Identification and validation of competencies for use in objective structured clinical examinations for lay caregivers.

Cancer care has shifted from the traditional hospital to alternative settings, thus requiring lay individuals to assume increased direct care responsibility. Cooperative Care is an example of an alternative acute care delivery model where a family member or a friend is responsible for care previously provided by healthcare professionals. The success of alternative models is dependent on effective educational programs with clearly defined expectations and methods for evaluating caregiver competence. Objective structured clinical examinations (OSCEs) provide a standardized approach to evaluating caregiver performance in a simulated situation. The purpose of the first phase of this instrument development project was to identify and validate competencies for inclusion in OSCEs to be used with lay caregivers in preparation for Cooperative Care. The study included multiple methods of data collection: analysis of documents, viewing videos, observation with note taking, and a focus group session. All classes and materials provided for lay caregivers were reviewed. Core content domains and competencies were identified and used to develop OSCEs. A focus group of healthcare providers responsible for the education and care of patients and their caregivers validated the competencies embedded within the OSCEs. This study demonstrated the efficacy of the approach used for the identification and validation of competencies for lay caregivers.

Biosimilars in the United States: Considerations for Oncology Advanced Practitioners.

Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory pathway-distinct from conventional biologics license applications-based on analytic and clinical studies demonstrating no clinically meaningful differences from the reference product. As policies on US biosimilars evolve, it is important that advanced practitioners receive comprehensive, ongoing education on them, particularly regarding differences from small-molecule drugs; their approval pathways vs. conventional regulatory pathways; evaluation of quality, safety, and efficacy; safety monitoring; and product identification to facilitate accurate safety reporting. Advanced practitioners will play a key role in educating nurses and patients on biosimilars. Nurse education should highlight any differences from the reference product (e.g., approved indications and delivery devices) and should emphasize assessment of substitutions, monitoring for adverse events (e.g., immune reactions), and the need for precise documentation for safety reports. Patient education should address differences between the biosimilar and reference product in administration, handling and storage, and self-monitoring for adverse events.