Introduction

The SPIRIT-Al and CONSORT-Al initiative is an international collaborative effort to improve the transparency and completeness of reporting of clinical trials evaluating interventions involving artificial intelligence (Al).

SPIRIT-Al: Standard Protocol Items: Recommendations for lnterventional Trials – Artificial Intelligence

CONSORT-AI: Consolidated Standards of Reporting Trials – Artificial Intelligence. 

Project aims

Al is a relatively new area for clinical study. And although there is lots of excitement about the potential of Al for improving health and care, its application in clinical practice is still unpredictable, with few interventions making it from published paper to real-world implementation. Part of the problem is that there has previously been no specific, universally agreed minimum standards for clinical trials of Al health interventions, which are crucial for making sure that studies follow good scientific practice and that reporting is complete, comprehensive and transparent. 

This makes it hard for researchers to properly design and report their studies, and to address potential sources of bias. It also makes it difficult for the health community to assess the quality of the findings and how (or even whether) an Al intervention might work in a particular setting. The risk is that we adopt new health technologies and products whose safety and efficacy aren't adequately supported by evidence.

By bringing together experts from around the globe, the aim of this project was to develop international, consensus-based guidance for those developing and reporting clinical trials of health interventions involving Al. 

Applications

The creation of the SPIRIT-Al and CONSORT-Al extensions are intended to help promote transparency and completeness for clinical trial protocols for Al interventions and assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise clinical trial protocols and reports. The SPIRIT-Al will help promote transparency and completeness for clinical trial protocols and the CONSORT-Al will help promote transparency and completeness in reporting clinical trials for Al interventions. 

Recent updates

The SPIRIT-Al and CONSORT-Al initiative was announced in Nature Medicine in October 2019. The two statements were developed simultaneously through international multi-stakeholder consensus and published in Nature Medicine, the British Medical Journal and the Lancet Digital Health in September 2020. The guidelines are supported by, and developed according to guidelines set out by, the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network. The use of the guidelines are endorsed by key medical journals for the reporting of clinical trials for Al interventions. 

The checklists can be used by researchers, peer reviewers and journal editors conducting and appraising clinical trials for Al systems. 
These checklists can be viewed on the SPIRIT-Al and CONSORT-Al website.

Organisers

Dr Xiaoxuan Liu

Clinical researcher, University of Birmingham and University Hospitals Birmingham

Funders