Implementation of Direct-to-Patient Mobile Teledermatology in VA.

BACKGROUND: Innovative technology can enhance patient access to healthcare but must be successfully implemented to be effective. OBJECTIVE: We evaluated Department of Veterans Affairs' (VA's) implementation of My VA Images, a direct-to-patient asynchronous teledermatology mobile application enabling established dermatology patients to receive follow-up care remotely instead of in-person. DESIGN /PARTICIPANTS/APPROACH: Following pilot testing at 3 facilities, the app was introduced to 28 facilities (4 groups of 7) every 3 months using a stepped-wedge cluster-randomized design. Using the Organizational Theory of Implementation Effectiveness, we examined the app's implementation using qualitative and quantitative data consisting of encounter data from VA's corporate data warehouse; app usage from VA's Mobile Health database; bi-monthly reports from facility representatives; phone interviews with clinicians; and documented communications between the operational partner and facility staff. KEY RESULTS: Implementation policies and practices included VA's vision to expand home telehealth and marketing/communication strategies. The COVID-19 pandemic dominated the implementation climate by stressing staffing, introducing competing demands, and influencing stakeholder attitudes to the app, including its fit to their values. These factors were associated with mixed implementation effectiveness, defined as high quality consistent use. Nineteen of 31 exposed facilities prepared to use the app; 10 facilities used it for actual patient care, 7 as originally intended. Residents, nurse practitioners, and physician assistants were more likely than attendings to use the app. Facilities exposed to the app pre-pandemic were more likely to use and sustain the new process. CONCLUSIONS: Considerable heterogeneity existed in implementing mobile teledermatology, despite VA's common mission, integrated healthcare system, and stakeholders' broad interest. Identifying opportunities to target favorable facilities and user groups (such as teaching facilities and physician extenders, respectively) while addressing internal implementation barriers including incomplete integration with the electronic health record as well as inadequate staffing may help optimize the initial impact of direct-to-patient telehealth. The COVID pandemic was a notable extrinsic barrier. CLINICAL TRIALS REGISTRATION: NCT03241589.

Organizational Readiness for Patient-Facing Mobile Teledermatology to Care for Established Veteran Patients in the United States.

Purpose: To improve patient access to skin care, the Department of Veterans Affairs (VA) developed a patient-facing asynchronous mobile teledermatology application (app), which allows patients to follow up remotely with dermatologists. To understand how the app would be received in VA, we examined Organizational Readiness for Change (ORC), an important prelude to effective implementation, which includes the shared resolve and collective ability of organizational members to implement a change. Methods: We used a mixed-methods multiple case study approach to assess ORC at three VA facilities. Data derived from a site process call, surveys, and semistructured telephone interviews of VA staff, field notes, and administrative data. Results: Participants at all three facilities supported the intervention and recognized the value of using the app to increase patients' access to dermatologists, but expressed concerns largely related to disruption of the pre-existing clinical workflow. Participants at the facility most actively using the app had the highest overall ORC score and reported the most facilitators. Facility leadership support when guided by a clinical champion minimized barriers by recognizing the complexities of health care provision at specialty clinics. Discussion: While provider buy-in remained a barrier, leadership, guided by the clinical champion, played a critical role instituting implementation strategies. The strong association between the ORC survey score and the presence of facilitators and barriers suggests that the ORC survey may be a rapid, convenient, and effective tool for health care systems to identify favorable sites for wider implementation of mobile telehealth care. Clinical Trials Identifier: NCT03241589.

Association between antihypertensive medications and risk of skin cancer in people older than 65 years: a population-based study.

BACKGROUND: The risk of skin cancer associated with antihypertensive medication use is unclear, although thiazides have been implicated in regulatory safety warnings. We aimed to assess whether use of thiazides and other antihypertensives is associated with increased rates of keratinocyte carcinoma and melanoma. METHODS: We conducted a population-based inception cohort study using linked administrative health data from Ontario, 1998-2017. We matched adults aged ≥ 66 years with a first prescription for an antihypertensive medication (thiazides, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, calcium channel blockers, ß-blockers) by age and sex to 2 unexposed adults who were prescribed a non-antihypertensive medication within 30 days of the index date. We evaluated each antihypertensive class in a separate cohort study. Our primary exposure was the cumulative dose within each class, standardized according to the World Health Organization's Defined Daily Dose. Outcomes were time to first keratinocyte carcinoma, advanced keratinocyte carcinoma and melanoma. RESULTS: The inception cohorts included a total of 302 634 adults prescribed an antihypertensive medication and 605 268 unexposed adults. Increasing thiazide exposure was associated with an increased rate of incident keratinocyte carcinoma (adjusted hazard ratios [HRs] per 1 Defined Annual Dose unit 1.08, 95% confidence interval [CI] 1.03-1.14), advanced keratinocyte carcinoma (adjusted HR 1.07, 95% CI 0.93-1.23) and melanoma (adjusted HR 1.34, 95% CI 1.01-1.78). We found no consistent evidence of association between other antihypertensive classes and keratinocyte carcinoma or melanoma. INTERPRETATION: Higher cumulative exposure to thiazides was associated with increased rates of incident skin cancer in people aged 66 years and older. Consideration of other antihypertensive treatments in patients at high risk of skin cancer may be warranted.

Acitretin for Secondary Prevention of Keratinocyte Cancers in a Veteran Population: A Retrospective Cohort Study.

Acitretin, a vitamin A derivative used for psoriasis, can prevent keratinocyte carcinoma (KC). It induced regression of keratoacanthomas (KA) in animal models, presumably by activating retinoic acid and retinoid X receptors that regulate gene expression for growth and proliferation.1,2.

Implementing Teledermatology for Rural Veterans: An Evaluation Using the RE-AIM Framework.

Introduction: Few systematic evaluations of implementing teledermatology programs in large health care systems exist. We conducted a longitudinal evaluation of a U.S. Department of Veterans Affairs (VA) initiative to expand asynchronous consultative teledermatology services for rural veterans. Methods: The reach, effectiveness, adoption, implementation, and maintenance framework guided the evaluation, which included analysis of quantitative VA administrative data as well as an online survey completed by participating facilities. The first 2 years of the program were compared with the year before the start of funding. Results: Sixteen hub facilities expanded teledermatology's reach over the 2-year period, increasing the number of referral spoke sites, unique patients served, and teledermatology encounters. Effectiveness was reflected as teledermatology constituted an increasing fraction of dermatology activity and served more remotely located patients. Adoption through defined stages of implementation progressed as facilities engaged in a variety of strategies to enhance teledermatology implementation, and facilitators and barriers were identified. Program maintenance was assessed by Program Sustainability Index scores, which reflected the importance of executive support, and ongoing concerns about staffing and longitudinal funding. Discussion: Enabling hubs to create solutions that best fit their needs and culture likely increased reach and effectiveness. Important facilitators included organizational leadership and encouraging communication between stakeholders before and during the intervention. Conclusions: A systematic analysis of teledermatology implementation to serve rural sites in VA documented a high degree of implementation and sustainability as well as areas for improvement.

Implementation of Mobile Teledermatology: Challenges and Opportunities.

Background: While teledermatology is well-established in the Department of Veterans Affairs (VA), its implementation is far from complete. To facilitate consultative teledermatology and extend its reach, VA introduced a mobile teledermatology application (app) at three VA sites. Methods: We evaluated the initial implementation process using a mixed-methods, multiple case study approach to assess organizational readiness for change (ORC), which included examining facilitators, barriers, and contextual factors that affected implementation. We conducted: (1) group interviews and bimonthly reports to understand site processes; (2) semistructured interviews and surveys of individual participants representing a range of implementation roles; and (3) a review of internal organizational documents. We identified themes from interviews using an iterative process, and computed an ORC score based on surveys. Results: Forty-three individuals participated in the study. Qualitative data from all sites, corroborated by survey data available from one site, revealed a high readiness for change with an ORC score of 4.2, where 5 = maximal readiness for change. Facilitators included support from leadership and clinical champions, active telehealth programs, and an understanding and appreciation of the program and the resources needed. At all sites, however, technical issues negatively affected adoption; these included a suboptimal information technology infrastructure, which led to the inoperability of the app at two sites, and technical inefficiencies related to users' unfamiliarity with new devices and inconsistent internet access. Conclusions: Although a strong commitment to change and a confidence to effect change existed, these alone were insufficient to surmount barriers to implementation effectiveness. Clinical Trials Registration: NCT03241589.

Pathologists' agreement on treatment suggestions for melanocytic skin lesions.

BACKGROUND: Although treatment guidelines exist for melanoma in situ and invasive melanoma, guidelines for other melanocytic skin lesions do not exist. OBJECTIVE: To examine pathologists' treatment suggestions for a broad spectrum of melanocytic skin lesions and compare them with existing guidelines. METHODS: Pathologists (N = 187) completed a survey and then provided diagnoses and treatment suggestions for 240 melanocytic skin lesions. Physician characteristics associated with treatment suggestions were evaluated with multivariable modeling. RESULTS: Treatment suggestions were concordant with National Comprehensive Cancer Network guidelines for the majority of cases interpreted as melanoma in situ (73%) and invasive melanoma (86%). Greater variability of treatment suggestions was seen for other lesion types without existing treatment guidelines. Characteristics associated with provision of treatment suggestions discordant with National Comprehensive Cancer Network guidelines were low caseloads (invasive melanoma), lack of fellowship training or board certification (melanoma in situ), and more than 10 years of experience (invasive melanoma and melanoma in situ). LIMITATIONS: Pathologists could not perform immunohistochemical staining or other diagnostic tests; only 1 glass side was provided per biopsy case. CONCLUSIONS: Pathologists' treatment suggestions vary significantly for melanocytic lesions, with lower variability for lesion types with national guidelines. Results suggest the need for standardization of treatment guidelines for all melanocytic lesion types.

The association of metformin use with keratinocyte carcinoma development in high-risk patients.

Keratinocyte carcinoma (KC) is the most common malignancy in white skinned populations. Metformin one of the most commonly prescribed drugs and has been reported to protect against solid cancers. The association between metformin and KC has not been studied in patients at high risk for a subsequent KC. The purpose of this study is to evaluate the association between metformin and KC development in high-risk patients. We performed a secondary analysis of patients enrolled in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial to compare risk for KC development between metformin users and non-users. Metformin-users compared to non-users had a significantly lower risk for squamous cell carcinoma with an adjusted Hazard ratio (HR): 0.45, (CI: 0.24-0.84, P < .01) and basal cell carcinoma (HR: 0.70, CI: 0.49-0.97, P < .03). Patients at high risk might benefit from metformin use against a subsequent KC.

Keratinocyte Carcinoma Mortality in the United States as Reported in Death Certificates, 2011-2017.

BACKROUND: Keratinocyte carcinoma (KC) mortality is relatively modest and its measures are subject to considerable error. Deaths due to KC have been decreasing through 2000 and were relatively stable until 2010. OBJECTIVE: To estimate the KC mortality rates (MRs) from 2011 to 2017 in USA based on death certificates. METHODS: A population-based analysis of Center of Disease Control and Prevention data. Main outcomes and measures were the age-adjusted (US 2000 standard population) MRs. RESULTS: Overall, KC MRs increased significantly (b = 0.04, p < .01). For the period studied, KC MR was 1.24 per 100,000 persons per year (0.62 for sun-exposed sites, 0.38 for genital and 0.23 for perianal sites). At sun-exposed genital and perianal anatomic sites, KC MRs have been increasing in whites, but not in blacks. CONCLUSION: There was a 17% decrease in the KC MRs until 2000, followed by an increase of 44% through 2017. The accuracy of KC MRs is uncertain. If indeed the increase in mortality is verified, causes may include an increase in KC incidence, an increase of immunosuppressed populations, and changes in the cause of death documentation.

Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials.

Recent progress in the treatment of advanced melanoma has led to unprecedented improvements in overall survival and, as these new melanoma treatments have been developed and deployed in the clinic, much has been learned about the natural history of the disease. Now is the time to apply that knowledge toward the design and clinical evaluation of new chemoprevention agents. Melanoma chemoprevention has the potential to reduce dramatically both the morbidity and the high costs associated with treating patients who have metastatic disease. In this work, scientific and clinical melanoma experts from the national Melanoma Prevention Working Group, composed of National Cancer Trials Network investigators, discuss research aimed at discovering and developing (or repurposing) drugs and natural products for the prevention of melanoma and propose an updated pipeline for translating the most promising agents into the clinic. The mechanism of action, preclinical data, epidemiological evidence, and results from available clinical trials are discussed for each class of compounds. Selected keratinocyte carcinoma chemoprevention studies also are considered, and a rationale for their inclusion is presented. These data are summarized in a table that lists the type and level of evidence available for each class of agents. Also included in the discussion is an assessment of additional research necessary and the likelihood that a given compound may be a suitable candidate for a phase 3 clinical trial within the next 5 years.

Cutaneous nevi and risk of melanoma death in women and men: A prospective study.

BACKGROUND: It was unclear whether an increased number of common nevi (moles) predicts melanoma death. OBJECTIVE: We prospectively examined the association between number of common nevi and risk of melanoma death. METHODS: Our study used data from the Nurses' Health Study (n = 77,288 women) and Health Professionals Follow-up Study (n = 32,455 men). In 1986, participants were asked about the number of moles they had with a ≥3-mm diameter on the upper extremity, and we stratified their answers into 3 categories (none, 1-2, or ≥3) on the basis of data distribution. RESULTS: During follow-up (1986-2012), 2452 melanoma cases were pathologically confirmed; among these, we identified 196 deaths due to melanoma. Increased number of nevi was associated with melanoma death; the hazard ratio (HR) for ≥3 nevi compared with no nevi was 2.49 (95% confidence interval [CI] 1.50-4.12) for women and 3.97 (95% CI 2.54-6.22) for men. Among melanoma cases, increased number of nevi was associated with melanoma death in men (≥3 nevi, HR 1.89, 95% CI 1.17-3.05) but not in women. Similarly, the number of nevi was positively associated with Breslow thickness in men only (Ptrend = .01). LIMITATIONS: This is an epidemiologic study without examination into mechanisms. CONCLUSION: Increased number of cutaneous nevi was significantly associated with melanoma death. High nevus count might serve as an independent prognostic factor to predict the risk of melanoma death particularly among male melanoma patients.

Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis.

Background: Most interventions for basal cell carcinoma (BCC) have not been compared in head-to-head randomized trials. Purpose: To evaluate the comparative effectiveness and safety of treatments of primary BCC in adults. Data Sources: English-language searches of MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Embase from inception to May 2018; reference lists of guidelines and systematic reviews; and a search of ClinicalTrials.gov in August 2016. Study Selection: Comparative studies of treatments currently used in adults with primary BCC. Data Extraction: One investigator extracted data on recurrence, histologic clearance, clinical clearance, cosmetic outcomes, quality of life, and mortality, and a second reviewer verified extractions. Several investigators evaluated risk of bias for each study. Data Synthesis: Forty randomized trials and 5 nonrandomized studies compared 18 interventions in 9 categories. Relative intervention effects and mean outcome frequencies were estimated using frequentist network meta-analyses. Estimated recurrence rates were similar for excision (3.8% [95% CI, 1.5% to 9.5%]), Mohs surgery (3.8% [CI, 0.7% to 18.2%]), curettage and diathermy (6.9% [CI, 0.9% to 36.6%]), and external-beam radiation (3.5% [CI, 0.7% to 16.8%]). Recurrence rates were higher for cryotherapy (22.3% [CI, 10.2% to 42.0%]), curettage and cryotherapy (19.9% [CI, 4.6% to 56.1%]), 5-fluorouracil (18.8% [CI, 10.1% to 32.5%]), imiquimod (14.1% [CI, 5.4% to 32.4%]), and photodynamic therapy using methyl-aminolevulinic acid (18.8% [CI, 10.1% to 32.5%]) or aminolevulinic acid (16.6% [CI, 7.5% to 32.8%]). The proportion of patients reporting good or better cosmetic outcomes was better for photodynamic therapy using methyl-aminolevulinic acid (93.8% [CI, 79.2% to 98.3%]) or aminolevulinic acid (95.8% [CI, 84.2% to 99.0%]) than for excision (77.8% [CI, 44.8% to 93.8%]) or cryotherapy (51.1% [CI, 15.8% to 85.4%]). Data on quality of life and mortality were too sparse for quantitative synthesis. Limitation: Data are sparse, and effect estimates are imprecise and informed by indirect comparisons. Conclusion: Surgical treatments and external-beam radiation have low recurrence rates for the treatment of low-risk BCC, but substantial uncertainty exists about their comparative effectiveness versus other treatments. Gaps remain regarding high-risk BCC subtypes and important outcomes, including costs. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42016043353).

Teledermatology Outcomes in the Providence Veterans Health Administration.

Background: As technology evolves, so does the integration of technology into health care delivery. Telemedicine, the use of information technology to provide remote health care, aims to improve patient access to quality care across a wide range of barriers. Introduction: Our objective was to determine whether teleconsultation leverages specialist expertise at one site within the United States' largest integrated health system. We evaluated the Providence Veterans Affairs Medical Center (PVAMC) teledermatology store-and-forward program. Materials and Methods: We evaluated 460 completed teleconsultations using retrospective chart review at the PVAMC in June-August 2016 for 12 postimaging outcomes, with no exclusion criteria. We determined outcomes using Computerized Patient Record System chart reviews. Results: Dermatologists completed 84-99% of all teleconsultations within 1 week after referral. Fifty one percent (51%) of patients required no dermatology clinic visit. Six percent (6%) of all teleconsultations were ultimately diagnosed with a biopsy-proven skin cancer. Sixty nine percent (69%) of referring providers prescribed recommended medications within 7 days. Discussion: We conclude that the PVAMC teledermatology program enables rapid access to dermatologic expertise while avoiding unnecessary clinic appointments. Conclusion: By detecting both weak links, and steps in the chain of care that successful teledermatology requires, our findings can help teledermatology systems within and outside the Veterans Affairs maximize their effectiveness.

Tetracycline use and risk of incident skin cancer: a prospective study.

BACKGROUND: Tetracycline is a photosensitising medication that increases skin vulnerability to UV-related damage. METHODS: We prospectively examined tetracycline use and risk of incident melanoma, squamous cell carcinoma (SCC), and basal cell carcinoma (BCC) based on 213 536 participants from the Nurses' Health Study (NHS), NHS2, and Health Professionals Follow-up Study. Information on ever use of tetracycline was asked via questionnaire. Diagnoses of melanoma and SCC were pathologically confirmed. RESULTS: Tetracycline use was associated with a modestly increased risk of BCC (ncase=36 377), with a pooled hazard ratio (HR) of 1.11 (95% confidence interval (CI)=1.02-1.21, P-trend=0.05 by duration of use). Tetracycline use was not significantly associated with melanoma (ncase=1831, HR=1.09, 95% CI=0.94-1.27) or SCC (ncase=3332, HR=1.04, 95% CI=0.91-1.18) risk overall. However, we observed positive interactions between tetracycline use and adulthood UV exposure on SCC risk (P-interaction=0.05). CONCLUSION: Tetracycline use was associated with a modestly increased risk of BCC, but was not associated with melanoma or SCC.

Impact of topical fluorouracil cream on costs of treating keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis.

BACKGROUND: It is unknown whether treatment costs for keratinocyte carcinoma (KC) and actinic keratosis (AK) can be lowered by spending more on chemoprevention. OBJECTIVE: To examine the impact of 1-course treatment with topical fluorouracil (5-FU) on the face and ears on KC and AK treatment costs over 3 years. METHODS: The Veterans Affairs Keratinocyte Carcinoma Chemoprevention trial compared the efficacy of topical 5-FU 5% with that of vehicle control cream for reducing KC risk. Trial data and administrative data on costs and utilization were analyzed to measure postrandomization encounters and treatment costs for KC and AK care. Adjusted models were used to test for statistically significant differences between treatment arms for number of treatment encounters and costs. RESULTS: One year after randomization, the control arm had a higher mean number of treatment encounters for squamous cell carcinoma (0.04) than the intervention arm (0.01) (P < .01). At 1 year, the intervention arm had lower treatment and dermatologic costs: $2106 (standard deviation, $2079) compared with $2444 (standard deviation, $2716) for the control patients (P = .02). After 3 years, the intervention arm incurred a cost of $771 less per patient. LIMITATIONS: Care not provided or paid for by the Department of Veterans Affairs was not included. Results may not be generalizable to other payers. CONCLUSION: We found significant cost savings for patients treated with 5-FU.

Pathologist characteristics associated with accuracy and reproducibility of melanocytic skin lesion interpretation.

BACKGROUND: Diagnostic interpretations of melanocytic skin lesions vary widely among pathologists, yet the underlying reasons remain unclear. OBJECTIVE: Identify pathologist characteristics associated with rates of accuracy and reproducibility. METHODS: Pathologists independently interpreted the same set of biopsy specimens from melanocytic lesions on 2 occasions. Diagnoses were categorized into 1 of 5 classes according to the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis system. Reproducibility was determined by pathologists' concordance of diagnoses across 2 occasions. Accuracy was defined by concordance with a consensus reference standard. Associations of pathologist characteristics with reproducibility and accuracy were assessed individually and in multivariable logistic regression models. RESULTS: Rates of diagnostic reproducibility and accuracy were highest among pathologists with board certification and/or fellowship training in dermatopathology and in those with 5 or more years of experience. In addition, accuracy was high among pathologists with a higher proportion of melanocytic lesions in their caseload composition and higher volume of melanocytic lesions. LIMITATIONS: Data gathered in a test set situation by using a classification tool not currently in clinical use. CONCLUSION: Diagnoses are more accurate among pathologists with specialty training and those with more experience interpreting melanocytic lesions. These findings support the practice of referring difficult cases to more experienced pathologists to improve diagnostic accuracy, although the impact of these referrals on patient outcomes requires additional research.

A risk adjustment approach to estimating the burden of skin disease in the United States.

Direct insurance claims tabulation and risk adjustment statistical methods can be used to estimate health care costs associated with various diseases. In this third manuscript derived from the new national Burden of Skin Disease Report from the American Academy of Dermatology, a risk adjustment method that was based on modeling the average annual costs of individuals with or without specific diseases, and specifically tailored for 24 skin disease categories, was used to estimate the economic burden of skin disease. The results were compared with the claims tabulation method used in the first 2 parts of this project. The risk adjustment method estimated the direct health care costs of skin diseases to be $46 billion in 2013, approximately $15 billion less than estimates using claims tabulation. For individual skin diseases, the risk adjustment cost estimates ranged from 11% to 297% of those obtained using claims tabulation for the 10 most costly skin disease categories. Although either method may be used for purposes of estimating the costs of skin disease, the choice of method will affect the end result. These findings serve as an important reference for future discussions about the method chosen in health care payment models to estimate both the cost of skin disease and the potential cost impact of care changes.

Complexities of perceived and actual performance in pathology interpretation: A comparison of cutaneous melanocytic skin and breast interpretations.

BACKGROUND: Little is known about how pathologists process differences between actual and perceived interpretations. OBJECTIVE: To compare perceived and actual diagnostic agreement before and after educational interventions. METHODS: Pathologists interpreted test sets of skin and/or breast specimens that included benign, atypical, in situ and invasive lesions. Interventions involved self-directed learning, one skin and one breast, that showed pathologists how their interpretations compared to a reference diagnoses. Prior to the educational intervention, participants estimated how their interpretations would compare to the reference diagnoses. After the intervention, participants estimated their overall agreement with the reference diagnoses. Perceived and actual agreements were compared. RESULTS: For pathologists interpreting skin, mean actual agreement was 52.4% and overall pre- and postinterventional mean perceived agreement was 72.9% vs 54.2%, an overestimated mean difference of 20.5% (95% confidence interval [CI] 17.2% to 24.0%) and 1.8% (95% CI -0.5% to 4.1%), respectively. For pathologists interpreting breast, mean actual agreement was 75.9% and overall pre- and postinterventional mean perceived agreement was 81.4% vs 76.9%, an overestimation of 5.5% (95% CI 3.0% to 8.0%) and 1.0% (95% CI 0.0% to 2.0%), respectively. CONCLUSIONS: Pathologists interpreting breast tissue had improved comprehension of their performance after the intervention compared to pathologists interpreting skin lesions.