Table 3 Adaptation of RE-AIM dimensions as applied to REMS assessment measures and Assessment Guidance categories
RE-AIM Dimension | General Description* | Description as Applied to REMS Assessments** | Assessment Guidance Category | Definitions of Assessment Guidance Category |
|---|---|---|---|---|
Reach | Reach refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative, intervention, or program | Patient (individual level) • Number of patients treated or enrolled (numerator) • Proportion of eligible patients (“valid denominator” given the drug’s indicated use) treated or enrolled • Characteristics of patients treated or enrolled compared with nonparticipants – representativeness | Outreach and Communications | Measures of the extent to which the REMS materials reached the intended stakeholders |
Effectiveness | Effectiveness refers to the impact of an intervention on important outcomes, including potential negative effects, quality of life, and economic outcomes | Patient (individual level) • Knowledge-Attitudes; Process-Behavior; Health Outcomes and/or Surrogates • Positive and negative (unintended) impacts; observed vs. expected rates of effectiveness • Heterogeneity (variability) of effect across different subpopulations | Safe Use Behaviors and Knowledge Health Outcomes | Measures of the extent to which safe use conditions are being adopted or followed, or of stakeholders’ knowledge about the REMS-related risk or knowledge of any safe use conditions Measures of the safety-related health outcome of interest or a surrogate of a health outcome |
Adoption | Adoption refers to the absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate the program | Health Care System (setting level) • Number of practices, clinics, hospitals or pharmacies certified or enrolled (numerator) • Proportion of eligible practices, clinics, hospitals or pharmacies (“valid denominator” given the drug’s indicated use) certified or enrolled • Characteristics of practices, clinics, hospitals or pharmacies certified or enrolled compared with non-adopters – representativeness Health Care Provider (agent level) • Number of prescribers and/or pharmacists certified or enrolled (numerator) • Proportion of eligible prescribers and/or pharmacists (“valid denominator” given the drug’s indicated use) certified or enrolled • Characteristics of prescribers and/or pharmacists certified or enrolled compared with non-adopters – representativeness | Outreach and Communications | Measures of the extent to which the REMS materials reached the intended stakeholders |
Implementation | At the setting level, implementation refers to the intervention agents’ fidelity to the various elements of an intervention’s protocol, including consistency of delivery as intended and the time and cost of the intervention Implementation elements include: implementation fidelity, adaptation, and cost of intervention At the agent level, implementation refers to the clients’ use of the intervention strategies | Health Care System (setting level) • Percent of targeted groups who were sent, received REMS information and/or training (by mode and frequency of distribution) • Curriculum consistency – fidelity and adaptation over time (by training modality) • Extent of completed, successful training and/or certification in the program • Incremental costs and resources required (fixed and variable) for REMS participation • Heterogeneity (variability) of implementation across different settings | Implementation and Operations | Measures of the extent to which the intended stakeholders are participating in the program, how effectively the REMS program is being implemented and any unintended consequences such as patient access or burden to the healthcare system |
Health Care Provider (agent level) • Educational effectiveness measured by: knowledge-attitudes, behavioral intention for safe use processes and procedures, observed behavior-compliance • Heterogeneity (variability) of implementation across different settings and/or provider characteristics | Safe Use Behaviors and Knowledge | Measures of the extent to which safe use conditions are being adopted or followed, or of stakeholders’ knowledge about the REMS-related risk or knowledge of any safe use conditions | ||
Maintenance | At the setting level, maintenance reflects the extent to which the program or processes become institutionalized or sustained as part of routine practice over time | Health Care System (setting level) • Cumulative real-world evidence of the integration of REMS processes and procedures into state and institutional policies, treatment guidelines, insurance requirements | Not included | Not applicable |
At the agent or individual level, maintenance reflects the extent to which practices become a stable part of the behavioral repertoire of the individual | Health Care Provider (agent level) & Patient (individual level) • Cumulative evidence over time to include: durability of knowledge; compliance with REMS processes and procedures; attrition rate (from the program); heterogeneity (variability) of attrition by subgroups, unintended outcomes, e.g., access or burden issues | Not included | Not applicable |