Abstract: SA-PO215
Combining a Digital Platform and Point-of-Care (POC) Testing to Extend Kidney Patient Participation in Cancer Trials: Technical Feasibility and Patient Acceptability Study (IDecide Program)
Session Information
- Onco-Nephrology: Clinical
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Onco-Nephrology
- 1500 Onco-Nephrology
Authors
- Ogden, Leanne A., Manchester Royal Infirmary, Manchester, United Kingdom
- Mitra, Sandip, Manchester University Hospitals, UK, Sale, United Kingdom
Group or Team Name
- Digital Experimental Cancer Research Team
Background
Recruitment to cancer clinical trials is an ongoing challenge and usually limited to patients with preserved kidney function. Eligibility often restricts recruitment to those with an eGFR of >50ml/min, this is arbitrary and not a risk-based approach driven by current clinical science in nephrology. Due to increased survival rates for both conditions, there is a significant population with both cancer and reduced kidney function. The aim of this body of research is to assess whether new technological advances in POC creatinine meters and digital science can be used to modernise eligibility criteria in oncology clinical trials through personalised risk-based monitoring. We created an approach that explored the potential and acceptability of using a POC device, data capture via a smartphone, and risk-categorisation through an Acute Kidney Injury (AKI) algorithm, to enable decision-making and the first step in addressing this unmet clinical need.
Methods
Three POC devices were evaluated for usability, size and complexity. A smart phone app was developed, which captures device data and sends securely to a Cloud environment. Creatinine testing, calibration and patient acceptability in the hospital was conducted over a 2 week period with 17 interactions (patient/carer/nurse), including 2 patient focus group with 8 participants from oncology and nephrology backgrounds.
Results
The Nova Biomedical Creatinine StatSensor® was the device chosen to enable home creatinine readings with good end user feedback and stable performance characteristics. The app user interface design was acceptable with patients based on patient acceptability testing.
Conclusion
This initial proof of concept successfully demonstrated that creatinine can be measured by a POC device, the data captured by an app and reported in near-real time. We have now developed a clinical rules engine based on the NHS/NICE published algorithm for AKI; and will be applying this to a clinical trial to detect AKI in patients receiving chemotherapy to quantify the potential clinical benefits. We aim that this will be the first step in a body of work to challenge traditional eligibility criteria for clinical trials and improve outcomes for this population of patients, through first improving their recruitment to cancer clinical trials.