Table 2 ACE checklist for the main report
Section/ Topic | Item No | Standard CONSORT 2010 checklist item | Extension for adaptive design randomised trials | Page No |
|---|---|---|---|---|
Title and abstract | 1a | Identification as a randomised trial in the title | ||
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) [136, 137] | Structured summary of trial design, methods, results, and conclusions (for specific guidance see ACE for abstracts, Table 3) | ||
Introduction | ||||
Background and objectives | 2a | Scientific background and explanation of rationale | ||
2b | Specific objectives or hypotheses | |||
Methods | ||||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | ||
3b«a | Type of adaptive design used, with details of the pre-planned trial adaptations and the statistical information informing the adaptations | |||
3c«3bb | 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 | ||
Participants | 4a | Eligibility criteria for participants | ||
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 | 6ab | 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 | |
6bb | 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 | 7ab | How sample size was determined | How sample size and operating characteristics were determined | |
7bc | 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 non-binding; pre-planned and actual timing and frequency of interim data looks to inform trial adaptations | ||
Randomisation | ||||
Sequence generation | 8a | Method used to generate the random allocation sequence | ||
8bb | 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 | ||
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 | |||
11ca | Measures to safeguard the confidentiality of interim information and minimise potential operational bias during the trial | |||
Statistical methods | 12ab | 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«a | For the implemented adaptive design features, statistical methods used to estimate treatment effects for key endpoints and to make inferences | |||
12c«12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | |||
Results | ||||
Participant flow (a diagram is strongly recommended) | 13ab | 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 | |
13b | For each group, losses and exclusions after randomisation, together with reasons | |||
Recruitment and adaptations | 14ab | Dates defining the periods of recruitment and follow-up | Dates defining the periods of recruitment and follow-up, for each group | |
14bd | Why the trial ended or was stopped | See expanded E&E text for clarification | ||
14ca | Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data | |||
Baseline data | 15a«15d | A table showing baseline demographic and clinical characteristics for each group | See expanded E&E text for clarification | |
15ba | Summary of data to enable the assessment of similarity in the trial population between interim stages | |||
Numbers analysed | 16d | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | See expanded E&E text for clarification | |
Outcomes and estimation | 17ad | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | See expanded E&E text for clarification | |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | |||
17ca | Report interim results used to inform interim decision-making | |||
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) [138] | ||
Discussion | ||||
Limitations | 20d | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | See expanded E&E text for clarification | |
Generalisability | 21d | Generalisability (external validity, applicability) of the trial findings | See expanded E&E text for clarification | |
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | ||
Other information | ||||
Registration | 23 | Registration number and name of trial registry | ||
Protocol | 24a«24 | Where the full trial protocol can be accessed | ||
SAP and other relevant trial documents | 24ba | Where the full statistical analysis plan and other relevant trial documents can be accessed | ||
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | ||