Helm J F, Russo M W, Biddle A K, Simpson K N, Ransohoff D F, Sandler R S
Center for Gastrointestinal Biology and Disease and Department of Medicine, University of North Carolina, Chapel Hill, USA.
Am J Gastroenterol. 2000 Nov;95(11):3250-8. doi: 10.1111/j.1572-0241.2000.03261.x.
Fecal occult blood testing has been shown to reduce mortality from colorectal cancer in large randomized, controlled trials conducted in the United States, Denmark, and the United Kingdom, and mathematical simulation modeling found it to be cost-effective relative to other health care services. Before making a concerted effort to implement mass fecal occult blood testing based on this evidence alone, however, we considered it prudent to critically re-evaluate the effectiveness and economic impact of screening in the US population as a whole.
To assess the effectiveness of screening, we projected published outcomes from each of the three large randomized controlled trials of fecal occult blood testing to the US population, as if each clinical trial had been done in the population as a whole. We then determined the resource costs of detection and treatment that would be associated with the outcomes predicted from each trial.
More than 1 million colorectal cancers could be expected to arise over 10 yr in the cohort of US residents eligible to enter a screening program in 1997, and trial outcomes indicate that > or = 60% of these cancers would be fatal. If the 60-67% compliance rate of the population-based randomized controlled trials were achieved, a fecal occult blood testing program would detect 30% of known colorectal cancers and save 100,000 lives over 10 yr. Screening would incur total costs of $3-4 billion over 10 yr, or $2,500 per life-year saved.
Mass fecal occult blood testing is cost-effective, and, although not inexpensive, many would consider the total cost acceptable. Even with a concerted effort to achieve compliance, however, the effectiveness of fecal occult blood testing would be limited to saving the lives of < or = 15% of those who otherwise would die from their cancer in the first 10 yr after beginning mass screening. The limitations of fecal occult blood testing suggest the need to further evaluate the role of endoscopy in screening, and to develop more effective, noninvasive screening tools.
在美国、丹麦和英国进行的大型随机对照试验表明，粪便潜血试验可降低结直肠癌死亡率，且数学模拟模型显示，相对于其他医疗服务，该试验具有成本效益。然而，在仅基于这一证据就齐心协力实施大规模粪便潜血试验之前，我们认为审慎地重新评估在美国全体人群中进行筛查的有效性和经济影响是明智的。
为评估筛查的有效性，我们将三项粪便潜血试验大型随机对照试验已发表的结果推算至美国人群，就好像每项临床试验都是在全体人群中进行的一样。然后，我们确定了与每项试验预测结果相关的检测和治疗资源成本。
预计在1997年有资格参加筛查项目的美国居民队列中，10年内将出现超过100万例结直肠癌，试验结果表明，这些癌症中≥60%将是致命的。如果达到基于人群的随机对照试验60% - 67%的依从率，粪便潜血试验项目将在10年内检测出30%已知的结直肠癌，并挽救100,000条生命。筛查在10年内将产生30亿至40亿美元的总成本，即每挽救一个生命年花费2500美元。
大规模粪便潜血试验具有成本效益，尽管成本不低，但许多人会认为总成本是可以接受的。然而，即使齐心协力实现依从性，粪便潜血试验的有效性也将仅限于在开始大规模筛查后的头10年内挽救≤15%原本会死于癌症的人的生命。粪便潜血试验的局限性表明有必要进一步评估内镜检查在筛查中的作用，并开发更有效、非侵入性的筛查工具。
