A METHOD FOR ESTIMATING THE PROBABILITY OF ADVERSE DRUG-REACTIONS
A METHOD FOR ESTIMATING THE PROBABILITY OF ADVERSE DRUG-REACTIONS
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DOI：
10.1038/clpt.1981.154
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发表时间：
1981-01-01
影响因子：
6.7
通讯作者：
GREENBLATT, DJ
中科院分区：
文献类型：
--
作者：
NARANJO, CA;BUSTO, U;GREENBLATT, DJ
对一种药物引起不良临床事件的概率的估计通常基于临床判断。缺乏一种确定因果关系的方法会在评估中产生很大的评分者之间和评价者内部的差异。按照确定的、可能的、可能的和可疑的药物不良反应(ADR)的常规分类和定义，2名医生和4名药剂师对随机抽取的63例疑似ADR进行独立评估，评价者之间的符合率为38-63%，kappa(一个机会校正的一致性指数)在0.21-0.40之间，组内相关可靠性系数(R[Est])为0.49。6周(测试)和22周(重测)后，相同的观察者通过为在建立药物(S)和不良事件(例如，时间序列)之间的因果关系时必须考虑的每个成分分配加权分数(ADR概率量表)来独立地重新分析63个病例。这些病例被随机分组，以最大限度地减少学习的影响。从总分中为该事件分配了一个概率类别。评价者之间的信度(范围：符合百分比=83-92%；kappa=0.69-0.86；r=0.91-0.95；R(Est)=0.92)和评价者内信度(范围：符合百分比=80-97%；kappa)。R=0.001.91~0.98)。重测维持评分者间信度(范围：R=0.84-0.94；R(Est)=0.87)。3名主治医师独立评估其他28例前瞻性收集的ADR病例的评分者之间的可靠性非常高(范围：R=0.76-0.87；R(EST)=0.80)。ADR概率量表具有共识效度、内容效度和同时效度。这种系统的方法为ADR的监测提供了一种灵敏的方法，可能适用于上市后的药物监测。
The estimation of the probability that a drug caused an adverse clinical event is usually based on clinical judgment. Lack of a method for establishing causality generates large between-raters and within-raters variability in assessment. Using the conventional categories and definitions of definite, probable, possible and doubtful adverse drug reactions (ADR), the between-raters agreement of 2 physicians and 4 pharmacists who independently assessed 63 randomly selected alleged ADR was 38-63%, kappa (.kappa., a chance-corrected index of agreement) varied from 0.21-0.40 and the intraclass correlation coefficient of reliability (R[est]) was 0.49. Six (testing) and 22 wk (retesting) later the same observers independently reanalyzed the 63 cases by assigning a weighted score (ADR probability scale) to each of the components that must be considered in establishing causal associations between drug(s) and adverse events (e.g., temporal sequence). The cases were randomized to minimize the influence of learning. The event was assigned a probability category from the total score. The between-raters reliability (range: percent agreement = 83-92%; .kappa. = 0.69-0.86; r = 0.91-0.95; R(est) = 0.92) and within-raters reliability (range : percent agreement = 80-97%; .kappa. = 0.64-0.95; r = 0.91-0.98) improved (P < 0.001). The between-raters reliability was maintained on retesting (range : r = 0.84-0.94; R(est) = 0.87). The between-raters reliability of 3 attending physicians who independently assessed 28 other prospectively collected cases of alleged ADR was very high (range : r = 0.76-0.87; R(est) = 0.80). The ADR probability scale has consensual, content and concurrent validity. This systematic method offers a sensitive way to monitor ADR and may be applicable to postmarketing drug surveillance.