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. 2020 Jun 17;21:528. doi: 10.1186/s13063-020-04334-x

Table 3.

ACE checklist for abstracts

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

E&E = explanation and elaboration

aModified items that require reference to both CONSORT for abstracts [136, 137] and ACE;

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;

cNew items that should only be applied in reference to ACE