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The strength of a systematic review hinges in large part on the quality of evidence it appraises. Observational studies, including cohort studies and case series, are positioned lower on the hierarchy of evidence, with cohort studies typically higher than case series. The often subtle differences between these study designs may lead to misclassification and can impact the strength of recommendations derived from such data. This manuscript offers an approach to delineate the differences between cohort studies and case series and provides clinical examples of these subtleties. By providing a simple approach for distinguishing cohort studies from case series, this manuscript seeks to assist researchers performing systematic reviews., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Importance: The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients., Objective: To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement., Design, Setting, and Participants: This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019., Exposures: Respondents read and returned the aforementioned paper survey, while nonrespondents did not., Main Outcomes and Measures: The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups., Results: Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold., Conclusions and Relevance: In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Background: Few studies show how dermatologic surgeons manage problems with site identification., Objective: To estimate frequency and characterize management of skin cancer treated by surgery when the anatomic location of the tumor is in question., Methods: Nationwide, prospective, multisite cohort study., Results: Among 17,076 cases at 22 centers, 98 (0.60%) were lesions in question for which site identification was initially uncertain, with these more often in patients who were male, older, and biopsied more than 30 days ago. Surgeons employed on average 5.0 (95% CI: 4.61-5.39) additional techniques to confirm the site location, with common approaches including: re-checking available documentation (90 lesions, 92%); performing an expanded physical examination (89 lesions, 91%); and asking the patient to point using a mirror (61 lesions, 62%). In 15%, photographs were requested from the biopsying provider, and also in 15%, frozen section biopsies were obtained. In 10%, the referring physician was contacted. Eventually, surgeons succeeded in definitively identifying 82% (80 of 98) of initially uncertain sites, with the remaining 18% (18 of 98) postponed. Most postponed surgeries were at non-facial sites., Limitations: Sites were academic centers., Conclusions: When the anatomic location of the tumor is uncertain, dermatologic surgeons use multiple methods to identify the site, and sometimes cases are postponed., Competing Interests: Conflicts of interest Dr Bolotin reported serving as principal investigator on a clinical trial sponsored by Replimune outside the submitted work. Dr Cohen reported serving as a clinical investigator, consultant, or speaker or trainer for Accure, Allergan, Almirall/Athenex, Avuta, Biofrontera Bioscience, Biopelle, Brickell Biotech, Croma, Elta, Endo Pharmaceuticals, Ferndale, Galderma, InMode, IntraDerm, Lutronic, Merz, Novan, PCA, Pulse Biosciences, Raziel, Recros Medica, Revance, Revision, Sciton, and Sente outside the submitted work. Dr Council reported receiving personal fees from Sanofi-Genzyme Regeneron, AbbVie, and Castle Biosciences outside the submitted work. Dr Schmults reported serving as the National Comprehensive Cancer Network nonmelanoma panel chair, on the American Society for Dermatologic Surgery board of directors, and as International Society for Dermatologic and Esthetic Surgery secretary. Dr Xu serves as the National Comprehensive Cancer Network nonmelanoma panel member. Drs Ahmed, Campbell, Ibrahim, Kang, Aylward, Bari, Cherpelis, Condon, Farhang, Firoz, Garrett, Geronemus, Golda, Humphreys, Hurst, Jiang, Karia, Asadi, Kouba, MacFarlane, Maher, Miller, Moioli, Morrow, Neckman, Pearson, Peterson, Poblete-Lopez, Prather, Ranario, Rubin, Swanson, Urban, Xu, Pearlman, Yoo, Harikumar, Schaeffer, Iyengar, Poon, Cahn and Alam and authors Shi, Koza, Ma, Haq, Nadir, Yi, Dave, Hisham, Lin, Dirr, Bhatti, Helming, Jacobson, and Weil have no conflicts of interest to declare., (Copyright © 2024. Published by Elsevier Inc.)

Competing Interests: Conflicts of interest Dr Bae reported serving on the advisory board for Abbvie outside the submitted work. Dr Mann reported serving as a consultant for Methapharma outside the submitted work. Author Ma; Drs Zafar, Goldman, Munavalli, Zimmet, Nguyen, Mishra, Cartee, Hsu, Silapunt, R.A. Weiss, and M.A. Weiss; Author Haq; Dr Ahmed; Authors Koza, Shi, and Dave; Drs Yi, Kang, Cahn, Kole, Friedmann, Chow, Minkis, Stücker, Schlick, Hoss, Hu, Kibbi, Saikaly, Greywal, Hooper, Vashi, Boucher, Ward, Neuhaus, Ghareeb, Luke, Karen, Suggs, Lucas, Decker, Brieva, Yoo, Suozzi, and Alam have no conflicts of interest to declare.

Diffuse dermal angiomatosis (DDA) is a rare, benign cutaneous disorder that can affect the breasts. Typically, it presents in middle-aged women and is increasingly associated with various risk factors that involve tissue hypoxia. We report this case of classical bilateral DDA of the breasts in a 56-year-old female patient. This case highlights the association of DDA with hypoxia-inducing risk factors, such as smoking. Management of the hypoxic risk factors resulted in the resolution of the bilateral ulceration caused by DDA in this patient. This case report aims to discuss the etiology, risk factors, clinical manifestations, and treatment modalities commonly used to manage this condition., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Shet et al.)

Acne scarring results from a common inflammatory condition present in many people. These scars can have an impact on quality of life by influencing self-esteem and social acceptance. Current acne scarring treatments, such as chemical peels and laser treatments, often have limited success due to their time-consuming nature and the variability of acne scar types. The subcision technique has shown promise for the treatment of rolling acne scars. There are few studies to date that examine the effects of multiple subcision treatments on rolling acne scars. We evaluated whether the use of multiple subcision treatments improved the appearance of rolling acne scars compared to no treatment. Five patients with rolling acne scars on both sides of their face who met inclusion and exclusion criteria were enrolled in the study. One side of the face was randomized to receive treatment, while the contralateral side of the face received no treatment. Subjects underwent five sequential subcision treatments, spaced 4 weeks apart, with two follow-up visits at weeks 20 and 36 from the 1st treatment. Photographs were taken before and after the initial treatment visit and at each subsequent visit. Acne scar appearance was evaluated by the subject, a blinded live rater, and two double-blinded dermatologist raters. Evaluations of treatment outcomes involved overall acne scar appearance on a 5-point scale, acne scar improvement on a percentage scale, a modified quantitative global scarring grading system, and potential treatment side effects. There was a greater decrease in global scarring scores in the multiple subcision side compared to the control side. There was a greater difference in the average acne scar appearance scores between the Week 36 follow-up visit and baseline for the multiple subcision side compared to that of the control side. 50% of patients reported being more satisfied with the treatment side compared to the control side in regard to overall improvement. The study results suggest that multiple subcision treatments may improve the appearance of rolling acne scars compared to no treatment., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Therapeutic options for acne scars include subcision and suction with microdermabrasion, but these treatment modalities have not been studied in conjunction. To compare effectiveness of subcision alone versus subcision with suction for the treatment of facial acne scars. Randomized, split-faced, evaluator-blinded control trial. Participants underwent one subcision treatment on both sides of the face followed by 10 sessions of suction to one side. Photographs at baseline, 1-month, and 4-months were assessed. Primary outcome measures were the validated Acne Scar Severity Scale (ASSS) (0 = no acne scarring, 4 = severe), Acne Scar Improvement Grading Scale (ASIGS) (-100 to 100%), and modified Quantitative Global Scarring Grades (QGSG) (point-based questionnaire instrument), as well as subject preference. Twenty-eight treatment areas and 154 treatments were analyzed. Dermatologist raters found no differences between subcision alone and subcision-suction at 1-month or 4-months. Mean subject-assessed percent improvement for subcision-suction was higher than that for subcision alone at 1-month (37% versus 24%, p = 0.04) but not at 4-months (p = 0.37). Subjects preferred combination therapy to monotherapy at 1-month (50% vs. 21%) and 4-months (43% vs. 21%). While blinded raters did not detect significant differences, subjects perceived combination treatment as working more quickly than monotherapy, and preferred combination treatment at all time points.Clinical trial registration NCT01696513 on Clinicaltrials.gov., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Competing Interests: Conflicts of interest Dr Bolotin reported serving as principal investigator on a clinical trial sponsored by Replimune outside the submitted work. Dr Cohen reported serving as a clinical investigator, consultant, or speaker or trainer for Accure, Allergan, Almirall/Athenex, Avuta, Biofrontera Bioscience, Biopelle, Brickell Biotech, Croma, Elta, Endo Pharmaceuticals, Ferndale, Galderma, InMode, IntraDerm, Lutronic, Merz, Novan, PCA, Pulse Biosciences, Raziel, Recros Medica, Revance, Revision, Sciton, and Sente outside the submitted work. Dr Council reported receiving personal fees from Sanofi Genzyme Regeneron, AbbVie, and Castle Biosciences outside the submitted work. Dr Riley has served as an advisory board member for Novartis Pharmaceuticals. The other authors have no conflicts of interest to declare.

Competing Interests: Conflicts of interest None disclosed.

Competing Interests: Conflicts of interest None disclosed.

Importance: Antagonist antibodies to programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) have shown remarkable activity in multiple tumor types. Recent US Food and Drug Administration approval of such agents for advanced melanoma, non-small cell lung cancer, and renal cell carcinoma has hastened the need to better characterize their unique toxicity profiles., Objective: To provide a clinical and pathologic description of the lichenoid mucocutaneous adverse effects seen in patients receiving anti-PD-1/PD-L1 treatment., Design, Setting, and Participants: Patients with advanced cancer who were referred to dermatology at Yale-New Haven Hospital, a tertiary care hospital, after developing cutaneous adverse effects while receiving an anti-PD-1 or PD-L1 antibody therapy either as monotherapy or in combination with another agent were identified. Medical records from 2010 to 2015 and available skin biopsy specimens were retrospectively reviewed., Main Outcomes and Measures: Patient demographic characteristics, concurrent medications, therapeutic regimen, type of disease, previous oncologic therapies, clinical morphology of cutaneous lesions, treatment of rash, peripheral blood eosinophil count, tumor response, and skin histologic characteristics if biopsies were available., Results: Patients were 13 men and 7 women, with a mean (range) age of 64 (46-86) years. The majority of cases (16 [80%]) had a clinical morphology consisting of erythematous papules with scale in a variety of distributions. Biopsies were available from 17 patients; 16 (94%) showed features of lichenoid interface dermatitis. Eighteen patients were treated with topical corticosteroids, and only 1 patient required discontinuation of anti-PD-1/PD-L1 therapy. Only 4 of 20 patients (20%) developed peripheral eosinophilia. Sixteen patients (80%) were concurrently taking medications that have been previously reported to cause lichenoid drug eruptions., Conclusions and Relevance: Papular and nodular eruptions with scale, as well as mucosal erosions, with lichenoid features on histologic analysis were a distinct finding seen with anti-PD-1/PD-L1 therapies and were generally manageable with topical steroids. Concurrent medications may play a role in the development of this cutaneous adverse effect.

Care of the oncologic patient requires an integral understanding of the adverse reactions of chemotherapy. With the advent of targeted agents and immunomodulating therapies, reactions to these newer treatments are of clinical interest. Cutaneous side effects of chemotherapeutic agents, including toxic erythema and mucositis, are common and may require cessation of treatment if associated with discomfort, superinfection, or negative impact on quality of life. This article reviews the cutaneous adverse reactions and treatment options of both conventional cytotoxic chemotherapeutic agents and newer targeted, multikinase inhibitors and immunomodulating therapies. An understanding of possible cutaneous reactions by all providers involved in the care of the oncologic patient is critical for prompt recognition, allowing for appropriate treatment and referral to dermatologists when necessary., (Copyright © 2016. Published by Elsevier Inc.)

Animals modulate their arousal state to ensure that their sensory responsiveness and locomotor activity match environmental demands. Neuropeptides can regulate arousal, but studies of their roles in vertebrates have been constrained by the vast array of neuropeptides and their pleiotropic effects. To overcome these limitations, we systematically dissected the neuropeptidergic modulation of arousal in larval zebrafish. We quantified spontaneous locomotor activity and responsiveness to sensory stimuli after genetically induced expression of seven evolutionarily conserved neuropeptides, including adenylate cyclase activating polypeptide 1b (adcyap1b), cocaine-related and amphetamine-related transcript (cart), cholecystokinin (cck), calcitonin gene-related peptide (cgrp), galanin, hypocretin, and nociceptin. Our study reveals that arousal behaviors are dissociable: neuropeptide expression uncoupled spontaneous activity from sensory responsiveness, and uncovered modality-specific effects upon sensory responsiveness. Principal components analysis and phenotypic clustering revealed both shared and divergent features of neuropeptidergic functions: hypocretin and cgrp stimulated spontaneous locomotor activity, whereas galanin and nociceptin attenuated these behaviors. In contrast, cart and adcyap1b enhanced sensory responsiveness yet had minimal impacts on spontaneous activity, and cck expression induced the opposite effects. Furthermore, hypocretin and nociceptin induced modality-specific differences in responsiveness to changes in illumination. Our study provides the first systematic and high-throughput analysis of neuropeptidergic modulation of arousal, demonstrates that arousal can be partitioned into independent behavioral components, and reveals novel and conserved functions of neuropeptides in regulating arousal.