Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, announced the publication of a new multi-domain model for capturing functional status in oncology through connected digital tools in Clinical & Translational Science.
The paper, titled: “A Proposed Multi-Domain Digital Model for Capturing Functional Status and Health-Related Quality of Life in Oncology,” highlights the importance of collecting continuous 24/7 functional status measures digitally to enable better clinical decisions and outcomes assessment.
Traditional clinical trial endpoints in oncology have long been crucial for evaluating novel treatments. However, the assessment of patients’ functional status – encompassing physical, cognitive, and behavioral functioning – holds increasing significance in influencing clinical decisions and understanding treatment outcomes. Koneksa’s innovative digital model aims to address limitations in existing functional status assessments by leveraging digital health technologies (DHTs) for both objective and self-reported outcomes.
The proposed model encompasses four key domains: physical activity data, vital signs, sleep variables, and health-related quality of life. By utilizing DHTs for data collection, Koneksa’s approach enables high-resolution, real-time measurements of objective data as patients navigate their daily lives outside hospital settings. This is complemented by electronic questionnaires tailored to each concept, ensuring comprehensive data collection.
“We’re introducing a transformative approach to functional status assessment in oncology and other disease areas,” said John Wagner, M.D, Ph.D., Chief Medical Officer, Koneksa. “This new digital measurement model not only addresses the limitations of traditional assessments, but also embraces the power of digital health technologies to capture a holistic assessment of patients’ health experiences.”
“Koneksa’s vision for digitally enabled data collection of functional status has several advantages over traditional approaches, such as more objective measures, as well as enabling a comprehensive understanding of how a patient is functioning outside the hospital setting,” said Elena Izmailova, Ph.D., Chief Scientific Officer, Koneksa. “This digital measurement model has already shown promise in early feasibility studies, and we look forward to applying this model into interventional trials with future partners and studies. Remote data collection also expands study accessibility, enabling a broader and more diverse representation of patients in clinical trials. Moreover, I personally pressure-tested the importance of collecting functional-status data during my own recent treatment for cancer. The results of my patient journey are published in JCO Clinical Cancer Informatics.”
SOURCE : BusinessWire