Transcript Outcomes Strategy - Association For The Advancement of

Developing a Comprehensive Content
Validated Pressure Ulcer Guideline
Association for the Advancement of Wound Care
Wound Care Specialty Clinical Section,
Guideline Department (GD)
http://www.aawconline.org/
Co-chairs: Susan Girolami, RN, BSN, CWOCN & Laura Bolton, Ph.D.
Mona Baharestani, PhD ANP CWOCN CWS
Teri Berger, RN, CWCN
Linda Foster, RN, BSN, CWCN
Roslyn Jordan, RN, BSN, CWOCN
Sofia Kahn, MD, MBBS, MGenSurgery
Diane Merkle, APRN, CWOCN
Patrick McNees, PhD, FAAN
Laurie Rappl, PT
Stephanie Slayton, PT, DPT, CWS
Jeremy Tamir, MD FAPWCA
Kathy T. Whittington, RN, MS, CWCN
AAWC Wound Care Specialty Council
Clinical Section, Guideline Department
Multi-disciplinary All-Volunteer Guideline
Department (GD) Team
Mission
Develop, optimize and maintain guidelines based
on best available evidence to improve wound care
practice, and serve as a liaison for other guideline
initiatives.
Background: Pressure Ulcers (PU)
 Incidence and costs of PU in USA
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280,000 hospital in-patients in 1993 rose 63% to 455,000 in 20031
257,412 Stage III / IV PU Medicare patients cost >$11 B in 20072
 Heavy clinical and caregiver burdens, worse in elderly
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72.3% of hospital in-patients with a PU were > 65 years of age1
 PU reduce quality of life, increase costs of care
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$37,800 mean charge/hospital stay principally for PU1
 Evidence-based care heals most Stage II PU in < 12 weeks3,4
 Inconsistent protocols of care impair PU prevention and
healing efforts5
1Healthcare
2CMS,
Cost & Utilization Project, AHRQ, 2006
2007
3Kerstein M. et al. Dis Management Health Outcomes, 2001, 9(11):651-636.
4Bolton L, McNees P, van Rijswijk L et al. JWOCN 2004; 31(3):65-71
5Bolton L., et al. Ostomy/Wound Management 2008; 54(11):22-30.
Figure 1. Prospective Cohort Study
More PU healed faster using consistent, evidence-based protocols than
retrospective same-agency controls.
Retrospective (n=120)
EB Home Telemedicine (n=76)
WEEKS TO HEAL
(% HEALED)
25
(10%)
20
15
(58%)
(36%)
(57%)
(34%)
10
5
(83%)
0
Stage II
Stage III
Stage IV
Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53.
Figure 2. PU Cohort Using Evidence-Based Protocols
In Home Care, Long Term Care, LTAC (N = 507)1
Depth: Thickness (th) Mean + SE heal time
Partial-th.(N = 134)
31 + 5 days
Full-th. (N = 373)
62 + 4 days
% Healed in 12 weeks
61%
36%
1 Bolton L, McNees P, van Rijswijk L. et al. JWOCN 2004; 31(3):65-71
Figure 3. Cohort Study: Pressure Ulcer Prevention
Using Evidence-Based Skin Care in Long Term Care 1
Pressure Ulcer Incidence Decreased During 5
Months On Protocol
15
10
P = 0.02
13.2 15
5
0
1.7
August 1999
3.5
Facility A (150 Beds)
87% Decrease
Facility B (110 Beds)
75% Decrease
December 1999
1 Lyder C et al. Ostomy / Wound Management 2002; 48(4):52-62.
Rationale: The brewing PU storm
 Professionals and institutions
are held accountable for PU
development and
management.
 Consistent evidence-based
management improves PU
incidence and outcomes.
 Differences among PU
protocols and guidelines
confuse caregivers reducing
consistency and quality of
care and outcomes.
Objectives of AAWC
Pressure Ulcer Care Initiative (PUCI)1
 Evaluate current PU
guideline recommendations

to assess need for one
comprehensive, contentvalidated PU guideline1
 Compile content validated
unified list of all current PU
guideline recommendations
 Provide best evidence for
each recommendation

to empower PU professionals
and caregivers
1Bolton
L., et al. Ostomy Wound Management 2008; 54(11):22-30.
AAWC Pressure Ulcer Care Initiative (PUCI):
Methods
 Timeline:
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January, 2008 - February, 2009
Guideline and literature searches: Jan-Oct, 08
Compile, simplify published PU guideline items: Feb-Nov 08
Content validate PUCI recommendations: Nov 08-Feb 09
Annotate recommendations with best evidence: Feb 08-ongoing
 Funding:
No industry funding to date
 AAWC provided meeting room at SAWC08 and
 AAWC connections for 12 teleconferences
 Personnel: Volunteer AAWC-Member Guideline Team:
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4 CWOCNs
3 CWCNs
2 Physicians
2 Physical Therapists (1 with PhD)
2 PhDs
AAWC PUCI: Methods

AAWC PUCI Content Validation Survey

Each recommendation rated for clinical relevance
1 = Not relevant
2 = Unable to assess relevance without further information
3 = Relevant but needs minor attention
4 = Very relevant and succinct
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Evidence from MEDLINE, EMBASE searches
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AHRQ (former AHCPR) criteria for levels of evidence
Level A: At least 2 human pressure ulcer RCTs
Level B: > 2 human PU non-randomized CTs or one plus a RCT
Level C: Less than 2 controlled trials; opinion or case series
Each PUCI recommendation annotated with best 3 studies
AAWC PUCI: Results to date
 Compiled 380 recommendations from:
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10 National Guideline Clearinghouse PU
guidelines
Wound Healing Society PU guideline
Draft NPUAP, EPUAP PU guidelines
Example Guideline Differences
Differences
Definitions
Procedures
Content
Focus
Evidence
Validation
Implications for Practice
Improper or inconsistent staging, documentation
affects outcomes and related reimbursement
Inconsistent measurement and monitoring of
progress delays recognition of impaired healing
Effective interventions: Support surfaces? Nutrition?
Care may be inconsistent if content is not uniform.
Provider focused content: e.g. RN, PT. Patient focus
improves PU prevention, diagnosis and care.
Level A ranged from 2 human PU RCTs to animal
studies. Inconsistent clinical relevance of evidence.
Content validation adds validity and clarity to
recommendations, reducing legal liability.
Example Differences In
Pressure Ulcer Measurement Methods
Geometric (longest length x longest perpendicular width)
measurements validated as an effective measure of total
wound area and as a strong predictor of wound healing
(p<0.05; n =260 wound patients)1
1Kantor J, Margolis DJ. 1.
Arch Dermatol 1998; 134: 1571-1574.
Geometric Method of Measuring
PU Length and Width
Ulcer orientation may change over
time increasing error of Body Axis
measurements e.g. head-toe may not
be longest length. Geometric method
avoids this error improving ability to
monitor pressure ulcer progress:
• Across care settings
• During each episode of care
AAWC PUCI Content Validity Survey
Survey and Respondent Characteristics
 Content validation survey to1700 AAWC members +
40,000 readers of O/WM, open to all.
 Clinical relevance ratings of recommendations
•
•
•
•
1 = Not relevant
2 = Too confusing to decide
3 = Relevant, need to improve
4 = Relevant and succinct
 Respondents: N= 31 (26 female, 5 male)
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20 Nurse professionals (10 WOCNs, 1 NP, 1 CWCN)
6 Physical Therapists
2 Physicians (Physiatrist, Plastic Surgeon)
2 Ph. D.
1 Podiatric specialist
 Most time spent in acute inpatient (61%) or outpatient
(33%) care, home care (55%), office practice (50%), or
group practice (33%)
Results: Mean Content Validity Index (CVI): Section 1:
Patient and PU Assessment Parameters (Part 1)
Items with Content Validity Index < 0.750 Require A-Level Evidence to Keep
Assessment Parameter
Mean C. V. I.
Risk assessment
Nutritional
0.922
0.897
• Anthropometric BMI (0.710)
Medical/surgical history
Psycho-social/quality of life
• Sexuality (0.233)
• Culture / ethnicity (0.433)
• Polypharmacy (0.742)
• Vocational rehab. (0.433)
• Peer counseling (0.300)
0.956
0.750
Results: Mean Content Validity Index (CVI): Section 1:
Patient and PU Assessment Parameters (Part 2)
Items with Content Validity Index < 0.750 Require A-Level Evidence to Keep
Assessment Parameter
Environmental
Mean C. V. I.
0.880
• Obtain fall history (0.742)
Physical exam
0.925
• Halogen light: skin (0.379)
• PU length, width
•Geometric (0.742)
•Anatomic (0.677)
Diagnostic tests
Documentation
0.897
0.935
Results: Mean Content Validity Index (CVI): Section 2:
Strategies for PU Prevention and Preventing PU Recurrence
Items with Content Validity Index < 0.750 Require A-Level Evidence to Keep
Prevention Parameter
Mean C. V. I.
Skin inspection & maintenance
0.919
• Use perineal antimicrobial cleanser (0.677)
• Use nonionic to replace anionic surfactants (0.667)
Hydration & nutrition plan of care
Rehabilitative & restorative programs
Position to manage pressure, shear, friction
Off-loading beds, chairs, OR equipment
Interdisciplinary approach
Education
0.941
0.927
0.972
0.935
0.952
0.966
PUCI Results: Guideline Section 3.
Mean CVI of Pressure Ulcer Treatment Strategies (Part 1)
Items with Content Validity Index < 0.750 Require A-Level Evidence to Keep
PU Treatment Strategy
Implement, continue PU prevention
Remove or alleviate PU causes
Manage local & systemic factors
Mean C. V. I.
0.967
0.935
0.896
• Debridement
• Mechanical with gauze (0.733)
• Laser (0.500)
• High flow irrigation (0.700)
• Whirlpool (0.433)
• Biological with maggots (0.700)
• Wound Cleansing with hydrotherapy (0.552)
• Hydrocolloid dressing cost effective (0.710)
PUCI Results: Guideline Section 3.
Mean CVI of Pressure Ulcer Treatment Strategies (Part 2)
Items with Content Validity Index < 0.750 Require A-Level Evidence to Keep
PU Treatment Strategy
Advanced, adjunctive PU modalities
Mean C. V. I.
0.777
• UV light/phototherapy (0.533)
• Pulsed Electromagnetic (0.517)
• Growth factors (0.645)
• Topical phenytoin (0.250)
• Topical estrogen (0.185)
• Infrared stimulation (0.393)
• Pedicle grafts (0.690)
Document management & outcomes
Provide appropriate palliative care
0.968
0.961
Conclusions
 Diverse guideline recommendations reduce consistency of
PU care, confuse professionals and diminish outcomes.
 To improve PU care consistency and outcomes AAWC GD
tested content validity of published PU recommendations
 Most recommendations had strong content validity (> 0.90)
 Areas of confusion included some aspects of:
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Psycho-social/quality of life
Skin and pressure ulcer evaluation
Skin and pressure care modalities for:
• Cleansing
• Debridement
• Advanced adjunctive therapies
Next steps:
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AAWC GD compile evidence supporting all recommendations
Retain recommendations with A-level evidence and/or CVI > 0.75