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Table 2 Potential aims of implementation feasibility studies and pilot studies

From: Guidance for conducting feasibility and pilot studies for implementation trials

Implementation study design Implementation strategy development Preliminary implementation effectiveness Implementation trial methods
Non-pilot feasibility studies (for example as part of Hybrid Type 1 trials) Explore implementation strategies (e.g., what supports are required and how would they be best delivered in order for service providers to undertake the intervention as part of routine practice?) [15].
Describe barriers and enablers to implementation strategies (e.g., What factors may influence the uptake of implementation strategies?) [56].
Describe acceptability, feasibility and/or appropriateness of implementation strategies [56].
Usually not part of non-pilot feasibility studies or Hybrid Type 1 designs. Describe any organisational/contextual factors that may influence future implementation trial methods, such as recruitment, retention, data collection procedures and number (sample size) and type (diversity) of organisations required for a future implementation trial [15].
Pilot studies (for example as part of Hybrid Type 2 trials) Assess barriers and enablers to delivery of the implementation strategies (e.g., What are factors that influenced the use of intervention? What are the factors that influenced fidelity to implementation?) [56].
Describe acceptability, feasibility and/or appropriateness of implementation strategies [56].
Establish preliminary evidence of strategy mechanisms (e.g., To determine if there is preliminary evidence that the hypothesised mechanism is responsible for the effect of the implementation strategy) [55].
To test potential effects of the implementation intervention (e.g., through measures such as adoption, fidelity, reach) [56]. To assess methods such as recruitment, retention, data collection tools and procedures, number (sample size) of organisations and type (diversity) of organisations, in order to inform a future implementation trial [17].