Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use
Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use
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DOI：
10.1016/j.cct.2010.07.004
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发表时间：
2010-11-01
影响因子：
2.2
通讯作者：
Wolf, Michael S.
中科院分区：
文献类型：
--
作者：
Shrank, William H.;Parker, Ruth;Wolf, Michael S.
背景：用药错误是一个重要的公共卫生问题，而对药物标签的理解不足是一个根本原因。研究表明，标签是可变的，质量很差，而且不是以患者为中心。没有真实世界的试验评估改进的药物标签是否可以影响适当的用药、依从性或健康结果。试验设计：我们开发了一种基于证据的处方标签，既涉及内容又涉及格式。改进后的标签包括通用用药时间表(UMS)，它标准化了使用说明，包括1)标准给药时间段(早上、中午、晚上和就寝时间)，2)数字与字母字符，3)分开每日剂量的“回车”，以及4)直观地描述剂量和频率的图形辅助。我们将评估向随机抽样的患者提供这一标签的效果，这些患者从北弗吉尼亚州的免费诊所、流动面包车和联邦合格的健康中心(FQHC)接受护理。我们将招募糖尿病或高血压患者；这些患者将被随机分配到所有标签改进的药物治疗或接受标准标签的处方。主要结果将是患者正确演示剂量说明的能力。其他结果包括依从性、错误率和健康结果。结论：据我们所知，这项试验是第一次在临床环境中评估处方标签改进对理解、用药和结果的影响。如果成功，这些发现可以被广泛应用，以促进安全和适当的药物使用，并支持制定标签的循证标准。(C)2010 Elsevier Inc.保留所有权利。
Background: Medication errors are an important public health concern, and poor understanding of medication labels are a root cause. Research shows that labels are variable, of poor quality, and not patient-centered. No real-world trials have evaluated whether improved medication labels can affect appropriate medication use, adherence or health outcomes.Trial design: We developed an evidence-based prescription label that addresses both content and format. The enhanced label includes a universal medication schedule (UMS) that standardizes the directions for use incorporating 1) standard time periods for administration (morning, noon, evening, and bedtime), 2) numeric vs. alpha characters, 3) 'carriage returns' to separate daily dose and 4) a graphic aid to visually depict dose and frequency. We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics, mobile vans and federally qualified health centers (FQHCs) in Northern Virginia. We will recruit patients with diabetes or hypertension; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels. The primary outcome will be the patient's ability to correctly demonstrate dosing instructions. Other outcomes include adherence, error rates and health outcomes.Conclusion: To our knowledge, this trial is the first to evaluate the effect of prescription label improvement on understanding, medication use and outcomes in a clinical setting. If successful, these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels. (C) 2010 Elsevier Inc. All rights reserved.