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©2016 National Pressure Ulcer Advisory Panel | www.npuap.org

Beyond Skin Changes At Life’s End (Scale)- Next Steps

R. Gary Sibbald, MD, M.Ed., DSc (Hons),

FRCPC (Med, Derm), FAAD, MAPWCA

Professor of Public Health & Medicine,

University of Toronto

Clinical Editor, Advances in Skin & Wound Care

Dr. Sibbald’s Potential Conflicts of InterestClinical Editor- Advances in Skin & Wound Care

Company/ Agency Paid

Lecturers

Advisory Board

Members

Research

Participants

Systagenix/ Acelity √ √ √

Mölnlycke √ √ √

RNAO- Registered Nurses

Association of Ontario

√ √

Galderma √

Leo √

Hollister √ √ √

Health Point/ Smith & Nephew √ √

Valeant √ √ √

Abbott/ Abbvie √ √ √

MH-CCAC, MHLTC, HQO =

Province of Ontario Government

√ √

Eli Lilly Canada Inc. √

Ferris Manufacturing Comp √

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Participants will explore:

• Why Are You Advocating This Terminology/ Concept?

– What is SCALE?

– How can we unify terminology?

– What will the regulator say?

• What Is The Evidence Supporting It?

– Swedish study + other presentations

• What Are The Benefits/Consequences Of This

Terminology?

– Need to measure degree of damage

(existing dermatology scoring systems)

– Can we produce a skin damage/

skin failure definition supported

by a scoring system

What is the Definition of SCALE?

“Physiological changes that occur as a

results of the dying process may affect

the skin and soft tissues and may

manifest as observable (objective)

changes in skin color, turgor, or

integrity, or as subjective symptoms

such as localized pain.” p. 226

Sibbald RG, Krasner DL, Lutz J. SCALE: Skin changes at Life’s End: Final consensus Statement: October 1, 2009. ASWC. 2010; 23(5):225-236.

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SCALE: How can we unify terminology?

“Skin changes at life’s end are a

reflection of compromised skin

(reduced soft-tissue perfusion,

decreased tolerance to external

insults, and impaired removal of

metabolic wastes).” P. 228

“ The skin is essentially a window into the health of the body,

and if read correctly, can provide a great deal of insight into

what is happening inside the body.” p. 226

Sibbald RG, Krasner DL, Lutz J. SCALE: Skin changes at Life’s End: Final consensus Statement: October 1, 2009. ASWC. 2010; 23(5):225-236.

Why are you advocating for this statement- SCALE

‘SCALE changes can be unavoidable

and may occur with the application of

appropriate interventions that meet or

exceed the standard of care.’ P. 228

Sibbald RG, Krasner DL, Lutz J. SCALE: Skin changes at Life’s End: Final consensus Statement: October 1, 2009. ASWC. 2010; 23(5):225-236.

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SCALEHow can we unify terminology?

“loss of skin integrity from any of a

number of factors, including

equipment or devices, incontinence,

chemical irritants, chronic exposure to

body fluids, skin tears, pressure,

shear, friction, and infections. ” P. 229

Sibbald RG, Krasner DL, Lutz J. SCALE: Skin changes at Life’s End: Final consensus Statement: October 1, 2009. ASWC. 2010; 23(5):225-236.

Terms Definition © Sibbald 2017

SCALE- Skin Changes at Life’s End –

may not have multiorgan failure

Pressure injuries, edema, ischemia (gangrene), purpura,

skin tears, blisters, moisture associated skin changes,

infections etc.

Unavoidable pressure injuries SCALE + multiorgan dysfunction,

Acute illnesses, Chronic illnesses, other situations

Stevens- Johnson Syndrome,

Staphylococcal Scalded Skin

Syndrome, Erythroderma

Skin injury (moderate- severe) but most have the ability

to repair the injury & skin does not fail

Skin Failure: Pressure injuries + other

SCALE manifestations with Multiorgan

Failure Syndrome, Acute illness,

Chronic illness

• skin and underlying tissue die due to

hypo-perfusion

• severe dysfunction or failure of other

organ systems

Multiorgan dysfunction (Failure)

System Irwin & Rippe. Intensive Care Medicine.

Archived from the original on November 7, 2005.

Presence of altered organ function in acutely ill patients

such that homeostasis cannot be maintained without

intervention. It usually involves two or more organ

systems

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What Will the Regulator Think? CMS F314: End of Life

“Continuing weight loss and

failure of a pressure ulcer* to heal

despite reasonable efforts to

improve caloric and nutrient intake

may indicate the resident is in multi-system failure or

an end-stage or end-of-life condition warranting an

additional assessment of the resident’s overall

condition. ”

• Regulatory language

• (Rev. 4, Issued 11-12-2004, Effective: 11-12-2004,

Implementation: 11-12-2004 §483.25(c) Pressure Sores )

What will the Regulator Think? CMS F314 ADVANCE DIRECTIVE

“A resident at the end of life,

in terminal stages of an illness

or having multiple system failures

may have written directions

for his or her treatment goals

(or a decision has been made by the resident’s surrogate or

representative, in accordance with state law).”

(Rev. 4, Issued 11-12-2004, Effective: 11-12-2004,

Implementation: 11-12-2004 §483.25(c) Pressure Sores )

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What Will the Regulator Think? F314 ADVANCE DIRECTIVE

“If a resident has a valid Advance Directive, the facility’s care must reflect a

resident’s wishes as expressed in the Directive, in accordance with state law.

However, the presence of an Advance Directive

does not absolve the facility from giving supportive and other pertinent care

that is not prohibited by the Advance Directive.

If the facility has implemented individualized approaches for end-of-life care in

accordance with the resident's wishes, and has implemented appropriate efforts

to try to stabilize the resident’s condition (or indicated why the condition cannot or

should not be stabilized) and to provide care to prevent or treat the pressure ulcer(including pertinent, routine, lesser aggressive approaches, such as, cleaning, turning,

repositioning), then the development, continuation, or progression of a pressure

ulcer may be consistent with regulatory requirements.”

(Rev. 4, Issued 11-12-2004, Effective: 11-12-2004

Implementation: 11-12-2004 §483.25(c) Pressure Sores )

What is the Evidence?Predictors For the Development of

Pressure Ulcer (Injury) in End of Life Care : A National Quality Register Study (Sweden)

• Recommendations for PI prevention are based on

consensus documents

• Retrospective, descriptive

comparative study design

• All deceased patients over 17 years old (n=60,319)

& registered in the Swedish Register of Palliative Care

(SRPC) during 2014 were included

(cannot determine causation!!!!)

• Statistical analysis by logistic regression

Carlsson, Gunningberg Journal of Palliative Medicine

Jan 2017, Vol. 20 No.1 p 53-58

© Sibbald 2017

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What is the Evidence?Swedish Data- Pressure Ulcers (Injuries)

Different Healthcare UnitsCarlsson Gunningberg 2017

Criteria Nursing

Home%

(NH)

Short

Stay at

NH %

SPC

Inpatient

Unit%

Hospital% General

PC –

Home

Care%

SPC

HC unit %

PI- S1-4 at

Admission

.-Death

Difference

6.9

16.8

+ 9.9

16.2

20.8

+4.6

19.0

29.7

+10.7

13.8

19.6

+5.8

11.0

18.6

+7.6

10.2

23.5

+13.3

PI –S 3-4 at

Admission

Death

Difference

2.3

4.9

+2.6

.

4.6

5.6

+1.0

4.1

6.2

+2.1

3.5

3.9

+0.4

2.6

4.6

+2.0

2.4

5.1

+3.7

S= Specialized PC= Palliative Care, HC= Home Care

• Palliative care had a significantly higher incidence of PI’s than nursing home

• Patients admitted to nursing homes may have time to heal PI,s prior to death

© Sibbald 2017

What is the Evidence?Swedish Data- Symptoms Associated with

Palliative End of Life Care Carlsson Gunningberg 2017

Model - Findings from steps in Multivariant Analysis

1. Type of

Facility

• Prevalence PI’s – 6.9% nursing homes to

19% specialized PC inpatient units

• Highest PI prevalence at death= 29.7% PC-Inpatient Unit

• Hospitals-highest rates-pain, anxiety, death rattles,

IV/ enteral feeds

2. + Age • ↑ age is a predictor of PI’s, Gender – no difference

3.+ Medical

Conditions

• General Palliative Care –Home Care not significantly

related to development of PI’s

• Higher risk of PI’s: cancer, neurological disease, Diabetes Mellitus,

post fractures, multiple diseases, infections

• Dementia was significantly associated with lower incidence of PI’s

4+ Length of

Stay

• Pain higher likelihood of developing PI’s, (? Reluctant to turn etc.) but

better pain control ↓ PI incidence and vice versa

• Nausea ↓ PI incidence, relief of nausea, ↑ PI incidence

• Patients loss of decision making ability= ↑ PI incidence

• Intravenous drip/ or enteral feeding -↓ PI occurrence

© Sibbald 2017

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What is the relationship between SCALE & Skin Failure

• Pressure injuries may be part of the

dying process

• Other skin injuries also can exist

• There are degrees of skin impact during

the dying process

• Not everyone with “SCALE” has skin

failure

• Skin compromise can exist without the

published definitions of skin failure

© Sibbald 2017

Modified from Wound Bed Preparation 2015

Personwith a ↑Risk or Non- Avoidable Pressure Injury

Identify & may not be able to

Treat the Cause

Patient/Family Centered Concerns

Non-AvoidableLocal wound care-alter if

healing potential

DebridementConservative

Inflammation/ Infection

Moisture Reduction/

comfort

Edge EffectNot usuallyindicated

© Sibbald et al., Advances – Oct 2015

Vascular

PI-RAISE

Co-existing

Disease/ Drugs

Pain

Activities daily living

Social Support

(Smoking)

Redistribute pressure- surfaces

(relieve heel pressure)

Activity -increase mobility

Incontinence &moisture management

Shear reduction

Enhance & Optimize Nutrition nutrition

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Is all Skin Failure/ Damage Equal?Renal Disease Example

Stage Description Glomerular

Filtration Rate

(mL/ min/ 1.73M)

1 Kidney damage with normal or GFR > 90

2 Kidney damage with mild in GFR 60-89

3 Kidney damage with moderate in GFR 30-59

4 Kidney damage with severe in GFR 15-30

5 Kidney failure <15

National Kidney Foundation Guidelines

Skin injury- ways of describingBenefits- Need Data not Chatta

Extent of Skin Injury

The area on the patients

palm is equivalent to

1% of the patients body

surface area

© Sibbald 2017

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Skin Damage is:Area involved + Extent of Skin Injury

+ ? Symptoms

Psoriasis Area& Severity

Index (PASI)• Combines Area +

0-4 score for:• Erythema (redness)

• Scale

• Infiltration (Thickness)

• Single score • 0 (no disease)

• 72 (maximal disease)

SCORAD “(SCORing

Atopic Dermatitis (AD)"• Assesses the severity (i.e. extent, intensity)

of atopic dermatitis

• 60% Weighting-intensity

• Amount of Scale 0-3

• 6 additional criteria: erythema, edema/ palpation,

oozing/crusting, excoriation (scratch marks),

xerosis (dry skin), lichenification (thickening),

• 20% spread (extent)- Rule 9’s, patients palm

• 20% subjective signs

• insomnia, pruritus 0-10 scale

• Single Score : • <25 - Mild AD

• 25–50 - Moderate AD

• >50 - Severe AD

© Sibbald 2017

Skin Damage/ Failure using a Modified Renal Example

Skin

Damage

Loss of

Normal Skin

Extent of

Skin Damage

Symptoms

1 Localized

external

injury

<10% injury How to relate

various injuries in

a meaningful way:

• Infections

• Ischemia

(gangrene)

• Pressure Injuries

• Edema

• Moisture

Associated Skin

Changes

• Purpura

• Skin Tears

• Blisters

Pain (p<0.001)

only significant

value in Swedish

study

(Nausea= less PI

(p<0.5) But relief of

nausea =↑PI

Not Significant:

*Confusion

*Anxiety

*Death Rattles

*Shortness of

Breath

2 Mild 11-25% ?

3 Moderate 26-50%?

4 Severe 51-75% ?

5 Skin

failure

76-100% or

localized severe

disease,

SCALE +

Multiorgan Failure

© Sibbald 2017

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Participants have asked:

• Why Are You Advocating This

Terminology/ Concept?

• What Is The Evidence Supporting It?

• What Are The Benefits/Consequences Of

This Terminology?

Question Response

Why are you advocating this

terminology/ Concept?

SCALE + MODS (Skin Failure) is one association

with unavoidable PI’s, SCALE +less severe injury also occurs

What is the evidence supporting

this?

Swedish Data quantitated the presence of (unavoidable)

pressure injuries as part of the dying process

What are the benefits/

consequences of this terminology?

• Use kidney disease to create a frame work for skin

compromise/ failure as part of the reason for unavoidable

pressure injuries with dying

• Build on validated dermatological disease severity

indexes that quantitate skin injury for measuring disease

disability & expected positive and negative responses to

treatment