Trends in Outcome Measures in Wound Care

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Trends in Outcome Measures in Wound Care

• Barbara M. Bates-Jensen PhD, RN, CWOCN
• Assistant Professor,
• UCLA School of Nursing David Geffen School of
  Medicine, Geriatrics

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5 Trends in Outcome Measures for Wound Care

• Specified time points rate of surface area
  changes as benchmarks
• Evaluation of the control group in RCTs
• Use of standardized tools an array of wound
  characteristics
• Real-life data
• Pain outcomes

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Wound Healing Outcome Measures Time

• Taken from Acute Wound Healing
• Inflammatory Phase Injury--Day 4
• Epithelialization
• Proliferative Phase Day 4-5--Day 21
• granulation, contraction, epithelialization
• Remodeling Phase Day 21--Year 1-2
• Scar tissue

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Specified time points

• FULL THICKNESS
• Improve q 2-4 weeks

• PARTIAL THICKNESS
• Improve q 1-2 weeks
• Heal 60 days

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Where do we get the 2-4 weeks time point from?

• Van Rijswijk (1993)
• n48 FT
• mean surface area reduction different at 2 4
  weeks for healed vs non-healed
• size reduction at 2 4 wks predictive

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Specified time points

• Heal faster during 1st 3 months
• Stage II 5.2x more likely to heal in 6 months
  than stage III/IV ulcers
• Stage III/IV improve slower than Stage II ulcers
• In 60 Days
• 75 stage II heal
• lt 20 stage III/IV heal
• Best reported healing rate 59 at 6 months of
  treatment

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Turns out we know quite a bit

• Brandeis, Morris, Nash, Lipsitz (1990)
• Healing increased in first 3 months
• stage II more likely to heal

• Bennett, Bellantoni, Ouslander, (1989)
• n95, NH, on air fluidized therapy over 4 yrs.
• Only 13 (14) healed completely, only 2 healed
  in less than 30 days.
• None treated less than 30 days had 50 reduction
  in size.

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And the information is not new

• Berlowitz and Wilking (1990)
• 79 of 100 ulcers improved
• 40 healed during 6-week follow-up with ordinary
  therapies
• admitted with ulcer

• Ferrell, Osterweil Christenson, (1993)
• PT52 FT32
• 75 of stage II healed in 60 days
• Less than 20 of FT

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Examples

• RCT diabetic foot ulcers, n77, 4 weeks
• Calcium alginate vs vaseline gauze
• Outcomes
• with granulation tissue gt 75
• Calcium alginates signif more P.04
• 40 decrease surface area
• 43 vs 29 NS
• Lalau, JD, Bresson, R, Charpentier, P, et al
  Efficacy and tolerance of calcium alginate versus
  vaseline gauze dressings in the treatment of
  diabetic foot ulcers. Diabetes Metab, 2002
  28(3)223-9.

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Examples

• Retrospective, matched-pairs, quasi-exp, chronic
  wounds with/without cancer, n36, 24 weeks
• Outcomes
• healed
• 44 vs 78, P.02
• Time to healing
• 55(SD 41) days vs 59(SD 48) days NS
• McNees, P, Meneses, KD. Pressure ulcers and other
  chronic wounds in patients with and patients
  without cancer A retrospective, comparative
  analysis of healing patterns. Ostomy Wound
  Manage, 2007 53(2) 70-8.

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Trends in time

• Reporting wounds healed within specified time
• 60 days for PT, 12 weeks typical wound healing
  study time
• Used as benchmark for regulators
• Reporting rate of size change
• Longitudinal outcomes
• Time to recurrence
• Patterns over time

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Patterns over time
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Rate of Surface Area Changes

• Van Rijswijk and Polansky (1994)
• deep stage III/IV
• Ulcers with 39 size reduction at 2 wks healed
  faster
• median time
• 53 versus 70 days

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Rate of surface area changes

• median times
• large size decrease
• 21 days
• small size decrease
• 26 days
• No change in size
• 34 days

• Bates-Jensen (1998)
• n143, retrospective
• 1-wk change in size predictive of time to 50
  healing
• positive predictive value for size decrease 70
• negative predictive value for size increase 87.5

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Evaluation of Control Group in RCTs

• The control group must achieve AT LEAST what can
  be achieved with standard, typical treatment

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An Example,

• Topical nerve GF in heel ulcers
• No chronic ulcers, no PVD, no DM
• RCT with 18/group, topical NGF vs. salt solution
  (vehicle control) daily x6 weeks
• 8 treated patients healed vs 1 control patient
• Ulcer improvement greater in treated group
• 6 week healing rate 44 topical NGF group
• Landi et al 2004, Ann Int Med
• Remember others have shown 40 healing in 6
  weeks all body sites just usual care

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More astute purveyors of research

• Were observers/raters blinded to intervention?
• Topical treatment studies
• Differential intervention dosing?
• Nutritional supplement studies
• Was standard care really provided to control
  group?

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Real-life Data

• What healing outcomes can be expected in real
  life scenarios?
• Natl. Pressure Ulcer Longitudinal Study (NPULS)
• Emphasis on Implementation Science

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Use of Standardized Tools

• Outcome measures wound characteristics

Necrotic Wound
Clean Wound
Granulation Tissue
Granulation fills Wound
Gradual Decrease in Exudate
Epidermal Resurfacing
Scar Tissue Remodeling
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NPUAP Pressure Ulcer Scale for Healing (PUSH)

• Size
• 10 categorical ratings
• Exudate
• None, Minimal, Moderate, Large
• Tissue Appearance
• Healed, Epithelial, Granulation, Slough, Necrotic
• Sum all 3 for total score
• www.npuap.org

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PUSH Tool
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Pressure Sore Status Tool

• 15 items
• 2 non-scored
• location shape
• 13 items rated on 1-5 scale
• 1best 5worst for the item
• Sum for total score (13-65 range)
• Add 13 item scores to obtain total score plot
  on continuum
• Available from author

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Pressure Sore Status Tool

• Size
• Depth
• Edges
• Undermining tunneling
• Necrotic tissue type amount
• Exudate type amount

• Surrounding Tissue Characteristics
• Color
• Induration
• Edema
• Granulation
• Epithelialization

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PSST Tool
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Bates-Jensen Wound Assessment Tool (BWAT)

• Second Generation of the PSST
• Changes to Undermining, Exudate type amount,
  Induration, Edema
• All none present choice for a score of 1
• Name change to reflect use with all chronic
  wounds
• Option for scoring healed wounds
• 1st 4 items score 0 when healed

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Total Score

• Add 13 item scores to obtain total score
• Plot total score on continuum to see progress

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Global Trend

• In Japan,
• DESIGN pressure ulcer healing tool used in
  research as main outcome measure along with
  surface area measures
• DESIGN validated against the Bates-Jensen Wound
  Assessment Tool

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Examples

• RCT collagen protein nutritional supplement vs
  placebo n71, 8 weeks
• Outcomes
• PUSH scale score changes
• Mean 3.6 (SD 4.66) vs 3.2 (SD 4.1) Plt.05
• Lee, SK, Posthauer, ME, Dorner, B, et al.
  Pressure ulcer healing with a concentrated,
  fortified, collagen protein hydrolysate
  supplement A randomized controlled trial. Adv
  Skin Wound Care, 2006 19(2) 92-6.

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Influence of Other Characteristics on Wound
Outcomes

• Acute Sickness Episodes
• Illness severity r/t ulcer development
• Horn, et al JAGS 2004, NPULS study
• Facility level characteristics
• RN staffing gt 0.25 hprd
• Aide staffing gt 2.0 hprd
• LVN turnover rate lt25
• Physical Health Diabetes, Cardiovascular Disease
• Psychosocial Health Caregiver, Patient

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Pain Outcomes

• Pain quality of life are important outcome
  measures for wound healing studies
• Previous research treated as
• Secondary outcomes
• Qualitative comments

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Pain Assessment

• Pain
• ProceduralDressing changes debridement
• Non-procedural painLiving with wound
• Chronic pain screen for LTC
• Do you have (pressure ulcer) pain every
  day/daily?
• Does (pressure ulcer) pain keep you from
  sleeping?
• Does (pressure ulcer) pain keep you from doing
  activities you enjoy?
• Do you have (pressure ulcer) pain now?

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Pain in Pressure Ulcers

• Mild to Moderate pain levels for those with stage
  II/III pressure ulcers
• Use of FACES, VAS, NRS scales
• Most able to differentiate pressure ulcer pain
  from other pain
• Both cognitively intact cognitively impaired
  able to respond
• 75 report pressure ulcer pain, YET only 2-6
  were administered analgesics for pressure ulcer
  pain

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Look for specific tool used in the outcome measure

• Visual Analogue Scale (VAS)
• Numerical Rating Scale (NRS)
• FACES Scale
• McGill Pain Questionnaire
• Pain Detection Screening Tool

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McGill Pain Questionnaire
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Pressure ulcer pain detection tool

• Do you have pressure ulcer pain now?
• Does pressure ulcer pain keep you from doing the
  things/activities you enjoy?
• Does pressure ulcer pain keep you from sleeping?
• Do you have pressure ulcer pain every day?

• Use VAS if yes
• For frail elderly with without cognitive
  impairment
• Measure of impact of pressure ulcer pain on ADLs
  function

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Ulcer Pain Benchmarks

• 132 hospitalized patients with stage I/II PUs
• Ulcer pain assessed with VAS
• Only 44 able to respond
• Mean VAS pain score of those responding
• 4cm stage I
• 3.5cm stage II
• 59 of those responding reported some degree of
  pain
• Dallam, et al (1995)

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Ulcer Pain Benchmarks

• 32 patients in hospitals, nursing homes, home
  health
• Stage II, III, IV ulcers
• Ulcer pain at rest at dressing changes
• Ulcer pain assessed with McGill Pain
  questionnaire
• Szor Bourguignon (1999)

• 84 pain at rest
• 87 pain at dressing changes
• Of which, 18 reported excruciating pain
• 42 pain at rest dressing changes

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More

• Patients from hospitals, nursing homes,
  outpatient clinics with stage II, III, IV
  pressure ulcers, post-op tissue flap for stage
  III/IV, diabetic ulcers
• McGill Pain questionnaire NRS (0-100)
• 35 of stage III/IV reported pain
• 17 of stage II
• Mean NRS
• Stage III/IV 54.2
• Stage II 47.5
• Roth et al (2004)

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Pain outcomes

• Use existing study data to evaluate whether or
  not study results are better than reported pain
  levels
• Inclusion of pain with a standardized tool for
  assessment as part of outcome of studies
  clinical practice

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Conclusions

• These 5 trends in wound outcomes provide
  clinicians researchers with increased
  specificity related to care practices and wound
  healing