Ethical process in human research published in thoracic surgery journals.

BACKGROUND: Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002. METHODS: We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852). RESULTS: Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%). CONCLUSIONS: There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

Prevention of thrombosis and embolism in children and adolescents with mechanical valve prostheses: warfarin versus antiplatelet agents.

BACKGROUND AND AIM OF THE STUDY: Postoperative thromboembolic complications associated with mechanical valve prosthesis implantation can be reduced with either antiplatelet agents or warfarin. Warfarin been shown to be more effective in adults, but the data are less clear in the pediatric population. METHODS: Seventy-two children and adolescents who survived mechanical valve implantation on the left side of the heart at the authors' institution were followed prospectively from August 1979 until December 2003. All patients underwent surgery before the age of 20 years, and follow up was included up to the age of 20 years. Initially, 53 patients received warfarin alone; mean follow up was 5.9 years, and total follow up 312 patient-years (pt-yr). Likewise, 19 patients received antiplatelet agents; mean follow up was 5.2 years, and total follow up 99 pt-yr. Results were examined using intent-to-treat analyses. RESULTS: Age, gender, race, valve size and position, mean time of follow up and crossover rates were not different between groups. No differences were detected in survival or freedom from thromboembolic and hemorrhagic events. Complications associated with warfarin use were substantially more severe than those associated with antiplatelet agents. CONCLUSION: The study results were inconclusive due to the small numbers of patient-years of follow up, but suggest that antiplatelet agents may be associated with less severe complications than warfarin. Moreover, warfarin and antiplatelet agents may be equally effective for clotting prophylaxis in children after valve replacement with St. Jude Medical prostheses.