Table 6 Adaptation of CFIR constructs as applied to REMS assessment measures and Assessment Guidance categories

A. Intervention Source

Perception of key stakeholders about whether the intervention is externally or internally developed.

Perception of key stakeholders’ about whether the REMS program is primarily developed externally (FDA/sponsor) or internally.

Not included

Not applicable

B. Evidence Strength & Quality

Stakeholders’ perceptions of the quality and validity of evidence supporting the belief that the intervention will have desired outcomes.

Stakeholders’ perception of the quality and validity of evidence supporting the belief that the program would achieve REMS goals.

Not included

Not applicable

C. Relative Advantage

Stakeholders’ perception of the advantage of implementing the intervention versus an alternative solution.

Stakeholders’ perception of the advantage of implementing the REMS versus an alternative solution, or not receiving the access to the product at all.

Not included

Not applicable

D. Adaptability

The degree to which an intervention can be adapted, tailored, refined, or reinvented to meet local needs.

The degree to which REMS requirements can be adapted, tailored, and refined to meet local needs and ease program implementation.

Not included

Not applicable

E. Trialability

The ability to test the intervention on a small scale in the organization, and to be able to reverse course (undo implementation) if warranted.

The degree to which the REMS program can be tested on a local scale or at specified points of care prior to implementation on a national level, or through a modification later in the program.

Not included

Not applicable

F. Complexity

Perceived difficulty of implementation, reflected by duration, scope, radicalness, disruptiveness, centrality, and intricacy and number of steps required to implement.

Perceived difficulty of REMS implementation, reflected by duration, scope, radicalness, disruptiveness, centrality, intricacy, and number of steps required to implement.

Not included

Not applicable

G. Design Quality & Packaging

Perceived excellence in how the intervention is bundled, presented, and assembled.

Perceived excellence of how the REMS program is bundled, presented, and assembled (i.e. quality of design and execution).

Not included

Not applicable

H. Cost

Costs of the intervention and costs associated with implementing the intervention including investment, supply, and opportunity costs.

Costs of the REMS program and costs associated with implementing the program including investment, supply, and opportunity costs.

Not included

Not applicable

A. Patient Needs & Resources

The extent to which patient needs, as well as barriers and facilitators to meet those needs, are accurately known and addressed by the organization.

The extent to which the REMS program is patient-focused and that patient needs, as well as barriers and facilitators to meet those needs, are accurately known and addressed by the sponsor.

Not included

Not applicable

B. Cosmopolitanism

The degree to which an organization is networked with other external organizations.

The extent and quality to which stakeholders are networked within the broader healthcare system to more quickly implement practices.

Not included

Not applicable

C. Peer Pressure

Mimetic or competitive pressure to implement an intervention; typically because most or other key peer or competing organizations have already implemented or are in a bid for a competitive edge.

Competitive pressure for healthcare providers to enroll in a REMS program due to the enrollment of other providers or those in the medical use process.

Not included

Not applicable

D. External Policy & Incentives

A broad construct that includes external strategies to spread interventions, including policy and regulations (governmental or other central entity), external mandates, recommendations and guidelines, pay-for-performance, collaboratives, and public or benchmark reporting.

Adoption encouraged by clinical care guidelines, reimbursement systems, and incentives such as pay-for-performance, and benchmark reporting.

Not included

Not applicable

A. Structural Characteristics

The social architecture, age, maturity, and size of an organization.

The effects of the point of care’s size, degree of vertical integration, number of departments, number of units/departments, and degree of specialization on the implementation of individual REMS programs.

Not included

Not applicable

B. Networks & Communications

The nature and quality of webs of social networks and the nature and quality of formal and informal communications between sponsors and their vendors.

The strength of formal and informal communications, networking, and relationships between sponsors, vendors, and points of care and their effects on the adoption of the REMS program and understanding of its goals.

Not included

Not applicable

C. Culture

Norms, values, and basic assumptions of a given organization.

The norms, values, and basic assumptions about risk management and the REMS program at the point of care and the extent of how relatively stable, subconscious, and socially constructed these are.

Not included

Not applicable

D. Implementation Climate

The absorptive capacity for change, shared receptivity of involved individuals to an intervention, and the extent to which use of that intervention will be rewarded, supported, and expected within their organization.

The absorptive capacity for change, shared receptivity of involved individuals to the program, and the extent to which use of the REMS will be rewarded, supported, and expected through policies, procedures, and systems within the points of care.

Not included

Not applicable

E. Readiness for Implementation

Tangible and immediate indicators of organizational commitment to its decision to implement an intervention.

Tangible and immediate indicators of stakeholders’ readiness for adoption of the REMS in terms of setting, culture, leadership, and evaluation.

Not included

Not applicable

A. Knowledge & Beliefs about the Intervention

Individuals’ attitudes toward and value placed on the intervention as well as familiarity with facts, truths, and principles related to the intervention.

Participants’ attitudes toward and value placed on the REMS as well as familiarity with facts, truth, and principles related to the program, including sufficient knowledge of the necessity for and skill of executing the REMS program.

Knowledge

Measures of the extent of stakeholders’ knowledge about the REMS-related risk or knowledge of any safe use conditions that are needed in order to mitigate the risk

B. Self-efficacy

Individual belief in their own capabilities to execute courses of action to achieve implementation goals.

Participants’ belief in their own capabilities to execute courses of action to achieve REMS goals.

Not included

Not applicable

C. Individual Stage of Change

Characterization of the phase an individual is in, as he or she progresses toward skilled, enthusiastic, and sustained use of the intervention.

Characterization of the phase a participant is in and additional strategies necessary for the skilled and enthusiastic maintenance of behavior.

Safe Use Behaviors

Measures of the extent to which safe use conditions are being adopted or followed

D. Individual Identification with Organization

A broad construct related to how individuals perceive the organization, and their relationship and degree of commitment with that organization.

A broad construct related to how participants perceive the REMS and their willingness to fully engage due to their degree of commitment with the sponsor.

Not included

Not applicable

E. Other Personal Attributes

A broad construct to include other personal traits such as tolerance of ambiguity, intellectual ability, motivation, values, competence, capacity, and learning style.

A broad construct to include other personal traits such as participants’ locus of control and other psychological concepts related to REMS implementation.

Not included

Not applicable

A. Planning

The degree to which a scheme or method of behavior and tasks for implementing an intervention are developed in advance, and the quality of those schemes or methods.

The degree to which a scheme or method of behavior and tasks for implementing the REMS are developed in advance, and the quality of the evidence supporting those steps to promote effective implementation.

Not included

Not applicable

B. Engaging

Attracting and involving appropriate individuals in the implementation and use of the intervention through a combined strategy of social marketing, education, role modeling, training, and other similar activities.

Carefully and thoughtfully attracting involving appropriate representatives from each stakeholder group in the implementation of the REMS program through a combined strategy of social marketing, education, role modeling, training, and other similar activities to meet participants’ needs.

Program Outreach and Communication

Measures of the extent to which the REMS materials reached the intended stakeholders

C. Executing

Carrying out or accomplishing the implementation according to plan.

Carrying out or accomplishing the REMS program according to plan (descriptive).

Program 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

D. Reflecting & Evaluating

Quantitative and qualitative feedback about the progress and quality of implementation accompanied with regular personal and team debriefing about progress and experience.

Quantitative and qualitative feedback (evaluative) about the progress and quality REMS implementation accompanied with regular personal and team debriefing about progress and experience.

Program 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