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Developing a Comprehensive Content Validated Pressure Ulcer Guideline

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.

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Developing a Comprehensive Content Validated Pressure Ulcer Guideline

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  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 • 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, 2006 2CMS, 2007 3Kerstein 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):65-71 5Bolton 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. (10%) (58%) (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) (57%) (34%) (83%) Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53.

  5. Figure 2. PU Cohort Using Evidence-Based Protocols In Home Care, Long Term Care, LTAC (N = 507)1 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

  6. Figure 3. Cohort Study: Pressure Ulcer Prevention Using Evidence-Based Skin Care in Long Term Care 1 P = 0.02 August 1999 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 • 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.

  9. 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

  10. 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 forlevels 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

  11. 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

  12. 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

  13. 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 care Geometric Method of Measuring PU Length and Width

  14. 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%)

  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 ParameterMean 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 ParameterMean 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 RecurrenceItems with Content Validity Index < 0.750 Require A-Level Evidence to Keep • Prevention ParameterMean 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 StrategyMean 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 StrategyMean 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: • 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

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