1. Research and Education Opportunities From a Content-Validated, Evidence- Based 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.comllbolton@gmail.com ©Association for the Advancement of Wound Care 2011

2. Collaborating Contributors Guideline Developers from the AAWC 1 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 Evaluators 2 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 Care 2. From North American Wound Care Council (NAWCC) Organizations

3. 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

4. Rationale: Evidence-Based Care Works To Prevent Pressure Ulcers Lyder C et al. Ostomy / Wound Management 2002; 48(4):52-62. Pre-protocol vs Protocol p = 0.02

5. 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

6. Depth: Thickness Mean + SE heal time % Healed in 12 weeks Partial (N = 134) 31 + 5 days 61% Full (N = 373) 62 + 4 days 36% Rationale: Real-World Evidence-Based Care 1 Predicts 12-week Pressure Ulcer Healing Settings: Home, Acute, Long Term Care 2,3 Stage 4 Heel Pressure Ulcer Courtesy la4seniors.com 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. Predictors of Healing 3 Area < 3.4 cm 2 (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 do 2. Prevent PU! Act early to heal them!

7. 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! 1 Bolton 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.

8. Methods 1 : 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 1 Bolton 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.

9. 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 relevant  2 = Too confusing to decide  3 = Clinically relevant, need to improve  4 = Clinically relevant and succinct Content Validity Index > 0.75 validated opinion PTCWOCNRNAPNMDPhD 61511632

10. 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

11. 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 Black 1 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

12. 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 Opportunities for Research or Education A Level Evidence and CVI value > 0.75Strong evidence & validity: Ready for implementation 0.75Strong content validity only: Opportunity for research A Level evidence and CVI value < 0.75Strong evidence only: Opportunity for education <A Level Evidence and CVI value < 0.75Opportunity for Research and Education Level of Evidence and Content Validity Research or Education Opportunities A Level Evidence + CVI value > 0.75Strong evidence & validity: Ready for implementation 0.75Strong content validity only: Research Opportunity A Level evidence + CVI value < 0.75Strong evidence only: Education Opportunity <A Level Evidence + CVI value < 0.75Opportunity for Research and Education Table 1. Criteria for Research and Education Opportunities

13. 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

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

15. 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

16. 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

17. 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)

18. 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

19. 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: 68.8% Belief, weak evidence: Research!

20. 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

21. 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!