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CARE 指南:基于共识的临床病例报告指南制定。

The CARE guidelines: consensus-based clinical case report guideline development.

机构信息

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA.

出版信息

J Clin Epidemiol. 2014 Jan;67(1):46-51. doi: 10.1016/j.jclinepi.2013.08.003. Epub 2013 Sep 12.

DOI:10.1016/j.jclinepi.2013.08.003
PMID:24035173
Abstract

BACKGROUND

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.

PRIMARY OBJECTIVE

Develop, disseminate, and implement systematic reporting guidelines for case reports.

METHODS

We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.

RESULTS

This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.

CONCLUSIONS

We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

摘要

背景

病例报告是一种叙述,为医疗、科学或教育目的,描述一个或多个患者经历的医疗问题。没有报告标准指导的病例报告不够严格,无法指导临床实践或为临床研究设计提供信息。

主要目标

制定、传播和实施病例报告的系统报告准则。

方法

我们使用了一个由三个阶段组成的共识过程,包括(1)会前文献回顾和访谈,以生成报告准则的项目,(2)面对面的共识会议起草报告准则,以及(3)会后反馈、审查和试点测试,随后是病例报告准则的定稿。

结果

这个共识过程涉及 27 名参与者,并产生了一个 13 项检查表的病例报告报告准则。检查表的主要项目是标题、关键词、摘要、引言、患者信息、临床发现、时间线、诊断评估、治疗干预、随访和结果、讨论、患者视角和知情同意。

结论

我们相信医学期刊实施 CARE(病例报告)准则将提高已发表病例报告的完整性和透明度,并且从病例报告中系统地收集信息将为临床研究设计提供信息,提供有效性和危害的早期信号,并改善医疗保健服务。

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