A Standards-based Approach to Development of Clinical Registries - Initial Lessons Learnt from the Gestational Diabetes Registry

Abstract

Gestational diabetes has implications for both mother and child with risk of complications during pregnancy, and type 2 diabetes later in life. This paper presents the initial lessons learned from the development of a clinical registry. The aims of the Registry are: 1) 100% successful diabetes screening within 3 months of delivery; 2) Annual type 2 diabetes screening; 3) Early warning in subsequent pregnancies. We have employed the openEHR standard which underpins our national interoperability reference architecture to represent the dataset and also to build the web-based registry system. Use of this rigorous methodology to tackle health information is expected to ensure semantic consistency of Registry data and maximise interoperability with other Sector projects. The development work has been facilitated by the ability to transform the dataset automatically into software code – ensuring clinical requirements accurately translated into technical terms. Dataset has been finalised, registry system has been developed and deployed for pilot implementation. Data entry is underway for participants after consenting. This registry is expected to increase the screening of women leading to earlier detection of diabetes. It should provide a valuable picture of the condition and is intended for extension and wider roll-out after evaluation