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.
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.
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.
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.
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.
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.
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.
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.
Intravitreal injection (IVI) is the most commonly performed intraocular procedure worldwide. Several manufacturers have developed glass prefilled syringe (PFS) devices to increase the ease of ...performing IVIs and reduce the complications associated with medication preparation. This formative human factors study assessed a novel, polymer PFS alternative to glass syringes to support development of a usable, silicone-free delivery platform for IVI. Thirteen retina specialists (RSs) with experience preparing a minimum of ≥10 IVIs per week completed the study. RSs were presented with the concept device and prototype instructions for use and completed hands-on tasks to simulate IVI. They then evaluated the concept device for ease of use, comfort, safety, and overall preference versus the IVI devices they are accustomed to using. The primary objectives were to assess the ease of use and acceptability of the proposed syringe design, evaluate the corresponding instructions for use (IFU), and identify any potential usability issues. The secondary objectives were to evaluate a new tamper-evident cap design and compare several externally printed dose marking designs. There were 130 total opportunities for use errors that deviated from the IFU. Of these 130 steps, 110 were a Success, 17 were Incomplete or Incorrect, 2 were Resolved, and 1 was the result of a Study Artifact. All 13 participants completed 3 Essential Tasks successfully and at least 10 participants completed each of the 4 Safety-Critical Tasks successfully. A total of 20 errors were made throughout the test simulation, most of which were rooted in unfamiliar use steps or transference behaviors. Overall, the concept device was found to be usable, acceptable, and safe for IVI by experienced RSs. RSs preferred the concept device to IVI products supplied in vials, but there was no notable preference for the concept device design compared to current glass PFSs used for IVI. The unique features of the concept device, including absence of silicone oil and break-resistance, were mostly recognized by participants and may offer an improvement to currently available systems for IVI.
Background: In the acute care setting, parenteral medication errors are well-studied. However, there is comparatively little research on how these issues translate to patient- or caregiver-prepared ...medications in the home, particularly with reconstituted medications.
Methods: This was an ethnographic study designed to identify issues associated with four reconstitution use scenarios. Preparation burden was determined by measuring the time and manipulations required to prepare reconstituted medications across three preparation phases (assembly, reconstitution, and transfer). Deviations from product instructions for use, sterility breaches, self-reported preparation complications, and supply storage conditions were also analyzed.
Results: A total of 14 participants completed the study. Overall, preparation burden was markedly higher when purpose-built reconstitution devices were not available. The majority of participants reported experiencing at least one complication associated with their medication preparation process; the reconstitution phase was the most significant source of both instructions for use deviations and breaches in sterility. Participants reported that the volume and variety of medication preparation supplies were a significant source of burden.
Conclusions: At-home preparation of reconstituted medications poses several challenges for patients and caregivers. As parenteral medications continue to shift towards self-administration, manufacturers should carefully consider the usability of such products and employ purpose-built reconstitution devices whenever possible.
Background: Self-injection of biologics is a mainstay of chronic disease treatment, yet the process of self-injection often causes persistent apprehension and anxiety, distinct from needle phobia. ...While literature alludes to the role that routines and rituals play in self-injection, there is no comprehensive study on the routines and rituals self-injectors employ, nor of the process by which they are discovered and ingrained. Methods: We conducted a mixed-method, observational pilot ethnography study of 27 patients with plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis with and without prior biologic self-injection experience. Patients submitted self-made videos, photos, and projective exercises of an actual biologic self-injection and completed validated instruments to assess burden of treatment. Videos and photos containing routine and ritual elements were thematically categorized based on functional and emotional benefit, and analyzed for differences based on current biologic, dosing frequency, time on current biologic, and burden of treatment measures. Results: During patients' initial at-home injections, training gaps became apparent, leading to a process of experimentation aimed at reducing pain/anxiety, increasing confidence, and building a consistent injection process. Routines were present in 27/27 (100%) patients and anchored the time, place, and process for injection, and incorporated approved use steps for the injection device. Ritual elements served as emotional coping strategies for patients and were present in 21/27 (77.8%) of patients. Conclusion: Our findings suggest that providing patients device training using adult learning principles, teaching routines and rituals concurrently, and providing at-home opportunities for practice with a device trainer may be useful strategies to reduce anxiety, avoid unnecessary experimentation, and improve adherence to injection therapy. While further studies are needed to generalize our findings, we posit that routine and ritual elements can be incorporated into existing patient-clinician interactions or novel digital interventions through mobile medical applications, smart training devices, and connected injection ecosystems. Keywords: training, drug delivery device, combination product, patient support, routines, rituals, burden of treatment, chronic disease, injection trainer, mixed methods research
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