Skip to main content

Table 3 Finalised CONSORT extension for adaptive design randomised trials (only new and modified items and those with expanded E&E text)

From: Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

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 Standard CONSORT 2010 checklist item [37, 65] 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
  1. ‘X « Y’ means original item Y has been renumbered to X; ‘X «’ means reordering resulted in the new item X replacing the number of the original item X; [expand E&E text for clarification] means we retain the original item but will discuss additional considerations relating to specific adaptive designs for clarification in the forthcoming explanation and elaboration (E&E) document