Knowledge Centre, Dutch Health Care Inspectorate, Utrecht, The Netherlands.
J Eval Clin Pract. 2011 Jun;17(3):411-9. doi: 10.1111/j.1365-2753.2010.01431.x. Epub 2011 Feb 21.
Reliable and valid judgments are necessary for regulatory authorities to merit confidence from care institutions and society and preserve authority. Moreover, limited reliability and validity of regulatory judgments increase the risk of limited improvement of the quality of health care. The goal of the study is to obtain insight in (dis) advantages of different regulatory instruments for regulation of health care.
In this study, the reliability and validity of judgments generated by a lightly structured and highly structured regulatory instrument used by the Dutch Health Care Inspectorate are compared.
Results indicate that the lightly structured instrument causes a large variety in discussed topics in regulatory visits: indicators pointing out potential risks in care are not always part of these discussions, by which incentives to improve care remain unjustly undone. Both types of instruments show variations in the meaning of judgments, indicating validity problems.
The results of our study suggest that regulation of health care requires thorough appraisal of instruments. Several requirements are identified: first, an instrument that justifies the complexity of care with an accompanying explicit set of standards is necessary. Second, commitment of inspectors to the instrument is essential. And third, training of inspectors is indispensable.
可靠和有效的判断对于监管机构来说是必要的，这有助于其赢得医疗机构和社会的信任，并维护其权威性。此外，监管判断的可靠性和有效性有限会增加医疗保健质量改善有限的风险。本研究的目的是了解（不）不同监管工具在监管医疗保健方面的优势。
在这项研究中，比较了荷兰医疗保健监察局使用的轻度结构化和高度结构化监管工具生成的判断的可靠性和有效性。
结果表明，轻度结构化工具在监管访问中引起了讨论主题的巨大差异：指出护理中潜在风险的指标并不总是这些讨论的一部分，因此改进护理的激励措施被不公正地忽视了。这两种类型的工具都显示出判断的含义存在差异，表明存在有效性问题。
我们的研究结果表明，医疗保健监管需要对工具进行彻底评估。确定了几个要求：首先，需要一种仪器，该仪器用一套明确的标准来证明护理的复杂性。其次，检查员对仪器的承诺是必不可少的。第三，检查员的培训是不可或缺的。
