ABSTRACT

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.

中文翻译：

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当前的生物起始范式：对自我注射训练中实践、未满足需求和创新机会的混合方法探索

摘要

背景

自我注射，尤其是生物制剂，已成为慢性病管理的支柱。尽管医疗保健提供者 (HCP) 培训有标签要求，但目前的注射开始经验已被证明是次优的。本研究描述了启动期间培训和支持方面的差距，并确定了为解决方案提供信息的理由。

方法

我们招募了执行常规生物制剂启动的 HCP (n = 18) 和目前自我注射生物制剂的患者 (n = 24)。参与者通过在线远程民族志工具完成了活动。我们对未使用生物制剂的患者（n = 5）进行了两个焦点小组。使用专题框架、Q 方法和定量评估分析数据。

结果

我们的结果表明存在相当大的差距。分析揭示了可以解释这些差距的五个共同主题：1) 向 HCP 提供了最少的生物特定专业指导；2) 细微的注射使用步骤并不普遍；3) 目前没有任何利益相关者“拥有”培训；4) HCP 和制造商提供的支持被认为是有偏见的；5) 情感负担没有考虑在内。

结论

我们的研究建议优化几个要素以促进成功启动，包括结构化会议、改进 HCP 注射装置知识、演示装置实践，以及关注情感和机械方面。调整这些因素有可能增加患者的信心，减轻 HCP 的负担，并提高治疗成功的可能性。