Laboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy, Porto University, Porto, Portugal.
Int J Clin Pharm. 2013 Aug;35(4):560-9. doi: 10.1007/s11096-012-9746-8. Epub 2013 Jun 2.
Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB.
To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use.
Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created.
A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed better but performance was inconsistent at subsections level, within the same DB.
The method developed allows quantification of the inclusion of relevant information items in DB and comparison with an "ideal database". It is necessary to consult diverse DB in order to find all the relevant information needed to support clinical drug use.
循证实践要求医疗决策基于最佳可用证据。“信息掌控”模式提出，临床医生应使用已评估相关性和有效性的信息源，并在护理点提供。药物数据库（DB）允许轻松快速地获取信息，并具有更频繁的内容更新的优势。在药物治疗方面，相关信息是支持安全有效使用药物的信息。因此，欧洲药品说明书概要（EG-SmPC）被用作评估 DB 中包含相关信息内容的标准。
开发和测试一种评估 DB 内容相关性的方法，通过评估被认为与有效和安全药物使用相关的信息项目的纳入情况。
对 EG-SmPC 中定义的原则进行层次组织和选择；定义评估所选信息项目纳入情况的标准；创建一个分类和量化系统，允许计算分数；计算分数的相对差异（RD），以便与“理想”数据库进行比较，该数据库定义为在每个信息项目中实现最佳量化的数据库；对 9 种药物数据库进行试点测试，使用文献中经常与发病率和死亡率相关的 10 种药物，以及在葡萄牙广泛使用的药物。主要观察指标：使用创建的分类和量化系统，计算药物专论中临床相关信息项目的个体和总体分数。
A--方法开发：选择部分、小节、相关信息项目和相应的要求；分类和量化系统；分数和 RD 计算程序。B--试点测试：计算了 9 种数据库的分数；总体而言，所有评估的数据库与“理想”数据库显著不同；一些 DB 表现更好，但在同一 DB 中，各小节的表现不一致。
所开发的方法允许对 DB 中相关信息项目的纳入情况进行量化，并与“理想数据库”进行比较。为了找到支持临床药物使用所需的所有相关信息，有必要查阅多种 DB。
