Section/topic and item no	Extension for pilot trials	Note where reported
Title and abstract
1a	Identification as a pilot or feasibility randomised trial in the title	✓ Title
1b	Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials)	✓ Abstract
Introduction
Background and objectives:
2a	Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial	✓ Introduction
2b	Specific objectives or research questions for pilot trial	✓ Introduction
Methods
Trial design:
3a	Description of pilot trial design (such as parallel, factorial) including allocation ratio	✓ Methods
3b	Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons	✓ Methods
Participants:
4a	Eligibility criteria for participants	✓ Methods
4b	Settings and locations where the data were collected	✓ Methods
4c	How participants were identified and consented	✓ Methods
Interventions:
5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	✓ Methods
Outcomes:
6a	Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed	✓ Methods
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	N/A
Sample size:
7a	Rationale for numbers in the pilot trial	✓ Methods
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	N/A
8b	Type of randomisation(s); details of any restriction (such as blocking and block size)	N/A
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	N/A
Implementation:
10	Who generated the random allocation sequence, enrolled participants, and assigned participants to interventions	N/A
Blinding:
11a	If done, who was blinded after assignment to interventions (eg, participants, care providers, those assessing outcomes) and how	N/A
Analytical methods:
12a	Methods used to address each pilot trial objective whether qualitative or quantitative	✓ Methods
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	✓ Results
13b	For each group, losses and exclusions after randomisation, together with reasons	N/A
Recruitment:
14a	Dates defining the periods of recruitment and follow-up	✓ Results
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	✓ Results
Numbers analysed:
16	For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomised group	✓ Results
Outcomes and estimation:
17a	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	✓ Results
Ancillary analyses:
18	Results of any other analyses performed that could be used to inform the future definitive trial	✓ Results
Harms:
19	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)	N/A
19a	If relevant, other important unintended consequences	N/A
Discussion
Limitations:
20	Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility	✓ Discussion
Generalisability:
21	Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies	✓ Discussion
Interpretation:
22	Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and considering other relevant evidence	✓ Discussion
22a	Implications for progression from pilot to future definitive trial, including any proposed amendments	✓ Discussion
Other information
Registration:
23	Registration number for pilot trial and name of trial registry	✓ Title page
Protocol:
24	Where the pilot trial protocol can be accessed, if available	✓ Methods
Funding:
25	Sources of funding and other support (such as supply of drugs), role of funders	✓ Discussion
26	Ethical approval or approval by research review committee, confirmed with reference number	✓ Methods