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Table 1 Summary of considerations for implementation feasibility and pilot studies [18, 48,49,50]

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

  Potential objectives*
Implementation strategy development Implementation effectiveness Implementation trial methods
Aims To assess or describe contextual and environmental factors in order to inform the development of an implementation strategy. To test the potential impact of an implementation strategy. To assess or describe the feasibility, utility, acceptability or quality of trial methods.
Design Formative, non-comparative designs. Focus usually on qualitative or mixed methods approaches.
Stand-alone study or as part of a Hybrid Type 1 design.
Summative and formative. Focus on comparative quantitative designs such as randomised or cluster randomised designs
Stand-alone study or as part of a Hybrid Type 2 design.
Summative and formative Focus may be quantitative, qualitative or mixed methods approaches.
Stand-alone study or as part of a Hybrid type 1 or 2 trial.
Measures Measures informing design or development of implementation strategy such as context, acceptability, adaptability, feasibility, compatibility, cost, culture, dose, complexity and self-efficacy. Measures of impact of implementation such as adoption, reach, fidelity and sustainability along with measures as per non-pilot implementation studies. Measures informing implementation trial methods including the feasibility, acceptability or quality of data collection procedures, survey items, tools, or data management strategies.
Sample size and power Justification of sample size based on achieving estimates of sufficient precision. Justification of sample size based on achieving estimates of sufficient precision to inform trial progression (using progression criteria). Justification of sample size based on achieving estimates of sufficient precision—which may or may not be linked to progression criteria.
Progression Criteria Not required given such studies are formative. Progression criteria set a priori based estimates of potential effects. Progression may be considered in conjunction with measures feasibility, acceptability or quality of methods (or other factors). Progression criteria may be set a priori in summative pilot trials assessing trial methods. Progression may be considered in conjunction with estimates of potential trial effects (or other factors).
Reporting Draw on relevant aspects of CONSORT extension for randomised pilot and feasibility trials, STaRi and reporting guidelines specific to the research design (e.g. STROBE) Draw on upon existing reporting standards such as CONSORT extension for randomised pilot and feasibility trials, STaRi guidelines and TIDieR. Draw on upon existing reporting standards such as CONSORT extension for randomised pilot and feasibility trials, STaRi guidelines and reporting guidelines specific to the research design.
  1. *Implementation feasibility or pilot studies may have multiple objectives, for example, pilot implementation studies embedded in Hybrid Type 2 trials may also aim to inform implementation strategy development
  2. CONSORT Consolidated Standards of Reporting Trials, STaRi Standards for Reporting Implementation Studies, STROBE Strengthening the Reporting of Observational Studies in Epidemiology, TIDieR Template for Intervention Description and Replication