2 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.

2.1 Patient satisfaction

What are the causative and contributory factors underlying the persistently very low levels of reported patient satisfaction for bladder cancer?

Why this is important

The urological cancers grouping (which includes bladder cancer but excludes prostate cancer) has consistently appeared near the bottom of the table of patient satisfaction comparisons of all cancer types in national patient experience surveys. Prostate cancer (which is also managed in urological services) is recorded separately and has continued to appear near the top of the tables.

It is uncertain why this is the case, except that there is now an accepted link between the level of clinical nurse specialist allocation, information and support provision and patient satisfaction. The urological cancers grouping has the lowest level of clinical nurse specialist allocation in comparison with all other cancer types or groupings (including prostate cancer). The prolonged pattern of intrusive procedures that dominate investigation, treatment and follow‑up regimens for bladder cancer may also contribute to this position. Additionally, there is concern that people with bladder cancer at or near the end of life, who are by that stage often quite frail and elderly, may not always have access to the full range of palliative and urological support and may, at times, be treated in general wards in hospital and experience significant symptoms of pain and bleeding (haematuria).

To explore this research question bladder cancer patients need to be identified separately from the generic group of urological cancer patients in nationally collected data sets.

2.2 BCG or primary cystectomy in high-risk non-muscle-invasive bladder cancer

Is primary radical cystectomy more effective than primary intravesical BCG in high-risk non‑muscle‑invasive bladder cancer, in terms of quality of life and cancer‑specific outcomes?

Why this is important

Options for people with high‑risk non‑muscle‑invasive bladder cancer include cystoscopy surveillance, BCG immunotherapy or radical surgery. To date, these have not been directly compared across the same population to understand their relative benefits.

Bladder‑sparing approaches avoid major surgery, but have a greater risk of cancer progression. The potential advantage of bladder‑sparing approaches compared with cystectomy in maintaining quality of life may be offset by continuing concern about cancer progression and morbidity from treatment. Primary cystectomy may improve survival; however, it has high short‑term risks and life‑changing consequences. It will be overtreatment for those people whose cancer would not have progressed.

2.3 Follow-up of high-risk non-muscle-invasive bladder cancer

In people with high‑risk non‑muscle‑invasive bladder cancer, are these follow‑up regimens equally effective in terms of identification of progression, cost effectiveness and health‑related quality of life?

  • Cystoscopic follow‑up at 3, 6, 12, 18, 24, 36 and 48 months, and then annually, interspersed with non‑invasive urinary tests.

  • Cystoscopic follow‑up at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months, and then annually thereafter.

Why this is important

Cystoscopy is currently the standard of care for follow‑up of people with high‑risk non‑muscle‑invasive bladder cancer. Regular cystoscopy may be associated with anxiety, procedural discomfort to the person and significant costs to the NHS.

Urine tests based on a variety of technologies (including cytology, fluorescence in‑situ hybridization [FISH] and proteomic platforms) can detect high‑grade recurrence, raising the possibility that 1 or more of these tests could be used to reduce the frequency of cystoscopy. This could improve acceptability to patients and reduce costs to the NHS without increasing the risk of disease progression.

There is a lack of evidence on the optimal frequency of follow‑up and whether the frequency of cystoscopy follow‑up can safely be reduced by substitution of urinary tests.

2.4 Biomarkers for treatment selection

In patients with muscle‑invasive bladder cancer suitable for radical treatment, does the use of biomarkers enable patients to select more effective treatment, and improve their outcomes, compared with treatment selected without biomarkers?

Why this is important

Response to surgery or radiotherapy is difficult to predict for individuals. There is variation not only in the cure rates for patients with muscle‑invasive bladder cancer treated with either surgery or radiotherapy, but also in the side effects experienced during and after treatment. The usefulness of current biomarkers in predicting treatment outcomes for individual patients has not been clearly established. Currently treatment decisions are based on patient‑related factors, and patient and clinician preference. Research into biomarkers that can predict the response of the patient's muscle‑invasive bladder cancer to either radiotherapy or surgery could help individual patients and clinicians decide which treatment is more suitable and is considered an important step toward individualised treatment.

2.5 Follow-up after radical treatment for organ-confined muscle-invasive bladder cancer

Is symptom‑based review as effective as scheduled follow‑up for people treated with radical cystectomy or radical radiotherapy for organ‑confined, muscle‑invasive bladder cancer? Outcomes of interest are overall survival, health‑related quality of life, resource use and cost.

Why this is important

Standard care after treatment for organ‑confined, muscle‑invasive bladder cancer is scheduled follow‑up at intervals set out by the treating team. Although this can be reassuring for both the patient and the treating team, it is not known whether scheduled follow‑up offers clinical benefit compared with symptom‑based review, which is increasingly used for people with other cancers. Moreover, there are significant costs associated with follow‑up. The current evidence about follow‑up is confined to cystectomy. There is no evidence concerning follow‑up after radiotherapy. In addition, the evidence on radiological follow‑up uses mainly outdated imaging techniques.

  • National Institute for Health and Care Excellence (NICE)