Turning And Repositioning To Reduce Pressure Injuries
The guidelines and formatting for this paper is attached as well as 4 articles being used. Below is the PICOT question that is used.
P : Hospitalized patients
I : Turning and repositioning
C (OPTIONAL) : N/A
0 : Reduce pressure injuries
T (OPTIONAL) : N/A
Clinical Question:
In hospitalized patients, does turning and repositioning reduce the risk of pressure injuries?
Gwynedd Mercy University
Frances M. Maguire School of Nursing and Health Professions
NUR 231 Evidence-Based Practice in Nursing
Evidence-Based Practice Paper Guidelines
EBP requires nurses to continuously cultivate a spirit of inquiry. Nurses must identify and appraise the most relevant and best evidence to integrate the evidence into clinical practice. Students will identify and discuss suggested best practice related to an identified clinical issue/problem.
1. Students may work individually or with a partner on this assignment (limit to one partner). One paper submitted per partnership.
2. Using the PICOT question developed in class, perform a search for research studies from professional, scholarly journals (nursing journals preferred) and/or best-practice guidelines from professional organizations.
3. Select at least four studies or guidelines that discuss evidence-based practice related to the specific PICOT question, published within the past 10 years. Do not use an article that is a literature review, synthesis or meta-analysis (consult with Professor Lynn or the research librarian if you have questions or need assistance).
4. Complete the Literature Review Template for the selected sources. This information will form the basis of the written assignment.
Paper:
5. Introduce the nursing problem. Provide a clear and concise description of the clinical practice issue/problem. Discuss the reason this topic is important to nursing practice (significance).
6. Translate the clinical nursing practice issue/problem into an investigational question. Identify each component of the PICOT question. The question must include all PICOT components.
7. Provide a discussion of each article, including the clinical problem and relevant background for the focus of the study/guideline.
a. If the source discusses a research study, include the research question (purpose), type of study (quantitative or qualitative) and results/conclusions (suggested strategies).
b. If the source discusses an evidence-based practice guideline, summarize the guideline (suggested strategies).
8. Describe potential barriers to implementing the research/guideline suggestions.
9. Identify potential strategies to address the barriers.
10. This paper must be written following APA guidelines, Times New Roman 12 double spaced. Include a reference list. Proper grammar, spelling and professional word choice is mandatory.
11. The body of the paper is not to exceed 6 pages.
12. Papers will be submitted through SafeAssign in Blackboard.
13. Refer to the Grading Criteria Rubric posted in Blackboard and the Course Polices in the syllabus.
Evidence-Based Practice Paper Format
· Title Page
· Abstract: Brief summary of the key points of the paper. No need for keywords.
· Introduction: Provide a clear and concise description of the clinical practice issue/problem and background. Discuss the reason this topic is important to nursing practice (significance) and include a minimum of one reference for your reasoning. Identify the PICOT question at the end of the Introduction, , including all PI(C)O(T) components.
· Review of Literature: Address the required content for each study/guideline. Try to make use of transitional sentences between the discussion of each resource.
· Summary of suggested best practices as identified by authors.
· Barriers: Identify potential barriers to implementation of the best-practice recommendations in the articles.
· Strategies: Identify potential strategies to address the barriers.
· Conclusion
· References
APA format: Make use of the library resources! See APA Style Guide and sample paper on the library’s webpage.
Headings are optional, but if you decide to use them, be certain to consult the APA Style Guide.
No first person, no pronouns.
Citations for a direct quote must have page number.
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Cochrane Database of Systematic Reviews
Repositioning for pressure ulcer prevention in adults (Review)
Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L
Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L.
Repositioning for pressure ulcer prevention in adults.
Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD009958.
DOI: 10.1002/14651858.CD009958.pub2.
www.cochranelibrary.com
Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
http://www.cochranelibrary.com
T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
18DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 2h versus 3h repositioning on standard hospital mattresses, Outcome 1 Pressure ulcer risk
(category 1 to 4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Analysis 1.2. Comparison 1 2h versus 3h repositioning on standard hospital mattresses, Outcome 2 Pressure ulcer risk
(category 2 to 4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Analysis 2.1. Comparison 2 4h versus 6h repositioning on viscoelastic foam mattresses, Outcome 1 Pressure ulcer risk
(category 1 to 4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Analysis 2.2. Comparison 2 4h versus 6h repositioning on viscoelastic foam mattresses, Outcome 2 Pressure ulcer risk
(category 2 to 4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Analysis 3.1. Comparison 3 30o tilt 3-hourly overnight versus 90o tilt overnight, Outcome 1 Pressure ulcer risk (category 1
to 4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
36APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
41WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
43INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iRepositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]
Repositioning for pressure ulcer prevention in adults
Brigid M Gillespie1, Wendy P Chaboyer1, Elizabeth McInnes2 , Bridie Kent3, Jennifer A Whitty4, Lukman Thalib5
1NHMRC Centre of Research Excellence in Nursing, Centre for Health Practice Innovation, Menzies Health Institute Queensland,
Griffith University, Brisbane, Australia. 2Nursing Research Institute, St Vincent’s Health Australia (Sydney) and Australian Catholic
University (ACU), School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Darlinghurst, Australia. 3School
of Nursing and Midwifery, Deakin Centre for Quality and Risk Management, Deakin University, Melbourne, Burwood, Australia. 4School of Pharmacy, The University of Queensland, Brisbane, Australia. 5Department of Community Medicine, Kuwait University,
Safat, Kuwait
Contact address: Wendy P Chaboyer, NHMRC Centre of Research Excellence in Nursing, Centre for Health Practice Innovation,
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. w.chaboyer@griffith.edu.au.
Editorial group: Cochrane Wounds Group.
Publication status and date: New, published in Issue 4, 2014.
Review content assessed as up-to-date: 6 September 2013.
Citation: Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults.
Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD009958. DOI: 10.1002/14651858.CD009958.pub2.
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
A pressure ulcer (PU), also referred to as a ’pressure injury’, ’pressure sore’, or ’bedsore’ is defined as an area of localised tissue damage
that is caused by unrelieved pressure, friction or shearing forces on any part of the body. PUs commonly occur in patients who are
elderly and less mobile, and carry significant human and economic impacts. Immobility and physical inactivity are considered to be
major risk factors for PU development and the manual repositioning of patients in hospital or long-term care is a common pressure
ulcer prevention strategy.
Objectives
The objectives of this review were to:
1) assess the effects of repositioning on the prevention of PUs in adults, regardless of risk or in-patient setting;
2) ascertain the most effective repositioning schedules for preventing PUs in adults; and
3) ascertain the incremental resource consequences and costs associated with implementing different repositioning regimens compared
with alternate schedules or standard practice.
Search methods
We searched the following electronic databases to identify reports of the relevant randomised controlled trials: the Cochrane Wounds
Group Specialised Register (searched 06 September 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013,
Issue 8); Ovid MEDLINE (1948 to August, Week 4, 2013); Ovid EMBASE (1974 to 2013, Week 35); EBESCO CINAHL (1982 to
30 August 2013); and the reference sections of studies that were included in the review.
Selection criteria
Randomised controlled trials (RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different
patient positions and measured PU incidence in adults in any setting.
1Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
mailto:w.chaboyer@griffith.edu.au
Data collection and analysis
Two review authors independently performed study selection, risk of bias assessment and data extraction.
Main results
We included three RCTs and one economic study representing a total of 502 randomised participants from acute and long-term care
settings. Two trials compared the 30º and 90º tilt positions using similar repositioning frequencies (there was a small difference in
frequency of overnight repositioning in the 90º tilt groups between the trials). The third RCT compared alternative repositioning
frequencies.
All three studies reported the proportion of patients developing PU of any grade, stage or category. None of the trials reported on pain,
or quality of life, and only one reported on cost. All three trials were at high risk of bias.
The two trials of 30º tilt vs. 90º were pooled using a random effects model (I² = 69%) (252 participants). The risk ratio for developing
a PU in the 30º tilt and the standard 90º position was very imprecise (pooled RR 0.62, 95% CI 0.10 to 3.97, P=0.62, very low quality
evidence). This comparison is underpowered and at risk of a Type 2 error (only 21 events).
In the third study, a cluster randomised trial, participants were randomised between 2-hourly and 3-hourly repositioning on standard
hospital mattresses and 4 hourly and 6 hourly repositioning on viscoelastic foam mattresses. This study was also underpowered and at
high risk of bias. The risk ratio for pressure ulcers (any category) with 2-hourly repositioning compared with 3-hourly repositioning
on a standard mattress was imprecise (RR 0.90, 95% CI 0.69 to 1.16, very low quality evidence). The risk ratio for pressure ulcers
(any category) was compatible with a large reduction and no difference between 4-hourly repositioning and 6-hourly repositioning on
viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02, very low quality evidence).
A cost-effectiveness analysis based on data derived from one of the included parallel RCTs compared 3-hourly repositioning using the
30º tilt overnight with standard care consisting of 6-hourly repositioning using the 90º lateral rotation overnight. In this evaluation
the only included cost was nursing time. The intervention was reported to be cost saving compared with standard care (nurse time cost
per patient EURO206.6 vs EURO253.1, incremental difference EURO-46.5; 95%CI: EURO-1.25 to EURO-74.60).
Authors’ conclusions
Repositioning is an integral component of pressure ulcer prevention and treatment; it has a sound theoretical rationale, and is widely
recommended and used in practice. The lack of robust evaluations of repositioning frequency and position for pressure ulcer prevention
mean that great uncertainty remains but it does not mean these interventions are ineffective since all comparisons are grossly under-
powered. Current evidence is small in volume and at risk of bias and there is currently no strong evidence of a reduction in pressure
ulcers with the 30° tilt compared with the standard 90º position or good evidence of an effect of repositioning frequency. There is a
clear need for high-quality, adequately-powered trials to assess the effects of position and optimal frequency of repositioning on pressure
ulcer incidence.
The limited data derived from one economic evaluation means it remains unclear whether repositioning every 3 hours using the 30º
tilt is less costly in terms of nursing time and more effective than standard care involving repositioning every 6 hours using a 90º tilt.
P L A I N L A N G U A G E S U M M A R Y
Repositioning to prevent pressure ulcers
Pressure ulcers, also called pressure injury, pressure sores, decubitus ulcers and bed sores are caused by pressure, rubbing or friction at
the weight-bearing bony points of the body (such as hips, heels and elbows). A pressure ulcer is characterised by an area of localised
injury to the skin or underlying tissue over a bony prominence that results from pressure or shearing, or a combination of both. Pressure
ulcers most commonly occur in the elderly, or those who are immobile, either when in bed or sitting. Repositioning (i.e. turning) is one
strategy used alongside other preventative strategies to relieve pressure, and so prevent development of pressure ulcers. Repositioning
involves moving the person into a different position to remove or redistribute pressure from a particular part of the body.
We identified three studies which recruited 502 people. Evidence to support the use of repositioning to prevent pressure ulcers is low in
volume and quality and we still do not know if particular positions or frequencies of repositioning reduce pressure ulcer development.
None of the trials reported on pain or quality of life. There is a need for further research to measure the effects of repositioning on pressure
ulcer development and to find the best repositioning regimen in terms of frequency and position. It is important to emphasise that this
2Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
lack of evidence showing that repositioning is effective or which repositioning regimen is the best does not mean that repositioning is
ineffective.
B A C K G R O U N D
Description of the condition
A pressure ulcer (PU) (also known as pressure sore, pressure in-
jury, or bedsore) is “a localised injury to skin or underlying tissue
usually over a bony prominence as a result of pressure or pressure
in combination with shear” (European Pressure Ulcer Advisory
Panel 2009; NPUAP 2009). PUs occur when the soft tissue is
compressed between a bony prominence and an external surface
for a prolonged period of time.
PU classification systems provide an accurate and consistent means
by which the severity and level of tissue injury of a PU can
be described and documented (Australian Wound Management
Association 2011).The words ’stage’ (European Pressure Ulcer
Advisory Panel 2009), ’grade’, and ’category’ are used interchange-
ably to describe the levels of soft-tissue injury. The original stag-
ing system includes Stages 1 to 4. Stage 1 reflects persistent
non-blanching erythema (redness) of the skin (Australian Wound
Management Association 2011; European Pressure Ulcer Advisory
Panel 2009). Stage 2 involves partial-thickness skin loss (epi-
dermis and dermis). Stage 3 reflects full-thickness skin loss in-
volving damage, or necrosis, of subcutaneous tissue, whereas in
Stage 4 the damage extends to the underlying bone, tendon or
joint capsule. However, more recently, two additional classifica-
tions have been identified, namely: ’unclassified/unstageable’ and
’deep tissue injury’ (Australian Wound Management Association
2011; European Pressure Ulcer Advisory Panel 2009; National
Pressure Ulcer Advisory Panel 2007). PUs are associated with pain,
an increased risk of infection and sepsis, longer hospital stays,
higher hospitalisation costs and mortality (Institute for Healthcare
Improvement 2008; Thomas 1996).
Despite a general consensus that PUs are preventable (Brandeis
2001), hospital-acquired PUs are among the top five adverse events
reported. Estimates of PU incidence in hospitalised patients have
ranged from less than 3% to over 30% (Nixon 2006;Queensland
Health 2008 Mulligan 2011,Schuurman 2009). Costs of treating
PUs vary globally, but represent a considerable financial burden
on hospital budgets wherever they occur. Costs to the Australian
healthcare system have been estimated at AUD 285 million per
annum (Mulligan 2011). The total cost for treatment of PUs in
the UK was GBP 1.4 billion to GBP 2.1 billion annually (4%
of total National Health Service’s expenditure) (Bennett 2004),
whilst the total cost in the US was estimated at USD 11 billion
per year (Institute for Healthcare Improvement 2008). Much of
this cost is allocated to nursing time (Bennett 2004).
Immobility and physical inactivity are considered to be major risk
factors for PU development in hospitalised patients (Allman 1995;
Institute for Healthcare Improvement 2008; Lindgren 2004),
however, the aged and individuals who have severely compromised
states of health are particularly at risk (Institute for Healthcare
Improvement 2008). For example, of the 3.55 million hospital
admissions in Australia each year (excluding day cases), 50% of pa-
tients will be at risk of PUs and 10% or more will develop an ulcer
(Queensland Health 2009). Screening tools based on individuals’
levels of activity and mobility scores have been widely used for
the assessment of PU risk (Braden 2005; Jalali 2005; Thompson
2005). Various interventions are in use and believed to reduce
the incidence of PUs with varying levels of supporting evidence
including different mattresses and overlays (Nixon 2006; Reddy
2006; Vanderwee 2005) and regular position changes (Buss 2002;
Krapfl 2008; Reddy 2006).
Description of the intervention
Repositioning (i.e. turning people to change their body position to
relieve or redistribute pressure) has long been a fundamental com-
ponent of pressure ulcer prevention (PUP). Manual repositioning
regimens are used in PU risk-prevention programs to re-distribute
pressure between the body and the support surface (Manorama
2010).The 90o lateral position has been shown in laboratory stud-
ies to decrease blood flow and transcutaneous oxygen tension close
to anoxic levels (extremely low levels of oxygen) and to increase
interface pressure. Conversely, this appears not to be the case when
the patient is placed in a 30o lateral inclined tilt position. Repo-
sitioning is regarded as also important for the prevention of other
complications associated with prolonged immobility such as pneu-
monia, joint contractures, and urinary tract infections.
Best practice guidelines developed in Europe, USA and Aus-
tralia advocate routine repositioning of people at risk of PUs.
These guidelines commonly advocate two-hourly repositioning
(Australian Wound Management Association 2011; Defloor 2000;
European Pressure UlcerAdvisory Panel 1998; Queensland Health
2009). These recommendations appear to be based on small stud-
ies (not RCTs) conducted 20 or more years ago, that either com-
pared different repositioning schedules or repositioning schedules
3Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
with no manual repositioning (spontaneous body movements)
(Exton-Smith 1961; Norton 1962; Palmen 1987; Smith 1990).
The usefulness of these studies for today’s decision making is fur-
ther compromised since the standard of hospital mattresses has
greatly improved since then.
How the intervention might work
Pressure, from lying or sitting on a particular part of the body
results in oxygen deprivation to the particular area (Defloor 2000).
Normally, this results in pain and discomfort, which stimulates
the person to change position. However, if the person is unable
to reposition themselves, or has impaired sensation and therefore
does not experience the discomfort, assistance will be required.
Repositioning reduces the duration of pressure experienced by
the tissues and so decreases tissue hypoxia (Catania 2007) and
consequently the theoretical risk of pressure ulceration (Braden
1987).
Negative aspects of frequent repositioning
Whilst frequent repositioning underpins current practice guide-
lines, it may also be associated with negative consequences for pa-
tients, nursing staff and health care (Australian Institute of Health
and Welfare 2009; Bureau of Labor Statistics 2002; Carskadon
2005; Dawson 2007; Humphries 2008; Raymond 2004; Vieira
2009). Repositioning can lead to disruption of sleep, particularly
sleep fragmentation (Humphries 2008). In acutely ill people, dis-
ruption of sleep can lengthen recovery, suppress immune function
and predispose people to infection (Carskadon 2005; Raymond
2004). A sleep cycle, which has light and deep stages of sleep, oc-
curs about every 90 minutes. Consequently if repositioning is un-
dertaken every two hours, it may result in fragmentation of sleep
at a detrimental stage of the sleep cycle (Dawson 2007).
Other negative effects of repositioning include possible increases
in patients’ pain perception. Although regular movement is impor-
tant, unnecessary repositioning may cause increased discomfort
for people with wounds, stiff joints, bony pain or contractures.
In addition to people experiencing the negative effects of reposi-
tioning, nurses experience musculoskeletal disorders at a rate ex-
ceeding that of workers in construction, mining, and manufactur-
ing (Bureau of Labor Statistics 2002). These injuries are attributed
partly to repeated manual patient-handling activities, often asso-
ciated with repositioning patients and working in extremely awk-
ward positions (Bureau of Labor Statistics 2002; Vieira 2009).
Back pain and injury have a major impact on the efficiency of the
nursing workforce (Trinkoff 2001). Registered nurses rank seventh
across all occupations for back injuries involving days away from
work in private industry (Bureau of Labor Statistics 2002). Back
injuries and the resultant workers’ compensation claims for nurses
are expensive (Dawson 2007). For example, injuries in the health-
care sector cost Australia over AUD 4.3 billion in 2005 to 2006
(Australian Safety and Compensation Council 2009). Reducing
the amount of manual handling undertaken by nurses when repo-
sitioning patients could have major nursing and hospital benefits.
Why it is important to do this review
PUs may be painful, distressing and life-threatening (causing in-
fection, sepsis and even death), yet many are preventable (Allman
1997; Schuurman 2009). Manual repositioning regimens are used
in PU risk-prevention programs to alternate areas of pressure dis-
tribution between the body and the support surface, including
when sitting or lying in a chair (Manorama 2010). These strate-
gies have major implications for repositioning hospitalised patients
and warrant investigation.
Whilst the potential negative aspects of repositioning have been
described, the magnitude of any benefits are also uncertain, as is
the optimum frequency of repositioning and the best position.
It is noteworthy that, more recently, the National Pressure Ulcer
Advisory Panel 2007 and the European Pressure Ulcer Advisory
Panel 2009 Guidelines did not advocate 2-hourly repositioning
as best practice due to a lack of empirical evidence. A rigorous
systematic review is required to summarise current evidence for
the effects of repositioning of adults, the optimal repositioning
schedules, and to ensure that future trials are based on the best
available evidence.
O B J E C T I V E S
The objectives of this review were to:
1. assess the effects of repositioning on the prevention of PUs
in adults, regardless of risk or in-patient setting;
2. ascertain the most effective repositioning schedules for
preventing PUs in adults; and
3. ascertain the incremental resource consequences and costs
associated with implementing different repositioning regimens
compared with alternate schedules or standard practice.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Any RCT that used a method of random allocation of adult pa-
tients (without an existing PU at baseline) between two or more
4Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
alternative repositioning interventions for PU prevention was el-
igible. We also included cluster-RCTs, irrespective of the cluster
group (i.e. patient, nurse, hospital). We excluded cross-over trials
(even if randomised) and quasi-randomised studies, i.e. studies
where treatment allocation was, for example, alternate or by date
of birth.
The review of health economic evidence included comparative
full and partial economic evaluations conducted within the frame-
work of eligible RCTs (i.e. cost-effectiveness analyses, cost-utility
analyses, cost-benefit analyses and cost-analyses of a repositioning
intervention and a relevant comparator), as well as RCTs report-
ing more limited information, such as estimates of resource use or
costs associated with repositioning and a comparator. The review
considered only health economics studies conducted alongside ef-
fectiveness studies included in the effectiveness component of the
review.
Types of participants
Any adult, without an existing PU, admitted to any healthcare or
long-term care setting.
Types of interventions
We anticipated that likely comparisons would include reposition-
ing regimens compared with other standard practices or with al-
ternative repositioning regimens. We included studies evaluating
the following comparisons:
1. Comparisons between the frequencies of repositioning, for
example 2-hourly turning, 3-hourly turning, 4-hourly turning
etc. where the only systematic difference between groups was the
frequency of repositioning.
2. Comparisons between different positions for repositioning,
for example chair positioning, 30o recumbent tilt versus 90o
lateral rotation, where the only systematic difference between
groups was the positioning.
3. Comparisons of the repositioning regimen with standard
practice (as defined by the author(s)).
Types of outcome measures
Primary outcomes
The proportion of participants with a new PU of any stage,
grade,or category using previously defined criteria (European
Pressure Ulcer Advisory Panel 1998; European Pressure Ulcer
Advisory Panel 2009; National Pressure Ulcer Advisory Panel
2007), or however defined by the trial authors, anywhere on the
body following recruitment into the study. We excluded trials
where the unit of analysis was the PU and not the person or group.
Secondary outcomes
1. Health-related quality of life (HRQoL) including utility
scores (however reported by the author(s)).
2. Procedural pain (however reported by the author(s)).
3. Patient satisfaction (however reported by the author(s)).
4. Cost including: costs of PU prevention; costs of related
health practitioner time or visits; costs avoided by PU prevention
(e.g. treatment costs per patient per PU wound; costs to treat
adverse events, infections or complications of PU; duration or
costs of hospital stay for PU wound healing, adverse events and
complications; indirect costs to society associated with PU such
as lost productivity).
5. Incremental cost per event avoided, such as per additional
PU prevented; incremental cost per life year gained; incremental
cost per quality adjusted life year (QALY) gained, and cost-
benefit ratio.
Search methods for identification of studies
Electronic searches
We searched the following electronic databases to identify reports
of relevant RCTs:
1. The Cochrane Wounds Group Specialised Register
(searched 06 September 2013);
2. The Cochrane Central Register of Controlled Trials
(CENTRAL) (2013, Issue 8);
3. Ovid MEDLINE (1948 to August, Week 4, 2013);
4. Ovid MEDLINE (In-Process & Other Non-Indexed
Citations September 04, 2013);
5. Ovid EMBASE (1974 to 2013 Week 35);
6. EBSCO CINAHL (1982 to 30 August 2013).
We searched the Cochrane Central Register of Controlled Trials
(CENTRAL) using the following exploded MeSH headings and
keywords:
#1 MeSH descriptor Pressure Ulcer explode all trees
#2 pressure NEXT (ulcer* or sore*):ti,ab,kw
#3 decubitus NEXT (ulcer* or sore*):ti,ab,kw
#4 (bed NEXT sore*) or bedsore*:ti,ab,kw
#5 (#1 OR #2 OR #3 OR #4)
#6 MeSH descriptor Posture explode all trees
#7 (reposition* or re-position*):ti,ab,kw
#8 position*:ti,ab,kw
#9 (turn* NEAR/5 patient*):ti,ab,kw
#10 (turn* NEAR/5 interval*):ti,ab,kw
#11 (turn* NEAR/5 frequen*):ti,ab,kw
#12 (body NEAR/5 postur*):ti,ab,kw
#13 turning:ti,ab,kw
#14 (pressure NEXT relie*):ti,ab,kw
#15 (mobilis* or mobiliz*):ti,ab,kw
5Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
#16 (#6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12
OR #13 OR #14 OR #15)
#17 (#5 AND #16).
We adapted this strategy to search Ovid MEDLINE, Ovid EM-
BASE and EBSCO CINAHL (See Appendix 1). We combined
the Ovid MEDLINE search with the Cochrane Highly Sensi-
tive Search Strategy for identifying randomised trials in MED-
LINE: sensitivity- and precision-maximising version (2008 revi-
sion) (Lefebvre 2011). We combined the EMBASE and CINAHL
searches with the trial filters developed by the Scottish Intercolle-
giate Guidelines Network (SIGN 2011).
We conducted separate searches to identify economic studies in
the following databases:
1. NHS Economic Evaluation Database (2013, Issue 8);
2. Ovid MEDLINE (In-Process & Other Non-Indexed
Citations August, week 4, 2013);
3. Ovid EMBASE (1948 to 2013 week 35);
4. EBSCO CINAHL (1982 to 30 August 2013);
5. EURONHEED (http://infodoc.inserm.fr/euronheed/);
6. Health Economics Evaluations Database HEED (http://
onhttp://onlinelibrary.wiley.com/book/).
We used the economics search strategy shown in Appendix 2 to
search Ovid MEDLINE and adapt this strategy to search other
databases.
We also searched the following clinical trials registries for details
of relevant protocols and contacted the relevant research teams in
November 2012:
1. Clinical trials.gov;
2. International Clinical Trials Registry Platform search Portal;
3. Australian and New Zealand Clinical Trials Registry;
4. Current Controlled Trials.
We did not restrict searches by language, study setting, date of
publication or publication status. We made every effort to obtain
translations of papers that were not published in English.
Searching other resources
We searched the reference lists of included studies and any sys-
tematic reviews identified by the search process and contacted cor-
responding authors of identified studies. Where appropriate, we
contacted experts in the field (e.g. council members of the Euro-
pean Wound Management Association, the National Pressure Ul-
cer Advisory Panel, the World Union of Wound Healing Societies,
and the Australian Wound Management Association) to ask for
information about any unpublished studies. We included confer-
ence proceedings or programme abstracts in our search. Where we
were unable to obtain details of the full study, we contacted the
author(s).
Data collection and analysis
Selection of studies
Two review authors (BG, EM) independently assessed all titles
and abstracts of studies retrieved from searching. Full reports of all
potentially relevant trials were retrieved for further assessment of
eligibility based on the inclusion criteria. Differences of opinion
were resolved by consensus or referral to a third review author
(WC). We recorded reasons for exclusion and were not blind study
authorship.
Data extraction and management
For eligible studies, two review authors (BG, EM) independently
extracted data using a pre-designed data collection tool while a
third author (WC) adjudicated where there were differences of
opinion. For studies where there was an economic component
included, JW (Health Economist) and BG extracted the relevant
data. We included studies published in duplicate, but extracted
data to ensure that information was not missed and identified
the primary reference for the purpose of this review. If data were
missing from reports, we attempted to contact the trial authors to
obtain the missing information. One review author (BG) entered
the data into Review Manager 5 software (RevMan) and data were
checked for accuracy by EM. Abstracted data included the follow-
ing information.
1. Author, title, journal title, year of publication, country.
2. Healthcare setting.
3. Inclusion/exclusion criteria.
4. Sample size.
5. Patient characteristics by treatment group.
6. Methods (number eligible and randomised, adequacy of
randomisation, allocation concealment, blinding, completeness
of follow-up).
7. Treatment of missing values (e.g. use of intention-to-treat,
per protocol or other imputation method).
8. Intervention details.
9. Types of outcome measures in relation to primary
(percentage of new PU) and secondary outcomes.
10. Analysis; results and conclusions relevant to review.
11. Funding sources.
For economic studies, we planned to extract additional data extract
in relation to the following.
1. Estimates of specific items of resource use per person.
2. Estimates of unit costs (extracted separately to resource use).
3. Price year and currency.
4. Decision-making jurisdiction.
5. Analytic perspective.
6. A point estimate and a measure of uncertainty (e.g.
standard error or confidence interval) for measures of
incremental resource use, costs and cost-effectiveness, if reported.
7. Details of any sensitivity analyses undertaken, and any
information regarding the impact of varying assumptions on the
magnitude and direction of results.
6Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
http://infodoc.inserm.fr/euronheed/
http://infodoc.inserm.fr/euronheed/
http://infodoc.inserm.fr/euronheed/
http://infodoc.inserm.fr/euronheed/
http://onhttp:/onlinelibrary.wiley.com/book/
http://onhttp:/onlinelibrary.wiley.com/book/
http://onhttp:/onlinelibrary.wiley.com/book/
http://onhttp:/onlinelibrary.wiley.com/book/
http://onhttp:/onlinelibrary.wiley.com/book/
http://onhttp:/onlinelibrary.wiley.com/book/
Assessment of risk of bias in included studies
Two review authors independently assessed the risk of bias of el-
igible trials (BG, EM) using The Cochrane Collaboration tool
for assessing risk of bias (Higgins 2011c).This tool addresses six
specific domains; namely sequence generation, allocation conceal-
ment, blinding, incomplete outcome data, selective outcome re-
porting and other issues that may potentially bias the study (see
Appendix 3 for details of the criteria on which the judgments were
based). Items were rated as low risk of bias, high risk of bias or
unclear (unknown) risk of bias. In assessing bias, the review au-
thors were not blinded to the names of trial authors, institutions,
or journals.
In assessing the risk of bias, we distinguished between primary
outcome (proportion of participants with a new PU), secondary
subjective outcomes (HRQoL, procedural pain, patient satisfac-
tion), and the objective economic outcome. As the primary out-
come for this review, regardless of how it was measured, was sub-
ject to potential observer bias, blinding of outcome assessment was
particularly important. We planned to make separate judgements
for secondary outcomes for the domain of incomplete outcome
data. We classified trials as being at overall high risk of bias if they
were rated as ’high’ for any one of three key domains (allocation
concealment, blinding of outcome assessors and completeness of
outcome data).
Disagreements between review authors were resolved by consensus
or referral to another review author (WC). Where there was a
high risk of bias in any of the key domains, we endeavoured to
contact the trial authors, and asked open-ended questions about
the design and conduct of the study. We reported bias, and within
economic evaluations, planned to use the Drummond checklist,
as recommended by The Cochrane Collaboration (Shemilt 2011),
to assess the methodological quality of full and partial economic
evaluations.
We presented an assessment of risk of bias using ’Risk of bias’ sum-
mary figures, which detail all the judgments in a cross-tabulation
of study by entry. This display of internal validity indicates the
weight the reader may give the results of each study. We classified
studies as being at high risk of bias overall if any one of the criteria
was judged to be at high risk of bias. We recorded trials as being
at unclear risk of bias if authors did not report validity criteria.
Measures of treatment effect
We have reported effect estimates for dichotomous outcomes (e.g.
relative proportions of people developing PU during follow up)
as risk ratios (RR) with 95% confidence intervals. RR is the pro-
portion of participants developing PUs in the experimental group
divided by proportion in the control group and indicates the like-
lihood of PU development on the experimental regimen (turning
frequency or position) compared with a standard treatment. We
have used the RR rather than odds ratio (OR), since ORs may be
misinterpreted as RR, and can give an inflated impression of the
effect size when event rates are greater than 20% (Deeks 2002).
We planned to use MD as a summary statistic in meta-analysis
when outcome measurements in all studies were made on the same
scale.
Review of economic evaluations
We planned to present a tabled analysis of economic data in accor-
dance with current guidance on the use of economics methods in
the preparation of Cochrane reviews (Shemilt 2011). We planned
to classify economic evaluations according to the framework in
Drummond 2005, and to assess the methodology using the check-
list published by Drummond and colleagues. We planned to tabu-
late the main characteristics and results of the identified economic
evaluation studies, and to expand these with a narrative descrip-
tion.
For any included studies, given the likely lack of direct compa-
rability in resource use and cost data between different health-
care contexts and settings, we did not intend to pool economic
outcomes. Rather, we planned to incorporate a discussion of key
drivers and impact of assumptions on the available economic eval-
uations, scenarios that are likely to lead to the most and least cost-
effective use of repositioning for PUP, as well as guidance on future
research that might be required to assess the economic value of
repositioning as an intervention for PUP.
Costs
If we found any economic studies, all substantial costs that were
observed to differ between people repositioned for PUP and peo-
ple administered the comparator treatment were intended to be
captured and reported as part of the review of economic evalua-
tions.
We planned to report resource utilisation and unit costs separately,
along with the currency and price year in each original study. These
costs would then be converted to 2012 values by employing a web-
based conversion tool that applies implicit price deflators for gross
domestic product (GDP) of that currency and then converted
into the currency most frequently observed in the articles reviewed
using Purchasing Power Parities (PPP) (Shemilt 2010).
The main costs were likely to be those associated with the devel-
opment of PUs, specialist and other practitioner costs as measured
by time or number of visits, potential cost-savings from a change
in the number of bed days in hospital, and costs stemming from
differing rates of adverse events and complications (including pro-
cedures initiated due to the failure of wounds to heal, such as am-
putation). We planned to identify key cost drivers that would en-
able users of the review to gain a clear understanding of the nature
of resource use associated with repositioning for PUP.
Health state utility weights
7Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
We planned to examine information on the change in HRQoL re-
ported by included trials via utilities measured by a multi-attribute
utility instrument (MAUI) or other approaches (such as the time
trade-off, standard gamble). We planned to assess the utility data
for comparability and representativeness considering issues such
as the stages of PU, the patient populations, timing of the baseline
point and follow-up collection, the MAUI used and the algorithm
for scoring the MAUI. We planned to present a discussion of the
potential impact on HRQoL attributable to the intervention as
part of the review.
Unit of analysis issues
In all trials included in our review, we treated the person as the
unit of analysis and we took into account the level at which ran-
domisation occurred. For a parallel group design, we collected and
analysed a single measurement for each outcome for each person.
In these types of studies, it was possible that the unit of analysis
was the PU rather than the individual person. We considered in-
stances where there were multiple observations per person for the
same outcome. Where this occurred we first used the PU that was
the most advanced in relation to its staging. If this could not be
determined, then we contacted the trial author(s).
For cluster-randomised trials that had not taken clustering into
account in the study analysis, we considered adjusted sample sizes
using the methods described in Chapter 16 of the Cochrane Hand- book for Systematic Reviews of Interventions (Higgins 2011a). How- ever the best estimate of a relevant intraclass correlation coefficient
(ICC) for estimating the design effect was so small (0.001) that
we used the original reported study data without adjustment. This
ICC (0.001) was estimated from a relevant cluster trial (Moore
2011) and identical to that estimated from a falls study (similar
patient group, similar context of care) (Cumming 2008) so we felt
justified in this approach.
Dealing with missing data
If some outcome data remained missing despite our attempts to
obtain complete outcome data from authors, we planned to per-
form an available-case analysis, based on the numbers of people
for whom outcome data were known since this is a more con-
servative approach in this context than using numbers originally
randomised and assuming that losses to follow up did not incur
pressure injury. We also planned to conduct best-case and worst-
case analysis where we needed to test the robustness of findings
to different assumptions about the outcomes of people who did
not contribute endpoint data. If standard deviations (SD) were
missing, we planned to impute them from other studies or, where
possible, computed them from standard errors (SE) using the for-
mula SD = SE x √
N, where these values were available (Higgins
2011a).
Assessment of heterogeneity
We considered clinical and statistical heterogeneity in relation to
the primary outcomes, PU incidence, and secondary outcomes
such as HRQoL patient satisfaction, and procedural pain. For
cluster-trials, we assessed the outcome at the same level as the
group allocation (Deeks 2011).
We assessed clinical heterogeneity by examining the types of par-
ticipants, and/or groups, interventions and their duration, and the
outcomes of each study. If appropriate, we pooled data using meta-
analysis (using RevMan 5). We did not plan to pool studies for
economic outcomes as the variability in, and generalisability of,
these outcomes were considered problematic.
Statistical heterogeneity was assessed visually and by using the Chi 2 statistic with significance being set at P value less than 0.10. In
addition we investigated the degree of heterogeneity by calculating
the I2 statistic (Deeks 2002). The I2 test examines the percentage
of total variation across studies due to heterogeneity rather than
chance. Values over 50% indicate a substantial level of heterogene-
ity. Where appropriate, in the absence of clinical heterogeneity and
in the presence of statistical heterogeneity (I2 greater than 60%),
we used a random effects model, Where studies were sufficiently
similar to consider pooling, we planned to use a fixed effect model
for low to moderate levels of heterogeneity (I2 values between 0%
and under 60%). We did not plan to pool studies where hetero-
geneity exceeded 75% (Higgins 2011b).
Assessment of reporting biases
We planned to assess potential publication bias using funnel plots
and to assess funnel plot asymmetry visually (Sterne 2011).
Subgroup analysis and investigation of heterogeneity
We planned a subgroup analysis, if possible, to examine the effect
of potentially influential factors on outcome, e.g. care setting and
patient characteristics.
Sensitivity analysis
We planned to perform sensitivity analyses where necessary to
test whether findings were robust to the method used to obtain
them, and compared the results of two or more meta-analyses
using different assumptions (Higgins 2011c).
Presentation of results
We planned to include the following primary and secondary out-
comes (both desirable and undesirable) in the summary of find-
ings tables:
1. development of a new PU;
2. HRQoL;
3. pain;
8Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
4. patient satisfaction;
5. costs;
6. incremental cost.
R E S U L T S
Description of studies
See Characteristics of included studies; Characteristics of excluded
studies; and, Characteristics of studies awaiting classification. With
the exception of the TURN trial (Bergstrom), we are not aware of
any relevant ongoing trials (ISRCTN register checked September,
2013).
Results of the search
Interventions search
Electronic searches yielded 258 results of which we excluded 254
because they did not meet one or more of our inclusion criteria.
We retrieved full text versions of the remaining four papers for
inspection, and included three trials in the review (Defloor 2005;
Moore 2011; Young 2004). See Figure 1 study flow diagram. All
the included trials had been published in the last 10 years. One
ongoing study was identified (Bergstrom) which will be considered
for inclusion in the next update of this review.
9Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 1. Study flow diagram for clinical studies
10Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Economic analysis search
Electronic searches yielded 238 references, of which 237 were ex-
cluded because they did not meet our inclusion criteria. One eco-
nomic substudy by Moore 2013 was identified. See Figure 2 study
flow diagram.
11Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 2. Study flow diagram for economic studies
12Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Included studies
Types of participants
We did not adjust sample sizes for clustering in the two cluster
RCTs (see above) (Defloor 2005; Moore 2011). A total of 1097
participants were enrolled in the three trials included in this re-
view (Defloor 2005; Moore 2011; Young 2004). Total numbers
randomised in the included studies were 838 (Defloor 2005), 213
(Moore 2011), and 46 (Young 2004). However, in Defloor 2005
only 262 participants were randomised to arms relevant to this re-
view meaning a total of 521 randomised participants were poten-
tially considered here. Ultimately 502 participants were included
in the analyses reported here as 19 people were lost to follow up
and we conducted a complete case analysis. Within these trials the
majority of participants were residents of long-term care settings
(Defloor 2005; Moore 2011), whilst one small study recruited 46
participants from a single acute care facility (Young 2004). Partic-
ipants in all three trials were aged over 65 years and all trials were
conducted in Europe (Belgium (Defloor 2005), Ireland (Moore
2011), and Wales (Young 2004)).
Types of interventions
In two of the three trials (Moore 2011; Young 2004), a 30º tilt
position was compared with a standard 90º supine/lateral position.
Participants in both the intervention and control groups were tilted
left side, back, right side, and back. Essentially, the Moore 2011
and Young 2004 trials compared the same tilts (30º vs 90º) and
the same repositioning frequency for the 30º tilt. However, there
was a difference in the frequency of repositioning overnight for
the 90º tilt groups. In the Moore 2011 trial, patients in the 90º tilt
group were repositioned 6-hourly overnight compared with two
to 3-hourly overnight in the Young 2004 trial.
The third trial (Defloor 2005) evaluated different repositioning
frequencies (2-, 3-, 4- and 6-hourly) using a semi-Fowler or lat-
eral position, in combination with standard or viscoelastic mat-
tresses. The participants receiving the 2 hourly and 3 hourly repo-
sitioning all received the standard hospital mattress whilst those
receiving the 4 and 6 hourly repositioning received viscoelastic
foam mattresses. In this study there was also a large “standard care”
arm comprising 576 people allocated care based on nurses’ clinical
judgement (a range of support surfaces but no repositioning). We
disregarded this treatment arm for the purposes of this review as it
systematically differed from the other 4 arms in both the allocation
of support surface and repositioning. In the other 4 groups, co-
interventions such as the use of nutritional supplements, skin care
and allocation of pressure relieving cushions during chair sitting
were also used.
Types of outcomes
The primary outcome in each of the included trials was the propor-
tion of participants developing a new PU (Defloor 2005; Moore
2011; Young 2004). Two trials reported the incidence of PU and
included Stages 1 to 4 over a 28-day period (Defloor 2005; Moore
2011), while the third trial reported a much briefer follow-up pe-
riod of 24 hours and reported only Stage 1 PU (i.e. non-blanch-
able erythema) (Young 2004).
Excluded studies
One trial was excluded after the full text had been screened
(Vanderwee 2007). In this trial, participants who had pre-existing
Stage 1 non-blanchable erythema at baseline were included, and
those who did not have non-blanchable erythema were excluded.
We had pre-specified that only studies where patients had no ex-
isting PU skin damage were eligible for inclusion.
Risk of bias in included studies
We present an assessment of the risk of bias using ’Risk of bias’
summary figures (Figure 3 and Figure 4), which detail all of the
judgements in cross-tabulations of study by entry. All three trials
were at unclear or at high risk of bias.
13Repositioning for pressure ulcer prevention in adults (Review)
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Figure 3. Risk of bias summary: review authors’ judgements about each risk of bias item for each included
study
14Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 4. Risk of bias graph: review authors’ judgements about each risk of bias item presented as
percentages across all included studies
Allocation
Random sequence generation
All three trials described a process to generate the random allo-
cation list (Defloor 2005; Moore 2011; Young 2004). Two tri-
als used a computer-based random number generator (Defloor
2005; Moore 2011), while the Young 2004 trial used sequentially-
numbered envelopes that contained a randomisation code. In the
Defloor 2005 trial, randomisation also occurred over a second 4-
week period. During this second period, each ward used a differ-
ent prevention scheme than used in the first 4-week period.
Allocation concealment
Assessment of allocation concealment in the three included trials
involved examination of whether trial authors described how the
assignment sequence was protected before and until allocation. We could not adequately assess the extent of allocation concealment
for the Defloor 2005 trial since the randomisation was influenced
during the trial by resources and we therefore rated this “unclear”.
In the Young 2004 trial, the allocation was concealed from the
researcher and the nurses in a sealed and sequentially numbered
envelope (low risk of bias). In the Moore 2011 study, allocation
concealment was achieved using remote randomisation (also low
risk of bias).
Blinding
Blinding of participants and personnel
It is hard to envisage how blinding of participants and personnel
to the frequency and nature of repositioning could be possible and
therefore all three trials are likely to be at risk of performance bias.
Two out of three trial reports did not state whether participants
and nursing staff were blinded (Defloor 2005; Young 2004). The
Moore 2011 trial was described as “open label”, usually meaning
that the participants, care givers and researchers were aware of
group allocation. The Defloor 2005 and Moore 2011 trials were
classified as at high risk of performance bias while the Young 2004
trial was classified as unclear risk of bias.
Blinding of outcome assessors
There was considerable variability in assessment of all grades of
PU among the three trials (Defloor 2005; Moore 2011; Young
2004). Such variability is problematic, as the use of a subjective
primary outcome measure is open to ascertainment bias.
Outcome measurement was not blinded in two trials (Defloor
2005; Moore 2011) and these were rated as high risk. In the
Young 2004 trial, the outcome assessor was “unaware” of group
allocation, as the positioning aids (pillows) were removed from
under the patient prior to outcome measurement (low risk). Only
15Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Moore 2011 considered the reliability of outcome using several
outcome assessors to minimise this form of bias. However, inter-
rater reliability data were not presented.
Incomplete outcome data
Assessment of whether incomplete outcome data had been ade-
quately addressed in each trial involved examining whether reasons
for attrition or exclusion were reported, whether there was re-in-
clusion of participants, and whether completeness of data for each
main outcome was described. In two of the three trials (Defloor
2005; Young 2004), participants were excluded from the analysis
in sufficient numbers to threaten bias. Defloor 2005 excluded 77
(9.2%) of 838 randomised participants from the analysis, and in
the Young 2004 trial, seven (15.2%) of the 46 randomised partici-
pants were excluded; two due to death (both in the control group)
and five in the experimental group, who were unable to tolerate the
intervention and for whom outcome data collection then ceased.
For both the Young 2004 and Defloor 2005 trials, we conducted
a complete case analysis (which makes no assumption about the
outcomes for patients lost to follow up as this was felt more con-
servative than analysing losses as if they had not sustained pressure
injury). Attrition bias and lack of intention-to-treat analysis were
contributing factors to incomplete outcome data. In Moore 2011,
all randomised participants were included in the analysis.
Selective reporting
Each study reported all pre-specified outcomes – as defined in the
papers – in the results. No published protocol was available for any
of these trials.
Other potential sources of bias
We planned to assess potential publication bias using funnel plots
and to assess funnel plot asymmetry visually, however, as only
three studies were included in this review, this was not appropriate
(Sterne 2011).
Effects of interventions
Comparison 1: frequencies of repositioning (one trial)
One cluster randomised trial (Defloor 2005) was included in this
comparison however we did not adjust the data for clustering as
the ICC of 0.001 (from Moore 2011 and Cumming 2008) was so
small as to make no difference.
Primary outcomes
The proportion of new pressure ulcers of any grade, stage or
category
In the Defloor 2005 trial, various repositioning regimens of dif-
ferent frequencies (2-, 3-, 4- and 6-hourly), positions (i.e. semi-
Fowlers and lateral), and support surfaces (i.e. viscoelastic and
standard mattresses) were compared.
For the purposes of this review we compared the outcomes for
repositioning frequency where the support surface was the same
for both groups i.e., 2-hourly vs. 3-hourly repositioning (all on the
standard hospital mattress) and 4-hourly vs. 6-hourly reposition-
ing (all on the viscoelastic foam mattress). On the standard hospi-
tal mattress, 39/63 (62%) participants receiving 2 hourly reposi-
tioning developed a pressure ulcer of any severity compared with
40/58 (69%) receiving 4-hourly repositioning (RR 0.90, 95% CI
0.69 to 1.16) (Analysis 1.1).
For participants nursed on viscoelastic foam mattresses, 30/66
(46%) of participants receiving 4-hourly repositioning developed
a pressure ulcer of any severity compared with 39/63 (62%) of
those receiving 6-hourly repositioning (RR 0.73, 95% CI 0.53 to
1.02) (Analysis 2.1).
The proportion of new pressure ulcers category 2 to 4
We also examined whether there was a treatment effect when only
breaks in the skin (category 2 to 4 ulcers) were analysed however
we did not pre-specify this analysis in our protocol and the results
are merely exploratory.
On the standard hospital mattress, 9/63 (14%) of participants re-
ceiving 2 hourly repositioning developed an ulcer of Category 2
and above compared with 14/58 participants (24%) receiving 3-
hourly repositioning (RR 0.59, 95% CI 0.28 to 1.26) (Analysis
1.2). On the viscoelastic foam mattress, 2/66 (3%) participants
receiving 4-hourly repositioning developed an ulcer of Category
2 or above compared with 10/63 (16%) receiving 6-hourly repo-
sitioning (RR 0.19, 95% CI 0.04 to 0.84) (Analysis 2.2).
Comparison 2: different positions for repositioning
Primary outcomes
The proportion of new pressure ulcers of any grade, stage or
category (two trials)
Both trials reported this outcome (Moore 2011; Young 2004).
Moore 2011 examined the use of 30° 3-hourly tilt (overnight)
compared with repositioning 6-hourly 90° tilt (overnight) in a
study involving 259 randomised (252 analysed) participants. The
16Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
incidence of pressure ulcers (Categories 1 and 2) was significantly
lower in the 30° tilt group (RR 0.27, 95% CI 0.08, 0.91) compared
with the 90° tilt group (Analysis 3.1). This study was at high risk
of bias due to unblinded outcome assessment.
In the small trial by Young 2004 (46 randomised, 39 analysed par-
ticipants), the main outcome was Category/Stage 1 non-blanch-
able erythema, and the follow-up period was 24 hours. A 3-hourly
30o tilt compared with a 3-hourly 90o lateral (overnight) and
supine position (overnight) was used. There was no statistically
significant difference in risk of pressure ulceration (RR 1.37, 95%
CI 0.25 to 7.41) (Analysis 3.1) however this comparison is grossly
underpowered with only 5 events.The trials of Moore 2011 and
Young 2004 compared the same tilts (30º vs 90º) using simi-
lar repositioning frequencies; 3-hourly for the 30º tilt; 6-hourly
overnight for the 90º tilt in Moore 2011; and 2- to 3-hourly
overnight in the Young 2004 trial therefore we pooled them us-
ing a random effects model (moderate to high heterogeneity, I2
= 69%). Overall there was no difference in the risk of Category/
Stage 1 or 2 pressure injury (persistent erythema) between 30º and
90º tilts however this comparison is at risk of a Type II error due
to the lack of statistical power (pooled RR 0.62, 95% CI 0.10 to
3.97) (Analysis 3.1).
Secondary outcomes
Health-related quality of life (HRQoL)
No trial reported health-related quality of life (HRQoL).
Procedural pain
No trial reported procedural pain.
Patient satisfaction
No trial reported patient satisfaction.
Cost
One within-trial cost evaluation by Moore 2013 is included in
this review. Moore 2013 performed a cost-effectiveness analysis
based on data derived from their cluster randomised controlled
trial (Moore 2011) comparing 3-hourly repositioning using the
30° tilt overnight (n=99, unadjusted for clustering) with standard
care consisting of 6-hourly repositioning using the 90° lateral rota-
tion overnight (n=114, unadjusted for clustering), in participants
recruited from 12 long term aged-care facilities in Ireland.
Moore 2013 compared the nursing time costs and incidence of
PU development over the four week trial period. Nurse time was
calculated from information recorded in the clinical study indicat-
ing number of turns per patient, nurses per turn, and nurse time
per turn. A unit cost of EURO23.94 per nurse hour was then ap-
plied, based on the rate for a staff nurse scale point 8 in mid-2009.
Efficacy was measured as PU incidence (the primary outcome of
the clinical trial), which would appear to be represented as the
number of patients developing a new PU during the four week
trial period. Moore 2013 also reported some data for the total cost
of dressings for treating PUs that developed during the trial, but
did not report a unit cost and did not include dressing costs in the
incremental analysis.
Incremental cost per event avoided
The 30° 3-hourly tilt positioning intervention was reported to be
cost saving in nurse time compared with standard care (mean nurse
time cost per patient EURO206.6 vs EURO253.1, incremental
difference EURO-46.5; 95%CI: EURO-1.25 to EURO-74.60)
(Moore 2013). The intervention dominated the control in terms
of cost-effectiveness, since the trial also found the intervention to
be more effective than the control. The lower nurse time cost for
the intervention group despite the greater turning frequency was
due to the lower time and reduced number of nurses required for
each turn.
Given the intervention dominated the control, it was unnecessary
for Moore 2013 to estimate an incremental cost-effectiveness ra-
tio although they did. There is some inconsistency in the report-
ing and interpretation of the incremental analysis made by Moore
2013, leading to a lack of clarity in the paper around the estimated
cost-effectiveness. Moore 2013 suggest their efficacy outcome in
the incremental analysis as both “patient free of PU” and “PU
avoided”. The rationale for changing between outcome measures
of “patient free of PU” and “PU avoided” is unclear. Neverthe-
less, in this instance these outcome measures would appear to be
equivalent since the number of patients developing an ulcer and
the number of PUs developing during the trial was the same (n=
16) (Moore 2011). Moore 2013 reported the incremental cost per
patient free of PU (-EURO73.40) and per pressure ulcer avoided
(-EURO547.00). Although not explicitly stated, the estimated in-
cremental cost effectiveness ratios appear to be intended to rep-
resent an incremental cost per additional incremental outcome. However, these values are inconsistent with each other, given the
incidence of PUs developing was the same in the trial (Moore
2011) regardless of whether defined as number of patients devel-
oping PU or number of PUs developing during the trial. Further,
neither of these values could be confirmed from the data provided
in the main body of the Moore 2013 paper. The former value (-
EURO73.40 per patient free of PU) appears to have been incor-
rectly estimated from the data presented in the paper. The lat-
ter value of -EURO547 per (additional) PU avoided is consistent
with the efficacy data presented in the abstract, but the efficacy
data presented in the abstract is inconsistent with efficacy data
presented in the main body of the report, and does not precisely
match the efficacy data provided in the original clinical trial report
(Moore 2011).
Despite this limitation in interpretation, the reported findings
17Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
suggest that for every 100 patients treated with the 3-hourly
repositioning intervention rather than standard care, EURO4,650
would be saved in nurse time costs and an additional 8 patients
would avoid a PU. Moore 2013 concluded that repositioning ev-
ery 3 hours using the 30° tilt is less costly in terms of nursing time
and more effective than standard care involving repositioning ev-
ery 6 hours using 90° tilt.
D I S C U S S I O N
Summary of main results
The proportion of new pressure ulcers of any grade,
stage or category
The main aim of this systematic review was to present and ap-
praise all existing evidence regarding the relative effectiveness of
repositioning on the prevention of PUs in adults. There is limited
evidence, with only three small trials and data from a total of 502
participants contributing to this analysis. Moreover the three trials
were at high risk of bias.
The results of the review are that we have insufficient evidence to
draw a reliable conclusion of whether more frequent repositioning
(in this review we report 2-hourly vs. 3-hourly, and 4-hourly vs. 6-
hourly) or different positions (the 30° tilt compared with the 90°
lateral position) are more effective in reducing pressure damage.
The lack of statistical power means we cannot say there is no bene-
fit associated with more frequent repositioning since in each com-
parison the proportion of people developing pressure ulcers was
lower in the groups receiving more frequent changes of position
but the differenced did not reach conventional levels of statistical
significance and so may be chance rather than “real” differences.
There was a statistically significant reduction in pressure ulcers
of Category 2 and above with 4-hourly repositioning compared
with 6-hourly (Defloor 2005) however we did not prespecify this
outcome and this finding is exploratory.
It is noteworthy that in Defloor 2005, 46% of participants receiv-
ing 4-hourly repositioning and 62% of those receiving 6-hourly
developed pressure damage, despite being nursed on viscoelastic
foam mattresses. This suggests that although another Cochrane re-
view (McInnes 2011) found that more advanced foam mattresses
reduce pressure damage relative to the standard hospital mattress,
high rates of pressure damage are still observed and careful moni-
toring of skin condition is required.
Repositioning regimens are widely used and recommended in best
practice guidelines (European Pressure Ulcer Advisory Panel 1998;
Australian Wound Management Association 2011), however there
is limited empirical evidence of their effect on the prevention
of pressure ulcers. That said, the theoretical rationale for reposi-
tioning (to reduce isolated tissue ischaemia by relieving pressure)
makes physiological sense. However current evidence does not en-
able conclusions to be drawn regarding the optimum position or
frequency of re-positioning. The lack of experimental evidence
for repositioning per se, or for specific positions and frequencies, should not be interpreted as evidence of ineffectiveness.
Overall completeness and applicability of evidence
There was limited evidence available to assess the benefits of dif-
ferent regimens for the prevention of pressure ulcers. Overall the
three studies in this review had sample sizes resulting in a lack of
statistical power to detect a treatment effect if it exists. Small sam-
ple sizes increase the risk of Type 2 errors and reduce the precision
of the estimates.
There was wide variation in sample sizes among the trials. Only one
of the trials was conducted in an acute care setting and included
only hospital patients over the age of 65 years (Young 2004). The
primary study outcome reported in all three trials was the inci-
dence of pressure ulcers. None of the included trials examined out-
comes such as pain, quality of life or participant satisfaction. Only
one trial author performed a parallel economic substudy (Moore
2013).
The focus of the interventions of the three trials that met our in-
clusion criteria varied, with two trials using tilts and three-hourly
overnight repositioning (Moore 2011; Young 2004), while the
third used various repositioning frequencies and positions in com-
bination with different types of mattresses (Defloor 2005). An-
other limitation was the inconsistency in follow-up periods, which
ranged between 24 hours (Young 2004) to 28 days (Defloor 2005
and Moore 2011). All three trials were conducted in Europe which
may limit the generalisability of the findings. Furthermore, tech-
nological developments in mattress composition and materials, as
well as bed design, has occurred since the two earliest studies were
conducted, which also limits the external validity of these results,
as it is likely that other support surfaces are now in use.
Quality of the evidence
The quality of the body of evidence has been appraised using the
GRADE approach in relation to study limitations, inconsistency
of results,indirectness, imprecision and risk of bias,as specified in
the Handbook (Schünemann 2011) and a Summary of Findings Table will be included in the next update. There is very low quality
of evidence from the three trials that assessed the use of different
repositioning regimens. The evidence was downgraded because
of the low number of participants with consequent imprecision
together with high risk of bias. The primary outcome, pressure
ulcer development, requires a subjective judgement of whether
18Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tissue damage has occurred (at least for Grade 1 pressure ulcer) and
only one study (Young 2004) used blinded outcome assessment.
Potential biases in the review process
We followed clearly defined, pre-specified procedures to prevent
potential bias in the review process. A comprehensive and system-
atic literature search was conducted, that was both transparent and
reproducible. That notwithstanding, it is possible that we missed
trials published in journals that were outside our search strategy.
Whilst we had intended to conduct a sensitivity analysis to test
the robustness of the results to different assumptions about the
outcomes of people who were lost to follow up, we felt that this
was not necessary due to the poor volume and quality of the evi-
dence and our consequent inability to draw any conclusions (no
sensitivity analysis would help in this regard).
None of the review authors has any conflict of interest.
Agreements and disagreements with other studies or reviews
Our results are consistent with others’ assessment of the evidence
for repositioning. The systematic review by Reddy 2006, was pub-
lished before one of our included trials, Moore 2011, was under-
taken. The results of the review by Reddy 2006 suggested that
the evidence around repositioning remains somewhat inconclu-
sive, and the methodology for PUP trials sub optimal.
A U T H O R S ’ C O N C L U S I O N S
Implications for practice
There is currently insufficient evidence that the 30° tilt is more
effective than the 90° tilt (two trials, only 21 events in total).
Repositioning in some form is recommended in all clinical guide-
lines though implementation is probably variable and highly de-
pendent on the available resources (particularly staffing levels). It
is noteworthy that more recent clinical guidelines no longer ad-
vocate repositioning patients every two hours (European Pressure
Ulcer Advisory Panel 2009; National Pressure Ulcer Advisory
Panel 2007).
It is surprising that, to date, there is little evidence available from
RCTs that addresses the question of whether repositioning pa-
tients does decrease the risk of acquiring pressure ulcers. The lack
of evidence is a cause for concern considering that estimates of
incidence of hospital-acquired pressure ulcers range from less than
3% to over 30% of patients (Mulligan 2011; Queensland Health
2008; Schuurman 2009; Nixon 2006).
The aetiology of pressure ulcer development is linked to localised
vascular obstruction that reduces capillary blood flow to the skin
surface area (European Pressure Ulcer Advisory Panel 2009). Thus,
there are reasonable grounds to expect that repositioning hospi-
talised patients will minimise the risk of oxygen deprivation and
nutrients that are required for tissue repair. However, the opti-
mal frequency with which this should occur must consider the
other negative effects of turning such as the potential for sleep
disruption,heightened increases in patients’ pain perception and,
for nurses, musculoskeletal injuries
Implications for research
There is an urgent need for appropriately-powered, high-quality,
multicentre trials to evaluate the clinical and cost effectiveness of
repositioning regimens on the prevention of pressure ulcers. The
modest sample sizes in the trials reviewed is a major limitation.
Thus in future trials, larger numbers of participants are needed,
particularly if cluster trials are conducted. Two of the thee trials
reviewed here were conducted in long-term care settings, therefore,
there is a need to use acute care settings to address the rise in
prevalence of hospital acquired pressure ulcers (Mulligan 2011).
Consistency in the measures used to classify pressure ulcers of
any severity is essential. Given the high costs associated with the
prevention and treatment of pressure ulcers, priority should be
given to robust RCTs with economic evaluations. Trialists should
consider comparisons of:
1. the repositioning frequencies and optimal positioning;
2. the effects of repositioning in patients with limited mobility
(e.g. paraplegia);
3. the economic costs (including incremental costs) of PUs;
and,
4. the economic and social impacts of PUs on patients’
HRQoL using valid and reliable HRQoL measures.
Good quality trials also need to address the methodological limi-
tations identified in the trials of this review. Trialists must ensure
transparency of research process and adhere to the CONSORT
statement for reporting RCTs (The CONSORT Statement 2010).
To minimise the sources of bias, trialists need to pay careful at-
tention to elements of research design and execution with regard
to allocation concealment, randomisation, blinding, and partici-
pant attrition (Polit 2010). For instance, having an observer who
is blinded to the outcome perform the outcome assessment. If
cluster-RCTs are used, trialists need also to consider the potential
for bias in terms of selection bias, baseline comparability, analysis,
and loss of clusters (Higgins 2011a).
A C K N O W L E D G E M E N T S
19Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
The authors would like to thank the following referees: Wounds
Group Editors Nicky Cullum and Andrea Nelson; Trials
Search Co-odinator Ruth Foxlee; Statistical Consultant Giovanni
Casazza; and, Expert Referees Zena Moore and Carol Dealey.The
authors also thank Ms Jodie Vickery from Griffith University for
assistance with selection of the economic studies and Elizabeth
Royle for copy editing.
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23Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Defloor 2005
Methods Study design: 5-armed cluster RCT with a 4-week (28-day) follow-up period (only 4
arms analysed in this review – see below)
Quote: “Each ward applied the prevention scheme selected for a period of 4 weeks. The
randomisation procedure was repeated for a second period of 4 weeks. During the second
period each ward used a different prevention scheme than used in the first period” (pp
39)
Ethics and informed consent: ethics approval and consent obtained.
Sample size calculation: yes.
ITT analysis: participants analysed in the groups to which they were assigned, but data
were incomplete for 24 participants, and they were not included in the analysis
Quote: “The observations were incomplete in the case of 24 patients.”
Participants Location: 32 wards across 11 nursing homes in Flanders, Belgium
Baseline data reported in relation to group comparisons for age, gender and Braden scale
scores
Mean ages:
Group A: 85.2 years (± 7.2)
Group B: 85.2 years (± 6.2)
Group C: 84.7 years (± 7.7)
Group D: 85.4 years (± 7.3)
Inclusion criteria: 838 people fulfilled inclusion criteria. This review excludes partici-
pants from the usual care group who received care that was different in terms of both
support surface AND repositioning
1. Geriatric residents with a Braden score of < 17 or a Norton score of < 12
2. Informed consent of the patient/family.
3. No PU at time of recruitment to study.
Exclusion criteria: none stated, but total of 1114 people excluded.
Interventions Aim(s): to investigate the effect of 4 different preventative regimes involving either fre-
quent turning (2- to 3-hourly) or the use of a pressure-reducing mattress in combination
with less frequent turning (4- to 6-hourly)
Group A: 2-hourly turning regimen on standard mattress (65 randomised, 63 analysed)
Group B: 3-hourly turning regimen on standard mattress (65 randomised, 58 analysed)
Group C: 4-hourly turning regimen on viscoelastic polyurethane (pressure-relieving)
mattress (67 randomised, 66 analysed)
Group D: 6-hourly turning regimen on viscoelastic polyurethane (pressure-relieving)
mattress (65 randomised, 63 analysed)
Alternating turning positions: semi-Fowlers with feet elevated 30o alternating with 30 o lateral rotation, pillow placement under back from shoulder on standard mattress
Specified sitting position: experimental group sitting periods were recorded but not
standardised; they sat on thick air cushions. Backrest tilt on chair, legs on footrest but
heels not supported. Cushion for back
Group 2 Control: n = 576 patients.
Care given according to patients’ level of risk; water mattresses, alternating mattresses,
24Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Defloor 2005 (Continued)
sheepskins and gel cushions; based on nurses’ clinical judgement. No PU risk assessment
tool used. For the purposes of this review we have disregarded this group since their
care was highly heterogeneous and differed systematically from the others in terms
of BOTH the support surface provision policy AND the (absence of a) repositioning
policy.
Study date(s): not stated.
Outcomes Primary outcome: incidence of a PU (any category) during a 28-day period.
Seondary outcomes: risk assessment using Braden and Norton scores.
Time points: twice weekly for 4 weeks
Notes Not reported whether water mattresses, alternating mattresses, sheepskins and gel cush-
ions were used singly or in combination with each other
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk Quote:“Using computerised randomisa-
tion tables, the prevention schemes were
randomly allocated to 32 wards (table 1)
Randomisation also occurred over a sec-
ond 4-week period. During this second pe-
riod, each ward used a different prevention
scheme than used in the first 4-week period
(pp. 39)
Diagram of randomisation schedule in-
cluded in the paper as a table pp 39
Allocation concealment (selection bias) Unclear risk Quote: “a sealed envelope containing all
the room numbers in a random order was
opened. The first 5 patients who satisfied
the inclusion criteria were included.”
Quote: “labour intensive nature of some
of the prevention schemes, the number of
patients participating in the experimental
groups was limited to 5 per ward.”
Comment: concern that allocation not
fully concealed
Blinding of participants and personnel
(performance bias)
All outcomes
High risk Quote: “’It was impossible to blind the
nurses for preventative care.”
Comment: Not blinded
Blinding of outcome assessment (detection
bias)
All outcomes
High risk Quote: “The nurses were blinded for the
Braden and Norton scores of their individ-
ual patients.”
Comment: impossible for nursing staff to
be blinded due to the differences in the
25Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Defloor 2005 (Continued)
types and varieties of turning regimens
Incomplete outcome data (attrition bias)
All outcomes
High risk Flow chart (fig 1, pp 41) showed patient
attrition across each of the 5 groups
Quotes:
“Of the 838 included patients, 761 patients
completed the 4-week study period.”
“The data on three patients were incom-
plete and it could not be guaranteed that
the protocol was strictly followed. Those
patients were excluded.”
Comment: ITT analysis not implemented
Selective reporting (reporting bias) Unclear risk Comment: clinical outcomes were pre-
sented in Tables 2 and 3 of the paper. A
published protocol was not available. Mea-
sures used reflect aims of the intervention
and outcomes
Other bias Low risk None identified.
Moore 2011
Methods Study design: 2-armed cluster RCT with a 4-week (28-day) follow-up period
Ethics and informed consent: ethics approval and consent obtained.
Sample size calculation: yes.
ITT analysis: yes, all participants randomised were analysed.
Participants Location: 12 hospital sites with long-term residents in Ireland.
Mean age: not reported
Baseline data reported in relation to group comparisons for age, gender and Braden scale
scores
Inclusion criteria:
1. In-patient in a long term geriatric facility.
2. Over 65 years of age.
3. At risk of PU development using the activity and mobility components of Braden
scale
4. No PU at time of recruitment to study.
5. No medical condition that would preclude the use of repositioning
6. Consent.
Exclusion criteria: patients with existing PU. Total of 57 patients excluded.
Interventions Aim(s): to examine whether repositioning using 30° tilt and 3-h repositioning reduces
the incidence of PU compared with usual care
Group 1: 30° tilt (n = 99 participants randomised, 99 analysed)
Repositioning by clinical staff using 30° tilt at night (left side, back, right side, back) 3-
h overnight (8 pm-8 am). During the day, position changes occurred 2-3h
Group 2: Usual care (n = 114 participants randomised, 99 analysed)
Usual care consisted of repositioning by clinical staff every 6-h using the 90° tilt (left
26Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Moore 2011 (Continued)
side, back, right side, back) overnight, (8 pm-8 am). During the day, position changes
occurred 2- to 3-h
Co-interventions : participants in both groups nursed as per planned care regarding
nutritional regimens, toileting, changing of incontinence pads, preparation for feeding,
and pressure redistribution devices on chairs. Repositioned every 2- to 3-h during the
day.
Outcomes Primary outcome: incidence of all PUs during a 28-day period
Quote: “The EPUAP pressure ulcer (PU) classification system, ranging from non-blanch-
ing erythema of intact skin to full scale tissue destruction” (Grades I to IV)
Quote: “A pressure ulcer was defined as localised areas of tissue damage caused to skin
and underlying soft tissue caused by sustained mechanical loading and shearing forces.”
Secondary outcomes:
• Risk assessment using Braden scale components to predict PU development:
• Activity scores
• Mobility
• Economic outcomes: 1) mean daily nurse time for repositioning, 2) nurse time
cost per patient, 3) cost of patient free of PU; and, 4) projected annual cost
Validity of measures: inter-rater reliability not reported, but quote: “The skin was then
assessed by the assigned key staff member, the clinical manager, and the researcher. Agree-
ment between assessors was reached by comparing patients’ skin condition to images of
the EPUAP grading system.”
Time points: weekly follow-up over 4 weeks.
Notes PU risk status on study entry not stated by group.
Imbalances in cluster size.
ICC used in analysis and reported in text, Kish design effect reported (pp 2639)
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk Quote: “The clusters were the specific study
sites (n=12) and these were randomly al-
located to either the intervention group or
the control group.”
Quote: “The allocation was generated by
a statistician not directly involved with the
study and was determined using comput-
erised randomisation.”
Allocation concealment (selection bias) Low risk Quote: “The allocation was generated by
a statistician not directly involved with the
study and was determined using comput-
erised randomisation.”
Quote: “ . . . allocation concealment was
achieved through use of distance randomi-
sation, meaning that the statistician, not
the researcher, controlled the randomisa-
27Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Moore 2011 (Continued)
tion sequence.”
Blinding of participants and personnel
(performance bias)
All outcomes
High risk Quote: ’The research design employed was
. . . open label, pragmatic“ (pp 2635)
Comment: Impossible for participants and
nurses to be blinded.
Blinding of outcome assessment (detection
bias)
All outcomes
High risk Quote: “The skin was then assessed by
the assigned key staff member, the clinical
nurse manager and the researcher. Agree-
ment between assessors was achieved by
comparing the participant’s skin condition
to the images on the EPUAP grading sys-
tem.”
Comment: not stated, but most likely im-
possible. In an effort to minimise this form
of bias, several assessors were used, although
inter-rater reliability data were not pre-
sented
Incomplete outcome data (attrition bias)
All outcomes
Low risk Quote: ”Data were analysed using SPPS
version 13 on an intention to treat (ITT)
basis.”
Flow chart (fig 3, pp 2639) showed pa-
tient attrition across the 2 groups, but same
number of patients who were randomised
were also analysed
Selective reporting (reporting bias) Low risk Comment: clinical outcome, development
of PU was reported. A published protocol
was not available. Measures used reflect
aims of the intervention and outcome
Other bias Unclear risk 1. No table/data to show baseline
comparisons for each group and whether
PU risk was equivalent at study entry.
2. Economic data: The rationale for
changing between outcome measures of
“patient free of ulcer” and “pressure ulcer
avoided” is unclear. In this instance these
outcome measures would appear to be
equivalent since the number of patients
developing an ulcer and the number of
PU developing during the trial was the
same (n=16).
28Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Young 2004
Methods Study design: RCT (groupings for allocation not reported) with a 24-h follow-up period
Ethics and informed consent: ethics approval and consent obtained
Sample size calculation: yes
ITT analysis: reported as ITT
Participants Location: medical ward of an acute general hospital in Wales, UK
Mean age:
Group 1: 70.1 years (± 11.1)
Group 2: 70.5 years (± 14.7)
Baseline data reported in relation to group comparisons for age, gender, weight, height
and Waterlow scale scores
Inclusion criteria:
1. Elderly patients
2. At risk of developing a pressure ulcer using Waterlow
3. Able to lie in 30° tilt position
4. Given informed consent
5. No existing pressure damage
6. Caucasian
Exclusion criteria: not stated
Interventions Aim(s): to examine the effects of the 30° tilt in reducing non-blanchable erythema
Group 1 Intervention: n = 23 patients randomised, 18 analysed
Repositioning using 30° tilt (left side, back, right side, back) 2-3-hourly overnight, 2-3-
hourly during the day
Sacrum and heels free from contact with support surface
Support mattress: alternating pressure mattress or low air loss mattress
Group 2 Control: n = 23 patients randomised, 21 analysed.
90° lateral and supine positions 2-3-hourly overnight, 2-3-hourly during the day
Support mattress: low air loss mattress.
Study date(s): April-July 1999
Outcomes Primary outcome: incidence of non-blanchable erythema during a 24-h period
Quote: “NBE was used as a definition for pressure damage.”
Validity of measures: not reported
Time points: one
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk Quote:“The randomisation was based on
block allocation“
Comment: No mention of how the blocks
were generated (i.e., computer or random
number table) or allocation ratio to each
block. Thus the process for electing the
blocks is unclear
29Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Young 2004 (Continued)
Allocation concealment (selection bias) Unclear risk Quote: “specific intervention being se-
lected by sequential opening of sealed
opaque envelopes.”
Quote: “The ward staff were then handed
the sequentially numbered envelopes con-
taining randomisation code and the re-
searcher left the clinical area.”
Comment: This trial used blocked ran-
domization with group assignments being
revealed after recruitment, therefore there
is the potential to be able to predict future
assignments
Potential for interference with envelopes,
which are more susceptible to manipula-
tion than are other approaches.
Blinding of participants and personnel
(performance bias)
All outcomes
High risk Comment: not stated. Impossible for nurs-
ing staff to be blinded due the differences
in the intervention and usual care. Difficult
to conceal from participants and nursing
staff once patients were randomised
Blinding of outcome assessment (detection
bias)
All outcomes
Low risk Quote: ”The next morning the researcher
was unaware of which method of reposi-
tioning had been used, therefore masking
the researcher to treatment allocation.”
Comment: researcher blinded totreatment
group
Incomplete outcome data (attrition bias)
All outcomes
High risk Quote: “A total of 7 patients had no post
intervention data collected.”
Quote: “Statistical comparisons were made
on an intention-to-treat basis.”
“No post-intervention assessment of pres-
sure damage was performed on any of these
seven subjects.”
Comment: use of ITT stated, however,
participants were excluded from the analy-
sis if they discontinued the intervention or
were nursed on a foam mattress (pp 92)
Selective reporting (reporting bias) Low risk Comment: clinical outcome, development
of PU was reported. A published protocol
was not available. Measures used reflect
aims of the intervention and outcome
Other bias Low risk Comments: None identified.
30Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Abbreviations
COI = conflict of interest
fig = figure
h = hour(s)
ICC = intra-cluster correlation coefficient
ITT = intention to treat analysis
NBE = non-blanchable erythema
pp = page(s)
PU = pressure ulcer
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Vanderwee 2007 Inclusion/Exclusion criteria: patients who had a pre-existing grade 1 PU (i.e. non-blanchable erythema) were
included, and those who did not have non-blanchable erythema (n = 1944) were excluded (fig 1, pp 63)
Abbreviations
fig = figure
PU = pressure ulcer
Characteristics of ongoing studies [ordered by study ID]
Bergstrom
Trial name or title TURN Study
Methods Cluster RCT
Participants 66 nursing short stay ( 90 days) aged care residents 65 years and over
Interventions In-bed repositioning every 2 h compared to 3 h or 4 h and associated continence care
Outcomes Incidence of PU
Starting date Started in 2008 and completed in June 2011
Contact information Nancy Bergstrom
Theodore J and Mary E Trumble Professor of Aging Research
Associate Dean for Research (Interim)
School of Nursing
University of Texas Health Science Center-Houston
6901 Bertner Ave, 6.625
Houston 77030
Email: Nancy.Bergstrom@uth.tmc.edu
31Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Bergstrom (Continued)
Notes Correspondence with N Bergstrom. Study has been submitted for publication and is under review at the time
of writing this review
32Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
D A T A A N D A N A L Y S E S
Comparison 1. 2h versus 3h repositioning on standard hospital mattresses
Outcome or subgroup title No. of
studies
No. of
participants Statistical method Effect size
1 Pressure ulcer risk (category 1 to
4)
1 121 Risk Ratio (M-H, Fixed, 95% CI) 0.90 [0.69, 1.16]
2 Pressure ulcer risk (category 2 to
4)
1 121 Risk Ratio (M-H, Fixed, 95% CI) 0.59 [0.28, 1.26]
Comparison 2. 4h versus 6h repositioning on viscoelastic foam mattresses
Outcome or subgroup title No. of
studies
No. of
participants Statistical method Effect size
1 Pressure ulcer risk (category 1 to
4)
1 129 Risk Ratio (M-H, Fixed, 95% CI) 0.73 [0.53, 1.02]
2 Pressure ulcer risk (category 2 to
4)
1 129 Risk Ratio (M-H, Fixed, 95% CI) 0.19 [0.04, 0.84]
Comparison 3. 30o tilt 3-hourly overnight versus 90o tilt overnight
Outcome or subgroup title No. of
studies
No. of
participants Statistical method Effect size
1 Pressure ulcer risk (category 1 to
4)
2 252 Risk Ratio (M-H, Random, 95% CI) 0.62 [0.10, 3.97]
33Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.1. Comparison 1 2h versus 3h repositioning on standard hospital mattresses, Outcome 1
Pressure ulcer risk (category 1 to 4).
Review: Repositioning for pressure ulcer prevention in adults
Comparison: 1 2h versus 3h repositioning on standard hospital mattresses
Outcome: 1 Pressure ulcer risk (category 1 to 4)
Study or subgroup 2h repositioning 3h repositioning Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Defloor 2005 39/63 40/58 100.0 % 0.90 [ 0.69, 1.16 ]
Total (95% CI) 63 58 100.0 % 0.90 [ 0.69, 1.16 ]
Total events: 39 (2h repositioning), 40 (3h repositioning)
Heterogeneity: not applicable
Test for overall effect: Z = 0.82 (P = 0.41)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours 2h repositioning Favours 3h repositioning
Analysis 1.2. Comparison 1 2h versus 3h repositioning on standard hospital mattresses, Outcome 2
Pressure ulcer risk (category 2 to 4).
Review: Repositioning for pressure ulcer prevention in adults
Comparison: 1 2h versus 3h repositioning on standard hospital mattresses
Outcome: 2 Pressure ulcer risk (category 2 to 4)
Study or subgroup 2h repositioning 3h repositioning Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Defloor 2005 9/63 14/58 100.0 % 0.59 [ 0.28, 1.26 ]
Total (95% CI) 63 58 100.0 % 0.59 [ 0.28, 1.26 ]
Total events: 9 (2h repositioning), 14 (3h repositioning)
Heterogeneity: not applicable
Test for overall effect: Z = 1.36 (P = 0.17)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours 2h Favours 3h
34Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 2.1. Comparison 2 4h versus 6h repositioning on viscoelastic foam mattresses, Outcome 1
Pressure ulcer risk (category 1 to 4).
Review: Repositioning for pressure ulcer prevention in adults
Comparison: 2 4h versus 6h repositioning on viscoelastic foam mattresses
Outcome: 1 Pressure ulcer risk (category 1 to 4)
Study or subgroup 4h repositioning 6h repositioning Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Defloor 2005 30/66 39/63 100.0 % 0.73 [ 0.53, 1.02 ]
Total (95% CI) 66 63 100.0 % 0.73 [ 0.53, 1.02 ]
Total events: 30 (4h repositioning), 39 (6h repositioning)
Heterogeneity: not applicable
Test for overall effect: Z = 1.85 (P = 0.065)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours 4h repositioning Favours 6h repositioning
Analysis 2.2. Comparison 2 4h versus 6h repositioning on viscoelastic foam mattresses, Outcome 2
Pressure ulcer risk (category 2 to 4).
Review: Repositioning for pressure ulcer prevention in adults
Comparison: 2 4h versus 6h repositioning on viscoelastic foam mattresses
Outcome: 2 Pressure ulcer risk (category 2 to 4)
Study or subgroup 4h repositioning 6h repositioning Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Defloor 2005 2/66 10/63 100.0 % 0.19 [ 0.04, 0.84 ]
Total (95% CI) 66 63 100.0 % 0.19 [ 0.04, 0.84 ]
Total events: 2 (4h repositioning), 10 (6h repositioning)
Heterogeneity: not applicable
Test for overall effect: Z = 2.20 (P = 0.028)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours 4h Favours 6h
35Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 3.1. Comparison 3 30o tilt 3-hourly overnight versus 90o tilt overnight, Outcome 1 Pressure ulcer
risk (category 1 to 4).
Review: Repositioning for pressure ulcer prevention in adults
Comparison: 3 30 o
tilt 3-hourly overnight versus 90 o
tilt overnight
Outcome: 1 Pressure ulcer risk (category 1 to 4)
Study or subgroup
30 o
tilt 3-hourly
overnight 90 o
tilt overnight Risk Ratio Weight Risk Ratio
n/N n/N
M- H,Random,95%
CI
M- H,Random,95%
CI
Moore 2011 3/99 13/114 54.7 % 0.27 [ 0.08, 0.91 ]
Young 2004 3/18 2/21 45.3 % 1.75 [ 0.33, 9.34 ]
Total (95% CI) 117 135 100.0 % 0.62 [ 0.10, 3.97 ]
Total events: 6 (30 o
tilt 3-hourly overnight), 15 (90 o
tilt overnight)
Heterogeneity: Tau2 = 1.24; Chi2 = 3.21, df = 1 (P = 0.07); I2 =69%
Test for overall effect: Z = 0.50 (P = 0.62)
Test for subgroup differences: Not applicable
0.001 0.01 0.1 1 10 100 1000
Favours 30 tilt Favours 90 tilt
A P P E N D I C E S
Appendix 1. Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL effectiveness search strategies
Ovid MEDLINE
1 exp Pressure Ulcer/ (5231)
2 (pressure adj (ulcer* or sore*)).tw. (4365)
3 (decubitus adj (ulcer* or sore*)).tw. (579)
4 (bedsore* or (bed adj sore*)).tw. (245)
5 or/1-4 (6546)
6 exp Posture/ (27564)
7 (reposition* or re-position*).tw. (6619)
8 position*.tw. (235791)
9 (turn* adj5 patient*).tw. (3591)
10 (turn* adj5 interval*).tw. (126)
11 (turn* adj5 frequen*).tw. (777)
12 turning.tw. (7625)
13 (body adj5 posture*).tw. (1092)
14 pressure relie*.tw. (417)
15 (mobilis* or mobiliz*).tw. (34978)
16 or/6-15 (301537)
36Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
17 5 and 16 (834)
18 randomized controlled trial.pt. (240548)
19 controlled clinical trial.pt. (39492)
20 randomized.ab. (195665)
21 placebo.ab. (91366)
22 clinical trials as topic.sh. (79465)
23 randomly.ab. (134439)
24 trial.ti. (72586)
25 or/18-24 (543387)
26 (animals not (humans and animals)).sh. (1612439)
27 25 not 26 (494803)
28 17 and 27 (107)
Ovid EMBASE
1 exp Decubitus/ (9094)
2 (pressure adj (ulcer$ or sore$)).tw. (5623)
3 (decubitus adj (ulcer$ or sore$)).tw. (773)
4 (bedsore$ or (bed adj sore$)).tw. (415)
5 or/1-4 (10271)
6 exp patient positioning/ (10577)
7 (reposition$ or re-position$).tw. (9126)
8 position$.tw. (316430)
9 (turn$ adj5 patient$).tw. (5673)
10 (turn$ adj5 interval$).tw. (168)
11 (turn$ adj5 frequen$).tw. (1215)
12 turning.tw. (10505)
13 (body adj5 posture$).tw. (1519)
14 or/6-13 (344598)
15 5 and 14 (1057)
16 Randomized controlled trials/ (24734)
17 Single-Blind Method/ (15386)
18 Double-Blind Method/ (85329)
19 Crossover Procedure/ (31526)
20 (random$ or factorial$ or crossover$ or cross over$ or cross-over$ or placebo$ or assign$ or allocat$ or volunteer$).ti,ab. (930632)
21 (doubl$ adj blind$).ti,ab. (89452)
22 (singl$ adj blind$).ti,ab. (9568)
23 or/16-22 (964333)
24 animal/ (717007)
25 human/ (8542238)
26 24 not 25 (478486)
27 23 not 26 (932575)
28 15 and 27 (175)
EBSCO CINAHL
S16 S5 and S15
S15 S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14
S14 TI body N5 posture* or AB body N5 posture*
S13 TI turning or AB turning
S12 TI turn* N5 frequen* or AB turn* N5 frequen*
S11 TI turn* N5 interval* or AB turn* N5 interval*
S10 TI turn* N5 patient* or AB turn* N5 patient*
S9 TI position* or AB position*
S8 TI ( reposition* or re-position* ) or AB ( reposition* or re-position* )
S7 (MH “Patient Positioning+”)
S6 (MH “Posture+”)
37Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
S5 S1 or S2 or S3 or S4
S4 TI ( bedsore or bed sore ) or AB ( bedsore or bed sore )
S3 TI ( pressure ulcer* or pressure sore* ) or AB ( pressure ulcer* or pressure sore* )
S2 TI decubitus or AB decubitus
S1 (MH “Pressure Ulcer”)
Appendix 2. Ovid MEDLINE economics search strategy
1 exp Pressure Ulcer/
2 (pressure adj (ulcer* or sore*)).tw.
3 (decubitus adj (ulcer* or sore*)).tw.
4 (bedsore* or (bed adj sore*)).tw.
5 or/1-4
6 exp Posture/
7 (reposition* or re-position*).tw.
8 position*.tw.
9 (turn* adj5 patient*).tw.
10 (turn* adj5 interval*).tw.
11 (turn* adj5 frequen*).tw.
12 turning.tw.
13 (body adj5 posture*).tw.
14 pressure relie*.tw.
15 (mobilis* or mobiliz*).tw.
16 or/6-15
17 5 and 16
18 economics/
19 exp “costs and cost analysis”/
20 economics, dental/
21 exp “economics, hospital”/
22 economics, medical/
23 economics, nursing/
24 economics, pharmaceutical/
25 (economic* or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic*).ti,ab.
26 (expenditure* not energy).ti,ab.
27 value for money.ti,ab.
28 budget*.ti,ab.
29 or/18-28
30 ((energy or oxygen) adj cost).ti,ab.
31 (metabolic adj cost).ti,ab.
32 ((energy or oxygen) adj expenditure).ti,ab.
33 or/30-32
34 29 not 33
35 letter.pt.
36 editorial.pt.
37 historical article.pt.
38 or/35-37
39 34 not 38
40 Animals/
41 Humans/
42 40 not (40 and 41)
43 39 not 42
44 17 and 43
38Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Appendix 3. Risk of bias criteria
1. Was the allocation sequence adequately generated?
Low risk of bias
The investigators describe a random component in the sequence generation process such as: referring to a random number table; using
a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.
High risk of bias
The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some
systematic, non-random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule
based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.
Unclear
Insufficient information about the sequence generation process to permit judgment of low or high risk of bias.
2. Was the treatment allocation adequately concealed?
Low risk of bias
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent
method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomisation);
sequentially-numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.
High risk of bias
Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation
based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate
safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case
record number; any other explicitly unconcealed procedure.
Unclear
Insufficient information to permit judgment of low or high risk of bias. This is usually the case if the method of concealment is not
described or not described in sufficient detail to allow a definite judgment, for example if the use of assignment envelopes is described,
but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.
3. Blinding – was knowledge of the allocated interventions adequately prevented during the study?
Low risk of bias
Any one of the following.
• No blinding, but the review authors judge that the outcome and the outcome measurement were not likely to be influenced by
lack of blinding.
• Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of
others unlikely to introduce bias.
39Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
High risk of bias
Any one of the following.
• No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.
• Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, and the non-blinding of others likely to introduce bias.
Unclear
Either of the following.
• Insufficient information to permit judgement of low or high risk of bias.
• The study did not address this outcome.
4. Were incomplete outcome data adequately addressed?
Low risk of bias
Any one of the following.
• No missing outcome data.
• Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing
bias).
• Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a
clinically relevant impact on the intervention effect estimate.
• For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing
outcomes not enough to have a clinically relevant impact on observed effect size.
• Missing data have been imputed using appropriate methods.
High risk of bias
Any one of the following.
• Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing
data across intervention groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce
clinically relevant bias in intervention effect estimate.
• For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing
outcomes enough to induce clinically relevant bias in observed effect size.
• ‘As-treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation.
• Potentially inappropriate application of simple imputation.
Unclear
Either of the following.
• Insufficient reporting of attrition/exclusions to permit judgement of low or high risk of bias (e.g. number randomised not stated,
no reasons for missing data provided).
• The study did not address this outcome.
5. Are reports of the study free of suggestion of selective outcome reporting?
Low risk of bias
Either of the following.
40Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
• The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the
review have been reported in the pre-specified way.
• The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that
were pre-specified (convincing text of this nature may be uncommon).
High risk of bias
Any one of the following.
• Not all of the study’s pre-specified primary outcomes have been reported.
• One or more primary outcomes are reported using measurements, analysis methods or subsets of the data (e.g. subscales) that
were not pre-specified.
• One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as
an unexpected adverse effect).
• One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis.
• The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Unclear
Insufficient information to permit judgment of low or high risk of bias. It is likely that the majority of studies will fall into this category.
6. Other sources of potential bias
Low risk of bias
The study appears to be free of other sources of bias.
High risk of bias
There is at least one important risk of bias. For example, the study:
• had a potential source of bias related to the specific study design used; or
• has been claimed to have been fraudulent; or
• had some other problem.
Unclear
There may be a risk of bias, but there is either:
• insufficient information to assess whether an important risk of bias exists; or
• insufficient rationale or evidence that an identified problem will introduce bias.
W H A T ’ S N E W
Last assessed as up-to-date: 6 September 2013.
41Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Date Event Description
24 February 2015 Amended Contact details updated.
C O N T R I B U T I O N S O F A U T H O R S
Wendy Chaboyer: conceived and designed the review, checked the quality of data extraction, analysed or interpreted data, performed
part of data analysis or interpretation, performed part of the writing or editing, made an intellectual contribution to, secured funding
for and approved the final version of the review prior to submission.
Brigid Gillespie: conceived, designed and co-ordinated the review. Extracted data, undertook quality assessment, analysed or interpreted
data, performed part of data analysis or interpretation, performed statistical analysis and completed the first draft of the review. Performed
part of writing or editing, made an intellectual contribution to and approved final review prior to submission. Wrote to study authors,
experts, and companies and acted as guarantor of the review.
Elizabeth McInnes: designed the review, extracted data, undertook quality assessment, analysed or interpreted data, performed part
of data analysis or interpretation, performed part of writing or editing and made an intellectual contribution to the review. Wrote to
study authors, experts, and companies, performed previous work that was the foundation of the current review and approved the final
review prior to submission.
Bridie Kent: analysed or interpreted data, performed part of data analysis or interpretation, performed part of writing or editing, made
an intellectual contribution and approved the final review prior to submission.
Jenny Whitty: analysed or interpreted data, performed part of data analysis or interpretation, performed part of writing or editing,
made an intellectual contribution, performed economic analysis and approved the final review prior to submission.
Lukman Thalib: analysed or interpreted data, performed part of data analysis or interpretation, performed part of writing or editing,
made an intellectual contribution and approved the final review prior to submission.
Contributions of editorial base
Nicky Cullum: advised on methodology, interpretation and protocol content, edited and re-wrote sections of the final review including
re-entering and analysing data, approved the final review prior to publication.
Sally Bell-Syer: co-ordinated the editorial process, advised on methodology, interpretation and content, edited the protocol.
Jo Dumville: checked the re-analysis of the data and checked the final version for publication after NC.
Ruth Foxlee: designed the search strategy and edited the search methods section.
D E C L A R A T I O N S O F I N T E R E S T
Dr Brigid Gillespie; Dr Wendy Chaboyer; Dr Elizabeth McInnes; Dr Bridie Kent; Dr Jennifer Whitty and Dr Lukman Thalib have
no conflicts of interest to declare.
42Repositioning for pressure ulcer prevention in adults (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
S O U R C E S O F S U P P O R T
Internal sources
• NHMRC, Australia.
The NHMRC provided funding for this review from its Centre of Research Excellence Scheme, which funds one or more of the
authors
• Jennifer Whitty received a Research Fellowship funded by the Queensland Government Department of Employment, Economic
Development and Innovation, Queensland Health and Griffith University, Australia.
External sources
• The National Institute from Health Research (NIHR) is the sole funder of the Cochrane Wounds Group, UK.
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
We had originally planned to undertake subgroup analyses based on type of setting (long-term and acute care) and the type of patient.
Although one study was conducted in an acute care setting, the others were set in long-term care facilities, and all with geriatric patients.
We have instead, undertaken a subgroup analysis with regard to tilt regimes (i.e. 30o versus 90o tilt) in relation to participants who
developed a grade 1 pressure ulcer.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Beds; Cost-Benefit Analysis; Patient Positioning [economics; ∗methods]; Pressure Ulcer [∗prevention & control]; Randomized Con-
trolled Trials as Topic; Time Factors
MeSH check words
Adult; Aged; Humans; Middle Aged
43Repositioning for pressure ulcer prevention in adults (Review)
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