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定义结直肠优化标准:一项德尔菲研究方案,旨在就结直肠手术康复前的关键标准达成国际共识。

Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation.

机构信息

The University of Edinburgh, Undergraduate Medical School, Edinburgh, UK.

Patient Representative, Liverpool, UK.

出版信息

BMJ Open. 2021 Mar 24;11(3):e047235. doi: 10.1136/bmjopen-2020-047235.

Abstract

INTRODUCTION

Prehabilitation in colorectal surgery is evolving and may minimise postoperative morbidity and mortality. With many different healthcare professionals contributing to the prehabilitation literature, there is significant variation in reported primary endpoints that restricts comparison. In addition, there has been limited work on patient-related outcome measures suggesting that patients with colorectal cancer needs and issues are being overlooked. The Defining Standards in Colorectal Optimisation Study aims to achieve international consensus from all stakeholders on key standards to provide a framework for reporting future prehabilitation research.

METHODS AND ANALYSIS

A systematic review will identify key standards reported in trials of prehabilitation in colorectal surgery. Standards that are important to patients will be identified by a patient and public involvement (PPI) event. The longlist of standards generated from the systematic review and PPI event will be used to develop a three-round online Delphi process. This will engage all stakeholders (healthcare professionals and patients) both nationally and internationally. The results of the Delphi will be followed by a face-to-face interactive consensus meeting that will define the final standards for prehabilitation for elective colorectal surgery.

ETHICS AND DISSEMINATION

The University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee has approved this protocol, which is registered as a study (200190120) with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of the standards developed by all stakeholders will increase the potential for comparative research that advances understanding of the clinical application of prehabilitation.

PROSPERO REGISTRATION NUMBER

CRD42019120381.

摘要

简介

结直肠手术的预康复正在发展,可能会降低术后发病率和死亡率。由于许多不同的医疗保健专业人员都在为预康复文献做出贡献,因此报告的主要终点存在很大差异,这限制了比较。此外,关于患者相关结局指标的研究工作有限,这表明结直肠癌患者的需求和问题被忽视了。定义结直肠优化研究标准旨在让所有利益相关者就关键标准达成国际共识,为未来的预康复研究提供报告框架。

方法和分析

系统评价将确定结直肠手术预康复试验中报告的关键标准。通过患者和公众参与(PPI)活动确定对患者重要的标准。从系统评价和 PPI 活动中生成的标准长名单将用于开发三轮在线 Delphi 流程。这将涉及所有利益相关者(医疗保健专业人员和患者),包括国内外。Delphi 的结果将随后进行面对面的互动共识会议,为择期结直肠手术的预康复定义最终标准。

伦理和传播

格拉斯哥大学医学、兽医和生命科学学院伦理委员会已批准本方案,该方案作为一项研究(200190120)在有效性试验核心结局测量倡议中注册。所有利益相关者制定的标准的发表将增加比较研究的潜力,从而提高对预康复临床应用的理解。

PROSPERO 注册号:CRD42019120381。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f24d/7993327/b4d5bd693fa7/bmjopen-2020-047235f01.jpg

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