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Photo by @matheo_jbt taken at Petite Camargue, Le Grau-du-Roi, France.

The CONSORT-AI Standards

An extension to the CONSORT 2010 minimum guidelines for reporting randomized trials

This article will not cover in full the CONSORT-AI standards, rather make the reader aware that they exist.

  1. Includes 14 new items for researchers to routinely include in their manuscripts when reporting on AI interventions.
  2. Calls on researchers who report on trials that include AI to fully explain the algorithm version, input and output data, integration into trial settings, expertise of the users, and the protocol for acting upon the AI system’s recommendations.

What are the checklist items?

They span several elements of clinical trial reporting. Here is some information from the article by Schneider:

  • They should also state the intended use of the AI intervention in the context of the clinical pathway, including its purpose and its intended users (whether healthcare professionals or patients).
  • Researchers should also report AI-specific information related to study participants, including the inclusion and exclusion criteria at the level of participants and input data. Additionally, they should describe how the AI intervention was integrated into the trial setting, including any onsite or offsite requirements.
  • The consensus statement also has six requirements related to intervention information, centering around the version of the algorithm, how the input data were acquired and selected, how poor quality and unavailable input data were assessed and handled, whether there was human-AI interaction in the handling of input data, the output of the intervention, and how the AI intervention’s outputs contributed to decision-making.
  • Harms were also addressed in the CONSORT-AI checklist. The working group called on researchers to describe results of any analysis of performance errors and how errors were identified.
  • The consensus document also calls for stating whether, and how, the AI intervention and its code can be accessed, and if there are any restrictions on its access or reuse.”

Written by

AI Policy and Ethics at www.nora.ai. Student at University of Copenhagen MSc in Social Data Science. All views are my own. twitter.com/AlexMoltzau

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