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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension

The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in p...

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Autores principales: Rivera, Samantha Cruz, Liu, Xiaoxuan, Chan, An-Wen, Denniston, Alastair K, Calvert, Melanie J, Ashrafian, Hutan, Beam, Andrew L, Collins, Gary S, Darzi, Ara, Deeks, Jonathan J, ElZarrad, M Khair, Espinoza, Cyrus, Esteva, Andre, Faes, Livia, Ferrante di Ruffano, Lavinia, Fletcher, John, Golub, Robert, Harvey, Hugh, Haug, Charlotte, Holmes, Christopher, Jonas, Adrian, Keane, Pearse A, Kelly, Christopher J, Lee, Aaron Y, Lee, Cecilia S, Manna, Elaine, Matcham, James, McCradden, Melissa, Moher, David, Monteiro, Joao, Mulrow, Cynthia, Oakden-Rayner, Luke, Paltoo, Dina, Panico, Maria Beatrice, Price, Gary, Rowley, Samuel, Savage, Richard, Sarkar, Rupa, Vollmer, Sebastian J, Yau, Christopher
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490785/
https://www.ncbi.nlm.nih.gov/pubmed/32907797
http://dx.doi.org/10.1136/bmj.m3210
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author Rivera, Samantha Cruz
Liu, Xiaoxuan
Chan, An-Wen
Denniston, Alastair K
Calvert, Melanie J
Ashrafian, Hutan
Beam, Andrew L
Collins, Gary S
Darzi, Ara
Deeks, Jonathan J
ElZarrad, M Khair
Espinoza, Cyrus
Esteva, Andre
Faes, Livia
Ferrante di Ruffano, Lavinia
Fletcher, John
Golub, Robert
Harvey, Hugh
Haug, Charlotte
Holmes, Christopher
Jonas, Adrian
Keane, Pearse A
Kelly, Christopher J
Lee, Aaron Y
Lee, Cecilia S
Manna, Elaine
Matcham, James
McCradden, Melissa
Moher, David
Monteiro, Joao
Mulrow, Cynthia
Oakden-Rayner, Luke
Paltoo, Dina
Panico, Maria Beatrice
Price, Gary
Rowley, Samuel
Savage, Richard
Sarkar, Rupa
Vollmer, Sebastian J
Yau, Christopher
author_facet Rivera, Samantha Cruz
Liu, Xiaoxuan
Chan, An-Wen
Denniston, Alastair K
Calvert, Melanie J
Ashrafian, Hutan
Beam, Andrew L
Collins, Gary S
Darzi, Ara
Deeks, Jonathan J
ElZarrad, M Khair
Espinoza, Cyrus
Esteva, Andre
Faes, Livia
Ferrante di Ruffano, Lavinia
Fletcher, John
Golub, Robert
Harvey, Hugh
Haug, Charlotte
Holmes, Christopher
Jonas, Adrian
Keane, Pearse A
Kelly, Christopher J
Lee, Aaron Y
Lee, Cecilia S
Manna, Elaine
Matcham, James
McCradden, Melissa
Moher, David
Monteiro, Joao
Mulrow, Cynthia
Oakden-Rayner, Luke
Paltoo, Dina
Panico, Maria Beatrice
Price, Gary
Rowley, Samuel
Savage, Richard
Sarkar, Rupa
Vollmer, Sebastian J
Yau, Christopher
author_sort Rivera, Samantha Cruz
collection PubMed
description The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
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spelling pubmed-74907852020-09-25 Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension Rivera, Samantha Cruz Liu, Xiaoxuan Chan, An-Wen Denniston, Alastair K Calvert, Melanie J Ashrafian, Hutan Beam, Andrew L Collins, Gary S Darzi, Ara Deeks, Jonathan J ElZarrad, M Khair Espinoza, Cyrus Esteva, Andre Faes, Livia Ferrante di Ruffano, Lavinia Fletcher, John Golub, Robert Harvey, Hugh Haug, Charlotte Holmes, Christopher Jonas, Adrian Keane, Pearse A Kelly, Christopher J Lee, Aaron Y Lee, Cecilia S Manna, Elaine Matcham, James McCradden, Melissa Moher, David Monteiro, Joao Mulrow, Cynthia Oakden-Rayner, Luke Paltoo, Dina Panico, Maria Beatrice Price, Gary Rowley, Samuel Savage, Richard Sarkar, Rupa Vollmer, Sebastian J Yau, Christopher BMJ Research Methods & Reporting The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial. BMJ Publishing Group Ltd. 2020-09-09 /pmc/articles/PMC7490785/ /pubmed/32907797 http://dx.doi.org/10.1136/bmj.m3210 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
spellingShingle Research Methods & Reporting
Rivera, Samantha Cruz
Liu, Xiaoxuan
Chan, An-Wen
Denniston, Alastair K
Calvert, Melanie J
Ashrafian, Hutan
Beam, Andrew L
Collins, Gary S
Darzi, Ara
Deeks, Jonathan J
ElZarrad, M Khair
Espinoza, Cyrus
Esteva, Andre
Faes, Livia
Ferrante di Ruffano, Lavinia
Fletcher, John
Golub, Robert
Harvey, Hugh
Haug, Charlotte
Holmes, Christopher
Jonas, Adrian
Keane, Pearse A
Kelly, Christopher J
Lee, Aaron Y
Lee, Cecilia S
Manna, Elaine
Matcham, James
McCradden, Melissa
Moher, David
Monteiro, Joao
Mulrow, Cynthia
Oakden-Rayner, Luke
Paltoo, Dina
Panico, Maria Beatrice
Price, Gary
Rowley, Samuel
Savage, Richard
Sarkar, Rupa
Vollmer, Sebastian J
Yau, Christopher
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title_full Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title_fullStr Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title_full_unstemmed Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title_short Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
title_sort guidelines for clinical trial protocols for interventions involving artificial intelligence: the spirit-ai extension
topic Research Methods & Reporting
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490785/
https://www.ncbi.nlm.nih.gov/pubmed/32907797
http://dx.doi.org/10.1136/bmj.m3210
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