Mix methods approach to explore patients' perspectives on the acceptability of a urinary biomarker test in replacement of cystoscopy in bladder cancer surveillance
OBJECTIVE: To determine the minimal accepted sensitivity (MAS) of a urine biomarker that patients are willing to accept to replace cystoscopy and to qualitatively assess their views and reasons. PATIENT AND METHODS: Patients were part of a prospective multi-center observational study recruiting patients with bladder cancer for a urine biomarker study (DETECT II; ClinicalTrials.gov: NCT02781428). A mix methods approach comprising of 1) Questionnaire to assess patients' experience with cystoscopy and patients' preference for cystoscopy vs urinary biomarker and 2). Semi-structured interviews to understand patient views, choice and reasons for their preference. RESULTS: A urine biomarker with MAS of 90% would be accepted by 75.8% of patients. This is despite a high self-reported prevalence of hematuria (51.0%), dysuria/ lower urinary tract symptoms (69.1%) and urinary tract infection requiring antibiotics (25.8%). There was no association between MAS with patient demographics, adverse events experienced, cancer characteristics and distance of patients' home to hospital. Qualitative analysis suggest that patients acknowledge that cystoscopy is invasive, embarrassing and associated with adverse events but are willing to tolerate the procedure due to a high sensitivity. Patients have confidence in cystoscopy and appreciate the visual diagnosis of cancer. Both low and high-risk patients would consider a biomarker with a reported sensitivity similar to cystoscopy. CONCLUSION: Patients value the high sensitivity cystoscopy accords despite the reported discomfort and adverse events experienced following cystoscopy. The sensitivity of a urinary biomarker must be close to cystoscopy before patients' acceptance
