Advertisement
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 |
