Todd V. Cartee

Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants – physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN). This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide. Diagnosis is based on signs and symptoms with management and treatment aimed to suppress inflammatory lesions, erythema, and telangiectasia. While many clinical trials of rosacea exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of rosacea. This project will utilize a methodology similar to previous core outcome set research. A long list of outcomes will be extracted over four phases: (1) systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will be examined by the Steering Committee to provide further insight. The Delphi process will then be performed to prioritize and condense the list of outcomes generated. Two homogenous groups of physicians and patients will participate in two consecutive rounds of Delphi surveys. A consensus meeting, composed of physicians, patients, and stakeholders, will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) and Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN). This study aims to develop a core outcome set to guide assessment in clinical trials of rosacea. The end-goal is to improve the reliability and consistency of outcome reporting, thereby allowing sufficient evaluation of treatment effectiveness and patient satisfaction.

Importance Excisional skin cancer surgery is a common procedure, with no formal consensus for mitigating the risk of wrong-site cutaneous surgery. Objective To systematically consider the usefulness and feasibility of proposed methods for correct biopsy site identification in dermatology. Evidence Review Survey study with a formal consensus process. Item development was via a literature review and expert interviews, followed by 2 stages of a Delphi process to develop consensus recommendations. Findings In total, 2323 articles were reviewed in the literature search, with data extraction from 14. Twenty-five experts underwent 30-minute structured interviews, which were transcribed and coded. The resulting survey was composed of 42 proposed interventions by multiple stakeholders (biopsying physicians, operating physicians, nurses, ancillary staff, patients, caregivers, and family members) at 3 time points (day of biopsy, delay and consultation period, and day of definitive surgery). Two rounds of a Delphi process with 59 experts (25 academic and 34 private practice) scored the survey. Strong consensus was obtained on 14 behaviors, and moderate consensus was obtained on 21 other behaviors. In addition, a 2-state simultaneous algorithm was developed to model surgeon behavior on the day of definitive surgery based on surgeon and patient perceptions. Conclusions and Relevance When definitive surgery is performed after the initial biopsy and by a different surgeon, procedures can be implemented at several time points to increase the likelihood of correct site identification. The specific circumstances of a case suggest which methods may be most appropriate and feasible, and some may be implemented. The risk of wrong-site cutaneous surgery can be reduced but not eliminated.

Mohs micrographic surgery (MMS) offers an unparalleled cure rate for cutaneous malignancy. Its success hinges on achieving reliably negative histologic margins. When assessing margins, Mohs surgeons generally examine multiple histologic sections per Mohs stage. In some cases, the most-peripheral section or sections are clear, but tumor is identified in deeper sections within the same tissue block. To explore approaches to margin analysis in these scenarios. A web-based survey was administered to members of the American College of Mohs Surgery investigating their standard practice when definitively tumor-free section(s) are examined during a Mohs stage before finding cancer in a deep section. Factors influencing the decision were explored. The number of clear sections required to declare margin negativity and terminate MMS (margin threshold) varied widely among respondents; 25% were comfortable with one clear section, whereas 19% would obtain an additional layer with eight clear sections. Margin thresholds depended on tumor type but were independent of surgeon experience. Although no consensus emerged, a majority of respondents would not take an additional layer with four clear sections if resecting basal cell carcinoma. Prospective outcomes data are needed to standardize management of this important oncologic issue.