Section/topic by item no | Standard CONSORT for abstracts and conference posters [84, 85] | Abstract extension for adaptive design randomised trials |
Title and abstract | ||
 Trial design | 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 |
 Outcome | Clearly defined primary outcome for this report | [expand E&E text for clarification] |
 Adaptation decisions made |  | Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data |
Section/topic by item no | Main report extension for adaptive design randomised trials | |
Trial design | ||
 3b «  pre-planned adaptive design features |  | Type of adaptive design used, with details of the pre-planned trial adaptations and the statistical information informing the adaptations |
 3c « 3b | 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 |
Outcomes | ||
 6a | 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 |
 6b | 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 | ||
 7a | How sample size was determined | How sample size and operating characteristics were determined |
 7b | 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 nonbinding; pre-planned and actual timing and frequency of interim data looks to inform trial adaptations |
Sequence generation | ||
 8b | 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 |
Blinding | ||
 11c Confidentiality and minimisation of operational bias |  | Measures to safeguard the confidentiality of interim information and minimise potential operational bias during the trial |
Statistical methods | ||
 12a | 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 «  Estimation and inference methods |  | For the implemented adaptive design features, statistical methods used to estimate treatment effects for key endpoints and to make inferences |
Participant flow (a diagram is strongly recommended) | ||
 13a | 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 |
Recruitment and adaptations | ||
 14a | Dates defining the periods of recruitment and follow-up | Dates defining the periods of recruitment and follow-up, for each group |
 14b | Why the trial ended or was stopped | [expand E&E text for clarification] |
 14c Adaptation decisions |  | Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data |
Baseline data | ||
 15a « 15 | A table showing baseline demographic and clinical characteristics for each group | [expand E&E text for clarification] |
 15b Similarity between stages |  | Summary of data to enable the assessment of similarity in the trial population between interim stages |
Numbers analysed | ||
 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | [expand E&E text for clarification] |
Outcomes and estimation | ||
 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | [expand E&E text for clarification] |
 17c Interim results |  | Report interim results used to inform interim decision-making |
 20 Limitations | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | [expand E&E text for clarification] |
 21 Generalisability | Generalisability (external validity, applicability) of the trial findings | [expand E&E text for clarification] |
Statistical analysis plan and other relevant trial documents | ||
 24b |  | Where the full statistical analysis plan and other relevant trial documents can be accessed |