Table 11 CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial

Title and abstract

1a

Identification as a pilot or feasibility randomised trial in the title

2

1b

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

2,3

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

n/a

Participants

4a

Eligibility criteria for participants

5,6

4b

Settings and locations where the data were collected

5

4c

How participants were identified and consented

5,6

Interventions

5

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

6,7

Outcomes

6a

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

8

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

6,7

Sample size

7a

Rationale for numbers in the pilot trial

n/a

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

10

8b

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

10

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

10

Implementation

10

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

10

Blinding

11a

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

n/a (19)

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

13,17,18

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

13,17,18

13b

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

13

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

11,12

Numbers analysed

16

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

14

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

14,24–27

Ancillary analyses

18

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

21–24

Harms

19

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

25

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

29,30

Generalisability

21

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

28,30