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开发澳大利亚黑色素瘤临床结局登记处(MelCOR):方案研究报告。

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper.

机构信息

Victorian Melanoma Service, Alfred Health, Melbourne, Victoria, Australia.

School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.

出版信息

BMJ Open. 2022 Sep 2;12(9):e062139. doi: 10.1136/bmjopen-2022-062139.

Abstract

INTRODUCTION

Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers.

METHODS AND ANALYSIS

A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians.

ETHICS AND DISSEMINATION

Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

摘要

简介

澳大利亚的黑色素瘤发病率居世界首位,不同的临床医生提供的治疗方法也各不相同。临床质量登记旨在发现这些治疗差异,并向临床医生和医疗机构提供匿名的基准反馈,以改善患者的治疗效果。澳大利亚黑色素瘤临床结局登记处(MelCOR)旨在收集广泛的、临床级别的皮肤黑色素瘤数据,并为医疗保健提供者提供匿名反馈。

方法和分析

将采用改良德尔菲法确定纳入 MelCOR 试点的关键临床质量指标。MelCOR 将前瞻性地收集与这些质量指标相关的数据,最初针对所有在维多利亚州和昆士兰州居住且经组织病理学确诊为黑色素瘤的 18 岁以上人群,通过两阶段的招募和同意过程进行。在第 1 阶段,现有的州癌症登记处联系治疗医生,并为他们提供选择自己或患者不直接与 MelCOR 联系的机会。第 1 阶段结束后,重新识别的临床数据将在同意豁免的情况下提供给 MelCOR。在第 2 阶段,州癌症登记处将直接联系患者,并邀请他们选择加入 MelCOR 并共享可识别数据。如果患者选择加入,MelCOR 将能够直接联系患者收集患者报告的结果测量数据。聚合数据将用于为参与机构/临床医生提供基准比较反馈。

伦理和传播

在成功收集试点数据后,将评估在澳大利亚范围内全面推广的可行性。关键质量指标数据将是 MelCOR 数据集的核心,以后会添加其他数据点。年度报告将首先提供给相关利益相关者,然后再提供给公众。MelCOR 已获得阿尔弗雷德伦理委员会的批准(58280/127/20)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/45c0/9442481/9884af986401/bmjopen-2022-062139f01.jpg

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