Do Surgical Trials Meet the Scientific Standards for Clinical Trials?

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials that use bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions toward the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based on adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999 through 2008, which reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials that appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This article reports our results and raises concerns about the methodologic, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice

Operationalizing Professionalism: A Course in Ethical Decision Making

All U.S. medical schools require some medical ethics education and must now ensure that their graduates, residents, and faculty exhibit competence in the area of professionalism and professional medical ethics. However, there remain many challenges to implementing formal ethics and professionalism education into medical school curricula. [See PDF for complete abstract

Bioethics in Latin America: 1989-1991

In our region, bioethics as an academic discipline and a public movement is still in its beginning stages. The historical changes resulting from scientific and technological advances in biomedicine and from the liberal and pluralist character of industrialized countries have barely begun to occur in the developing countries of Latin America, which remain largely “pretechnical” in their orientation. Bioethics as a secular discipline, with its principles of beneficence, autonomy, and justice, and its emphasis on the rational and free agent in the therapeutic relationship, has not yet reached Latin America.Facultad de Ciencias Médica

Are Surgical Trials with Negative Results Being Interpreted Correctly?

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (b 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated