Table 1.

Potential Application of Implementation Science Outcomes to Pilot Study Design and Interpretation

Implementation outcome	Example pilot study result	Implication/responsive adjustment	Available measurement
Acceptability	Stakeholders perceive randomization to control group unacceptable	Intervention momentum or perceived lack of equipoise may hinder recruitment; consider education or switch to non-traditional trial design	Survey Semi-structured interviews
	Planned RCT outcomes unimportant to stakeholders	Consider highly valued outcomes as primary outcome of planned RCT if feasible	Include Survey, semistructured interviews here or merge cell with above
Adoption	Low adoption (number of patients willing to try intervention)	Consider modifying intervention to encourage uptake, anticipate dilution of treatment effect in intention-to-treat analyses	Study records
Appropriateness	Intervention perceived as poor fit for certain settings or subgroups	Consider enhancing support for settings or subgroups, anticipate generalizability limitations. Safeguard against disparities in enrollment	Surveys Semi-structured interviews
Feasibility	Study protocol perceived to be complex, difficult to adhere to Trial intervention has become usual care	Adapt protocol to maximize likelihood of successful RCT Anticipate poor separation between usual care and intervention groups	Surveys Semi-structured interviews Administrative data
Fidelity	High rate of protocol violations, crossovers	Anticipate dilution of treatment effect	Study records
Penetration	Low screening, eligibility, or consent rates, poor sample representativeness	Adapt recruitment strategies	Study records