The standardized development method of the Japanese guidelines for cancer screening.

BACKGROUND 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. METHODS Based on the development processes of other guidelines, an original method, unique to Japan, was established to develop the Japanese cancer screening guidelines. RESULTS 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. CONCLUSION 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.