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## Complete Summary

#### GUIDELINE TITLE

The use of pressure-relieving devices (beds, mattresses and overlays)
for the prevention of pressure ulcers in primary and secondary care.

#### BIBLIOGRAPHIC SOURCE(S)

National Collaborating Centre for Nursing and Supportive Care. The use
of pressure-relieving devices (beds, mattresses and overlays) for the
prevention of pressure ulcers in primary and secondary care. London
(UK): National Institute for Clinical Excellence (NICE); 2003 Oct. 126
p.

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Pressure ulcers (also called pressure sores, bed sores, pressure
injuries, or decubitus ulcers)

#### GUIDELINE CATEGORY

Prevention\
Risk Assessment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Nursing\
Preventive Medicine\
Surgery

#### INTENDED USERS

Allied Health Personnel\
Health Care Providers\
Hospitals\
Patients\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To evaluate and summarise the clinical and cost evidence for the use
    of pressure-relieving devices in preventing pressure ulcers

-   To highlight gaps in the research evidence

-   To formulate evidence-based and, where possible, cost effective
    clinical practice recommendations on the prevention of pressure
    ulcers using pressure-relieving devices based on the best evidence
    available to the Guideline Development Group (GDG)

-   To consider the resource implications of using pressure-relieving
    devices to prevent pressure ulcers

#### TARGET POPULATION

Individuals of all ages who are vulnerable to or at elevated risk of
developing pressure ulcers (including those undergoing surgery and
post-operative care)

Note: The guideline does not include recommendations on the treatment of
existing pressure ulcers.

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Use of Pressure-Relieving or Pressure-Redistributing Devices to
Prevent Pressure Ulcers**

**Low-tech Devices**

1.  Standard foam mattresses

2.  Alternative foam mattresses/overlays (e.g., high-specification foam,
    viscoelastic, convoluted foam, cubed foam); these are conformable
    and aim to redistribute pressure over a larger contact area

3.  Gel-filled mattresses/overlays

4.  Fluid-filled mattresses/overlays

5.  Fibre-filled mattresses/overlays.

6.  Air-filled mattresses/overlays

**High-tech Devices**

1.  Alternating pressure (AP) devices: the patient lies on air-filled
    sacs, which sequentially inflate and deflate and relieve pressure at
    different anatomical sites for short periods; these devices may
    incorporate a pressure sensor

2.  Air fluidised devices: warmed air is circulated through fine ceramic
    beads covered by a permeable sheet; these allow support over a
    larger contact area

3.  Low air loss (LAL) devices: patients are supported on air-filled
    sacs inflated at a constant pressure, through which air can pass

4.  Turning beds/frames (kinetic or profiling beds): beds that either
    aid manual repositioning of the patient or reposition the patient by
    motor-driven turning and tilting

Note: The guideline is relevant to, but does not cover, risk factors,
skin inspection, seating or general positioning of patients (unrelated
to pressure-relieving devices), and pressure-relieving aids (e.g.,
water-filled gloves). Although aspects of risk assessment related to the
allocation of pressure-relieving devices are covered, the reader is
referred to detailed discussion of this topic in the National Institute
for Clinical Excellence (NICE 2001) guidelines *Inherited Guideline B.
Pressure Ulcer Risk Assessment and Prevention*.

Pressure-relieving aids such as water-filled gloves, sheepskins,
doughnut-type devices, cushions, limb protectors, and seating were not
considered, as recommendations about their use have been issued by NICE
(due for review in 2005). The NICE (2001) guidelines reported that there
is insufficient evidence for sheepskins, wheelchair cushions, and limb
protector pads as pressure-relieving devices.

#### MAJOR OUTCOMES CONSIDERED

-   Incidence of new pressure ulcers

-   Grades of new pressure ulcers

-   Quality adjusted life year

-   Quality of life

-   Cost measures, including cost-effectiveness, costs of
    pressure-relieving devices, and costs of treating pressure ulcers

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Evidence for Clinical Effectiveness**

In April 2001, a Health Technology Assessment (HTA) review was published
on pressure-relieving devices for the prevention and treatment of
pressure ulcers. This review updated the earlier Cochrane systematic
review (Beds, Mattresses and Cushions for Pressure Sore Prevention and
Treatment). For the purposes of this guideline, the HTA review was
updated by the Cochrane Wounds Group (CWG)and National Collaborating
Center for Nursing and Supportive Care (NCC-NSC) staff to provide the
most up-to-date and rigorous source of clinical effectiveness evidence.

**Types of Studies**

-   Randomised controlled trials (RCTs) comparing beds, mattresses, and
    overlays that measured the incidence of new pressure ulcers as an
    objective measure of outcome

-   Economic evaluations were included only if they were part of an RCT.

-   No restriction on the basis of language, publication status, or year
    of study

**Search Strategy for Clinical Effectiveness**

Nineteen electronic databases were searched between 1966 and June 1998
using a sensitive search strategy designed in collaboration with an
information specialist from the Centre for Reviews and Dissemination
(CRD).

Subsequently, the Specialist Trials Register of the CWG (compiled and
regularly updated from searches of the Cochrane Controlled Trials
Register), MEDLINE, Cinahl, Embase, etc., were searched up to October
2002.

The electronic search was supplemented by a hand search of five
specialist wound care journals, twelve conference proceedings, and a
search of systematic reviews held on the National Health Service (NHS)
CRD Database of Abstracts of Reviews of Effectiveness (DARE). The
bibliographies of all retrieved and relevant publications were searched
for further studies. Relevant economic evaluations were searched to add
economic-related search terms to those used in the search for clinical
trials. Authors of trials were contacted and asked to provide details of
any associated economic evaluations.

Details of the search strategy are given in Appendix 2 of the original
guideline document.

**Inclusion/Exclusion Process**

Retrieved studies were assessed for relevance by a single reviewer and
decisions on final inclusion checked by a second reviewer; disagreements
were resolved by discussion with a third reviewer. Rejected studies were
checked by the CWG.

Where study details were lacking, the authors were invited to provide
further information.

**Additional Evidence (Economic, Quality of Life, Epidemiology)**

The aim of the cost-effectiveness review was to identify the most
up-to-date information that was generalisable to the United Kingdom (UK)
context, to facilitate the cost effectiveness modelling process. Cost
data, economic evaluations, epidemiological and quality of life evidence
were all sought as part of this review in order to comprehensively
inform UK estimates and uncertainty ranges of the cost of
pressure-relieving devices, cost of treating pressure ulcers, and
quality of life estimates. Consequently, searches were undertaken by the
National Collaborating Center for Nursing and Supportive Care (NCC-NSC)
to identify:

-   Economic evaluations and costing studies of pressure ulcers and/or
    pressure-relieving devices (cost effectiveness review)

-   Quality of life measures for patients who have pressure ulcers
    and/or who use pressure-relieving devices (quality of life review)

-   Studies that may provide information about the absolute risk of
    developing pressure ulcers for different patient groups in the UK
    (epidemiological review)

For economic evaluations, randomized controlled trials (RCTs) were
sought. For costing and quality of life studies the study design
inclusion criteria were necessarily broad in order to maximise the
likelihood of obtaining useful data. For the epidemiological studies,
cohort designs were sought for incidence studies and cross-sectional
designs for prevalence studies. For all topics, systematic literature
search methods were used, covering a number of databases (see Appendix 2
of the original guideline document). Details concerning selection
criteria for articles can be found in section 5 of the original
guideline document.

**Submission of Evidence Process**

In March 2002, stakeholders registered with NICE were invited to submit
a list of evidence for consideration to ensure that relevant material to
inform the evidence base was not missed.

#### NUMBER OF SOURCE DOCUMENTS

**Clinical Effectiveness**

For the update of the clinical effectiveness review, 54 articles were
assessed for eligibility; seven relevant articles were data extracted
and included. In total, 41 randomised controlled trials were included in
the review, including the seven new studies identified (see Appendix 3
of the original guideline document). Twenty-one trials involved patients
without pre-existing pressure ulcers (intact skin); four included
patients with ulcers greater than stage 1; three included both patients
with and without ulcers, and in 13 studies it was unclear.

**Results of Search/Sift for Economic Evaluations and Cost Studies**

Total number of hits: 1,352\
Potentially relevant from title/abstract: 240\
Full article ordered: 141\
Final number of economic evaluations included: 3\
Final number of costing studies included: 11

**Results of Search/Sift for Quality of Life Studies**

Total number of hits: 302\
Potentially relevant from title/abstract: 9\
Meets eligibility criteria: 9\
Full article ordered and appraised: 9\
Final number included: 7

**Results of Search/Sift Process for Epidemiology Update**

Total number of hits: 2,431\
Potentially relevant from title/abstract: 182\
Meets eligibility criteria from title/abstract: 30\
Full article ordered and appraised: 20\
Final number included: 15

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**I**: Evidence from meta-analysis of randomised controlled trials or at
least one randomised controlled trial

**II**: Evidence from at least one controlled trial without
randomisation or at least one other type of quasi-experimental study

**III**: Evidence from non-experimental descriptive studies, such as
comparative studies, correlation studies, and case-control studies

**IV**: Evidence from expert committee reports or opinions and/or
clinical experience of respected authorities

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis of Randomized Controlled Trials\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Data Abstraction for Clinical Effectiveness**

Data from included trials were extracted by two reviewers into
preprepared data extraction tables. Discrepancies were discussed and
resolved. The following data were extracted from each study:

-   Patient inclusion/exclusion criteria

-   Care setting

-   Key baseline variables by group (e.g., age, sex, baseline risk,
    baseline area of existing ulcers)

-   Description of the interventions and numbers of patients randomised
    to each intervention

-   Description of any co-interventions/standard care

-   Duration and extent of follow-up

-   Outcomes (incidence and severity of new pressure ulcers)

-   Acceptability and reliability of devices if reported

If data were missing from reports, then attempts were made to contact
the authors to complete the information necessary for the critical
appraisal. If studies were published more than once, the most detailed
report was used as the basis of the data extraction.

**Appraisal of Methodological Quality**

The methodological quality of each trial was assessed by two researchers
independently. The following quality criteria were used:

-   Description of inclusion and exclusion criteria used to derive the
    sample from the target population

-   Description of a priori sample size calculation

-   Evidence of allocation concealment at randomisation

-   Description of baseline comparability of treatment groups

-   Outcome assessment stated to be blinded

-   Incident ulcers described by severity grading as well as frequency
    (stage 1 ulcers are not breaks in the skin and are subject to more
    inter-rater variation)

-   Clear description of main interventions

**Data Synthesis**

For each trial, relative risk (RR) was calculated for outcomes such as
number of patients developing ulcers and number of pressure ulcers
healed; 95% confidence intervals (95% CIs) were included when sufficient
detail allowed their calculation. The results from replicated studies
were plotted onto graphs and discussed by narrative review. Unique
comparisons were not plotted and the relative risk is stated in the
text. Individual study details are presented in the evidence table
(Appendix 3 of the original guideline document). Where there was more
than one trial comparing similar devices using the same outcome, and in
the absence of obvious methodological or clinical heterogeneity,
statistical heterogeneity was tested for by chi-squared test. In the
absence of significant statistical heterogeneity, studies with similar
comparisons were pooled using a fixed effects model (Clarke M, & Oxman
AD, eds. Summarising effects across studies. Cochrane Reviewers Handbook
4.0 \[updated July 1999\]; Section 8.3. In: The Cochrane Library
\[database on CD-ROM\]. The Cochrane Collaboration. Oxford: Update
Software; 2000, issue 1). If heterogeneity was observed, both random and
fixed effects models were used to pool the data. All statistical
analysis was performed on Revman (v3.1.1) and conducted by the Cochrane
Wounds Group (CWG).

**Evidence Synthesis and Grading**

For the update of the clinical effectiveness reviews, data from existing
trials of effectiveness of pressure-relieving devices were synthesised
with new trials in a narrative review. There were insufficient trials to
necessitate the re-analysis of existing meta-analyses. The data from
included studies pertaining to costs, economic evaluation, epidemiology,
and quality of life were also qualitatively synthesised into a narrative
format. Information from the reviews on costs, economic evaluations, and
epidemiology was used in the economic modelling. All included studies
are summarised in evidence tables (Appendices 7 to 9 of the original
guideline document) as well as discussed in the appropriate evidence
reviews.

Evidence gradings were assigned to each evidence review using the
evidence hierarchy shown in the field titled \"Rating Scheme for the
Strength of the Evidence\" in this summary and in Table 2 of the
original guideline document, which is the only hierarchy recommended by
the National Institute for Clinical Excellence (NICE) at the time of
writing. (It should be noted that the hierarchy strictly applies to
questions of effectiveness.)

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

**Guideline Development Group (GDG)**

The guideline recommendations were developed by a multidisciplinary and
lay Guideline Development Group (GDG) convened by the National Institute
for Clinical Excellence (NICE)-funded National Collaborating Centre for
Nursing and Supportive Care (NCC-NSC) with membership approved by NICE.
Members included representatives from:

-   patient groups

-   nursing

-   field of tissue viability and wound care

-   medicine

-   allied health

-   researchers

-   staff from the NCC-NSC

The GDG met six times between May 2002 and July 2003. An additional
meeting to formulate patient-related review questions relating to the
guideline topic was held in July 2002.

**Formulating and Grading Recommendations**

In order for the GDG to formulate a clinically useful recommendation, it
was agreed that the following factors be considered:

-   The best available evidence, with preference given to empirical
    evidence over expert judgement, including:

    -   a profile of the cost data

    -   results of economic modelling

    -   effectiveness data taking into account the strength of evidence
        (level, quality, precision) as well as the size of effect and
        relevance of the evidence

    -   where reported, data regarding additional outcomes, such as
        comfort, adverse effects, and patient acceptability, associated
        with the use of pressure-relieving devices

-   A comparison between the outcomes for alternative interventions
    where possible (this was limited because key comparisons such as
    between high-tech devices and high-specification foam mattresses are
    not available)

-   The feasibility of interventions, including the cost of the
    intervention; acceptability to clinicians, patients, and carers; and
    appropriateness of device

-   The balancing of benefits against risks including, where reported,
    all patient-relevant endpoints (including adverse effects, comfort,
    and acceptability where reported) and the results of the economic
    modelling

-   The applicability of the evidence to groups defined in the scope of
    the guideline, having considered the profile of patients recruited
    to the trials and data obtained from our review of the
    epidemiological data and quality of life literature

This information was presented to the group in the form of evidence
tables and accompanying summaries, which were discussed at GDG meetings.
Where the GDG identified issues that impacted on considerations of the
evidence and the ability to formulate implementable and pragmatic
guideline recommendations, these were summarised in the GDG commentary
sections.

The GDG agreed that the existing Royal College of Nursing (RCN)
guideline recommendations on pressure-relieving devices would provide a
useful starting point for formulating recommendations in the light of
the additional evidence pertaining to clinical effectiveness and the new
economic evidence. These guideline recommendations were subsequently
revised to reflect the views of the GDG and their interpretation of the
current evidence. Issues with the data, interpretation of the evidence,
and the wording were discussed until there was agreement on the wording
and grading.

Where the GDG decided that hard evidence was essential before any
recommendations could be considered, recommendations for future research
were made (see Section 7 of the original guideline document). The group
then ranked these in order of importance so that the top five could be
included in the NICE version. As described in the original guideline
document, there were shortcomings in the data, and so some of the review
questions could not be fully and satisfactorily answered by empirical
evidence. In some instances extrapolated evidence was used; this
sometimes resulted in Level I evidence being graded as Level IV,
particularly where the evidence was extrapolated beyond trial subjects
and settings (see Section 6 of the original guideline document). The
grading of the recommendations was agreed at a GDG meeting, using the
scheme described in the section of this summary titled \"Rating Scheme
for the Strength of the Recommendations\" and in Table 8 of the original
guideline document.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**\*Recommendation Grades**

**A**: Directly based on category I evidence

**B**: Directly based on:

-   category II evidence, or

-   extrapolated recommendation from category I evidence

**C**: Directly based on:

-   category III evidence, or

-   extrapolated recommendation from category I or II evidence

**D**: Directly based on:

-   category IV evidence

-   extrapolated recommendation from category I, II, or III evidence

**\*\*Grading Scheme**

***Evidence***

**1**: Generally consistent finding in a majority of multiple acceptable
studies

**2**: Either based on a single acceptable study, or a weak or
inconsistent finding in multiple acceptable studies

**3**: Limited scientific evidence that does not meet all the criteria
of acceptable studies or absence of directly applicable studies of good
quality. This includes expert opinion.

\*From Eccles M, Mason J. (2001) How to develop cost conscious
guidelines. *Health Technology Assessment* 5(16).

\*\*Adapted from Waddell G, Feder G, McIntosh A, et al (1996) *Low Back
Pain Evidence Review*. London: Royal College of General Practitioners.

#### COST ANALYSIS

**Cost Effectiveness Review Methods**

To fulfill the Department of Health (DoH) and Welsh Assembly Government
remit, the National Institute for Clinical Excellence (NICE) requested
that the cost-effectiveness evidence of pressure-relieving devices be
assessed. In accordance with the objectives of the scope, cost
effectiveness was addressed in the following way:

-   A comparison of the cost and cost effectiveness of
    pressure-relieving beds, mattresses, and overlays compared with
    standard support surfaces

-   An investigation of which types of pressure-relieving surfaces are
    the most cost effective for prevention of pressure ulcers

**Incremental Cost Per Pressure Ulcer Averted**

In the first instance, the incremental cost effectiveness between
different devices could be reported in terms of the incremental cost per
pressure ulcer averted. This is a ratio of the difference in costs to
the health service of using different devices divided by the difference
in the number of pressure ulcers averted. The cost to the health service
includes any savings derived through using pressure-relieving devices:

= Difference in costs to the health service

[between pressure-relieving devices]{.underline}

Difference in number of pressure ulcers averted

**Incremental Cost Per Quality-Adjusted Life Year (QALY)**

If possible, the likely decrement in QALYs associated with a pressure
ulcer of a particular stage could be estimated and cost effectiveness
then be reported in terms of the cost per QALY gained. Costs incurred by
patients and their informal carers is documented and reported where
available:

= Difference in costs to the health service

[between pressure-relieving devices]{.underline}

Difference in QALYs

Information requirements for cost effectiveness models (incremental cost
per pressure ulcer averted and incremental cost per QALY) included the
following:

-   Comparison of the relative risk of developing a pressure ulcer
    between devices

-   Epidemiology of the absolute risk of developing a pressure ulcer for
    patient groups

-   Cost of device per patient

-   Cost of treating pressure ulcers

-   Estimate of QALYs

Results of the cost-effectiveness evidence retrieval and appraisal can
be found in section 5.7 of the original guideline document. A simple
cost-effectiveness model is also presented. The model highlighted a lack
of evidence for key model parameters for estimating the cost
effectiveness of different pressure-relieving devices.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review\
Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The guideline was validated through two consultations.

1.  The first draft of the guideline (the full guideline, National
    Institute for Clinical Excellence \[NICE\] guideline, and Quick
    Reference Guide) were consulted with Stakeholders and comments were
    considered by the Guideline Development Group (GDG).

2.  The final consultation draft of the full guideline, the NICE
    guideline, and the Information for the Public were submitted to
    stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review
prior to publication.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Evidence categories (I-IV) and recommendation grades (A-D and 1-3) are
defined at the end of the Major Recommendations field.

**Risk Assessment and Prevention**

**Identifying Individuals Vulnerable to or at Elevated Risk of Pressure
Ulcers**

**3** - Assessing an individual\'s risk of developing pressure ulcers
should involve both informal and formal assessment procedures.

**3** - Risk assessment should be carried out by personnel who have
undergone appropriate training to recognise the risk factors that
contribute to the development of pressure ulcers and know how to
initiate and maintain correct and suitable preventative measures.

**3** - The timing of risk assessment should be based on each individual
case. However, it should take place within 6 hours of the start of
admission to the episode of care.

**3** - If an individual is considered not to be vulnerable to or at
elevated risk of pressure ulcers on initial assessment, reassessment
should occur if there is a change in an individual\'s condition that
increases risk (see recommendations under \"Risk Factors\" below).

**3** - All formal assessments of risk should be documented/recorded and
made accessible to all members of the interdisciplinary team.

**Use of Risk Assessment Tools**

**1** - Risk assessment tools should only be used as an *aide memoire*
and should not replace clinical judgment.

If use of a risk assessment tool is preferred (to assist clinical
judgment), it is recommended that a scale that has been tested for use
in the same specialty is chosen.

**Risk Factors**

**2** - An individual\'s potential to develop pressure ulcers may be
influenced by the following intrinsic risk factors, which therefore
should be considered when performing a risk assessment:

-   Reduced mobility or immobility

-   Sensory impairment

-   Acute illness

-   Level of consciousness

-   Extremes of age

-   Vascular disease

-   Severe chronic or terminal illness

-   Previous history of pressure damage

-   Malnutrition and dehydration

**2** - The following extrinsic risk factors are involved in tissue
damage and should be removed or diminished to prevent injury: pressure,
shearing, and friction.

**2** - The potential of an individual to develop pressure ulcers may be
exacerbated by the following factors, which therefore should be
considered when performing a risk assessment: medication and moisture to
the skin.

**Patient Factors to Consider in Selecting Pressure-relieving Device**

**D** - Decisions about which pressure-relieving device to use should be
based on cost considerations and an overall assessment of the
individual. Holistic assessment should include all of the following and
should not be based solely on scores from risk assessment tools:

-   Identified levels of risk

-   Skin assessment

-   Comfort

-   General health state

-   Lifestyle and abilities

-   Critical care needs

-   Acceptability of the proposed pressure-relieving equipment to the
    patient and/or carer

**Provision for All Individuals Vulnerable to Pressure Ulcers**

**B** - All individuals assessed as being vulnerable to pressure ulcers
should, as a minimum provision, be placed on a high-specification foam
mattress with pressure-relieving properties

**Patients at Elevated Risk of Developing Pressure Ulcers**

**D** - Although there is no research evidence that high-tech pressure
relieving mattresses and overlays are more effective than
high-specification (low-tech) foam mattresses and overlays, professional
consensus recommends that consideration should be given to the use of
alternating pressure or other high-tech pressure-relieving systems:

-   As a first-line preventative strategy for people at elevated risk as
    identified by holistic assessment

-   When the individual\'s previous history of pressure ulcer prevention
    and/or clinical condition indicates that he or she is best cared for
    on a high-tech device

-   When a low-tech device has failed

**Patients Undergoing Surgery**

**D** - All individuals undergoing surgery and assessed as being
vulnerable to pressure ulcers should, as a minimum provision, be placed
on either a high-specification foam theatre mattress or other
pressure-redistributing surface.

**Repositioning and 24-hour Approach to Provision of Pressure-Relieving
Devices**

**D** - The provision of pressure-relieving devices needs a 24- hour
approach. It should include consideration of all surfaces used by the
patient

**D** - Support surface and positioning needs should be assessed and
reviewed regularly and determined by results of skin inspection, patient
comfort, ability, and general state. Thus repositioning should occur
when individuals are on pressure relieving devices

**D** - The management of a patient in a sitting position is also
important. Even with appropriate pressure relief, it may be necessary to
restrict sitting time to less then 2 hours until the condition of an
individual with elevated risk changes

**Coordinated Time Specified Approach**

**D** - A pressure ulcer reduction strategy should incorporate a
coordinated approach to the acquisition, allocation, and management of
pressure-relieving equipment. The time elapsing between assessment and
use of the device should be specified in this strategy.

**Education and Information-giving**

**D** - All healthcare professionals should be educated about:

-   Pressure ulcer risk assessment and prevention

-   Selection, use, and maintenance of pressure-relieving devices

-   Patient education and information giving

**D** - Individuals vulnerable to or at elevated risk of developing
pressure ulcers and their carers should be informed verbally and in
writing about:

-   The prevention of pressure ulcers using pressure-relieving
    strategies

-   The use and maintenance of pressure-relieving devices

-   Where they can seek further advice and assistance

**Definitions**:

**Evidence Categories**

**I**: Evidence from:

-   meta-analysis of randomised controlled trials, or

-   at least one randomised controlled trial

**II**: Evidence from:

-   at least one controlled study without randomisation, or

-   at least one other type of quasi-experimental study

**III**: Evidence from non-experimental descriptive studies, such as
comparative studies, correlation studies and case-control studies

**IV**: Evidence from expert committee reports or opinions and/or
clinical experience of respected authorities

**Recommendation Grades**

**A**: Directly based on category I evidence

**B**: Directly based on:

-   category II evidence, or

-   extrapolated recommendation from category I evidence

**C**: Directly based on:

-   category III evidence, or

-   extrapolated recommendation from category I or II evidence

**D**: Directly based on:

-   category IV evidence

-   extrapolated recommendation from category I, II, or III evidence

**Grading Scheme**

***Evidence***

**1**: Generally consistent finding in a majority of multiple acceptable
studies

**2**: Either based on a single acceptable study, or a weak or
inconsistent finding in multiple acceptable studies

**3**: Limited scientific evidence that does not meet all the criteria
of acceptable studies or absence of directly applicable studies of good
quality. This includes expert opinion.

#### CLINICAL ALGORITHM(S)

Algorithms are provided in the original guideline document for pressure
ulcer risk assessment and prevention.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Although the guideline does not cover treatment of existing pressure
    ulcers, its recommendations will be useful in preventing pressure
    ulcers on other areas of the patient\'s body and further pressure
    damage to existing pressure ulcers.

-   Prevention of pressure ulcers has benefits for both the
    health-related quality of life of the patient/carer and the health
    services.

**Subgroups Most Likely to Benefit**

Groups at high risk of developing a pressure ulcer generally include
those with the following intrinsic risk factors:

-   Reduced mobility or immobility

-   Sensory impairment

-   Acute illness

-   Level of consciousness

-   Extremes of age

-   Previous history of pressure damage

-   Vascular disease

-   Severe chronic or terminal illness

-   Malnutrition

#### POTENTIAL HARMS

Equipment safety is an important issue in relation to the use of
pressure-relieving devices. In particular, cross-infection can happen if
equipment is inadequately decontaminated between patients and injury is
possible if users of such equipment (patients, carers, and healthcare
professionals) have not been educated about appropriate use.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   As with any clinical guideline, recommendations may not be
    appropriate for use in all circumstances. One limitation of a
    guideline is that it simplifies clinical decision-making. Decisions
    to adopt any particular recommendations must be made by
    practitioners in the light of:

    -   Available resources

    -   Local services, policies, and protocols

    -   The patient\'s circumstances and wishes

    -   Available personnel and devices

    -   Clinical experience of the practitioner

    -   Knowledge of more recent research findings

-   The recommendations in this document are not designed to be used as
    a \"stand-alone\" product and should be used in conjunction with the
    existing National Institute for Clinical Excellence (NICE 2001)
    guideline on risk assessment and prevention, which can be found on
    the NICE Web site at:
    <http://www.nice.org.uk/pdf/clinicalguidelinepressuresoreguidancercn.pdf>.

-   Healthcare professionals should use their clinical judgement and
    consult with patients when applying the recommendations, which aim
    to reduce the negative physical, social, and financial impact of
    pressure ulcers.

**Terminology**

1.  Where the term \"carer\" is used, this refers to unpaid carers as
    opposed to paid carers (e.g., care workers).

2.  There is much debate in the literature and amongst experts about the
    appropriateness of the term \"pressure-relieving.\" For the purposes
    of this guideline, \"pressure-relieving\" is used as an umbrella
    term for all pressure-reducing and pressure-redistributing devices.
    The term is also consistent both with recent guidelines and the
    evidence review on which this guideline is partly based. A glossary
    of pressure-relieving devices is given in Appendix 1 of the original
    guideline document.

3.  Pressure ulcers have also been known previously as pressure sores,
    bedsores, decubitus ulcers, and pressure injuries.

4.  The Guideline Development Group (GDG) decided to use the terms
    \"vulnerable to pressure ulcers\" and \"at elevated risk of pressure
    ulcers\" rather than the commonly used terms \"at risk\" and \"at
    very high risk.\" The latter terms imply that there are reliable
    cut-off points for identifying risk, yet there is little evidence to
    show that using a pressure ulcer risk scale alone is better than
    clinical judgement for assessing risk or that allocation of
    pressure-relieving devices can be linked to risk assessment scales.
    \"Vulnerable to pressure ulcers\" means someone who is likely to
    develop pressure ulcers unless special care is given (special care
    meaning a planned intervention following holistic assessment); \"at
    elevated risk of pressure ulcers\" means someone who is especially
    likely to develop pressure ulcers unless special care is given.

5.  Pressure-relieving devices can be divided into low-tech and
    high-tech devices.\*

*Low-tech devices*. These provide a conforming support surface that
distributes the body weight over a large area, and include the
following:

-   Standard foam mattresses

-   Alternative foam mattresses/overlays (e.g., high-specification foam,
    viscoelastic, convoluted foam, cubed foam); these are conformable
    and aim to redistribute pressure over a larger contact area.

-   Gel-filled mattresses/overlays

-   Fluid-filled mattresses/overlays

-   Fibre-filled mattresses/overlays

-   Air-filled mattresses/overlays

*High-tech devices*. These are dynamic systems that include the
following:

-   Alternating pressure devices: the patient lies on air-filled sacs,
    which sequentially inflate and deflate and relieve pressure at
    different anatomical sites for short periods; these devices may
    incorporate a pressure sensor.

-   Air fluidised devices: warmed air is circulated through fine ceramic
    beads covered by a permeable sheet; these allow support over a
    larger contact area.

-   Low air loss devices: patients are supported on air-filled sacs
    inflated at a constant pressure, through which air can pass.

-   Turning beds/frames (kinetic or profiling beds): beds that either
    aid manual repositioning of the patient or reposition the patient by
    motor-driven turning and tilting.

\*From Cullum N, Nelson EA, Sheldon T (2001) Systematic reviews of wound
care management (5): pressure-relieving beds, mattresses and cushions
for the prevention and treatment of pressure sores. In Cullum N, Nelson
EA, Flemming K et al. Systematic reviews of wound care management: (5)
beds; (6) compression; (7) laser therapy, therapeutic ultrasound,
electrotherapy and electromagnetic therapy. *Health Technology
Assessment* 5(9).

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Implementation in the National Health Service**

Local health communities should review their existing service provision
for pressure ulcer risk assessment and prevention including the use of
pressure-relieving devices (beds, mattresses, and overlays) for the
prevention of pressure ulcers in primary and secondary care as they
develop their Local Delivery Plans. The review should consider the
resources required to implement the recommendations set out in the
original guideline document and described in the \"Major
Recommendations\" field above, the people and processes involved, and
the timeline over which full implementation is envisaged. It is in the
interests of patients that the implementation timeline is as rapid as
possible.

Relevant local clinical guidelines and protocols should be reviewed in
the light of this guidance and revised accordingly.

Suggested audit criteria for the use of pressure-relieving devices are
listed in Section 8 of the original guideline document. These can be
used as the basis for local clinical audit, at the discretion of those
in practice.

**Dissemination of the Guideline**

The guideline has been produced in both full and summary formats and as
a version for the public (Information for the Public). Full copies of
the guideline are available through the NICE Web site
([http://www.nice.org.uk](http://www.nice.org.uk/)) in Portable Document
Formant (PDF) and the summary through the National Electronic Library
for Health (NeLH) (<http://www.nelh.nhs.uk/>) and National Guideline
Clearinghouse ([http://www.guideline.gov](http://www.guideline.gov/)).

#### IMPLEMENTATION TOOLS

Audit Criteria/Indicators\
Clinical Algorithm\
Patient Resources\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

National Collaborating Centre for Nursing and Supportive Care. The use
of pressure-relieving devices (beds, mattresses and overlays) for the
prevention of pressure ulcers in primary and secondary care. London
(UK): National Institute for Clinical Excellence (NICE); 2003 Oct. 126
p.

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Oct

#### GUIDELINE DEVELOPER(S)

National Collaborating Centre for Nursing and Supportive Care - National
Government Agency \[Non-U.S.\]

#### SOURCE(S) OF FUNDING

National Institute for Clinical Excellence (NICE)

#### GUIDELINE COMMITTEE

Guideline Development Groups

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Guideline Developers*: Ms Jo Rycroft-Malone, Project Officer (RCN
Institute); Ms Elizabeth McInnes, Formerly Project Officer RCN Institute

*Expert Consensus Group Members*: Ms Maureen Benbow, Tissue Viability
Nurse, Leighton Hospital; Dr Mary R. Bliss, Consultant Geriatrician,
Bryning Day Hospital; Dr Michael Clark, Senior Research Fellow,
University of Wales College of Medicine, Cardiff; Ms Linda Clarke,
Patient Services Manager, Spinal Injuries Association, London; Mrs Carol
Dealey, Research Fellow, University Hospital Birmingham NHS Trust; Dr
Krzysztof Gebhardt, Clinical Nurse Specialist for Pressure Sore
Prevention, St Georges Hospital, London; Ms Deborah Hofman, Clinical
Nurse Specialist, Wound Healing Unit, The Churchill Hospital, Oxford; Ms
Pennie Roberts, Head of Physiotherapy Studies, Leeds Metropolitan
University; Dr Shyam Rithalia, Senior Lecturer, University of Salford;
Professor John Young; Consultant Geriatrician St Lukes Hospital,
Bradford

*Pressure-relieving Devices Group Members*: Dr Paul Yerrell (Group
Leader) Oxford Brookes University; Mr Malcolm Blanch, Carers UK; Dr
Michael Clark, Wound Healing Research Unit, University of Wales College
of Medicine; Mr Mark Collier, United Lincolnshire Hospitals NHS Trust;
Mr Louis Hecht, Tissue Viability Society; Mr Nick Malone, Oxford
Radcliffe Trust; Dr Jed Rowe, Royal College of Physicians; Dr Eileen
Scott, North Tees & Hartlepool NHS Trust; Mrs Fiona Stephens, Royal
College of Nursing (now East Kent PCTs); Mr Adam Thomas, RADAR; Dr
Elizabeth White, College of Occupational Therapists

*National Collaborating Centre for Nursing and Supportive Care Members*:
Ms Sue Boyt, Administrator; Dr Gill Harvey, Director; Ms Rosa Legood,
Health Economist (seconded from Health Economics Research Centre,
University of Oxford); Ms Elizabeth McInnes, Senior R&D Fellow; Mr Robin
Snowball, Information Scientist (seconded from Cairns Library, John
Radcliffe Hospital, Oxford); Mr Edward Weir, Centre Manager

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the guideline development group (GDG) were required to
make formal declarations of interest at the outset, which were recorded.
GDG members were also asked to declare interests at the beginning of
each GDG meeting. This information is recorded in the meeting minutes
and kept on file at the National Collaborating Centre for Nursing and
Supportive Care (NCC-NSC).

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) format
from the [National Institute for Clinical Excellence (NICE) Web
site](http://www.nice.org.uk/page.aspx?o=CG007).

Print copies: Available from the National Health Service (NHS) Response
Line 0870 1555 455, ref: N0330. 11 Strand, London, WC2N 5HR.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   The prevention and treatment of pressure ulcers. Quick reference
    guide. National Institute for Health and Clinical Excellence (NICE),
    2005 Sep. 2 p. Electronic copies: Available in Portable Document
    Format (PDF) from the [National Institute for Clinical Excellence
    (NICE) Web
    site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29883).

-   Pressure ulcers and pressure relieving devices\--some common
    questions and answers. National Institute for Clinical Excellence,
    2003 Oct. 5 p. Electronic copies: Available in Portable Document
    Format (PDF) from the [NICE Web
    site](http://www.nice.org.uk/page.aspx?o=90617).

-   Pressure ulcer prevention. Pressure ulcer risk assessment and
    prevention, including the use of pressure-relieving devices (beds,
    mattresses and overlays) for the prevention of pressure ulcers in
    primary and secondary care. Clinical practice algorithms. National
    Institute for Clinical Excellence, 2003 Oct. 4 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [NICE Web
    site](http://www.nice.org.uk/page.aspx?o=89895).

Print copies: Available from the National Health Service (NHS) Response
Line 0870 1555 455. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Section 8 of the [original
guideline document](http://www.nice.org.uk/page.aspx?o=CG007).

#### PATIENT RESOURCES

The following is available:

-   Pressure ulcers - prevention and treatment. Understanding NICE
    guidance - information for people with pressure ulcers (also known
    as pressure sores or bed sores) and those at risk of developing
    pressure ulcers, their families and carers, and the public. National
    Institute for Health and Clinical Excellence (NICE), 2005 Sep. 18 p.

Electronic copies: Available from the [National Institute for Clinical
Excellence (NICE) Web
site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29887).

Print copies: Available from the National Health Service (NHS), 11
Strand, London, WC2N 5HR. Response Line 0870 1555 455, ref N0479.

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on July 13, 2004. The information
was verified by the guideline developer on November 26, 2004.

#### COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the
guideline developer\'s copyright restrictions.

### DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008