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手术交接核心结局测量指标(SH-CORE):制定手术交接临床试验核心结局集的方案。

Surgical Handover Core Outcome Measures (SH-CORE): a protocol for the development of a core outcome set for trials in surgical handover.

机构信息

RCSI SIM Centre for Simulation Education and Research, 123 St. Stephen's Green, Co. Dublin, Ireland.

RCSI StAR MD Programme, St. Stephen's Green, Co. Dublin, Ireland.

出版信息

Trials. 2024 Jun 10;25(1):373. doi: 10.1186/s13063-024-08201-x.

Abstract

BACKGROUND

Surgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area. This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and evidence synthesis in future studies of surgical handover between doctors.

METHODS

This study adheres to the Core Outcome Measures in Effectiveness Trials (COMET) initiative guidance for COS development, including the COS-Standards for Development (COS-STAD) and Reporting (COS-STAR) recommendations. It has been registered prospectively on the COMET database and will be led by an international steering group that includes surgical healthcare professionals, researchers, and patient and public partners. An initial list of reported outcomes was generated through a systematic review of interventions to improve surgical handover (PROSPERO: CRD42022363198). Findings of a qualitative evidence synthesis of patient and public perspectives on handover will augment this list, followed by a real-time Delphi survey involving all stakeholder groups. Each Delphi participant will then be invited to take part in at least one online consensus meeting to finalise the COS.

ETHICS AND DISSEMINATION

This study was approved by the Royal College of Surgeons in Ireland (RCSI) Research Ethics Committee (202309015, 7th November 2023). Results will be presented at surgical scientific meetings and submitted to a peer-reviewed journal. A plain English summary will be disseminated through national websites and social media. The authors aim to integrate the COS into the handover curriculum of the Irish national surgical training body and ensure it is shared internationally with other postgraduate surgical training programmes. Collaborators will be encouraged to share the findings with relevant national health service functions and national bodies.

DISCUSSION

This study will represent the first published COS for interventions to improve surgical handover, the first use of a real-time Delphi survey in a surgical context, and will support the generation of better-quality evidence to inform best practice.

TRIAL REGISTRATION

Core Outcome Measures in Effectiveness Trials (COMET) initiative 2675.  http://www.comet-initiative.org/Studies/Details/2675 .

摘要

背景

手术交接与护理失误的重大风险相关。现有研究显示,该领域干预措施的评估结果存在方法学缺陷,且尚未达成共识。本文报告了一个制定核心结局集(COS)的方案,以支持未来医生间手术交接的标准化、可比性和证据综合。

方法

本研究遵循核心结局测量在有效性试验(COMET)倡议指导下的 COS 开发,包括 COS 标准制定(COS-STAD)和报告(COS-STAR)建议。它已在 COMET 数据库中进行了前瞻性注册,并将由一个国际指导小组领导,该小组包括外科医疗保健专业人员、研究人员以及患者和公众合作伙伴。通过系统回顾干预措施以改善手术交接(PROSPERO:CRD42022363198),生成了一份报告结局清单。患者和公众对手交接看法的定性证据综合分析结果将补充这份清单,随后是一项涉及所有利益相关者群体的实时 Delphi 调查。每位 Delphi 参与者随后将被邀请参加至少一次在线共识会议,以确定 COS。

伦理与传播

本研究已获得爱尔兰皇家外科医学院伦理委员会的批准(RCSI)(202309015,2023 年 11 月 7 日)。研究结果将在外科科学会议上展示,并提交给同行评议的期刊。通俗易懂的摘要将通过国家网站和社交媒体传播。作者旨在将 COS 纳入爱尔兰国家外科培训机构的交接课程,并确保在国际上与其他研究生外科培训项目共享。鼓励合作者将研究结果与相关的国家卫生服务部门和国家机构共享。

讨论

这将是第一个发表的用于改善手术交接的干预措施的 COS,也是首次在外科领域使用实时 Delphi 调查,这将支持生成更好质量的证据,以提供最佳实践。

试验注册

核心结局测量在有效性试验(COMET)倡议 2675。http://www.comet-initiative.org/Studies/Details/2675。

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Core Outcome Set-STAndards for Development: The COS-STAD recommendations.核心结局集-开发标准:COS-STAD建议
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The COMET Handbook: version 1.0.《COMET手册:第1.0版》
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