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Development process
What’s new in the recommendations
Level A recommendations
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Develop joint EPUAP/NPUAP pressure ulcer
prevention and treatment guideline
Guideline is intended for
◦ Use of health care professionals
◦ Hospital, long term care, assisted living at home
◦ Guide patients and carers on range of prevention
strategies
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Guideline development
GDG NPUAP
Group (GDG)– from both
EPUAP and NPUAP
Carol Dealey – Chair EPUAP
GDG
Janet Cuddigan & Diane
Langemo – Co-Chairs of
NPUAP GDG
6 members from each
society
GDG EPUAP
EPUAP GDG
Dr. Carol Dealey
United Kingdom
Chair
Dr. Katrien Vanderwee
Belgium
Coördinator
Dr. Michael Clark
United Kingdom
Prof. Dr. Tom Defloor
Belgium
Dr. Lisette Schoonhoven
The Netherlands
Anne Witherow
Northern Ireland
European Launch International Pressure Ulcer Guidelines
NPUAP GDG
Dr. Janet Cuddigan
Co-Chair
Nebraska, USA
Dr. Diane Langemo
Co-Chair
North Dakota, USA
Dr. Joyce Black
Nebraska, USA
Dr. Mona Baharestani
Tennessee, USA
Mary Ellen Posthauer
Indiana, USA
Evan Call
Utah, USA
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EPUAP were leading PU prevention guideline
◦ In collaboration with the American NPUAP
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NPUAP were leading PU treatment guideline
◦ In collaboration with EPUAP
1.
Identifying the
Evidence
◦ Databases
◦ Search strategy
2.
Evaluating the
Evidence
◦ Evidence Tables
◦ Quality of Evidence
◦ Level of Evidence
3. Drafting
Recommendations
4. Strength of Evidence
Rating (A, B, C)
5. Summarizing
supporting evidence
6. Peer Review
– GDG
– Stakeholders
– EPUAP-NPUAP Boards
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Identify scientific literature on pressure ulcer
prevention and treatment in several electronic
databases :
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PubMed
Cinahl (Cumulative Index to Nursing & Allied Health Literature)
EMBASE (The Exerpta Medica Database)
AMED (Allied and Complementary Medicine Database)
Cochrane databases (Cochrane Database of Systematic
Reviews, The Cochrane Central Register of Controlled Trials)
 Health Technology Assessment database
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Sensitive search strategy developed in
PubMed
◦ Pressure ulcer
AND
◦ Prevention OR Aetiology OR Prevention OR Skin assessment
OR Risk assessment OR Nutrition OR Repositioning
AND
◦ Design (including systematic review, meta-analysis, RCT,
CCT, cohort, case-control, case series n>10)
AND
Period limitation:
◦ Human studies
> 01/01/1998
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All the references were screened by the GDG
based on inclusion criteria:
◦ Published in a peer reviewed journal
◦ Primarily focuses on one of the following topics
 Prevention or Treatment of PU
 Causes of PU
 PU risk assessment
◦ Abstract available
◦ Study
 Has to use one of the following designs:
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Randomised controlled trial
Controlled clinical trial
Cohort studies
Case-control studies
Case series
 Should include at least 10 subjects
◦ Review / Meta-analysis
 Has to use the Cochrane methodology
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Exclusion criteria:
◦ Economic evaluations
◦ Animal studies (unless other not available)
◦ Studies of chronic wounds (unless sub- group of 10
or > subjects with pressure ulcers was analyzed
separately)
◦ Note: If treatment was proven effective in other chronic
wounds, the treatment was considered for use in pressure
ulcers in the absence of studies of humans with pressure
ulcers (SOE at C level).
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Existing Evidence Summaries
◦ Evidence Tables from Previous Guidelines or other
Sources:
AHCPR (AHRQ)
Paralyzed Veterans of America
Registered Nurses of Ontario
NICE
◦ Previous guidelines (AMDA, AWMA, EPUAP, NICE, PVA,
RNAO, Singapore, WOCN, WHS)
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The full papers of relevant references were
obtained
Small Working Groups (SWGs) reviewed the
literature for specific topics
All papers were evaluated by 2 members of
SWGs
◦ First reviewer
 Evidence table
 Methodology checklist
◦ Second reviewer
 Checks evidence table
 Checks methodology checklist
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Evidence table
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Methodology checklist
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The GDG undertook a quality check of 10% of
evidence tables, randomly selected
Level of Evidence was noted for each study,
using a classification system adapted from
Sackett (1987)
Level
I
Large randomized trial with clear-cut results (and low risk of error)
II
Small randomized trial with uncertain results (and moderate to high risk of
error)
III
Non randomized trial with concurrent or contemporaneous controls
IV
Non randomized trial with historical controls
V
Case Series with no controls. Specify number of subjects.
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Evidence tables allowed the SWGs to develop
guideline statements
Uniformity and internal consistency
Guideline statements and supporting text
were sent to GDG for review
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Identifies the strength of cumulative evidence
supporting a recommendation
Strength of Evidence Ratings for Each Recommendation
Level
Criteria
A
The recommendation is supported by direct scientific evidence from
properly designed & implemented controlled trials on pressure ulcers in
humans (or humans at risk for pressure ulcers) providing statistical
results that consistently support the guideline statement. (Level I
studies required)
B
Recommendation are supported by direct scientific evidence from
properly designed & implemented clinical series on pressure ulcers in
humans (or humans at risk for pressure ulcers) providing statistical
results that consistently support the recommendation. (Level II, III, IV,
V studies)
C
The recommendation is supported by indirect evidence (e.g., studies in
normal human subjects, humans with other types of chronic wounds,
animal models) and/or expert opinion.
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SWGs summarized the evidence supporting
each recommendations
Recommendations with SOE rating A or B
required an explicit summary of one or more
studies of human subjects with a PU or at risk
for PU development.
The level of evidence for each study is also
identified
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Whole process could be followed by
stakeholders on a website
http://www.pressureulcerguideline.org
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Register as stakeholder
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Interest in PU
Contribute to guideline by reading draft guideline
Ensuring all relevant evidence has been included
Commenting on guideline
Stakeholders
◦ Individual
◦ Representative for
a society /organisation
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Every stakeholder was informed
◦ About search filter, inclusion criteria, retrieved
references and given the opportunity to comment
◦ When statements were available for review and
given the opportunity to comment on the
statements both by suggesting literature that might
have been missed and commenting on the text
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The full GDG met to discuss each comment
and review the suggested literature
The guideline text was then revised in the
light of the literature/comments as
appropriate
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The guidelines will be in several formats:
◦ Quick Reference Guide
◦ Clinical Practice Guideline
◦ Technical version
◦ Patient and carer version
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This version has all the guideline statements
and some text. It does not include references.
It will be available on the website for free
download as separate prevention and
treatment guidelines.
It will also be available in hard copy with both
prevention and treatment included – for
purchase
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This version will have the methodology, the
statements and the underpinning evidence
and all the references.
It will include both prevention and treatment
It will be available for purchase in a number
of formats: book, CD-Rom, on-line
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Will contain a brief description of the
methodology, all the papers reviewed, the
evidence tables, list of papers reviewed but
not used.
It will be on the websites
It will probably only be accessed by the
seriously mad or those doing PhD studies!
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This will not form part of the international
guideline products – it is too difficult to
produce a document that reflects all the
varied healthcare symptoms.
We were advised that this was best
undertaken at a national level. NPUAP will
produce a version for the USA
It would be good to have details of any
national versions on the EPUAP website so
that people can be directed to them
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Full guideline documentation runs to several
hundred pages!
‘Quick’ versions run to over 80 pages!
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When can you get your hands on them?
The QRG treatment and CPG are with the copy
editor at present. We have just agreed on the
artwork for the covers.
We hope to have them on the website by
mid-September, but an email alert will be
sent out
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Bulgarian
Dutch
French
German
Hebrew
Japanese
Spanish
Swedish
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We want these guidelines to be widely used
as possible.
We know they may need to be adapted to
meet local needs
However, we would expect that the
International Guidelines would be
acknowledged.
Guidance will be provided at the front of the
document on the precise wording etc
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The next challenge is get these guidelines
implemented into clinical practice
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That is probably a harder task to achieve!
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It will be a good point for future discussion
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New Components
◦ Use validated system
 NPUAP-EPUAP Pressure Ulcer Classification System
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We agree on:
◦ Definition of pressure ulcer
◦ Definition of four “categories or stages”
◦ Additional categories for USA
 Suspected Deep Tissue Injury
 The “Unstageables”
•
A pressure ulcer is localized injury to the
skin and/or underlying tissue usually
over a bony prominence, as a result of
pressure, or pressure in combination
with shear. A number of contributing or
confounding factors are also associated
with pressure ulcers; the significance of
these factors is yet to be elucidated.
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Intact skin with nonblanchable redness of
a localized area
usually over a bony
prominence.
Discoloration of the
skin, warmth, edema,
hardness or pain may
also be present .
Darkly pigmented skin
may not have visible
blanching.
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Partial thickness
loss of dermis
presenting as a
shallow open ulcer
with a red pink
wound bed,
without slough.
May also present
as an intact or
open/ruptured
serum-filled
blister.
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Full thickness tissue
loss. Subcutaneous
fat may be visible
but bone, tendon or
muscle are not
exposed. Some
slough may be
present. May include
undermining and
tunneling.
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Full thickness
tissue loss with
exposed bone,
tendon or muscle.
Slough or eschar
may be present.
Often include
undermining and
tunneling.
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Focus upon assessment of healing (PUSH tool)
Pain in pressure ulcer, as categories change
pain increases
Use of dc electrotherapies?
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Etiology
Risk Assessment
Skin Assessment
Nutrition
Repositioning
Support Surfaces
Special Population: Patients in operating room
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Classification of PU
Assessment & Monitoring Healing
Nutrition for Healing
Pain Assessment & Management
Support Surfaces
Principles of Wound Bed Preparation &
Biofilms (Scientific Explanation to Guide
Treatment Decisions)
Wound Cleansing
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Debridement
Dressings
Assessment and Treatment of Infection
Biophysical Agents
Growth Factors & Biological Dressings
Operative Repair
Palliative Care
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Offer high-protein mixed oral nutritional
supplements and/or tube feeding, in addition
to the usual diet, to individuals with
nutritional risk and pressure ulcer risk
because of acute or chronic diseases, or
following a surgical intervention
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Repositioning should be undertaken to
reduce the duration and magnitude of
pressure over vulnerable areas of the body
Frequency of repositioning will be influenced
by variables concerning the individual
(Strength of Evidence = C) and the support
surface in use
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Use higher-specification foam mattresses
rather than standard hospital foam
mattresses for all individuals assessed as at
risk for pressure ulcer development
There is no evidence of the superiority of one
higher-specification foam mattress over
alternative higher-specification foam
mattresses
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Both alternating pressure active support
overlays and replacement mattresses have a
similar efficacy in terms of pressure ulcer
incidence
That’s all the ‘A’ level recommendations
covering prevention!
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Consider the use of direct contact
(capacitative) electrical stimulation (ES) in the
management of recalcitrant Category/Stage
II, III, and IV pressure ulcers to facilitate
wound healing
Only ‘A’ level recommendation in treatment
of pressure ulcers!
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Lots of pressure ulcer activity but few strong
recommendations
Guidance for future research?
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Prevention
B level
C level
No SOE
Treatment
B level
C level
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