Cette actualisation est bienvenue. La ligne directrice CONSORT (Consolidated Standards of Reporting Trial) a eu un rôle structurant majeur sur la publication des essais randomisés contrôlés par les revues scientifiques. C’est la plus vieille des lignes directrices, proposée dans les années 1990. Il y a eu plusieurs versions (1996, 2001 et 2010) et la ligne directrice 
CONSORT 2025 est bienvenue. Ce n’a jamais été une grille d’évaluation des articles publiant des essais randomisés, bien qu’elle soit structurante pour la rédaction. Il y a des outils pour évaluer ces publications.
Ce travail concrétise aussi le rapprochement CONSORT / SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). C’est très bien. Cette actualisation est un très gros travail, bien détaillé dans les divers articles. Il faudra une version en français, mais viendra-t-elle ? Il y a de nombreuses organisations qui supportent ce travail, dont l’Université Paris Cité (mes félicitations à Isabelle Boutron, Centre d’épidémiologie clinique, Hôtel Dieu, Paris qui participe à ce travail).
Nombreux changements, dont une meilleure demande de l’application de la science ouverte
L’article princeps est publié simultanément (avril 2025) par The BMJ, JAMA, The Lancet, Nature Medicine, PLOS Medicine. L’article est très détaillé avec les listes de tous les experts ayant contribué à ce travail pendant quelques années. 
Dans le groupe exécutif, géré à Oxford, la France est représentée (Isabelle Bouton, Paris). Il y a un site dédié à CONSORT et SPIRIT. La grille a 30 items ; il y a un modèle de diagramme de flux. Je conseille de lire la checklist et surtout la ‘Expanded checklist‘, bine détaillée et claire. Plutôt que commenter les changements, j’ai reproduit ci-dessous intégralement un encadré de l’article, sans le traduire :
Summary of Main Changes in CONSORT 2025
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Addition of New Checklist Items
Item 4: Added item on data sharing, including where and how individual deidentified participant data, statistical code, and any other materials can be accessed.
Item 5b: Added item on financial and other conflicts of interest of manuscript authors.
Item 8: Added item on how patients and/or the public were involved in the design, conduct, and/or reporting of the trial.
Item 12b: Added item on eligibility criteria for sites and for individuals delivering the interventions, where applicable.
Item 15: Added item on how harms and other unintended effects were assessed.
Item 21: Added items to define who is included in each analysis (eg, all randomized participants) and in which group (item 21b), and how missing data were handled in the analysis (item 21c).
Item 24: Added item on intervention delivery, including how the intervention and comparator were actually administered (item 24a) and details of concomitant care received during the trial (item 24b).
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Completely Revised Checklist Items
Item 3: Revised item to include where the statistical analysis plan can be accessed in addition to the trial protocol.
Item 10: Revised item to include reporting of important changes to the trial after it commenced, including any outcomes or analyses that were not prespecified.
Item 26: Revised item to specify for each primary and secondary outcome the number of participants included in the analysis and the number of participants with available data at each time point for each treatment group.
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Deletion of Checklist Item
Deleted item on generalizability of trial findings, which is now incorporated under trial limitations (item 30).
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Integration of Checklist Items From Key CONSORT Extensions
Addition of items related to reporting of how harms were assessed and analyzed (items 7, 15, 21a, 23a, and 27), how outcomes were measured and analyzed (items 14 and 26), and how the intervention and comparator were actually administered and by whom (item 24).
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Structure and Organization of Checklist Items
Restructuring of checklist, with a new section on open science, which includes items that are conceptually linked, such as trial registration (item 2), where the trial protocol and statistical analysis plan can be accessed (item 3), sharing of deidentified participant-level data (item 4), and funding and conflicts of interest (item 5).
Aligned wording of some CONSORT checklist items with that of Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist items and vice versa.
Clarified and simplified wording of some items.
