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CLINICAL ISSUES

A randomised controlled clinical trial of repositioning, using the 30 tilt,


for the prevention of pressure ulcers
Zena Moore, Seamus Cowman and Ronan M Conroy

Background. Pressure ulcers are common, costly and impact negatively on individuals. Pressure is the prime cause, and
immobility is the factor that exposes individuals to pressure. International guidelines advocate repositioning; however, there is
confusion surrounding the best method and frequency required.
Design. A pragmatic, multi-centre, open label, prospective, cluster-randomised controlled trial was conducted to compare the
incidence of pressure ulcers among older persons nursed using two different repositioning regimens.
Method. Ethical approval was received. Study sites (n = 12) were allocated to study arm using cluster randomisation. The
experimental group (n = 99) were repositioned three hourly at night, using the 30 tilt; the control group (n = 114) received
routine prevention (six-hourly repositioning, using 90 lateral rotation). Data analysis was by intention to treat; follow-up was
for four weeks.
Results. All participants (n = 213) were Irish and white, among them 77% were women and 65% aged 80 years or older. Three
patients (3%) in the experimental group and 13 patients (11%) in the control group developed a pressure ulcer (p = 0035; 95%
CI 00310038; ICC = 0001). All pressure ulcers were grade 1 (44%) or grade 2 (56%). Mobility and activity were the highest
predictors of pressure ulcer development (b = 0246, 95% CI = 0319 to 0066; p = 0003); (b = 0227, 95% CI = 0041
0246; p = 0006).
Conclusion. Repositioning older persons at risk of pressure ulcers every three hours at night, using the 30 tilt, reduces the
incidence of pressure ulcers compared with usual care. The study supports the recommendations of the 2009 international
pressure ulcer prevention guidelines.
Relevance to clinical practice. An effective method of pressure ulcer prevention has been identified; in the light of the problem of
pressures ulcers, current prevention strategies should be reviewed. It is important to implement appropriate prevention strategies, of which repositioning is one.
Key words: 30 tilt, activity, mobility, nurses, nursing, pressure ulcer, prevention, repositioning
Accepted for publication: 19 January 2011

Authors: Zena Moore, PhD, MSc, FFNMRCSI, PG Dip, Dip


Management, RGN, Lecturer in Wound Healing & Tissue Repair
and Research Methodology, Faculty of Nursing & Midwifery, Royal
College of Surgeons in Ireland; Seamus Cowman, PhD, MSc,
FFNMRCSI, PG Cert Ed (Adults), Dip N (London), RNT, RGN,
RPN, Professor and Head of Department, Faculty of Nursing &
Midwifery, Royal College of Surgeons in Ireland; Ronan M Conroy,

DSc, Associate Professor, Division of Population Health Sciences,


Royal College of Surgeons in Ireland, Dublin, Ireland
Correspondence: Dr Zena Moore, Lecturer in Wound Healing
& Tissue Repair and Research Methodology, Faculty of Nursing &
Midwifery, RCSI, 123 St Stephens Green, Dublin 2, Ireland.
Telephone: +353 1 4022414.
E-mail: zmoore@rcsi.ie

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644


doi: 10.1111/j.1365-2702.2011.03736.x

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Z Moore et al.

Introduction
Pressure ulcer is a significant health care problem despite
considerable investment in education, training and prevention
equipment (Vanderwee et al. 2007a). The impact of pressure
ulcers on the individual is profound (Gorecki et al. 2009), and
costs associated with the prevention and management of
pressure ulcers are also considerable (Posnett & Franks 2008).
Changing demographics predict an increase in the older
population in the future; therefore, owing to the likelihood
of an associated increase in health care problems, it is probable
that the number of pressure ulcers will also increase.

Background
The primary cause of pressure ulcers is prolonged, unrelieved
pressure, and an individual needs to be exposed to this
causative factor for tissue breakdown to occur. Activity and
mobility scores of individuals (using the Braden pressure ulcer
risk assessment tool) have been found to be statistically
significantly predictive of pressure ulcer development
(p < 0001) (Oot-Giromini 1993, Nixon et al. 2000).
Other researchers have also noted the relationship between
mobility status and the development of pressure ulcers, van
Marum et al. (2000) [odds ratio (OR) 36; p = 0001];
Papanikolaou et al. (2003) (OR 541 p = 0001, 95% CI
2001463); Berlowitz et al. (2001) (OR 11) Lindgren et al.
(2004) (OR 053, p = 0011); and Fisher et al. (2004) (OR
530 (95% CI 5286353153; p < 001) all linking immobility with pressure ulcer development.
Repositioning is an important component in the prevention
of pressure ulcers (NICE 2005) and involves moving the
individual into a different position to remove or redistribute
pressure from a particular part of the body (Krapfl & Gray
2008). Certain patient positions are not useful in terms of
pressure ulcer prevention (Seiler et al. 1986, Colin et al. 1996,
Sachse et al. 1998, Defloor 2000). The 90 lateral position has
been shown to decrease blood flow and transcutaneous oxygen
tension (TcPO2) to near anoxic levels and to increase interface
pressures (IP). Conversely, this is not the case when the
individual is placed in the 30 lateral inclined position (Seiler
et al. 1986, Colin et al. 1996, Sachse et al. 1998, Defloor
2000). The authors, therefore, conclude that the 90 lateral
position should be avoided (Seiler et al. 1986, Colin et al.
1996, Sachse et al. 1998, Defloor 2000). The challenge in
interpreting this evidence is that these studies have been
conducted on healthy volunteers; therefore, the exact application to clinical practice has yet to be established. Realistically, one would not expect individuals at risk of pressure ulcer
development to be able to withstand different positioning
2634

techniques better than healthy volunteers. Therefore, it seems


logical that positions that reduce blood flow substantially
should be avoided in clinical practice.
There are only two studies exploring the timing of
repositioning on the incidence of pressure ulcers (Defloor
et al. 2005, Vanderwee et al. 2007b). The first study,
undertaken by Defloor et al. (2005), explored the effects of
a variety of patient turning regimens on the incidence of
pressure ulcers. The turning regimens consisted of four
intervention groups: two-hourly (n = 65) or three-hourly
turning (n = 65) on a standard foam mattress, four-hourly
(n = 67) and six-hourly turning (n = 65) on a visco-elastic
foam mattress and one control group standard care
(n = 576) (Defloor et al. 2005). For the intervention groups,
the positioning used for the patients while in bed was the 30
semi-fowler position. The researchers identified that turning
four hourly on a visco-elastic foam mattress resulted in
statistically less pressure ulcers, compared with all of the
other repositioning groups, including standard care
(p = 0003; OR 013; 95% CI 003-048) (Defloor et al.
2005). The inclusion of the mattress is a confounding
variable, as it is not clear whether the effect relates to
repositioning frequency alone or to the mattress alone or the
effect of the combination of mattress and repositioning.
A further study explored whether more frequent repositioning would influence the incidence of pressure ulcers
(Vanderwee et al. 2007b). The study used two-hourly, 30
lateral positioning, followed by four-hourly, semi-fowler 30
supine positioning (alternated), when patients were nursed on
a visco-elastic foam overlay (on top of the standard mattress)
(Vanderwee et al. 2007b). The outcome of interest was
pressure ulcer incidence; the experimental group (n = 122)
was compared with a control group (n = 113) nursed on the
same type of foam overlay and positioned using the same
technique, but this position was changed every four hours
(Vanderwee et al. 2007b). In the experimental group, 164%
of the patients developed a pressure ulcer, whereas 212% of
the control group developed a pressure ulcer, but this
difference was not statistically significant (Vanderwee et al.
2007b). The challenge with this study is that both the
treatments offered to the intervention and control groups are
quite similar. For half of the time, both groups were
undergoing the exact same intervention, which in itself may
have minimised the possibility of identifying a difference
between the group should one actually exist.
International best practice advocates the use of repositioning as an integral component of a pressure ulcer prevention
strategy (EPUAP & NPUAP 2009). However, there remains
little scientific evidence on which to base clinical decisions.
Thus, it is important to explore this intervention in detail.

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

Clinical issues

Pressure ulcer is a significant problem; in clinical practice,


repositioning is recommended. However, the problem is that
the exact frequency and method of repositioning to adopt
remains unclear. Therefore, the research question for this
study was the following: what is the effect of repositioning
three hourly at night, using the 30 tilt, on the incidence of
pressure ulcers, in older patients at risk of pressure ulcer
development hospitalised in long-term care settings?

Methods
The research design employed in this study was a multicentre, pragmatic, open-label, prospective cluster-randomised
controlled clinical trial (RCT). The research hypothesis was
as follows: repositioning older hospitalised patients at risk of
pressure ulcer development, using the 30 repositioning
technique, will reduce the incidence of pressure ulcer development compared with routine pressure ulcer prevention
measures. Ethical approval was received from the Local
Research Ethics Committee. Data were collected using the
Braden scale, the malnutrition universal screening tool
(MUST), the EPUAP pressure ulcer classification system and
the EPUAP minimum data set.
Allocation to the study groups was by cluster randomisation; this choice was based on advice from the Local Research
Ethics Committee, a statistician and the external reviewers
of the study protocol. Cluster randomisation involves
randomising units rather than individuals to the different
arms of a study, such as units in a hospital (Medical Research
Council 2002). It increases efficiency and study protocol
compliance while avoiding contamination (Donner & Klar
2004). Contamination is said to occur when an intervention
is given to an individual but may affect others in the trial
(Puffer et al. 2005) or when the intervention is given by
accident to the control group.
Disadvantages of cluster randomisation include the fact
that all of the individuals in the cluster cannot be assumed to
be independent of one another, and furthermore, the analysis
is not at the level of randomisation but is rather at the group
level (Elley et al. 2004). A way to overcome the disadvantages is to allow for the effects of clustering in the analysis of
the data (Hahn et al. 2005). The CONSORT statement
extension to cluster randomised trials recommends that
results for each primary outcome of the study be reported
with the associated coefficient for intracluster correlation
(ICC) (Campbell et al. 2004). Normally, with individual
randomisation one would expect that there to be a variance
in the responses in study groups. Clustering can exert an
effect on this variance yielding a correlation of responses in
the clusters. The ICC analyses this correlation, and results

Prevention of pressure ulcers

close to zero are desirable because this suggests that the


in-cluster variance is greater than the between-cluster variance (Killip et al. 2004).
The clusters were the specific study sites (n = 12), and these
were randomly allocated to either the intervention group or
the control group. The allocation was generated by a
statistician not directly involved with the study and was
determined using computerised randomisation; allocation
concealment was achieved through use of distance randomisation, meaning that the statistician, not the researcher,
controlled the randomisation sequence.
The experimental group were repositioned, by the clinical
staff, using the 30 tilt (left side, back, right side, back) every
three hours during the night. The 30 tilt is a patientrepositioning technique that can be achieved by rolling the
patient 30 to a slightly tilted position with pillow support at
the back (Seiler et al. 1986) (Fig. 1). The hand under the heels
in the image indicates that the heels should be offloaded from
the bed. The control group were repositioned, by the clinical
staff, according to usual practice (Fig. 2). Usual practice was
repositioning every six hours at night, using 90 lateral
rotation. Night-time was taken to mean between the hours of
8 pm8 am. No further manipulation of patient care was
undertaken.
To maximise the patients continuation with activities of
daily living, both groups were nursed during the day
according to planned care. This meant that pressure redistribution devices in current use on the bed and on the chair were
continued (Table 1), as were all nutritional interventions.
Furthermore, repositioning continued as per nursing activities
and was undertaken during toileting regimens, changing of
incontinence pads, preparation for feeding and for sleep
periods (using the 30 tilt). Thus, during the day, the patients
positions were altered every 23 hours.

Data collection
The Braden scale is a pressure ulcer risk assessment scale
(Braden & Bergstrom 1987) comprising six subscales: sensory
perception, moisture, activity, mobility, nutrition and friction/
shear. Each subscale is ranked numerically; all but one is
scored 14, and a score of 4 indicates no problem with regard to
the specific subscale, whereas a score of 1 indicates a significant
problem. The friction and shear subscale is scored 13. The
scores for each of the subscales are totalled to give a final score
ranging from 623; as scores become lower, predicted risk
becomes higher (Braden & Bergstrom 1987). The Braden
scale is the most widely tested risk assessment tool currently
available and the most frequently used in clinical practice
(Pancorbo-Hidalgo et al. 2006).

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

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Z Moore et al.

The 30 degree tilt

1. Nursing staff assessed the patient using the Braden tool and
apply the inclusion criteria
2. Researcher consented the patient. If the patient was unable to
consent then assent was sought from the next of kin and
consent from the medical officer
3. Patient specific data were recorded by the researcher using the
data collection tool

Intervention

Three hourly turning using 30


degree tilt

Control
Routine pressure ulcer
prevention

1. A skin assessment was conducted by the nursing staff at each


repositioning episode and recorded on the data collection sheet
2. Changes in skin condition were graded by researcher and the nursing
staff, using the EPUAP pressure ulcer grading system
3. The patient was nursed as per planned care during the day
4. The patient continued in the study for a period of 4 weeks

Figure 2 Study protocol.

The 90 degree lateral rotation

Figure 1 (a) The 30 tilt. (b) The 90 lateral rotation.

The MUST is a five-step tool to identify adults who are


malnourished, at risk of malnutrition or obese (Elia 2003). It
is intended for use in hospitals, community and other care
settings and has been developed for use by all care workers
(Elia 2003). The scores range from 06, a score of 0 indicates
low risk, a score of 1 indicates medium risk and a score of 2
2636

or more indicates high risk (Elia 2003). The kappa scores


vary from j = 070089 compared with other screening tools
(Stratton et al. 2003, 2004).
The EPUAP pressure ulcer classification is a four-stage
system, ranging from non-blanching erythema of intact skin to
full-scale tissue destruction (European Pressure Advisory Panel
1999). The inter-rater reliability varies from j = 031097,
with more experienced nurses consistently scoring higher
(j = 080) (Defloor & Schoonhoven 2004) than those less
familiar with pressure ulcergrading systems (j = 033) (Beeckman et al. 2007).
The EPUAP minimum data set comprises patient-specific
data reporting age, gender, Braden score, continence, severity
and location of pressure ulcers and any interventions used to
assist prevention (support surfaces and repositioning) (European Pressure Ulcer Advisory Panel 2002). Overall, the
instrument is sufficiently robust to capture pressure ulcer
prevalence and prevention data across different care settings
and countries (Vanderwee et al. 2007a).
The primary outcome of interest was the incidence of
pressure ulcers that occurred in the study groups during the
28 days of the study. A pressure ulcer was defined as localised
areas of tissue damage to skin and underlying soft tissue
caused by sustained mechanical loading and shearing forces
(Stekelenburg et al. 2006, Beeckman et al. 2007), and all
grades of pressure ulcers were considered. The rationale for
inclusion of grade 1 pressure ulcer damage was that it is
considered to be an important indicator of risk for the
development of more severe pressure ulcer development
(Bennett et al. 2004, Beeckman et al. 2007).
Before beginning the study, a DVD demonstrating the 30
tilt was made. Education was delivered by the researcher and

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

Clinical issues

Prevention of pressure ulcers

Table 1 Prevention equipment in use on


the bed and the chair cross-tabulated by the
Research Group

Prevention equipment bed

None

Prevention equipment chair


None

Non-powered
device
Powered device
NA

Research Group
Total
Research Group
Total
Research Group
Total
Research Group

Intervention
Control

1
1

Intervention
Control

3
14
17
1
1

Control
Intervention
Control

Total

followed a specific pre-determined format. For the experimental group, the education session included explanation of
the purpose of the study, the data collection sheets and the
pressure ulcergrading system. In addition, the staff was
shown the repositioning DVD, and the repositioning technique was demonstrated until the staff was confident in its
use. Practical demonstrations of the 30 tilt were also
undertaken using one of the staff members as a model. For
the control group, the education consisted of explanation of
the purpose of the study, the data collection sheets and the
pressure ulcergrading system.
Data were collected for each subject in accordance with
the study protocol for a four-week period (Defloor et al.
2005, Vanderwee et al. 2007b). Throughout the study, the
staff recorded each repositioning episode on a data collection sheet. The patients skin was assessed at each turning
episode, and this information was recorded on the data
collection sheet. If any changes in skin integrity were noted,
the researcher was informed. The skin was then assessed by
the assigned key staff member, the clinical nurse manager
and the researcher. Agreement between the assessors was
achieved by comparing the participants skin condition to
the images on the EPUAP grading system. Poisson regression, adjusted for clustering by hospital, was used to
calculate the incidence rate ratio and its associated confidence interval.
It is recommended to conduct regular checkups and
reinforcement of protocol adherence to reduce non-concordance (Pocock 1983). To this end, the researcher visited the
wards at random times throughout the day and at night, to
ensure compliance with the repositioning schedule and the
data collection. A staff member from Nursing Administration
and from each ward was also assigned as the liaison person,
and he/she monitored compliance with repositioning and data
collection.

Non-powered
device

Powered
device

Total

2
3
3
6
1
1
1
0
1

2
0
2
72
84
156
2
2
17
8
25

3
1
4
78
101
179
4
4
18
8
26

Sampling
This study was conducted across 12 long-term care of the
older person hospitals in both urban and rural locations in
Ireland. Justification for use of these sites was that they are
state run and share commonality in patient population and
nursing service delivery, thereby displaying homogeneity. The
subjects of interest for this study were older hospitalised
patients at risk of pressure ulcer development. The inclusion
criteria were as follows:
An in-patient in a long-term care of the older person
hospital.
Over the age of 65 years.
At risk of pressure ulcer development as identified using
the activity and mobility components of the Braden
pressure ulcer risk assessment scale.
No pressure ulcer at the time of recruitment to the study.
No medical condition that would preclude the use of
repositioning.
Consent to participate in the study or have assent provided by the multidisciplinary team in collaboration with
the next of kin.
The rationale for exclusion of those with existing pressure
ulcers was that if patient has a pressure ulcer, it is recommended to avoid weight bearing over the ulcer to maximise
perfusion of the wound bed. If those with pressure ulcers
were included, this would have introduced a risk of nonadherence to the study protocol as the patient may have been
unable to lie in one of the study positions.
The sample size was calculated a priori, with consideration
of the incidence of the problem, the power of the study, the
effect size and the level of significance (Kirby et al. 2002).
The sample size was determined on the basis of an expected
incidence of 15% in the control group and a 90% power to
detect a reduction in pressure ulcer incidence from 1510%.

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

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Z Moore et al.

The rationale for choosing an incidence of 15% relates to the


reviewed literature, which suggests that rates vary from
771%; however, most commonly figures of between 730%
are reported. Therefore, in an endeavour not to overestimate
the incidence, a conservative figure of 15% was chosen. The
sample size required was two groups of 398 participants. As
the centres followed the same management principles and
treated similar groups of patients, no significant clustering
effect was foreseen in the study. In view of the reported low
ICCs for treatment-associated variables between practices
(Knox & Chondros 2004), we did not inflate the sample size.
Potential subjects were assessed by nursing staff according
to the inclusion criteria. An information leaflet was given by
the researcher to the patient (if appropriate), explaining the
nature and purpose of the study and inviting them to
participate. The researcher then visited the patients, having
allowed them time to absorb the information (at least
24 hours later), to obtain consent. If the patient was unable
to consent, then assent was sought by the researcher from the
multidisciplinary team in collaboration with the next of kin,
where available. Where there was no next of kin or the next
of kin was not available, assent was sought from the
multidisciplinary team.

Analyses
Data were analysed using SPSS version 13 on an intention to
treat (ITT) basis. The differences between the two arms of the
study were assessed using the chi-squared test (Pallant 2005).
Multiple regression analysis was conducted to determine

which risk factors most closely reflected pressure ulcer risk.


Statistical significance was set at the 5% level, 95% CI, and
ICC are reported as appropriate.

Results
Participants were selected from 12 long-term care of the
older person hospital settings in the Republic of Ireland
(Fig. 3). Two hundred and seventy patients were assessed
for their potential eligibility for participation in the study
(Fig. 4). Of these, 57 were excluded for the following
reasons; 20 did not meet the inclusion criteria because of
mobility and activity scores; 16 had pre-existing pressure
ulcers and 21 refused to participate. Therefore, 213 participants were enrolled into the study, with 114 participants
enrolled in the control arm of the study and 99 enrolled in
the experimental arm. Of these, 20 individuals (9%) were
able to consent for themselves. Seventy-nine per cent of the
participants were women, with 53% aged between 81
90 years, and a further 13% aged between 91100 years.
MUST analysis identified that 70% were considered to have
low risk of malnutrition.
Eighty-seven per cent of the participants were chair-fast
and 77% had very limited activity. At baseline, no repositioning care plan was documented for 79% of the participants when in bed or for 74% of the participants when seated
on a chair. Ninety-nine per cent of patients had a pressure
redistribution device in use for when they were seated in a
chair, whereas 86% (control) and 96% (experimental) had a
pressure redistribution device in use on the bed.

Flow of clusters through the study


Randomised (n = 12)

Allocated to experimental arm (n = 10)

Allocated to
control arm (n = 2)

Hospital 1
(n = 12)*

Hospital 2
(n = 16)*

Hospital 3
(n = 12)*

Hospital 1

Hospital 4
(n = 13)*

Hospital 5
(n = 17)*

Hospital 6
(n = 14)*

Hospital 2

Hospital 7
(n = 2)*

Hospital 8
(n = 2)*

Hospital 9
(n = 7)*

Hospital 10
(n = 4)*

2638

(n = 45)*

(n = 69)*

*= Number of participants in
each cluster

Figure 3 Flow of clusters through the


study.

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

Clinical issues

Prevention of pressure ulcers

Flow of participants through the study

Assessed for eligibility (n = 270)


Excluded (n = 57)
Not meeting inclusion criteria (n = 20)
Refused to participate (n = 21)
Other reasons (n = 16)

Randomised (n = 213)

Figure 4 Flow of participants through the


study.

Allocated to control arm (n = 114)


Did not receive intervention (n = 2)

Allocated to experimental arm (n = 99)


Did not receive intervention (n = 8)

Lost to follow up (n = 0)
Discontinued (n = 3)

Lost to follow up (n = 0)
Discontinued (n = 3)

Analysed (n = 114)
Excluded from analysis (n = 0)

Analysed (n = 99)
Excluded from analysis (n = 0)

Chi-squared analysis did not identify any statistical difference between the groups for age, sex and Braden activity scores;
however, a statistically significant association was noted for
Braden mobility scores, with more of the experimental group
noted to be bed-fast (20 experimental group, eight control
group; v2 = 8067; p = 0005; ICC = 0005). Similarly, a
statistically significant association for MUST scores was noted,
with more of the control group scoring high risk (one
experimental group, 15 control group; v2 = 17776;
p 00001; ICC = 0005). However, no statistical association
between MUST score and pressure ulcer development was
noted during the study (v2 = 0174; p = 0917; ICC = 0005).
Six patients died during the study period, three patients in
each of the study groups. Two individuals randomised to the
control group and eight patients randomised to the experimental group did not participate in the study although
consent to participate was received. Chi-squared analysis
identified no statistically significant association between the
study groups and failure to participate in the study
(v2 = 360; p = 058; ICC = 0001).

Table 2 The size of the clusters and the


number of pressure ulcers that developed in
each cluster

Incidence of pressure ulcers


Three patients in the experimental group and 13 patients in
the control group developed a pressure ulcer during the study
period (p = 0035; 95% CI 00310038; ICC = 0001).
Table 2 outlines the size of the clusters and the numbers of
pressure ulcers in each cluster. The incidence of pressure
ulcers was 11% in the control group and 3% in the
experimental group (incidence rate ratio 027, 95% CI
008093, p = 0038, ICC 0001). This yields a preventable
fraction of 73% (95% CI 94922%). The OR of pressure
ulcer development in the experimental group was 0243 (95%
CI 00670879; p = 0034). The clustering effect in the trial
data was negligible; with a Kish design effect (DEFF) of 102
in respect of the incidence of pressure ulcers. The Kish design
effect is the ratio between the variance of an estimator made
without taking clustering into account and the same variance
calculated taking clustering into account. In this case, the
value is very close to 1, indicating that the clustering has little
effect on the effect size estimates.

Cluster number
1
Pressure ulcer developed
during the study yes
Pressure ulcer developed
during the study no
Total

10

11

12

Total

10

16

11

16

11

13

16

14

42

59

197

12

16

12

13

17

14

45

69

213

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

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Z Moore et al.

Among study participants who did not have a pressure


redistribution device in use on the chair, no patient developed
a pressure ulcer. Of those who did not have pressure
redistribution device in use on the bed, two patients in the
control group developed a pressure ulcer, whereas no patient
in the experimental group developed a pressure ulcers. Chisquare analysis identified no statistically significant relationship between the use of a pressure redistribution device in the
bed or the chair and the number of pressure ulcers that
developed (p = 066 and p = 057 respectively).
Sixteen pressure ulcers developed during the study, of these
seven were classified as grade 1, and of these, six were in the
control group and one was in the experimental group. Nine
pressure ulcers were classified as grade 2 and of these seven
were in the control group and two were in the experimental
group. Ninety-four per cent of pressure ulcers were located
on the sacrum/buttocks. One pressure ulcer was located on
the knee, with no pressure ulcer located on the heels. In the
experimental group, the mean time to pressure ulcer development was 26 days (range three days). In the control group,
the mean time to pressure ulcer development was 17 days
(range 24 days).
To analyse which risk factor most closely predicts pressure
ulcer development, standard multiple regression analysis was
conducted, using the enter method, with grade of pressure
ulcer as the dependent variable. The results of the analysis
show that mobility and activity were the highest predictors of
pressure ulcer development, and this finding was noted to be
statistically significant (b = 0246, 95% CI = 0.319 to
0066; p = 0003); (b = 0227, 95% CI = 00410246;
p = 0006), respectively (Table 3).

Discussion
The demographic profile of the participants in this study is
similar to that of two previous studies (Defloor et al. 2005,
Vanderwee et al. 2007b). In both of these studies (Defloor
et al. 2005, Vanderwee et al. 2007b), the majority of
participants were women, with an average age of 85 or

Table 3 Multiple regression analyses: risk factors for pressure ulcer


development

Mobility
Activity

2640

Unstandardised
coefficients

Standardised
coefficients

SE
0192 0064
0143 0052

95% CI for B
t-test

0246
0227

Sig

2996 0003
2769 0006

Upper Lower
0319
0041

0066
0246

87 years and were residing in a long stay setting. Similarly, in


this study, the majority of participants were women and aged
between 8089 years.
In this study, the highest predictors of pressure ulcer
development were mobility and activity scores. No relationship between the other components of the Braden scale and
pressure ulcer development was noted. These findings concur
with those of Nixon et al. (2000), Mino et al. (2001),
Berlowitz et al. (2001), Papanikolaou et al. (2003), Lindgren
et al. (2004), Keelaghan et al. (2008), Mertens et al. (2008)
and Kottner et al. (2009).
In this study, all pressure ulcers were grade 1 or grade 2
damage, and 96% were located on the sacrum. The location
of pressure ulcers reflects that previously reported in the
international literature (Davis & Caseby 2001, Bours et al.
2002, Lahmann et al. 2006, Capon et al. 2007, Vanderwee
et al. 2007b, Keelaghan et al. 2008, Paquay et al. 2008).

The effect of repositioning on pressure ulcer incidence


The incidence of pressure ulcers in this study was 11% in the
control group and 3% in the experimental group (p = 0035;
95% CI 00310038; ICC = 0001). This incidence included
pressure ulcers of EPUAP grades 14 (Defloor & Schoonhoven 2004). Defloor et al. (2005) found that the incidence of
pressure ulcers (grade 14) (EPUAP) among those repositioned every four hours was 424 and 46% for those
repositioned every six hours. However, the authors (Defloor
et al. 2005) excluded grade 1 pressure ulcers in the presentation of the main study findings, thus report an incidence of
3% (four-hourly turning) and 159% (six-hourly turning),
compared with 20% in the standard care group. Vanderwee
et al. (2007b) only reported pressure ulcers of grade 2 or
greater (EPUAP) and identified the incidence as 164% in the
experimental group and 212% in the control group.
Excluding grade 1 pressure ulcers in this study analysis, the
incidence is 2% in the experimental group and 6% in
the control group. However, this was not the intention at
the outset of this study, and as such the data are presented to
include grade 1 pressure ulcer damage.
The role of repositioning has been discussed in the
literature for centuries, with the first recording being that of
Robert Graves in 1848 (Sebastian 2000). Although it makes
logical sense that repositioning will make a difference to
pressure ulcer incidence, the challenge lies in determining
how the patient should be repositioned and how often the
position be altered. In the strive for evidence-based practice,
the role of repositioning does not fit well as there is a clear
lack of scientific evidence available to support its practice.
There are only two studies that have explored its role in

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

Clinical issues

prevention in the clinical setting (Defloor et al. 2005,


Vanderwee et al. 2007b) and none that have determined its
effect in treatment (Moore & Cowman 2009). The two
studies of prevention have methodological issues, such as
confounding extraneous variables that may be exerting an
effect and similarities between the control and experimental
groups, which influence the confidence that one may have on
the study outcomes.
The findings of this study adds to the existing evidence base
and support the recommendations of the international
pressure ulcer prevention guidelines (EPUAP & NPUAP
2009) and also enhance the drive for repositioning individuals at risk of pressure ulcers. In this study with the use of the
30 tilt with a three-hourly repositioning schedule, a reduction in pressure ulcers of 67% was realised. It is therefore
reasonable to suggest that repositioning has a valuable
contribution to make in the development of effective pressure
ulcer prevention strategies.

Limitations of the study


There were limitations attached to the study including the
final sample size and the variance in the sizes of the clusters.
An adequate sample size is considered to be a key quality
marker in clinical trials (Eldridge et al. 2008). The target of
398 participants in each arm of the study was difficult to
achieve for several extraneous reasons. Despite these challenges, 213 participants were recruited to the study. This
study is pragmatic in nature; thus, it is reflective of circumstances encountered in daily clinical practice. The study,
although recruiting less than the target sample, shows a
significant treatment benefit; however, the associated confidence intervals are wide.
An imbalance between the sizes of the clusters is not
unique to this study and has been alluded to in the literature
as being a challenge with cluster randomisation (Klar &
Donner 2001). In the present study, randomisation of the
study sites was based on the size of the sites, where the
statistician considered both large and smaller unit sizes in
the allocation to study group. However, for the reasons
alluded to above, the study sites did not always yield the
expected numbers, resulting in an imbalance in the sizes of
the clusters. The imbalance between cluster sizes would be
more relevant if there were a significant clustering effect.
The complete absence of such an effect is probably
attributable to the uniform patient mix and management
policy in the centres.

Prevention of pressure ulcers

Conclusions and recommendations


Pressure ulcers are common, costly and impact negatively
on health-related quality of life. Immobility is the key risk
factor that predisposes an individual to the development of
pressure ulcers, thus interventions to combat this risk need to
be focussed initially on mobility. Adopting the 30 tilt and
three-hourly repositioning has shown to make a statistically
significant difference to pressure ulcer incidence compared
with standard care and would prevent roughly three-quarters
of pressure ulcers. Pressure ulcers remain a significant
problem; therefore, it is contended that it is now time to
reconsider our prevention practices to reduce the prevalence
and incidence of what is considered to be largely a preventable problem.

Relevance to clinical practice


Individuals will not develop pressure ulcers unless they are
exposed to pressure. Poor mobility is the prime factor that
exposes the individual to pressure and as such to the risk of
tissue damage. Targeting the primary risk factor may lead to
improvements in clinical outcomes. The 30 tilt, three-hourly
repositioning has been shown to result in better outcomes in
terms of pressure ulcer incidence. Thus, this method of
repositioning appears to be a low technological yet effective
method of pressure ulcer prevention. The findings from the
study have significance for clinical practice; in that, they
support the recommendations of the EPUAP/NPUAP 2009
pressure ulcer prevention guidelines.

Acknowledgements
This study was funded by a Health Research Board of Ireland
Clinical Nursing & Midwifery Research Fellowship. The
authors are grateful to the participants for enabling this study
to be conducted. The authors are also grateful to the staff in
the clinical sites for giving of their time so freely.

Contributions
Study design: ZM, SC, RC; data collection and analysis: ZM,
SC, RC and manuscript preparation: ZM, SC, RC.

Conflict of interest
The authors have no conflicts of interest to declare.

 2011 Blackwell Publishing Ltd, Journal of Clinical Nursing, 20, 26332644

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Z Moore et al.

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