Table 2 CONSORT checklist of information to include when reporting a pilot trial

 1a

Identification as a randomised trial in the title

Identification as a pilot or feasibility randomised trial in the title

 1b

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

Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials)

  2a

Scientific background and explanation of rationale

Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial

  2b

Specific objectives or hypotheses

Specific objectives or research questions for pilot trial

  3a

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

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

  3b

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

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

  4a

Eligibility criteria for participants

  4b

Settings and locations where the data were collected

  4c

How participants were identified and consented

  5

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

  6a

Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed

Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed

  6b

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

Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons

  6c

If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial

  7a

How sample size was determined

Rationale for numbers in the pilot trial

  7b

When applicable, explanation of any interim analyses and stopping guidelines

   8a

Method used to generate the random allocation sequence

   8b

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

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

  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

  10

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

  11a

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

  11b

If relevant, description of the similarity of interventions

  12a

Statistical methods used to compare groups for primary and secondary outcomes

Methods used to address each pilot trial objective whether qualitative or quantitative

  12b

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

Not applicable

  13a

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 approached and/or assessed for eligibility, randomly assigned, received intended treatment, and were assessed for each objective

  13b

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

  14a

Dates defining the periods of recruitment and follow-up

  14b

Why the trial ended or was stopped

Why the pilot trial ended or was stopped

  15

A table showing baseline demographic and clinical characteristics for each group

  16

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

For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomised group

  17a

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

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

  17b

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

Not applicable

  18

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory

Results of any other analyses performed that could be used to inform the future definitive trial

  19

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

  19a

If relevant, other important unintended consequences

  20

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

Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility

  21

Generalisability (external validity, applicability) of the trial findings

Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies

  22

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

Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and considering other relevant evidence

  22a

Implications for progression from pilot to future definitive trial, including any proposed amendments

  23

Registration number and name of trial registry

Registration number for pilot trial and name of trial registry

  24

Where the full trial protocol can be accessed, if available

Where the pilot trial protocol can be accessed, if available

  25

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

  26

Ethical approval or approval by research review committee, confirmed with reference number