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TITLE
and
ABSTRACT
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1
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Does the title or abstract indicate that the study is a "pilot"?
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INTRODUCTION
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Background
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2
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Scientific background for the main study and explanation of rationale for assessing feasibility through piloting
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METHODS
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Participants and setting
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3
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• Eligibility criteria for participants in the pilot study (these should be the same as in the main study -- if different, state the differences)
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• The settings and locations where the data were collected
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Interventions
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4
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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
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Objectives
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5
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• Specific scientific objectives and hypotheses for the main study
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• Specific feasibility objectives
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Outcomes
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6
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• Clearly defined primary and secondary outcome measures for the main study
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• 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
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Sample size
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7
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Describe how sample size was determined
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• 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).
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Feasibility Criteria
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8
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Clearly describe the criteria for assessing success of feasibility -- these should be based on the feasibility objectives
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Statistical Methods
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9
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Describe the statistical methods for the analysis of primary and secondary feasibility outcomes
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Ethical Aspects
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10
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• State whether the study received research ethics approval
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• State how informed consent was handled -- given the feasibility nature of the study
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RESULTS
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Participant flow
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11
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Flow of participants through each stage (a flow-chart is strongly recommended).
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• Describe protocol deviations from pilot study as planned, together with reasons
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• State the number of exclusions at each stage and reasons for exclusions
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Recruitment
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12
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Report the dates defining the periods of recruitment and follow-up
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Baseline data
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13
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Report the baseline demographic and clinical characteristics of the participants
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Outcomes and estimation
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14
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For each primary and secondary feasibility outcome, report the point estimate of effect and its precision (e.g., 95% confidence interval [CI]) -- if applicable
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DISCUSSION
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Interpretation
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15
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Interpretation of the results should focus on feasibility, taking into account
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• the stated criteria for success of feasibility;
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• study hypotheses, sources of potential bias or imprecision -- given the feasibility nature of the study
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• the dangers associated with multiplicity of analyses and outcomes
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Generalizability
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16
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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
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Overall evidence of feasibility
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17
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General interpretation of the results in the context of current evidence of feasibility
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• Focus should be on feasibility
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