Patient reported outcome measures and quality indicators for NMIBC

9. PATIENT REPORTED OUTCOME MEASURES AND QUALITY INDICATORS FOR NMIBC

9.1. Patient Reported Outcome Measures and Patient Reported Experience Measures in NMIBC

As NMIBC is associated with a significant number of hospital visits and interventions (TURBT, re-TURBT, surveillance cystoscopy, intravesical instillations), survivorship has a significant effect on patient QoL [525, 526]. Several Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) have been developed to gauge the impact of treatment and surveillance on patients with a view to improving quality of care; however, due to lack of standardisation and heterogeneity none of them can currently be recommended for use in clinical practice [527]. In an effort to add further outcome measures of importance to patients with NMIBC, a NMIBC Symptom Index (NMIBC-SI) has been developed [528].

To provide the best possible care, clinicians should always be cognisant of the impact of disease and treatment (including surveillance) on their patients’ QoL. The use of PROMs is an important endpoint for quality metrics and RCTs should systematically incorporate PROMs for patient-centred research design. A prospective evaluation, where 108 patients filled out the ICIQ-LUTS questionnaire regarding urinary symptoms, postoperative side effects, and QoL (EQ-5D-3L) at days one and 14 postoperatively, found that the most frequently reported outcomes were postoperative haematuria and pain. Patients undergoing TURBT reported longer lasting haematuria, a higher perception of pain, and a more negative impact on QoL, compared to patients undergoing TULA [290]. From the ENVISION single arm trial, where patients received chemo-ablation with Mitomycin (UGN-102) instead of TURBT, patients perceived that TURBT interfered more with their routine/responsibilities; urinary symptoms were perceived to be similar, but bleeding, catheter issues, and time to resuming sexual activity lasted longer with TURBT, and patients would recommend UGN-102 to other patients as it was perceived to be less invasive, less painful, and less time-consuming than TURBT [529].

9.2. Quality Indicators in bladder cancer

Evidence based QIs and QPIs are designed to be surrogates of good practice and consequently, outcomes. They allow for the gap between efficacy and effectiveness to be narrowed, i.e. being able to bring research evidence and guideline recommendations into real world practice by improving compliance to them [530]. They also permit objective monitoring of the quality of care and thus facilitate quality control as well as service and process improvements.

Several QIs for BC have been suggested [531-534]. The table below represents the general and NMIBC-related QIs adapted from Leow et al., [533] and the Scottish QPI programme [534]. Quality indicators and QPIs should be SMART (Specific, Measurable, Achievable, Relevant, Trainable) [530]. In 2014, Scotland introduced such a programme for BC [534] and have been an exemplar by demonstrating high levels of compliance to QPIs while reducing practice variation across the country, and also demonstrating the clinical value of such a programme [184], including development of prognostic models [504].

Successful implementation of a QI programme has the potential to inspire and catalyse clinical excellence in contemporary BC practice [530]. It is equally important that prospective audit-feedback mechanisms are utilised to improve outcomes and modify QIs using emerging evidence, to ensure they are fit for purpose [535].

Table 9.1: Quality indicators for general aspects of BC and NMIBC care, adapted from [533, 534]

General aspects of BC care	Recommended Quality Indicators
Appropriate imaging for patients newly diagnosed with BC.	Newly diagnosed BC patients who have cross-sectional imaging of upper urinary tract (e.g. CT, MRI or US), as recommended in Section 5.4.
Participation in clinical trials	Availability of clinical trials to BC patients who are treated at a particular health care facility.
Aspects of NMIBC care	Recommended Quality Indicators
Pre-operative:
Counselling	At the time of diagnosis, patients should be counselled to discontinue tobacco smoking.
Intra-operative:
Tumour/patient history	Use of an intra-operative checklist, as recommended in Table 5.1.
Conduct of TURBT	Patients with muscle present in specimen from initial TURBT (excluding Ta LG disease).
Conduct of TURBT	Use of a Bladder Diagram, as per Figure 5.1.
Re-staging TURBT	Restaging TURBT should be performed within two to six weeks of the initial TURBT and include resection of the primary tumour site, as recommended in Section 5.13.
Post-operative:
Risk stratification and surveillance counselling for patients with NMIBC	Use the EAU 2021 Risk Stratification for progression and the 2006 EORTC scoring model for recurrence to counsel patients with NMIBC on treatment and surveillance.
Intravesical therapy	Patients who received immediate post-TURBT instillation of intravesical chemotherapy, excluding those with contraindications (e.g. incomplete resection, suspected perforation, significant haematuria).
Intravesical therapy	Intermediate- and high-risk NMIBC patients who were counselled and subsequently initiated adjuvant intravesical chemotherapy or BCG, respectively.
Multidisciplinary team management	Patients with high risk and very high risk NMIBC should be discussed in a multi-disciplinary meeting to ensure comprehensive review and options.
Appropriate frequency of surveillance based on stage/grade of BC	Appropriate intervals between cystoscopic surveillance, as per Table 8.2.
	Appropriate assessment of the upper urinary tract in high-risk patients.

BC = bladder cancer; BCG = bacillus Calmette-Guérin; CT = computed tomography; EAU = European Association of Urology; EORTC = European Organisation for Research and Treatment of Cancer; MRI = magnetic resonance imaging; NMIBC = non-muscle-invasive bladder cancer; TURBT = transurethral resection of the bladder tumour; US = ultrasound.