Title: Identifying the facilitators and barriers to implementation of tumour biopsy in the diagnostic pathway for small renal masses
Funder: Department of Health and Social Care

Abstract: Research Question: What are the facilitators and barriers to the implementation of tumour biopsy in the diagnostic pathway of small renal masses? Background: The incidence of small renal masses (SRM) is increasing, in part due to increased uptake of imaging, however, earlier diagnosis and treatment has had no impact on overall kidney cancer mortality. The combination of rising incidence but stable mortality can be indicative of over-diagnosis and over-treatment. Up to 30% of renal masses are benign, and imaging cannot distinguish these from malignant lesions. Current standard practice is to surgically excise SRM with either partial (leaving rest of normal kidney) or radical (remove tumour and kidney as a whole) nephrectomy. Surgery has an overall complication rate 20% and a 0.5% mortality rate. Alternative management strategies include active surveillance or ablation, which are less invasive and have less complications. Renal tumour biopsy (RTB) can impact on treatment decision making by distinguishing benign or low grade tumours from high grade cancers with over 99% sensitivity and specificity. Having adopted RTB in our diagnostic pathway for SRM, our audited experience has shown that almost all patients (141 of 143) with benign or low-grade histology on RTB chose to avoid surgery in favour of surveillance or ablation. However, RTB is not adopted routinely across the UK. The British Association of Urology Surgeons nephrectomy audit showed that over a 4 year period and 32130 surgical cases, only 7% of patients were offered RTB. A recent study in Canada found that only 12% of urologists offered RTB routinely, and over half never offered it. Aims and objectives: This study aims to identify facilitators and barriers (professional and organisational) to understand what issues need to be addressed to enable the successful implementation of RTB for the benefit of patients with SRM. Methods: A mixed-methods approach: Qualitative semi-structured interviews with clinicians, commissioners and patients will be used to capture detailed insights into personal experience and perceptions regarding RTB. Participants will be recruited from 5 hospitals ranging from high to low procedural volume. Patient and public focus groups to explore common trends, perceptions and assumptions while providing diversity among participants. A questionnaire based on the influential facilitators and barriers elicited from the interviews and focus groups will be developed to assess the prevalence of such perceptions from a wider population. Roundtable workshops to include both patients and clinicians to discuss viewpoints and construct intervention strategies. Health economic analysis will be conducted and a decision-analytic model developed to estimate the cost-effectiveness of RTB adoption. Timelines for delivery: The study is scheduled to take 24 months: 3 months preparation, 9 months for interviews and focus groups, 6 months for questionnaires and roundtable discussions, 6 months for analysis and report. Anticipated impact and dissemination: This study will provide insight to develop implementation strategies to improve access to RTB, that could make a major change to clinical practice to benefit patients. Findings will be disseminated at national conferences, peer-reviewed journals and patient websites such as Kidney Cancer UK and Royal Free Charity.

Lay abstract: Background to the research: Kidney tumours are increasingly detected in patients having investigations for unrelated symptoms. Currently, it is not possible to tell whether a tumour is benign or cancer by a scan, blood or urine test. Most patients diagnosed with a kidney tumour are offered surgery, but this carries serious risks. These include a 1 in 20 risk of a major complication requiring intervention such as injury to the bowel, liver or spleen and a 1 in 200 risk of death. A biopsy can usually tell whether a kidney tumour is benign or cancer. Some hospitals offer biopsies for small kidney tumours and it can change the way in which a patient may want to have their tumour treated. Instead of surgery, patients with benign tumours often choose to have monitoring or alternative treatments such as freezing the tumour which has less risks. Most side effects of biopsies (discomfort, bruising and blood in the urine) resolve without treatment. Nearly 6 in 10 kidney tumours are benign or are low grade (59%), meaning that they are unlikely to cause harm. This means that over half of patients can potentially avoid surgery if they have a biopsy. Aims of the research: Currently, access to biopsies is not equal across the UK. We want to find out what the barriers are and what action is required to offer a tumour biopsy service to all patients to help guide treatment decision and improve outcomes. Design and methods used: We will interview doctors, commissioners, and patients to explore current service and viewpoints on the role of biopsy in the diagnosis of kidney lumps. We will include at least 5 hospitals to cover high, medium and low volume centres and get representation across the health delivery service. Patient and public involvement: We have conducted a pre-study online survey with the Kidney Cancer UK (KCUK) charity. 140 patients, family members and general public responded 89% said that knowing whether a tumour was benign or cancerous would help decide whether or not to have surgery 93% thought it was important to find out why some hospitals didn t offer kidney tumour biopsies 94% thought it was important to find out how a tumour biopsy service could be implemented so that every patient had access to it if they wanted only 22% of patients were offered a biopsy Our patient representatives for this study have been involved in drafting the study protocol and will represent patient views on the trial management committee. Dissemination: We will present the findings from this study at national and international clinical meetings. We will also communicate results to the kidney cancer community via social media and the KCUK and Royal Free Hospital websites.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS;RENAL AND UROGENITAL