Table 3

Pilot Study - Checklist: Items to include when reporting a pilot study

PAPER SECTION

Item

Descriptor

Reported on Page #

TITLE and ABSTRACT

1

Does the title or abstract indicate that the study is a "pilot"?

INTRODUCTION

Background

2

Scientific background for the main study and explanation of rationale for assessing feasibility through piloting

METHODS

Participants and setting

3

• Eligibility criteria for participants in the pilot study (these should be the same as in the main study -- if different, state the differences)

• The settings and locations where the data were collected

Interventions

4

Provide precise details of the interventions intended for each group and how and when they were actually administered (if applicable) -- state clearly if any aspects of the intervention are assessed for feasibility

Objectives

5

• Specific scientific objectives and hypotheses for the main study

• Specific feasibility objectives

Outcomes

6

• Clearly defined primary and secondary outcome measures for the main study

• Clearly define the feasibility outcomes and how they were operationalized -- these should include key elements such as recruitment rates, consent rates, completion rates, variance estimates, etc

Sample size

7

Describe how sample size was determined

• In general for a pilot of a phase III trial, there is no need for a formal sample size calculation. However, confidence interval approach may be used to calculate and justify the sample size based on key feasibility objective(s).

Feasibility Criteria

8

Clearly describe the criteria for assessing success of feasibility -- these should be based on the feasibility objectives

Statistical Methods

9

Describe the statistical methods for the analysis of primary and secondary feasibility outcomes

Ethical Aspects

10

• State whether the study received research ethics approval

• State how informed consent was handled -- given the feasibility nature of the study

RESULTS

Participant flow

11

Flow of participants through each stage (a flow-chart is strongly recommended).

• Describe protocol deviations from pilot study as planned, together with reasons

• State the number of exclusions at each stage and reasons for exclusions

Recruitment

12

Report the dates defining the periods of recruitment and follow-up

Baseline data

13

Report the baseline demographic and clinical characteristics of the participants

Outcomes and estimation

14

For each primary and secondary feasibility outcome, report the point estimate of effect and its precision (e.g., 95% confidence interval [CI]) -- if applicable

DISCUSSION

Interpretation

15

Interpretation of the results should focus on feasibility, taking into account

• the stated criteria for success of feasibility;

• study hypotheses, sources of potential bias or imprecision -- given the feasibility nature of the study

• the dangers associated with multiplicity of analyses and outcomes

Generalizability

16

Generalizability (external validity) of the feasibility. State clearly what modifications in the design of the main study (if any) would be necessary to make it feasible

Overall evidence of feasibility

17

General interpretation of the results in the context of current evidence of feasibility

• Focus should be on feasibility

Thabane et al. BMC Medical Research Methodology 2010 10:1   doi:10.1186/1471-2288-10-1