CONSORT-AI: new reporting guidelines for clinical trials involving AI


  • Heather Mason
  • Univadis Medical News
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides guidelines for reporting randomised trials. In recognition of the growing role of interventions involving artificial intelligence (AI), a new CONSORT-AI extension has been published in Nature Medicine.

The need for an updated version of the CONSORT guideline stemmed from the recognition that most recent AI studies are inadequately reported and that existing reporting guidelines do not fully cover potential sources of bias specific to AI systems.

The CONSORT-AI extension was developed in parallel with the SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) companion statement through a staged consensus process involving literature review and expert consultation.

The CONSORT-AI extension includes 14 new items, recommending that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases.

AI is a rapidly evolving field, and there will be the need to update CONSORT-AI in order to ensure transparency, minimise potential biases, and promote the trustworthiness of the results, the authors say.