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CONSORT and Its Extensions for Reporting Clinical Trials

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Principles and Practice of Clinical Trials

Abstract

Well-designed and properly executed randomized controlled trials provide the most reliable evidence on the efficacy of healthcare interventions. However, there is overwhelming evidence that the quality of reporting of randomized trials is not always optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Trials with inadequate methods are also associated with bias, especially exaggerated treatment effects (Savovic et al. 2012; Wood et al. 2008). Critical appraisal of the quality of clinical trials is only possible if the design, conduct, and analysis of randomized trials are thoroughly and accurately reported. The CONSORT (CONsolidated Standards of Reporting Trials) statement is comprised of a checklist of essential items that should be included in reports of randomized controlled trials and a diagram documenting the flow of participants through a trial. The objective of CONSORT is to provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are clear, complete, and transparent (Moher et al. 2010a; Schulz et al. 2010a). Readers, peer reviewers, and editors can also use CONSORT to help them interpret the reports of randomized trials. CONSORT is not meant to be used as a quality assessment instrument, rather, the content of CONSORT relates to the internal and external validity of trials. Many items not explicitly mentioned in CONSORT may also be included in a report, such as information about approval by an ethics committee, informed consent from participants, and, where relevant, existence of a data and safety monitoring committee. The CONSORT statement thus addresses the minimum trial reporting criteria and should not deter authors from including other information they consider important (Moher et al. 2010a).

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Author information

Authors and Affiliations

  1. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

    Sally Hopewell

  2. Epidemiology and Biostatistics Research Center (CRESS), Inserm UMR1153, Université de Paris, Paris, France

    Isabelle Boutron

  3. Centre for Journaology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canadian EQUATOR centre, Ottawa, ON, Canada

    David Moher

Authors
  1. Sally Hopewell
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  2. Isabelle Boutron
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  3. David Moher
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Corresponding author

Correspondence to Sally Hopewell .

Editor information

Editors and Affiliations

  1. Samuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, CA, USA

    Steven Piantadosi

  2. Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, MD, USA

    Curtis L. Meinert

Section Editor information

  1. Department of Epidemiology, Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

    Tian**g Li

  2. The Johns Hopkins Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, USA

    Curtis L. Meinert

  3. Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, USA

    Steven Piantadosi

Additional information

Chapter dedicated to Professor Doug Altman

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Hopewell, S., Boutron, I., Moher, D. (2020). CONSORT and Its Extensions for Reporting Clinical Trials. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_188-1

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  • DOI: https://doi.org/10.1007/978-3-319-52677-5_188-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-52677-5

  • Online ISBN: 978-3-319-52677-5

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