Ian A. Maher

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

BackgroundRosacea 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/designThis 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).DiscussionThis 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.

Identifying and defining complications of dermatologic surgery to be tracked in the American College of Mohs Surgery (ACMS) Registry.

BACKGROUND In recent years, increasing emphasis has been placed on value-based health care delivery. Dermatology must develop performance measures to judge the quality of services provided. The implementation of a national complication registry is one such method of tracking surgical outcomes and monitoring the safety of the specialty. OBJECTIVE The purpose of this study was to define critical outcome measures to be included in the complications registry of the American College of Mohs Surgery (ACMS). METHODS A Delphi process was used to reach consensus on the complications to be recorded. RESULTS Four major and one minor complications were selected: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. LIMITATIONS This article addresses only one aspect of registry development: identifying and defining surgical complications. CONCLUSION The ACMS Registry aims to gather data to monitor the safety and value of dermatologic surgery. Determining and defining the outcomes to be included in the registry is an important foundation toward this endeavor.

Experience vs experiments with the purse-string closure: unexpected results.

In this issue of JAMA Dermatology, Joo and colleagues1 report the results of a randomized clinical trial (RCT) comparing purse-string suture closure to secondary intention healing for wounds on the trunk and extremities. By rigorously examining a commonly used dermatologic procedure, their work has the potential to immediately impact the daily practice of dermatologists. The purse-string suture has been used to repair cutaneous defects for nearly 3 decades.2 Indeed, the purse-string repair has been noted by numerous authors to improve cosmesis, reduce scar size, speed healing, and minimize complications compared with secondary intention healing.3-6 However, when examined in this RCT, the purse-string closure showed no benefit over granulation in terms of cosmetic outcome, scar area, or complication risk. This is not the first time nor will it be the last that an intuitive hypothesis appears not to be borne out by experimental results.7 With the increasing emphasis on health care outcomes, a higher standard of evidence is being demanded of the medical community to justify the use of interventions. This study is a perfect example of why observational experience—even of substantial volume—is not a substitute for well-designed, blinded trials.8-10 As always, the reader should be aware of this study’s limitations. It was a single-center study—there is the potential that other surgeons could perform the purse-string differently, in a way that may impact outcomes. Additionally, suture gauge was not standardized, and this might have affected the results. The study was also restricted to wounds on the trunk and extremities, and thus the findings cannot necessarily be extrapolated to wounds on the head and neck. While healing time was 2 weeks shorter with the purse-string closure, the difference did not reach statistical significance, nor was the study powered to detect a difference in healing time, nor was healing time assessed in person by the investigators. Healing time represents an important outcome for patients, and the shorter healing time for purse-string closure found in this study is certainly worth exploring further. A 2-week advantage in healing time could in and of itself represent a reason to perform this technique. To further rationalize value-based decisions, RCTs like those performed by Joo and colleagues1 could use standardized outcomes of interest. For instance, ideally, all studies on wound closures would measure a standard set of experimental outcomes (eg, scar score) in the same way (eg, using the same scar scale), thus allowing for more direct comparisons of studies and more meaningful and efficient meta-analysis. This is the concept underlying core outcome sets and core outcome measures. Core outcome sets are an agreed set of minimum parameters that are measured and reported in every study concerning a given disease, procedure, or condition.11 These outcomes should be meaningful to all stakeholders, including patients, physicians, and payers. Efforts to develop core outcome sets have been under way in fields as diverse as rheumatology and pain management as well as within dermatology for eczema and psoriasis.11-14 Core outcome measures are the instruments that are used to measure the outcomes in the core outcomes sets. For example if aesthetic appearance as measured by scar score were selected as a core outcome for all studies of reconstructive techniques, it would be measured in all studies using the same agreed scar scale (the core outcome measure). By reporting all results, even negative ones, within the core set in every trial, reporting bias is minimized, and comparisons between studies are more meaningful and better able to guide decision making. The development and implementation of core outcome sets and their core outcome measures are not a simple task. An iterative, time-intensive process may be needed to integrate patient, regulator, and payer input. In addition, a significant nucleus of researchers would need to participate, and relevant journals would need to allocate space to publish all results from the core outcome sets. Eventually, by making our study of procedures more rigorous and standardized, we will be better able to answer difficult questions regarding clinical care. Congratulations to Joo and colleagues1 on an excellent study that is truly a step in the right direction.

Transposition Flaps: Principles and Locations.

BACKGROUND Transposition flaps are frequently used to repair defects of the head and neck after tumor extirpation with Mohs micrographic surgery. OBJECTIVE To review the basic principles underlying single-stage transposition flaps and also their utility relative to location on the head and neck. MATERIALS AND METHODS A review of the literature on transposition flaps was performed with specific reference to the principles of single-stage transposition flaps, including rhomboid flaps and their variations, multilobed flaps, and the locations where transposition flaps are frequently executed on the head and neck. RESULTS Numerous articles have been written with regard to the techniques for designing and executing transposition flaps. The primary advantages of transposition flaps include less undermining as compared to large sliding flaps and the superior ability to displace tension away from the defect and from free margins. Optimal cosmesis with these flaps can be achieved with appropriate sizing of flaps (or lobes), appropriate undermining, and meticulous suturing. CONCLUSION The versatility of transposition flaps makes them optimal for repair of defects on the head and neck and utilization of the outlined key principles and techniques aid in achieving an aesthetic result.

Pruritic, recurrent, erythematous plaques

a t(17;22) chromosomal translocation linking the collagen 1A1 (COL1A1) gene from chromosome 17 with the platelet-derived growth factor beta (PDGFb) gene from chromosome 22. This translocation allows the PDGFb receptor tyrosine kinase to become constitutively active, leading to the proliferation of spindle cells seen in this disease. This mutation also renders the tumor responsive to imatinib mesylate therapy, a molecular-targeted therapy that inhibits multiple tyrosine kinases, including the PDGFb receptor tyrosine kinase that is overactive in DFSP. For primary, localized disease, wide local excision may be curative, although recurrence rates as high as 9% have been reported. Mohs micrographic surgery (MMS) is another effective treatment option. Although MMS is a more time consuming procedure, recurrence rates as low as 1.5% have been reported with this technique, likely because of the complete margin analysis of MMS. The tight margin control present in MMS also allows for maximal tissue sparing, an attribute that is important for tumors with poor cosmetic and functional placement, such as those on the head and neck where DFSPs commonly arise. Because DFSPs rarely metastasize, staging is not usually recommended at the time of diagnosis, and local nodal excision is not warranted. Radiotherapy has been used as an adjunct to excision, especially in recurrent, aggressive tumors and when margins are positive and wider resection is contraindicated. Although DFSP is primarily managed surgically, the discovery of the t(17;22) translocation in the vast majority of DFPSs has given clinicians the therapeutic option of imatinib mesylate for unresectable, recurrent, and metastatic tumors. Because up to 10% of cases lack the t(17;22) translocation, fluorescence in situ hybridization of tumor cells to determine the translocation’s presence is recommended before initiating imatinib mesylate therapy. Reports have documented partial to complete responses in patients with DFSPs after treatment with imatinib. While larger trials are still needed to determine the typical response, long-term success, and appropriate duration and timing of imatinib therapy in DFSP, the results of two prospective, phase II trials of imatinib for inoperable DFSP have recently been published. These revealed an overall response rate of 46%, a 1year progression-free survival rate of 58%, and a median time to progression of 1.7 years. A concern that needs to be addressed is the possibility that the beneficial effect of imatinib may occur in a histologically discontinuous fashion, leaving some rests of neoplastic cells unchanged amidst areas of responsive tissue. This could serve as a potential pitfall during margin analysis, especially during MMS, of surgical specimens obtained after imatinib therapy. Whether imatinib is most useful as neoadjuvant, adjuvant, or primary therapy for DFSP remains to be determined. Regardless of the treatment used, the locally infiltrative pattern of DFSP growth make recurrence a realistic risk. Currently, it is recommended that patients should be examined every 6 months for at least 5 years after the diagnosis and then annually thereafter. For this series, the recommended choices are: 8, b; 9, b; 10, b; 11, b; 12, d; 13, c.

Reconstruction of a large defect of the glabella and forehead.

A43-year-old African American woman had a lesion excised using Mohs micrographic surgery requiring 2 stages and resulted in a 3.5 · 2.1 cm defect (Figure 1). She had presented with an indurated fibrotic plaque on the forehead and glabella measuring approximately 2.5 cm in diameter (Figure 2). Histological examination revealed the diagnosis of cellular fibrous histiocytoma. As the tumor interdigitated with frontalis, the inferior aspect of the defect extended to the corrugator complex and periosteum. How would you reconstruct this defect?

The Wave Flap: A Single-Stage, Modified Nasal Sidewall Rotation Flap for the Repair of Defects Involving the Mid-Alar Groove.

BACKGROUND Reconstruction of defects straddling the alar groove presents the dual challenges of resurfacing the nasal sidewall and alar subunits while simultaneously recreating the alar groove. The wave flap (WF) is a modified, medially based, nasal sidewall rotation flap that uses locally recruited tissue from the nasal sidewall to facilitate color and texture match and permit camouflage of scars. OBJECTIVE To detail a surgical repair for defects in the horizontally oriented middle third of the alar groove. MATERIALS AND METHODS This retrospective case series describes a technique for repair of defects involving the alar groove. Using postoperative photographs, outcomes were assessed by blinded noninvestigator dermatologist raters using the Observer Scar Assessment Scale. RESULTS Between February 2012 and June 2013, 10 patients were reconstructed using a WF design. Subjective assessment of scar vascularity, pigment, pliability, relief, and thickness by 3 independent reviewers yielded an overall cosmesis score of 11.1 (out of 50). No complications were noted. CONCLUSION The WF provides an excellent reconstructive option for Mohs defects of the middle third of the alar groove by recruiting local tissue and permitting maximum scar camouflage. A well-designed and executed WF provides cosmetically exceptional results for defects of the alar groove.

Transpositional Modification of the Posterior Auricular Pull‐Through Flap: A New Twist

migration to occur unimpeded underneath. A unique attribute of the silicone gel used for these patients is that it does not require a secondary bandage. It dries to form a bacteriostatic film, which may decrease exposure to bacteria, antigens, and irritation, inhibiting inflammation and, in turn, angiogenesis. This property may inhibit exuberant granulation tissue, which may inhibit epidermal migration.

Quantification of noninvasive fat reduction: A systematic review

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.

Using Grafts and Granulation to Improve Nasal Repair

Skin grafts offer a dynamic repair option for nasal defects of appropriate size, depth, and location. Granulation and grafting can successfully be used as stand-alone reconstructive options or in conjunction with flap repair. This article reviews suitable indications for graft and granulation use in nasal repair to achieve optimum functional and esthetic outcomes.