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Reporting guidelines under development for clinical trials protocols

Reporting guidelines under development for clinical trials protocols and SPIRIT extensions

 (year of registration 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)

PLOT (Protocol Lab for Online Trials) (2019)

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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.

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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.

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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:

 

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PLOT (Protocol Lab for Online Trials) (registered 5 December 2019)

The PLOT consortium aims to build a research reporting checklist for protocols of randomised controlled trials involving online participation of patients and citizens. PLOT is designed as an extension of the SPIRIT reporting guideline but focussed on the reporting of patient and public involvement (PPI) in trials conducted through the internet. The checklist will apply to clinical trials and also to mixed methods studies protocols.

The group has reviewed the literature on patient and public involvement in the design of clinical trials, about the engagement of citizens in clinical trials through online sources and about dissemination practices about PPI. They are also identifying uncertainties around informed consent.

An online Delphi process will be used to develop the reporting guideline to be used in writing protocols for clinical trials involving self-recruitment. This process involves a wide range of stakeholders: researchers, clinicians, patient and public representatives, guideline developers, publishers, epidemiologists, methodologists, ethicists, content experts, funders, journal editors. The PLOT research reporting guideline will be piloted with student groups, new career researchers, English as a second language contributors, and members of the public (planned for mid-2020). The group plans to publish the PLOT reporting guideline as an open-access document in the last quarter of 2021.

There is a dissemination plan for PLOT involving a dedicated website, the inclusion in EQUATOR database, publishing editorials, lobbying with journals, academic institutions and funders, presentations in conferences, posting in social media, and online training.

 

 

Page last updated on 5 December 2019