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      Systematic survey of the design, statistical analysis, and reporting of studies published in the 2008 volume of the Journal of Cerebral Blood Flow and Metabolism

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          Abstract

          Translating experimental findings into clinically effective therapies is one of the major bottlenecks of modern medicine. As this has been particularly true for cerebrovascular research, attention has turned to the quality and validity of experimental cerebrovascular studies. We set out to assess the study design, statistical analyses, and reporting of cerebrovascular research. We assessed all original articles published in the Journal of Cerebral Blood Flow and Metabolism during the year 2008 against a checklist designed to capture the key attributes relating to study design, statistical analyses, and reporting. A total of 156 original publications were included (animal, in vitro, human). Few studies reported a primary research hypothesis, statement of purpose, or measures to safeguard internal validity (such as randomization, blinding, exclusion or inclusion criteria). Many studies lacked sufficient information regarding methods and results to form a reasonable judgment about their validity. In nearly 20% of studies, statistical tests were either not appropriate or information to allow assessment of appropriateness was lacking. This study identifies a number of factors that should be addressed if the quality of research in basic and translational biomedicine is to be improved. We support the widespread implementation of the ARRIVE (Animal Research Reporting In Vivo Experiments) statement for the reporting of experimental studies in biomedicine, for improving training in proper study design and analysis, and that reviewers and editors adopt a more constructively critical approach in the assessment of manuscripts for publication.

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          Most cited references21

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          Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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            Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.

            The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.
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              High agreement but low kappa: II. Resolving the paradoxes.

              An omnibus index offers a single summary expression for a fourfold table of binary concordance among two observers. Among the available other omnibus indexes, none offers a satisfactory solution for the paradoxes that occur with p0 and kappa. The problem can be avoided only by using ppos and pneg as two separate indexes of proportionate agreement in the observers' positive and negative decisions. These two indexes, which are analogous to sensitivity and specificity for concordance in a diagnostic marker test, create the paradoxes formed when the chance correction in kappa is calculated as a product of the increment in the two indexes and the increment in marginal totals. If only a single omnibus index is used to compared different performances in observer variability, the paradoxes of kappa are desirable since they appropriately "penalize" inequalities in ppos and pneg. For better understanding of results and for planning improvements in the observers' performance, however, the omnibus value of kappa should always be accompanied by separate individual values of ppos and pneg.
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                Author and article information

                Journal
                J Cereb Blood Flow Metab
                Journal of Cerebral Blood Flow & Metabolism
                Nature Publishing Group
                0271-678X
                1559-7016
                April 2011
                15 December 2010
                1 April 2011
                : 31
                : 4
                : 1064-1072
                Affiliations
                [1 ]Department of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh , Edinburgh, Scotland, UK
                [2 ]Departments of Neurology and Experimental Neurology, Center for Stroke Research, Charité University Medicine Berlin , Berlin, Germany
                [3 ]Department of Medical Statistics, Computer Sciences and Documentation, University Hospital of Friedrich-Schiller-University Jena , Jena, Germany
                [4 ]Department of Neurology, NHS Forth Valley , Stirling, Scotland, UK
                Author notes
                [* ]Departments of Neurology and Experimental Neurology, Center for Stroke Research Berlin, Charité University Medicine , Berlin 10098, Germany. E-mail: ulrich.dirnagl@ 123456charite.de
                Article
                jcbfm2010217
                10.1038/jcbfm.2010.217
                3070978
                21157472
                b88209e2-44dd-4bb4-bb8f-f9dc2de306fd
                Copyright © 2011 International Society for Cerebral Blood Flow & Metabolism, Inc.

                This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/

                History
                : 30 September 2010
                : 25 October 2010
                : 03 November 2010
                Categories
                Original Article

                Neurosciences
                consort,validity,bias,translation,quality,arrive
                Neurosciences
                consort, validity, bias, translation, quality, arrive

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