Research and Education Opportunities
From a Content-Validated, EvidenceBased Pressure Ulcer Guideline
NPUAP Las Vegas, NV, February 25-26, 2011
Presented on Behalf of AAWC Guideline Department
And NAWCC Research, Education Collaborators
Laura Bolton, PhD, Adj. Assoc. Professor Surgery (Bioengineering),
Robert Wood Johnson Univ. Medical School,
New Brunswick, NJ, USA E-mail: llbolton@gmail.com
©Association for the Advancement of Wound Care 2011
Collaborating Contributors
Guideline Developers from the
AAWC1 Guideline Department
Collaborating Research and
Education Evaluators2
• Association for the Advancement of Wound
Care (AAWC): Sue Girolami, RN, BSN, CWOCN,
Laura Bolton, PhD
• Canadian Assoc. for Enterostomal Therapy
• DeSales Foster MSN, CWOCN, CRNP, GNP-BC (CAET): Mary Hill, RN, BScN, MN, CETN(C)
• Linda Foster, RN, BSN, CWCN
• Canadian Association of Wound Care
• Roslyn Jordan, RN, BSN, CWOCN
(CAWC): M. Gail Woodbury, PhD, MAPWCA
• Sofia Kahn, MD, MBBS, M Gen. Surgery
•Mexican Wound Healing Association
• Diane Merkle, APRN, CWOCN
(AMCICHAC): Jose Contreras-Ruiz, MD
• Patrick McNees, PhD, FAAN
•National Pressure Ulcer Advisory Panel
• Laurie Rappl, PT
(NPUAP): Joyce Black PhD, RN, CPSN, CWCN
• Stephanie Slayton, PT, DPT, CWS
• Jeremy Tamir, MD FAPWCA
•Wound Healing Society (WHS): Joie Whitney,
• Kathy T. Whittington, RN, MS, CWCN
PhD, RN, CWCN, FAAN and Laura Bolton, PhD
Co-chairs: Laura Bolton, Ph.D. and Susan
Girolami, RN, BSN, CWOCN
• Mona Baharestani PhD ANP, CWOCN CWS
• Teri Berger, RN, CWCN
1. Association for the Advancement of Wound Care
2. From North American Wound Care Council (NAWCC) Organizations
Purpose / Continuing Education Objectives
Highlight PU Research & Education Needs
• Describe how to unify
pressure ulcer guidelines
using content validity and
best available evidence
• Identify good evidence
that is not believed:
educational opportunities
• Recognize widely held
opinions that need
research to find if they
work and are safe
Rationale: Evidence-Based Care Works
To Prevent Pressure Ulcers
Percent Pressure Ulcer Incidence Per Month
Pre-Protocol
Protocol (5 mo)
Pre-protocol vs Protocol p = 0.02
LTC 110 Bed Center B Reduced PU
Incidence 75%
LTC 150 Bed Center A Reduced PU
Incidence 87%
15
3.5
1.7
13.2
Lyder C et al. Ostomy / Wound Management 2002; 48(4):52-62.
Rationale: Evidence-Based Care Works
To Heal Pressure Ulcers: In Home Telemedicine
More Wounds Healed Faster With Fewer Visits
Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53
Rationale: Real-World Evidence-Based Care1
Predicts 12-week Pressure Ulcer Healing
Settings: Home, Acute, Long Term Care2,3
Full-thickness PU take twice as long to heal as partialthickness do2. Prevent PU! Act early to heal them!
Stage 4 Heel Pressure Ulcer
Courtesy la4seniors.com
Depth: Thickness
Partial (N = 134)
Full
(N = 373)
Predictors of Healing3
Area < 3.4 cm2 (p<0.0001)
Partial-thickness(p<0.0001)
Unknown depth (p=0.02)
Hydrocolloid or fiber use (p=0.02)
Mean + SE heal time
31 + 5 days
62 + 4 days
% Healed in 12 weeks
61%
36%
1. Solutions® Algorithms of Wound Care, www.guidelines.gov
2. Bolton L , McNees P, van Rijswijk et al, JWOCN, 2004; ; 31(3):65-71
3. Smitten A, Bolton L Adv Skin WC, 2005; 18(4):192-193.
Rationale:1 Improve Pressure Ulcer Outcomes!
• Professionals confused. PU guidelines differ in:
– Scope, definitions, validation, evidence criteria,
procedures recommended
– Recommendations for risk assessment, diagnosis,
prevention, treatment and outcome measures.
• Improve consistency, quality of PU care. Inform!
– Strength of Evidence > Strength of Opinion: Educate!
– Strength of Opinion > Strength of Evidence: Research!
– Strong Evidence and Opinion: Implement!
1Bolton
LL, Girolami S, Slayton S, et al. Assessing the need for developing a
comprehensive content-validated pressure ulcer guideline. Ostomy / Wound
Management 2008; 54(11):22-30.
Methods1 : Guideline Development
• Timeline: January, 2008 - February, 2009
–
–
–
–
12 Guidelines and literature searches: Jan-Oct, 08
Compile, simplify recommendations: Feb-Nov 08
Content validate recommendations: Nov 08-Feb 09
MEDLINE derived best evidence: Feb 08-Feb 11
• Funding AAWC only: annual meeting; monthly
teleconferences
• Volunteer Interdisciplinary AAWC Guideline Dept
– 4 CWOCN, 3 CWCN, 2 MD, 1 PT, 1 PT PhD, 2 PhD
1Bolton
LL, Girolami S, Slayton S, et al. Assessing the need for developing a
comprehensive content-validated pressure ulcer guideline. Ostomy Wound
Management 2008; 54(11):22-30.
Methods:
Content Validation by Online Survey
• Dec 2008-Feb 2009—Nov 2009 invitation to:
– 20,000 Ostomy/Wound Management readers
– 1700 AAWC members
• 31 Multidisciplinary Respondents : Degrees
PT
6
CWOCN
15
RN
11
APN
6
MD
3
PhD
2
• Rated all 368 recommendations :
1 = Not clinically relevant
2 = Too confusing to decide
3 = Clinically relevant, need to improve
4 = Clinically relevant and succinct
• Content Validity Index > 0.75 validated opinion
Methods:
Evidence Source & Criteria
• Evidence Sources: MEDLINE, EMBASE
• AHRQ (former AHCPR) evidence criteria
– Level A:
 Efficacy: > 2 human pressure ulcer RCTs
 Diagnostic/screening: > 2 PU cohorts validate
– Level B: 1 RCT plus > 1 PU non-random CTs
– Level C: < 2 controlled trials; opinion, case series
Methods: Collaborating Organization NAWCC
Research and Education Evaluators
Association for the Advancement of Wound Care (AAWC):
•Sue Girolami , RN, BSN, CWOCN, Laura Bolton, PhD
Canadian Association for Enterostomal Therapy (CAET):
• Mary Hill, RN, BScN, MN, CETN(C)
Canadian Association of Wound Care (CAWC):
• M. Gail Woodbury, PhD, MAPWCA
National Pressure Ulcer Advisory Panel (NPUAP):
•Joyce Black1 PhD, RN, CPSN, CWCN
Wound Healing Society (WHS):
•Joie Whitney, PhD, RN, CWCN, FAAN, Laura Bolton, PhD
•AMCICHAC (Mexican Wound Healing Association:
•Jose Contreras-Ruiz, MD, Former President of AMCICHAC
Methods:
Research & Education Evaluation
Each evaluator analyzed a portion of the 368 content-validated,
evidence-linked recommendations using criteria in Table 1.
Table 1. Criteria for Research and Education Opportunities
Level of Evidence and Content
Research or Education
Validity
Opportunities
A Level Evidence + CVI value > 0.75 Strong evidence & validity:
Ready for implementation
<A Level Evidence + CVI value > 0.75 Strong content validity only:
Research Opportunity
A Level evidence + CVI value < 0.75 Strong evidence only:
Education Opportunity
<A Level Evidence + CVI value < 0.75 Opportunity for Research
and Education
Results: Content Validity Survey
Multidisciplinary Respondents
• Gender: 26 female, 5 male
• Settings: acute, chronic, home or office
• Professional credentials
 20 Nurse professionals
 10 WOCNs, 1 NP, 1 CWCN
 6 Physical Therapists
 3 Physicians
 Specialties: Physiatrist, Plastic Surgeon, Podiatrist
 2 Ph D researchers
Results: More Belief Than Evidence
(N = 368 Recommendations)
26.4%
N = 97
63.0
N = 232
10.6%
N = 39
Level A
Level B
Level C
Results: Content Validity and Evidence
More Research than Education “Ops”
Evidence Level
>0.75
CVI __
CVI <0.75
Level C
4.9%
Level B
Level A
Not ready for PU use
0.0%
1.9%
Evidence without belief: Educate!
Belief with weak evidence 68.8%: Research!
10.6%
Ready for PU use
24.5%
58.2%
Results:
1.9% Evidence without belief: Educate!
• Patient/pressure ulcer assessment
Patient body mass index
Culture/ethnicity
How to measure ulcer length, width
• Pressure ulcer treatment
Enzymatic debridement
Hydrocolloid dressing use,
Monochromatic light stimulation
Results:
68.8% Belief, weak evidence: Research!
• Patient and pressure ulcer assessment
Physical exam
Laboratory diagnostic testing
Documenting skin condition
Documenting response to treatment
Documenting pressure ulcer stage
Stage I
Heel Pressure Ulcer
(Source: Medscape)
Results:
68.8% Belief, weak evidence: Research!
• Pressure ulcer prevention / prevent recurrence
 Skin Inspection and maintenance: All aspects
 Nutrition, fluid intake, appetite stimulants for pressure
ulcer prevention and treatment
 Mobility, exercise, positioning and pressure
redistribution interventions and equipment
 Interdisciplinary approach, consults and educational
interventions
Results:
68.8% Belief, weak evidence: Research!
• Pressure ulcer treatment
Preventive interventions, support surfaces and
pressure redistribution devices
Mechanical and surgical debridement
All surgical interventions (e.g. closing or grafting)
Antimicrobial cleansing or dressing products
Filling ulcer dead space
Hydrating ulcers or stabilizing temperature
Preventing and managing pain and palliative care
Compare advanced/adjunctive treatments to A-level
non-gauze controls
Results: 4.9% Not Ready for PU Use:
Need Research and Education Before
Considering Pressure Ulcer Use
• Pressure ulcer assessment
Using halogen lamp to assess PU or anatomic
length and width to assess ulcer area change
•
Pressure ulcer treatment
Surgical or sharp as the first choice of
debridement, laser or pulsatile lavage debridement
Topical phenytoin, estrogen or skin equivalents
Conclusions
• Real-world evidence shows evidence-based care works.
• AAWC “Guideline of Pressure Ulcer Guidelines”
– Accessible at www.aawconline.org and at
–
–
–
–
National Guideline Clearinghouse www.guidelines.gov
Measured evidence and opinion strength
Provides basis to identify research, education opportunities.
Unique guideline development process highlights what we know,
don’t know and need to know.
• Collaboration worked to find research/education needs
– Members of AAWC, AMCICHAC , CAWC, CAET, NPUAP, WHS
• Much research and education are needed to improve
pressure ulcer patient outcomes!