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

OBJECTIVES: To update SPIRIT 2013 and CONSORT 2010 reporting guidelines. METHODS: For SPIRIT 2025, a comprehensive review process incorporating scoping reviews, expert consultations, and a Delphi survey led to a revised checklist. CONSORT 2025 underwent a similar update, addressing methodological advancements and user feedback gathered through scoping reviews, expert consultations, and a Delphi survey. RESULTS: Key changes 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 has also been strengthened. The SPIRIT 2025 statement provides a 34-item checklist, a schedule diagram, and an expanded checklist with explanations. Similarly, seven new items were added, three revised, and one deleted, with content integrated from existing CONSORT extensions. A new Open Science section was also incorporated. The CONSORT 2025 statement offers a 30-item checklist, a flow diagram, and a detailed explanatory checklist. CONCLUSION: Both updated statements and explanatory articles aim to enhance transparency and completeness in trial protocols and reporting. Widespread adoption by investigators, funders, ethics committees, journals, and regulators should improve the quality and usability of research, ultimately benefiting patients and others. PLAIN LANGUAGE SUMMARY: We have updated two important guidelines, SPIRIT and CONSORT, to make research studies easier to understand and more reliable. We did this by carefully reviewing existing research and getting feedback from experts around the world. The new SPIRIT 2025 guideline has 34 items to help researchers report their study plans clearly. It includes new sections on how to assess potential risks, describe the treatment, and involve patients in the research. We also added a new section about sharing data openly. The new CONSORT 2025 guideline has 30 items to help researchers report the results of their studies. It includes new sections on harms, outcomes, nondrug treatments, and how treatments are tailored to individuals. Like SPIRIT 2025, it also has a new section on open science. We have also created detailed guides to help people use these new guidelines. We hope that by using these updated guidelines, researchers, funders, ethics committees, journals, and regulators will help improve the quality of research and ultimately benefit patients.