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Upgrading instructions for authors of scholarly journals

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        The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development

        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) premeeting 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) postmeeting 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.
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          Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis

          Objectives To assess how often stratified randomisation is used, whether analysis adjusted for all balancing variables, and whether the method of randomisation was adequately reported, and to reanalyse a previously reported trial to assess the impact of ignoring balancing factors in the analysis. Design Review of published trials and reanalysis of a previously reported trial. Setting Four leading general medical journals (BMJ, Journal of the American Medical Association, Lancet, and New England Journal of Medicine) and the second Multicenter Intrapleural Sepsis Trial (MIST2). Participants 258 trials published in 2010 in the four journals. Cluster randomised, crossover, non-randomised, single arm, and phase I or II trials were excluded, as were trials reporting secondary analyses, interim analyses, or results that had been previously published in 2010. Main outcome measures Whether the method of randomisation was adequately reported, how often balanced randomisation was used, and whether balancing factors were adjusted for in the analysis. Results Reanalysis of MIST2 showed that an unadjusted analysis led to larger P values and a loss of power. The review of published trials showed that balanced randomisation was common, with 163 trials (63%) using at least one balancing variable. The most common methods of balancing were stratified permuted blocks (n=85) and minimisation (n=27). The method of randomisation was unclear in 37% of trials. Most trials that balanced on centre or prognostic factors were not adequately analysed; only 26% of trials adjusted for all balancing factors in their primary analysis. Trials that did not adjust for balancing factors in their analysis were less likely to show a statistically significant result (unadjusted 57% v adjusted 78%, P=0.02). Conclusion Balancing on centre or prognostic factors is common in trials but often poorly described, and the implications of balancing are poorly understood. Trialists should adjust their primary analysis for balancing factors to obtain correct P values and confidence intervals and to avoid an unnecessary loss in power.

            Author and article information

            [1 ]Departments of Rheumatology and Research & Development, Dudley Group NHS Foundation Trust (Teaching Trust of University of Birmingham), Russells Hall Hospital, Dudley, United Kingdom
            [2 ]Department of Medical Chemistry, Yerevan State Medical University, Yerevan, Armenia
            [3 ]Head of the Russian Regional Chapter of the European Association of Science Editors; Chief Editor of International Scientific Researches, Moscow, Russian Federation
            [4 ]Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, United Kingdom
            Author notes
            Croat Med J
            Croat. Med. J
            Croatian Medical Journal
            Croatian Medical Schools
            June 2014
            : 55
            : 3
            : 271-280
            24891286 4049215 CroatMedJ_55_0271 10.3325/cmj.2014.55.271
            Copyright © 2014 by the Croatian Medical Journal. All rights reserved.

            This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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