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An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials

Nature Medicine volume 28, pages 1740–1743 (2022)Cite this article

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Results from clinical trials can be deemed trustworthy only if they are properly conducted and their methods are fully reported. The SPIRIT and CONSORT checklists, which have improved clinical trial design, conduct and reporting, are being updated to reflect recent advances and improve the assessment of healthcare interventions.

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Acknowledgements

Supported by the Medical Research Council–National Institute for Health Research Better Methods, Better Research (MR/W020483/1] (S.H., R.T, J.A.d.B. and G.S.C.). This funder is not involved in any aspect of the research work. J.A.d.B. and G.S.C. are supported by Cancer Research UK (C49297/A29084). G.S.C. is supported by the National Institute for Health Research Biomedical Research Centre, Oxford. The reporting guideline under development is registered on the EQUATOR Network database. Approval for the Delphi survey was obtained from the Central University Research Ethics Committee, University of Oxford (20 July 2022; R76421/RE001].

Author information

Authors and Affiliations

  1. Oxford Clinical Trials Research Unit / Centre for Statistics in Medicine, University of Oxford, Oxford, UK

    Sally Hopewell & Ruth Tunn

  2. Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France

    Isabelle Boutron

  3. Centre d’Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France

    Isabelle Boutron

  4. Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, Ontario, Canada

    An-Wen Chan

  5. UK EQUATOR Centre/Centre for Statistics in Medicine, University of Oxford, Oxford, UK

    Gary S. Collins & Jennifer A. de Beyer

  6. Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Asbjørn Hróbjartsson, Camilla Hansen Nejstgaard & Lasse Østengaard

  7. Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark

    Asbjørn Hróbjartsson, Camilla Hansen Nejstgaard & Lasse Østengaard

  8. Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Kenneth F. Schulz

  9. Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

    David Moher

Authors
  1. Sally Hopewell
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  2. Isabelle Boutron
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  3. An-Wen Chan
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  4. Gary S. Collins
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  5. Jennifer A. de Beyer
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  6. Asbjørn Hróbjartsson
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  7. Camilla Hansen Nejstgaard
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  8. Lasse Østengaard
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  9. Kenneth F. Schulz
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  10. Ruth Tunn
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  11. David Moher
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Contributions

S.H., I.B., A.-W.C., A.H., K.F.S. and D.M. were responsible for the concept; S.H., I.B., A.-W.C., G.S.C., A.H., K.F.S. and D.M. were responsible for the funding; S.H. and I.B. drafted the manuscript; and all authors critically revised the manuscript for important intellectual content and approved the final version.

Corresponding author

Correspondence to Sally Hopewell.

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Competing interests

All authors are involved in the development, update, implementation, and dissemination of numerous reporting guidelines and are members of the SPIRIT–CONSORT Working Group. S.H., I.B., A.-W.C., A.H., K.F.S. and D.M. are members of the SPIRIT–CONSORT Executive Group. G.S.C. is the director of the UK EQUATOR Centre, D.M. is the director of the Canadian EQUATOR Centre, and J.A.d.B. is affiliated with the UK EQUATOR Centre; these are all part of the EQUATOR Network, an organization that promotes reporting guidelines. I.B. is deputy director of the French EQUATOR Centre.

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Hopewell, S., Boutron, I., Chan, AW. et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med 28, 1740–1743 (2022). https://doi.org/10.1038/s41591-022-01989-8

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