Development of the Japanese SF-36 was completed in two phases: Phase 1: Japanese version 1.1 was produced according to International Quality of Life Assessment (IQOLA) project guidelines, but some results of psychometric tests were unexpected. First, scores varied little across physical-functioning items. Second, using factor analysis, we could not clearly distinguish the scales designed to measure the "physical" component of quality of life from those designed to measure the "mental" component. Phase 2: Focus-group discussions revealed that limited had often been interpreted as limited by a doctor. Therefore, is difficult to do was used instead (version 1.2). Results of two surveys indicated that version 1.2 yields scores that are reliable by internal consistency and test-retest standards and yields two principal components. In Japan, however, the pattern of correlations between some scales and the principal components differs from that in the United States. Iterative use of qualitative and quantitative methods was very important in developing the Japanese SF-36.