PAPER SECTION | Item | Descriptor | Reported on Page # |
---|---|---|---|
TITLE and ABSTRACT | 1 | Does the title or abstract indicate that the study is a "pilot"? | Â |
INTRODUCTION | Â | Â | Â |
Background | 2 | Scientific background for the main study and explanation of rationale for assessing feasibility through piloting | Â |
METHODS | Â | Â | Â |
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 | Â |
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 | Â |
 |  | • 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 | Â |
Statistical Methods | 9 | Describe the statistical methods for the analysis of primary and secondary feasibility outcomes | Â |
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 | Â | Â | Â |
Participant flow | 11 | Flow of participants through each stage (a flow-chart is strongly recommended). | Â |
 |  | • 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 | Â |
Baseline data | 13 | Report the baseline demographic and clinical characteristics of the participants | Â |
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 | Â |
DISCUSSION | Â | Â | Â |
Interpretation | 15 | Interpretation of the results should focus on feasibility, taking into account | Â |
 |  | • 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 | Â |
Overall evidence of feasibility | 17 | General interpretation of the results in the context of current evidence of feasibility | Â |
 |  | • Focus should be on feasibility |  |