Improving the completeness and transparency of protocols and reports of randomized trials: SPIRIT 2025 and CONSORT 2025.

We developed SPIRIT 2025 and CONSORT 2025 together and in a similar manner. To ascertain new evidence to inform both updates we completed two scoping reviews. The results of the scoping reviews helped inform the SPIRIT and CONSORT Delphis. Following two Delphi rounds and an international online consensus meeting, draft checklists for both reporting guidelines were drafted. SPIRIT 2025 contains a 34-item checklist. Compared to the original SPIRT 2013 reporting guideline, SPIRIT 2025 include the addition of two new items, revisions to five, and the deletion or merging of five, alongside a new Open Science section. Emphasis on harm assessment, intervention description, and patient/public involvement was also strengthened. CONSORT 2025, compared to CONSORT 2010, is a 30-item checklist with seven new items, three revised, and one deleted, with content integrated from existing CONSORT extensions - Harms, Outcomes, Non-pharmacological Treatment, and TIDieR. As with SPIRIT 2025, CONSORT 2025 also includes a new open science section. Both reporting guidelines also include updated extensive explanation and elaboration papers meant to be pedagogical assistants to facilitate the use of both reporting guidelines. Widespread adoption of SPIRIT 2025 and CONSORT 2025 by investigators, funders, ethics committees, journals, and regulators should improve the quality and usability of research, ultimately benefiting patients and the broader research ecosystem.