Objective: The research evaluated the differences in formatting of adverse drug reaction (ADR) information in drug monographs in commonly used drug information (DI) databases. Methods: A cross-sectional analysis of formatting of ADR information for twenty commonly prescribed oral medications in seven commonly used DI databases was performed. Databases were assessed for presentation of ADR information, including presence of placebo comparisons, severity of ADR, onset of ADR, formatting of ADRs in percentile (quantitative) format or qualitative format, whether references were used to cite information, whether ADRs are grouped by organ system, and word count of the ADR section. Data were collected by two study investigators and discrepancies were resolved via consensus. Chi-square analyses and one-way analysis of variance (ANOVA) were used to evaluate for mean group differences in categorical and continuous data, respectively. Results: The seven DI databases varied significantly on each analyzed ADR variable, including variables known to impact interpretation such as placebo comparisons and qualitative versus quantitative formatting. Placebo comparisons were most common among monographs in Micromedex In-Depth Answers (70%) but were absent among monographs in Epocrates, Lexicomp, and Micromedex. Quantitative information was commonly used in most databases but was absent in Epocrates. Average word counts were higher in Clinical Pharmacology and Micromedex In-Depth answers compared to other databases. Conclusion: Substantial variation in ADR formatting exists between the most common DI databases. These differences may translate into alternative interpretations of medical information and, thus, impact clinical judgment. Further studies are needed to assess whether these differences impact clinical practice.

中文翻译：

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药品信息数据库中药品不良反应格式的评价

目的：本研究评估了常用药物信息（DI）数据库中药物专着中药物不良反应（ADR）信息格式的差异。方法：对七个常用 DI 数据库中 20 种常用口服药物的 ADR 信息格式进行横断面分析。评估数据库的 ADR 信息，包括安慰剂比较的存在、ADR 的严重性、ADR 的发生、百分位（定量）格式或定性格式的 ADR 格式、参考文献是否用于引用信息、ADR 是否按器官分组系统和 ADR 部分的字数。数据由两名研究调查人员收集，差异通过共识解决。卡方分析和单因素方差分析 (ANOVA) 分别用于评估分类数据和连续数据中的平均组差异。结果：七个 DI 数据库在每个分析的 ADR 变量上都有显着差异，包括已知会影响解释的变量，例如安慰剂比较和定性与定量格式。安慰剂比较在 Micromedex In-Depth Answers 的专着中最为常见（70%），但在 Epocrates、Lexicomp 和 Micromedex 的专着中则没有。定量信息在大多数数据库中普遍使用，但在 Epocrates 中没有。与其他数据库相比，Clinical Pharmacology 和 Micromedex In-Depth 答案的平均字数更高。结论：最常见的 DI 数据库之间存在 ADR 格式的巨大差异。这些差异可能会转化为对医学信息的替代解释，从而影响临床判断。需要进一步的研究来评估这些差异是否会影响临床实践。