Table 4 Proposed extensions to the current CONSORT diagram [15]

Identification as a randomised trial in the title

Identification as an adaptive randomised trial if it is an adaptive design

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts [16, 17])

Include the term ‘adaptive design’ or ‘adaptive methods’

 Background and objectives

Scientific background and explanation of rationale

Rational for implementing an adaptive design

Specific objectives or hypotheses

 Trial design

Description of trial design (such as parallel, factorial) including allocation ratio

Define what adaptive design/ adaptive method will be applied

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Any changes during the trial should be reported as an adaptive method.

 Participants

Eligibility criteria for participants

Any changes in eligibility during the trial, should be classed as an adaptive design or adaptive method.

Settings and locations where the data were collected

 Interventions

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

 Outcomes

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

Any changes to trial outcomes after the trial commenced, with reasons

Any changes during the trial are classed as an adaptive method and should be mentioned.

 Sample size

How sample size was determined

Any changes to sample size or power during trial classed as an adaptive design or adaptive method and should be mentioned.

When applicable, explanation of any interim analyses and stopping guidelines

Explain why the interim analysis will be taking place, if potential pre-planned adaptations during interim analysis taking place then these should be mentioned in the methods as well (3b). Include details of any planned stopping boundaries for either the trial or dropping any of the intervention arms.

 Sequence generation

Method used to generate the random allocation sequence

Type of randomisation; details of any restriction (such as blocking and block size)

Details if adaptive randomisation has been implemented.

 Allocation concealment mechanism

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

 Implementation

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

 Blinding

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

If relevant, description of the similarity of interventions

 Statistical methods

Statistical methods used to compare groups for primary and secondary outcomes

Details of how the adaptive design or the adaptive methods were applied Details of how the statistical methods were evaluated before implementation i.e. through the use of simulations?

Methods for additional analyses, such as subgroup analyses and adjusted analyses

 Participant flow (a diagram is strongly recommended)

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome

Ensure any adaptations are shown on this diagram, such as dropping of arms, treatment switching.

For each group, losses and exclusions after randomisation, together with reasons

 Recruitment

Dates defining the periods of recruitment and follow-up

Why the trial ended or was stopped

Any changes to recruitment during trial classed as an adaptive method, should be mentioned.

 Baseline data

A table showing baseline demographic and clinical characteristics for each group

 Numbers analysed

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

 Outcomes and estimation

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

 Ancillary analyses

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

 Harms

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms [18])

 Limitations

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

 Generalisability

Generalisability (external validity, applicability) of the trial findings

If ad-hoc adaptive methods were implemented, at what point was it decided to implement this and why.

 Interpretation

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

 Registration

Registration number and name of trial registry

 Protocol

Where the full trial protocol can be accessed, if available

First and last protocol, with a list of amendments made.

 Funding

Sources of funding and other support (such as supply of drugs), role of funders