Department of Business Administration, Lund University, Lund, Sweden.
Department of Health Care Policy, Harvard Medical School, Boston, MA, USA.
J Intern Med. 2016 Feb;279(2):160-72. doi: 10.1111/joim.12438. Epub 2015 Oct 5.
Multi-institutional quality improvement registries (QI registries) are a promising approach to quality improvement. They are also used for clinical research, public quality reporting and other valuable purposes. The aim of this study was to identify elements and outcomes of national policies to promote registries in Sweden and to compare them with recent policies in the USA.
This case study draws on previous studies of Swedish registries and on interviews, observations and document studies conducted in Sweden and the USA.
In Sweden, registries are fostered by favourable patient data regulation and an indirect control approach combining government funding with soft regulation and professional self-governance. This enables the development of high-quality QI registries which are used for improvements by engaged clinicians, for clinical research and for decision support for practitioners and stakeholders. For example, Riks-HIA/Swedeheart achieved improved outcomes in cardiac intensive care, SCAAR/Swedeheart was used in a unique registry-based randomized trial, and the Swedish Rheumatology Quality Register provides a Web interface for patient encounters and clarifies adverse effects of biologic drugs. Still, the system has persistent limitations, especially the administrative burden on participants. In the USA, Medicare's programme for qualified clinical data registries and other recent changes mirror Swedish policies. Automated data capture is a US advantage, but uncertain funding and complex data regulations stall registry development in the USA.
The findings of this study indicate that tailor-made data regulation and a soft regulatory policy approach foster high-quality QI registries with multiple meaningful uses. These findings offer a framework for further cross-country comparative study to evaluate registry policies.
多机构质量改进登记处（QI 登记处）是质量改进的一种有前途的方法。它们也被用于临床研究、公共质量报告和其他有价值的用途。本研究的目的是确定促进瑞典登记处的国家政策的要素和结果，并将其与美国最近的政策进行比较。
本案例研究借鉴了以前对瑞典登记处的研究以及在瑞典和美国进行的访谈、观察和文件研究。
在瑞典，登记处受到有利的患者数据监管和间接控制方法的促进，该方法将政府资金与软监管和专业自治相结合。这使得能够开发高质量的 QI 登记处，这些登记处用于由参与的临床医生进行改进，用于临床研究，并为从业者和利益相关者提供决策支持。例如，Riks-HIA/Swedeheart 在心脏重症监护方面取得了改善的结果，SCAAR/Swedeheart 用于独特的基于登记处的随机试验，瑞典风湿病质量登记处为患者就诊提供了 Web 界面，并澄清了生物药物的不良反应。尽管如此，该系统仍存在持续的局限性，特别是对参与者的行政负担。在美国，医疗保险的合格临床数据登记处计划和其他最近的变化反映了瑞典的政策。自动数据捕获是美国的优势，但不确定的资金和复杂的数据法规阻碍了美国登记处的发展。
本研究的结果表明，定制的数据监管和软监管政策方法促进了具有多种有意义用途的高质量 QI 登记处。这些发现为进一步进行跨国比较研究以评估登记处政策提供了框架。
