Differences in quality of life in patients with cutaneous lupus erythematosus with varying income levels.

BACKGROUND: Cutaneous lupus erythematosus (CLE) is an autoimmune photosensitive skin condition. The impact of income on quality of life has been incompletely characterized in CLE. OBJECTIVES: We aimed to assess how annual income affects quality of life among CLE patients. METHODS: In this cross-sectional study of 238 patients with CLE, relationships between predictor variables including annual income and each SKINDEX-29 + 3 subdomain were identified using univariate and multivariable analyses. In addition, answers to individual SKINDEX-29 + 3 questions were compared across income groups. Clinical factors in patients making less than <10,000 USD (N = 85) with worse SKINDEX-29 + 3 scores were also identified by univariate and multivariable analyses. RESULTS: Patients making <10,000 USD annually experienced worse quality of life across multiple SKINDEX-29 + 3 subdomains (p < 0.05). These patients specifically experienced poorer quality of life relating to social isolation and self-consciousness. (p < 0.001). Among those making <10,000 USD, predictors for worse quality of life included females, smokers, and those with higher skin disease activity were identified (p < 0.05).Limitations: This is a single center study. Income was also self-reported and could not be verified. CONCLUSIONS: Lower income is related to poorer quality of life in patients with CLE. Specifically, patients experience limitations regarding social isolation and self-consciousness.

Development of a patient decision aid for the management of superficial basal cell carcinoma (BCC) in adults with a limited life expectancy.

BACKGROUND: Basal cell carcinoma (BCC) is a slow-growing, rarely lethal skin cancer that affects people 65 years or older. A range of treatment options exist for BCC, but there is little evidence available to guide patients and providers in selecting the best treatment options. OBJECTIVES: This study outlines the development of a patient decision aid (PDA) for low-risk BCC that can be used by patients and providers to assist in shared decision-making. METHODS: In accordance with the International Patient Decision Aids Standards (IPDAS) Collaboration framework, feedback from focus groups and semi-structured interviews with patients and providers, an initial prototype of the PDA was developed. This was tested using cognitive interviews and iteratively updated. RESULTS: We created eighteen different iterations using feedback from 24 patients and 34 providers. The key issues identified included: 1) Addressing fear of cancer; 2) Communicating risk and uncertainty; 3) Values clarification; and 4) Time lag to benefit. LIMITATIONS: The PDA does not include all possible treatment options and is currently paper based. CONCLUSIONS: Our PDA has been specifically adapted and designed to support patients with a limited life expectancy in making decisions about their low risk BCC together with their doctors.

Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: A cohort study.

BACKGROUND: The effectiveness of 5-fluorouracil compared with that of imiquimod for preventing keratinocyte carcinoma is unknown. OBJECTIVE: To compare the effectiveness of 5-fluorouracil and that of imiquimod in preventing keratinocyte carcinoma in a real-world practice setting. METHODS: We identified 5700 subjects who filled prescriptions for 5-fluorouracil or imiquimod for treatment of actinic keratosis in 2007. An intention-to-treat analysis controlling for potential confounding variables was used to calculate 2- and 5-year cumulative risk differences for subsequent keratinocyte carcinoma overall and in field-treated areas. RESULTS: 5-Fluorouracil was associated with a statistically significant decreased risk of any keratinocyte carcinoma compared with imiquimod (adjusted hazard ratio [aHR], 0.86; 95% confidence interval [CI], 0.76-0.97), but there were no significant differences in risk by tumor subtype (for squamous cell carcinoma: aHR, 0.89; 95% CI, 0.74-1.07; for basal cell carcinoma: aHR, 0.87; 95% CI, 0.74-1.03) or site-specific keratinocyte carcinoma (aHR, 0.96; 95% CI, 0.81-1.14). There were no significant differences in 2- or 5-year cumulative risk of keratinocyte carcinoma among those treated with 5-fluorouracil versus with imiquimod. LIMITATIONS: Generalizability to other practice settings may be limited. CONCLUSIONS: Whereas 5-fluorouracil was more effective in reducing keratinocyte carcinoma risk overall, we found no differences in the short- or long-term risk of subsequent site-specific keratinocyte carcinoma in a real-world practice setting.

A real-world, community-based cohort study comparing the effectiveness of topical fluorouracil versus topical imiquimod for the treatment of actinic keratosis.

BACKGROUND: The most widely used topical agents for the field-based treatment of multiple actinic keratoses (AKs) are 5-fluorouracil and imiquimod, but their comparative effectiveness has not been assessed in a real-world setting. OBJECTIVE: We compared the effectiveness of 5-fluorouracil and imiquimod in reducing risk for subsequent AKs in a large, integrated health care delivery system in northern California. METHODS: In this cohort study, we identified adult health plan members who had an AK diagnosed in 2007 and who subsequently filled a prescription for 5-fluorouracil or imiquimod (N = 5700). We followed subjects for subsequent AKs identified by the International Classification of Diseases codes and estimated the 2-year (short-term) and 5-year (long-term) differences in cumulative risk while controlling for potential confounding by pretreatment variables. RESULTS: 5-Fluorouracil reduced the short-term incidence of subsequent AKs (cumulative risk difference -4.54% [95% confidence interval, -7.91% to -1.17%]), but there was no statistically significant evidence of a long-term decreased risk (cumulative risk difference -1.43% [95% confidence interval, -3.43% to 0.05%]) compared with that with imiquimod. LIMITATIONS: This is a retrospective study with limited ascertainment of all relevant potential confounding variables. CONCLUSION: We found that 5-fluorouracil appeared to be significantly more effective than imiquimod in the short-term, but not long-term, prevention of subsequent AKs.

All-cause mortality in patients with basal and squamous cell carcinoma: A systematic review and meta-analysis.

BACKGROUND: There are varying reports of the association of basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (SCC) with mortality. OBJECTIVE: To synthesize the available information on all-cause mortality after a diagnosis of BCC or SCC in the general population. METHODS: We searched PubMed (1966-present), Web of Science (1898-present), and Embase (1947-present) and hand-searched to identify additional records. All English articles that reported all-cause mortality in patients with BCC or SCC were eligible. We excluded case reports, case series, and studies in subpopulations of patients. Random effects model meta-analyses were performed separately for BCC and SCC. RESULTS: The searches yielded 6538 articles, and 156 were assessed in a full-text review. Twelve studies met the inclusion criteria, and 4 were included in the meta-analysis (encompassing 464,230 patients with BCC and with 175,849 SCC), yielding summary relative mortalities of 0.92 (95% confidence interval, 0.83-1.02) in BCC and 1.25 (95% confidence interval, 1.17-1.32) in SCC. LIMITATIONS: Only a minority of studies controlled for comorbidities. There was significant heterogeneity in meta-analysis (χ2P < .001, I2 > 98%), but studies of SCC were qualitatively concordant: all showed statistically significant increased relative mortality. CONCLUSIONS: We found that patients with SCC are at higher risk for death from any cause compared with the general population.

Development of a Comprehensive Quality-of-Life Measure for Facial and Torso Acne.

Background Acne is a chronic skin disorder which generally presents in adolescence but continues into adulthood, and negatively affects both physical and psychosocial well-being. Presently, there are no validated acne-specific quality-of-life (QoL) measures that include dimensions for both facial and torso acne. OBJECTIVE: The objective of this study was to develop a QoL instrument for both facial and torso acne (CompAQ) in accordance with recommended standards. METHODS: A literature review and Delphi survey of patients and clinicians were used to develop the conceptual framework for outcomes perceived important to acne patients. An initial version of the measure was developed, CompAQ-v1, and pilot tested with patients via cognitive interviews. RESULTS: The Delphi survey generated 4 domains (physical, psychological, sociological, and treatment) and 54 items. These, along with a literature review and input from clinical experts, informed the development of the CompAQ-v1. Eleven cognitive interviews were conducted, resulting in the second version of the measure, CompAQ-v2. Psychometric validation resulted in the final 20-item CompAQ measure comprising 5 domains. An abbreviated 5-item measure was also developed (CompAQ-SF). CONCLUSION: CompAQ and CompAQ-SF are instruments intended to evaluate QoL in patients with acne on their face or torso. The former is a 21-item QoL intended for research, while the latter is intended for clinical practice.

Risk of cutaneous squamous cell carcinoma after treatment of basal cell carcinoma with vismodegib.

BACKGROUND: Vismodegib is a first-in-class agent targeting the hedgehog signaling pathway for treatment of patients with locally advanced basal cell carcinoma (BCC) and metastatic BCC. There have been concerns about the development of squamous cell carcinoma (SCC) in patients treated with this drug. OBJECTIVE: We sought to determine whether treatment with vismodegib is associated with an increase in the risk of cutaneous SCC. METHODS: In this retrospective cohort study, patients treated with vismodegib as part of phase I and II clinical studies were compared with participants from the University of California, San Francisco, Nonmelanoma Skin Cancer Cohort who received standard therapy for primary BCC. In total, 1675 patients were included in the analysis, and the development of SCC after vismodegib exposure was assessed. RESULTS: The use of vismodegib was not associated with an increased risk of subsequent development of SCC (adjusted hazard ratio, 0.57; 95% confidence interval, 0.28-1.16). Covariates including age, sex, history of previous nonmelanoma skin cancer, and number of visits per year were significantly associated with the development of SCC. LIMITATIONS: A limitation of the study was that a historic control cohort was used as a comparator. CONCLUSIONS: Vismodegib was not associated with an increased risk of subsequent SCC when compared with standard surgical treatment of BCC.

Tumor recurrence of keratinocyte carcinomas judged appropriate for Mohs micrographic surgery using Appropriate Use Criteria.

BACKGROUND: The use of Mohs micrographic surgery (MMS) has increased greatly to treat basal cell and cutaneous squamous cell carcinomas (keratinocyte carcinoma [KC]), and consensus-based Appropriate Use Criteria (AUC) were developed to identify tumors for which MMS is appropriate. OBJECTIVE: We sought to compare recurrence rates after different treatments in tumors judged appropriate for MMS. METHODS: We used data from an observational prospective cohort study and retrospectively categorized consecutive tumors as appropriate for MMS according to the AUC. Among appropriate tumors, we used survival analyses to compare 5-year recurrence rates after treatments. RESULTS: Among tumors appropriate for MMS (N = 1483), adjusted 5-year recurrence rates were 2.9% (range, 1.4-4.3%) after MMS, 5.5% (range, 3.1-7.9%) after excision, 4.0% (range, 0.6-7.2%) after destruction, and 5.9% (range, 1.5-10.2%) after other treatments. In tumors treated only with MMS or excision (the most similar subgroups), the adjusted hazard ratio of 5-year recurrence after MMS was 0.6 (95% confidence interval, 0.3-1.0; P = .06). LIMITATIONS: This study is limited by its uncertain generalizability, lack of randomization, and unmeasured characteristics. CONCLUSION: The AUC identified tumors for which recurrence would be less common after MMS than after excision, but the absolute difference in recurrence rates was small.

Early detection of melanoma: reviewing the ABCDEs.

Over the course of their nearly 30-year history, the ABCD(E) criteria have been used globally in medical education and in the lay press to provide simple parameters for assessment of pigmented lesions that need to be further evaluated by a dermatologist. In this article, the efficacy and limitations of the ABCDE criteria as both a clinical tool and a public message will be reviewed.

Self-reported pigmentary phenotypes and race are significant but incomplete predictors of Fitzpatrick skin phototype in an ethnically diverse population.

BACKGROUND: Fitzpatrick skin phototype (FSPT) is the most common method used to assess sunburn risk and is an independent predictor of skin cancer risk. Because of a conventional assumption that FSPT is predictable based on pigmentary phenotypes, physicians frequently estimate FSPT based on patient appearance. OBJECTIVE: We sought to determine the degree to which self-reported race and pigmentary phenotypes are predictive of FSPT in a large, ethnically diverse population. METHODS: A cross-sectional survey collected responses from 3386 individuals regarding self-reported FSPT, pigmentary phenotypes, race, age, and sex. Univariate and multivariate logistic regression analyses were performed to determine variables that significantly predict FSPT. RESULTS: Race, sex, skin color, eye color, and hair color are significant but weak independent predictors of FSPT (P<.0001). A multivariate model constructed using all independent predictors of FSPT only accurately predicted FSPT to within 1 point on the Fitzpatrick scale with 92% accuracy (weighted kappa statistic 0.53). LIMITATIONS: Our study enriched for responses from ethnic minorities and does not fully represent the demographics of the US population. CONCLUSIONS: Patient self-reported race and pigmentary phenotypes are inaccurate predictors of sun sensitivity as defined by FSPT. There are limitations to using patient-reported race and appearance in predicting individual sunburn risk.

Development and psychometric validation of the Chinese version of Skindex-29 and Skindex-16.

BACKGROUND: Dermatological disease significantly affects patient's health-related quality of life (HrQoL). Skindex is one of the most frequently used dermatology-specific HrQoL measures. Currently no Chinese version of Skindex is available. The aim of this study was to translate and culturally adapt Skindex-29 and Skindex-16 into Chinese, and to evaluate their reliability and validity. METHODS: Translation and cultural adaption were performed following guidelines for cross-cultural adaption of health-related quality of life measures. Subsequently, a cross-sectional study was conducted in which patients with dermatological disease (n = 225) were enrolled. The Chinese version of Skindex-29 and Skindex-16 and Dermatology Life Quality Index (DLQI) were completed. Reliability was evaluated with internal consistency using Cronbach's alpha. Validity was evaluated using known-groups validity, convergent validity and factor structure validity. RESULTS: There were both seven items of Skindex-29 and Skindex-16 requiring a second forward- and backward- translation to achieve the final satisfactory Chinese version. The internal consistency reliability was high (range of Cronbach's alpha for the scales of Skindex-29 0.85-0.97, Skindex-16 0.86-0.96). Known-group validity was demonstrated by higher scores from patients with inflammatory dermatosis than from patients with isolated skin lesions (P < 0.05). Evidence of factor structure validity of the Skindex-29 and Skindex-16 was demonstrated by both exploratory factor analysis that accounted for 68.66% and 77.78% of the total variance, respectively, and confirmatory factor analysis with acceptable fitness into the expected three-factor structure. CONCLUSION: This study has developed semantically equivalent translations of Skindex-29 and Skindex-16 into Chinese. The evaluation of the instruments' psychometric properties shows they have substantial evidence of reliability and validity for use as HrQoL instruments in Chinese patients with dermatological disease.

Itch as a patient-reported symptom in ambulatory care visits in the United States.

BACKGROUND: European studies have shown that itch is a widespread symptom, yet little is known about its frequency in the United States. OBJECTIVE: We sought to describe ambulatory care visits to clinicians in the United States for which itch was coded as a patient symptom. METHODS: This study uses retrospective data from the National Ambulatory Medical Care Survey from 1999 through 2009. RESULTS: Itch was coded as a symptom for an average of 7 million visits per year or approximately 1% of all outpatient visits, which was nearly 40% of the number of visits for the symptom of low back pain. Patients seen in visits for itch were more likely to be black or Asian than other patients (20% vs 14%). They were also more likely than other patients to receive a new medication (68% vs 36%) and were over twice as likely to receive 2 or more new medications (31% vs 14%). LIMITATIONS: Secondary data sets may not optimally capture patient reports and some of the procedures or medications may have been ordered for reasons other than itch. CONCLUSION: Visits to clinicians for itch represent a sizeable proportion of ambulatory care visits in the United States, and research on the epidemiology, treatments, and causes of itch should be a priority.

Fitzpatrick skin phototype is an independent predictor of squamous cell carcinoma risk after solid organ transplantation.

BACKGROUND: Solid organ transplant recipients (OTR) are at an increased risk of developing squamous cell carcinoma (SCC) of the skin after transplantation. In predominantly white cohorts, Fitzpatrick skin type (FST) has been reported to be a risk factor for developing posttransplantation skin cancers. OBJECTIVE: Our goal was to determine if FST is a statistically significant risk factor for the development of SCC after solid organ transplantation in a diverse US population of OTR. METHODS: A cohort of OTR completed a questionnaire of demographic factors, transplant type, FST, and skin cancer history. Univariate and multivariate analyses were performed to determine the risk factors for development of SCC after transplantation. RESULTS: As expected, male subjects had an increased risk for SCC compared with female subjects (P = .02), and those aged 50 years and older at the time of transplantation were more likely to develop SCC compared with those younger than 50 years (P < .001). The risk of SCC increased with each incremental decrease in FST, from FST VI to FST I (linear test for trend P < .001). LIMITATIONS: Our questionnaire did not ask specifically about immunosuppressive medications; instead, organ transplant category was used as a proxy for level of immunosuppression. CONCLUSIONS: FST, a patient-reported variable, is an independent risk factor for the development of SCC in OTR, and should be elicited from patients who have gone or will undergo organ transplantation.