Research and Education Opportunities From a Content-Validated, Evidence-

Based Pressure Ulcer Guideline

NPUAP Las Vegas, NV, February 25-26, 2011Presented 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 ContributorsGuideline Developers from the AAWC1 Guideline Department

Co-chairs: Laura Bolton, Ph.D. and Susan Girolami, RN, BSN, CWOCN

• Mona Baharestani PhD ANP, CWOCN CWS

• Teri Berger, RN, CWCN• DeSales Foster MSN, CWOCN, CRNP, GNP-

BC• Linda Foster, RN, BSN, CWCN • Roslyn Jordan, RN, BSN, CWOCN• Sofia Kahn, MD, MBBS, M Gen. Surgery• 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

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 (CAET): Mary Hill, RN, BScN, MN, CETN(C)

• Canadian Association of Wound Care (CAWC): M. Gail Woodbury, PhD, MAPWCA

• Mexican Wound Healing Association (AMCICHAC): Jose Contreras-Ruiz, MD

• National Pressure Ulcer Advisory Panel (NPUAP): Joyce Black PhD, RN, CPSN, CWCN

• Wound Healing Society (WHS): Joie Whitney, PhD, RN, CWCN, FAAN and Laura Bolton, PhD

1. Association for the Advancement of Wound Care2. From North American Wound Care Council (NAWCC) Organizations

Purpose / Continuing Education ObjectivesHighlight 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 WorksTo Prevent Pressure Ulcers

1.7

3.5

13.2

15

LTC 150 Bed Center A Reduced PU Incidence 87%

LTC 110 Bed Center B Reduced PU Incidence 75%

Percent Pressure Ulcer Incidence Per MonthPre-Protocol Protocol (5 mo)

Lyder C et al. Ostomy / Wound Management 2002; 48(4):52-62.

Pre-protocol vs Protocol p = 0.02

Rationale: Evidence-Based Care WorksTo 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

Depth: Thickness Mean + SE heal time % Healed in 12 weeksPartial (N = 134) 31 + 5 days 61% Full (N = 373) 62 + 4 days 36%

Rationale: Real-World Evidence-Based Care1 Predicts 12-week Pressure Ulcer Healing Settings: Home, Acute, Long Term Care2,3

Stage 4 Heel Pressure Ulcer Courtesy la4seniors.com

1. Solutions® Algorithms of Wound Care, www.guidelines.gov2. Bolton L , McNees P, van Rijswijk et al, JWOCN, 2004; ; 31(3):65-713. Smitten A, Bolton L Adv Skin WC, 2005; 18(4):192-193.

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)

Full-thickness PU take twice as long to heal as partial-thickness do2. Prevent PU! Act early to heal them!

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 PhD1Bolton 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

• Rated all 368 recommendations :1 = Not clinically relevant2 = Too confusing to decide3 = Clinically relevant, need to improve4 = Clinically relevant and succinct

• Content Validity Index > 0.75 validated opinion

PT CWOCN RN APN MD PhD

6 15 11 6 3 2

Methods: Evidence Source & Criteria

• Evidence Sources: MEDLINE, EMBASE• AHRQ (former AHCPR) evidence criteria

– Level A: Efficacy: > 2 human pressure ulcer RCTsDiagnostic/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.

Level of Evidence and Content Validity

Research or Education 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

Table 1. Criteria for Research and Education Opportunities

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 Therapists3 Physicians

Specialties: Physiatrist, Plastic Surgeon, Podiatrist2 Ph D researchers

Results: More Belief Than Evidence(N = 368 Recommendations)

Results: Content Validity and Evidence More Research than Education “Ops”

Not ready for PU use

Evidence without belief: Educate!

Belief with weak evidence 68.8%: Research!

Ready for PU use

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 treatmentEnzymatic debridementHydrocolloid dressing use, Monochromatic light stimulation

Results: 68.8% Belief, weak evidence: Research!

• Patient and pressure ulcer assessmentPhysical examLaboratory diagnostic testingDocumenting skin condition Documenting response to treatmentDocumenting 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

• Pressure ulcer treatmentPreventive interventions, support surfaces and pressure

redistribution devicesMechanical and surgical debridement All surgical interventions (e.g. closing or grafting)Antimicrobial cleansing or dressing productsFilling ulcer dead spaceHydrating ulcers or stabilizing temperaturePreventing and managing pain and palliative careCompare advanced/adjunctive treatments to A-level

non-gauze controls

Results: 68.8% Belief, weak evidence: Research!

Results: 4.9% Not Ready for PU Use:Need Research and Education Before

Considering Pressure Ulcer Use

• Pressure ulcer assessmentUsing 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!