Hamashima Chisato, Saito Hiroshi, Nakayama Tomio, Nakayama Takeo, Sobue Tomotaka
Cancer Screening Technology Division, Research Center for Cancer Prevention and Screening, National Cancer Center, 5-1-1 Tsukiji Chuo-ku, Tokyo 104-0045, Japan.
Jpn J Clin Oncol. 2008 Apr;38(4):288-95. doi: 10.1093/jjco/hyn016. Epub 2008 Mar 12.
To reduce cancer mortality, effective screening should be implemented properly. In Japan, the Research Group for Cancer Screening developed screening guidelines; however, the development process was not well established.
Based on the development processes of other guidelines, an original method, unique to Japan, was established to develop the Japanese cancer screening guidelines.
The guideline development process involved the following steps: topic selection, development of the analytic framework, systematic literature review, translation to recommendations, consultation and publication. Mortality reduction related to cancer screening was evaluated using both direct and indirect evidence. To select appropriate articles, an analytic framework for cancer screening program with key questions was developed. Direct evidence was defined as a single body of evidence that established the linkage between screening and health outcomes such as mortality and incidence. The use of indirect evidence to determine the level of evidence was limited to situations where test accuracy could be compared with that of a method whose evidence was supported by randomized, controlled trials. Eight levels of evidence were defined based on the study design and quality. The benefits of each screening modality were determined based on the level of evidence according to the results of the systematic review. Balancing the benefits and harms, five grades of recommendation were formulated for population-based and opportunistic screening. After organized consultations, three types of guidelines were published.
We developed a unique, standardized method for developing cancer screening guidelines in Japan. Based on this process, previously developed cancer screening guidelines have been revised.
为降低癌症死亡率,应妥善实施有效的筛查。在日本,癌症筛查研究小组制定了筛查指南;然而,其制定过程并不完善。
基于其他指南的制定过程,建立了一种日本独有的原创方法来制定日本癌症筛查指南。
指南制定过程包括以下步骤:主题选择、分析框架的制定、系统文献综述、转化为建议、咨询和发布。使用直接和间接证据评估与癌症筛查相关的死亡率降低情况。为选择合适的文章,制定了一个带有关键问题的癌症筛查项目分析框架。直接证据被定义为确立筛查与健康结果(如死亡率和发病率)之间联系的单一证据体。在能够将检测准确性与证据得到随机对照试验支持的方法进行比较的情况下,才将间接证据用于确定证据水平。根据研究设计和质量定义了八个证据级别。根据系统综述的结果,基于证据级别确定每种筛查方式的益处。在权衡益处和危害后,针对基于人群的筛查和机会性筛查制定了五个推荐等级。经过组织咨询后,发布了三种类型的指南。
我们在日本开发了一种独特的、标准化的癌症筛查指南制定方法。基于这一过程,之前制定的癌症筛查指南已得到修订。