Development of a core outcome set for basal cell carcinoma.

BACKGROUND: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. OBJECTIVE: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. METHODS: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. RESULTS: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. LIMITATIONS: English-speaking patients and professionals rated outcomes extracted from English language studies. CONCLUSION: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

Core Outcome Set for Actinic Keratosis Clinical Trials.

Importance: Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews. Objective: To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process. Evidence Review: Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019. Findings: A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible. Conclusions and Relevance: Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.

Combined treatment of disfiguring facial angiofibromas in tuberous sclerosis complex with surgical debulking and topical sirolimus.

Tuberous sclerosis complex (TSC) is an autosomal-dominant disorder that causes the formation of hamartomatous tumors such as facial angiofibromas (FAs). We present a combination of surgical debulking via shave biopsy, curettage, and electrocautery followed by application of sirolimus ointment 1% to the nose to treat FAs in the setting of TSC. This novel approach achieved an optimal therapeutic response in our patient with minimal recurrence of FAs after 1 year of follow-up.

Behavior of Cutaneous Adnexal Malignancies: a Single Institution Experience.

Cutaneous adnexal malignancies are biologically and pathologically diverse, and associated with a range of clinical outcomes. Given their rarity, the prognosis and optimal treatment of these neoplasms remains unclear. A single institution database from a tertiary care cancer center of patients treated for malignant cutaneous adnexal tumors was retrospectively analyzed. Clinicopathologic variables and outcome measures were analyzed in patients undergoing wide excision with or without sentinel node biopsy. 103 patients were analyzed; the majority of tumors were of eccrine sweat gland derivation (n = 69, 70%), and these exhibited a higher rate of nodal involvement and overall worse outcome. Sixteen patients (16%) demonstrated nodal metastasis, which included 10 (10%) with nodal disease at presentation and 6 who developed nodal metastasis during followup. 20 patients underwent sentinel node biopsy, and 2 (10%) had a positive sentinel node. 62% of nodal metastases occurred in patients with porocarcinoma. Seven patients died of disease (7%) with a median time from diagnosis to death of 48 months (range, 10-174). After a median follow up of 44.7 months, age > 70 years and larger tumor size were significantly associated with worse overall survival. Adnexal malignancies are rare tumors, and there is a paucity of information to guide the clinician in determining optimum surgical and medical treatment. Tumors of eccrine derivation, especially porocarcinomas, have a high risk of nodal involvement and may be considered for sentinel node biopsy.

Update and Review of Bleeding Considerations in Dermatologic Surgery: Anticoagulants and Antiplatelets.

BACKGROUND: Bleeding is an unavoidable risk of dermatologic surgery. The risk may be higher in patients taking agents that affect hemostasis. OBJECTIVE: The aim of this study was to provide an updated review of current anticoagulant and antiplatelet therapy available in the market and their associated risk of bleeding complications in cutaneous surgery. MATERIALS AND METHODS: A review of PubMed and MEDLINE was performed to review the English-language medical literature. RESULTS: Many anticoagulant and antiplatelet therapies exist. Several studies recommend the continued use of antiplatelet and anticoagulant medications in the perioperative period. Combination regimens and novel oral anticoagulants may be associated with an increased risk of bleeding. CONCLUSION: An updated understanding of antiplatelet and anticoagulant agents is critical for the surgeon. Current evidence does not support the discontinuation of antiplatelet and anticoagulant agents in the perioperative period under most circumstances. However, relevant data on novel oral anticoagulant agents are still sparse, suggesting that a precautionary approach is warranted.

Update and Review of Bleeding Considerations in Dermatologic Surgery: Hemostatic Techniques and Treatment Strategies for Bleeding Complications.

BACKGROUND: There are many intraoperative and postoperative techniques to aid hemostasis in dermatologic procedures. An updated understanding is critical for the surgeon. OBJECTIVE: To provide an updated review of methods for hemostasis and therapies for postprocedural purpura and ecchymosis applicable to dermatology. MATERIALS AND METHODS: A review of Ovid MEDLINE was performed to review the English-language medical literature of hemostatic options and their use in cutaneous surgery. All available publication years were included from 1946 to present. RESULTS: A comprehensive and current list of hemostatic options used in the intraoperative and postoperative period is provided along with traditional and emerging therapies for postprocedural purpura and ecchymosis. CONCLUSION: A myriad of options exist for minimizing and treating bleeding complications. The appropriate use and updated knowledge of hemostatic options is provided.

Patients believe that cosmetic procedures affect their quality of life: An interview study of patient-reported motivations.

BACKGROUND: Although treatments to address cosmetic concerns are common, patients' self-reported motives for considering such procedures have not been systematically explored. OBJECTIVE: To develop a framework of categories to describe patients' self-reported motivations for undergoing minimally invasive cosmetic procedures. METHODS: Face-to-face, semistructured patient interviews were conducted with adult participants who had undergone or were considering minimally invasive cosmetic dermatologic procedures. A qualitative constant comparative approach was used to analyze interview transcripts, yielding themes and subthemes. RESULTS: A total of 30 interviews were completed. Most patient-reported motivations for cosmetic procedures could be subsumed under 8 general categories (themes): (1) mental and emotional health, (2) cosmetic appearance, (3) physical health, (4) work and/or school success, (5) social well-being, (6) cost and/or convenience, (7) procedural perceptions, and (8) timing of treatment. Many individual motivations in these categories were unrelated to desire for physical beauty. In particular, participants wanted to avoid being self-conscious, enhance confidence, reduce the time and expense required to conceal physical imperfections, and be perceived as capable at work. LIMITATIONS: Only English-speaking patients in the United States were interviewed. CONCLUSION: Patient-reported motivations for cosmetic procedures mostly pertained to physical and psychosocial well-being. Indeed, a desire for improved cosmetic appearance was only 1 of the 8 themes revealed through the patient interviews.

Quantitative evaluation of skin shrinkage associated with non-invasive skin tightening: a simple method for reproducible linear measurement using microtattoos.

Non-invasive skin-tightening devices can induce thermal denaturation and skin shrinkage via externally applied radiofrequency emissions or high-frequency ultrasound. Therefore, the purpose of this study is to develop and test a method for measurement of skin reduction associated with application of such energy devices. Twenty-five healthy participants with mild to moderate skin laxity of the arms were enrolled. Pinpoint microtattoos were placed at each of the treatment sites to delineate two 6 × 12 cm rectangles per subject. A non-stretchable filament, tape and marking pen apparatus was used to measure the size of each rectangle before treatment and at follow-up visit by two blinded investigators. After randomization, one side received a single pass with a radiofrequency device (6.78 MHz), while the contralateral side received multiple passes. Participants underwent two treatment sessions to each side 2 weeks apart, and returned for follow-up 4 weeks after the second treatment. Length and area measurement were analyzed to assess precision and accuracy of measurements and to compare efficacy of treatment between pre- and post-treatment. Concordance correlation coefficients (CCC) demonstrated substantial inter-investigator reliability and precision in length measurements (CCC, 0.94 to 0.98 in pre-treatment; 0.95 to 0.98 in post-treatment). Measurements at the 6-week post-treatment follow-up demonstrated a statistically significant skin reduction in all six of the measured parameters. A simple skin measurement method requiring minimal instrumentation can quantitatively evaluate skin shrinkage associated with non-invasive skin-tightening devices.

Utility of a High-Resolution Superficial Diagnostic Ultrasound System for Assessing Skin Thickness: A Cross-Sectional Study.

BACKGROUND: Compared with other imaging modalities, ultrasound is relatively deeply penetrating and can be used to evaluate deep dermal and subcutaneous structures. OBJECTIVE: Image skin thickness of the face and neck using high-frequency diagnostic ultrasound devices. MATERIALS AND METHODS: Skin overlying 20 different predesignated face and neck anatomic sites in 32 individuals was imaged using 2 commercially available high-frequency diagnostic ultrasound devices, a dedicated imaging device and a diagnostic device bundled with a therapeutic device. At each site, the subcutaneous and combined epidermal and dermal layer thicknesses were assessed by blinded expert raters. RESULTS: Similar skin thickness measurements were obtained. Notably, subcutaneous fat depth was measured to be 0.2 cm at the forehead; 0.5 cm at the mental eminence; and 0.6 cm at the submental, supraglenoid, and temporal regions. The combined epidermal and dermal thickness was approximately 0.1 cm at the zygomatic process, suborbital area, inferior malar region, gonion, supraglenoid area, and nasolabial-buccal, and nasolabial fold regions. CONCLUSION: This is the first study using high-resolution superficial diagnostic ultrasound to map skin thickness of the face and neck at standard anatomic locations. Ultrasound is an inexpensive, noninvasive, and convenient means to monitor dermatologic conditions and guide their treatment.

Quantification of noninvasive fat reduction: A systematic review.

BACKGROUND AND OBJECTIVE: Noninvasive fat reduction appears effective, but there are various methods for quantifying changes. The objective of this review is to assess comparative utility measures of subcutaneous fat. STUDY DESIGN/MATERIALS AND METHODS: Articles describing noninvasive fat reduction were searched using MEDLINE, EMBASE, CINAHL and Scopus electronic databases on two dates (January 28, 2014 and February 16, 2016). Titles of studies and abstracts were screened for eligibility. Manual review was performed by two investigators to detect those that: (1) included original data; (2) were randomized controlled trials, or prospective or retrospective cohort studies; (3) quantified fat outcomes; and (4) enrolled at least 10 subjects. RESULTS: Of 1,057 retrieved articles, 36 met criteria. Most reported four or more measurement techniques. Circumference measurements were most commonly cited. Other objective techniques, like caliper thickness, ultrasound, magnetic resonance imaging (MRI), and three-dimensional (3D) photography, were also used. Common subjective methods were evaluation of standardized photographs by blinded raters and patient satisfaction surveys. CONCLUSIONS: For quantifying noninvasive fat reduction, all available methods had significant limitations: photographic comparisons were subjective; circumference or caliper measurements were confounded; ultrasound was operator dependent; MRI was expensive; computed models and simulations were in early development. As new technologies are developed, the need for reliable, accurate and practical measures of subcutaneous fat will increase. Lasers Surg. Med. 50:96-110, 2018. © 2017 Wiley Periodicals, Inc.

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: 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. METHODS/DESIGN: 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). DISCUSSION: 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.

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. METHODS/DESIGN: A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. DISCUSSION: The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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.

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

BACKGROUND: Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. OBJECTIVE: To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. MATERIALS AND METHODS: The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. RESULTS: The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

Purple patches in an immunocompromised patient: a report of secondary disseminated cutaneous mucormycosis in a man with chronic lymphocytic leukemia.

A 60-year-old man with chronic lymphocytic leukemiadeveloped a deeply violaceous annular patchwith a halo of erythema on the right thigh duringhospitalization for neutropenic fever. Associatedsymptoms included chronic cough and fatigue.Bilateral lung opacities with hilar lymphadenopathywere noted on chest computed tomographyscan. Punch biopsy and tissue culture confirmeda diagnosis of secondary disseminated cutaneousmucormycosis. Although rare, physicians shouldinclude mucormycosis in the differential diagnosisof purpuric patches in immunosuppressed patients.Prompt skin biopsy and tissue culture may optimizethe success of treatment.

Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: 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. METHODS/DESIGN: 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). DISCUSSION: 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.