Statistics and Ethics in Surgery and Anesthesia

Ethical issues raised by human experimentation, especially in medicine, have been of increasing concern in the last half of the 20th century. Except for issues of consent and capacity to consent, ethical concerns raised by controlled trials center about the fact that individuals are being subjected, randomly, to different treatments. Two arguments are raised, and in each the patients are seen to be the losers. The first argument is an expression of the fear that the trial, by withholding a favorable new therapy, imposes a sacrifice on the part of some of the patients (the control group). The second argument raises the opposite concern that, by getting an untested new therapy, some patients (those in the experimental group) are exposed to additional risk. To a large extent, both arguments imply that investigators know in advance which is the favorable treatment. Some empirical evidence on these issues can be obtained by examining how potential new therapies are evaluated and what the findings are. How often do new therapies turn out to be superior when they are tested, and how much better or worse is a new therapy likely to be than the standard treatment? We have investigated such questions for surgery and anesthesia.