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皮肤科结局评估研究方案的制定。

Protocol of a scoping review of outcome domains in dermatology.

机构信息

Department of Dermatology, Feinberg School of Medicine, Chicago, Illinois, USA.

Charité Universitätsmedizin Berlin, Berlin, Germany.

出版信息

BMJ Open. 2024 Feb 6;14(2):e079632. doi: 10.1136/bmjopen-2023-079632.

Abstract

INTRODUCTION

Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases.

METHODS AND ANALYSIS

We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts.

ETHICS AND DISSEMINATION

This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

摘要

简介

核心结局集(COS)是在特定疾病或临床领域的临床试验或实践中应至少测量的一致结局(领域(子领域)和工具)。在全球范围内,COS 的数量正在增加,并且在学科内可能存在领域(子领域)和工具的概念重叠。本范围综述的目的是绘制和分类与皮肤病相关的 COS 项目确定的所有结局。

方法和分析

我们将对与皮肤病相关的 COS 计划的结局进行范围综述,以确定所有概念及其定义。我们将搜索 PubMed、Embase 和 Cochrane 图书馆。搜索日期将为 2010 年 1 月 1 日(即核心结局测量在有效性试验(COMET)成立的时间)至 2024 年 1 月 1 日。我们还将审查 COMET 数据库和 C3 网站,以确定正在开发和发布的 COS 部分(领域和/或工具)。该综述将通过向 COS 组织、皮肤科组织和患者组织的相关利益相关者查询额外开发的 COS 进行补充。然后,将生成的结局的长列表映射到概念上相似的概念中。

伦理和传播

本研究得到西北大学皮肤科部门研究基金的支持。由于本方案是由没有参与患者护理的工作人员研究人员完成的,因此豁免了伦理委员会审查。如果存在利益冲突,将通过用相关冲突参与者替换或重新分配来解决。结果将通过在同行评议的期刊上发表、社交媒体帖子和 COS 组织的宣传来传播。

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