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Table 2 ACE checklist for the main report

From: The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Section/ Topic Item No Standard CONSORT 2010 checklist item Extension for adaptive design randomised trials Page No
Title and abstract 1a Identification as a randomised trial in the title   
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) [136, 137] Structured summary of trial design, methods, results, and conclusions (for specific guidance see ACE for abstracts, Table 3)  
Introduction     
Background and objectives 2a Scientific background and explanation of rationale   
2b Specific objectives or hypotheses   
Methods     
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio   
3b«a   Type of adaptive design used, with details of the pre-planned trial adaptations and the statistical information informing the adaptations  
3c«3bb Important changes to methods after trial commencement (such as eligibility criteria), with reasons Important changes to the design or methods after trial commencement (such as eligibility criteria) outside the scope of the pre-planned adaptive design features, with reasons  
Participants 4a Eligibility criteria for participants   
4b Settings and locations where the data were collected   
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered   
Outcomes 6ab Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Completely define pre-specified primary and secondary outcome measures, including how and when they were assessed. Any other outcome measures used to inform pre-planned adaptations should be described with the rationale  
6bb Any changes to trial outcomes after the trial commenced, with reasons Any unplanned changes to trial outcomes after the trial commenced, with reasons  
Sample size and operating characteristics 7ab How sample size was determined How sample size and operating characteristics were determined  
7bc When applicable, explanation of any interim analyses and stopping guidelines Pre-planned interim decision-making criteria to guide the trial adaptation process; whether decision-making criteria were binding or non-binding; pre-planned and actual timing and frequency of interim data looks to inform trial adaptations  
Randomisation    
Sequence generation 8a Method used to generate the random allocation sequence   
8bb Type of randomisation; details of any restriction (such as blocking and block size) Type of randomisation; details of any restriction (such as blocking and block size); any changes to the allocation rule after trial adaptation decisions; any pre-planned allocation rule or algorithm to update randomisation with timing and frequency of updates  
Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned   
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions   
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how   
11b If relevant, description of the similarity of interventions   
11ca   Measures to safeguard the confidentiality of interim information and minimise potential operational bias during the trial  
Statistical methods 12ab Statistical methods used to compare groups for primary and secondary outcomes Statistical methods used to compare groups for primary and secondary outcomes, and any other outcomes used to make pre-planned adaptations  
12b«a   For the implemented adaptive design features, statistical methods used to estimate treatment effects for key endpoints and to make inferences  
12c«12b Methods for additional analyses, such as subgroup analyses and adjusted analyses   
Results     
Participant flow (a diagram is strongly recommended) 13ab For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome and any other outcomes used to inform pre-planned adaptations, if applicable  
13b For each group, losses and exclusions after randomisation, together with reasons   
Recruitment and adaptations 14ab Dates defining the periods of recruitment and follow-up Dates defining the periods of recruitment and follow-up, for each group  
14bd Why the trial ended or was stopped See expanded E&E text for clarification  
14ca   Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data  
Baseline data 15a«15d A table showing baseline demographic and clinical characteristics for each group See expanded E&E text for clarification  
15ba   Summary of data to enable the assessment of similarity in the trial population between interim stages  
Numbers analysed 16d For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups See expanded E&E text for clarification  
Outcomes and estimation 17ad For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) See expanded E&E text for clarification  
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended   
17ca   Report interim results used to inform interim decision-making  
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory   
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) [138]   
Discussion     
Limitations 20d Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses See expanded E&E text for clarification  
Generalisability 21d Generalisability (external validity, applicability) of the trial findings See expanded E&E text for clarification  
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence   
Other information    
Registration 23 Registration number and name of trial registry   
Protocol 24a«24 Where the full trial protocol can be accessed   
SAP and other relevant trial documents 24ba   Where the full statistical analysis plan and other relevant trial documents can be accessed  
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders   
  1. “X« Y” means original CONSORT 2010 item Y has been renumbered to X;
  2. “X«” means item reordering resulted in new item X replacing the number of the original CONSORT 2010″ item X”;
  3. ACE Adaptive designs CONSORT Extension, E&E explanation and elaboration, SAP statistical analysis plan
  4. aNew items that should only be applied in reference to ACE;
  5. bModified items that require reference to both CONSORT 2010 and ACE;
  6. cReplacement (modified) item that only requires reference to ACE;
  7. dItem wording remains unchanged in reference to CONSORT 2010 but we expanded the ACE explanatory text to clarify additional considerations for certain adaptive designs. These unchanged items require reference to CONSORT 2010 except for item 14b