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. |