Box 4.

Summary of significant changes to the CONSORT 2010 statement

New items—Introduces seven new items that are specific to AD randomised trials ▪ 3b on pre-planned AD features, ▪ 11c on confidentiality and minimisation of operational bias, ▪ 12b on estimation and inference methods, ▪ 14c on adaptation decisions, ▪ 15b on similarity between stages, ▪ 17c on interim results and, ▪ 24b on SAP and other relevant trial documents. Restructuring—Renumbers four standard items to accommodate the new items ▪ 3b is now 3c (on losses and exclusions) to accommodate the new item 3b, ▪ 12b is now 12c (on methods for additional analyses) to accommodate the new item 12b, ▪ 15 on baseline demographics and clinical characteristics is now 15a to accommodate new item 15b and, ▪ 24 on access to protocol is now 24a to accommodate new item 24b. Modified items—Modifies nine standard items ▪ 3b (now 3c) on important changes to the design or methods after commencement, ▪ 6a on pre-specified primary and secondary outcomes, ▪ 6b on changes to trial outcomes after commencement, ▪ 7a on sample size, ▪ 7b on interim analyses and stopping rules, which is now a replacement capturing adaptive decision-making criteria to guide adaptation(s), ▪ 8b on type of randomisation, ▪ 12a on statistical methods to compare groups, ▪ 13a on participants randomised, treated, and analysed, ▪ 14a on dates for recruitment and follow-up. Expanded text—Expands the E&E text for clarification on six items without changes to item wording ▪ 14b on why the trial ended or was stopped, ▪ 15 (now 15a) on baseline demographics and clinical characteristics, ▪ 16 on numbers randomised, ▪ 17a on primary and secondary outcome results, ▪ 20 on limitations and, ▪ 21 on generalisability. Restructuring—Renames two subsection headings to reflect new ACE content ▪ “recruitment” renamed to “recruitment and adaptations” ▪ “sample size” renamed to “sample size and operating characteristics” Restructuring—Introduces a new subsection heading ▪ “Statistical analysis plan and other trial-related documents” to accommodate item 24b Modifies abstract item 1b and introduces an extension for journal and conference abstracts New item—Introduces one new item (on adaptation decisions made) On “adaptation decisions made” Modified item—Modifies one standard item On “trial design” Expanded text—Expands the E&E text for clarification on one item for certain ADs in particular circumstances without changes to item wording On “outcome” Item numbers or section/topic referenced here are presented in Tables 2 and 3