Otite media acuta

Riferimenti: Pagina di riferimento AIFA: https://www.aifa.gov.it/farmaci-antibiotici Edizione italiana del “The […]

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Recurrence Rate of Melanoma In Situ Excised With a 5-mm Excisional Margin

The recommendations for treating invasive melanoma have evolved dramatically during the past century. The surgical practices of radically wide margins and amputations were abandoned when evidence from randomized clinical trials (RCTs) showed that surgical margins as narrow as 1 cm were safe for most melanomas. In contrast, the recommendations for surgical margins for melanoma in situ (MIS) are not based on RCTs and exist with some controversy. The earliest recommendations of a 5-mm surgical margin for MIS was suggested by the National Institutes of Health by a panel of dermatologists in 1991 based on their experience rather than scientific evidence, and this became the recommended excision margin adopted by many national and international groups writing clinical guidelines. At the same time, the experience of Mohs surgeons and others looking carefully at the width of surgical margins necessary to achieve negative histologic margins led to a different conclusion. Multiple studies from various institutions showed that MIS often extends beyond a 5-mm clinical margin, and wider margins were necessary to avoid local recurrence and tumor progression. Although no RCTs were performed to my knowledge, the preponderance of evidence from these sources came to the same conclusion that margins wider than 5 mm for MIS are necessary to provide negative histologic margins in 97% of real-world lesions of MIS. However, the controversy continued about surgical margins for subgroups of MIS based on histology (MIS vs lentigo maligna), location (head and neck vs trunk and extremity), and other clinical parameters. Today, most clinical guidelines recommend a range of margins of 0.5 to 1 cm for all MIS, noting that the goal of excision is negative histologic margins.

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Error in Byline

The Original Investigation titled “Neoadjuvant Dual Checkpoint Inhibitors vs Anti-PD1 Therapy in High-Risk Resectable Melanoma: A Pooled Analysis,” published online March 28, 2024, and in the May 2024 issue was corrected to fix a spelling error in the eighth author’s surname. The spelling for Bryan T. Carroll was corrected from “Carrol” to “Carroll.”

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Safety and adherence to medications and self-care advice in oncology (SAMSON): pilot randomised controlled trial protocol

Introduction
With the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments’ efficacy and toxicity is drawing more attention. Mobile phone interventions may be a practical solution to support patients taking OAMs at home, yet evidence to inform the efficacy of these interventions is lacking. The safety and adherence to medications and self-care advice in oncology (SAMSON) pilot randomised control trial (RCT) aims to evaluate the acceptability, feasibility and potential efficacy of a novel digital solution to improve medication adherence (MA) among people with cancer.

Methods and analysis
This is a two-arm, 12-week, pilot RCT aiming to enrol 50 adults with haematological, lung or melanoma cancers at an Australian metropolitan specialised oncology hospital, who are taking oral anti-cancer medicines. Participants will be randomised (1:1 allocation ratio) to either the intervention group (SAMSON solution) or the control group (usual care). The primary outcomes are the acceptability and feasibility of SAMSON. The secondary outcomes are MA, toxicity self-management, anxiety and depressive symptoms, health-related quality of life, and parameters relating to optimal intervention strategy. Quantitative data will be analysed on a modified intention-to-treat basis.

Summary
While multicomponent interventions are increasingly introduced, SAMSON incorporates novel approaches to the solution. SAMSON provides a comprehensive, patient-centred, digital MA intervention solution with seamless integration of a mobile platform with clinical consultations that are evidence-based, theory-based, co-designed and rigorously tested. The pilot trial will determine whether this type of intervention is feasible and acceptable in oncology and will provide a foundation for a future full-scale RCT.

Ethics and dissemination
Primary ethics approvals were received from Peter MacCallum Cancer Centre and Swinburne University of Technology Human Research Ethics Committees (HREC/95332/PMCC and 20237273–15836). Results will be disseminated via peer-reviewed publications and presentations at international and national conferences.

Trial registration number
The protocol has been prospectively registered on the Australian New Zealand Clinical Trials Registry with trial registration number (ACTRN12623000472673).

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