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Table 3 ACE checklist for abstracts

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 Standard checklist description Extension for adaptive design randomised trials
Title Identification of study as randomised  
Authors Contact details for the corresponding author  
Trial designa Description of the trial design (for example, parallel, cluster, non-inferiority) Description of the trial design (for example, parallel, cluster, non-inferiority); include the word “adaptive” in the content or at least as a keyword
Methods   
Participants Eligibility criteria for participants and the settings where the data were collected  
Interventions Interventions intended for each group  
Objective Specific objective or hypothesis  
Outcomeb Clearly defined primary outcome for this report See expanded E&E text for clarification
Randomisation How participants were allocated to interventions  
Blinding (masking) Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment  
Results   
Numbers randomised Number of participants randomised to each group  
Recruitment Trial status  
Adaptation decisions madec   Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data
Numbers analysed Number of participants analysed in each group  
Outcome For the primary outcome, a result for each group and the estimated effect size and its precision  
Harms Important adverse events or side effects  
Conclusions General interpretation of the results  
Trial registration Registration number and name of trial register  
Funding Source of funding  
  1. E&E = explanation and elaboration
  2. aModified items that require reference to both CONSORT for abstracts [136, 137] and ACE;
  3. bItem wording remains unchanged in reference to CONSORT for abstracts [136, 137], but we expanded the ACE explanatory text to clarify additional considerations for certain adaptive designs;
  4. cNew items that should only be applied in reference to ACE