Maghroudi Ekram, van Hooijdonk Charlotte M J, van Dijk Liset, Boland Gudule, de Haas Channah, Journée-Gilissen Marleen, van der Velden Janneke, Vervloet Marcia, Westerhof Henk, Rademakers Jany J D J M, Borgsteede Sander D
Department of Patient Information, Health Base Foundation, Houten, Netherlands.
Department of Family Medicine, Research School CAPHRI, Maastricht University, Maastricht, Netherlands.
Front Pharmacol. 2020 Jul 15;11:981. doi: 10.3389/fphar.2020.00981. eCollection 2020.
Patients receive information about their medication from different sources, including prescription labels. These labels are physically attached to each package dispensed to patients and contain the most important instructions on how to use the medication correctly. However, many patients experience difficulties in understanding and applying the instructions on these labels correctly, especially patients with limited health literacy. The aim of this study is to investigate the comprehensibility of prescription label instructions among patients with adequate and limited health literacy skills, and to implement improvements in primary health care.
We used a mixed-methods approach, which consisted of four phases. Phase 1 (desk research) was divided into a systematic literature review on the comprehensibility of prescription label instructions (1a) and a content analysis of the textual elements in Dutch prescription label instructions (1b). In phase 2 (patient studies), semi-structured interviews were conducted to investigate the comprehensibility of seven prescription labels among patients with different health literacy skills (2a), and a quantitative study in which the comprehensibility of six optimized prescription labels was compared among patients with different health literacy skills (2b). Patient studies were conducted in eight Dutch pharmacies. In phase 3 optimized prescription label instructions were implemented in national medication databases which has been supported by a guideline (3a), and education of pharmacy workers (3b). Phase 4 consists of evaluating the optimized prescription label instructions by experiences from patients and pharmacists.
This mixed-methods approach will result in scientific publications of the individual studies, and a guideline on how to compose comprehensible prescription label instructions to be put on medication packages. Optimized prescription label instructions will be implemented in national medication databases.
This protocol describes a mixed-method research to compose and implement comprehensible prescription label instructions and will lead to knowledge about the comprehensibility of textual elements in these labels, with specific attention for patients with limited health literacy. Implementation of optimized prescription label instructions will lead to a better understanding of them, which may contribute to improved medication adherence. A limitation is that non-textual aspects of prescription labels are not investigated.
患者从包括处方标签在内的不同来源获取有关其药物治疗的信息。这些标签实际贴在分发给患者的每个包装上，并包含有关正确使用药物的最重要说明。然而，许多患者在正确理解和应用这些标签上的说明时遇到困难，尤其是健康素养有限的患者。本研究的目的是调查具有足够和有限健康素养技能的患者对处方标签说明的可理解性，并在初级卫生保健中实施改进措施。
我们采用了一种混合方法，该方法包括四个阶段。第1阶段（案头研究）分为对处方标签说明可理解性的系统文献综述（1a）和对荷兰语处方标签说明中的文本元素的内容分析（1b）。在第2阶段（患者研究），进行了半结构化访谈，以调查不同健康素养技能的患者对七个处方标签的可理解性（2a），以及一项定量研究，比较不同健康素养技能的患者对六个优化处方标签的可理解性（2b）。患者研究在荷兰的八家药店进行。在第3阶段，在国家药物数据库中实施了优化的处方标签说明，并得到了一项指南的支持（3a），同时对药剂工作人员进行了培训（3b）。第4阶段包括通过患者和药剂师的经验评估优化的处方标签说明。
这种混合方法将产生各个研究的科学出版物，以及一份关于如何编写可理解的处方标签说明以贴在药品包装上的指南。优化的处方标签说明将在国家药物数据库中实施。
本方案描述了一项混合方法研究，以编写和实施可理解的处方标签说明，并将产生有关这些标签中文本元素可理解性的知识，特别关注健康素养有限的患者。实施优化的处方标签说明将导致对其有更好的理解，这可能有助于提高药物治疗的依从性。一个局限性是未对处方标签的非文本方面进行调查。
