1. 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

2. 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.

3. Background: Pressure Ulcers (PU) §Incidence and costs of PU in USA l 280,000 hospital in-patients in 1993 rose 63% to 455,000 in 2003 1 l 257,412 Stage III / IV PU Medicare patients cost >$11 B in 2007 2 §Heavy clinical and caregiver burdens, worse in elderly l 72.3% of hospital in-patients with a PU were > 65 years of age 1 §PU reduce quality of life, increase costs of care l $37,800 mean charge/hospital stay principally for PU 1 §Evidence-based care heals most Stage II PU in < 12 weeks 3,4 §Inconsistent protocols of care impair PU prevention and healing efforts 5 1 Healthcare Cost & Utilization Project, AHRQ, 2006 2 CMS, 2007 3 Kerstein M. et al. Dis Management Health Outcomes, 2001, 9(11):651-636. 4 Bolton L, McNees P, van Rijswijk L et al. JWOCN 2004; 31(3):65-71 5 Bolton L., et al. Ostomy/Wound Management 2008; 54(11):22-30.

4. Figure 1. Prospective Cohort Study More PU healed faster using consistent, evidence-based protocols than retrospective same-agency controls. (34%) (83%) (58%) (57%) (10%) (36%) Healing: 42% healed in each group (p=0.627) Velocity of area (p=0.43) and depth (p=0.09) reduction were similar Greater total ulcer depth reduction in AQAg group (Fig.1; p= 0.042) Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53.

5. Depth: Thickness (th) Mean + SE heal time % Healed in 12 weeks Partial-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 Protocols In Home Care, Long Term Care, LTAC (N = 507) 1

6. Figure 3. Cohort Study: Pressure Ulcer Prevention Using Evidence-Based Skin Care in Long Term Care 1 August 1999 P = 0.02 December 1999 1 Lyder C et al. Ostomy / Wound Management 2002; 48(4):52-62.

7. 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.

8. Objectives of AAWC Pressure Ulcer Care Initiative (PUCI) 1 § Evaluate current PU guideline recommendations l to assess need for one comprehensive, content- validated PU guideline 1 §Compile content validated unified list of all current PU guideline recommendations §Provide best evidence for each recommendation l to empower PU professionals and caregivers 1 Bolton L., et al. Ostomy Wound Management 2008; 54(11):22-30.

9. AAWC Pressure Ulcer Care Initiative (PUCI): Methods §Timeline: January, 2008 - February, 2009 lGuideline and literature searches: Jan-Oct, 08 lCompile, simplify published PU guideline items: Feb-Nov 08 lContent validate PUCI recommendations: Nov 08-Feb 09 lAnnotate recommendations with best evidence: Feb 08-ongoing §Funding: No industry funding to date lAAWC provided meeting room at SAWC08 and lAAWC connections for 12 teleconferences §Personnel: Volunteer AAWC-Member Guideline Team: l4 CWOCNs l3 CWCNs l2 Physicians l2 Physical Therapists (1 with PhD) l2 PhDs

10. AAWC PUCI: Methods §AAWC PUCI Content Validation Survey l 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 l 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 l Each PUCI recommendation annotated with best 3 studies

11. AAWC PUCI: Results to date §Compiled 380 recommendations from: l 10 National Guideline Clearinghouse PU guidelines l Wound Healing Society PU guideline l Draft NPUAP, EPUAP PU guidelines

12. DifferencesImplications 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

13. 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 1 Kantor 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 care Geometric Method of Measuring PU Length and Width

14. 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) l 20 Nurse professionals (10 WOCNs, 1 NP, 1 CWCN) l 6 Physical Therapists l 2 Physicians (Physiatrist, Plastic Surgeon) l 2 Ph. D. l 1 Podiatric specialist §Most time spent in acute inpatient (61%) or outpatient (33%) care, home care (55%), office practice (50%), or group practice (33%)

15. 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 0.922 Nutritional 0.897 Anthropometric BMI (0.710) Medical/surgical history 0.956 Psycho-social/quality of life 0.750 Sexuality (0.233) Culture / ethnicity (0.433) Polypharmacy (0.742) Vocational rehab. (0.433) Peer counseling (0.300)

16. 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 0.897 Documentation 0.935

17. 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 0.941 Rehabilitative & restorative programs 0.927 Position to manage pressure, shear, friction 0.972 Off-loading beds, chairs, OR equipment 0.935 Interdisciplinary approach 0.952 Education 0.966

18. 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)

19. 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 0.968 Provide appropriate palliative care 0.961

20. 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: l Psycho-social/quality of life l Skin and pressure ulcer evaluation l Skin and pressure care modalities for: Cleansing Debridement Advanced adjunctive therapies § Next steps: l AAWC GD compile evidence supporting all recommendations l Retain recommendations with A-level evidence and/or CVI > 0.75