Outcomes of Staged Excision With Circumferential en Face Margin Control for Lentigo Maligna of the Head and Neck.

BACKGROUND: Treatment practices vary for lentigo maligna (LM). Staged excision with circumferential margin control (SECMC) has the potential to achieve low recurrence rates. OBJECTIVES: To evaluate the clinical outcomes of SECMC using permanent, paraffin-embedded sections and delayed reconstruction. METHODS: We conducted a retrospective, uncontrolled, observational cohort study involving patients who underwent staged excision for LM of the head and neck at Women's College Hospital in Toronto, Canada, from September 2010 to March 2013. Recurrence and infection rates were ascertained from patient charts and postal surveys. RESULTS: One hundred and two patients (45 female, 57 male) were included with a median follow-up time of 1410.5 (IQR 260-1756) days. The median age was 69 (IQR 61-79) years. Approximately one-fifth (21%, 21/102) of patients required greater than 0.5 cm margins to achieve histological clearance. One patient (1/102) upstaged to invasive melanoma based on the initial stage of excision. The infection rate was 6% (6/102) and the 5-year cumulative recurrence rate was 1.4% (95% CI 0.2-9.6%). CONCLUSION: SECMC using permanent sections and delayed reconstruction appears to be a safe and effective treatment method for LM on the head and neck. Randomized trials are needed to help define the optimal treatment.

Melanoma incidence, stage, and survival after solid organ transplant: A population-based cohort study in Ontario, Canada.

BACKGROUND: Risk of melanoma is increased with potentially worse outcomes after solid organ transplant. OBJECTIVE: To estimate the incidence, stage, and survival in transplant recipients with melanoma. METHODS: Population-based, retrospective, observational study using linked administrative databases. Adults receiving their first solid organ transplant from 1991 through 2012 were followed to December 2013. RESULTS: We identified 51 transplant recipients with melanoma, 11 369 recipients without melanoma, and 255 matched patients with melanoma from the nontransplant population. Transplant recipients were at increased risk of melanoma (standardized incidence ratio, 2.29; 95% confidence interval [CI], 2.07-2.49) and more likely to be diagnosed at stages II through IV (adjusted odds ratio, 4.29; 95% CI, 2.04-9.00) compared with the nontransplant population. Melanoma-specific mortality was increased in transplant recipients compared with the nontransplant population (adjusted hazard ratio, 1.93; 95% CI, 1.03-3.63). Among transplant recipients, all-cause mortality was increased after melanoma compared with those without melanoma (stage T1/T2: adjusted hazard ratio, 2.18; 95% CI, 1.13-4.21; T3/T4: adjusted hazard ratio, 4.07; 95% CI, 2.36-7.04; III/IV: adjusted hazard ratio, 7.92; 95% CI, 3.76-16.70). LIMITATIONS: The databases did not contain data on immunosuppressive drugs; ascertainment of melanoma metastasis relied on pathology reports. CONCLUSION: Melanoma after solid organ transplant is more often diagnosed at a later stage and leads to increased mortality, even for early-stage tumors.

Skin cancer screening after solid organ transplantation: Survey of practices in Canada.

Guidelines recommend annual dermatology screening after solid organ transplantation to facilitate early detection of keratinocyte carcinoma (nonmelanoma skin cancer), the most common posttransplant malignancy. There are limited data on adherence levels and barriers to screening. We conducted a cross-sectional survey of 477 physicians and nurses providing posttransplant care in Canada. The questionnaire asked about skin cancer screening and education practices, including the perceived importance and barriers. Whereas care providers viewed skin cancer screening as important for adult patients (median rating of 10/10, interquartile range 8-10), only 53% ensured annual screening for white adult transplant recipients. Having a screening policy in place (adjusted odds ratio 6.78, 95% confidence interval 3.12-14.74) and a dermatologist present at the transplant center (adjusted odds ratio 2.19, 95% confidence interval 1.03-4.67) were independently associated with higher adherence. Long wait times, lack of specialized transplant dermatologists, long travel distances, and insufficient priority were cited as the most common barriers for access to dermatologic care. Skin cancer education was provided to patients by over three quarters of care providers. Given the self-reported lack of adherence to annual skin cancer screening, there is need to develop, evaluate, and implement interventions that improve screening rates and skin cancer outcomes.

Treatment for Lentigo Maligna of the Head and Neck: Survey of Practices in Ontario, Canada.

BACKGROUND: Lentigo maligna is an in situ form of cutaneous melanoma that commonly arises on the head and neck. Various surgical and nonsurgical treatment options are available but no randomized trials exist to guide practice. OBJECTIVE: To determine the current treatment practices for lentigo maligna of the head and neck in Ontario, Canada. MATERIALS AND METHODS: Cross-sectional survey of dermatologists, plastic surgeons, and head and neck surgeons. RESULTS: The response rate was 35% (190/542). Wide excision with immediate reconstruction was the most commonly recommended treatment for tumors on the cheek (69%), whereas staged excision with margin control was recommended most often for tumors on the nasal ala (60%). Overall, 5 mm was the most frequently recommended initial surgical margin (69%); 26.5% of respondents recommended margins wider than 5 mm. For tumors on the nasal ala, eyelid, and ear helix, more than 30% of respondents recommended an initial margin narrower than 5 mm. CONCLUSION: Although surgical excision is the predominant treatment modality for lentigo maligna on the head and neck, practices vary considerably in terms of the type of excision and the initial margin used. Potential response bias and the geographic restriction of our sample may limit the generalizability of our results.

Surgical management of peritoneal dialysis peritonitis: the impact of peritoneal sclerosis.

BACKGROUND: Peritonitis is a life-threatening complication of peritoneal dialysis. Peritoneal sclerosis is associated with long-term peritoneal dialysis. The aim of this study was to assess the effect of peritoneal sclerosis on outcomes following laparotomy for peritoneal dialysis peritonitis. METHODS: A series of 63 consecutive patients underwent laparotomy for peritoneal dialysis peritonitis. Patients were divided into two groups, those with and those without simple peritoneal sclerosis identified at laparotomy. Medical, anaesthetic, and surgical notes were used for data collection. Patients with known encapsulating peritoneal sclerosis were excluded from the study. RESULTS: Patients with simple peritoneal sclerosis had a statistically significant longer duration of peritoneal dialysis. They also had a significantly higher risk of major complications postoperatively and a greater relative risk for mortality. CONCLUSIONS: There is an increased prevalence of simple peritoneal sclerosis with long-term peritoneal dialysis. Patients with simple peritoneal sclerosis have higher incidence of postlaparotomy complications. Patients on long-term peritoneal dialysis should be treated aggressively for peritoneal dialysis peritonitis to reduce complication/mortality rates. Evidence of simple peritoneal sclerosis at laparotomy should preclude further peritoneal dialysis.

Application of Recursive Partitioning to Derive and Validate a Claims-Based Algorithm for Identifying Keratinocyte Carcinoma (Nonmelanoma Skin Cancer).

Importance: Keratinocyte carcinoma (nonmelanoma skin cancer) accounts for substantial burden in terms of high incidence and health care costs but is excluded by most cancer registries in North America. Administrative health insurance claims databases offer an opportunity to identify these cancers using diagnosis and procedural codes submitted for reimbursement purposes. Objective: To apply recursive partitioning to derive and validate a claims-based algorithm for identifying keratinocyte carcinoma with high sensitivity and specificity. Design, Setting, and Participants: Retrospective study using population-based administrative databases linked to 602 371 pathology episodes from a community laboratory for adults residing in Ontario, Canada, from January 1, 1992, to December 31, 2009. The final analysis was completed in January 2016. We used recursive partitioning (classification trees) to derive an algorithm based on health insurance claims. The performance of the derived algorithm was compared with 5 prespecified algorithms and validated using an independent academic hospital clinic data set of 2082 patients seen in May and June 2011. Main Outcomes and Measures: Sensitivity, specificity, positive predictive value, and negative predictive value using the histopathological diagnosis as the criterion standard. We aimed to achieve maximal specificity, while maintaining greater than 80% sensitivity. Results: Among 602 371 pathology episodes, 131 562 (21.8%) had a diagnosis of keratinocyte carcinoma. Our final derived algorithm outperformed the 5 simple prespecified algorithms and performed well in both community and hospital data sets in terms of sensitivity (82.6% and 84.9%, respectively), specificity (93.0% and 99.0%, respectively), positive predictive value (76.7% and 69.2%, respectively), and negative predictive value (95.0% and 99.6%, respectively). Algorithm performance did not vary substantially during the 18-year period. Conclusions and Relevance: This algorithm offers a reliable mechanism for ascertaining keratinocyte carcinoma for epidemiological research in the absence of cancer registry data. Our findings also demonstrate the value of recursive partitioning in deriving valid claims-based algorithms.

Systematic review of melanoma incidence and prognosis in solid organ transplant recipients.

Cutaneous melanoma carries the potential for substantial morbidity and mortality in the solid organ transplant population. We systematically reviewed the literature published from January 1995 to January 2012 to determine the overall relative risk and prognosis of melanoma in transplant recipients. Our search identified 7,512 citations. Twelve unique non-overlapping studies reported the population-based incidence of melanoma in an inception cohort of solid organ transplant recipients. Compared to the general population, there is a 2.4-fold (95% confidence interval, 2.0 to 2.9) increased incidence of melanoma after transplantation. No population-based outcome data were identified for melanoma arising post-transplant. Data from non-population based cohort studies suggest a worse prognosis for late-stage melanoma developing after transplantation compared with the general population. For patients with a history of pre-transplant melanoma, one population-based study reported a local recurrence rate of 11% (2/19) after transplantation, although staging and survival information was lacking. There is a need for population-based data on the prognosis of melanoma arising pre- and post-transplantation. Increased incidence and potentially worse melanoma outcomes in this high-risk population have implications for clinical care in terms of prevention, screening and reduction of immunosuppression after melanoma development post-transplant, as well as transplantation decisions in patients with a history of pre-transplant melanoma.

Guidelines for randomized clinical trial protocol content: a systematic review.

BACKGROUND: All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. METHODS: We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. RESULTS: Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. CONCLUSIONS: Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.