Table 4 Adaptation of PRECEDE-PROCEED phases as applied to REMS assessment measures and Assessment Guidance categories. Predisposing, Reinforcing, and Enabling Constructs in Educational / Ecological Diagnosis and Evaluation (PRECEDE Structure)
PRECEDE Phase | General Description | Description as Applied to REMS Assessments | Assessment Guidance Category | Definitions of Assessment Guidance Categories |
|---|---|---|---|---|
1. Social Assessment | Determine what the target population wants and the ultimate desired result. Identify specific health problems that may contribute to the target population’s quality of life, social goals, or problems; Diagnose severity of the problem as perceived by the target population | Summarize the benefit-risk profile of the drug and unmet medical need Identify patient health and treatment preferences for the target patient group Determine if patients are willing to take on risks associated with REMS medications in the context of treatment benefits, ensuring that they are sufficiently informed to share decision making and are confident in their ability to comply with REMS. | Not included | Not applicable |
2. Epidemiological Assessment | Identify the prevalence, health determinants, and burden of the identified problems; Set priorities and goals | Benefit-risk assessment that a REMS is necessary to ensure the benefits outweigh the risks Identify the gap in knowledge or aspect of human behavior that leads to risk (e.g. alcohol use resulting in an interaction with the drug) Epidemiological data of the risks that the REMS is intended to address Epidemiological data on the target population REMS goal presented in a “SMART” format – the overall, safety-related health outcome(s) that the REMS is designed to achieve | Not included | Not applicable |
3. Educational and Ecological Assessment | Categorize the predisposing, enabling, or reinforcing factors most likely to result in behavior change | Identify workflow preferences for the target healthcare provider Intermediate, measurable REMS objectives presented in a “SMART” format Determine which REMS materials and Participant Requirements would be most inducive to achieving goal. Health literacy & self-efficacy (ability to do what is required) | Not included | Not applicable |
4. Administrative and Policy Assessment and Intervention Alignment | Identify administrative, organizational, and policy factors required for development and implementation of the intervention as well as resources and barriers | Identify clinical workflow preferences for the target healthcare settings Determine the REMS interventions e.g., ETASU to achieve objectives or other Applicant Requirements Clinical/medical practice guidelines | Not included | Not applicable |