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Table 3 Pilot Study - Checklist: Items to include when reporting a pilot study

From: A tutorial on pilot studies: the what, why and how

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