
99
6
Appendix 5
Table of evidence
91
Eff
ect
size
1.
No
sig
nif
ican
t
dif
fere
nce
Inte
rven
tion
-con
tro
l=-1
.6%
(95%
CI,
p=
.21
)
2.
Sig
nif
ican
t dif
fere
nce
in h
igh
est
risk
pat
ien
ts
(in
tub
ated
>24
hr
+
hea
vy
bac
teri
al g
row
th
in s
pu
tum
sam
ple
s)
Inte
rven
tion
-con
tro
l=-5
0%
(95%
CI,
p=
.02
)
Ou
tco
me
mea
sure
s
1.
Ov
eral
l ra
te o
f
no
soco
mia
l p
neu
mon
ia
as d
efin
ed b
y t
he
Cen
ters
fo
r D
isea
se
Con
tro
l an
d P
reven
tion
Fo
llo
w-u
p
-Sp
utu
m s
amp
les
wer
e
coll
ecte
d a
t th
e ti
me
of
extu
bat
ion
.
-If
the
sub
ject
s w
ere
not
extu
bat
ed w
ith
in 2
4
hou
rs o
f su
rger
y, s
pu
tum
sam
ple
s w
ere
ob
tain
ed
routi
nel
y e
ver
y 4
8 h
ou
rs
unti
l ex
tub
atio
n.
-No
soco
mia
l p
neu
mon
ia
was
dia
gn
ose
d
ind
epen
den
tly b
y t
he
phy
sici
an a
nd
in
fect
ion
con
tro
l p
ract
itio
ner
.
Con
tro
l
-Tre
atm
ent
pro
toco
l sa
me
as i
nte
rven
tion
gro
up
exce
pt
exper
imen
tal
dru
g
was
rep
lace
d w
ith
Lis
teri
ne
(phen
oli
c
mix
ture
)
(n=
291
)
Inte
rven
tion
-Ora
l ri
nse
appli
ed
pre
oper
ativ
ely
and
twic
e d
aily
fo
r 10
day
s
po
sto
per
ativ
ely
or
unti
l ex
tub
atio
n,
trac
heo
sto
my,
dea
th o
r dia
gn
osi
s
of
pneu
mon
ia
usi
ng
Per
idex
(0.1
2%
chlo
rhex
idin
e
glu
con
ate
)
(n=
270
)
Su
bje
ct
Char
acte
rist
ics
-Pat
ients
und
ergo
ing
hea
rt s
urg
ery
-+/-
CO
PD
-+/-
DM
+/-
his
tory
of
smok
ing
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
CA
BG
: co
ron
ary
art
ery
byp
ass
gra
ftin
g
DM
: dia
bet
es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
NG
tub
e: n
asog
astr
ic t
ube
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
ion
SS
I: s
urg
ical
sit
e in
fect
ion
ICU
: in
ten
siv
e ca
re u
nit
IV:
intr
aven
ou
s
LO
S:
length
of
stay
Stu
dy D
esig
n
RC
T
(n=
561
)
Bib
liog
rap
hic
cit
atio
n
Su
san
et
al.
Am
J C
rit
Ca
re,
2002
Appendix 5
Table of evidence
92
Eff
ect
size
Sig
nif
ican
t dif
fere
nce
in:
4.
rate
s o
f no
soco
mia
l
infe
ctio
n w
ith
S. au
reu
s
among
car
rier
s o
f S
. au
reu
s
Inte
rven
tion
-con
tro
l=-3
.3%
(95
% C
I, p
=0
.02
)
Ou
tco
me
mea
sure
s
pri
mar
y o
utc
om
e:
1.
rate
of
S. au
reu
s
infe
ctio
ns
at s
urg
ical
site
s; s
eco
ndar
y
outc
om
e:
2.
rate
s o
f su
rgic
al-s
ite
infe
ctio
ns
amo
ng
pat
ients
wit
h n
asal
carr
iag
e o
f S
. au
reu
s,
3. ov
eral
l an
d
site
-sp
ecif
ic r
ates
of
no
soco
mia
l in
fect
ion
,
4.
rate
s o
f no
soco
mia
l
infe
ctio
n w
ith
S. au
reu
s
Fo
llo
w-u
p
-Pat
ients
wer
e
mo
nit
ore
d f
or
a m
ean o
f
30 d
ays
afte
r o
per
atio
ns.
-Pat
ients
wer
e ex
amin
ed
and
med
ical
rec
ord
s
rev
iew
ed e
ver
y t
hre
e to
fiv
e day
s an
d
tele
pho
ned
dis
char
ged
pat
ients
wee
kly
du
ring
the
foll
ow
-up
per
iod
to
det
erm
ine
any
sig
ns
or
sym
pto
ms
of
infe
ctio
n.
Pat
ients
wit
h s
ign
s an
d
sym
pto
ms
of
infe
cti
on
wer
e as
ked
to t
elep
ho
ne
the
stud
y p
erso
nn
el
imm
edia
tely
.
Con
tro
l
iden
tica
l-ap
pea
rin
g
pla
cebo
oin
tmen
t ap
pli
ed
in t
he
sam
e w
ay a
s
inte
rven
tion
gro
up
(n=
2018
)
Inte
rven
tion
2%
mup
iro
cin
calc
ium
oin
tmen
t
app
lied
by h
ealt
h
care
wo
rker
s w
ith
cott
on s
wab
s to
inte
rio
r o
f ea
ch
ante
rio
r n
aris
tw
ice
dai
ly f
or
up
to 5
day
s b
efo
re
oper
atio
n (
n=
20
12
)
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
CA
BG
: co
ron
ary
art
ery
byp
ass
gra
ftin
g
DM
: dia
bet
es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
NG
tub
e: n
asog
astr
ic t
ube
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
ion
SS
I: s
urg
ical
sit
e in
fect
ion
ICU
: in
ten
siv
e ca
re u
nit
IV:
intr
aven
ou
s
LO
S:
length
of
stay
BM
I: b
ody
mas
s in
dex
S.
aure
us:
sta
ph
ylo
cocc
us
aure
us
Su
bje
ct
Char
acte
rist
ics
-Pat
ients
und
ergo
ing
surg
ery
-BM
I>20
Stu
dy D
esig
n
RC
T
(n=
3864
)
Bib
liog
rap
hic
cit
atio
n
Per
l et
al.
N E
ngl
Med
, 20
02
Appendix 5
Table of evidence
93
Eff
ect
size
No
sig
nif
ican
t
dif
fere
nce
.
6.
rate
s o
f d
eath
s
and
co
mp
lica
tion
s
due
to i
nfe
ctio
ns
is n
ot
calc
ula
ted
Ou
tco
me
mea
sure
s
pri
mar
y:
1.
rate
of
any
wo
und
infe
ctio
n a
t
surg
ical
sit
es;
seco
nd
ary
:
2.
rate
s o
f S
.
aure
us
infe
ctio
ns,
3.
rate
s o
f
over
all
no
soco
mia
l
infe
ctio
ns
and
4. no
soco
mia
l
S.
aure
us
infe
ctio
ns,
5.
rate
s o
f nas
al
S.
aure
us
clea
ran
ce,
6.
rate
s o
f
dea
ths
and
com
pli
cati
on
s
due
to
infe
ctio
ns
Fo
llo
w-u
p
-A s
teri
le c
ott
on s
wab
mois
tened
wit
h s
teri
le
wat
er w
as r
ubbed
alo
ng t
he
enti
re i
nner
surf
ace
of
both
nost
rils
and p
late
d o
n t
o b
lood a
gar
for
S.
aure
us
cult
ure
, usi
ng s
tandar
d l
abora
tory
tech
niq
ues
.
-Nas
al c
ult
ure
s w
ere
obta
ined
tw
o w
eeks
bef
ore
surg
ery a
nd a
gai
n a
t ad
mis
sion j
ust
pri
or
to
surg
ery.
Wound s
wab
s or
aspir
ates
wer
e
obta
ined
post
oper
ativ
ely u
nder
ase
pti
c
condit
ions
from
any w
ound w
ith e
vid
ence
of
infl
amm
atio
n.
Intr
a-oper
ativ
e w
ound c
ult
ure
s
wer
e obta
ined
fro
m p
atie
nts
hav
ing s
urg
ical
wound d
rain
age
or
deb
ridem
ent
and b
lood
cult
ure
s obta
ined
fro
m a
ll f
ebri
le a
nd s
epti
c
pat
ients
.
-Pro
spec
tive
wound s
urv
eill
ance
was
car
ried
out
by a
res
earc
h a
ssis
tant;
the
RA
vie
wed
mic
robio
logy l
ogs
and n
urs
ing r
eport
s to
det
ect
pote
nti
al w
ound i
nfe
ctio
ns
biw
eekly
.
-Eac
h s
urg
eon c
om
ple
ted a
form
al
post
dis
char
ge
surv
eill
ance
six
to e
ight
wee
ks
afte
r su
rger
y. G
P a
nd p
atie
nts
wer
e co
nta
cted
by
tele
phone
twic
e m
onth
ly t
o e
nsu
re t
he
abse
nce
of
wound i
nfe
ctio
ns
afte
r dis
char
ge.
Pat
ients
wer
e as
ked
to t
elep
hone
the
inves
tigat
ors
if
signs
and s
ym
pto
ms
of
infe
ctio
ns
dev
eloped
.
Con
tro
l
iden
tica
l-ap
pea
rin
g
pla
cebo
ad
min
iste
red
the
sam
e w
ay a
s
inte
rven
tion
gro
up
(n=
133
)
Inte
rven
tion
2%
mup
iro
cin
oin
tmen
t
adm
inis
tere
d
intr
anas
ally
wit
h
a Q
-tip
cott
on
app
lica
tor
to t
he
ves
tib
ule
of
bo
th
nar
es t
wic
e dai
ly
for
sev
en d
ays
bef
ore
su
rger
y
(n=
133
)
Su
bje
ct
Char
acte
rist
ics
-Pat
ients
und
ergo
ing
CA
BG
/ val
ve
surg
ery
-BM
I>23
+/-
his
tory
of
DM
,
hyp
erte
nsi
on
,
smok
ing
-wit
h n
asal
S.
aure
us
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
CA
BG
: co
ron
ary
art
ery
byp
ass
gra
ftin
g
DM
: dia
bet
es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
NG
tub
e: n
asog
astr
ic t
ube
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
ion
SS
I: s
urg
ical
sit
e in
fect
ion
ICU
: in
ten
siv
e ca
re u
nit
IV:
intr
aven
ou
s
LO
S:
length
of
stay
BM
I: b
ody
mas
s in
dex
S.
aure
us:
sta
ph
ylo
cocc
us
aure
us
RA
: re
sear
ch a
ssis
tant
GP
: gen
eral
pra
ctit
ioner
Stu
dy D
esig
n
RC
T
(n=
263
)
Bib
liog
rap
hic
cit
atio
n
Ko
nv
alin
ka,
A., E
rret
t, L
., &
Fo
ng
, I.
W.
Jou
rnal
of
Hosp
ital
Infe
ctio
n, 2
006
Appendix 5
Table of evidence
94
Eff
ect
size
Sig
nif
ican
t dif
fere
nce
in:
1.
CH
X-P
LA
C=
-7;
CH
X/C
OL
-PL
AC
=-6
(95
% C
I,
p=
.025).
2.
gra
m-n
egat
ive
mic
roo
rgan
ism
(vs.
PL
AC
):
HR
for
CH
X=
0.8
26 (
95
% C
I,
p=
.007);
HR
for
CH
X/
CO
L=
.44 (
95%
CI,
p<
.001
);
gra
m-p
osi
tive
mic
roorg
anis
m:
HR
for
CH
X=
.695 (
95%
CI,
p<
.001),
HR
for
CH
X/C
OL
=.7
32 (
95
%C
I,
p<
.001).
3.
(Day
s 5
-8)
CH
X/C
OL
-PL
AC
=-2
4%
(P=
.007);
CH
X/C
OL
-CH
X=
-22
%(P
=.0
1
1);
4.
CH
X-P
LA
C:
HR
=1.1
2,
95%
CI,
CH
X/C
OL
-PL
AC
:
HR
=1.0
2,
95%
CI
Ou
tco
me
mea
sure
s
pri
mar
y o
utc
om
e:
1. ti
me
to V
AP.
Sec
ond
ary
outc
om
e:
2. o
ral
colo
niz
atio
n w
ith
gra
m-p
osi
tive
and
gra
m-n
egat
ive
mic
roo
rgan
ism
s,
3. en
do
trac
hea
l
colo
niz
atio
n,
4. al
l-ca
use
IC
U
mo
rtal
ity.
Fo
llo
w-u
p
-VA
P w
as d
iag
no
sed
on
clin
ical
dec
isio
n o
f
trea
tin
g p
hy
sici
ans,
sub
stan
tiat
ed b
y
adju
dic
atio
n b
y t
hre
e
inte
nsi
vis
ts r
evie
win
g
case
rec
ord
fo
rms
of
all
pat
ients
by r
ecei
vin
g i
n
sets
of
10 p
atie
nts
info
rmat
ion a
nd v
erif
ied
all
dia
gn
osi
s b
ased
on
obje
ctiv
e V
AP
cri
teri
a.
-Cli
nic
al p
ulm
onar
y
infe
ctio
n s
core
s (C
PIS
s)
of
all
pat
ien
ts w
ere
calc
ula
ted
dai
ly.
-Oro
phar
yng
eal
swab
s
wer
e co
llec
ted d
aily
;
end
otr
achea
l as
pir
ates
wer
e obta
ined
on
clin
ical
ind
icat
ion
or
twic
e w
eekly
if
no
clin
ical
cult
ure
s w
ere
obta
ined
.
Con
tro
l
Vas
elin
e F
NA
(P
LA
C,
pla
cebo
). A
dm
inis
trat
ion
met
hod
sam
e as
tre
atm
ent
gro
up.
(n=
130
)
Inte
rven
tion
trea
tmen
t ar
m 1
:
chlo
rhex
idin
e 2%
in
pet
role
um
jel
ly (
vas
elin
e)
FN
A (
CH
X)
(n=
127).
Tre
atm
ent
arm
2:
chlo
rhex
idin
e 2%
wit
h
coli
stin
2%
in V
asel
ine
FN
A (
CH
X/C
OL
)(n=
128).
The
trea
tmen
t w
as
adm
inis
tere
d 4
tim
es d
aily
,
afte
r re
movin
g r
emnan
ts
of
the
pre
vio
us
dose
wit
h a
gau
ze m
ois
tened
wit
h
sali
ne
(NaC
l 0.9
%).
Appro
xim
atel
y 2
cm
, 0.5
g
of
pas
te w
as p
ut
on a
glo
ved
fin
ger
tip a
nd
adm
inis
tere
d t
o e
ach s
ide
of
the
bucc
al c
avit
y. T
his
met
hod w
as t
aught
to e
ach
nurs
e on t
he
par
tici
pat
ing
war
ds
to p
reven
t
dif
fere
nce
s in
dis
trib
uti
on/
appli
cati
on o
f th
e tr
ial
med
icat
ion.
Su
bje
ct
Char
acte
rist
ics
-Pat
ients
nee
din
g
mec
han
ical
ven
tila
tion
fo
r
at l
east
48
hou
rs
-GC
S<
8
Fo
otn
ote
:
RC
T:
rando
miz
ed c
on
tro
lled
tri
al;
NaC
l: s
odiu
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: dia
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es
m
elli
tus
CO
PD
: ch
ronic
ob
stru
ctiv
e pu
lmon
ary
dis
ease
VA
P:
ven
tila
tion
ass
oci
ated
pn
eum
onia
LR
TI:
lo
wer
res
pir
ato
ry t
ract
in
fect
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SS
I: s
urg
ical
sit
e in
fect
ion
ICU
: in
ten
siv
e ca
re u
nit
FN
A:
fine
nee
dle
asp
irat
e
LO
S:
length
of
stay
BM
I: b
ody
mas
s in
dex
S.
aure
us:
sta
ph
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cocc
us
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us
RA
: re
sear
ch a
ssis
tant
GP
: gen
eral
pra
ctit
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S:
Gla
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om
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Stu
dy D
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n
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Ko
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06
95
Appendix 6: Quality assessment table
Author(s) and year of publication Segers, P., Speekenbrink, R. G. H., Ubbink, D. T., van Ogtrop, M. L., & de Mol, B. A. (2006)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question.
Well covered Stated in objective: To determine the efficacy of perioperative decontamination of the nasopharynx and oropharynx
with 0.12% chlorhexidine gluconate for reduction of nosocomial infection after cardiac surgery.
Randomization Well covered After written consent and assessment of baseline characteristics. Computer-generated randomization was carried
out by local pharmacy to dispense active or placebo trial medications.
Allocation concealment Adequately addressed Computer-generated randomization was carried out by pharmacy only, which is not involved in the study, to ensure
allocation concealment.
Blinding Well covered 1. Blinding was ensured by identical packaging of trial medication, labeled only with the randomization number
and was continued until data collection was completed.
2. Treatment remained blinded throughout the follow-up period for the patients, entire surgical and intensive
care unit staff, and investigators.
3. Blinding was to be overruled only in the case of severe allergic reactions or adverse effects.
Homogeneity of comparison groups Poorly addressed Only number and percentage of patients were compared; stated difference between the 2 trial groups were analyzed
by means of a chi-squared or t test but without detailed explanation of the difference in significant categories, if
any.
Treatment under investigation Well covered The only difference was the 0.12% chlorhexidine gluconate solution as oral rinse or nasal gel. All patients were
treated according to the local open heart surgery protocol.
Validity and reliability of relevant outcome
measure(s)
Not applicable Diagnosis of nosocomial infection was made according to the criteria developed by the Centers for Disease Control
and Prevention. Incidence of nosocomial infection, rate of Staphylococcus aureus nasal carriage and duration of
hospital stay cannot be assessed with validity and reliability.
96
Attrition (%, intervention versus control group) 1.2 versus 1.8
Method(s) of data analysis Analysis was performed on a modified intention-to-treat basis. None of the subjects received controlled medication
in treatment group or vice versa. Subjects were excluded if received preoperative selective decontamination of the
digestive tract.
Level of evidence 1++
Bias Improved by:
1. Low risk of attrition bias. Attrition rate less than 2%.
2. Selection bias was minimized by clear randomization and allocation concealment method.
3. Response bias was minimized by blinding of subjects, staffs and investigators.
Affected by:
1. Statistical significance not presented when comparing baseline characteristics between treatment and control
group.
Certainty of outcomes due to interventions Yes The outcome is solely affected by the intervention.
Applicability of findings for the evidence based
practice guideline development
Yes The target population and settings of the guideline is matched.
97
Author(s) and year of publication Susan, H., Paul, H., Jacqueline, J. A., Mark, L., & et al. (2002)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question.
Well covered Stated in objective: To test the effectiveness of 0.12% chlorhexidine gluconate oral rinse in decreasing microbial
colonization of respiratory tract and nosocomial pneumonia in patients undergoing open heart surgery.
Randomization Poorly addressed Taken place after consent and assessment of baseline characteristics. Patients were consecutively randomized to
experimental or control group according to patients’ medical record numbers.
Allocation concealment Not addressed No evidence of allocation concealment was reported.
Blinding Not addressed No evidence of blinding method was reported.
Homogeneity of comparison groups Well covered P value in comparison of all subjects characteristics were insignificant. Analysis of variance and chi-square tests
were used to compare subjects characteristics between groups.
Treatment under investigation Well covered The only difference was Peridex as oral rinse. Subjects in control group received Listerine. Both groups received
preoperative and perioperative prophylactic antibiotics as part of routine heart surgery protocol.
Validity and reliability of relevant outcome
measure(s)
Adequately addressed Diagnosis of nosocomial infection was made by using a tool according to the criteria for nosocomial pneumonia
developed by the Centers for Disease Control and Prevention. Validity and reliability of tool was not stated.
Nosocomial pneumonia was diagnosed independently by the physician and infection control practitioner. Interrater
reliability was established at 98%.
98
Attrition (%, intervention versus control group) 10 versus 3
Method(s) of data analysis Based on intention-to-treat principle. Subjects were treated and analyzed according to the group that initially
randomized.
Level of evidence 1+
Bias Improved by:
1. Baseline characteristics between treatment and control group were balanced and statistically insignificant.
Affected by:
1. Attrition rate is high in intervention group which was resulted from death and tracheostomy.
2. Allocation concealment was not stated which increases risk of selection bias.
3. Unknown blinding towards physicians and infection control practitioner may affect response bias.
Certainty of outcomes due to interventions Yes The outcome is solely affected by the intervention.
Applicability of findings for the evidence based
practice guideline development
Yes The target population and settings of the guideline is matched.
99
Author(s) and year of publication DeRiso II, A. J., Ladowski, J. S., Dillon, T. A., Justice, J. W., & Peterson, A. C. (1996)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question.
Well covered As stated in objective: To test the effectiveness of oropharyngeal decontamination on nosocomial infections.
Randomization Well covered Taken place after consent and assessment of baseline characteristics. The pharmacy randomized the patients by
means of a computer-driven random number generator.
Allocation concealment Adequately addressed The randomization was carried out by pharmacy only, which is not involved in the study, to ensure allocation
concealment.
Blinding Adequately addressed Treatment and placebo were of identical packaging and labeling produced by pharmacy, which is not involved in
treatment administration, data collection and data analysis. Radiologists were unaware of patients’ group.
Homogeneity of comparison groups Adequately addressed The difference of subjects’ characteristics between treatment and control groups was statistically insignificant.
Treatment under investigation Adequately addressed The difference was 0.12% chlorhexidine gluconate oral rinse. All patients received standard oral care and open
heart surgery protocol. However, other therapy such as systemic antibiotics, pressor agents, and nutritional support
were allowed in both groups as clinically indicated.
Validity and reliability of relevant outcome
measure(s)
Not applicable Diagnosis of infection was made according to the criteria developed by the Centers for Disease Control and
Prevention. Incidence of nosocomial infection, rate of nosocomial respiratory infections and use of nonprophylactic
systematic antibiotics cannot be assessed with validity and reliability.
100
Attrition (%, intervention versus control group) Not reported No case of drop out was reported.
Method(s) of data analysis Based on intention-to-treat principle. Subjects were treated and analyzed according to the group that initially
randomized.
Level of evidence 1++
Bias Improved by:
1. Baseline characteristics between treatment and control group were balanced and statistically insignificant.
2. Blinding towards physicians and subjects minimize response bias.
3. Clear randomization method minimized selection bias.
Affected by:
1. Attrition rate is not reported, which may affect results interpretation.
2. Allocation concealment was not stated which increases risk of selection bias.
Certainty of outcomes due to interventions Yes The outcome is solely affected by the intervention.
Applicability of findings for the evidence based
practice guideline development
Yes The target population and settings of the guideline is matched.
101
Author(s) and year of publication Koeman et al. (2006)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question.
Well covered As stated in objective: To determine the effect of oral decontamination with CHX or CHX/COL on VAP incidence
and time to development of VAP.
Randomization Well covered Taken place after consent and assessment of baseline characteristics. Patients were randomly assigned to one of
three study groups by a computerized randomization schedule.
Allocation concealment Not addressed No evidence of allocation concealment is reported.
Blinding Well covered Trial medication was produced and labeled by the Department of Clinical Pharmacy of the University Hospital
Maastricht. Experimental and placebo pastes were tasteless and of comparable smell and consistency.
VAP diagnosis was made by 3 intensivists reviewing case record forms of all participating patients. The intensivists
were blinded for patient treatment and study center.
Whether the treatment administrators were blinded was not explicitly stated.
Homogeneity of comparison groups Poorly addressed Only number and percentage of patients characteristics was shown without denoting statistical significance.
Treatment under investigation Well covered The only difference was (1) chlorhexidine 2% and (2) chlorhexidine 2% and colistine 2%.
Validity and reliability of relevant outcome
measure(s)
Not reported No evidence on the definition of diagnosing VAP is reported.
No evidence on validity and reliability of clinical pulmonary infection scores (CPISs) was reported.
Other outcome measures were measured as rates and cannot be assessed with validity and reliability.
Attrition (%, intervention versus control group) CHX/COL: 1.56 vs. 0.76
CHX: 1.57 vs. 0.76
102
Method(s) of data analysis Based on intention-to-treat principle. Subjects were treated and analyzed according to the group that initially
randomized.
Level of evidence 1-
Bias Improved by:
1. Low attrition bias. Attrition rate is less than 2%.
2. Blinding towards physicians and subjects minimize response bias.
3. Clear randomization method minimized selection bias.
Affected by:
1. Statistical significance not presented when comparing baseline characteristics between treatment and
control group.
2. Allocation concealment was not stated which increases risk of selection bias.
3. In case of different interpretation in diagnosing VAP, consensus was reached through telephone
conversations by the intensivists, which affects transparency.
4. Patients with consent withdrawn were analyzed, which affects interpretation of effects of the study
medication.
Certainty of outcomes due to interventions Yes
Applicability of findings for the evidence based
practice guideline development
Yes
103
Author(s) and year of publication Perl et al. (2002)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question.
Well covered As stated in abstract: To determine whether intranasal treatment with mupirocin reduces the rate of S. aureus
infections at surgical sites and prevents other nosocomial infections.
Randomization Not addressed Taken place after consent and assessment of baseline characteristics. No evidence of randomization method was
reported.
Allocation concealment Not addressed No evidence of allocation concealment was reported.
Blinding Well covered The treatment ointment and placebo were identical in appearance which blinded the subjects and treatment
administrators.
Three physicians who were unaware of the patients’ treatment assignments reviewed the records of all patients
infected with S. aureus at surgical sites to ensure the criteria for infection were met.
Homogeneity of comparison groups Poorly addressed Only number and percentage of patients characteristics was shown without denoting statistical significance.
Treatment under investigation Adequately addressed The difference is 2% mupirocin calcium ointment.
Surgeons used standard prophylactic antimicrobial regimens when appropriate.
Validity and reliability of relevant outcome
measure(s)
Adequately addressed Laboratory confirmation of S. aureus nasal carriers and patients with infection.
No evidence was stated on the definition of surgical site infection.
Attrition (%, intervention versus control group) 12.4 vs. 10.4
104
Method(s) of data analysis Based on intention-to-treat principle. Subjects were treated and analyzed according to the group that initially
randomized.
Level of evidence 1-
Bias Improved by:
1. Blinding towards physicians and subjects minimize response bias.
Affected by:
1. Statistical significance not presented when comparing baseline characteristics between treatment and
control group.
2. Attrition rate is more than 10%. Risk of attrition bias increased.
3. Allocation concealment was not stated which increases risk of selection bias.
Certainty of outcomes due to interventions Yes
Applicability of findings for the evidence based
practice guideline development
Yes
105
Author(s) and year of publication Konvalinka, A., Errett, L., Fong, I.W. (2006)
Internal Validity Comments Descriptions
Appropriateness and clarity of research question
Well covered As stated in abstract: To determine whether nasal mupirocin administered preoperatively to S. aureus carriers
reduces the rates of sternal and leg wound infections after cardiac surgery.
Randomization Well covered Taken place after consent and assessment of baseline characteristics. The randomization numbers were computer
generated with 1:1 ratio for mupirocin and placebo.
Allocation concealment Adequately addressed The code in randomization was available to the research pharmacist.
Blinding Well covered The research assistant (data collector) was unaware of the randomization assignment.
The pharmacists divided the treatment groups into A and B. Blinding was maintained by the pharmacist until after
analysis.
Homogeneity of comparison groups Adequately addressed The only statistically significant difference between the patients in treatment and control groups was chronic
obstructive pulmonary disease. Whether difference in other characteristics was not explicitly stated.
Treatment under investigation Well covered The only difference is 2% mupirocin ointment.
Validity and reliability of relevant outcome
measure(s)
Adequately addressed Laboratory confirmation of patients with infection.
Prospective wound surveillance, microbiology logs and nursing reports review was carried out by a research
assistant to detect potential wound infection bi-weekly.
Each surgeon completed formal post discharge surveillance 6-8 weeks after surgery.
General practitioners and patients were contacted by telephone twice monthly to ensure absence of wound
infections following discharge. Patients were asked to phone the investigators if signs of infections developed.
106
Wound infections was defined according to the Nosocomial Infection Surveillance System definitions. The
reliability and validity of the system was not reported.
Attrition (%, intervention versus control group) 2.98 vs. 0.78
Method(s) of data analysis Initial analysis was based on intention-to-treat principle. Subjects were treated and analyzed according to the group
that initially randomized.
Reanalysis was taken place (actual treatment analysis) for patients in placebo group who received treatment or vice
versa.
Level of evidence 1++
Bias Improved by:
1. Majority of baseline characteristics were balanced between treatment and control group and was statistically
insignificant to interfere with study results.
2. Blinding towards physicians, subjects and data collectors minimize response bias.
3. Clear randomization method minimized selection bias.
4. Allocation concealment has carried out which minimized risk of selection bias.
5. Clear method of data analysis.
Affected by:
1. Risk of attrition bias. Attrition rate is about 2% in treatment group.
Certainty of outcomes due to interventions Yes
Applicability of findings for the evidence based
practice guideline development
Yes
107
Appendix 7
Flowchart of the nurse initiated guideline
Oronasopharyngeal care at least twice daily:
0.12% chlorhexidine gluconate
Solution/ nasal gel
Cotton swabs/ Q-tip cotton applicator/
sponge
Patient education with instructions:
15ml
Apply for 30s
No eating/ drinking afterwards
2% mupirocin
calcium on
nostrils
2%
chlorhexidine +
2% colistin
petroleum gel
Preoperatively Post-operatively
Assessment
Intervention
Nasal S. aureus
carrier?
=/>48 hours of
intubation?
Intervention
If any signs and symptoms of infection:
Stop!
Consult medical treatment as soon
as possible
108
Appendix 8
Timetable, proposed number and role of staffs
Stakeholders Responsibilities
DOM Leading, coordination of different
parties, human & financial resources
management
WM, NO, APN Arrangement of staff duties, acts as
facilitator
Nurses Implement the guideline and provide
patient education
Investigator Offer help, plan arrangement and
promote implementation
Timetable
Communication with managerial levels 1st-2
nd week
Communication with nurses 3rd
-6th
week
Communication with patients From 7th
week, ongoing
Pilot test 7th
-13th
week
Pilot test evaluation 14th
week
Actual implementation 15th
week
Data collection One week & one month after patient
discharge, ongoing
Interview to staffs Every 4th
week/ month
Formative evaluation 1st, 3
rd, 6
th, 9
th month
Summative evaluation 52th
week
109
Appendix 9
Questionnaire for evaluating level of satisfaction from clients
The pre and post operative oronasopharyngeal care interventions for cardiac
patients
Evaluation questionnaire for participants
Thank you for participating the program. Please kindly take 1-2 minutes to
fill out this evaluation questionnaire. Your comments and advice are highly
valuable on determination of the quality provision of the program and aid in
future improvements.
Please circle on the number: (e.g. ○1 )
Strongly Strongly
Disagree agree
1. The program met its objectives. 1 2 3 4 5
2. Content of intervention is easy 1 2 3 4 5
to understand.
3. Instructions given is clear and 1 2 3 4 5
comprehensible.
4. Interventions is easy to carry 1 2 3 4 5
out.
5. Nurses provide adequate 1 2 3 4 5
assistance & advice.
6. The time to carry out the 1 2 3 4 5
intervention is adequate.
7. You have adequate skills 1 2 3 4 5
to carry out the intervention.
8. You feel more confident 1 2 3 4 5
in self care after joining this
program.
9. You feel more stressful in 1 2 3 4 5
taking part in this program.
110
10. Overall, this program is worth 1 2 3 4 5
conducting.
Strengths of the program:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Weakness of the program:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Suggestions for improvement:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
THE END. THANK YOU.
111
Appendix 10
Questionnaire for evaluating level of satisfaction from nurses
The pre and post operative oronasopharyngeal care interventions for cardiac
patients
Evaluation questionnaire for service providers
Thank you for participating the program. Please kindly take 1-2 minutes to
fill out this evaluation questionnaire. Your comments and advice are highly
valuable on determination of the quality provision of the program and aid in
future improvements.
Please circle on the number: (e.g. ○1 )
Strongly Strongly
Disagree agree
Training
1. You know the objectives of the 1 2 3 4 5
program.
2. Content of intervention is easy 1 2 3 4 5
to understand.
3. Instructions given is clear and 1 2 3 4 5
comprehensible.
4. Adequate training is provided. 1 2 3 4 5
5. Overall, you are satisfied with 1 2 3 4 5
the training provided.
---------------------------------------------------------------------------------------------
Service delivery
6. Interventions is easy to carry 1 2 3 4 5
out.
7. The time to carry out the 1 2 3 4 5
intervention is adequate.
8. Adequate resources and support 1 2 3 4 5
given to carry out the intervention.
9. The guideline improves the 1 2 3 4 5
112
quality of patient care.
10. Overall, you are satisfied with the 1 2 3 4 5
mode of service delivery.
----------------------------------------------------------------------------------------------
Usefulness
11. You know more about 1 2 3 4 5
decolonization therapy after this
program.
12. You have acquired adequate skills 1 2 3 4 5
in carrying out the guideline.
----------------------------------------------------------------------------------------------
Feasibility
13. You feel confident in conducting 1 2 3 4 5
the guideline.
14. You feel more stressful in 1 2 3 4 5
carrying out the intervention.
15. Your job satisfaction is increased 1 2 3 4 5
by taking part in the guideline.
16. The guideline is feasible to 1 2 3 4 5
implement in the long term.
17. Overall, this program is worth 1 2 3 4 5
conducting.
Strengths of the program:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Weakness of the program:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Suggestions for improvement:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
THE END. THANK YOU.
113
Appendix 11
Sample size calculation
RCT Intervention, % Control, %
Segars et al., 2006 9.3 15.8
DeRiso II et al., 1996 2.9 9.4
Average 6.1 12.6
With power=80%, alpha=0.05, after substitute the data into the sample size
calculator, the sample size is about 170 clients.
Considering the dropout rate is 1.56% (Koeman, 2006) and 1.51% (Segars et al.,
2006), the final sample size is 175.
114
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