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: [email protected] ©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!