Developed over Quantify’s many years of experience with Nordic registry data and expertise in data science, the proprietary Qniform software was developed to provide reliable, reproducible, and efficient data management in real-world evidence (RWE) studies across the Nordics. Qniform validates raw data and creates analysis data with cross-Nordic interoperability.
The Nordics offer excellent national administrative databases with universal coverage of its approximate 26 million inhabitants. Data includes all health care visits, diagnoses and procedures, prescribed treatments, long-term sick-leaves, demographics and causes of death. Individual linkage across registers allows for longitudinal studies of large cohorts.
To utilize these data successfully in RWE projects requires that certain conditions are fulfilled:
- The requested data was extracted and delivered correctly by the data holder
- The variables contained in the data are sufficiently detailed and correctly formatted
- The application’s inclusion and exclusion criteria have been correctly applied
- Erroneous data is identified and managed appropriately
- Incomplete data is imputed according to best practices where appropriate
- Variables are comparable between countries
In a perfect world, each success factor above would be a non-issue. However, in Quantify’s extensive experience using these datasets, there are often quality issues related to data delivery that need to be detected. Timing is critical as there is a short window during which any errors need to be pointed out to the data holder closes the data extraction assignment. It is critical that potential errors are identified quickly and systematically – a primary function of Qniform.
Using data from multiple Nordic countries is central to pooled or parallel studies. Although the registry data structure and content are similar in many ways, there are a variety of subtle differences between countries that must be managed correctly to optimize cross-country comparability. For example, are multiple procedure codes ranked in order of importance or not? Do costs only reflect the share paid by the patient or are paid subsidies also included? To ensure cross-country comparability, Qniform transforms or creates new variables which corresponds to a pre-defined target format that is harmonized across the Nordics.
The application of Qniform within RWE projects ensures critical elements of data quality and validation are completed quickly and according to best practices. Quantify’s Qniform software is the first step to ensuring the success and impact of any RWE study.