Smith P, Arnesen H
Red Cross Clinic, Oslo, Norway.
J Intern Med. 1990 Sep;228(3):253-6. doi: 10.1111/j.1365-2796.1990.tb00227.x.
Follow-up of 270 subjects who declined to participate in a trial of oral anticoagulant therapy after acute myocardial infarction revealed a higher mortality (25.6%) than that for participants in the placebo group (20.2%). The excess mortality in terms of odds ratios was 1.35 (90% confidence interval 1.02-1.79). Age was the only predictor of death. The event rate from ischaemic cardiovascular disease was lower among non-consenters than among participants (49.3% vs. 74.8%), as was the rate of death during the first year of follow-up. In conclusion, the differing mortality and dissimilar patterns of specific causes of death in non-consenters and placebo-treated participants emphasize the need for caution in extrapolation of treatment effects to the non-consenting group. Thus the size of the non-consenting group has implications for generalization of the overall results.
对270名在急性心肌梗死后拒绝参与口服抗凝治疗试验的受试者进行随访发现，其死亡率（25.6%）高于安慰剂组受试者（20.2%）。就优势比而言，额外死亡率为1.35（90%置信区间1.02 - 1.79）。年龄是唯一的死亡预测因素。缺血性心血管疾病的事件发生率在不同意参与者中低于参与者（49.3%对74.8%），随访第一年的死亡率也是如此。总之，不同意参与者与接受安慰剂治疗参与者在死亡率及特定死因模式上的差异，强调了在将治疗效果外推至不同意组时需谨慎。因此，不同意组的规模对总体结果的推广有影响。
