Bullock Nicholas, Mubarak Mohamed, Morris Ceri, Clements Colette, Geere Clare, Tidball Sarah, Bois Elizabeth, Davies Michael, Featherstone Jonathan, Narahari Krishna, Weeks Ian, Kynaston Howard
Division of Cancer and Genetics Cardiff University School of Medicine Cardiff UK.
Department of Urology Cardiff and Vale University Health Board Cardiff UK.
BJUI Compass. 2023 Apr 3;4(4):446-454. doi: 10.1002/bco2.234. eCollection 2023 Jul.
To determine the acceptability of a non-invasive urinary biomarker test in place of conventional flexible cystoscopy for the diagnosis of bladder cancer in patients referred to a Rapid Access Haematuria Clinic (RAHC) with suspected urological malignancy.
Patients attending a RAHC were recruited to a prospective observational study evaluating a novel urinary biomarker (URO17™) for the detection of bladder cancer and invited to complete a two-part structured questionnaire. Questions related to demographics, attitudes towards conventional cystoscopy and the minimal acceptable sensitivity (MAS) at which a urinary biomarker would be considered an alternative to flexible cystoscopy both before and after undergoing the procedure.
A total of 250 patients completed the survey; the majority of whom were referred with visible haematuria (75.2%). One hundred seventy-one (68.4%) would be willing to accept a urinary biomarker in place of cystoscopy, with 59 (23.6%) expressing preference for the biomarker with a MAS as low as 85%. Conversely, 74 patients (29.6%) would not be willing to accept a urinary biomarker, regardless of its sensitivity. A significant number of patients reported a change in MAS after undergoing cystoscopy, with 80 (32.0%) and 16 (6.4%) increasing and decreasing the required value respectively ( = 0.001). The greatest increase was seen in the proportion of patients unwilling to accept a urinary biomarker regardless of its sensitivity, rising from 29.6% to 38.4%.
Although many patients attending a RAHC would be willing to accept a urinary biomarker test in place of conventional flexible cystoscopy for the detection of bladder cancer, effective patient, public and clinician engagement will be necessary at all stages of implementation if it is to become an established component of the diagnostic pathway.
确定在疑似泌尿系统恶性肿瘤而被转诊至快速血尿诊所（RAHC）的患者中，一种非侵入性尿液生物标志物检测替代传统软性膀胱镜检查用于膀胱癌诊断的可接受性。
招募到RAHC就诊的患者参与一项前瞻性观察性研究，评估一种新型尿液生物标志物（URO17™）用于检测膀胱癌，并邀请他们完成一份分为两部分的结构化问卷。问题涉及人口统计学信息、对传统膀胱镜检查的态度以及在接受该检查前后，尿液生物标志物被视为替代软性膀胱镜检查的最低可接受敏感性（MAS）。
共有250名患者完成了调查；其中大多数因肉眼血尿被转诊（75.2%）。171名患者（68.4%）愿意接受尿液生物标志物检测替代膀胱镜检查，59名患者（23.6%）表示更倾向于接受MAS低至85%的生物标志物检测。相反，74名患者（29.6%）无论生物标志物检测的敏感性如何，都不愿意接受。大量患者报告在接受膀胱镜检查后MAS发生了变化，分别有80名患者（32.0%）和16名患者（6.4%）提高和降低了所需值（P = 0.001）。最大的变化是，无论生物标志物检测的敏感性如何，不愿意接受的患者比例从29.6%上升至38.4%。
尽管许多到RAHC就诊的患者愿意接受尿液生物标志物检测替代传统软性膀胱镜检查来检测膀胱癌，但如果要使其成为诊断流程的既定组成部分，在实施的各个阶段都需要患者、公众和临床医生的有效参与。
