Section/Topic | Item No | Standard Checklist item | Extension for adaptive designs |
---|---|---|---|
Title and abstract | |||
1a | Identification as a randomised trial in the title | Identification as an adaptive randomised trial if it is an adaptive design | |
1b | 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’ | |
Introduction | |||
Background and objectives | 2a | Scientific background and explanation of rationale | Rational for implementing an adaptive design |
2b | Specific objectives or hypotheses | ||
Methods | |||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | Define what adaptive design/ adaptive method will be applied |
3b | 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 | 4a | Eligibility criteria for participants | Any changes in eligibility during the trial, should be classed as an adaptive design or adaptive method. |
4b | Settings and locations where the data were collected | ||
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | |
Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | |
6b | 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 | 7a | 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. |
7b | 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. | |
Randomisation: | |||
Sequence generation | 8a | Method used to generate the random allocation sequence | |
8b | Type of randomisation; details of any restriction (such as blocking and block size) | Details if adaptive randomisation has been implemented. | |
Allocation concealment mechanism | 9 | 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 | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | |
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | |
11b | If relevant, description of the similarity of interventions | ||
Statistical methods | 12a | 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? |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | ||
Results | |||
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 | Ensure any adaptations are shown on this diagram, such as dropping of arms, treatment switching. |
13b | For each group, losses and exclusions after randomisation, together with reasons | ||
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | |
14b | Why the trial ended or was stopped | Any changes to recruitment during trial classed as an adaptive method, should be mentioned. | |
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | |
Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | |
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) | |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | ||
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | |
Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms [18]) | |
Discussion | |||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | |
Generalisability | 21 | 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 | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | |
Registration | 23 | Registration number and name of trial registry | |
Protocol | 24 | Where the full trial protocol can be accessed, if available | First and last protocol, with a list of amendments made. |
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders |