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Quality of reporting in abstracts of RCTs published in emergency medicine journals: a protocol for a systematic survey of the literature

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      Abstract

      IntroductionThe quality of reporting of abstracts of randomised controlled trials (RCTs) in major general medical journals and in some category-specific journals was shown to be poor before the publication of the ConsolidatedStandards of ReportingTrials (CONSORT) extension for abstracts in 2008, and an improvement in the quality of reporting of abstracts was observed after its publication. The effect of the publication of the CONSORT extension for abstracts on the quality of reporting of RCTs in emergency medicine journals has not been studied. In this paper, we present the protocol of a systematic survey of the literature, aimed at assessing the quality of reporting in abstracts of RCTs published in emergency medicine journals and at evaluating the effect of the publication of the CONSORT extension for abstracts on the quality of reporting.Methods and analysisThe Medline database will be searched for RCTs published in the years 2005–2007 and 2014–2015 in the top 10 emergency medicine journals, according to their impact factor. Candidate studies will be screened for inclusion in the review. Exclusion criteria will be the following: the abstract is not available, they are published only as abstracts, still recruiting, or duplicate publications. The study outcomes will be the overall quality of reporting (number of items reported) according to the CONSORT extension and the compliance with its individual items. Two independent reviewers will screen each article for inclusion and will extract data on the CONSORT items and on other variables, which can possibly affect the quality of reporting.Ethics and disseminationThis is a library-based study and therefore exempt from research ethics board review. The review results will be disseminated through abstract submission to conferences and publication in a peer-reviewed biomedical journal.

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      Most cited references 24

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      CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

      The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience
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        Understanding interobserver agreement: the kappa statistic.

        Items such as physical exam findings, radiographic interpretations, or other diagnostic tests often rely on some degree of subjective interpretation by observers. Studies that measure the agreement between two or more observers should include a statistic that takes into account the fact that observers will sometimes agree or disagree simply by chance. The kappa statistic (or kappa coefficient) is the most commonly used statistic for this purpose. A kappa of 1 indicates perfect agreement, whereas a kappa of 0 indicates agreement equivalent to chance. A limitation of kappa is that it is affected by the prevalence of the finding under observation. Methods to overcome this limitation have been described.
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          Statistical analysis of correlated data using generalized estimating equations: an orientation.

           J Hanley (2003)
          The method of generalized estimating equations (GEE) is often used to analyze longitudinal and other correlated response data, particularly if responses are binary. However, few descriptions of the method are accessible to epidemiologists. In this paper, the authors use small worked examples and one real data set, involving both binary and quantitative response data, to help end-users appreciate the essence of the method. The examples are simple enough to see the behind-the-scenes calculations and the essential role of weighted observations, and they allow nonstatisticians to imagine the calculations involved when the GEE method is applied to more complex multivariate data.
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            Author and article information

            Affiliations
            [1 ] departmentDepartment of Emergency , Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico , Milano, Italy
            [2 ] departmentDepartment of Health Sciences , Università degli Studi di Milano , Milano, Italy
            [3 ] departmentGeriatric Unit , Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico , Milano, Italy
            [4 ] departmentDepartment of Clinical Sciences and Community Health , Università degli Studi di Milano , Milano, Italy
            [5 ] departmentDepartment of Emergency , Area Nord, Azienda Unita Sanitaria Locale di Bologna , Bologna, Italy
            [6 ] departmentDepartment of Clinical and Experimental Medicine , Università degli Studi di Parma , Parma, Italy
            [7 ] departmentDepartment of Health Research Methods, Evidence, and Impact , McMaster University , Hamilton, Ontario, Canada
            [8 ] Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare , Hamilton, Ontario, Canada
            [9 ] General Practitioner Course, Regione Marche – Servizio Sanità , Ancona, Italy
            [10 ] departmentDepartment of Emergency Medicine , Ospedale Niguarda Ca’ Granda , Milano, Italy
            [11 ] departmentDivision of Emergency Medicine , McMaster University , Hamilton, Ontario, Canada
            [12 ] departmentDepartments of Paediatrics and Anaesthesia , McMaster University , Hamilton, Ontario, Canada
            [13 ] Centre for Evaluation of Medicine, St Joseph’s Healthcare , Hamilton, Ontario, Canada
            [14 ] Population Health Research Institute, Hamilton Health Sciences , Hamilton, Ontario, Canada
            Author notes
            [Correspondence to ] Dr. Lehana Thabane; thabanl@ 123456mcmaster.ca
            Journal
            BMJ Open
            BMJ Open
            bmjopen
            bmjopen
            BMJ Open
            BMJ Open (BMA House, Tavistock Square, London, WC1H 9JR )
            2044-6055
            2017
            27 April 2017
            : 7
            : 4
            28450467
            5566942
            bmjopen-2016-014981
            10.1136/bmjopen-2016-014981
            © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. 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/

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            Emergency Medicine
            Protocol
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            1691
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