1．Spontaneous Report Database and Case-control Studies / 薬剤疫学

ABSTRACT

In the current review, the relationship between the reporting odds ratio (ROR) and the case-control study is addressed.The proportional mortality ratio (PMR) obtained in the proportional mortality studies in the death registry cannot be regarded as the risk ratio (RR) in the cohort study, but, the mortality odds ratio (MOR) estimated by using deaths unrelated to the exposure as ‘controls’ can be regarded as the RR.In 2004, Rothman et al proposed to estimate the ROR which can be regarded as the RR by using proper ‘control events’ in the spontaneous reports database. However, in the study conducted in Japan where the RORs estimated from 20 ‘control events’ were compared with the RRs obtained from many ‘drug use investigations’, the ROR vs RR plots were so diverse.The author of the current review concludes that the study estimating the ROR in the spontaneous reports cannot be regarded as the case-control study as the case-control study should estimate the RR of the cohort study in the source population as the odds ratio (OR).The ‘disproportionality measures’ like the ROR in the spontaneous reports database should be used primarily to detect the signals of the association between a drug and an adverse outcome. However, spontaneous reports can contribute to the characterization of the adverse drug reactions and to determining the causal relationship as well. The methods of signal detection are evolving and it is hoped that Japanese researchers contribute to their further developments.