Gagnier Joel J, Kienle Gunver, Altman Douglas G, Moher David, Sox Harold, Riley David
1Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA.
J Diet Suppl. 2013 Dec;10(4):381-90. doi: 10.3109/19390211.2013.830679.
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.
Develop, disseminate, and implement systematic reporting guidelines for case reports.
We used a three-phase consensus process consisting of (a) pre-meeting literature review and interviews to generate items for the reporting guidelines; (b) a face-to-face consensus meeting to draft the reporting guidelines; and (c) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.
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.
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.
病例报告是一种叙述性文件,出于医学、科学或教育目的,描述一名或多名患者所经历的医学问题。在缺乏报告标准指导的情况下撰写的病例报告不够严谨,无法指导临床实践或为临床研究设计提供参考。
制定、传播并实施病例报告的系统报告指南。
我们采用了一个三阶段的共识过程,包括:(a)会前文献综述和访谈,以生成报告指南的条目;(b)面对面的共识会议,以起草报告指南;以及(c)会后反馈、评审和试点测试,随后最终确定病例报告指南。
这一共识过程有27名参与者参与,最终形成了一份包含13个条目的清单——一份病例报告的报告指南。该清单的主要条目包括标题、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、随访与结果、讨论、患者视角以及知情同意。
我们相信,医学期刊实施CARE(病例报告)指南将提高已发表病例报告的完整性和透明度,并且病例报告信息的系统汇总将为临床研究设计提供参考,提供有效性和危害的早期信号,并改善医疗服务。