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, MGenSurgeryDiane 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

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.

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, 20062CMS, 20073Kerstein 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):65-715Bolton L., et al. Ostomy/Wound Management 2008; 54(11):22-30.

Figure 1. Prospective Cohort Study More PU healed faster using consistent, evidence-based protocols than retrospective same-agency controls.

0

5

10

15

20

25

WE

EK

S T

O H

EA

L

(

% H

EA

LE

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Stage II Stage III Stage IV

Retrospective (n=120) EB Home Telemedicine (n=76)

(34%)

(83%)

(58%)

(57%)

(10%)

(36%)

Kobza L, Scheurich A. Ostomy/Wound Management 2000; 46(10):48-53.

Depth: Thickness (th) Mean + SE heal time % Healed in 12 weeksPartial-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 ProtocolsIn Home Care, Long Term Care, LTAC (N = 507)1

Figure 3. Cohort Study: Pressure Ulcer Prevention

Using Evidence-Based Skin Care in Long Term Care 1

13.2 15

1.7 3.50

5

10

15

Pressure Ulcer Incidence Decreased During 5 Months On Protocol

Facility A (150 Beds)87% DecreaseFacility B (110 Beds)75% Decrease

August 1999

P = 0.02

December 1999

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

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.

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.

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

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 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 Each PUCI recommendation annotated with best 3 studies

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

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

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 careGeometric Method of Measuring

PU Length and Width

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%)

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 0.922Nutritional 0.897

• Anthropometric BMI (0.710)Medical/surgical history 0.956Psycho-social/quality of life 0.750

• Sexuality (0.233)• Culture / ethnicity (0.433)• Polypharmacy (0.742)• Vocational rehab. (0.433)• Peer counseling (0.300)

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 0.897Documentation 0.935

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

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)

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 0.968Provide appropriate palliative care 0.961

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