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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