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      Methodological quality and synthesis of case series and case reports

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          Abstract

          Case reports and case series are uncontrolled study designs known for increased risk of bias but have profoundly influenced the medical literature and continue to advance our knowledge. In this guide, we present a framework for appraisal, synthesis and application of evidence derived from case reports and case series. We propose a tool to evaluate the methodological quality of case reports and case series based on the domains of selection, ascertainment, causality and reporting and provide signalling questions to aid evidence-based practitioners and systematic reviewers in their assessment. We suggest using evidence derived from case reports and case series to inform decision-making when no other higher level of evidence is available.

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          Most cited references27

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          New evidence pyramid

          A pyramid has expressed the idea of hierarchy of medical evidence for so long, that not all evidence is the same. Systematic reviews and meta-analyses have been placed at the top of this pyramid for several good reasons. However, there are several counterarguments to this placement. We suggest another way of looking at the evidence-based medicine pyramid and explain how systematic reviews and meta-analyses are tools for consuming evidence—that is, appraising, synthesising and applying evidence.
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            In defense of case reports and case series.

            Case reports and case series have their own role in the progress of medical science. They permit discovery of new diseases and unexpected effects (adverse or beneficial) as well as the study of mechanisms, and they play an important role in medical education. Case reports and series have a high sensitivity for detecting novelty and therefore remain one of the cornerstones of medical progress; they provide many new ideas in medicine. At the same time, good case reporting demands a clear focus to make explicit to the audience why a particular observation is important in the context of existing knowledge.
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              The CARE guidelines: consensus-based clinical case reporting guideline development.

              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. 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. 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.
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                Author and article information

                Journal
                BMJ Evid Based Med
                BMJ Evid Based Med
                ebmed
                ebm
                BMJ Evidence-Based Medicine
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2515-446X
                2515-4478
                April 2018
                2 February 2018
                : 23
                : 2
                : 60-63
                Affiliations
                [1 ] Evidence-Based Practice Center, Mayo Clinic , Rochester, Minnesota, USA
                [2 ] departmentDivision of Gastroenterology, Hepatology, and Nutrition , University of Minnesota, Center for Chronic Diseases Outcomes Research, Minneapolis Veterans Affairs Healthcare System , Minneapolis, Minnesota, USA
                [3 ] Digestive Center for Diagnosis and Treatment , Damascus, Syrian Arab Republic
                [4 ] departmentDepartment of Gastroenterology and Hepatology , Mayo Clinic , Rochester, Minnesota, USA
                Author notes
                [Correspondence to ] Dr Mohammad Hassan Murad, Evidence-Based Practice Center, Mayo Clinic, Rochester, MN 55905, USA; murad.mohammad@ 123456mayo.edu
                Author information
                http://orcid.org/0000-0001-5502-5975
                Article
                ebmed-2017-110853
                10.1136/bmjebm-2017-110853
                6234235
                29420178
                a17553b4-e44e-412b-b854-9563e08af679
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 4 January 2018
                Categories
                General Medicine
                1506
                2363
                655
                EBM Implementation
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                epidemiology
                epidemiology

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