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.

Ossifying fibromyxoid tumor of soft parts presenting as a scalp cyst.

BACKGROUND: Ossifying fibromyxoid tumor of soft parts (OFMT) is a rare mesenchymal neoplasm of intermediate malignant potential. The tumor most commonly occurs on the extremities with a male predominance. We present an unusual case of OFMT occurring as a cystic lesion on the scalp of a female. CASE HISTORY: A 67-year-old woman presented with a 6-year history of a well demarcated cystic scalp mass. Physical examination revealed a slightly movable, multilobular mass of the left parietal scalp which was subsequently excised. Histological evaluation revealed an OFMT comprised of bland, small cells and a thick collagenous capsule containing an incomplete rim of lamellar bone. CONCLUSION: OFMT is an unusual tumor which can usually be considered as having an intermediate risk of malignancy. It generally occurs in the extremities with a male predominance. The clinical differential for a cystic mass on the scalp is broadened by this unusual case of an OFMT.

Repair of defects on nasal sebaceous skin.

BACKGROUND: Reconstructive procedures performed on sebaceous nasal skin are prone to partial flap necrosis, scar spread and inversion, and tissue mismatch. An ideal repair would optimize vascular integrity, minimize closure tension, and use adjacent tissue. OBJECTIVE: The purpose of this article is to describe a flap design and dynamics that permit satisfactory reconstruction of small- to medium-sized defects on nasal sebaceous tissue. METHODS: A modified advancement flap is described that may be used on central and off-midline defects of the nasal tip. RESULTS: Use of the modified advancement flap resulted in good cosmetic results with few adverse postsurgical events. CONCLUSIONS: The modified advancement flap satisfies the requirements of a hardy blood supply, minimization of closure tension, and use of adjacent tissue. The surgical results are predictable and rarely associated with complications.

Srcasm modulates EGF and Src-kinase signaling in keratinocytes.

The Src-activating and signaling molecule (Srcasm) is a recently described activator and substrate of Src-family tyrosine kinases (SFKs). When phosphorylated at specific tyrosines, Srcasm associates with Grb2 and p85, the regulatory subunit of phosphoinositide 3-kinase; however, little is known about the role of Srcasm in cellular signaling. Data presented here demonstrate that epidermal growth factor (EGF) receptor ligands promote the tyrosine phosphorylation of endogenous and adenovirally transduced Srcasm in keratinocytes, and that increased levels of Srcasm activate endogenous SFKs, with a preference for Fyn and Src. In addition, Srcasm potentiates EGF-dependent signals transmitted by SFKs in keratinocytes. Tyrosine phosphorylation of Srcasm is dependent on growth factors and the activity of EGFR and SFKs. Increased Srcasm expression enhances p44/42 mitogen-activated protein kinase activity and Elk-1-dependent transcriptional events. Elevated Srcasm levels inhibit keratinocyte proliferation while promoting specific aspects of keratinocyte differentiation. Lastly, Srcasm levels are decreased in human cutaneous neoplasia. Collectively, these data demonstrate that Srcasm plays a role in linking EGF receptor- and SFK-dependent signaling to differentiation in keratinocytes.

Gene expression profiling of porokeratosis demonstrates similarities with psoriasis.

BACKGROUND: Porokeratosis (PK) is a clinically heterogeneous entity associated with sharply demarcated, annular, or serpiginous lesions with a hyperkeratotic ridge. This disorder is associated with aberrant keratinocyte differentiation that histologically manifests as a stack of parakeratin termed the cornoid lamella; this structure represents the peripheral hyperkeratotic ridge of clinical lesions. Histologically, the keratinocytes forming the cornoid lamella demonstrate an altered differentiation program. However, the molecular basis of PK remains incompletely understood. METHODS: As a first step in characterizing PK at the molecular level, gene expression profiling was performed on a cornoid lamella isolated from a large, Mibelli-type porokeratotic lesion. As a control, gene expression profiling of peripheral uninvolved epidermis was also performed. The gene expression profile of cornoid lamellar keratinocytes was compared with similar profiles obtained from a psoriatic plaque and cutaneous squamous cell carcinoma. RESULTS: Our study demonstrates a striking similarity between the gene expression profiles of PK and psoriasis. In addition, novel markers of the porokeratotic keratinocytes were identified, including keratin 16, S-100 A8 and A9, and connexin 26. CONCLUSIONS: This study supports the hypothesis that PK is a disorder of hyperproliferative keratinocytes exhibiting similarity at the molecular level to psoriasis. Consequently, some therapeutic modalities efficacious for psoriasis may be of benefit in PK.

A dorsal nasal advancement flap for off-midline defects.

BACKGROUND: The repair of nasal tip defects often poses a challenge as many of the commonly used techniques for repair of the distal nose can result in obvious scars, mismatched skin, or distortions of the nasal contour that can compromise the aesthetic outcome. OBJECTIVE: Our aim was to create a novel nasal tip flap and examine outcomes of its use. METHODS: The dorsal nasal advancement flap was studied in 30 patients. RESULTS: All patients had good to outstanding results and no complications. CONCLUSION: This new flap, a modified Burow's advancement flap adapted to the nasal tip, provides an alternative to full-thickness skin grafts and transposition, rotation, and pedicle flaps for repair of the distal nose that is easy to execute and has optimal aesthetic results.