School of Education, Languages and Linguistics, Faculty of Humanities and Social Sciences, University of Portsmouth, Park Building, King Henry I St., Portsmouth PO1 2BZ, UK.
Int J Environ Res Public Health. 2024 Sep 29;21(10):1301. doi: 10.3390/ijerph21101301.
Patient information leaflets (PILs) are essential tools in healthcare, providing crucial information about medication use. In the European Union, the European Medicines Agency (EMA) oversees the regulation and standardisation of PILs to ensure their readability and accessibility. However, challenges persist in ensuring these documents are comprehensible and user-friendly. This study employs a qualitative analytical approach, reviewing existing literature and regulatory documents to identify gaps in the EU user testing policies for PILs. It focuses on the diversity of participant samples, the independence of the testing process, and the robustness of user testing protocols. Findings indicate that current user testing practices often lack diversity and may be biased when pharmaceutical companies conduct their own tests. Additionally, there is a lack of user testing protocols for translated PILs, potentially compromising their accuracy and cultural relevance. To improve the efficacy of PILs, it is essential to include diverse and representative samples in user testing, mandate independent third-party evaluations, implement protocols for user testing on translated PILs, and ensure continuous updates to guidelines based on the latest best practices in health communication. These measures will enhance patient safety and understanding of medication information.
患者信息手册（PILs）是医疗保健中必不可少的工具，提供了关于药物使用的重要信息。在欧盟，欧洲药品管理局（EMA）负责监管和规范 PILs，以确保其可读性和可及性。然而，在确保这些文件易懂且便于用户使用方面仍然存在挑战。本研究采用定性分析方法，审查现有文献和监管文件，以确定 PIL 用户测试政策在欧盟存在的差距。它侧重于参与者样本的多样性、测试过程的独立性以及用户测试协议的稳健性。研究结果表明，目前的用户测试实践往往缺乏多样性，并且制药公司进行自己的测试时可能存在偏见。此外，对于翻译后的 PIL，缺乏用户测试协议，可能会影响其准确性和文化相关性。为了提高 PIL 的效果，在用户测试中纳入多样化和有代表性的样本、强制进行独立的第三方评估、为翻译后的 PIL 实施用户测试协议以及根据健康传播的最新最佳实践不断更新指南至关重要。这些措施将提高患者安全性和对药物信息的理解。
