Siddiki Hassan, Fletcher J G, McFarland Beth, Dajani Nora, Orme Nicholas, Koenig Barbara, Strobel Marguerite, Wolf Susan M
Mayo Clinic Department of Radiology, USA.
J Law Med Ethics. 2008 Summer;36(2):320-31, 213. doi: 10.1111/j.1748-720X.2008.00276.x.
Incidental findings (IFs) of potential medical significance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography (CT) colonography (CTC) studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defined plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical significance will be detected and reported in CTC research studies.
在参与大型计算机断层扫描(CT)结肠成像(CTC)研究的无症状受试者中,约5%-8%会出现具有潜在医学意义的偶然发现(IFs),有症状的受试者中这一比例为16%,且其发生率会因CT采集技术的不同而进一步变化。虽然大多数CTC研究项目都有明确的计划来检测和披露IFs,但这些计划大多只是口头传达。书面同意文件还应告知受试者在CTC研究中如何检测和报告具有潜在医学意义的IFs。