Interface Analysis Associates, 1821 Saratoga Ave, Suite #200, Saratoga, CA, 95070, USA.
Medical Affairs Oncology and Long-Term Care, Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA.
Adv Ther. 2021 Jun;38(6):3129-3142. doi: 10.1007/s12325-021-01739-1. Epub 2021 May 4.
Octreotide acetate subcutaneous injection is indicated to treat acromegaly and the symptoms of carcinoid tumors and vasoactive intestinal peptide tumors (VIPomas). This formative human factors study assessed the octreotide acetate pen injector and accompanying instructions for use (IFU) with self-trained participants.
The study enrolled patients with diagnoses of acromegaly, carcinoid tumors, or VIPomas and healthcare practitioners (HCPs) who treat patients with these diagnoses. The IFU provided a stepwise process with illustrations to train participants on using the pen injector. Participants familiarized themselves with the pen injector and the IFU before administering 2 unaided injections into skin-like pads; administering the full dose into the pad was considered a successful injection. The investigators evaluated each injection by performance measures-specific tasks necessary to safely and correctly administer the medication-and subjective measures, which included participant comments, feedback from questions, and suggestions for improvements.
The study enrolled 11 participants-8 patients and 3 HCPs. Participants had a success rate of 100% for both injections. Errors included 1 participant priming the pen with the incorrect dose and 2 participants not holding the injector button for 10 s after the injection. Neither error led to a failed injection. To improve the IFU, participants suggested changing the order of wording on the priming step, clarifying illustrations of the plunger, and stronger indications to hold the injector button.
The octreotide pen injector and IFU were usable by self-trained participants. Participant errors and suggestions provided a foundation for recommendations to improve the IFU.
醋酸奥曲肽皮下注射适用于治疗肢端肥大症和类癌瘤以及血管活性肠肽瘤（VIP 瘤）的症状。这项形成性人体因素研究评估了醋酸奥曲肽笔式注射器及其随附的使用说明书（IFU），参与者是自行接受培训的。
该研究招募了诊断为肢端肥大症、类癌瘤或 VIP 瘤的患者和治疗这些诊断患者的医疗保健从业者（HCP）。IFU 提供了一个分步过程，并附有插图，以培训参与者使用笔式注射器。在进行 2 次无辅助的皮肤样垫内注射之前，参与者熟悉笔式注射器和 IFU；将全剂量注入垫内被认为是成功的注射。研究人员通过特定于性能措施的任务评估每次注射，这些任务对于安全和正确给药是必要的，还评估了主观措施，包括参与者的意见、问题反馈和改进建议。
该研究共招募了 11 名参与者-8 名患者和 3 名 HCP。所有参与者的两次注射成功率均为 100%。错误包括 1 名参与者在预充时使用了错误的剂量，2 名参与者在注射后未按住注射器按钮 10 秒。这两个错误都没有导致注射失败。为了改进 IFU，参与者建议改变预充步骤中的措辞顺序，澄清活塞的插图，并加强按压注射器按钮的指示。
奥曲肽笔式注射器和 IFU 可由自行接受培训的参与者使用。参与者的错误和建议为改进 IFU 提供了依据。
