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Abstract of dissertation entitled
Evidence-‐Based Guidelines for the Prevention of Pressure Ulcers Using
Pressure-‐Relieving Support Surface for Bedbound Elderly
Submitted by
Wong Mei Ting
For the degree of Master of Nursing in the University of Hong Kong
July 2013
Background
Pressure ulcer prevention has been an important and a common
health care problem in every health care setting. Pressure ulcers are the
clinical situation that can be avoided. To prevent pressure ulcer, the
main strategy is to reduce either the pressure contact time, or
magnitude of pressure, between a patient and his or her support
surface. Pressure-‐relieving support surfaces are shown to be effective in
preventing the development of pressure ulcer with strong evidence
support.
2
In Hong Kong, the low compliance of the ward staff to apply
pressure-‐relieving support surfaces for at risk patients is compared with
other countries. Therefore, a feasible evidence-‐based guideline of using
pressure-‐relieving support surfaces to prevent pressure ulcers stands
out from the multi-‐interventions pressure ulcer prevention guideline to
maximize its effectiveness in this clinical issue.
Purpose
Reviewing the needs in modifying the current clinical practice and
guidelines in local setting, the aim of the dissertation is to develop
evidence-‐based guidelines for prevention of pressure ulcers using
pressure-‐relieving support surface for bedbound elderly. The findings
are used to develop recommendations for nursing guideline to prevent
pressure ulcers through the utilization of pressure-‐relieving support
surface in Hong Kong public hospital setting.
Methods
Four electronic databases published from 1937 to 2012 were
searched. All the studies extracted were randomised controlled trials
while focusing on using pressure-‐relieving support surfaces to prevent
pressure ulcers of adult patients. The quality of each study was assessed
by a methodology checklist, the Scottish Intercollegiate Guideline
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Network in order to justify the level of evidence of the studies’ internal
validity.
Conclusion
From the evidence, the clearest conclusion that can be drawn is
that a range of pressure-‐relieving mattresses and overlays in the
prevention of pressure ulcers can outperform the standard hospital
mattress. It can be applied to any health care settings. The reviewed
studies have shown that pressure-‐relieving mattresses are effective on
at risk patients, especially they are in advanced age with low mobility.
Therefore, this evidence-‐based guidelines will serve in the medical
rehabilitation wards to reduce the number of elderly from developing
pressure ulcer after using the pressure-‐relieving supporting surfaces.
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Evidence-‐Based Guidelines for the Prevention of Pressure Ulcers Using
Pressure-‐Relieving Supporting Surface For Bedbound Elderly
Submitted by
Wong Mei Ting
Bachelor of Nursing C.U.H.K
A dissertation submitted in partial fulfillment of the requirements for the Degree of
Master of Nursing at the University of Hong Kong
July 2013
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Declaration
I declare that this dissertation 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.
Sign:
6
Acknowledgements
I would like to express my wholehearted thanks to Professor
Sophia Chan and Dr. William Li, my supervisors, who have given me
constant guidance, encouragement and support in order to facilitate me
to finish this dissertation.
Also, I would like to say thank you to my family, fellow classmates,
my colleagues and all my friends for all their support and being generous
throughout the journey. Despite that hardship, this dissertation makes
me learn a lot apart from the curriculum which is worthwhile and
valuable for me.
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Table of Contents Declaration Acknowledgements Table of Contents Chapter One Introduction Page
1.1 Background 11
1.1.1 Definition of Pressure Ulcer
1.1.2 Prevalence of Pressure Ulcer and Its Importance
1.1.3 Intervention to Prevent Pressure Ulcer
1.2 Affirming the Needs 12
1.2.1 Definition of Pressure-‐Relieving Support Surfaces
1.2.2 Current Practice in Local Setting and Study Significance
1.3 Objectives 14
Chapter Two Critical Appraisal
2.1 Search and appraisal strategies 16
2.1.1 Inclusion Criteria
2.1.2 Exclusion Criteria
2.1.3 Search Strategies for Related Studies
2.2 Results 19
2.2.1 Tables of Evidence
2.2.2 Quality Assessment
2.2.3 Summarize of the Study Characteristic and Methodological Issues
2.2.3.1 Study Design
2.2.3.2 Patient Characteristic
2.2.3.3 Study Setting
2.2.3.4 Sample Size
2.2.3.5 Allocation Concealment
2.2.3.6 Blinding of Subjects and Assessors
2.2.3.7 Intervention Effectiveness
8
2.2.3.8 Outcome Measurement
2.2.3.9 Drop Out Rate Page
2.2.3.10 Potential Source of Bias
2.3 Summary and Synthesis 25
2.3.1 Analysis and Summary of the Evidence
2.3.2 Implications
Chapter Three Translation and Application
3.1 Implementation Potential 29
3.1.1 Transferability of Findings
3.1.1.1 Target Setting
3.1.1.2 Target Audience
3.1.1.3 Philosophy of Care
3.1.1.4 Sufficient Patient Benefit
3.1.1.5 Time for Implementation and Evaluation
3.1.2 Feasibility
3.1.2.1 Organization Level
3.1.2.2 Individual Level
3.1.3 Cost and Benefit Ratio
3.2 Evidence-‐Based Practice Guideline 36
3.2.1 Objectives of Evidence-‐Based Practice Guideline
3.2.2 Intended Users and Setting
3.2.3 Target Population
3.2.4 Levels of Evidence and Grades of Recommendations
3.2.5 Description of Guideline
Chapter Four Implementation Plan
4.1 Communication Plan 41
4.1.1 Stakeholders
4.1.2 Communication Process
4.2 Pilot Study Plan 46
4.2.1 Enrollment Strategies
4.2.2 Staff Training
4.2.3 Data Collection
4.2.4 Review of Guideline
9
4.3 Evaluation Plan 50
4.3.1 Identifying Outcomes and Measurements Page
4.3.1.1 Patient Outcomes
4.3.1.2 Healthcare Provider Outcomes
4.3.1.3 System Outcome
4.3.2 Nature and Number of Clients to be Involved
4.3.3 Timing and Frequency of the Measurements
4.3.4 Data Analysis
4.3.5 Basis of Adopting the Innovation
Appendices 55
References 78
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List of Appendices
Page
Appendix 1 IOWA Model 54
Appendix 2 Flowcharts of four search engines 55
Appendix 3 Table of Evidence 56
Appendix 4 Quality Assessment 61
Appendix 5 The Methodology Checklist 67
Appendix 6 Level of Evidence an Grade of Recommendation 69
Appendix 7 Pressure Ulcer Prevention and Management Policy 70
Appendix 8 Reminder Form Attached to Original Norton Scale Assessment Form 72
Appendix 9 An overall guide for the use of pressure-‐relieving supporting surfaces 73
Appendix 10 Clinical Audit Form 74
Appendix 11 Satisfaction Questionnaire (Training Session) 75
Appendix 12 Satisfaction Questionnaire (After implementation of new guideline) 76
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Chapter One Introduction
1.1 Background
1.1.1 Definition of Pressure Ulcer
Pressure ulcer prevention has been an important and common health care
problem in every health care setting, like in acute or sub-‐acute hospitals, or in long
stay care facilities. According to National and European Pressure Ulcer Association
Panels (2009), pressure ulcers can be known as pressure sores, decubitus ulcers or
bedsores. They are caused by pressure, shearing force or rubbing at the weight-‐
bearing bony prominences of immobilized people. Most affected area can be hips,
buttocks, heels and elbows.
1.1.2 Prevalence of Pressure Ulcer and Its Importance
The overall prevalence rate of pressure ulcer is 11.9% in the United States
(VanGilder, Amlung, Harrison, & Meyer, 2009) while 12% in the United Kingdom
(Blaber, 1993) and 23% in European countries (Vanderwee, Clark, Dealey,
Gunningberg, & Defloor, 2007). There is a small-‐scale study carried out in Hong Kong
showing that the incidence rate of pressure ulcer could be up to 25% (Kwong, Pang,
Aboo, & Law, 2009). People have to suffer from pain and the complication brought
by pressure ulcer, thus pressure ulcer reduces their health status and even their
quality of life. It also has been showed that pressure ulcers are associated with an
increased risk of mortality rate by two to four times (Allman, 1997; Bo, et al., 2003;
Clarke, 1997; Clough, 1994; Grewal, 1999; Thomas, 1996). The problem of pressure
ulcer not only affects patient’s own health, but also causes a significant financial
burden to health care system. It is estimated that management of pressure ulcer
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issue accounted for £1.4 to £2.1 billion in the UK (Bennett, Dealey, & Posnett, 2004).
The estimated annual expenditure in the US on managing pressure ulcers has been
calculated at $7.5 billion (Brandeis, et al., 1994). Some national institutions like the
Audit Commission (1991), the National Quality Forum, and the Agency for
Healthcare Quality, suggested and selected that pressure ulcers as the indicator for
patient safety and quality standards of hospital care. It is found that the length of
stay for patients with pressure ulcer is two to three times longer than those patients
with similar cases without. Therefore, it is suggested that pressure ulcer is an
international health care problem affecting both individual’s health and the whole
health care system.
1.1.3 Intervention to Prevent Pressure Ulcer
To prevent pressure ulcer, the main strategy is to reduce either the pressure
contact time, or magnitude of pressure, between a patient and his or her support
surface, or both. Health care professionals use their effort to prevent pressure ulcers
by using a range of pressure-‐relieving support surfaces such as cushions, mattresses,
or overlays which are widely used in any kinds of health care setting.
1.2 Affirming the Needs
1.2.1 Definition of Pressure-‐Relieving Support Surfaces
Pressure ulcers are the clinical situation that can be avoided. Pressure-‐
relieving support surfaces are shown to be effective in preventing the development
of pressure ulcer with strong evidence supported by a systematic review from the
Cochrane (Mclnnes, et al., 2011). Under the definitions set out by the Royal College
of Nursing guidelines, pressure-‐relieving support surfaces included all kinds of beds,
mattresses and overlays as well as cushions and other devices that can redistribute
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patient’s weight over a large contact area (Cullum, Nelson, Flemming, & Sheldon,
2001).
1.2.2 Current Practice in Local Setting and Study Significance
Mattresses or overlays are the equipment that patients lie on for most of the
time during their admission, especially important for those immobile elderly. People
in advanced age (Thomas, 2001), with impaired nutrition (Banks, 1998), impaired
mobility or who are immobile (Allman, 1997) or using inappropriate pressure-‐
relieving equipment are at high risk of developing pressure ulcers.
In Hong Kong, according to the data from a public hospital, the prevalence
rate of pressure ulcer is around 8.6% (Kwan, 2010). Only 7% of high-‐risk patients
were offered pressure-‐relieving mattress. From observation during clinical work,
pressure-‐relieving support surfaces were underused even when such equipment was
available. Support surfaces were not given according to patient’s level of risk of
developing pressure ulcers, but patients were assigned to their beds wherever there
was a vacancy once they were admitted to hospitals. In current practice, strategies
on prevention of pressure ulcers often come in a combination of interventions.
Although the provision of support surface to at risk patent is included in the
guideline, not every nurse is aware of the importance of offering the appropriate
mattresses for high-‐risk patients. Junior nurses may be afraid of being blamed for
adding workload to health care workers if patient needs bed transfer from standard
mattress to special mattress. Sometimes, high-‐risk patients were not offered the
special mattress until it was suggested by wound nurse or by senior and experienced
nurses. The alertness of providing appropriate equipment is rather low in clinical
setting. According to a national retrospective study in the USA, there was low
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compliance of ward staff to apply for pressure-‐relieving devices for at-‐risk patients
(7.5%) (Lyder, 2001) during the implementation of multi-‐interventions pressure ulcer
prevention guideline. On the other hand, a national Dutch survey found that there
was no significant change in implementing the pressure ulcer prevention practices
after introducing a specific hospital pressure ulcer prevention policy as well as the
pressure-‐relieving mattresses to the ward staff (De Laat, et al., 2006). All these
results show that compliance for nursing staff to follow a multi-‐interventions policy
to prevent pressure ulcer through the use of pressure-‐relieving devices is low.
Both Hong Kong and other countries are facing the same kind of difficulty—
compliance and awareness of nursing staff. Therefore, a feasible evidence-‐based
guidelines of using pressure-‐relieving support surfaces to prevent pressure ulcers
should be carried out as a standalone measure from the multi-‐interventions pressure
ulcer prevention guideline in order to maximize its effectiveness in this clinical issue.
1.3 Objectives
Reviewing the needs in modifying the current clinical practice and guidelines
in local setting, the aim of this dissertation is to develop an evidence-‐based guideline
for prevention of pressure ulcers using pressure-‐relieving support surface for
bedbound elderly. The findings are used to develop recommendations for the
nursing guideline to prevent pressure ulcers through the utilization of pressure-‐
relieving support surface in Hong Kong public hospitals setting.
The objectives are:
1. To gather the best evidence for presenting the effective use of the
intervention, pressure-‐reliving support surfaces, through reviewing
related literatures;
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2. To sum up and synthesize the evidence to develop an evidence-‐based
guidelines to prevent pressure ulcers using pressure-‐relieving support
surface for bedbound elderly;
3. To assess the potential for implementation of the reviewed studies
through evaluating their transferability, feasibility and cost effectiveness
of the intervention in applying the guideline on bedbound elderly in Hong
Kong public hospitals setting;
4. To translate and develop the evidence-‐based guideline on the targeted
population;
5. To develop an implementation plan and evaluation plan of the evidence-‐
based guideline.
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Chapter Two Critical Appraisal
2.1 Search and Appraisal Strategies
Reviewing of evidence on the effectiveness of pressure-‐relieving support
surface among hospitalized adult patients will be performed in this chapter. The
search and appraisal strategies were prepared with reference of IOWA model
(Melnyk, 2005; Polit & Beck, 2008) (Appendix 1), which consist of tables of evidence,
a methodological quality assessment and then a synthesis of findings from the
reviewed studies on the intervention affecting incidence rate or its degree of
pressure ulcer. A research question was established: is there any evidence-‐based
guidelines available to prevent pressure ulcers using any support surface for
bedbound elderly patients?
2.1.1 Inclusion Criteria
Here are the inclusion criteria for the studies that are selected for review.
There are four categories taken for consideration.
1. Type of studies: randomised controlled trials (RCT) or quasi-‐randomised trials
that compared support surfaces, and the outcome should measure the
incidence of new pressure ulcers or the severity of new pressure ulcers
developed. Clinical trials are eligible for inclusion only if they measure
outcomes objectively.
2. Types of participants: all adult patients who are at risk of developing pressure
ulcers in any health care setting are included. Studies involving people who
had pre-‐existing pressure ulcers or who are free of pressure ulcers were
included.
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3. Type of interventions: studies involving any pressure-‐relieving support
surfaces in the form of mattresses and overlays are included.
a. “Low-‐tech” constant low pressure surfaces:
-‐ Standard foam mattresses.
-‐ Mattresses or overlays that are comfortable and can help to
redistribute pressure over large contact area of patient’s body, they
include: alternative foam; or bead-‐filled; or water-‐filled; or air-‐filled;
or gel-‐filled mattresses/ overlays; or sheepskins.
b. “High-‐tech” support surfaces
-‐ Alternating-‐pressure mattresses/ overlays: lying on the air sacs which
can be inflated and deflated continuously to relieve pressure at
different body parts of patients while a pressure sensor may be
incorporated.
-‐ Air-‐fluidized beds: a kind of constant low pressure support surface
with a structure of fine ceramic beads circulated with warmed air and
is covered by a permeable sheet.
-‐ Low-‐air-‐loss beds: another kind of constant low pressure support
surface with a series of air sacs through which warmed air passes.
4. Type of outcome measures: the primary outcomes would be the incidence of
new pressure ulcers or severity of pressure ulcer developed while the
secondary outcomes would be patient’s comfort, costs of devices, and
acceptability to health care staff.
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2.1.2 Exclusion Criteria
For studies that measure subjective outcomes like saying “better or worse
skin condition” and involve interventions applied to patients who were on operating
theatre tables or wheelchairs were all excluded.
2.1.3 Search Strategies for Related Studies
The electronic databases PuMed (1948 to August 26, 2012), The Cochrane
Library (1948 to August 26, 2012), OvidSP Medline (1948 to August 26, 2012) and
EBSCO CINHAL (1937 to August 26, 2012) were used for the search of related
studies. The language of studies were limited to English. “AND” was used for search
as main concept. The keywords used for searching are “support* surface*”,
“mattress*”, “overlay*”, “bed*” as well as “pressure ulcer”.
By August 26, 2012, a total of 7640 studies were retrieved from the above 4
electronic databases. After screening through the titles or abstract of the studies, it
was narrowed down to 173 of them which were relevant to the interest of study.
Finally, 5 studies were included as they satisfy for the inclusion criteria. They were all
randomised controlled trials and focused on using pressure-‐relieving support
surfaces to prevent pressure ulcer of adult patients. Support surfaces like cushions,
turning or titling beds with setting in operation theatres or targeting at pediatric
patients or studies about wheelchairs were all excluded.
The searching flowcharts regarding to the four electronic search engines
were shown in Appendix 2.
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2.2 Results
2.2.1 Tables of Evidence
Through extracting and recording the data from the five sampled studies,
tables of evidence are established in this part. The following information will be
entered into columns in the Table of Evidence (Appendix 3).
a. Citation
b. Study Design
c. Patient Characteristics
d. Setting and Countries
e. Intervention
f. Control
g. Length of Study
h. Outcome Measures
i. Effect Size
2.2.2 Quality Assessment
The quality of each study was assessed by a kind of methodology checklist
(Appendix 4) which is specific to RCT study design, the Scottish Intercollegiate
Guideline Network (SIGN) (2011). SIGN was established in 1993 for developing
evidence-‐based guidelines of clinical practice for the National Health Service (NHS) in
Scotland. It acts as a vehicle translating new knowledge into evidence-‐based
guidelines through justifying the level of evidence (Appendix 4) of the study’s
internal validity.
Each study was examined through the following aspects:
1. Appropriateness and clarity of the research question
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2. Random assignment of the subjects
3. Allocation concealment
4. Blinding of subjects and investigators
5. Similarity between experimental and control groups at baseline
6. Treatment under investigation
7. Validity and reliability of the relevant outcome measure(s)
8. Drop-‐out rate
9. Intention to treat analysis
10. The results are comparable more than one clinical areas
The following wordings are used to indicate how well each of the above
aspects was addressed in the studies. They are “well-‐covered”; “adequately
addressed”; “poorly addressed”; “not addressed”; “not reported”; and “not
applicable”. The detail of how to make judgment to meet the criterion of each
aspect is fully explained in the SIGN website (2011). The detail of the quality
assessment of each study is set ut in Appendix 4. The level of evidence is rated by
the methodological quality of study (Appendix 5) which is based on the overall
assessment done in the previous part. In RCT studies, they are graded as “1++”, “1+”,
or “1-‐“, according to the SIGN grading system (see Appendix 6). A summary table of
the five reviewed RCT studies is illustrated in the last table in Appendix 4. The studies
with the “++” coding means all or most of the criteria have been fulfilled whereas
the results of the studies are thought unlikely to change. For studies with “+” coding
are those where some of the criteria have been fulfilled, while the conclusions of the
studies are seemed to be unlikely to alter. Among the 5 studies, none of them is
graded as “-‐“ which means the result is thought likely to change.
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2.2.3 Summarize of Study Characteristics and Methodological Issues
2.2.3.1 Study Design
Among all five reviewed studies are randmised controlled trials which are
considered as the most reliable form of scientific evidence in the hierarchy of
evidence. Four studies (Studies 2-‐5) evaluated the effectiveness between “low tech”
mattresses/ overlays and standard hospital mattresses (Berthe, Bustillo, & Fontaine,
2007; Hofman et al., 1994; Jolley, et al., 2004; Russell, et al., 2003) while one study
(Study 1) evaluated the difference between “high tech” mattress and “high tech”
overlay (Nixon, et al., 2006).
2.2.3.2 Patient Characteristics
All five studies involved adult patients in their trials, only one of them did not
state clearly the mean age of the participants, whereas the patients with mean age
of 62.2 to 84 years old were involved in the other four studies. Two studies included
participants without pre-‐existing pressure ulcers; two studies included patients with
ulcers not greater than or just equal to grade 2 at baseline; one of them did not
specify whwther the participants had pre-‐existing pressure ulcers or not. Three
studies stated the participant’s level of risk of pressure ulcers clearly by using
different assessment tools and showed that they are all at low to high risk of
pressure ulcers development; one study recorded that 79% of participants were
bedbound with nearly 40% were in poor nutritional status; one study did not specify
its participants in this aspect.
All five studies showed no difference between the experimental and control
groups in terms of patient characteristics. They all matched well at baseline and
therefore the results were comparable.
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Most participants involved in the studies were in advanced age, with
impaired mobility or nutritional status, and were at risk of pressure ulcers
development. Therefore bedbound elderly is the vulnerable group that needs
further care.
2.2.3.3 Study Setting
All five studies involved general wards of fourteen hospitals in the United
Kingdom, two hospitals in European countries and one hospital in Australia. They
were set in medical, surgical, orthopedic and rehabilitation wards.
Since the studies were carried out in area with multiple sites, the results
were comparable in all sites.
2.2.3.4 Sample Size
Three of the studies involved over a thousand of participants in their clinical
trials with the greatest number of 1971 patients while one study involved only 44
patients. The median sample size was 1168 (range from 44 to 1971). The studies
stated that their results were adequately powered by such a large number of
population participating in their clinical trials with power calculations.
2.2.3.5 Allocation Concealment
The method of randomization was unclear in two of the five studies. Three of
them stated clearly how they randomised their participants, for example, through
automated telephone service or use of sealed envelopes. One of the studies tried to
modify the randomization procedure to circumvent the potential selection bias.
2.2.3.6 Blinding of Subjects and Assessors
It was difficult or even not possible to disguise the randomization
intervention to the participants in the trials, ward nursing staff and nurses who were
23
responsible to conduct skin assessment. It would be unethical to move those elderly
who were seriously ill away from their beds. Therefore, none of the five reviewed
studies could perform blinding on both subjects and assessors.
Some of the studies tried to minimize the bias by having a second
independent assessor and using an objective reliable instrument.
2.2.3.7 Intervention Effectiveness
Four studies compared “low tech” mattress or overlay with the standard
hospital mattresses for the prevention of pressure ulcers, three of them showed
significant reduction in the incidence or severity of pressure ulcers among at risk
patients when patients were placed on either cubed foam mattress, viscoelastic
polymer foam mattress or sheepskin overlay. One high quality RCT compared
between two “high tech” support surfaces, pressure-‐alternating mattress and
pressure-‐alternating overlay. The result showed no significant difference between
these two “high tech” support surfaces. However, it was found that incidence rate of
pressure ulceration was similar to the range of risk reported in other trials with
comparable population incorporating an alternating pressure support surfaces.
Therefore, among five RCTs, four of them showed that pressure-‐relieving mattress or
overlay were effective in reducing the incidence of pressure ulcer development.
2.2.3.8 Outcome Measurement
All of the studies set their primary outcomes as the incidence rate of pressure
ulcers. In this issue of pressure ulcer, incidence can be interpreted as the probability
that the development of pressure ulcers over a specified period of an individual. This
can explain how an individual having no pre-‐existing pressure ulcers to having one or
more as well as having no pre-‐existing pressure ulcer at a given site to developing a
24
pressure ulcer at that site, in any grades. However, prevalence is seldom used
because it based on 2 criteria: (1) incidence; and (2) duration, which means the
period for the pressure ulcer to heal and the time that patient could survive. To
explain in more detail, there is a possibility that the incidence rate has no change,
but the pressure ulcers can heal more quickly. If prevalence is used to show how
effective the preventive interventions are, then false interpretations can be resulted.
Changes in incidence or duration can be reflected in the prevalence rate, while the
changes of risk factors or protective factors can only be reflected when incidence is
used. Therefore, in studies of preventive interventions, use of incidence is preferred
in measuring the outcomes. Besides incidence, median time for the occurrence of
pressure ulcers was also adopted as measurement of outcome, as it can show the
length of delay in time for the occurrence of ulceration development.
2.2.3.9 Drop Out Rate
The drop out rate ranged from 0% to 18.19% with median rate of 0.04%. The
study with the highest drop out rate did not specifiy the reason of missing
participants while a per protocol analysis was used. Three of the trials conducted
intention to treat analysis to calculate the data. The reasons of dropping out were
death of patients or re-‐inclusion of participants.
2.2.3.10 Potential Sources of Bias
Four of the studies stated clearly that the nursing care provided to both
experimental and control groups were the same. They followed the pressure ulcer
prevention policy of their own hospitals whatever the types of supporting surfaces
the participants were on. Only one study did not state it clearly. This can ensure that
the outcome measures were solely affected by the interventions carried out in the
25
clinical trials, and the supporting surfaces, but not affected by other procedures.
2.3 Summary and Synthesis
2.3.1 Analysis and Summary of the Evidence
Four RCTs comparing “standard” hospital mattresses with “low tech”
supports for the prevention of ulcers were reviewed in this study (Berthe, Bustillo, &
Fontaine, 2007; Hofman et al., 1994; Jolley, et al., 2004; Russell, et al., 2003). When
patients was assigned to lie on either cubed foam mattress (Comfortex Decube)
(Hofman, 1994); sheepskin overlay (Jolley, et al., 2004); or vsicoelastic polymer foam
mattress (Russell, et al., 2003), the incidence and severity of pressure ulcers in at risk
patients were significantly reduced when they were compared with standard
hospital mattresses. However, one RCT (Berthe, Bustillo, & Fontaine, 2007) showed
that there is no statistically significant difference between using the “low tech” and
the standard mattress in reducing pressure ulcer incidence rate. There were reasons
why such study was included. First, it was a high quality study with low risk of bias
and large sample size. Second, we cannot ignore those ineffective studies and blind
ourselves. Most importantly, it pointed out the problem during the analysis of the
evidence. It should be emphasized that there is no international definition for the
constitution of a standard foam hospital mattress. Even the type of standard
mattresses may change from time to time within countries, and even within
hospitals, not to mention that there are probably differences across countries. This
was a problem of heterogeneity. According to a systematic review (McInnes,
Jammali, Bell-‐Syer, Dumville, & Cullum, 2011), it has undertaken the issue of
heterogeneity between different trials and has done a separate meta-‐analysis of
studies which based on the trials carried out in the UK. Within the same country, it
26
was likely that the variation in the types of standard hospital mattress was lower.
And the result of the alternative foam support over standard support was favoured.
Therefore, foam alternatives or “low tech” support surfaces can significantly reduce
the incidence of pressure ulcers in at-‐risk patients when compared with the standard
hospital foam, or we can say using pressure relieving support surfaces have effect on
prevention of pressure ulcer.
From another high quality RCT study (Nixon, et al., 2006), two “high tech”
support surfaces were compared and insignificant difference was found. As it is
mentioned that incidence rate of pressure ulceration was similar to the range of risk
reported in other trials with comparable population incorporating an alternating
pressure support surfaces. The study stated that both types of the pressure
alternating support surfaces were effective in the prevention of pressure ulcer.
Although there are two studies showing no significant difference in the
incidence of pressure ulcers (Berthe, Bustillo, & Fontaine, 2007; Nixon, et al, 2006),
they both found there was a difference in the median time for occurrence of
pressure ulcers with one of them with significant result. Due to a delay in
development of pressure ulcers and reduction in the length of stay in hospital when
patients were placed on high-‐specification mattress or overlay, a reduction of costs
can be achieved (Nixion, et al., 2006).
In a nutshell, both “low tech” and “high tech” can achieve the reduction of
the incidence of pressure ulcers for at risk patients with significant result. Pressure-‐
relieving support surfaces were proved to be effective by high quality RCTS in
prevention of pressure ulcers.
2.3.2 Implications
27
Pressure ulcer was found not only reducing individual’s health status and
quality of life, increasing death rate due to its complications, but also causing burden
to the whole healthcare system. Once ulcers develop, patients have to stay longer in
the health care setting for the treatment of sores. From the evidence, the clearest
conclusion that can be drawn is that a range of pressure-‐relieving mattresses and
overlays in the prevention of pressure ulcers can outperform the standard hospital
mattress. It can be applied to any health care settings. The above reviewed studies
have shown that pressure-‐relieving mattresses are effective on at risk patients,
especially for those in advanced age with low mobility. In the current setting of my
hospital, there is no evidence-‐based guideline on this specific intervention. Special
mattresses were given to patients according to nurse’s clinical experience.
In view of the importance of this issue, an evidence-‐based guideline for
prevention of pressure ulcers using pressure-‐relieving support surface for bedbound
elderly is recommended for development and improvement. Some evidence-‐based
recommendations are made as follows.
1. Pressure-‐relieving mattress or overlay should be assigned to
patients within 24 hours of admission once they were assessed to
be at risk by using an objective and reliable pressure ulcer risk
assessment tool and who are bedbound.
2. Elderly will be the targeted population with age greater than 60
years old, which is the cut-‐off age agreed by the United Nation
(WHO, 2102).
28
3. Nurses and health care providers should continue to follow the
pressure ulcer prevention policy adpoted by their own hospitals like
repositioning every 2-‐4 hours, performing of skin assessment every
day, or making referral to dietitian when patient’s body mass index
(BMI) is out of the normal range, etc.
4. Continuous assessment should be carried out for other at risk
patients. When there is a condition change, those patients may fit
the criteria. Provision of pressure-‐relieving support surfaces should
then provided.
29
Chapter 3 Translation and Application
The innovated programme is designated for the use in rehabilitation wards,
since patients who need extended care or further training will be transferred to
rehabilitation wards from acute wards. The length of hospitalization stay will be
longer, usually more than 7 days or can be up to months, for patients in
rehabilitation wards. Pressure ulcer is one of the clinical problems that patients need
extra care and require longer length of stay. The need in preventing of pressure
ulcers was affirmed in chapter one, together with the literature review appraisals in
chapter two, the following chapter, will emphasize on the discussion of the
implementation potential of the innovated programme and the application of the
evidence-‐based guideline.
3.1 Implementation Potential
With the evidence reviewed in chapter one, before the implementation of
the innovated programme, a number of issues should be considered to determine
the implementation potential of the innovation in a particular setting (Polit, Beck, &
Hungler, 2006). The issues included are the transferability of the findings, feasibility
of the implementation and the cost-‐benefit ratio of the innovation.
3.1.1 Transferability of Findings
The main focus in this section is to determine whether the findings in the
literatures reviewed in chapter two are transferrable or make good sense to
implement the innovation in the new practice setting.
30
3.1.1.1 Target Setting
The innovation will first be implemented in a male medical convalescence
(MC) rehabilitation ward with maximum numbers of beds of 41. It is similar to the
reviewed studies which involved general wards including medical, surgical,
orthopedic and rehabilitation wards in other countries. Whereas, rehabilitation ward
is the target setting in this innovation.
The nature of MC is for the person who is recovering from an illness or
operation to stay in the rehabilitation ward for extended care or training. The
progress of recovery for elderly is usually slow. In-‐patient elderly require more care
before they are fit for discharge. Therefore, it is an appropriate place to perform the
innovation in this sub-‐acute area.
3.1.1.2 Target Audience
Patients with mean age 62 to 84 years old were assessed in the reviewed
literatures. The age of the target population will be 60 years or above, which is the
cut-‐off age agreed by the United Nation (WHO, 2102). The target population will be
male since the innovation is carried out in the male rehabilitation ward. The range of
the possible Norton total score varied from 5 to 20 with score below 14 as the cut-‐
off score equating an individual being at risk (Table 3.1). Norton scale is chosen
because it is relatively easy to use and exhibits less over-‐prediction than the
Waterloo scale or the Braden scale (Kwong, et al., 2005). And most importantly, it is
hospital policy to use Norton score (Appendix 7) for each patient who is admitted to
the hospital for assessing patient’s risk of developing pressure ulcers. The scale will
be used in the target setting. The patient’s characteristics between reviewed
literatures and the target setting are compared and listed in detail in the table 3.2.
31
Table 3.1 Norton Risk Assessment Score Physical Condition
Mental Condition
Activity Mobility Incontinent
Good 4 Alert 4 Ambulant 4 Full 4 Not 4 Fair 3 Apathetic 3 Walk-‐help 3 Slightly
limited 3 Occasional 3
Poor 2 Confused 2 Chair-‐bound
2 Very limited 2 Usually urine
2
Very Poor 1 Stupor 1 Stupor 1 Immobile 1 Doubly 1 Table 3.2 Patient’s characteristics between reviewed literatures and the target setting. Patient’s Characteristics Reviewed Literatures Target Setting Sample Size 44-‐1971 360 Age 62.2-‐84 60 years old or above Gender Both Male Risk of Pressure Ulcers Development
Low to High Risk Norton Score ≤ 14 (= at risk)
Mobility 79% are bedbound Bedbound Pre-‐Existing of Pressure Ulcers
Both with or without Both with or without
3.1.1.3 Philosophy of Care
Our hospital’s mission is to provide people-‐oriented health care services
(New Territories West Cluster, 2012). Therefore, to prevent patients from developing
pressure ulcers through utilization of the appropriate facilities can help people to
remain health and integrity. To provide holistic care to patients is a part of our
mission— to be people-‐oriented.
3.1.1.4 Sufficient Patient Benefit
According to the Hospital Authority Statistical Report 2010-‐2011, (2012),
58.1% of in-‐patients are age 60 years old or above. It means that one of two
admitted patients is elderly. One of three patients who are transferred to
rehabilitation ward is bedbound elderly, while on average there are three patients
transferred from acute wards to this male MC rehabilitation ward daily. Therefore,
around 30 bedbound elderly can be recruited in a month. The sample size can reach
32
360 bedbound elderly when the innovation lasts for a year, which is similar to the
range of the reviewed literatures.
From the reviewed studies, the incidence rate of pressure ulcers
development can be effectively reduced by 2%-‐7%. The calculation of the number of
patients benefited is as follows:
Number of patients recruited in each ward in each month = 10.
Number of patient recruited in each ward in one year = 120.
Number of patients recruited in 6 rehabilitation wards in one year =
120 x 6 = 720.
Number of patients benefited = 720 x 2% to 720 x % = 14 to 50.
There will be 14 to 50 patients suffering less from this health problem
annually. So, it is sufficient to benefit from the innovation.
3.2.1.5 Time for Implementation and Evaluation
Since 10 low-‐air-‐loss beds are already available for use in the target ward, the
only preparation is the extra reminder form (Appendix 8) attached to the original
Norton Scale Assessment form. The next step is briefing to all nursing staff on how to
fill in the form and reminding them to check the waiting list during every shift to help
eligible patient to change to the appropriate bed as soon as possible if the nurse is
the ward-‐in-‐charge in that shift. Also, every nursing staff should be reminded to
continue to perform the bundle of care to prevent pressure ulcers like turning
patient every 2 hours, daily skin inspection etc. as set out in the hospital clinical
guideline. 2 weeks time is adequate for preparation and briefing to all nursing staff.
A nurse will be selected randomly in the pilot ward and then he or she will perform
33
the assessment and fill in the reminder form under the supervision of the innovation
team member.
The pilot plan will be carried out for 3 months so that every nursing staff has
a few chances to fill in the form. After that, the plan will be evaluated by the
innovation team. The innovation will be implemented for one year to be in line with
the period for study which varied from 2 weeks to 3 years from the reviewed
literatures. In between the implementation period, audit will continue at the end of
every month by any nurse in the ward, while evaluation meeting will be held after 6
months of implementation and at the end of the innovation.
The innovation not only matches the philosophy of care of the hospital, but
an adequate numbers of patients can also benefit from the changes. The only
change of workflow is the sequence of assessment has been adjusted—with
pressure ulcer risk assessment being the first priority for every patient who is
transferred from acute ward. The extra workload is to fill in the form only for those
patients who meet the criteria. Therefore, the proposed innovation is transferrable
to the target setting.
3.1.2 Feasibility
It is important for the innovation to get support from both the organization
and the frontline staff, i.e. nurses. When the innovation is recognized by the
administration, it is easier to obtain resources or external assistance to promote the
innovation. At the same time, when frontline staff can get involved or can have full
control over the new programme, they would gain satisfaction from the success and
be more willing to pay effort to the project. That makes the innovation becomes
feasible in reality.
34
3.1.2.1 Organization Level
Pressure ulcer has been an indicator for patient safety and quality standards
of hospital care. There is a pressure ulcer prevention and management committee in
our cluster to upgrade the quality of pressure ulcer prevention and management by
consolidating and coordinating the expertise and resources in various disciplines and
departments. Also, one of their objectives is to promote evidence-‐based pressure
ulcer assessment and management. With the evidence showing the effectiveness of
the intervention, we, nurses as a team, are confident that the administration or the
committee would support our innovation.
For equipment, the 10 low-‐air-‐loss beds are already available for use. The
only document needed to be prepared is the reminder form (Appendix 8) and a file
to keep the waiting list as well as the audit forms.
3.1.2.2 Individual Level
Every nurse can have a chance to be the auditor to the programme since
audit will be taken every month. Through the audit, nurses can get involved in the
project and have commitment to the innovation as well as be more willing to take
part in the process. Nurses will have the authority to carry out the innovation and
determine to provide the appropriate nursing care to their patients. Also, no extra
training session is needed since every nurse is familiar with the pressure ulcer
prevention and management guideline. The minimal change is a swab of the
sequence of work, which every nursing staff can handle it easily.
3.1.3 Cost and Benefit Ratio
Here comes to the assessment of cost and benefits of the innovation. It
encompasses likely costs and benefits to patients, staff and overall organization.
35
During the implementation of the innovation, patients do not have to expose to any
risks, and nursing staff do not need to spend extra hour in dealing with the
procedure. The potential benefit for patients is to avoid the development of
pressure ulcer during their hospital stay. The main cost is the maintenance cost of
the 10 low-‐air-‐loss beds in long run (Table 3.3). The price of the bed will not be
included for calculation because the 10 low-‐air-‐loss beds already exists in every
rehabilitation ward. However, if the innovation is not implemented, patients have to
suffer from the pain and cost brought by the development of pressure ulcer. Since it
is found that the length of stay for patients with pressure ulcer is two to three times
longer than those patients with similar condition without the ulcers, not only the
cost of the hospital stay of a patient will be double, but also the cost of treating the
pressure ulcers would be increased (Table 3.4). Besides the material cost of
performing the dressing to the ulcers, patients will have to suffer from pain of the
wound, bear the risk of infection and the increased probability of readmission to the
hospital for treating the infection.
Table 3.3 The running cost of the equipment Unit Price Quantity Total Costs Maintenance cost of the beds per annual
HKD $1,500 per bed
10 HKD $15,000
Reminder forms per annual HKD $1 360 HKD $360 Audit forms per annual HKD $1 12 HKD $12 Grand Total HKD $15372 Table 3.4 Extra cost for a patient who have a pressure ulcer Unit Price Quantity Total Costs Cost of hospital stay HKD $68* (Day) 21 HKD $952 Cost of dressing HKD $80# (Day) 21 HKD $1680 Cost of dressing material HKD $50 21 HKD $1050 Grand Total HKD $3682 * Daily price of stay in rehabilitation ward in Hong Kong # Price for a community nurse to perform a wound dressing
36
The running cost for the equipment is only $15372 per annum. But, for
treating a patient with pressure ulcer, the cost would be at least HKD $3682 per
patient while the range of expenditure would be $51548 to $184100 (calculated
according to the estimated number of patients having pressure ulcer to be reduced
after the intervention). Workload of nursing staff will be minimized if the number of
pressure ulcers decreases. Also, staff morale will be improved if they find the
intervention effective. After taking into account of with all these factors, the benefits
of implementation of the innovation outweigh the cost of it.
3.2 Evidence-‐Based Practice Guideline
With the appraisal of selected literatures and evaluation of the
implementation potential of the innovation, an evidence-‐based guideline regarding
the topic of pressure ulcers will be developed in this chapter. The detail of the
guideline as well as the levels of evidence and grades of recommendations will be
discussed here.
3.2.1 Objectives of Evidence-‐Based Practice Guideline
The purpose of writing this guideline is to help health care staff to:
-‐Make use of the protocol to improve the quality of pressure ulcer prevention and
management and reduce the incidence of pressure ulcers development among the
high-‐risk patients.
-‐Formulate clinical instructions for the use of pressure-‐relieving supporting surfaces
for at risk patient based in the best evidence available in the cluster.
37
3.2.2 Intended Users and Setting
All nurses working in all specialties of adult wards under the same cluster will
be the users of the guideline.
3.2.3 Target Population
All hospitalized bedbound elderly will be the target population.
3.2.4 Levels of Evidence and Grades of Recommendations
The SIGN (2011) grading system is adopted to justify the level of evidence
(Appendix 6) of the statements and grades of recommendations (Appendix 6).
Recommendation 1.0: Skin and Pressure Ulcer Risk assessment
1.1 Use a structured risk assessment scale and perform skin assessment to identify
an individual at risk of developing pressure ulcers on admission or transfer within
24 hours. (Grade of recommendation: C)
Available evidence: An integral component of pressure ulcer prevention consists
of pressure ulcer risk assessment which is widely used in the clinical practice.
(More & Cowman, 2010) (2++)
1.2 Peform risk and skin re-‐assessment after admission or transfer or when change
of condition. (Grade of recommendation: C)
Available evidence: It is necessary to perform periodic inspection of patient’s skin
condition in clinical practice for prevention of pressure ulcer development.
(Kwong, et al., 2005) (2+)
Recommendation 2.0: Preventive Intervention for Patients With Pressure Ulcer or
Norton Score ≤ 14
2.1 Provide skin care, continence care, nutritional care, repositioning as well as
38
encourage highest level of mobility for patients with pressure ulcer or Norton
Score ≤ 14. (Grade of recommendation: A)
Available evidence: Bed-‐sores are managed by multidisciplinary approach whenever
necessary. (Berthe, Bustillo, & Fontaine, 2007) (1++)
Recommendation 3.0: Use of Pressure-‐Relieving Mattress for At Risk Patients
3.1 Use alternating-‐pressure mattresses rather than standard hospital mattresses for
at risk patients (Grade of recommendation: A)
Available Evidence: Alternating-‐pressure mattresses to standard hospital mattresses
can reduce the incidence of pressure ulcer in people who are at risk. (Berthe,
Bustillo, & Fontaine, 2007, Jolley, et al., 2004, Russell, et al., 2003) (1++) (1+) (1++)
3.2 Regular turning and repositioning should be continued where possible for all
individuals at risk of developing pressure ulcers. (Grade of recommendation: A)
Available evidence:
Patients at risk should be mobilized every two hours. (Berthe, Bustillo, & Fontaine,
2007) (1++)
Turning every 4 hours on pressure-‐relieving mattress resulted in a significant
reduction in the number of pressure ulcers. (Defloor, Bacquer, & Grypdonck, 2005)
(1+)
3.3 All health care staff should be educated with the knowledge of risk assessment
and preventive measures; the selection and use of pressure-‐relieving mattresses;
patient information and information-‐giving. (Grade of recommendation: B)
Available evidence:
The benefits of mattresses can be further improved by better and careful education
of nursing staff. (Hofman et al., 1994) (1+)
39
3.2.5 Description of the Guideline
The Norton Risk Assessment Score is used to evaluate patient’s risk of
developing pressure ulcers immediately after each of the patient is admitted to
rehabilitation wards within 24 hours. Patients are then assigned to low-‐air-‐loss beds,
“high-‐tech” supporting surface, if they meet all the criteria: a. age greater than or
equal to 60 years old; b. Norton score smaller than or equal to 14, which is a cut-‐off
score equating to individual being at risk (Norton et al., 1962); c. bedbound; and d.
with or without pre-‐existing pressure ulcers. The nurse who is in-‐charge of the
patient should perform the assessment.
Documentation of the score, date of commencement and the number of
pressure ulcers on the form should be done after the assessment as well as the
patient is settled on the bed. If all the low-‐air-‐loss beds are occupied, put the
patient’s name down on the waiting list. Check bed vacancy every shift and arrange
the patient to the designated bed as soon as possible. Perform the Norton Scale
Assessment for each patient every week or if there is any condition change. Assign
the patients to the appropriate beds once they meet the criteria.
Provide care according to the pressure ulcer prevention policy adpoted by
the hospital regardless of whether patients are on the low-‐air-‐loss beds or standard
beds.
Document the score, date of discharge and the number of newly developed pressure
ulcers when the patient is transferred to other wards or discharged from hospital.
The primary outcome measurement of this programme will be the incidence of the
new pressure ulcer developed during the stay in rehabilitation wards.
40
The overall guide of the protocol will be presented as a flowchart
(Appendix 9).
41
Chapter 4: Implementation Plan
After developing EBP guideline in the previous chapter, the actual
implementation timeline of using pressure-‐relieving support surface to prevent
pressure ulcers will be discussed in this part. In which the communication strategies
with different stakeholders in the hospital, the detail of the pilot test of the plan and
how to evaluate the whole process of implementation of the guideline are all
included.
4.1 Communication Plan
4.1.1 Stakeholders
For implementing the evidence-‐based guidelines to prevent pressure ulcers
using pressure-‐relieving supporting surfaces in the rehabilitation department, it is
essential to gain support from the key stakeholders. Identification of stakeholders
can facilitate the success of the innovation. The Chief of Service (COS), the
Department Operational Manager (DOM), and the 2 consultants of the department
in the hospital are the policy makers as well as decision makers. They can provide
administrative support, allocate resources and approve funding for the plan. The
COS could make arrangement on medical manpower and also have the final decision
on the implementation of the innovation as well as the budget plan. Whereas DOM
could make arrangement on nursing manpower for the implementation of the plan.
The Pressure Ulcer Prevention and Management Committee in our cluster is
also one of the key stakeholders. The committee will streamline and guide the
service provisions in any matter related to prevention of pressure ulcers. The policy
42
paper issued by the committee serves as the cluster-‐wide reference for prevention
of pressure ulcers. The guideline should be verified by the committee before it is
released for use in the cluster.
All 90 frontline staff in the 6 medical rehabilitation wards are also the
stakeholders in this innovation. All the nurses have to perform pressure ulcer risk
assessment for every newly transferred patient. They have to understand the detail
of the guideline and then implement the plan according to the proposed protocol in
order to achieve a better patient outcome. Among the 90 staff, the 4 ward managers
and the 12 Advance Practice Nurses (APNs) will work with the selected senior nurses
including me in the innovation programme to monitor the progress of the
innovation. They are skilled and experienced in clinical area, and capable to handle
any potential problems and provide concrete suggestion to modify the guideline
when necessary. They will also make use of the allocated resources and provide
training to all the other nurses so as to make sure everything runs smooth in the
plan.
Moreover, other stakeholders include 12 medical officers, wound nurse,
multi-‐disciplinary teams like physiotherapists, occupational therapists and dietitian.
They could provide treatment and professional suggestion when there is a
deterioration of patient’s pressure ulcer.
4.1.2 Communication Process
After identifying the stakeholders of the innovation, the whole
communication plan would be developed in this part. The innovation will last for 18
43
months (Table 4.1) including 2 months of communication with the stakeholders
(Table 4.2), 3 months for the pilot test (Table 4.3), 1 year of implementation period
and 1 month for evaluation plan.
Table 4.1 Timeline for Innovation Programme
Month
Phase
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Communication
with stakeholder
Pilot Test
Implementation * * * * * * * * * * * *
Evaluation
*Clinical Audit
Proposer will firstly approach the senior frontline nursing staff and APNs who
are experienced in taking care of geriatric patients. It will be discussed with them
about the severity and high prevalence rate of pressure ulcers developed among
bedbound elderly and planning, the use of new evidence-‐based guideline to prevent
pressure ulcers using pressure-‐relieving supporting surface. Their comments and
suggestions will be collected through the informal meeting like during handover and
mealtime. Other frontline nurses may oppose the idea in fear that the workload
would be increased. It is important to gain their support because they are the ones
44
who carry out the new guideline during the whole process. To gain their support,
opposing staff and supportive senior nurses will be approached in a group to explain
the situation on this clinical issue. To persuade them by using figures and statistic
from the reviewed studies as well as stating that the presence of pressure ulcers is
the real reason leading to the increased workload. At the end of the meeting, listen
to their concerns and opinions regarding to the new practice and then getting their
consensus so as to facilitate the implementation of the new guideline. This process
of obtaining opinions and modification would take a month after visiting the 6
medical rehabilitation wards.
Table 4.2 Communication Timeline
Week
Phase
1 2 3 4 5 6 7 8
Communication
with frontline
nurse
Communication
with administrative
level
Formation of
innovation team
45
The evidence-‐based guideline will be proposed to ward manager, wound
nurse and the committee members who have the same intention towards the better
practice on the issue of pressure ulcers. With the support from them, it should be
further discussed with them the detail of the new guideline, the significance of the
clinical issue, the need of change, the sufficiency of evidence to support the
innovation, the cost to benefit ratio as well as the content of the new guideline, all of
them will be presented in ward meeting to gain support from other ward managers
and DOM in rehabilitation department,
After the ward meeting, proposer together with the committee members and
the supportive APNs and ward manger will approach the COS and other heads of the
multi-‐disciplinary teams. A formal presentation and a written proposal with the
evidence-‐based guideline will be presented for their better understanding and
seeking their approval from the administrative level.
After 2 weeks of discussion and with the support and recognition from the
administrative level, an innovation team will be formed including proposer, one APN
in charge with 6 senior nurses from each rehabilitation ward as coordinators. The
innovation team will organize training sessions for all frontline staff to attend. The
detail of the training session will be further elaborated in the next part -‐-‐ pilot study
plan. All the information including background and the time schedule of the
programme and how the pilot test be carried out as well as the content of the new
guideline will be updated in the intranet under the category of the Pressure Ulcer
Prevention and Management Committee while every staff will be notified for the
change through email.
46
A coordinator in each ward will help solving problems raised by the frontline
staff during the implementation period. They can clarify the process of innovation
and to ensure proper use of the guideline. A written copy of the evidence-‐based
guideline manual will also be kept in each ward for easy access.
To sustain the innovation programme, the innovation team as well as the
committee members will monitor the progress of the innovation every month by
clinical audit and assessing nurses’ compliance and satisfaction with the new
guideline. They would also gather the comments and feedbacks through informal
chatting with the frontline staff. Then the coordinators can report any difficulties
encountered in their ward to the team every 2 weeks. As such modification,
evaluation and improvement of the guideline can be made in order to make
revisions to the new guideline if necessary based on the evidence collected.
4.2 Pilot Study Plan
Pilot test is to determine the feasibility of the proposed change so as to avoid
any unexpected difficulties during the implementation period. It also helps to
evaluate the proposed change to determine whether revisions are needed before
implementing the innovation in the designated clinical area. It is also used to assess
whether the written evidence-‐based guideline is clear enough to be understood,
whether the chosen instruments assess the outcome properly, whether the training
effective, and to identify any problems encountered (Polit, Beck, & Hungler, 2006).
In this innovation programme, the pilot study plan will be carried out for 3 months
including staff training session and the implementation period using the new
guideline in 3 out of the 6 rehabilitation wards. Each ward will recruit 10 cases each
47
month, therefore in total, there will be 60 subjects for evaluation after 2 months of
pilot test.
Table 4.3 Timeline for Pilot Study Plan
Week
Phase
1 2 3 4 5 6 7 8 9 10 11 12
Staff training
Pilot test * * * *
Review of guideline
* Clinical Audit
4.2.1 Enrollment Strategies
The participants to be enrolled in the pilot test are the same as the inclusion
and exclusion criteria written in the proposed guideline. Patients with age of 60
years old or above who scores 14 marks or below after being assessed by a nurse
using the Norton Scale Assessment (Appendix 7) once the patient is admitted to the
pilot ward will be recruited as eligible participants in the pilot test. Patients should
be bedbound male who can be with or without pre-‐existing pressure ulcers during
admission to rehabilitation ward. Convenience sampling will be used. The sample
size will be 10 patients from each pilot ward, then there will be 60 patients in total
among the 3 pilot wards chosen in 2 months of pilot test.
48
4.2.2 Staff Training
Staff training sessions will be conducted in the first 2 weeks. The 45 frontline
staff from the pilot wards will be divided into 5 groups and attend the small lectures
organized by the innovation team in a conference room on five different days for
one hour in every lecture. Each staff can be more attentive and concentrated when
they are learning in small groups. They will be told about the purpose of the whole
innovation, evidence support about the change, the detail of the new guidelines, the
schedule of the pilot test, use of the new reminder form (Appendix 8) and what they
exactly have to do during the implementation period. For every newly transferred
patient, nurse has to perform pressure ulcer risk using the Norton Scale Assessment
form. If the patient meets all the criteria listed in the reminder form, low-‐air-‐loss bed
should be provided for the eligible patient and nursing care should be provided
according to Pressure Ulcer Prevention Management Policy. All the incidence of
pressure ulcer development, stage and site of the wound should be accurately
documented.
4.2.3 Data Collection
Incidence of pressure ulcer and the median time for the occurrence of
pressure ulcers are the patient outcomes. Recruited patient’s particulars including
age, gender, medical diagnosis and even laboratory result can be retrieved from the
Clinical Management System (CMS) since there is a gum label on each reminder
form. The existing date and stage of pressure ulcer should be documented in the
reminder form as well. Coordinator from each pilot ward will collect a copy of the
reminder forms every week, no matter the patient has discharged or still is an in-‐
49
patient. If any undesired effect occurred or problems found after the innovation like
patient or relative refuses the use of low-‐air-‐loss bed for patient, patient feeling
uncomfortable when using the designated bed, every incidence should document in
the reminder form with reasons. All data will be computerized for evaluation.
Every staff is required to fill in a questionnaire regarding to the satisfaction
level towards the training sessions. Clinical audit (Appendix 10) will be performed
every 2 week for 2 months to check if all the required details in the reminder forms
are correctly documented. A nurse will be selected randomly in the pilot ward and
then he or she will perform the assessment and fill in the reminder form under the
supervision of the innovation team member. By the time, the innovation team
member will mark down the accuracy on the audit sheet and kept for further
evaluation.
4.2.4 Review of Guideline
After the pilot test has been carried out for 2 months, the process of
reviewing the guideline takes around 2 weeks to complete. So the whole pilot study
plan will be completed by 3 months. A review board will be formed by the
innovation team, wound nurse, and ward managers to discuss and analyzed the data
collected from the document and observation, and share the comments and
suggestions from the frontline nursing staff. According to the evaluation,
amendment on the guideline will be made within a week. And then the amended
guideline will be presented to COS and DOM during the department meeting to seek
final recognition. The amended guideline would be sent to the ethics approval board
and the Pressure Ulcer Prevention and Management Committee for approval before
50
proceeding to the implementation phase.
The cost spent on the innovation pilot test will also be evaluated which can
help identify unexpected cost and further estimate the spending during the
implementation period.
4.3 Evaluation Plan
Evaluation can assess how effective the innovation is. It helps identifying
whether it is worth to apply the innovation in the target clinical setting as well as
assessing whether the objectives specified at the planning stage have been reached.
It is essential to identify the patient outcomes, healthcare provider outcomes and
system outcomes before and after the innovation in this evaluation plan.
4.3.1 Identifying Outcomes and Measurements
4.3.1.1 Patient outcomes
The primary patient outcome is the incidence of developing new pressure
ulcer whereas the aim of the innovation is to reduce the number of bedbound
elderly suffering from having pressure ulcers. The effectiveness of the use of low-‐air-‐
loss bed can be determined by the proportion that the development of pressure
ulcers over a specified period of an individual.
The median time for the occurrence of pressure ulcers was also adopted as
measurement of secondary outcome, as it can show the how much delay in time for
the occurrence of ulceration development. Development of pressure ulcers
sometimes is unavoidable on certain kind of patients, e.g. patients who are in poor
51
nutritional status or with multiple comorbidities. This type of patients can suffer less
if there is a delay in time for the occurrence of ulceration development.
4.3.1.2 Healthcare provider outcomes
Staff satisfaction level towards the innovation and the training session will be
measured by a self-‐reported questionnaire (Appendix 11). The questionnaire is a 5-‐
point Likert scale with score 1 (strongly disagree) to 5 (strongly agree). A higher
mean score represents a higher level of satisfaction of the staff. Each frontline staff
is required to fill in the questionnaire after the training session and the innovation
implementation (Appendix 12).
4.3.1.3 System outcome
The cost effectiveness of using the innovation will be the system outcome.
The cost and maintenance of using low-‐air-‐loss bed and the benefit brought from the
innovation are expected to be lower than the cost for treating the pressure ulcers
like use of dressing materials, nursing staff to perform dressing for patients, or
medication to treat wound infection and the cost of prolonged hospital stay.
4.3.2 Nature and Number of Clients to be Involved
The target patients should meet the same inclusion and exclusion criteria
which has been discussed in the pilot test. Patients with age of 60 years old or above
who scores 14 marks or below after assessed by a nurse using the Norton Scale
Assessment once the patient is admitted or transferred to the rehabilitation wards
within 24 hours will be recruited as eligible participants. Patients should be
bedbound male who may be with or without pre-‐existing pressure ulcers during
admission or transfer to rehabilitation ward. Convenience sampling will be used as
the sampling method. All target patients will be followed up from the date of
52
admission or transfer until they are discharged. The number of new pressure ulcers
developed will be counted on their discharge date. In order to test whether the
incidence rate of pressure ulcer development is less than 10% after the
implementation of the use of low-‐air-‐loss bed, a two-‐tailed z-‐test for testing one
proportion by Russ Lenth will be used (Lenth, 2012). With 80% power to detect the
incidence rate of pressure ulcer development, the incidence rate of pressure ulcer
development before innovation in clinical setting is 17%, null value will be 0.17 and
actual value is 0.1. 194 eligible patients would be required for the implementation of
the innovation. During the 1-‐year implementation period, the eligible number of
patients among the 6 rehabilitation wards is calculated as follows:
Number of patients recruited in each ward in each month = 10.
Number of patients recruited in each ward in one year = 10 x 12 = 120.
Number of patients recruited in 6 wards in one year = 120 x 6 = 720.
Therefore, it is enough to have 720 patients for carrying out the data
analysis.
4.3.3 Timing and Frequency of the Measurements
Different timing and frequency of measurements will be based on different
kinds of outcomes. The whole innovation will take 1 year to implement while result
of data analysis will be published every 6 months. To measure the patients’ primary
outcome, any newly development of pressure ulcers during the innovation will be
the main focus. Therefore, daily skin assessment must be performed for every at risk
patient which is the basic care for monitoring the progress of pressure ulcer
53
development. Any newly developed pressure ulcer should be clearly documented in
the reminder form with date and wound characteristic like stage, size and site of it.
The measurement of the secondary outcome -‐-‐ the median time for the occurrence
of pressure ulcers can also be captured from this sheet. All the reminder form will be
collected by the innovation team every two week and the data will be computerized.
For staff satisfaction regarding to the training session, the data will be
collected once they have finished the training session. While for staff satisfaction
level towards the innovation, data will be obtained before the start of the innovation
and every 6 months since the innovation. The cost of the innovation will also be
measured every 6 months.
4.3.4 Data Analysis
After the whole innovation has finished, the data would be computerized and
analyzed using two-‐tailed z-‐test for testing one proportion to see whether the
incidence rate of pressure ulcer development would be reduced by 7% after the
implementation of the new guideline when compared with the adoption of the
original hospital guideline during the same period in the last year. The nominal level
of significance would be 0.05. 95% confidence interval would be used to determine
the staff satisfaction towards the innovation. Cost including setup cost such as
material cost and personnel cost would be summed up and calculated at the end of
the innovation.
4.3.5 Basis of Adopting the Innovation
To determine whether the innovation is effective, certain criteria and stated
objectives should be met. The clinical data and evidence from the reviewed studies
should be taken into consideration for the effectiveness of the innovation. If the
54
result or outcome of the innovation is similar to the reviewed studies under similar
clinical setting, the innovation can be considered effective and it can be adopted.
In this innovation, if the incidence rate of pressure ulcer development can be
reduced by 7% after the implementation of new guideline, it is considered as a
significant difference. For the median time for the occurrence of pressure ulcers, it is
estimated that the innovation can impose at least 5 days of delay. Staff should at
least score 3 out of the 5-‐point Likert scale regarding to the staff satisfaction level on
the training session as well as the innovation which means that they do not disagree
with the use of new guideline. The estimated cost for the whole innovation is
$15000 which should be lower than the cost of treating patient having pressure
ulcers $184100.
55
Appendix 1: IOWA Model
Assemble Relevant Research & Related Literature
Critique & Synthesize Research for Use in Practice
NoYes
Yes
Is ChangeAppropriate for
Adoption inPractice?
YesInstitute the Change in Practice
Is Therea SufficientResearch
Base?
Monitor and Analyze Structure, Process, and Outcome Data
2. National Agencies or Organizational Standards & Guidelines3. Philosophies of Care4. Questions from Institutional Standards Committee5. Identification of Clinical Problem
1. Risk Management Data
Problem Focused Triggers Knowledge Focused Triggers
• Staff• Cost• Patient and Family
Pilot the Change in Practice1. Select Outcomes to be Achieved2. Collect Baseline Data3. Design Evidence-Based Practice (EBP) Guideline(s)4. Implement EBP on Pilot Units5. Evaluate Process & Outcomes6. Modify the Practice Guideline
The Iowa Model ofEvidence-Based Practice to Promote Quality Care
REQUESTS TO:Marita Titler, PhD, RN
Office of Nursing ResearchThe University of Iowa Hospitals and Clinics
Iowa City, IA 52242-1009
Revised April 1998 © UIHC
2. Process Improvement Data3. Internal/External Benchmarking Data4. Financial Data
1. New Research or Other Literature
ConsiderOther
Triggers
Is this Topica Priority For the
Organization?
No
Form a Team
Base Practice on Other Types of Evidence:1. Case Reports2. Expert Opinion3. Scientific Principles4. Theory
Conduct Research
Continue to Evaluate Qualityof Care and New Knowledge
No
Disseminate Results• Environment
= a decision pointDO NOT REPRODUCE WITHOUT PERMISSION
ReferenceTitler, M.G., Kleiber, C., Steelman, V., Rakel, B., Budreau, G., Everett, L.Q., Buckwalter, K.C.,Tripp-Reimer, T., & Goode C. (2001).The Iowa Model of Evidence-Based Practice to Promote Quality Care. Critical Care Nursing Clinics of North America, 13(4), 497-509.
56
Appendix 2: Flowcharts of Four Search Engines 1. PubMed (1948 to August 26, 2012) Code Keywords Results 1 support* surface* 458956 2 mattress* 2670 3 overlay* 10301 4 bed* 94937 5 pressure ulcer 12623 6 #1 OR #2 OR #3 OR #4 AND #5 1561
Maual screening of full publicantions and final included studies (n=3)
Electronic search from PubMed (n=1561)
First manual screening on title with full text available (n=11)
Manually excluded: Studies that are unrelated to or no elements of using pressure-‐relieving support surface to prevent pressure ulcer and not fit for the inclusion criteria while fall on the exclusion criteria(n=1550)
Manually excluded: No randomised controlled trial; systematic review(n=8)
57
Appendix 3: Table of Evidence Study 1: “High Tech” support surface vs. “High Tech” support surface
Nixon, J., Granny, G., Iglesias, C., Nelson, E. A., Hawkins, K., Phillips, A., … Cullum, N. (2006). Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial. British Medical Journal, 332(7555), 1413-‐5.
Citation Study Design (Level of Evidence)
Patient Characteristics
Setting and
Countries
Intervention Control Length of Study
Outcome Measures
Effect Size
1. Nixon, et al., 2006
RCT (1++)
-‐Median age 76 (55-‐100) years old -‐Existing of wound: 5.9% -‐Grade 1 pressure ulcer: 16.5% -‐Bedbound: 79% -‐Poor nutritional status: 39.3% -‐Expected length of stay at least 7 days
-‐Admitted as either acute or elective in 11 hospitals in UK, within 24 hours (n=1971)
Pressure alternating mattress (n=982)
Pressure alternating overlay (n=989)
3 years and 4 months
Primary Outcome: 1. Incidence of pressure ulcers Secondary Outcomes: 2.Estimated median time to healing of existing pressure ulcer 3. Dissatisfaction by patients 4. Delay in time of ulceration
1. 10.3% vs 10.7% (p=0.75) 2. 20 days for both groups (p=0.86) 3. 18.9% vs 23.3% (p=0.02) 4. 10.64 days longer in intervention group
58
Appendix 3: Table of Evidence Study 2: “Low Tech” support surface vs. standard hospital mattress
Berthe, J.-‐V., Bustillo, A., Melot, C., & Fontaine, S.-‐D. (2007). Does a foamy-‐block mattress system prevent pressure sores? A prospective randomised clinical trial in 1729 patients. Acta Chirurgica Belgica, 107, 155-‐161.
Citation Study Design (Level of Evidence)
Patient Characteristics
Setting and
Countries
Intervention Control Length of Study
Outcome Measures
Effect Size
2. Berthe, Bustillo, & Fontaine (2007)
RCT (1++)
-‐All patients free of bedsores admitted for at least 24 hours
-‐Medical and surgical departments in a hospital in Belgium (n=1729))
Foamy-‐block (Kliniplot) mattress (n=657)
Standard hospital mattress (n=1072)
7 months
Primary Outcome: 1.Incidence of pressure ulcers Secondary Outcome: 2. Median time for the occurrence of pressure ulcers
1. 3.2% vs 1.9% (p=0.154) 2. 31 days (6-‐87) vs 18 days (2-‐38) (p<0.001)
59
Appendix 3: Table of Evidence Study 3: “Low Tech” support surface vs. standard hospital mattress
Jolley, D. J., Wright, R., McGowan, S., Hickey, M. B., Campbell, D. A., Sinclair, R. D., & Montgomery, K. C. (2004). Preventing pressure ulcers with Australian Medical Sheepskin: an open-‐label randomised controlled trial. Medical Journal of Australia, 180, 324-‐327.
Citation Study Design (Level of Evidence)
Patient Characteristics
Setting and Countries
Intervention Control Length of Study
Outcome Measures
Effect Size
3. Jolley, et al., (2004)
RCT (1+)
-‐Mean age: 62.2 years old -‐Free of bedsores -‐Mean score for pressure ulcer risk using Barden scale: 15.8 (with <12 as high risk; 13-‐14 as moderate risk; 15-‐18 as low risk) -‐Expected length of stay more than 48 hours
-‐Admitted with low to moderate risk of developing a pressure ulcer on the Barden Pressure Ulcer Risk Assessment Scale -‐A hospital in Australia (n=441)
Sheepskin overlay (n=218)
Standard hospital mattress (n=223)
5 months Primary outcomes: 1. The cumulative incidence risk of pressure ulcers (95% CI)
1. 9.6% (6.1%-‐14.3%) vs 16.6% (12.0%-‐22.1%)
60
Appendix 3: Table of Evidence Study 4: “Low Tech” support surface vs. standard hospital mattress
Russell, L. J., Reynolds, T. M., Park, C., Rithalia, S., Gonsalkoraie, M., Birch, J., … Iglesias, C. (2003). Randomized clinical trial comparing 2 support surfaces: result of the prevention of pressure ulcers study. Advance Skin Care, 16(6), 317-‐327.
Citation Study Design (Level of Evidence)
Patient Characteristics
Setting and Countries
Intervention Control Length of Study
Outcome Measures
Effect Size
4. Russell, et al., (2003)
RCT (1++)
-‐Median age: 83 (79-‐87) years old -‐Waterlow score: 15-‐20
-‐Elderly acute care, rehabilitation and orthopedic wards at 3 hospital in UK (n=1168)
Viscoelastic polymer foam mattress (n=562)
Standard hospital mattress (n=504)
Median range days for experimental group: 8-‐14; for control group: 9-‐17
Primary Outcomes: 1. The incidence of developing grade 1 pressure ulcers 2. The incidence of developing grade 2-‐4 pressure ulcers (Relative risk of standard hospital mattress / foam mattress)
1. 19.9% vs 26.3% (p=0.004) 2. 8.5% vs 10.9% (RR 0.78; 95% CI 0.55 to 1.11)
61
Appendix 3: Table of Evidence Study 5: “Low Tech” support surface vs. standard hospital mattress
Hofman, A., Geelkerken, R. H., Wille, J., Hamming, J. J., Hermans, J., & Breslau, P. J. (1994). Pressure sores and pressure-‐decreasing mattresses: controlled clinical trial. The Lancet, 343, 568-‐571.
Citation Study Design (Level of Evidence)
Patient Characteristics
Setting and Countries
Intervention Control Length of Study
Outcome Measures
Effect Size
5. Hofman, (1994)
RCT (1+)
-‐Mean age: 84 years old -‐Pressure-‐sore risk score: >8 -‐All patients with femoral-‐neck fracture -‐Patients with pressure sores of grade 2 or more were excluded
-‐A hospital in Netherlands (n=44)
Cubed foam mattress (Comfortex DeCube) (n=21)
Standard hospital mattress (n=23)
2 weeks Primary Outcomes: 1. The incidence of developing grade 2 or greater pressure ulcer
1. 24% vs 68% (p=0.0067)
62
Appendix 4: Quality Assessment Study 1: Nixon, et al., 2006 Internal Validity Criterion Description 1. Appropriateness and clarity of the research question
Well-‐covered Clearly stated: “To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability.”
2. Random assignment of the subjects Well-‐covered Randomisation was done after informed written consent
3. Allocation concealment Well-‐covered “Randomisation was through an independent, secure, 24 hour randomisation automated telephone service by Clinical Trials Research Unit (CTRU), University of Leeds.”
4.Blinding of subjects and investigators Not applicable
“Owing to the nature of the mattresses under investigation, it was not possible to mask the randomised intervention to the patients participating in the trial, ward nursing staff or the CRNs conducting the skin assessments”.
5. Similarity between experimental and control groups at baseline
Well-‐covered Matched well at baseline
6. Treatment under investigation Not reported 7. Validity and reliability of the relevant outcome measure(s)
Well-‐covered All pre-‐specified outcomes were reported
8. Drop out rate 0.05% “One patient was randomised twice and therefore excluded.”
9. Intention to treat analysis Well-‐covered ITT analysis conducted 10. Results are comparable more than one clinical areas
Well-‐covered “11 hospitals in six NHS trusts. The target population… who had been admitted to vascular, orthopaedic, medical, or care of elderly people wards, either acute or elective admissions…”
Overall rate: 8/10 Level of evidence: 1++
63
Appendix 4: Quality Assessment Study 2: Berthe, Bustillo, & Fontaine, 2007 Internal Validity Criterion Description 1. Appropriateness and clarity of the research question
Well-‐covered Clearly stated: “To determine the effectiveness in pressure-‐sore prevention of an interface pressure-‐decreasing mattress, the Kliniplot mattress, used in our institution since 1978.”
2. Random assignment of the subjects Well-‐covered “All patients free of bed-‐sores admitted for at least 24 hours ro three medical and three surgical departments… were freely assigned to a bed…” “Oral informed consent was obtained…”
3. Allocation concealment Well-‐covered “All patients….were freely assigned to a bed which has been randomly equipped in advance either with a Kliniplot mattress, or with a standard mattress.” “The bed randomization was modified in favour of the standard mattress by using a 1:2 allocation ratio to circumvent a potential selection bias.”
4.Blinding of subjects and investigators Not applicable
“The patients were admitted by the chief nurse of each department, who knew the repartition of the Kliniplot mattresses and the standard mattresses.” “Also, each type of mattress was easily recognizable by the nursing staff…”.
5. Similarity between experimental and control groups at baseline
Well-‐covered No difference between the two groups for the risk of developing a bedsore.
6. Treatment under investigation Well-‐covered “Both groups were nursed according ot the global pressure sore prevention policy of the hospital”
7. Validity and reliability of the relevant outcome measure(s)
Well-‐covered All pre-‐specified outcomes reported.
8. Drop out rate 0% No participants were died or dropped out for both groups.
9. Intention to treat analysis Well-‐covered ITT analysis conducted 10. Results are comparable more than one clinical areas
Well-‐covered 3 medical and 3 surgical departments in a Belgium hospital.
Overall rate: 9/10 Level of evidence: 1++
64
Appendix 4: Quality Assessment Study 3: Jolley, et al., (2004) Internal Validity Criterion Description 1. Appropriateness and clarity of the research question
Well-‐covered Clearly stated: “To estimate the effectiveness of a new high-‐performance Australian medical sheepskin in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers.”
2. Random assignment of the subjects Well-‐covered Randomisation was done after formal informed consent
3. Allocation concealment Well-‐covered Shuffling cards (?): “Patients were randomly allocated to receive....... using numbered cards in individually sealed opaque envelopes; blocks of 16 envelopes (eight of each group) were shuffled before use”
4.Blinding of subjects and investigators Not applicable
“As it was logistically impossible to blind patients, ward staff and research nurses to the treatment group this was an open-‐label, unblinded trial”
5. Similarity between experimental and control groups at baseline
Well-‐covered Matched well at baseline for age, sex, mean pressure ulcer risk score
6. Treatment under investigation Well-‐covered “Patients in the sheepskin group received usual nursing care, including repositioning, as determined by ward staff.”
7. Validity and reliability of the relevant outcome measure(s)
Well-‐covered All pre-‐specified outcomes reported.
8. Drop out rate 18.19% “539....were randomly allocated. Of these, 441 received the allocated intervention. All 441 were followed up to the endpoints...”.
9. Intention to treat analysis Poorly addressed Data for 441 not 539. Is a per protocol analysis.
10. Results are comparable more than one clinical areas
Adequately addressed “All patients who were admitted to the hospital… were eligible for the trial if they were at low to moderate risk of developing a pressure ulcer…”
Overall rate: 6.5/10 Level of evidence: 1+
65
Appendix 4: Quality Assessment Study 4: Russell, et al., 2003 Internal Validity Criterion Description 1. Appropriateness and clarity of the research question
Well-‐covered Clearly stated: “To determine whether a viscoelastic polymer foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost effectiveness in comparison with standard hospital mattress.”
2. Random assignment of the subjects Well-‐covered Different randomisation procedure for sites 1 and 2 from site 3: “equipment allocation at 2 sites was made by converting random numbers...on a 50:50 basis (0-‐0.5 and 0.5-‐ 1.0). At site 3, trial numbers were allocated sequentially and the patient chose from1 of 2 opaque envelopes. No blocking or stratification was used at any site”
3. Allocation concealment Not reported Unclear 4.Blinding of subjects and investigators Not applicable
“Because the data collection team examined participants at bedside and the experimental mattress surface is distinctive, data collection could not be blinded”
5. Similarity between experimental and control groups at baseline
Well-‐covered No statistically significant differences on prognostic indicators at baseline between groups.
6. Treatment under investigation Well-‐covered All were given standard nursing care.
7. Validity and reliability of the relevant outcome measure(s)
Well-‐covered All pre-‐specified outcomes were reported
8. Drop out rate 0.00% “Participants who died were included in all statistical analyses”; ITT analysis conducted on all randomised patients (excluding 2 where protocol violations had occurred).
9. Intention to treat analysis Well-‐covered ITT analysis conducted 10. Results are comparable more than one clinical areas
Well-‐covered “Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom.”
Overall rate: 8/10 Level of evidence: 1++
66
Appendix 4: Quality Assessment Study 5: Hofman, 1994 Internal Validity Criterion Description 1. Appropriateness and clarity of the research question
Well-‐covered Clearly stated: “To judge the effectiveness of the DeCube mattress, in a prospective controlled randomised clinical trail, the development of pressure sores on either our standard hospital mattress or the DeCube mattress in patients with a femoral-‐neck fracture and a concomitant high risk for the development of pressure sores.”
2. Random assignment of the subjects Well-‐covered Randomisation was done. 3. Allocation concealment Poorly addressed “Each group of 6 consecutively admitted
patients was randomly divided into 3 patients nursed preoperatively and postoperatively on the standard Vredestein polyproleen SG 40 hospital mattress (Vredestein, Netherlands) and 3 nursed on the comfotex DeCube”. Method of randomization not described.
4.Blinding of subjects and investigators Not applicable
“The study was not blinded with respect to observer or nurse”.
5. Similarity between experimental and control groups at baseline
Well-‐covered Groups were similar at baseline for pressure ulcer risk; haemoglobin; total serum protein and serum albumin.
6. Treatment under investigation Well-‐covered “Both group were treated according to the Dutch consensus protocol for the prevention of pressure sores.”
7. Validity and reliability of the relevant outcome measure(s)
Well-‐covered Main outcome of interest was occurrence of pressure ulcers and this was recorded.
8. Drop out rate 0.04% Of the 46 patients randomised, 2 were excluded due to the randomisation not being performed correctly (no further details) both in control group.
9. Intention to treat analysis Poorly addressed By week 1, 1 patient had left each group (1 death, 1 discharge). By 2 weeks post randomisation, 4 patients in each group had been discharged or died. It is not totally clear but seems that only those remaining (n = 17 comparedwith 19) were included in the 2 weeks analysis.
10. Results are comparable more than one clinical areas
Adequately addressed
“All patients admitted to our hospital with a femoral-‐neck fracture and with a pressure-‐sore risk score of 8 points or more.” Did not specify clearly the kinds of wards in the study.
Overall rate: 6.5/10 Level of evidence: 1+
67
Appendix 4: Quality Assessment Table of Summary of the 5 Sampled RCT Studies
W—Well-‐covered; NA—Not applicable; NR—Not reported; AA—Adequately addressed; PA—Poorly addressed
Internal Validity/ Citation
1 2 3 4 5 6 7 8 9 10 Overall Rate
Level of Evidence
1. Nixon, et al., 2006 W W W NA W NR W 0.5% W W 8/10 1++
2. Berthe, Bustillo, & Fontaine, 2007
W W W NA W W W 0% W W 9/10 1++
3. Jolley, et al., 2004 W W W NA W W W 18.19% PA AA 6.5% 1+
4. Russell, et al., 2003 W W NR NA W W W 0.00% W W 8/10 1++
5. Hofman, 1994 W W PA NA W W W 0.04% PA AA 6.5/10 1+
68
Appendix 5: The Methodology Checklist METHODOLOGY CHECKLIST: RANDOMISED CONTROLLED TRIALS
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
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
69
Appendix 5: The Methodology Checklist (Continue)
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.
70
Appendix 6: Level of Evidence and Grade of Recommendation Designed by the Scottish Intercollegiate Guideline Network (SIGN, 2011) 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 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, eg. case reports, case series 4 Expert opinion Grades of recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. 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
71
Appendix 7: Pressure Ulcer Prevention and Management Policy
72
Appendix 7: Pressure Ulcer Prevention and Management Policy (Continue)
73
Appendix 8: Reminder form attached to original Norton Scale Assessment Form
Norton Risk Assessment Score (Reminder) *Attach to the original Norton Scale Assessment form *Fill in this form immediately when patient is transferred to rehabilitation ward and meets the following criteria:
-‐ Age 60 or above ☐ -‐ Norton Score < or = 14 ☐ -‐ Bedbound ☐
à Provide Low-‐air-‐loss bed
Label for patient’s particulars
Date of Commence: Provision of Low-‐air-‐loss Bed Yes ( )
No ( ) àMark down patient’s name on waiting list àOther reason:
Number of pre-‐existing pressure ulcers
Site Stage
Date of Transfer/ Discharge: Number of pressure ulcers before transfer/ discharge Existing Date:
Site Stage
74
Appendix 9: An overall guide for the use of pressure-‐relieving supporting surfaces
Perform Norton Score for patient on admission or transfer within 24 hours
with Norton Score ≤ 14 ?
Perform Norton Score and re-‐assessment for patient after admission or transfer or any condition change
Complete the Norton Risk Assessment Score (Reminder) form (see Figure 3.1) Meet all the criteria? -‐Age 60 or above -‐Bedbound -‐Norton Score≤ 14
Provide Standard Hospital Bed
Provide Standard Hospital Bed +
Provide nursing care according to Pressure Ulcer Prevention & Management Policy (see Appendix 4)
Provide Pressure-‐Relieving Supporting Surfaces e.g. low-‐air-‐loss bed
+ Provide nursing care according to Pressure Ulcer Prevention & Management Policy (see Appendix 4)
Mark down patient’s name on the waiting list *Ward-‐in-‐charge should check vacancy every shift and assign eligible patient to appropriate bed as soon as possible
Yes No
Yes
No
No Vacancy
Norton Score≤ 14
Remarks: *Audit will be performed every month to check the documentation of the forms *The Norton Risk Assessment Score (Reminder) form will be kept filed after patient is discharged/ transferred/ dead.
75
Appendix 10: Clinical Audit Form Nursing Standard for Patient Care (Audit Form) Unit/ Dept:____________________ Date:____________________ Topic: Pressure Ulcer Prevention and Management (Use of Pressure-‐Relieving Supporting Surface) Please ‘ ✓ ’ in the appropriate column Standard Criteria Source of
Information Yes No N/A Remarks
1* Assess patient’s condition and the need for pressure-‐relieving supporting surface
AN / AP/ AF / O / CR
2 Explain the purpose of use of pressure-‐relieving supporting surface to patient/ significant others
AN / AP/ AF / O / CR
3 Assess the patient using Norton Scale Assessment form properly
AN / AP/ AF / O / CR
4 Fill in the Reminder Form correctly AN / AP/ AF / O / CR
5 Ensure the hospital policy for the pressure ulcer prevention and management are observed
AN / AP/ AF / O / CR
6 Use the pressure-‐relieving supporting surface properly and correctly
AN / AP/ AF / O / CR
7 Observe patient closely for complications AN / AP/ AF / O / CR
8 Evaluate the need to continue the use of pressure-‐relieving supporting surface
AN / AP/ AF / O / CR
9* Observe, document and report patient’s ongoing condition
AN / AP/ AF / O / CR
Total Score
*Critical item AN = Ask Nurse; AP = Ask Patient; AF = Ask Family; O= Observe; CR = Check Record; NA = Not Applicable Please circle the appropriate Source of Information. Compliance Percentage: ___________________ Auditor: _________________ ( ) Auditor Signature: _____________ Name Ward/Unit
76
Appendix 11: Satisfaction Questionnaire (Training Session) Self-‐reported Satisfaction Questionnaire (Training Session) Please circle the following: 5 = Highly Agree 4 = Agree 3 = Neutral 2 = Disagree 1 = Highly Disagree 1. Content of training session is relevance 5 4 3 2 1 2. Content of training session is valuable 5 4 3 2 1 3. Duration of training session is appropriate 5 4 3 2 1 4. Understand well what the speaker has told 5 4 3 2 1 5. Venue and format of training session 5 4 3 2 1 6. Competent to use the new guideline 5 4 3 2 1 after training session
Any other comment(s)? _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ Date: _____________________ Name: ________________________________ Title: __________________________________ Ward: _________________________________
Thanks your attention!
77
Appendix 12: Satisfaction Questionnaire (After implementation of new guideline) Self-‐reported Satisfaction Questionnaire (After implementation of new guideline) Please circle the following: 5 = Highly Agree 4 = Agree 3 = Neutral 2 = Disagree 1 = Highly Disagree 1. Understand well the content of guideline 5 4 3 2 1 2. The guideline is user-‐friendly 5 4 3 2 1 4. Resource(s) and material(s) provided properly 5 4 3 2 1 5. Support and help given when necessary 5 4 3 2 1 6. Workload after implementation is appropriate 5 4 3 2 1 7. Innovation is beneficial to patients 5 4 3 2 1 8. Competent to use the new guideline 5 4 3 2 1 9. Will continue to use the new guideline 5 4 3 2 1 Any other comment(s)? _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ Date: _____________________ Name: ________________________________ Title: __________________________________ Ward: _________________________________
Thanks your attention!
78
References
Allman, R. M. (1997). Pressure ulcer prevalence, incidence, risk factors and
impact. Clinical Geriatric Medicine, 13, 421-‐426.
Audit Commission (1991). The Virtue of patients: Making the best of ward
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