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Last updated: 13 January 2023, 1:35pm

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Last updated: 22 November 2022, 7:17pm

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Last updated: 13 January 2022, 11:33am

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Last updated: 4 November 2021, 4:43pm

Melanie Morris, NPCA Lead Epidemiologist

The NPCA’s aim is to stimulate and support local and national quality improvement interventions and – through annual re-auditing – assess the impact of these interventions. A key component is the ‘outlier process’, whereby the NPCA identifies where improvement is required.

Appropriate performance measures are essential when trying to understand the quality of care received by patients and how this varies by hospital. Many men experience treatment-related side effects after radical surgery or radiotherapy for localised prostate cancer including detrimental impacts on urinary, bowel and/or sexual functioning. To help us to understand the impact of these side-effects after radical treatment, the NPCA has developed ‘treatment-outcome’ measures that are meaningful and relevant to patients and clinicians .

Over the years, the NPCA team have developed various indicators, validating and testing their use before integrating them into the audit itself. Now we are considering the implications of moving in our analyses from the use of our current three-tiered risk stratification system to one with five tiers. In our short report, published in February 2021, we lay out the impact this would have on one area of the audit’s reporting: the assessment of the potential ‘over-treatment’ of men with low-risk disease.

What is the current classification system and how is it used?

The three-tiered system of low-, intermediate- and high-risk/locally advanced groups is advocated in the 2019 NICE guidelines and the NPCA has used a similar system, based on a modified D’Amico classification, for several years. We take the anonymised data on each man’s PSA level, Gleason score and the size of his tumour (gathered by each Trust or Health Board, and provided to us by our data partners), and combine them in an established algorithm to assign him to one of these three risk groups or to metastatic disease status.

We use the stratification to restrict our analyses to the relevant men: for instance, we examine the proportion of men with high-risk/locally advanced disease receiving radical prostate cancer therapy. This gives us a measure of the potential ‘under-treatment’ of men who should be eligible for this treatment.

We also use the risk groups to examine the proportion of men classified as having low-risk disease who receive radical treatment and thus the potential for ‘over-treatment’ in this group. These proportions have been coming down steadily over recent years: from 12% in 2016 to 4% in this year’s and last year’s Reports. There is a range across providers, however, with some still as high as 16%. The short report examined how the new five-tiered stratification system would impact these estimates of ‘over-treatment’.

What is the new system?

Several risk stratification tools exist which use the same clinical measures as our current three-tiered system and studies have shown that these have differing abilities to predict prostate cancer mortality and other outcomes (1-3). A five-tiered risk stratification system better describes the range of disease presentation and more closely predicts outcomes for patients, for example by splitting the intermediate group into ‘favourable’ and ‘unfavourable’ prognoses. Five-tiered systems are already used in the USA and one has recently been developed using ‘real world’ UK registry data by Vincent Gnanapragasam and colleagues called the Cambridge Prognostic Group (CPG) classification (4), the only system derived in the UK. It has now been tested in over 80,000 men across three countries, and Matt Parry and other members of the NPCA team collaborated with Vincent to explore its relevance to the NPCA  (5).

CPG1 encompasses more men than the existing low-risk group, including some men who previously would have been in the intermediate-risk group: it comprises men who have a Gleason score of 6 and a PSA <10ng/ml and a tumour at stage T1 or T2.

Another major difference is that Gleason score 7 is subdivided in the CPG, picking up the difference, for instance, between one made up of 3+4 (more grade 3 cells than grade 4 cells, more ‘favourable’) versus one made up of 4+3. This difference is reflected in the split of CPG2 and CPG3, which are both within the existing intermediate-risk group.

The CPG also has two tiers which correspond to the current high-risk group, dividing men with higher grade prostate cancer (Gleason score 9-10) or a stage T4 tumour, or those with a combination of Gleason score 8, PSA >20ng/ml or Stage 3 (making up CPG5), from men with only one of these last features of their cancer, who generally have better prognosis (CPG4).

Why might the CPG be preferable for use in the audit assessment of ‘over-treatment’?

The ability to subdivide our cohorts of men more precisely is beneficial to the analysis of trends in treatment. Focusing on our assessment of the ‘over-treatment’ indicator, we wanted to examine what impact using the CPG classification would have by comparing it to using the three-tiered risk grouping for the same cohort of men.

Importantly, CPG1 included more men: 15% of men in the cohort compared to 6% into the low-risk group. By their clinical characteristics, all of these men would have been eligible for active surveillance, rather than radical treatment. So, by using the CPG classification we not only have a more robust measure due to larger numbers, but one that encompasses more clinically relevant patients for the indicator.

In our comparison, 4% of men classified as having low-risk disease had radical treatment, compared to 10% of those classified in the CPG1 group. The socio-demographic characteristics of men in both of these lowest risk groups were similar to each other, whether they received radical treatment or not, showing that the differences in treatment receipt did not originate there.

By including more eligible men in the indicator, we can also better highlight for providers where they might need to examine practice and make changes. Using CPG1, we found more variation was apparent between providers, and five were highlighted as being outside the expected range of values, whereas only one (a different one) was outside these limits when restricting to the low-risk group.

What are the possible challenges?

We rely on the completeness and accuracy of the data we receive to make these classifications and so the audit, as always, is only as good as the data we put in. We know that during the pandemic data gathering and collating has been extra challenging and we may need to produce our next audit report on the basis of reduced datasets, but going forward we expect to be able to use the full and complete data as before, allowing the CPG classification to be implemented.

We also know that we still need to consider men whose disease is node positive (who were previously included in the high-risk/locally advanced group, but are not encompassed by the CPG classification) and men with metastatic disease. If we adopt the CPG classification throughout the audit, the treatments given to these groups of men and their outcomes, will continue to be monitored separately.

Finally, we know that any post-hoc classification system may not exactly reflect clinical decisions that were made at the time; these, of course, will consider various factors beyond the clinical characteristics. We don’t pretend to advise here about the utility of the different systems for clinical practice, but we are heartened to hear anecdotally that the five-tiered CPG system is being used more and more by clinicians, and that NICE are conducting a review into including it in their guidelines.

We wouldn’t expect the radical treatment of men with the lowest risk prostate cancer to ever reach zero, as patient choice and other considerations will always lead to some men receiving that treatment. But these risk stratification systems are our best resource for judging the appropriateness of treatments that the data show us were given to those men, and the CPG classification appears our best bet to do that robustly and for a wide range of indictors.

(1) Zelic R, Garmo H, Zugna D, et al. Predicting Prostate Cancer Death with Different Pretreatment Risk Stratification Tools: A Head-to-head Comparison in a Nationwide Cohort Study. Eur Urol. 2020 Feb;77(2):180-188.

(2) Gnanapragasam VJ, Barrett T, Thankapannair V, et al. Using prognosis to guide inclusion criteria, define standardised endpoints and stratify follow-up in active surveillance for prostate cancer. BJU Int. 2019;124(5):758-67.

(3) Gnanapragasam VJ, Lophatananon A, Wright KA, Muir KR, Gavin A, Greenberg DC (2016) Improving Clinical Risk Stratification at Diagnosis in Primary Prostate Cancer: A Prognostic Modelling Study. PLoS Med. 2016. 13(8): e1002063.

(4) Gnanapragasam VJ, Bratt O, Muir K, et al. The Cambridge Prognostic Groups for improved prediction of disease mortality at diagnosis in primary non-metastatic prostate cancer: a validation study. BMC Med. 2018;16(1):31.

(5) Parry MG, Cowling TE, Sujenthiran A, et al. Risk stratification for prostate cancer management: value of the Cambridge Prognostic Group classification for assessing treatment allocation. BMC Med. 2020;18(1):114.

Last updated: 27 April 2022, 8:42am

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Last updated: 14 January 2021, 2:22pm

Julie Nossiter, NPCA Audit Lead

The NPCA’s aim is to stimulate and support local and national quality improvement interventions and – through annual re-auditing – assess the impact of these interventions. A key component is the ‘outlier process’, whereby the NPCA identifies where improvement is required.

Appropriate performance measures are essential when trying to understand the quality of care received by patients and how this varies by hospital. Many men experience treatment-related side effects after radical surgery or radiotherapy for localised prostate cancer including detrimental impacts on urinary, bowel and/or sexual functioning. To help us to understand the impact of these side-effects after radical treatment, the NPCA has developed ‘treatment-outcome’ measures that are meaningful and relevant to patients and clinicians .

For the first time in 2019, the NPCA publicly reported validated and precise measures detecting urinary complications following surgery (radical prostatectomy) and bowel complications following radiotherapy (external beam radiation [EBRT]). These were based on data from routine clinical datasets, independent of individual clinician reporting. We also published measures of urinary, bowel and sexual function reported by patients in the NPCA Patient Survey. These indicators are adjusted for differences in patients’ age, prostate cancer risk group, other underlying conditions and deprivation status, enabling a fair comparison of the outcomes among NHS Hospitals.

Using funnel plots to compare individual hospital results with the national average, we identify ‘potential negative outliers’ whose performance is outside acceptable limits (further from the national average than would usually occur by chance alone). This information is fed back to clinical teams providing an opportunity for the hospitals to review the completeness and accuracy of their data with support from the NPCA team. After a period of reflection and exploration of possible causes, clinical teams develop a local improvement plan which is published by the NPCA alongside the results. The NPCA team also provide these results to other national quality improvement endeavours such as the National Clinical Audit Benchmarking initiative which supports Care Quality Commission hospital inspections, NHS England’s Clinical Outcomes Publication programme and the Getting it Right First Time (GIRFT) programme.

A potential limitation of the outlier process is that by targeting only the limited number of ‘outlier’ hospitals we mirror a ‘high-risk’ approach (rather than a population approach) of preventing poor quality care, with improvement endeavours restricted to the hospitals affected. The NPCA Quality Improvement workshop provided an opportunity to ‘close the circle’ by bringing together clinicians from surgical and radiotherapy centres across England and Wales including poorer performers, performance exemplars (positive outliers whose outcomes are consistently better than the national average) and all hospitals in between (whose performance is within expected limits).

Clinicians from the ‘better’ performing centres illustrated the steps they’d taken, and the protocols they’d developed, to reduce treatment-related toxicity after radical treatment for prostate cancer. Clinicians from the ‘under’ performing centres bravely shared their experience of the outlier process, the efforts undertaken to evaluate their practices and processes of care, and the changes made as a result.

It is clear that the outlier process can act as a catalyst to stimulate and promote local quality improvement. However, in order to spread quality improvement that can be scaled up to a national level (the population approach), the NPCA outlier process is embedded within a reporting programme that disseminates the results for all hospitals and illustrates both examples of good practice and learnings from hospitals who are embarking upon an improvement journey. This enables trusts to understand their performance relative to their peers and to make improvements as required.

It was encouraging to see the level of engagement by clinicians across the board during the workshop and their commitment to improving the outcomes for men undergoing radical treatment. We are committed to reporting treatment outcomes each year and assessing whether the changes implemented translate into a reduction in complication rates. Future NPCA workshops will provide more opportunities to reflect on the lessons learnt, to share best practice and to spread improvement mechanisms.

Last updated: 9 March 2021, 10:09am

Steve Allen, Tackle Prostate Cancer

I have been involved with NPCA as a patient representative for Tackle Prostate Cancer for two years. I have to say this was initially quite a daunting experience – if nothing else because of all the acronyms that were so freely used (and that I had not a clue about). Like many patients, I was also totally unaware of the size and complexity of the Audit and what information was collected.

When I was asked to become involved with a Quality Improvement workshop I was a little sceptical about the whole thing and what might be achieved. I have to confess that, as well as being a patient who has experienced prostate cancer, I am also a retired consultant anaesthetist. I was therefore aware of the reticence that some consultants (and other senior healthcare professionals) can have about comments being made on the standards of practice within their hospital and indeed about their own personal performance. Was this meeting a potential recipe for disaster?

I could not have been more wrong.

The over-arching impression I have of the day is one of total open-ness from all who attended. There was a willingness to take part in constructive dialogue to improve the quality of care for their patients. Of particular note were those speakers who talked very honestly about their experience of being identified by NPCA as having outcomes that were much lower that average and how they initiated strategies to improve matters. It was also quite obvious that such situations were handled very sensitively by the NPCA staff involved – there was never an air of ‘accusation’ but more one of wishing to help and support. (I must confess to sometimes having wandering moments of random thought during some meetings, and during this part of the day a song came into my mind: “It ain’t what you do, it’s the way that you do it – that’s what gets results”. That seemed to sum up the way in which under-performance was identified and handled by NPCA.)

But what of patients? What do they want to see from QI initiatives? What would benefit them? I went to the meeting with a totally open mind, but also with a number of questions as well.

What do patients want from ‘Data’?

Many patients are not familiar with the NPCA website and the detailed individual results available on their own hospital unit. Indeed, some might feel almost guilty at checking up on such results – and what would they do anyway if their results were poor? Is it better to be blissfully ignorant?

Some other patients, like myself, are heavily involved in such activities as raising awareness of prostate cancer, working towards better screening and diagnosis, highlighting areas where treatments can be improved etc. The NPCA Audit provides a wealth of reliable and up to date information which can be used when giving presentations and talking to others. However, these results could be in a slightly more accessible form. The Infographic and Patient Summary goes some way to address that, but more could be done. Greater publicity of the available results, easier access within the NPCA website, clearer interpretations of the more complex comparisons of results – much could be improved a little. This is now being addressed through the recently formed NPCA Patient Forum. A group of patients recruited from all over the UK has already begun to initiate its own QI in terms of information presented, and put forward cogent and practical comments.

What do patients expect of their treatment?

• No side effects
• Minimal impact on quality of life
• Equilibrium between quantity and quality of life

Much can be gained from the NPCA results reporting on patients’ experience of care following diagnosis, and the side effects and quality of life following radical surgical or radiotherapy treatment. For instance, information on such problems as incontinence and sexual dysfunction are of paramount importance to patients and are reported by the NPCA. As the NPCA only started reporting for men diagnosed from 2014, information on the ‘quantity of life’ will be reported after further follow-up.

Performance indicators are used each year so that direct comparisons can be made and changes can be identified – all very much to the benefit of patients. Given the opportunity, patients would probably include many more.

What do patients expect of their healthcare providers?

• The use of up to date technologies for both diagnosis and treatment
• Improved availability of support services:
– Access to nurse specialists
– Sufficient information and support
– Adequate access to specialist services – incontinence and sexual dysfunction clinics
– Ease of access to the hospital itself – adequate free car parking for regular attendances for treatment
• Local availability of all treatments wherever possible

Findings from the NPCA have highlighted many such important factors on the basis of clinical data. Examples are the uptake of mpMRI (multiparametric MRI) and its implementation before prostate biopsy, the earlier appropriate use of adjuvant therapies (chemotherapy) in newly diagnosed metastatic prostate cancer.

The NPCA surveys hospital teams each year to find out about the provision of support services. However, patients have sometimes questioned the accuracy of the responses of their local unit. Units may report that a service is available, while patients’ experience is that not all are offered or can access the service that might exist in theory. However, the NPCA cannot be criticised for that. They can only report the information given to them.

Those of us aiming to improve the care of patients need hard data and robust results to support our efforts. NPCA does contribute greatly to this. We could do with more, but we have to understand how difficult and time-consuming such a process is. However, that shouldn’t stop us from asking and pushing for more.

As a patient I want the hugely complex task that is the NPCA not just to have the ‘static’ outcome of reporting reliable results, but also the ‘dynamic’ outcome of healthcare providers using this information to improve the quality of care for their patients. The QI workshop reassured me that this was happening and would continue to do so.

What can I do with this information as a patient?

Like many others, I have a passion for improving the lives of other patients. I can use positive outcomes demonstrated by the results to reassure others of the improvements in care that are being achieved. I can also use the negatives to highlight the areas where is more work to be done. It is, for example, quite staggering that 16% of men still have metastatic disease at the time of diagnosis – despite the efforts of many of us to promote awareness of PSA testing in appropriate men. There is still a lot to do.

Obviously one of the problems of statistics and data is that you can select and highlight the bits that you want to. Ensuring proper use of the information is as important as producing it.

Which brings me back to the song – but with an added word: “It ain’t only what you do, it’s the way that you do it – that’s what gets results..”

Last updated: 9 November 2020, 10:40pm

Arunan Sujenthiran, NPCA Clinical fellow and Urology Specialist Registrar

During the NPCA’s Quality Improvement workshop we described the journey we have taken over the last few years to investigate some common side-effects that can occur following prostate cancer treatment. This is a key priority for the NPCA as we know many men live with the consequences of their prostate cancer treatment for many years, even once their cancer is cured.

The NPCA evaluates common side-effects (urinary and bowel) following surgery (radical prostatectomy) and radiotherapy. During the Quality Improvement workshop we explained how we developed “treatment-related indicators” to capture these side-effects; and then how these “indicators” have been used to compare providers and to evaluate newer treatments.

Indicator Development & Validation

Within the NPCA we have linked large data sets related to patient, disease and treatment characteristics in a partnership with our data sharing partners. One of these data sets, Hospital Episodes Statistics (HES), is an administrative dataset that includes both procedural codes (OPCS-4) and diagnostics codes (ICD-10). We developed and validated treatment-related toxicity indicators, primarily based on these codes, to capture severe urinary and bowel side-effects following radical treatment. During the presentation we highlighted steps taken by the NPCA team to ensure these indicators were transparent and robust in their methodology (1).

Patient-reported outcome measures (PROMs)

The NPCA has also carried out a Patient Survey to determine men’s views of their outcomes following treatment, including questions about their quality of life and sexual/urinary/bowel functioning. Questionnaires were sent to all men who received or were candidates for radical treatment. The workshop audience was encouraged by the excellent patient engagement achieved with almost three quarters of men (73%) responding. Answers from the questionnaire were used to generate validated scores (from the EPIC-26 scale) representing urinary incontinence and sexual function after radical prostatectomy, and bowel and sexual function after radiotherapy.

Evaluation of treatment modalities

These indicators have been used to assess variation across NHS centres and to evaluate newer surgical and radiotherapy treatments. The first study evaluated the three techniques used to perform radical prostatectomy. The robotic approach has been rapidly adopted in the UK without robust evidence on functional outcomes compared to the previous standard of open or laparoscopic surgery. Using our treatment-related toxicity indicators, on the basis of routine data, we showed that robotic-assisted radical prostatectomy resulted in significantly less urinary toxicity than either laparoscopic or open radical prostatectomy. We found specifically that “stricture-related” toxicity was lower after robotic-assisted radical prostatectomy (2).

We also compared functional outcomes reported by men undergoing the different surgical modalities. We found that robotic-assisted radical prostatectomy was associated with slightly higher sexual function scores (an increase of 3.5 points on a scale of 0-100) compared with the open approach but this did not meet the threshold for a clinically meaningful change, suggesting that most patients would not identify this difference as important. There were no differences in urinary or bowel function scores between the surgical modalities (3).

We also investigated treatment-related toxicity comparing 3D-conformal radiotherapy (3D-CRT) with intensity-modulated radiotherapy (IMRT) in both the primary and post-prostatectomy settings. In the primary setting, IMRT resulted in significantly less urinary toxicity and similar bowel toxicity (4). In the post-prostatectomy setting however, we found no difference between IMRT and 3D-CRT in terms of urinary and bowel toxicity (5). Given IMRT is now widely used in the UK, these studies supported current practice though raised questions about the benefit of IMRT in the post-prostatectomy setting.

Further work has compared treatment-related toxicity using ‘prostate-only’ versus ‘prostate and pelvic lymph node’ IMRT. In this study we found that there was no significant difference in urinary and bowel toxicity between the two groups (6). We therefore recommended that pelvic lymph node irradiation should be considered in the high-risk population.

The final study we presented was a comparison of hypofractionated and conventionally fractionated radiotherapy. There has been a transition to hypofractionation in the UK but toxicity remains uncertain in older men and locally advanced disease. Using our real-world data sets we were able to evaluate this and found no difference in severe urinary and bowel toxicity with hypofractionation (7). We found similar results when PROMs were used to compare the groups, which further supports the use of hypofractionation as the standard for radiotherapy in men with non-metastatic prostate cancer (8).

The session was concluded by discussing some of the future research work the NPCA will be working on including the effect of high dose-rate (HDR) brachytherapy boost on toxicity and outcomes of other prostate cancer treatment modalities such as focal therapy. This was followed by questions from the audience who were interested in the indicators used as well as the breadth of research questions we have answered using real-world data.

There was lively discussion regarding the importance of nationally collected PROMs as part of the NPCA to inform treatment decision making and quality improvement.

1) Sujenthiran A, Charman SC, Parry M, et al. Quantifying severe urinary complications after radical prostatectomy: the development and validation of a surgical performance indicator using hospital administrative data. BJU Int. 2017;120(2):219‐225.

2) Sujenthiran A, Nossiter J, Parry M, et al. National cohort study comparing severe medium-term urinary complications after robot-assisted vs laparoscopic vs retropubic open radical prostatectomy. BJU Int. 2018;121(3):445‐452.

3) Nossiter J, Sujenthiran A, Charman SC, et al. Robot-assisted radical prostatectomy vs laparoscopic and open retropubic radical prostatectomy: functional outcomes 18 months after diagnosis from a national cohort study in England. Br J Cancer. 2018;118(4):489‐494.

4) Sujenthiran A, Nossiter J, Charman SC, et al. National Population-Based Study Comparing Treatment-Related Toxicity in Men Who Received Intensity Modulated Versus 3-Dimensional Conformal Radical Radiation Therapy for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017;99(5):1253‐1260.

5) Sujenthiran A, Nossiter J, Parry M, et al. Treatment-related toxicity in men who received Intensity-modulated versus 3D-conformal radiotherapy after radical prostatectomy: A national population-based study. Radiother Oncol. 2018;128(2):357‐363.

6) Parry MG, Sujenthiran A, Cowling TE, et al. Treatment-Related Toxicity Using Prostate-Only Versus Prostate and Pelvic Lymph Node Intensity-Modulated Radiation Therapy: A National Population-Based Study. J Clin Oncol. 2019;37(21):1828‐1835.

7) Sujenthiran A, Parry M, Nossiter J, et al. Comparison of Treatment-Related Toxicity With Hypofractionated or Conventionally Fractionated Radiation Therapy for Prostate Cancer: A National Population-Based Study [published online ahead of print, 2020 Mar 3]. Clin Oncol (R Coll Radiol). 2020;S0936-6555(20)30044-3.

8) Nossiter J, Sujenthiran A, Cowling TE, et al. Patient-Reported Functional Outcomes After Hypofractionated or Conventionally Fractionated Radiation for Prostate Cancer: A National Cohort Study in England. J Clin Oncol. 2020;38(7):744‐752.

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Last updated: 9 November 2020, 10:38pm

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Last updated: 14 January 2021, 11:36am