Transcript Identifying Benchmarks for the Skin Cancer Index

IMPROVING MEASUREMENTS OF QUALITY
OF LIFE IN SKIN CANCER PATIENTS:
Identifying Benchmarks for the
Skin Cancer Index
Kimberly Shao, B.S.
Lynne Taylor, M.S., Ph.D.
Thuzar Shin, M.D., Ph.D.
Jeremy Etzkorn, M.D.
Chris Miller, M.D.
Joseph Sobanko, M.D.
No financial disclosures
INTRODUCTION
Clinical research fellow
 Division of Dermatologic Surgery and Cutaneous
Oncology (Perelman Center for Advanced Medicine)
 University of Pennsylvania
INTRODUCTION
Primary Investigator: Dr. Joseph Sobanko
 Assistant Professor and Director of Dermatologic
Surgery Education at the Hospital of the University of
Pennsylvania
 Founding member of iMPROVeD (Measurement of
PRiority Outcome Variables in Dermatologic surgery)
SKIN CANCER: EPIDEMIOLOGY
 Worldwide, nonmelanoma skin cancer (NMSC) is the most
common cancer affecting white-skinned individuals, and the
incidence is increasing
 In the US, 3.3 million persons were treated for at least 1
skin cancer in 2012
HOW DO WE MEASURE OUTCOMES?
 Mortality
3,500,000
 75% from
3,000,000
2,500,000
2,000,000
Incidence
Mortality
1,500,000
1,000,000
500,000
0
Per Year in the
US
for all Skin Cancers
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6421a6.htm
melanomas
 Less utility when
applied to skin
cancer treatments
HOW DO WE MEASURE OUTCOMES?
Survival Rates
 Basal cell (BCC) and squamous cell carcinomas (SCC)
are highly curable if detected early and treated
 Five-year survival for melanoma detected and treated
before spread to the lymph nodes is 98%
HOW DO WE MEASURE OUTCOMES?
Recurrence
 5-year tumor recurrence
for all procedural
treatments is low
HOW DO WE MEASURE OUTCOMES?
Adverse Events
 Minimal risk of major complications
 Studies show <1%-3% minor adverse events
WHY DOES SKIN CANCER MATTER?
WHAT ELSE CAN WE USE?
Patient-reported outcomes (PROs)
 Satisfaction
 Scar Appearance
 Quality of Life
 Societal interactions
 Emotional Health
 Psychosocial Distress
WHAT DO WE KNOW?
 Some earlier studies showed
skin cancer had minimal effects
on QOL
 However, most
of the QOL
instruments
were validated in
other
dermatologic
conditions
WHAT DO WE (NOW) KNOW?
 Approximately 20-25%
of skin cancer patients
have reported elevated
levels of anxiety or
symptoms of
depression
 Studies have also shown
diminished quality of life
(QOL) following a
diagnosis of skin cancer
HOW SHOULD WE MEASURE PROS?
Disease-specific instruments
 European Organization for Research and Treatment of
Cancer Quality of Life Questionnaire - Melanoma
module (EORTC QLQ-M)
 Functional Assessment of Cancer Therapy – Melanoma
(FACT-M)
HOW SHOULD WE MEASURE PROS?
Disease-specific instruments
 Skin Cancer Quality of Life Impact Tool (SCQOLIT)
 Skin Cancer Quality of Life Questionnaire (SCQOL)
HOW ARE WE MEASURING PROS?
Skin Cancer Index (SCI)
 Validated, patient-reported instrument developed to
measure QOL in skin cancer patients
Scale: 0-100
 with higher values indicating increased QOL
 15 questions split into 3 subscales:
 1) Emotions
 2) Societal interactions
 3) Appearance-related concerns
SCI
During the past month, how much have you…
1. Worried that your skin cancer will spread to another part of
your body?
2. Felt anxious about your skin cancer?
3. Worried that family members may also develop skin cancer?
4. Worried about the cause of skin cancer?
5. Felt frustrated about your skin cancer?
6. Worried that your tumor may become a more serious type of
skin cancer?
7. Worried about new skin cancers occurring in the future?
8. Felt uncomfortable when meeting new people?
9. Felt concerned that your skin cancer may worry friends or
family?
10. Worried about the length of time before you can go out in
the public?
11. Felt bothered by people’s questions related to your skin
cancer?
12. Felt embarrassed by your skin cancer?
13. Worried about how large the scar will be?
14. Thought about how skin cancer affects your attractiveness?
15. Thought about how noticeable the scar will be to others?
Very
Much
Quite Moderately
A
a Bit
Little
Bit
Not
at All
SCI: BENEFITS
 SCI is a relatively quick instrument.
 Generalized instruments may not capture QOL issues that
are most relevant to patients with skin cancer.
 Especially true for appearance!
 As a majority of skin cancers are located on the head
and neck, skin cancer and its treatments involve highly
visible areas.
SCI: LIMITATIONS
 No validated benchmarks for normal scores
 No established clinical correlates
IN COMPARISON…
HOSPITAL ANXIETY AND DEPRESSION
SCALE (HADS)
 Validated, self-reported instrument
 Designed to measure anxiety and depression in non-
psychiatric-hospital patients*
 14 questions
 7 anxiety
 7 depression
HOSPITAL ANXIETY AND DEPRESSION
SCALE (HADS)
 Scale: 0-21, with higher values indicating increased suspicion
for clinical anxiety or depression
 Has established cut-offs:
0-7: Normal
8-10: Borderline case
11-21: Probable clinical anxiety or
depression
OBJECTIVE
 Identify the relationship between the SCI and the HADS
 Establish clinically meaningful cut-off scores for the SCI
METHODS
 Cross-sectional study
 Enrollment: February 1st, 2015-April 1st, 2015
PARTICIPANTS
 Inclusion criteria:
 18 or older
 Biopsy-proven skin cancer
 Treated at the Division of Dermatologic Surgery at
the Perelman Center for Advanced Medicine or
Buck’s County
 Exclusion criteria:
 Nodal or distant metastases
 High grade melanoma
PROTOCOL
 Immediately prior to surgery, patients were asked to
provide and complete:
Demographics
2. Health information
3. SCI
4. HADS
1.
STATISTICAL ANALYSIS
 Summary statistics were calculated from sociodemographic
and health survey questions
 Missing data from unanswered questions in the SCI or
HADS were imputed using means from the same individual’s
subscale scores
STATISTICAL ANALYSIS
 SCI and HADS scores (and each of their subscales) were
correlated via linear regression
 ROC curve analysis was performed to determine cut-off
point for the SCI
 Logistic regressions were conducted for dichotomous
outcomes and to estimate relative risk ratios
TABLE 1A: DEMOGRAPHICS
 Total: n = 134
 62% males
 Average age: 65.4 years
 All Caucasian
 Range of educational levels, income levels, employment
statuses
TABLE 1B: MEDICAL CHARACTERISTICS
 16% were immunosuppressed
 Majority were healthy or had mild systemic disease
 (e.g. obesity, well-controlled DM/HTN, mild lung disease)
 70% with prior history of skin cancer
TABLE 1B: MEDICAL CHARACTERISTICS
Medical Characteristics
Current diagnosis (n = 130)
Basal cell carcinoma
Squamous cell carcinoma
Melanoma
Other
Anatomic location (n = 134)
Scalp
Face
Neck
Back
Chest
Upper extremity
Lower extremity
N (%)
59 (45)
62 (48)
7 (5)
2 (2)
17 (13)
92 (69)
4 (3)
3 (2)
2 (1)
7 (5)
9 (7)
TABLE 2A: SCI TOTAL SCORES
Demographic
Characteristics
Average Metric Score
Age (n=115)
40-60
60-80
> 80
Income (n=126)
> 150K
Employment (n = 131)
Homemaker
Self-employed
Mean
69.8
SCI Total
95% CI p-value
(66.3, 73.4)
<0.001
60.1
74.8
79.3
(53.6, 66.6)
(69.8, 79.7)
(68.3, 90.3)
0.011
60.4
(53.3, 67.5)
0.002
51.6
51.0
(36.0, 67.3)
(35.4, 66.7)
TABLE 2B: SCI EMOTION SUBSCALE
Demographic
Characteristics
Average Metric Score
Income (n = 126)
> 150K
Employment (n = 131)
Homemaker
Self-employed
SCI Emotion
Mean 95% CI p-value
59.2
(54.9, 63.4)
0.010
46.4
(37.7, 55.1)
0.004
35.1
33.3
(15.9, 54.4)
(14.1, 52.6)
TABLE 2C: SCI SOCIAL SUBSCALE
Demographic
Characteristics
Average Metric Score
Age (n=115)
40-60
60-80
> 80
SCI Social
Mean 95% CI
79.8
pvalue
(76.5, 83.2)
0.027
74.3
82.9
89.4
(68.0, 80.6)
(78.1, 87.6)
(78.8, 100.0)
TABLE 2D: SCI APPEARANCE SUBSCALE
Demographic
Characteristics
Average Metric Score
Gender (n=128)
Male
Female
Age (n=115)
40-60
60-80
> 80
Income (n = 126)
> 150K
Employment (n = 131)
Homemaker
Self-employed
SCI Appearance
Mean
95% CI p-value
70.5
(65.8, 75.2)
0.015
75.6
63.4
(69.6, 81.7)
(55.6, 71.2)
< 0.001
55.0
78.6
84.5
(46.4, 63.5)
(72.1, 85.0)
(70.0, 98.9)
0.006
57.3
(47.9, 66.8)
0.001
46.9
54.2
(26.1, 67.6)
(33.4, 74.9)
TABLE 3: HADS- ANXIETY SCORES
Demographic
Characteristics
Average Metric Score
Age (n=115)
40-60
60-80
> 80
Employment (n = 131)
Homemaker
Self-employed
HADS-Anxiety
Mean
95% CI
p-value
5.0
(4.5, 5.6)
0.006
6.2
4.1
4.9
(5.2, 7.2)
(3.3, 4.9)
(3.2, 6.6)
0.004
7.7
7.5
(5.2,
10.2)
(5.0,
10.0)
TABLE 3: HADS-DEPRESSION SCORES
Demographic
Characteristics
Average Metric Score
Income (n = 126)
< 25K
HADS-Depression
Mean
95% CI
p-value
2.9
(2.4, 3.3)
0.036
4.5
(2.8, 6.2)
TABLE 3: HADS-DEPRESSION SCORES
Medical Characteristics
Average Metric Score
Immune status (n = 131)
Immunosuppressed
ASA Health Status (n = 130)
Life-threatening systemic disease
Anatomic location (n = 134)
Scalp
Face
Neck
Back
Chest
Upper extremity
Lower extremity
HADS-Depression
Mean 95% CI p-value
2.9
(2.4, 3.3)
< 0.001
5.1
(3.9, 6.2)
0.008
8.0
(4.3, 11.7)
0.018
2.5
(1.2, 3.7)
2.6
(2.0, 3.1)
3.3
(0.7, 5.8)
6.7
(3.8, 9.6)
4.0
(0.4, 7.6)
5.4
(3.5, 7.3)
2.6
(0.9, 4.2)
FIGURE I: SCATTERPLOT OF HADS-ANXIETY
AND SCI TOTAL SCORE
r = - 0.39, p<0.001
FIGURE 2: SCATTERPLOT OF HADSDEPRESSION AND SCI TOTAL SCORE
r = - 0.045, p = 0.6079
FIGURE 3: ROC CURVE FOR SCI TOTAL
SCORE AS A PREDICTOR OF HADSANXIETY ≥8
• Area under curve (AUC) = 0.6821 (p=0.003, 95% CI 0.5750-0.7892)
• For SCI Total Score of ≤78, sensitivity is 84.4% (specificity 48.0%)
TABLE 4: RELATIVE RISK RATIO FOR FOR
SCI TOTAL SCORE OF ≤78 AS A PREDICTOR
OF HADS-ANXIETY ≥8
Measure
Risk
95% CI
SCI > 78
0.09
0.03-0.20
SCI ≤ 78
0.34
0.24-0.45
Relative Risk
3.65
1.50-8.87
p-value
0.004
DISCUSSION
 Young age, female gender, higher income, and lack of full- or
part-time employment were associated with reduced QOL
 In regards to appearance, women were 2x more likely to
report reduced QOL
 Facial location of skin cancer magnified the disparities
DISCUSSION
 SCI has a statistically significant moderate inverse linear
relationship with HADS-Anxiety score
 In the ROC Curve analysis for a HADS-Anxiety cut-off of ≥8/21
 AUC was >0.50
 Indicates SCI’s predictive ability to discriminate those with a
HADS anxiety subscale score of ≥8 from normal subjects
DISCUSSION
 Cut-off score for SCI of ≤78 showed a sensitivity of 84.4%
 SCI of ≤78 showed nearly 4x greater risk of having a HADS
Anxiety score of ≥8
CONCLUSION & SIGNIFICANCE
 The Skin Cancer Index (SCI) can be used as a single-
instrument screening tool for clinical anxiety.
 This allows physicians to identify and risk-stratify those
patients who are more likely to have psychosocial distress.
WHY NOT JUST USE THE HADS?
 SCI provides disease-specific information about the impact
of skin cancer on factors such as emotional health, societal
interactions, and appearance-related concerns.
 Can be used to measure concerns in patients receiving
surgical treatment
FUTURE DIRECTIONS
 We plan to either develop interventions or improve peri-
operative counseling to help those at risk for clinical anxiety
 Using the subscales of the SCI, may even be able to narrow
a foci for interventions (e.g. appearance-related concerns)
ACKNOWLEDGMENTS
 PI and mentor: Dr. Sobanko
 Statistical assistance: Dr. Taylor
 Co-authors: Dr. Shin, Dr. Etzkorn, Dr. Miller
 Chair of the Department of Dermatology: Dr. George Cotsarelis
 University of Pennsylvania
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