Mortality in non-consenters in a post-myocardial infarction trial.
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.
Red Cross Clinic, Oslo, Norway.
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P
Smith
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H
Arnesen
D000367:Age Factors; D000368:Aged; D002423:Cause of Death; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality*; D009664:Norway / Q000453:epidemiology; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012044:Regression Analysis; D012307:Risk Factors; D015996:Survival Rate; D014859:Warfarin / Q000627:therapeutic use
D014859:Warfarin