developing a comprehensive content validated pressure ulcer guideline association for the...
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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, MGenSurgeryDiane 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 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 72.3% of hospital in-patients with a PU were > 65 years of age1
PU reduce quality of life, increase costs of care $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 Cost & Utilization Project, AHRQ, 20062CMS, 20073Kerstein 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):65-715Bolton 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.
0
5
10
15
20
25
WE
EK
S T
O H
EA
L
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% H
EA
LE
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Stage II Stage III Stage IV
Retrospective (n=120) EB Home Telemedicine (n=76)
(34%)
(83%)
(58%)
(57%)
(10%)
(36%)
Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53.
Depth: Thickness (th) Mean + SE heal time % Healed in 12 weeksPartial-th.(N = 134) 31 + 5 days 61% Full-th. (N = 373) 62 + 4 days 36%
1 Bolton L, McNees P, van Rijswijk L. et al. JWOCN 2004; 31(3):65-71
Figure 2. PU Cohort Using Evidence-Based ProtocolsIn Home Care, Long Term Care, LTAC (N = 507)1
Figure 3. Cohort Study: Pressure Ulcer Prevention
Using Evidence-Based Skin Care in Long Term Care 1
13.2 15
1.7 3.50
5
10
15
Pressure Ulcer Incidence Decreased During 5 Months On Protocol
Facility A (150 Beds)87% DecreaseFacility B (110 Beds)75% Decrease
August 1999
P = 0.02
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, content-validated 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: 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: 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
Evidence from MEDLINE, EMBASE searches 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: 10 National Guideline Clearinghouse PU
guidelines Wound Healing Society PU guideline Draft NPUAP, EPUAP PU guidelines
Differences Implications for Practice
Definitions Improper or inconsistent staging, documentation affects outcomes and related reimbursement
Procedures Inconsistent measurement and monitoring of progress delays recognition of impaired healing
Content Effective interventions: Support surfaces? Nutrition? Care may be inconsistent if content is not uniform.
Focus Provider focused content: e.g. RN, PT. Patient focus improves PU prevention, diagnosis and care.
Evidence Level A ranged from 2 human PU RCTs to animal studies. Inconsistent clinical relevance of evidence.
Validation Content validation adds validity and clarity to recommendations, reducing legal liability.
Example Guideline Differences
Example Differences InPressure 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.
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 careGeometric Method of Measuring
PU Length and Width
AAWC PUCI Content Validity SurveySurvey 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) 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 0.922Nutritional 0.897
• Anthropometric BMI (0.710)Medical/surgical history 0.956Psycho-social/quality of life 0.750
• Sexuality (0.233)• Culture / ethnicity (0.433)• Polypharmacy (0.742)• Vocational rehab. (0.433)• Peer counseling (0.300)
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 Mean C. V. I.
Environmental 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 0.897Documentation 0.935
Results: Mean Content Validity Index (CVI): Section 2: Strategies for PU Prevention and Preventing PU RecurrenceItems 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 0.941Rehabilitative & restorative programs 0.927Position to manage pressure, shear, friction 0.972Off-loading beds, chairs, OR equipment 0.935Interdisciplinary approach 0.952Education 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 Mean C. V. I.
Implement, continue PU prevention 0.967 Remove or alleviate PU causes 0.935
Manage local & systemic factors 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 Mean C. V. I.
Advanced, adjunctive PU modalities 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 0.968Provide appropriate palliative care 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: Psycho-social/quality of life Skin and pressure ulcer evaluation Skin and pressure care modalities for:
• Cleansing• Debridement • Advanced adjunctive therapies
Next steps: AAWC GD compile evidence supporting all recommendations Retain recommendations with A-level evidence and/or CVI > 0.75