Learning From Mistakes: The Case of Clinical Electrophysiology

Since the time of Claude Bernard, progress has been based on medical evidence. Today, however, statistical findings increasingly prevail over the spirit customarily required for evaluating medical evidence. We may have to change our mode of reasoning to prevent the discovery of error from becoming our primary source of progress. A statistics-based conclusion is relevant only if the contribution and importance of the criteria studied are taken into account. Statistical science recognizes this, but statistics users, particularly physicians, often ignore it. Consequently, the inappropriate use of statistics leads to mistakes, even misinformation, at times when clinical judgment would be a more reliable way of avoiding error.Therapeutic trials are regulated by strict rules: They must be prospective, placebo-controlled, randomized, and analyzed according to predefined end points on an intention-to-treat basis. Moreover, the analysis of non-prestratified subgroups is discouraged. Nevertheless, instances in which an observational study leads to significantly different conclusions are quite exceptional; to quote Benson and Hartz,1 “. . . [there is] little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials.”When investigating a drug combination that is considered clinically valid, it is almost impossible to carry out the trial in full compliance with all regulations. This is exemplified by the study on the combination of amiodarone and β-blockers in sudden-death prevention.2 It is difficult to reconcile so-called pragmatic trials (ie, those with large, nonrelevant targets) and so-called tedious trials (ie, those with exaggeratedly narrow targets).Certain methods for investigating arrhythmias and assessing antiarrhythmic drugs were considered essential until the day they were challenged. Clinical electrophysiology began in the late 1960s with programmed stimulation to investigate sustained arrhythmias; this was followed by the Holter method for quantification of …