The current paradigm for biologic initiation: a confirmatory quantitative analysis of self-injection training practices.

BACKGROUND: Self-injected biologic therapies have gained significant prevalence across numerous therapeutic areas. A lack of specific guidance on best practices may lead to inadequate biologic initiation and training. We previously conducted a small-sample, qualitative analysis designed to identify gaps in self-injection training. METHODS: A total of 277 HCPs performing routine biologic initiation and 264 patients currently self-injecting biologics completed this quantitative study remotely using an online survey. The primary objective was to validate previous qualitative findings and firmly characterize the current paradigm. As an exploratory objective, the study examined associations that may exist between training experiences and patient-reported outcomes. RESULTS: Most patients (91.7%) reported receiving formal self-injection training, commonly conducted over one or two sessions. The mean overall training time reported was 37.8 and 30.4 minutes by patients and HCPs, respectively. Over one-third of patients reported lacking confidence that they could correctly self-inject during the first 6 months of treatment. CONCLUSION: Current training practices may not be adequate to prepare patients to start their therapies. Considerable attention must be paid to providing patients with multiple opportunities for training sessions, training devices, and medical information for home access. Further studies should prospectively examine the impact of training techniques on patient-reported outcomes.

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-naïve 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.