Nurse‐led one stop hematuria clinic: Outcomes from 2,714 patients

Abstract Objectives Objective of this study is to report the results of nurse led hematuria clinic service outcome of 2,714 patients. Subjects and methods We conducted a retrospective, single center review of 2714 patients with visible and nonvisible hematuria managed by a well‐trained nurse specialist in a rapid access clinic (RAC) between 2014 and 2020. All patients received a full review, flexible cystoscopy performed by a nurse, and ultrasound of urinary tracts. After investigations, patients were reassured and discharged or referred for rigid cystoscopy, TURBT, and CT urography. Results In total, 2714 patients attended the RAC between October 2014 and March 2020. Of these, 1684 (62%) were males and 1030 (38%) females. The median age of patients was 68.3 (IQR 58‐79). Of the 1030 females, 500 (48.5%) presented with nonvisible hematuria (NVH), and 530 (51.5%) presented with visible hematuria (VH). The median age was 66 (IQR 56‐76). The number of females diagnosed with any form of malignancy was 72 (7% of all females). Of the 1684 males, 288 (17.1%) presented with NVH, and 1396 (82.9%) presented with VH. The median age was 72 (IQR 59‐81). The number of males diagnosed with some form of malignancy was 258 (15.3% of all males). Overall, 1926 patients presented with VH and 788 patients presented with NVH. After investigations, 290 patients (15.1%) with VH and 40 (5.1%) patients with NVH had some form of malignancy. The highest number of malignancies found in VH was bladder cancer (n = 222, 11.5%), followed by prostate (n = 28, 1%), renal (n = 23, 0.8%), UT urothelial (n = 17, 0.6%), gynaecological (n = 7, 0.3%), and gastrointestinal (n = 5, 0.2%) cancer. The highest number of pathologies found in NVH was infection (n = 44, 5.6%). Cancer detection rate for symptomatic NVH was more than double that of asymptomatic NVH, 6.5% versus 3.1%, respectively. Conclusion Overall, 15.1% with VH and 5.1% with NVH present with malignancy. Nurse‐led rapid access hematuria clinic and flexible cystoscopy investigation by trained nurse is safe and feasible.


| INTRODUC TI ON
Hematuria is an indicator for mainly urinary tract malignancy, particularly bladder cancer but also upper tract, prostate and occasionally renal cancer; nevertheless, it presents also in benign urological pathologies such as urinary tract infections (UTI) and renal calculi. 1,2 Various guidelines recommend hematuria investigations depending on patient age and risk factors for malignancy; however, there is no standardized strategy. 2 Hematuria diagnostics commonly include cystoscopy, upper tract imaging (ultrasound, computed tomography, intravenous and magnetic resonance urography) and on occasion urine cytology and novel urinary biomarkers. 1,3 Due to costly investigations, the economic impact on healthcare organisations of hematuria investigations is significant, 4 particularly seen during the recently experienced pandemic with additional resource requirement, when health care has been reallocated and redeployed.
The importance of a rapid diagnostic service when investigating hematuria has been demonstrated, particularly when considering the relationship between hematuria and bladder cancer and other urological malignancies. 5 It has been shown that early diagnosis, which can optimally occur in a rapid diagnostic service, can appreciably improve prognosis. 5 The national health system (NHS) "two-week wait referral" helps alleviate the issues of diagnostic delays. 6 Many one-stop hematuria clinics (OSHC) have been established in the UK, which are especially useful given the extensive waiting times for out-patient appointments and the lengthy system of investigating and diagnosing patients which can take up to a number of weeks and multiple hospital visits. 7 Alongside the concerns of untimely diagnoses and extensive investigations lies the issue of the increasing pressure on medical professionals to deliver high-quality, timely services despite the lack of growth in number of consultants available to deliver that care, 8 including the care and workload for bladder cancer. 9 Therefore, there has been a growth in the role of the nurse practitioner. The value of a nurse practitioner to target shortages and imbalances has already been demonstrated, 10 particularly in areas such as primary care to allow for comanagement with physicians. 11 In urology, it has been shown that with adequate training, nurse practitioners can provide diagnostic services such as prostate biopsy and flexible cystoscopy with diagnostic yield equivalent to that of a consultant urologist. 8,9 The aim of this study was to ensure the efficacy and safety of nurse-led hematuria clinic, as opposed to a purely clinician-led clinic, and to analyze the hematuria clinic outcomes.

| ME THODS AND MATERIAL S
Two senior urology Clinical nurse specialists carried out the "onestop" hematuria rapid access clinic (RAC). They had received appropriate training for clinical assessment of patients and performing flexible cystoscopy.
The nurse led hematuria RAC was piloted for a year, as an assessment for patients presenting with non-visible haematuria (NVH), which incorporated arranging investigations and reviewing their results. The clinic then developed into assessing patients with visible hematuria (VH) alongside a urology registrar, who was responsible for reviewing patient results. After undergoing additional training to perform digital rectal examinations (DRE) with a consultant at a prostate assessment clinic and IRMER training to enable organisation of scans, the nurse led hematuria clinic was implemented. The one stop clinic was then designed as a method to reduce patient hospital visits by having all investigations within a single appointment. Currently, a clinical nurse specialist (CNS) has been managing, assessing and reviewing patients at the OSHC for the past 10 years. The nurse led RAC is run as part of the urology outpatient clinic, in parallel to a consultant clinic, therefore a consultant is always available for advice or a second opinion. This also allowed for constant maintenance of cystoscopy training. Discharge letters are completed by the CNS, with a copy given to the named consultant for review. To ensure safety and credibility of the OSHC, a prospective patient database was maintained to avoid misdiagnoses and complications, the outcomes of which were presented periodically to the hospital audit department. The clinic was approved by the clinical governance committee, with subsequent audits of the data completed after registration by the local hospital audit committee.
Between October 2014 and March 2020, 2714 patients were referred to the weekly hematuria RAC. The hematuria clinic pathway is outlined diagrammatically in Figure 1. Patients were referred mostly by general practitioners (GPs), but also some by physicians of other specialties. Most patients were referred as per the national institute for health and care excellence (NICE) 2 week wait guidelines, published in 2015, which included referrals for unexplained VH in individuals 45 years and over or for unexplained NVH in individuals aged 60 and over. 12 Some patients did not meet the NICE referral criteria and were referred as per the discretion of the treating physician. All patients who attended the RAC were included in this study, as they all had hematuria. the CNS, who then reviewed the reports. Following the initial general assessment, a flexible white light cystoscopy was performed by a second CNS.
At this stage, after the history, examination, USS and cystoscopy, patients were informed of their outcomes. Some patients were subsequently reassured and discharged, whilst others were listed for further investigation, including rigid cystoscopy, CTU and TURBT.
All pathologies were followed up according to the appropriate local guidelines. Patient details and outcomes were entered, prospectively, into a Microsoft Access database and analyzed using the statistical analysis ToolPak software on Microsoft Excel.
In 2018, 76 randomly selected patients were asked to carry out questionnaires, over a period of 6 months, to evaluate patient satisfaction of the OSHC to assess patient experiences with the RAC. Overall, most patients with either VH or NVH had bladder cancer (n = 248, 9.1%), followed by benign prostatic hyperplasia (n = 246, 9.1%).
After bladder cancer, prostate cancer was the second most common malignant finding (n = 28, 1%). There were also 23 renal (0.8%), 17 UT urothelial (0.6%), 7 gynaecological (0.3%) and 5 gastrointestinal (0.2%) cancers (Table 3).  Note: Numbers in parentheses are percentage prevalence of each disease within subgroups. %* denotes percentage prevalence of disease within that hematuria subgroup. %** denotes percentage prevalence of disease within the total number of patients diagnosed with the disease. %*** denotes percentage prevalence of disease within the patient cohort.
We did look further into the VH group and found that 1177 (61.1%) were symptomatic (s-VH) and 749 (38.9%) were asymptomatic VH (a-VH), respectively. Overall, 185 (15.7%) patients with s-VH were diagnosed with malignancy and 105 (14%) with a-VH were diagnosed with malignancy. Therefore, the cancer detection rates were similar in both groups. The age group with most cancers detected was the 90 years and above age group for s-VH (35.4%) but was 80-89 years for a-VH (23.6%); however, there were reasonably high cancer detection rates in all ages above 70 years (Figures 2 and   3). Only 4 cancers were detected in patients younger than 50 years, but 3 of these were patients presenting with a-VH; these patients were diagnosed with NMIBC.
In the s-NVH group, 30 (6.5%) patients were diagnosed with malignancy and in the a-NVH group, 10 (3.1%) were diagnosed with malignancy. Therefore, the cancer detection rate for s-NVH was more than double that of a-NVH (6.5% vs. 3.1%). The majority of cancers were detected in patients aged 80 or above for both s-NVH and a-NVH (Figures 4 and 5). Only 2 cancers were detected in patients younger than 50 years; neither of these were urological cancers. majority of these patients were either discharged or were found to have the same pathology as when initially investigated. 5 patients were found to have malignancy upon return. In one of these cases, the patient had initially cancelled further investigations, and so was a returning patient to complete the hematuria workup (pT2 bladder TCC +CIS). In two of the cases, there was a 3-year gap between the initial and return visit (both prostate cancer). One patient returned one year later with pTa bladder TCC +CIS, and the final case was of a NVH patient returning with VH a few months later and found to have a small renal mass on CT.
Patient satisfaction questionnaires yielded a total of 1074 of 1292 possible responses. The HCQ consisted of a Likert scale, composed "Strongly agree", "Agree", "Disagree" and "Strongly disagree" options. Patients had an overwhelmingly positive experience at the RAC, with 1031 (96.0%) responses indicating "Strongly Agree" or "Agree". As regards the role of nurse practitioner in the hematuria clinic, responses were generally positive (100% "Strongly Agree" or "Agree"). Most negative responses were in relation to waiting times for ultrasound and flexible cystoscopy on the day of OSHC (8% and 14% of answers indicated were "Disagree" and "Strongly Disagree"), with minimal dissatisfaction for the nurse-led aspect of the clinic.

| D ISCUSS I ON
The results of this retrospective study are representative of current expectations regarding hematuria and the diagnoses following a presentation of either NVH or VH, ultimately underlining the safety and efficacy of a nurse-led hematuria clinic. Literature shows that the presence of VH is a far greater risk factor for urological malignancies than NVH with the estimated detection rates of genitourinary cancer in patients presenting with VH and NVH of 13.2%-24.2% and 1.2%-9.4% respectively. 6,[14][15][16][17] This is comparable to our cancer detection rates at 15.1% and 5.1% for VH and NVH, respectively.
Up to 60% of patients who are investigated for hematuria in different countries will have no identifiable cause 18 ; comparatively, our study found that 59.2% of patients were able to be reassured and discharged or had no pathological findings, without requiring further intervention by a doctor. Direct consultant supervision in the clinic is therefore not required in order to safely investigate patients. A one-stop nurse-led hematuria clinic allows for efficient management of patients, especially given that the prevalence of hematuria is 5%-20%. 14 13 We can assume that the thorough investigations over the course of the day can help put patients' minds at rest, as inevitably, the finding of blood in urine can be a distressing experience. This should be taken into consideration for anyone starting their own clinic. Further considerations include adequate training of the nurse cystoscopist to carry out cystoscopies, as well as sufficient experience in diagnostic cystoscopy before working in the RAC; adequate training of the CNS running the clinic and performing a review and examination of the patient.
Experience can be gained through other, similar clinics such as a LUTS clinic. And finally, ensuring the OSHC is running parallel to a consultant-led clinic to allow for the availability of supervision and guidance at all times.
Limitations of this study include the incompleteness of our data.
Patients were not followed up through their entire patient journey, so some facts are still unknown such as treatment and survival data.
Furthermore, patients that were discharged from the hematuria clinic may have had to be followed up for other pathologies however this long-term follow up data was not recorded. The RAC proforma was limited; data on significant risk factors such as BMI, dietary habits etc was not collected. Some data was undocumented in the database such as drug history and past medical history which may also provide key insights into the significance of malignancies detected.
It is also important to acknowledge that the data represents patients from a single hospital and so our findings may not be generalisable to the wider community. Though the majority of patients underwent some form of imaging (primarily US) and flexible cystoscopy on the same day, we acknowledge that not every patient underwent all testing including a CT as well, due to external factors such as patient preference, scheduling issues and other unknown reasons. Although many patients were referred as per the NICE guidelines for urgent referrals, many patients were also referred that did not meet the NICE guidelines. Finally, a formal economic evaluation has not been covered by the present study.
In conclusion, this study provides a unique evaluation of a large volume of prospective data from a hematuria rapid access clinic. Our results validate previous studies conducted on the OSHC, particularly malignancy and significant urological pathology detection rates.
Therefore, a Nurse led hematuria clinic is feasible and can be safely performed by nurses following the appropriate training with analogous outcomes to the literature.

CO N FLI C T O F I NTE R E S T S
All authors have nothing to disclose.