Table 2 CONSORT 2010 checklist for reporting pilot, randomised controlled trials (RCTs) and the location of information for the MATE trial
Section/topic | Item no | Checklist item | Reported on page no |
|---|---|---|---|
Title and abstract | |||
| Â | 1a | Identification as a pilot or feasibility randomised trial in the title | 1 |
1b | Structured summary of pilot trial design, methods, results and conclusions (for specific guidance, see CONSORT abstract extension for pilot trials) | 3 | |
Introduction | |||
 Background and objectives | 2a | Scientific background and explanation of rationale for future definitive trial and reasons for randomised pilot trial | 4 |
2b | Specific objectives or research questions for pilot trial | 4 | |
Methods | |||
 Trial design | 3a | Description of pilot trial design (such as parallel, factorial) including allocation ratio | 5 |
3b | Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons | 7 | |
 Participants | 4a | Eligibility criteria for participants | 5 |
4b | Settings and locations where the data were collected | 5 | |
4c | How participants were identified and consented | 5 | |
 Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 5 |
 Outcomes | 6a | Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed | 5/6 |
6b | Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons | n/a | |
6c | If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial | 5/6 | |
 Sample size | 7a | Rationale for numbers in the pilot trial |  |
7b | When applicable, explanation of any interim analyses and stopping guidelines | n/a | |
Randomisation | |||
 Sequence generation | 8a | Method used to generate the random allocation sequence | 5 |
8b | Type of randomisation(s); details of any restriction (such as blocking and block size) | 5 | |
 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 | 5 |
 Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 5 |
 Blinding | 11a | If done, who was blinded after assignment to interventions (for example participants, care providers, those assessing outcomes) and how | n/a |
11b | If relevant, description of the similarity of interventions | n/a | |
 Statistical methods | 12 | Methods used to address each pilot trial objective whether qualitative or quantitative | 5 |
Results | |||
 Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly assigned, received intended treatment and were assessed for each objective | 5 |
13b | For each group, losses and exclusions after randomisation, together with reasons | 5 | |
 Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 5 |
14b | Why the pilot trial ended or was stopped | n/a | |
 Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 5 |
 Numbers analysed | 16 | For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomised group | 7–8 |
 Outcomes and estimation | 17 | For each objective, results including expressions of uncertainty (such as 95% confidence interval) for any estimates. If relevant, these results should be by randomised group | 7–8 |
 Ancillary analyses | 18 | Results of any other analyses performed that could be used to inform the future definitive trial | 7–8 |
 Harms | 19 | All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms) | 8 |
19a | If relevant, other important unintended consequences | 8 | |
Discussion | |||
 Limitations | 20 | Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility | 9–12 |
 Generalisability | 21 | Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies | 9–12 |
 Interpretation | 22 | Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms and considering other relevant evidence | 9–12 |
22a | Implications for progression from pilot to future definitive trial, including any proposed amendments | 9–12 | |
Other information | Â | ||
 Registration | 23 | Registration number for pilot trial and name of trial registry | 5 |
 Protocol | 24 | Where the pilot trial protocol can be accessed, if available | 5 |
 Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 2 |
26 | Ethical approval or approval by research review committee, confirmed with reference number | 4 | |