The Current Paradigm For Biologic Initiation: A Mixed-Methods Exploration Of Practices, Unmet Needs, And Innovation Opportunities In Self-Injection Training

Background: Self-injection, particularly of biologics, has become a mainstay of chronic disease management. Despite labeling requirement for healthcare provider (HCP) training, current injection initiation experiences have been shown to be suboptimal. This study characterizes gaps in training and support during initiation and identifies rationales to inform solutions. Methods: We enrolled HCPs (n = 18) performing routine biologic initiation and patients (n = 24) currently self-injecting biologics. Participants completed activities through an online, remote ethnography tool. We conducted two focus groups with biologic-naive patients (n = 5). Data was analyzed using thematic frameworks, Q methodology, and quantitative assessments. Results: Our results suggest considerable gaps exist. Analysis revealed five common themes that could explain these gaps: 1) minimal biologic-specific professional instruction is provided to HCPs; 2) nuanced injection use-steps are not universally understood; 3) no one stakeholder currently 'owns' training; 4) support offered by HCPs and manufacturers is perceived as biased; and 5) emotional burden is not accounted for. Conclusions: Our study suggests optimizing several elements to facilitate successful initiations, including structured sessions, improved HCP injection device knowledge, demo-device practice, and focus on both emotional and mechanical aspects. Aligning these factors has potential to increase patient confidence, reduce burden on HCPs, and improve probability of success on therapy.