The Patient Safety Culture Scale for Chinese Primary Health Care Institutions: Development, Validity and Reliability.

BACKGROUND: Existing patient safety culture assessment tools are mostly developed in western countries and may not be suitable for Chinese primary health care institutions. Primary care plays an important role in China's medical system, and a targeted tool for its patient safety culture is urgently needed. OBJECTIVE: The aim of the study was to develop a dependable instrument to assess the patient safety culture in Chinese primary health care institutions. METHODS: Three phases were undertaken to develop the scale. The first phase developed a pilot scale by literature review, focus groups, and 2-round Delphi expert consultation. The second phase conducted a pilot survey. The third phase carried out a formal survey to test reliability and validity, involving 369 participants from 9 primary health care institutions. RESULTS: The final scale included 32 items under 7 dimensions. For reliability, the Cronbach α coefficients among dimensions varied from 0.754 to 0.926, and the Cronbach α for the scale was 0.940. For content validity, the corrected item-level content validity varied between 0.64 and 1, the scale-level content validity index/universal agreement was 0.625, and the scale-level content validity index/average was 0.93. For construct validity, the Spearman correlations of dimension-total score varied between 0.129 and 0.851, all Spearman correlations of the dimension-total score were greater than that of interdimensions and the Spearman correlations of item-total score ranged from 0.042 to 0.775. The results of the confirmatory factor analysis indicated that the model fitted well. CONCLUSIONS: The Patient Safety Culture Scale for Chinese primary health care institutions demonstrated good reliability and acceptable validity; thus, it can be used as an assessment instrument for patient safety culture in Chinese primary health care institutions.