Abstract

Background

: This user experience study evaluated the suitability of single-use versus multi-dose follitropin alfa pen injectors for self-administration by women undergoing fertility treatment.

Methods

: Twenty-four fertility patients and 19 specialist nurses were recruited in four European countries to assess their use of Bemfola® (a single-use pen), Gonal-f®, and Ovaleap® (multi-use pens). Participants completed usability tests in which their performance in assembling and administering doses of each pen was assessed against defined critical steps for ensuring safe and correct administration.

Results

: Critical error rates among nurses were 4%, 40%, and 49% for Bemfola®, Ovaleap®, and Gonal-f®, respectively; and among patients were 7%, 16%, and 38%. The most frequently reported critical errors occurred with the multi-use pens and were incorrect/lack of priming and failure to check the dose window prior to setting a new dose. The need to ‘top up’ doses from a new pen or cartridge when a pen contained insufficient dose also caused errors. The single-use pens did not cause these errors. Overall, 63% of nurses and 67% of patients had most confidence in Bemfola® for correct dosing and self-administration.

Conclusions

: Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors.

中文翻译：

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ART治疗中剂量错误的风险：单次使用与多次使用的促卵泡激素阿尔法笔的用户体验

摘要

背景

：该用户体验研究评估了接受生育力治疗的妇女自我使用与多次使用促卵泡激素阿尔法笔式注射器的适应性。

方法

：在四个欧洲国家/地区招募了24名生育患者和19名专科护士，以评估他们对Bemfola®（单用笔），Gonal-f®和Ovaleap®（多用笔）的使用情况。参加者完成了可用性测试，其中按照确定的关键步骤评估了他们在组装和给药每支笔时的性能，以确保安全正确地给药。

结果

：Bemfola®，Ovaleap®和Gonal-f®的护士严重错误率分别为4％，40％和49％；分别为7％，16％和38％。最常报告的严重错误是多用笔发生的，是不正确的/没有灌注的，并且在设置新剂量之前无法检查剂量窗口。当笔的剂量不足时，需要从新的笔或墨盒中“补充”剂量，这也会导致错误。一次性笔不会引起这些错误。总体而言，63％的护士和67％的患者对Bemfola®的正确剂量和自我管理方式最有信心。

结论

：一次性笔比多功能笔需要更少的准备和管理步骤，并且相关的关键处理错误更少。