Stürzlinger Heidi, Genser Dieter, Hiebinger Cora, Windisch Friederike
Gesundheit Österreich GmbH, ÖBIG Forschungs- und Planungsgesellschaft mbH, 1010 Wien, Österreich.
GMS Health Technol Assess. 2009 Feb 3;5:Doc02. doi: 10.3205/hta000064.
Colorectal cancer (CC) is the second most common cancer and cause of cancer death for both men and women in Germany. Various methods for early detection of CC exist, including conventional coloscopy which is reimbursed within the scope of cancer screening, as well as computertomography-coloscopy (CTC) which is currently not reimbursed.
CTC is a mere diagnostic procedure which has a lower risk of perforation than conventional coloscopy. However, as it is an x-ray procedure, it exposes the patient to radiation. Conventional coloscopy is considered the gold standard due to its high sensitivity and specificity for locating adenomas. Furthermore, it offers the advantage that in addition to extended diagnostic measures therapeutic measures can be undertaken during the procedure.
This HTA-report aims to evaluate the effectiveness and efficiency of CTC in comparison to conventional coloscopy in the early detection and diagnosis of colorectal cancer and/or its precursors and which ethical and legal aspects have to be considered.
The systematic literature search (27 international literature data bases) yielded a total of 1,713 abstracts. After a two-step selection process 36 publications remained to be assessed.
The results regarding the effectivity of CTC in diagnosis and screening for colorectal cancer and/or its precursors are partly promising, however, they are very heterogeneous. Therefore, regarding its sensitivity and specificity, CTC cannot be considered an equivalent alternative to conventional coloscopy for diagnosis and screening. The heterogeneity of results is due to technical (device type, settings), patient dependent (preparation) and operator dependent (training) factors. No economic results for a comparison of the procedures for diagnosis exist. Regarding the cost-effectiveness of a CTC-screening, international model calculations are available. According to this calculation, the CTC-screening is cost-effective compared to the option 'no screening'; however, conventional coloscopy-screening is generally more cost-effective.
If modern CTC-devices are used with adequate technical settings, software, appropriate patient preparation and training of the operator, better results regarding sensitivity can be expected. Basically, the fact that no therapeutic measures (polypectomy) can be taken during CTC compared to conventional coloscopy needs to be considered. Unanswered medical questions pertain to the interval of examinations for screening (considering the radiation exposure), the approach to small polyps and the significance of flat and depressed lesions. Regarding its cost-effectiveness, conventional coloscopy-screening results in greater health benefits and lower costs than CTC-screening in most model calculations. These results cannot be applied to Germany directly. An important ethical aspect is the consideration of patient preferences regarding the procedures. Legal aspects concern the stipulation and maintenance of quality standards.
At this time, a clear endorsement of CTC as an alternative procedure for diagnosis and screening to the current gold standard conventional coloscopy cannot be given. On the basis of the available literature this holds true for both the medical as well as the economic assessment. However, despite the numerous studies and analyses on this topic, this assessment is afflicted with uncertainties. Due to the rapid development of CTC, short term revisions of these research questions are needed.
在德国,结直肠癌(CC)是男性和女性中第二常见的癌症及癌症死亡原因。存在多种CC早期检测方法,包括在癌症筛查范围内可报销的传统结肠镜检查,以及目前未报销的计算机断层扫描结肠镜检查(CTC)。
CTC仅是一种诊断程序,与传统结肠镜检查相比,其穿孔风险较低。然而,由于它是一种X射线程序,会使患者受到辐射。传统结肠镜检查因其对腺瘤定位的高敏感性和特异性而被视为金标准。此外,它的优势在于除了扩展诊断措施外,还可在检查过程中采取治疗措施。
本卫生技术评估报告旨在评估CTC与传统结肠镜检查相比,在结直肠癌和/或其癌前病变的早期检测和诊断中的有效性和效率,以及必须考虑哪些伦理和法律方面的问题。
系统文献检索(27个国际文献数据库)共获得1713篇摘要。经过两步筛选过程后,剩余36篇出版物有待评估。
关于CTC在结直肠癌和/或其癌前病变诊断和筛查中的有效性结果部分令人鼓舞,但非常不一致。因此,就其敏感性和特异性而言,CTC不能被视为诊断和筛查的传统结肠镜检查的等效替代方法。结果的不一致性归因于技术(设备类型、设置)、患者相关(准备情况)和操作人员相关(培训)因素。不存在用于比较诊断程序的经济结果。关于CTC筛查的成本效益,有国际模型计算结果。根据此计算,与“不筛查”选项相比,CTC筛查具有成本效益;然而,传统结肠镜检查筛查通常更具成本效益。
如果使用具有适当技术设置、软件、适当患者准备和操作人员培训的现代CTC设备,有望在敏感性方面取得更好的结果。基本上,与传统结肠镜检查相比,需要考虑在CTC过程中无法采取治疗措施(息肉切除术)这一事实。未解决的医学问题涉及筛查检查的间隔时间(考虑辐射暴露)、小息肉的处理方法以及扁平凹陷性病变的意义。就其成本效益而言,在大多数模型计算中,传统结肠镜检查筛查比CTC筛查带来更大的健康益处且成本更低。这些结果不能直接应用于德国。一个重要的伦理方面是考虑患者对这些程序的偏好。法律方面涉及质量标准的规定和维护。
目前,不能明确认可CTC作为当前金标准传统结肠镜检查的诊断和筛查替代程序。基于现有文献,在医学评估和经济评估方面均如此。然而,尽管对该主题进行了大量研究和分析,但该评估仍存在不确定性。由于CTC的快速发展,需要对这些研究问题进行短期修订。