The CARE guidelines: consensus-based clinical case report guideline development.
Gagnier JJ., Kienle G., Altman DG., Moher D., Sox H., Riley D.
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 (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. 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.