Rapola J M, Virtamo J, Korhonen P, Haapakoski J, Hartman A M, Edwards B K, Heinonen O P
National Public Health Institute, Helsinki, Finland.
Eur J Epidemiol. 1997 Feb;13(2):133-8. doi: 10.1023/a:1007380408729.
We validated diagnoses of acute myocardial infarction (AMI) and death from coronary heart disease (CHD) found in the Finnish National Hospital Discharge Register and the Register of Causes of Death from a sample of the 29,133 men participating in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. The cases were traced to hospitals and institutes performing medico-legal death cause examinations and all relevant information was collected. The cardiac events were re-evaluated according to the diagnostic criteria of the Finnish contribution to the WHO MONICA project, i.e. the FINMONICA criteria. Altogether 408 cases of non-fatal AMI (n = 217) and death from CHD (n = 191) were reviewed. In the re-evaluation 94% of them (95% confidence interval 92-96%) were diagnosed as either definite (57%) or possible (37%) AMI. Non-fatal cases were more often classified definite AMI in the review, whereas fatal cases were more often classified possible AMI. Age or trial supplementation group did not affect classification, and no secular trend was observed. In conclusion, the diagnoses of AMI and death from CHD in the registers were highly predictive of a true major coronary event defined by strict criteria, thus their use in endpoint assessment in epidemiological studies and clinical trials is justified.
我们对在芬兰国家医院出院登记册和死亡原因登记册中发现的急性心肌梗死(AMI)诊断以及冠心病(CHD)死亡情况进行了验证,这些数据来自参与α-生育酚、β-胡萝卜素癌症预防研究的29,133名男性样本。对病例进行追踪,找到进行法医死因检查的医院和机构,并收集了所有相关信息。根据芬兰对世界卫生组织MONICA项目的贡献所制定的诊断标准,即FINMONICA标准,对心脏事件进行了重新评估。总共对408例非致命性AMI(n = 217)和CHD死亡病例(n = 191)进行了审查。在重新评估中,其中94%(95%置信区间92 - 96%)被诊断为确诊(57%)或可能(37%)AMI。非致命病例在审查中更常被分类为确诊AMI,而致命病例更常被分类为可能AMI。年龄或试验补充组不影响分类,也未观察到长期趋势。总之,登记册中AMI和CHD死亡的诊断对于由严格标准定义的真正重大冠状动脉事件具有高度预测性,因此它们在流行病学研究和临床试验的终点评估中的应用是合理的。