Table 7 Comparison of implementation science frameworks as applied to REMS program assessment

RE-AIM

▪ Flexible and intuitively generalizable to REMS program evaluation; has been applied across a wide range of clinical, public health, and educational settings.

▪ Includes assessment of program sustainability, which enables constructs assessing burden on the healthcare delivery system and barriers to patient access

▪ Requires careful delineation of adoption (i.e., among REMS health care implementers) vs. reach (i.e., among patients receiving the drug and thereby the benefits of the risk mitigation measures)

▪ Traditionally, an evaluation tool, although it has been used to inform program design

PRECEDE-PROCEED

▪ Explicitly links program design assumptions with program evaluation metrics

▪ Supports continuous process improvement evaluation, which enables REMS modification and revision over time

▪ Phases narrowly defined, requiring at times broader application

▪ Traditionally, applied to population-health programs; may be less applicable for some clinical settings (e.g., provider activities in a hospital)

CFIR

▪ Integrates key constructs from multiple implementation science frameworks

▪ Includes health system organizational measures, such as, administrative and leadership endorsement and organizational readiness to change, which enables greater evaluation of program implementation and operations

▪ Less intuitive to apply to REMS program evaluation, with categories often overlapping or including repetitive constructs

▪ Focused on evaluating program implementation, lacking measures to assess health outcomes and impact

▪ Traditionally, applied to clinical quality improvement programs; may be less applicable for some non-clinical settings (e.g., patient activities at home)