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Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed

Nature Medicine volume 25, pages 1467–1468 (2019)Cite this article

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An Author Correction to this article was published on 12 November 2019

This article has been updated

As artificial intelligence moves into the realm of clinical trials, consideration is needed on whether the current CONSORT and SPIRIT reporting statements are sufficient to ensure transparency.

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Change history

  • 12 November 2019

    An amendment to this paper has been published and can be accessed via a link at the top of the paper.

References

  1. US Food and Drug Administration. Artificial Intelligence and Machine Learning in Software as a Medical Device (accessed 18 September 2019). https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

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Acknowledgements

This initiative is funded by the Wellcome Trust, Health Data Research UK and the Alan Turing Institute.

Author information

Authors and Affiliations

  1. Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Xiaoxuan Liu & Alastair K. Denniston

  2. University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

    Xiaoxuan Liu & Alastair K. Denniston

  3. Health Data Research UK, London, UK

    Xiaoxuan Liu, Christopher Holmes & Alastair K. Denniston

  4. Moorfields Eye Hospital NHS Foundation Trust, London, UK

    Xiaoxuan Liu & Livia Faes

  5. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Samantha Cruz Rivera, Melanie J. Calvert & Alastair K. Denniston

  6. Department of Ophthalmology, Cantonal Hospital Lucerne, Lucerne, Switzerland

    Livia Faes

  7. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Lavinia Ferrante di Ruffano & Jonathan Deeks

  8. Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK

    Christopher Yau

  9. Alan Turing Institute, London, UK

    Christopher Yau, Sebastian J. Vollmer & Christopher Holmes

  10. National Institute of Health Research BRC for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust, London, UK

    Pearse A. Keane & Alastair K. Denniston

  11. Patient Safety Translational Research Centre, Imperial College London, London, UK

    Hutan Ashrafian & Ara Darzi

  12. University of Warwick, Coventry, UK

    Sebastian J. Vollmer

  13. Medignition, Zurich, Switzerland

    Lucas Bachmann

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

    An Wen Chan

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

    David Moher

  16. School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada

    David Moher

Consortia

The CONSORT-AI and SPIRIT-AI Steering Group

  • Xiaoxuan Liu
  • , Samantha Cruz Rivera
  • , Livia Faes
  • , Lavinia Ferrante di Ruffano
  • , Christopher Yau
  • , Pearse A. Keane
  • , Hutan Ashrafian
  • , Ara Darzi
  • , Sebastian J. Vollmer
  • , Jonathan Deeks
  • , Lucas Bachmann
  • , Christopher Holmes
  • , An Wen Chan
  • , David Moher
  • , Melanie J. Calvert
  •  & Alastair K. Denniston

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Competing interests

The authors declare no competing interests.

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Cite this article

The CONSORT-AI and SPIRIT-AI Steering Group. Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed. Nat Med 25, 1467–1468 (2019). https://doi.org/10.1038/s41591-019-0603-3

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  • DOI: https://doi.org/10.1038/s41591-019-0603-3

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