Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...) surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

Background Decisions regarding Cardio-Pulmonary Resuscitation (CPR) and Do Not Attempt Resuscitation (DNAR) orders remain demanding, as does including patients in the process. Objectives To explore physicians’ justification for CPR/DNAR orders and decisions regarding patient inclusion, as well as their reports of how they initiated discussions with patients. Methods We administered a face-to-face survey to residents in charge of 206 patients including DNAR and CPR orders, with or without patient inclusion. Results Justifications were provided for 59% of DNAR orders and included (...) severe comorbidity, patients and families’ resuscitation preferences, patients’ age, or poor prognosis or quality of life. Reasons to include patients in CPR/DNAR decisions were provided in 96% and 84% of cases, and were based on respect for autonomy, clinical assessment of the situation as not too severe, and the view that such inclusion was required. Reasons for not including patients were offered in 84% of cases for CPR and in 70% for DNAR. They included absent decision-making capacity, a clinical situation viewed as good (CPR) or offering little hope of recovery (DNAR), barriers to communication, or concern that discussions could be emotionally difficult or superfluous. Decisions made earlier in the patient's management were infrequently viewed as requiring revision. Residents reported a variety of introductions to discussions with patients. Conclusions These results provide better understanding of reasons for CPR/DNAR decisions, reasons for patient inclusion or lack thereof, and ways in which such inclusion is initiated. They also point to potential side-effects of implementing CPR/DNAR recommendations without in-depth and practical training. This should be part of a regular audit and follow-up process for such recommendations. (shrink)

The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction—describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a subtler appreciation for clinical equipoise—in particular the distinction between (...) de facto and de jure interpretations of the concept—allows the concept to explain when and why a placebo control may be necessary to answer a question of clinical importance. (shrink)

Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...) surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”. While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the (...) effects of knowledge framing and its impact on ethical, medical, economical and legal decisions. (shrink)

Debate continues about the ethics of sham surgery controls. The most powerful argument for sham surgery controls is that rigorous experiments are needed to demonstrate safety and efficacy of surgical procedures. Without such experiments, there is danger of adopting worthless procedures in clinical practice. Opponents of sham surgery controls argue that sham surgery constitutes unacceptable violation of the rights of research subjects. Recent philosophical discussion has used two thought experiments—the transplant case and the trolley problem—to explore the circumstances under which (...) individuals may be harmed to benefit a larger group. The transplant case is felt to exemplify circumstances that forbid harming some to benefit a larger group while the trolley problem exemplifies circumstances that permit harming some to benefit others. I argue that sham surgery controls satisfy criteria derived from the trolley problem and are morally permissible. (shrink)