A new pen device for injection of recombinant human growth hormone: a convenience, functionality and usability evaluation study

Sauer, Maritta; Abbotts, Carole

doi:10.2147/ppa.s149412

Cited by 5 publications

(8 citation statements)

References 9 publications

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“…The new pen device incorporates several features that are designed to improve the user experience, such as an aluminum body, a multi-use cartridge system, cartridge viewing and dose display windows, a rotating dose selection knob, and an injection button. This evaluation showed that the pen device and associated materials could be used safely and effectively by the intended users, similar to the outcome reported after the functionality and ease of use testing of the pen device [10]. The testing process presented here is consistent with other usability engineering assessments for pen devices [17][18][19][20].…”

Section: Discussionsupporting

confidence: 81%

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A pen device for injection of recombinant human growth hormone: a European usability engineering study

Cachemaille

Warren

Moss

2020

Expert Opinion on Drug Delivery

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Objective: The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. Research design and methods: Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. Results: Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. Conclusions: The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

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Section: Discussionsupporting

confidence: 81%

“…The Aluetta™ pen device is a reusable, multi-dose injection pen for use with r-hGH (Somatropin [Saizen®], Merck KGaA, Darmstadt, Germany) [10]. The new pen device was designed to provide an easy to use, lightweight, reusable, multi-dose injection device for patients injecting Saizen®.…”

Section: Introductionmentioning

confidence: 99%

A pen device for injection of recombinant human growth hormone: a European usability engineering study

Cachemaille

Warren

Moss

2020

Expert Opinion on Drug Delivery

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“… 21 The widespread acceptance of pre-filled injection devices is, therefore, driven by a range of benefits including convenience, simplicity, suitability for home use, reduction in wasted products and associated environmental benefits, and greater dose precision. 12 , 13 , 19 , 20 …”

Section: Discussionmentioning

confidence: 99%

“…In the current study, a list of attributes of a pre-filled gonadotropin self-injection pen device was prepared which contained a total of 14 options ( Table 1 ). The options were selected to reflect standard attributes investigated in prior research and similar publications examining pre-filled injection pens 13 , 20 , 21 and were validated by feedback obtained from fertility specialist nurses regarding features of pen devices that were considered to be of greatest importance. Attributes were intended to cover key areas including training, injection preparation, injection experience, how the injection fits into the patient’s daily routine and the overall appearance/look of the injection pen.…”

Section: Methodsmentioning

confidence: 99%

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR®)

Mesmaeker¹,

Calles²,

Smith³

2023

PPA

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Purpose This study aimed to identify the most important attributes for a gonadotropin pen as perceived by assisted reproductive technology (ART) patients and fertility nurses, and to examine how well a prototype HP-hMG (MENOPUR ® ) pen reflects these preferences. Patients and Methods This market research study incorporated a two-part survey with respondents (N=221) from Poland, Spain and the UK. Respondents included patients (n=141) who consulted a fertility specialist in the previous 2 years, and fertility nurses (n=80) who assisted in at least 75 ART cycles/year. Patients were divided into two subgroups depending on their experience with ART (experienced and naïve). Key attributes for an injection pen, as perceived by patients and nurses, were assessed via an online survey and ranked by their relative importance using Anchored Maximum Difference Scaling. After performing a dummy injection, respondents compared the attributes of an unbranded prototype pen against the key attributes identified. Results Across all survey respondents, the ability to correct the dialed dose was considered to be the most important product attribute of a gonadotropin pen. Confidence in the patient’s ability to inject correctly at home was also identified as a key attribute, considered by both nurses and naïve patients as extremely high. When considering the prototype pen device, almost all study respondents reported a positive experience (99%) with 72% rating it as “very good”. The prototype pen was perceived to possess the key attributes considered important for a gonadotropin pen by patients and nurses, including correcting the dose, the ability to self-inject safely and correctly, ease of preparation and use, and an injection which appeared to be as painless as possible. Conclusion The prototype pen was found to perform well across all key attributes, especially those considered most important in gonadotropin pens, suggesting that it is a user-friendly option for patients undergoing ART.

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“…5 Prefilled syringes ensure accurate dosing, sterility, and improved safety. 6 Consequently, the development of self-injection devices has improved patient acceptance of injections, ease of use compared with the conventional needle and syringe, 7 and patient experience and preference. 8 Newer autoinjector technologies are designed to further ease patient burden, facilitate self-injection, and improve treatment adherence and convenience; 6,8 these are considered by healthcare professionals to be advantageous to manual syringe injections.…”

Section: Introductionmentioning

confidence: 99%

<p>Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine</p>

Mead¹,

Dammerman²,

Rasmussen³

2020

PPA

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Purpose: Erenumab-aooe (erenumab, Aimovig ®)-a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) receptor-is approved for the prevention of migraine in adults in a number of countries. The approved monthly dosage of erenumab (70 and/or 140 mg, depending on the country) is available as a single, prefilled autoinjector for subcutaneous administration in most countries where it is approved. This study evaluated the patient-reported ease-of-use, ability to learn self-injection, confidence in performing a simulated self-injection, and ergonomics of a prefilled autoinjector device for erenumab (SureClick ® autoinjector) in individuals in the US with migraine. Patients and Methods: Participants with migraine headaches, all of whom were naïve to the use of an autoinjector for migraine or another condition and CGRP therapy, were recruited from three US-based headache centers. Each participant received a supervised demonstration of the autoinjector during a 30-minute one-on-one session using a standard protocol-driven script. Participants then practiced a simulated injection into an artificial tissue pad using the autoinjector and were asked to rate their agreement with 19 statements about the device on a 5-point Likert scale (1 = completely disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = completely agree). Results: Participants who completed the study and provided responses (n = 204) were between 21 and 85 years of age, inclusive, and 73% were female. More than 90% of the participants completely or somewhat agreed with 16/19 statements relating to the device, including ease-of-use, ability to self-inject, and confidence in using the device, with an average rating of >4.5 on the 5-point Likert scale. Participants rated the size of the device and the compactness of the device as 4.23/5 and 4.26/5, respectively. Conclusion: The erenumab-prefilled disposable autoinjector was consistently highly rated across categories by individuals with migraine, with an average rating of >4.5 on the 5-point Likert scale; results were consistent across the three study centers.

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A new pen device for injection of recombinant human growth hormone: a convenience, functionality and usability evaluation study

Cited by 5 publications

References 9 publications

A pen device for injection of recombinant human growth hormone: a European usability engineering study

A pen device for injection of recombinant human growth hormone: a European usability engineering study

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR®)

<p>Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine</p>

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