From the School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, PR China.
Center for Health Services Research Cologne, University of Cologne, Cologne, Germany.
J Patient Saf. 2021 Mar 1;17(2):114-121. doi: 10.1097/PTS.0000000000000733.
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.
The aim of the study was to develop a dependable instrument to assess the patient safety culture in Chinese primary health care institutions.
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.
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.
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.
现有的患者安全文化评估工具大多在西方国家开发,可能不适用于中国的基层医疗机构。基层医疗在中国的医疗体系中起着重要作用,因此迫切需要针对其患者安全文化的工具。
本研究旨在开发一种可靠的工具来评估中国基层医疗机构的患者安全文化。
采用文献回顾、焦点小组和两轮德尔菲专家咨询相结合的方法,分三个阶段开发量表。第二阶段进行了试点调查。第三阶段进行了正式调查,以测试可靠性和有效性,涉及来自 9 家基层医疗机构的 369 名参与者。
最终量表包括 7 个维度下的 32 个项目。信度方面,维度间的 Cronbach α系数在 0.754-0.926 之间,量表的 Cronbach α系数为 0.940。内容效度方面,校正后的项目水平内容效度在 0.64-1 之间,量表水平内容效度指数/一致性为 0.625,量表水平内容效度指数/平均值为 0.93。结构效度方面,维度总分的 Spearman 相关系数在 0.129-0.851 之间,维度总分的所有 Spearman 相关系数均大于维度间的 Spearman 相关系数,项目总分的 Spearman 相关系数范围为 0.042-0.775。验证性因子分析的结果表明模型拟合良好。
中国基层医疗机构患者安全文化量表具有良好的信度和可接受的效度;因此,可作为中国基层医疗机构患者安全文化的评估工具。