Recruitment and intervention delivery

Assess enrollment adherence and procedures

Measure the procedures the later trial depends on, including recruitment burden and intervention fidelity. Randomization may be piloted but is not mandatory for every feasibility study.

Flow diagram

Recruitment and intervention deliveryF1.S1Assess recruitment proceduresF1.S2Specify assignment if applicableF1.S3Assess intervention deliveryF1.S4Assess retention and proceduresF1.S5Assess operational safetyF1.N1Feasibility process measuresProcessMeasureDenominatorCollectionResponsibilityBarrierF1.S0 Start flowRecruitment and intervention deliveryF1.S999 End flowEnd flow

Steps

Assess recruitment procedures

Specify approach, eligibility, consent and recruitment measures.

Specify assignment if applicable

Document whether randomized and any allocation procedures.

Assess intervention delivery

Define fidelity, adherence, acceptability and practical barriers.

Assess retention and procedures

Track completion, workload and missing assessments.

Assess operational safety

Specify collection, escalation and participant protection.

Recruitment and intervention delivery

End flow

Tables and supporting information

Feasibility process measures

Feasibility process measuresProcessMeasureDenominatorCollectionResponsibilityBarrier

Measure the feasibility of the intended later study.

Sources