Translation, Adaptation, and Validation of Survey on Patient Safety Culture for Ambulatory Care in Japan

Abstract Objective There is no validated questionnaire in Japan to measure the culture of safety in ambulatory care clinics. Therefore, we developed the Japanese version of the Medical Office Survey on Patient Safety Culture (MOSPSC) of the Agency of Healthcare Research and Quality (AHRQ) in the United States with the aim to establish a tool for evaluating and benchmarking the safety culture of outpatient clinics in Japan. Materials and methods This research uses both qualitative and quantitative approaches to translate, adapt and validate the MOSPSC questionnaire which consists of 62 questions. The process involved seven steps such as translation by two independent bilingual physicians, drafting and reviewing, backtranslation by two separate translation companies, semantic equivalence assessment by AHRQ and revision, pretest, focused discussion, and finalizing the questionnaire after expert review and proofreading. An actual safety culture survey was conducted with mainly online and paper versions at four clinics in Tokyo. The survey results were then evaluated for patient safety dimensions, reliability and construct validity. Results Efforts are made to select appropriate terminology during tool adaptation processes due to different language and medical system between Japan and the United States. The response rate in the actual survey was 66.4% (242/364). Confirmatory factor analysis showed that factor loading and goodness of fit indices were better when 3 items were removed from the original 10-composite model with 38 items. The Cronbach’s alpha coefficients of composite measures ranged from 0.62 to 0.78 in the original model and 0.62 to 0.85 in the new model, indicating good internal consistencies. Conclusions Considering the differences in medical systems, culture, and language between the United States and Japan, the instrumented was adapted with a satisfactory content validity and reliability.