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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