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

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      Author(s): 1 , , 2 , 3
      Publication date (Electronic):
      Journal: BMC Medicine
      Publisher: BioMed Central

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          Abstract

          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.

          To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

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          Most cited references17

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          Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

          Joel Lexchin, Lisa Bero, Benjamin Djulbegovic … (2003)
          To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
          Article 0 comments Cited 468 times – based on 0 reviews     Review now
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            Systematic reviews in health care: Assessing the quality of controlled clinical trials.

            P Jüni, D Altman, M. Egger (2001)
            Article 0 comments Cited 453 times – based on 0 reviews     Review now
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              Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

              Kerry Dwan, Douglas G. Altman, Juan A. Arnaiz … (2008)
              Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Med
                Title: BMC Medicine
                Publisher: BioMed Central
                ISSN (Electronic): 1741-7015
                Publication date Collection: 2010
                Publication date (Electronic): 24 March 2010
                Volume: 8
                Page: 18
                Affiliations
                [1 ]Family Health International, Research Triangle Park, NC 27709, USA
                [2 ]Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, UK
                [3 ]Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
                Article
                Publisher ID: 1741-7015-8-18
                DOI: 10.1186/1741-7015-8-18
                PMC ID: 2860339
                PubMed ID: 20334633
                SO-VID: a702085a-bfaa-4943-bb2b-d96013d44c29
                Copyright © Copyright ©2010 Schulz et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 17 February 2010
                Date accepted : 24 March 2010
                Categories
                Subject: Correspondence

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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