Disproportionality analyses of spontaneous reports.
Disproportionality analyses of spontaneous reports.
复制标题
自发报告的不成比例分析。
DOI：
10.1002/pds.995
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发表时间：
2004
影响因子：
2.6
通讯作者：
Hennessy,Sean
中科院分区：
文献类型：
--
作者：
Hennessy,Sean
病例报告和病例系列被广泛认为对提出假设有用，以便在随后的对照研究中进行检验，但通常不足以构成因果关系的令人信服的证据。然而，病例报告的发表很常见，似乎很少引起人们的关注，即它助长了对特定因果关系的毫无根据的信念。这大概是因为人们普遍认识到病例报告的可解释性有限。执行药物警戒的人员有时会对来自自发报告系统的数据进行定量分析，作为对个别病例报告进行定性检查的补充。例如，对于给定的药物，可以计算特定事件的相对频率与该药物报告的所有事件的相对频率，除以其他药物的相应数量。如果频率以比例表示，则该比例为比例报告比（PRR）；如果以赔率表示，则该比率为报告赔率比（ROR）。PRR和ROR统称为歧化度量。在其他地方讨论了PRR与ROR的相对优点。2 - 4
Case reports and case series are widely regarded as useful for raising hypotheses to be tested in subsequent controlled studies, but generally insufficient to constitute convincing evidence of a cause-effect relationship. Nevertheless, publication of case reports is common and seems to evoke little concern that it fosters unfounded beliefs about particular cause-effect relationships. This is presumably because of the widespread recognition of the limited interpretability of case reports.Those performing pharmacovigilance sometimes perform quantitative analyses of data from spontaneous reporting systems as a supplement to qualitatively examining individual case reports. For example, one can calculate, for a given drug, the relative frequency of a specific event versus all events reported for that drug, divided by the corresponding quantity for other drugs. If the frequencies are expressed as proportions, then this ratio is the proportional reporting ratio (PRR); 1 if expressed as odds, then the ratio is the reporting odds ratio (ROR). 2, 3 Collectively, the PRR and ROR are known as disproportionality measures. The relative merits of the PRR versus the ROR are discussed elsewhere. 2–4