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      • Record: found
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      Is Open Access

      CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials

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      Author(s): 1 , * , 2 , 3 , for the CONSORT Group
      Publication date (Electronic):
      Journal: PLoS Medicine
      Publisher: Public Library of Science

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          Abstract

          Kenneth Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.

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          Most cited references17

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          K Schulz, I. Chalmers, R Hayes … (1995)
          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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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.
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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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                Author and article information

                Journal
                Journal ID (nlm-ta): PLoS Med
                Journal ID (publisher-id): PLoS
                Journal ID (pmc): plosmed
                Title: PLoS Medicine
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Print): 1549-1277
                ISSN (Electronic): 1549-1676
                Publication date Collection: March 2010
                Publication date (Print): March 2010
                Publication date (Electronic): 24 March 2010
                Volume: 7
                Issue: 3
                Electronic Location Identifier: e1000251
                Affiliations
                [1 ]Family Health International, Research Triangle Park, North Carolina, United States of America
                [2 ]Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom
                [3 ]Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
                Author notes

                ICMJE criteria for authorship read and met: KFS DGA DM. Wrote the first draft of the paper: KFS. Contributed to the writing of the paper: KFS DGA DM. KFS, DGA, and DM participated in meetings and regular conference calls, planned the CONSORT 2007 meeting at Montebello, developed the agenda, prepared background research, identified and invited participants, contributed to the CONSORT meeting, drafted the manuscript, and, after critical review by the CONSORT Group, finalized the text of the manuscript. Members of the CONSORT Group attended the meeting, except for those noted in the Acknowledgments, and provided input on and review of the revised checklist and text of this article. Some members also prepared background material.

                ¶ Membership of the CONSORT Group is provided in the Acknowledgments.

                KFS is distinguished scientist and vice president of Family Health International, DGA is professor at University of Oxford, and DM is senior scientist at Ottawa Hospital Research Institute.

                Article
                Publisher ID: 09-PLME-GG-2646R1
                DOI: 10.1371/journal.pmed.1000251
                PMC ID: 2844794
                PubMed ID: 20352064
                SO-VID: 7736d130-f636-4d38-9793-d729b1eb2d5a
                Copyright © Schulz et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                History
                Page count
                Pages: 7
                Categories
                Subject: Guidelines and Guidance
                Subject: Non-Clinical Medicine/Research Methods

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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