Table 3.
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