Revolutionising Clinical Studies: The REBECCA 360° Solution to Accurate and Explainable Quality of Life Monitoring

Understanding patients’ Quality of Life (QoL) is a pivotal aspect of healthcare research, intricately linked to their daily behaviour, physical condition, and emotional well-being. However, capturing these elements objectively has always been a challenge. Medical and pharmaceutical interventions can influence QoL, often accompanied by side effects and adverse events.

While Traditional Randomised Control Trials (RCTs) have long been considered the gold standard for evaluating the impact of medications and medical interventions on QoL, they possess certain limitations. RCTs can falter when faced with an overwhelming number of parameters or when the selected cohort fails to represent the diverse characteristics of the population. Thankfully, recent years have seen a surge in the recognition of the potential advantages offered by real-world data (RWD).

In this article, we delve into how the innovative REBECCA 360° platform accomplishes this feat.

Within the REBECCA framework, the collection of RWD surpasses the confines of traditional Electronic Health Records. It incorporates QoL indices derived from wearable devices that capture signals such as physical activity and heart rate. Additionally, it draws from smartphones, assimilating data on daily mobility, self-reports, and even photos. Furthermore, it taps into the vast realm of social media and online interactions, which provide valuable insights into our emotions and mood.

By harnessing real-world data, researchers can potentially reduce the cost and duration of clinical studies while gaining deeper, more meaningful insights into the QoL of patients. However, working with RWD, which is inherently observational, presents two significant challenges.

The first challenge lies in collecting data from diverse and often dissimilar sources. The second challenge revolves around analysing the data beyond the scope of an exploratory study. The REBECCA 360° platform tackles these challenges head-on by capturing data from various sources, including electronic Case Report Forms (eCRFs), wearables, smartphones, and a web browser plugin that tracks patients’ emotional states through their online behaviour. REBECCA has developed its own information model, capable of accommodating traditional clinical indicators as well as novel behavioural, physiological, and online behaviour indicators. Furthermore, novel statistical methodologies have been devised to address noise, bias, and missing values in the data.

While addressing the first challenge of collecting and harmonising data is crucial, it is in surpassing the exploratory phase that the REBECCA solution truly shines. To achieve this, the REBECCA 360° platform incorporates causal modelling methods at the heart of its data analysis. Directed Acyclic Graphs (DAGs) are employed to express causal relationships and confounding variables within the data. When combined with real-world data, DAGs can generate explainable estimations of treatment effects for specific population groups. Simultaneously, the REBECCA monitoring and causal assessment tools serve as valuable resources for clinical personnel, offering guidance and insights for individual patient care and interventions.

In conclusion, the REBECCA 360° platform represents a promising solution that complements traditional RCTs. By harnessing the power of real-world data (RWD) from diverse sources and applying advanced causal modelling methods, it enables accurate and explainable monitoring of patients’ Quality of Life (QoL). With its potential to revolutionise clinical studies, REBECCA paves the way for enhanced healthcare research and improved patient care.