Case study:
How SCAPIS Study Collected and Analysed More Than 30 Million Datapoints in Trial Online EDC
About SCAPIS
Heart and lung diseases are universal health challenges representing a worldwide health challenge and an urgent need for comprehensive research efforts. And that’s how the SCAPIS initiative was born. The Swedish CArdioPulmonary bioImage Study (SCAPIS), is a nationwide initiative in Sweden, an observational clinical study seeking to understand, predict, and prevent cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) utilizing a population-based cohort design.
Six Swedish universities with support from well-known health foundations came together for this study and since beginning of 2014, SCAPIS recruited 30,154 participants, men and women aged between 50 and 64 years old, across all of Sweden with the purpose of investigating CVD and COPD to be able to predict and prevent these conditions.Challenge
SCAPIS aimed to understand heart and lung conditions, as well as the prevalence and predictors of atherosclerosis and CVD by creating an extensive research data source, as extensive as possible and investigating the participants’ pool with detailed imaging and functional analyses of the cardiovascular and pulmonary systems.
In order to do so, SCAPIS required a robust and secure data capture system that could store, manage process and analyse a vast amount of data for an extended period of time as well while ensuring data integrity and security.
Solution
Replior’s Trial Online EDC system is designed specifically for clinical trials in need of a robust while secure database capable to manage large amounts of data with a fully responsive design, suitable for various devices. Its simple user interface facilitates accurate and, specifically for this case, fast data entry.
Because of Trial Online EDC’s adaptability and intuitive nature, we ensured that staff at many different levels from all six universities could effectively enter, manage and analyse data, contributing to a smooth study operation. We also ensured fast data entry with features such as automatic data saving and validation, while ensuring data integrity and compliance with regulatory standard thanks to a comprehensive audit trail.
Results
Over 30 million data points and 450,000 examinations were captured and managed in Trial Online EDC which led to key findings, particularly contributing to understanding the prevalence and risk factors of heart and lung diseases.
The SCAPIS study revealed a high incidence of atherosclerosis among the study participants, with approximately 40% of them showing plaque in the coronary arteries. This finding highlighted the vital importance of early detection and management of coronary artery disease and so, SCAPIS implemented a personalized participant screening questionnaire which, together with CCTA imaging, allowed for the identification of those participants with higher risk of cardiovascular disease.
Conclusion
SCAPIS study not only successfully managed to store, analyse and manage a large data study but also contributed to public health policies by showing the need for early screening and early intervention strategies to address heart and lung diseases. Trial
Online EDC played an important role in the success of SCAPIS study by showing not only that it can easily manage large-scale complex clinical trials but also that it can facilitate the processing of extensive data through its data management features.
We all learned through the SCAPIS study the importance of integrating advanced data management systems in large-scale medical research. There is immense value in extensive data collection and its analysis that can easily help us understand complex diseases and reshape public healthcare strategies through continued innovation and adoption of systems such as Trial Online EDC in healthcare.