Comparative effectiveness of patient-centered strategies to improve FDA medication guides.
Comparative effectiveness of patient-centered strategies to improve FDA medication guides.
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以患者为中心的策略改进 FDA 用药指南的比较有效性。
DOI：
10.1097/mlr.0000000000000182
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发表时间：
2014
期刊：
影响因子：
3
通讯作者：
Lambert,Bruce
中科院分区：
文献类型：
--
作者：
Wolf,MichaelS;Bailey,StacyC;Serper,Marina;Smith,Meredith;Davis,TerryC;Russell,AllisonL;Manzoor,BeenishS;Belter,Lisa;Parker,RuthM;Lambert,Bruce
背景：医学指南是唯一的食品和药物管理局监管的书面病人信息来源与处方药一起分发。尽管他们的潜在价值，研究发现他们有有限的效用。目的：为了评估以患者为中心的策略的有效性，设计医学指南，以提高理解。设计：横断面，随机试验。设置：两个初级保健诊所在芝加哥，伊利诺伊州;一个在公立大学医院和私人学术医疗中心内的其他。患者：共1003名成人年龄在18 - 85岁。干预：3种典型医学指南内容的格式和布局（按阅读难度、长度、曝光度）进行了几种方式的修改，以促进信息的可及性。与患者合作，评估了3个最首选的版本。第一个使用2列来组织内容（列），第二个模仿了非处方药的“药物事实”标签（药物事实），第三个遵循健康素养的最佳做法，使用一个简单的表格格式（健康素养原型）。措施：量身定制的理解评估的内容，从3个代表性的Med Guides.Results：理解是显着更大的所有3个原型相比，目前的标准（所有P <0.001）。健康素养原型始终表现出最高的理解得分，在多变量分析中，优于药物事实[β = − 4.43，95%置信区间（CI），− 6.21至− 2.66]和列（β = − 4.04，95% CI，− 5.82至− 2.26）原型。两人年纪都比较大（60岁以上：β =-10.54，95%CI，-15.12至-5.96），低水平和边缘识字技能与理解力较差独立相关（低：β = − 31.92，95% CI，− 35.72至− 28.12;边缘：β = − 12.91，95% CI，− 16.01至− 9.82）。应用循证医学实践重新设计的医疗指南显着提高了患者的理解。虽然一些年龄和识字率的差异减少了健康素养的格式，特别是，年龄较大和低识字率仍然独立与较差的理解。可能需要更积极的策略来确保所有患者都被告知他们的处方药物。试验注册：临床试验。Gov #NCT 01731405.美国食品药品监督管理局（FDA）要求制药行业开发和传播消费者友好的、有形的药物信息材料，称为"药物指南"（Med Guides），用于被认为具有"严重和重大公共健康问题"的处方药。1，2 Med Guides是FDA“风险评估和缓解策略”（又名REMS）的重要组成部分，也是极少数强制性保证之一，即患者在使用前收到处方药的安全信息，可能会防止严重的不良反应。3，4这些材料还传达了正确的药物依从性的重要性，以实现最佳的健康益处。医学指南的价值进一步强调了研究表明，医生和药剂师经常错过机会，以咨询病人适当使用处方药和相关的风险。5–8
Background:Med Guides are the only Food and Drug Administration-regulated source of written patient information distributed with prescriptions drugs. Despite their potential value, studies have found them to have limited utility.Objective:To evaluate the effectiveness of patient-centered strategies for the design of Med Guides to improve comprehension.Design:A cross-sectional, randomized trial.Setting:Two primary care clinics in Chicago, Illinois; one based in a public university hospital and the other within a private academic medical center.Patients:A total of 1003 adults aged 18–85 years.Intervention:The format and layout of content from 3 typical Med Guides (by reading difficulty, length, exposure) were modified several ways to promote information accessibility. Working with patients, the 3 most preferred versions were evaluated. The first used 2 columns to organize content (Column), a second mimicked over-the-counter “Drug Facts” labeling (Drug Facts), and the third followed health literacy best practices using a simple table format (Health Literacy prototype).Measures:Tailored comprehension assessment of content from 3 representative Med Guides.Results:Comprehension was significantly greater for all 3 prototypes compared with the current standard (all P< 0.001). The Health Literacy prototype consistently demonstrated the highest comprehension scores, and in multivariable analyses, outperformed both the Drug Facts [β=− 4.43, 95% confidence interval (CI),− 6.21 to− 2.66] and Column (β=− 4.04, 95% CI,− 5.82 to− 2.26) prototypes. Both older age (older than 60 y: β=− 10.54, 95% CI,− 15.12 to− 5.96), low and marginal literacy skills were independently associated with poorer comprehension (low: β=− 31.92, 95% CI,− 35.72 to− 28.12; marginal: β=− 12.91, 95% CI,− 16.01 to− 9.82).Conclusions:The application of evidence-based practices to the redesign of Med Guides significantly improved patient comprehension. Although some age and literacy disparities were reduced with the Health Literacy format in particular, both older age and low literacy remained independently associated with poorer comprehension. More aggressive strategies will likely be needed to gain assurances that all patients are informed about their prescribed medications.Trial Registration:Clinical Trials. Gov# NCT01731405.The Food and Drug Administration (FDA) requires the pharmaceutical industry to develop and disseminate consumer-friendly, tangible medication information materials, known as “Medication Guides”(Med Guides) for prescription drugs that are deemed to possess “serious and significant public health concerns.” 1, 2 Med Guides are an essential part of the FDA’s “risk evaluation and mitigation strategies”(aka REMS) and one of the very few mandated assurances that patients receive a prescribed drug’s safety information before use, potentially preventing serious adverse effects. 3, 4 These materials also convey the importance of proper medication adherence to achieve optimal health benefits. The value of Med Guides is further underscored by research showing that both physicians and pharmacists frequently miss opportunities to counsel patients on appropriate use of prescribed medications and associated risks. 5–8