Although visible blood in the urine is well known to be a red flag symptom of bladder and kidney cancer, many patients with these cancers present with other lower risk symptoms. These include symptoms of urinary tract infections (UTIs) and non-visible blood (non-visible haematuria, NVH) in the urine. At present, national guidelines recommend that patients with unexplained persistent NVH and painful urination be referred urgently, and recurrent UTIs be referred routinely for specialist assessment. However, the exact risk of cancer in these patients is unknown, especially in those with recurrent presentations.
This study aims to examine the risk of bladder and kidney cancer in patients with non-alarm symptoms such as UTIs and non-visible blood in the urine. It will examine the risk of cancer of the symptoms alone, as well as in combination with other risk factors, including sex and age. It will also consider the cancer risk in patients with multiple episodes of UTIs and NVH over intervals of different lengths. In this way, clinicians can better understand the risk in different patient groups, and therefore provide more tailored management (treatment, referral, or monitoring) of patients with non-alarm cancer symptoms.
Our secondary aim is to examine the pros and cons of monitoring or re-referring symptomatic patients at different intervals following previous specialist investigations. We will also consider the health economic implications of implementing these risk stratifying approaches in the management pathway.
Our findings will improve the risk stratification of symptomatic patients of urological cancer, and further refine clinical guidelines.
Early diagnosis of cancer is associated with improved survival and patient-reported outcomes. However, timely detection of bladder and kidney cancer can be challenging as urinary symptoms are common and can be due to other benign conditions. Although current NICE guidelines suggest a non-urgent referral in patients with unexplained recurrent or persistent UTIs, the definition of ‘recurrence’ and ‘persistence’ is not clear. Further, it is not known what the risk of bladder or kidney cancer is in patients with recurrent UTIs, making monitoring and safety netting challenging in primary care.
Besides UTIs, there is a lack of consensus regarding the management of NVH. Understanding the risk of NVH for urinary tract cancers in the context of other risk factors may improve diagnostic yield and allow better risk stratification and management of patients.
The primary aim of this study is to provide up-to-date, novel evidence on the positive predictive values (PPVs) in patients of symptoms and diagnoses of UTIs and NVHs, especially in recurrent episodes. Conditional logistic regression will be used, and PPVs will be converted for combinations of symptoms and other risk factors such as age, sex, smoking status, BMI and deprivation. We aim to better identify patient categories at increased risk of cancer, so that guidance for referrals of patients with UTIs can be refined.
A secondary aim of the study is to examine the value of different intervals for the monitoring of NVH and recurrent UTIs following previous urological investigations (eg. cystoscopy and imaging test), so that appropriate clinical guidance can be developed for the monitoring of symptomatic patients in primary care.
We will develop and perform model-based health economic analyses to assess the value (additional cost per quality-adjusted life-year gained) of different approaches to risk stratification of these patients to determine their use in patient management.
1. Odds ratios, converted to positive predictive values (PPV), for cancer associated with low risk urological symptoms . These non-alarm symptoms include UTI and NVH, individually and in combination with other risk factors (age, sex), for single and repeated episodes.
2. Other outcomes of interest to inform the health economic analysis will include bladder or kidney cancer diagnosis, other common cancer diagnoses, other non-malignant disease (including benign tumours), cancer stage at diagnosis for any cancer, cancer route to diagnosis, diagnostic tests (including ultrasound, CT, cystoscopy and any other relevant tests), referrals, A&E attendances, hospital admissions, treatments, and mortality.
Yin Zhou - Chief Investigator - Queen Mary University of London
Yin Zhou - Corresponding Applicant - Queen Mary University of London
Borislava Mihaylova - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Fiona Walter - Collaborator - Queen Mary University of London
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Panagiotis (Panos) Alexandris - Collaborator - Queen Mary University of London
Stephen Duffy - Collaborator - Queen Mary University of London
Wei Shen Tan - Collaborator - University College London ( UCL )
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;NCRAS Cancer Registration Data;No additional NCRAS data required;ONS Death Registration Data;Patient Level Index of Multiple Deprivation