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

ABSTRACT

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.

KEYWORDS:

• Self-injection
• biologic initiation
• injection training
• training device
• patient support
• injection anxiety
• drug delivery device
• combination product

Author contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for integrity of the work as a whole, and have given final approval to the version to be published. Secondary research of literature: J Hawthorne, D Katsaros; study design, execution: A Rinaldi, K Brigham, M D’Auria, E Bajars; Data Analysis: J Hawthorne, M D’Auria, K Brigham, D Katsaros; substantial contributions to manuscript preparation: J Hawthorne, D Katsaros; critical revision of manuscript for important intellectual content: C Franzese, M Coyne, J Hawthorne, D Katsaros; review of manuscript for clinical accuracy: C Franzese, J Hawthorne, D Katsaros.

Declaration of interest

All authors are employees of Matchstick. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here

Additional information

Funding

Matchstick received consulting fees and research support from Noble. The study was funded through an unrestricted grant, and the sponsor exercised no control over the study design, analysis, or reporting of results, and had no editorial oversight of the contents of the manuscript.