Enhancing the QUAlity and Transparency Of health Research

EQUATOR resources in German | Portuguese | Spanish

Reporting guidelines under development for clinical trials protocols

Reporting guidelines under development for clinical trials protocols and SPIRIT extensions

 (year of development in brackets)

SPIRIT Extension for trials in Child Health: SPIRIT-C (2014)

SPIRIT Extension for N-of-1 Trial Protocols (SPENT) (2015)

Protocol Guidelines for Artificial Intelligence and Machine Learning Interventions in Randomised Trials (SPIRIT-AI Extension) (2019)

_____________________________________________

SPIRIT Extension for trials in Child Health: SPIRIT-C (registered 22 September 2014)

An official extension of the SPIRIT 2013 Statement defining standard protocol items for clinical trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in Q2-3 2014. A Consensus meeting was held 15 September 2014. In April 2019, the group informed that the SPIRIT-C Statement and the Explanation and Elaboration documents will be published in Q3 2019.

_____________________________________________

SPIRIT Extension for N-of-1 Trial Protocols (SPENT) (registered 18 November 2015)

SPENT will extend the SPIRIT Statement (Standardized Protocol Items: Recommendations for Interventional Trials) to the reporting of individual and series N-of-1 trial protocols.

_____________________________________________

Protocol Guidelines for Artificial Intelligence and Machine Learning Interventions in Randomised Trials (SPIRIT-AI Extension) (registered 21 June 2019)

The steering group proposes to create an extension of the SPIRIT reporting guideline focussed on the reporting of trials involving artificial intelligence (AI) and machine learning interventions including diagnostic tools, decision-making tools and treatments. The reporting guideline development follows the methodology recommended by the EQUATOR Network, in the following phases:

The group plans to publish the reporting guideline as an open access document in March 2020.

Steering Group:

 

 

 

Page last updated on 15 July 2019