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用于评估药物不良反应的三种算法的比较。

Comparison of three algorithms used to evaluate adverse drug reactions.

作者信息

Michel D J, Knodel L C

出版信息

Am J Hosp Pharm. 1986 Jul;43(7):1709-14.

PMID:3752106
Abstract

The consistency of three algorithms in evaluating adverse drug reactions (ADRs) was studied. As part of a hospital's ADR protocol, doctor of pharmacy students were required to collect and summarize all ADR data. Algorithms by Kramer, Naranjo, and Jones were used to evaluate all ADRs between January and May 1984. Kramer's algorithm was used for every reported ADR; Naranjo's and Jones' algorithms were used to check consistency in scoring among ADRs already scored with the Kramer algorithm. The two numerical scales (Kramer and Naranjo) were compared using linear regression. The results of all three algorithms were translated into categories of suspicion (A = definite or probable; B = probable; C = possible; and D = unlikely, doubtful, or remote) and evaluated for consistency with a weighted kappa (kw) statistical test. A total of 28 ADRs were evaluated, and the correlation (r = 0.87) between the total numerical scores of the Kramer and Naranjo algorithms was significant. Comparison of the Kramer and Naranjo algorithms showed 67% agreement with a kw value of 0.43 (-1 = perfect disagreement and +1 = perfect agreement). Similarly, there was 67% agreement (kw = 0.48) between Kramer's algorithm and Jones' algorithm. Agreement between Naranjo's and Jones's algorithms was 64%, but the kw value was only 0.28. The simpler and less time-consuming Naranjo algorithm compared favorably with the Kramer algorithm in scoring ADRs; more data are needed to support the use of the Jones algorithm.

摘要

研究了三种评估药物不良反应(ADR)算法的一致性。作为医院ADR方案的一部分,要求药学专业学生收集并汇总所有ADR数据。使用Kramer、Naranjo和Jones算法评估1984年1月至5月期间的所有ADR。对每例报告的ADR使用Kramer算法;使用Naranjo和Jones算法检查已用Kramer算法评分的ADR之间评分的一致性。使用线性回归比较两种数值量表(Kramer和Naranjo)。将所有三种算法的结果转化为怀疑类别(A = 肯定或很可能;B = 很可能;C = 可能;D = 不太可能、可疑或可能性极小),并通过加权kappa(kw)统计检验评估一致性。共评估了28例ADR,Kramer和Naranjo算法的总数值评分之间的相关性(r = 0.87)具有显著性。Kramer和Naranjo算法的比较显示一致性为67%,kw值为0.43(-1 = 完全不一致,+1 = 完全一致)。同样,Kramer算法和Jones算法之间的一致性为67%(kw = 0.48)。Naranjo算法和Jones算法之间的一致性为64%,但kw值仅为0.28。在对ADR评分方面,更简单且耗时更少的Naranjo算法与Kramer算法相比具有优势;需要更多数据来支持Jones算法的使用。

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