Presentation on theme: " Development process What’s new in the recommendations Level A recommendations."— Presentation transcript:
Development process What’s new in the recommendations Level A recommendations
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
Guideline development 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 NPUAP GDG EPUAP
European Launch International Pressure Ulcer Guidelines EPUAP GDG Dr. Carol Dealey United Kingdom Chair Dr. Michael Clark United Kingdom Dr. Lisette Schoonhoven The Netherlands Dr. Katrien Vanderwee Belgium Coördinator Prof. Dr. Tom Defloor Belgium Anne Witherow Northern Ireland
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
EPUAP were leading PU prevention guideline ◦ In collaboration with the American NPUAP 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
Identify scientific literature on pressure ulcer prevention and treatment in several electronic databases : 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
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 ◦ Human studies Period limitation: > 01/01/1998
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: 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
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).
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)
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
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 ILarge randomized trial with clear-cut results (and low risk of error) IISmall randomized trial with uncertain results (and moderate to high risk of error) IIINon randomized trial with concurrent or contemporaneous controls IVNon randomized trial with historical controls VCase Series with no controls. Specify number of subjects.
Evidence tables allowed the SWGs to develop guideline statements Uniformity and internal consistency Guideline statements and supporting text were sent to GDG for review
Identifies the strength of cumulative evidence supporting a recommendation Strength of Evidence Ratings for Each Recommendation LevelCriteria AThe 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) BRecommendation 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) CThe 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.
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
Whole process could be followed by stakeholders on a website
Register as stakeholder ◦ 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
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 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
The guidelines will be in several formats: ◦ Quick Reference Guide ◦ Clinical Practice Guideline ◦ Technical version ◦ Patient and carer version
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
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
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!
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
Full guideline documentation runs to several hundred pages! ‘Quick’ versions run to over 80 pages!
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 alert will be sent out
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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
The next challenge is get these guidelines implemented into clinical practice That is probably a harder task to achieve! It will be a good point for future discussion
Classification New Components ◦ Use validated system NPUAP-EPUAP Pressure Ulcer Classification System 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.
Intact skin with non- blanchable 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.
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.
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.
Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present. Often include undermining and tunneling.
Focus upon assessment of healing (PUSH tool) Pain in pressure ulcer, as categories change pain increases Use of dc electrotherapies?
Topics Etiology Risk Assessment Skin Assessment Nutrition Repositioning Support Surfaces Special Population: Patients in operating room
Topics 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
Topics Debridement Dressings Assessment and Treatment of Infection Biophysical Agents Growth Factors & Biological Dressings Operative Repair Palliative Care
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
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
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
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!
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!
Lots of pressure ulcer activity but few strong recommendations Guidance for future research?
Prevention B level 12 C level50 No SOE5 Treatment B level44 C level294