Webinar: Prof. Sally Hopewell - Enhancing the transparency and reporting of randomised trials: updated SPIRIT and CONSORT 2025 guidelines

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The SPIRIT and CONSORT Statements are widely adopted reporting guidelines for reporting of trial protocols and results of randomised trials. This webinar will present the updated SPIRIT 2025 and CONSORT 2025 guidelines (published simultaneously in the BMJ, JAMA, Lancet, Nature Med and PLoS Med) which have been extensively revised to reflect recent methodological advancements and feedback from end users. The updated guidelines followed established methodology involving evidence-based recommendations and expert consensus. Updating the SPRIT and CONSORT checklists together also allowed alignment of the content, providing consistent guidance on reporting a trial through its life-cycle, from design to results.

This webinar will highlight a number of substantive changes to SPIRIT 2025 and CONSORT 2025, including the rationale for the addition of new items and revising the content of existing items. Both checklists have also been restructured, with a new section on Open Science, which includes items conceptually linked, such as trial registration, where the trial protocol and statistical analysis plan can be accessed, sharing of de-identified participant level data, funding and conflicts of interest. The wording between CONSORT and SPIRIT checklist items has also been revised to clarify and simplify items. Together, SPIRIT 2025 and CONSORT 2025 provide updated, harmonised guidance for reporting randomised trial protocols and results, respectively. Their adherence has potential to enhance the transparency of trial reporting for the benefit of authors, editors, and others.

Speaker:

Professor Sally Hopewell is Professor of Clinical Trials and Evidence Synthesis based at the Oxford Clinical Trials Research Unit and Centre for Statistics in Medicine, University of Oxford. She is involved in leading the design and delivery of clinical trials within the OCRTU portfolio. Her key areas of research expertise are in the design, conduct and transparent reporting of randomised trials and systematic reviews. Prof Hopewell has published (h-index 86) more than 300 studies in these areas, and has been instrumental in leading the development of key reporting guidelines including the CONSORT 2025 and SPIRIT 2025 Statements which were published simultaneously in the BMJ, JAMA, Lancet, Nature Med and PLoS Med. She is also chief investigator on NIHR funded trials of in the areas of paediatric and adult rehabilitation and musculoskeletal sciences and co-investigator on a number of other NIHR funded trials and evidence synthesis. She has a particular research interest in data sharing, development of core outcome sets, pilot and feasibility studies, paediatric trials and trials of complex interventions.