评估欧洲医生对玻璃体腔内注射阿布西普的安全知识和安全使用信息:在传播最新的风险最小化材料后对医生的第二次调查。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2024-01-01 Epub Date: 2023-12-05 DOI:10.1007/s40290-023-00506-7
Laurie J Zografos, Elizabeth Andrews, Dan L Wolin, Brian Calingaert, Eric K Davenport, Alexander Michel, Margarete Latocha, Ursula Maria Schmidt-Ott, Nejra Lovic, Lynne R Brunck, Kristian T Johnson, Kiliana Suzart-Woischnik
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引用次数: 0

摘要

背景:作为IVT-AFL风险最小化计划的一部分,已经在欧盟分发了材料,告知医生关于玻璃体内afliberept (IVT-AFL)的安全使用。目的:我们旨在衡量医生对IVT-AFL关键安全信息的知识和理解。方法:目前的研究是对早期调查(第1波)的后续横断面调查(第2波),通过评估医生对关键安全信息的了解来检查IVT-AFL教育材料的有效性。根据第一阶段的结果,对教育材料进行了修订,使其更侧重于主要关注的项目(例如,在有生育能力的妇女中使用、程序资料);法国、德国、意大利、西班牙和英国的医生完成了一份调查问卷,以评估他们对修订教材中关键安全信息的了解程度。结果:454名受访医师(4715名;应答率9.6%),大多数报告收到了IVT-AFL产品特性摘要(SmPC;89%)和处方指南(82%)。超过一半的患者报告收到了注射过程视频(54%)和患者手册(65%)。正确率最高的是教育材料和SmPC强调的程序步骤、最重要的风险和安全使用问题。结论:医生对IVT-AFL安全使用的知识和理解,包括促使修订教材的问题,表明需要重新考虑教材的开发方法,以遵循最佳实践(例如,只关注关键信息和与最终用户进行预测试)。
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Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials.

Background: Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IVT-AFL) as part of the risk-minimization plan for IVT-AFL.

Objective: We aimed to measure physician knowledge and understanding of key safety information for IVT-AFL.

Methods: The current study was a follow-up cross-sectional survey ('wave 2') to an earlier survey ('wave 1') examining the effectiveness of the IVT-AFL educational materials by assessing physician knowledge of the key safety information. Based on wave 1 results, the educational materials were revised to focus more on items of key concern (e.g., use in women of childbearing potential, procedural information); physicians in France, Germany, Italy, Spain, and the UK completed a questionnaire to evaluate their knowledge of key safety information in the revised educational materials.

Results: Among 454 physician respondents (of 4715 invited; response rate 9.6%), most reported having received the IVT-AFL Summary of Product Characteristics (SmPC; 89%) and Prescriber Guide (82%). More than half reported receiving the Injection Procedure Video (54%) and Patient Booklet (65%). The highest percentage of correct answers was observed for questions concerning procedural steps, the most important risks, and safe use as emphasized by the educational materials and the SmPC.

Conclusion: Physician knowledge and understanding of safe use of IVT-AFL, including for questions that prompted revisions to the educational materials, suggests the need to reconsider methods for developing educational materials to follow best practices (e.g., focusing on only key messages and pretesting with end users).

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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