Leuven University Fertility Center (LUFC), University Hospital Leuven, Gasthuisberg, Belgium.
Reprod Biomed Online. 2012 Mar;24(3):293-300. doi: 10.1016/j.rbmo.2011.11.020. Epub 2011 Dec 7.
Quality management according to ISO 9001:2008 guidelines includes infertility care quality assessment and improvement. This study aimed to describe the development process of a questionnaire for infertility management. A literature review, qualitative interviews with experts and patients resulted in a content-valid and face-valid questionnaire. Three cross-sectional surveys were performed in 2004, 2007 and 2008 in a tertiary university infertility centre. First (2004), the questionnaire – measuring eight a-priori dimensions of infertility management – was tested. Second (2007), improvement projects for infertility management were evaluated. Third (2008), factor analysis was performed and internal consistency was documented. The developed patient questionnaire to evaluate infertility management and pre-set desired levels of agreement served to set targets for and assess quality improvement projects. The final patient questionnaire to evaluate infertility management within an ISO framework was valid and reliable and contained 14 items covering four dimensions of infertility management: Telephone Access, Reception, Information and Patient-centeredness. ISO 9001:2008-certified infertility centres can evaluate infertility management with this 14-item questionnaire. This top-down approach to evaluate the patients’ perspective on quality aspects selected by health professionals can be complementary to the bottom-up approach evaluating the patients’ complete experiences of quality of care.
根据 ISO 9001:2008 指南进行质量管理包括对不孕护理质量的评估和改进。本研究旨在描述不孕管理问卷的开发过程。通过文献回顾、对专家和患者的定性访谈，形成了内容有效和表面有效的问卷。2004 年、2007 年和 2008 年在一所三级大学不孕中心进行了三次横断面调查。第一次（2004 年），测试了测量不孕管理八个事先确定维度的问卷。第二次（2007 年），评估了不孕管理的改进项目。第三次（2008 年），进行了因子分析并记录了内部一致性。开发的评估不孕管理和预先设定的一致性水平的患者问卷用于为质量改进项目设定目标和评估。在 ISO 框架内评估不孕管理的最终患者问卷是有效和可靠的，包含 14 个项目，涵盖不孕管理的四个维度：电话访问、接待、信息和以患者为中心。经过 ISO 9001:2008 认证的不孕中心可以使用这个 14 项的问卷来评估不孕管理。这种自上而下的方法评估了卫生专业人员选择的患者对质量方面的看法，可以与自下而上的方法相辅相成，评估患者对护理质量的全面体验。
