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

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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.

Introduction

What is new?

  • A case report is a detailed narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or several patients.

Case reports present clinical observations customarily collected in healthcare delivery settings. They have proved helpful in the identification of adverse and beneficial effects, the recognition of new diseases, unusual forms of common diseases, and the presentation of rare diseases [1]. For example, our understanding of the relationship between thalidomide and congenital abnormalities [2] and the use of propranolol for the treatment of infantile hemangiomas began with case reports [3]. Case reports may generate hypotheses for future clinical studies, prove useful in the evaluation of global convergences of systems-oriented approaches, and guide the individualization and personalization of treatments in clinical practice [4], [5]. Furthermore, case reports offer a structure for case-based learning in healthcare education and may facilitate the comparison of healthcare education and delivery across cultures.

Case reports are common and account for a growing number of articles in medical journals [6]; however their quality is uneven [7], [8]. For example, one study evaluated 1,316 case reports from four peer-reviewed emergency-medicine journals and found that more than half failed to provide information related to the primary treatment that would have increased transparency and replication [9]. Written without the benefit of reporting guidelines, case reports often are insufficiently rigorous to be aggregated for data analysis, inform research design, or guide clinical practice [7], [9].

Reporting guidelines exist for a variety of study designs including randomized controlled trials (Consolidated Standards of Reporting Trials, or CONSORT) [10], observational studies (Strengthening the Reporting of Observational studies in Epidemiology, or STROBE) [11], and systematic reviews and meta-analyses (Preferred Reporting Items for Systematic Reviews and Meta-Analyses, or PRISMA) [12]. Empirical evidence suggests that a journal's adoption of the CONSORT statement as a guide to authors is associated with an increase in the completeness of published randomized trials [13]. Guidelines have been developed for adverse-event case reports [14]; however, general reporting guidelines for case reports do not exist. Our primary objective was to develop reporting guidelines for case reports through a consensus-based process.

Section snippets

Research design

We followed the Guidance for Developers of Health Research Reporting Guidelines [15] and developed a three phase consensus process [16]. This consisted of (1) a pre-meeting literature review followed by interviews to generate items for a case report checklist, (2) a face-to-face consensus meeting for drafting a reporting guideline, and (3) post-meeting feedback and pilot testing followed by finalization of the case report guidelines.

Participants

We contacted 28 individuals who fulfilled at least one of four

Results

The CAse REport (CARE) guidelines checklist is structured to correspond with key components of a case report and capture useful clinical information (including ‘meaningful use’ information mandated by some insurance plans).

The checklist begins with a statement that describes the narrative of a case report. The meeting CARE group felt that a case report should tell a story using prose that has a consistent style across all sections, including the rationale for any conclusions and take-away

Discussion

This 13-item checklist provides a framework to satisfy the need for completeness and transparency for published case reports. We attempted to strike a balance between adequate detail and the concise writing that is one of the appealing characteristics of a case report. Our consensus process resulted in a set of essential items for authors to consider when submitting a case report for publication.

While case reports have long been an important source of new ideas and information in medicine [21],

Limitations

The CARE guidelines and their development have several possible limitations. First, these guidelines were developed through a consensus method and thus represent the opinions of the participants. However, consensus was easily reached during our meeting, we referred to the empirical evidence where available, and we received feedback from a wide selection of individuals, beyond those involved in our consensus meeting. Second, we recognize that causality determinations are a challenge for case

Conclusions

Anticipating a long future for case reports, we have provided guidance in the form of reporting standards for use by healthcare stakeholders around the world. The growth of case reports in an era in which clinical trials and systematic reviews dominate the tables of content of medical journals indicates that case reports have value, particularly with the increasing importance of individualized care. Unlike randomized controlled trials, case reports are individual reports related to the care of

Acknowledgments

J.J.G., University of Michigan, and D.R., Global Advances in Health and Medicine, organized this consensus-based guideline-development project. The Department of Orthopedic Surgery, the Office of the Vice-President of Research at the University of Michigan, and Global Advances in Health and Medicine® provided funding for this project. D.M. is funded through a University of Ottawa Research Chair. Funding support was used to reimburse the travel-related expenses of conference attendees. There

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    1

    For a complete list of the CARE Group see the Author Contributions listing at the end of this publication.

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