Due to the high risk of recurrence of non-muscle invasive bladder cancer, all patients undergo regular cystoscopic surveillance for early detection. As cystoscopy is invasive, costly and increases the burden of the disease considerably, there is significant ongoing research and development into non-invasive urinary biomarker substitutes. This study aims to assess the level of sensitivity required before patients accept a new urinary biomarker.
We studied the preferences for a hypothetical diagnostic urinary biomarker and compared this to usual care (cystoscopy) at different levels of sensitivity among 437 patients with bladder cancer (354 men and 83 women) from the UK Bladder Cancer Prognosis Programme. A standard gamble approach was used to estimate the minimally acceptable sensitivity (MAS) of the new biomarker. Additionally, non-parametric statistical analyses were performed to investigate the association between surveillance preference and various patient characteristics.
Almost half of patients (183, 43%) would not replace cystoscopy with a urinary biomarker unless it was 100% sensitive. The median MAS was 99.9999%, and nearly 85% of patients demanded a sensitivity of at least 99% before preferring a urinary biomarker test over cystoscopy. These results were consistent across all patient characteristics and demographic categories.
Our results indicate that patients demand urinary biomarkers as sensitive as cystoscopy before they would be willing to forego cystoscopy for bladder cancer surveillance.
World journal of urology. 2019 Mar 23 [Epub ahead of print]
Frits H M van Osch, Duncan Nekeman, Neil K Aaronson, Lucinda J Billingham, Nicholas D James, K K Cheng, Richard T Bryan, Maurice P Zeegers
Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK. ., Department of Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Birmingham, UK., Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands., Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK., Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK., Department of Complex Genetics, Nutrition and Metabolism in Translational Research (NUTRIM), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.