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Guideline of guidelines: Asymptomatic Microscopic Haematuria

Abstract

The aim of the present study was to review major organizational guidelines on the evaluation and management of asymptomatic microscopic haematuria (AMH). We reviewed the haematuria guidelines from: the American Urological Association; the consensus statement by the Canadian Urological Association, Canadian Urologic Oncology Group and Bladder Cancer Canada; the American College of Physicians; the Joint Consensus Statement of the Renal Association and British Association of Urological Surgeons; and the National Institute for Health and Care Excellence. All guidelines reviewed recommend evaluation for AMH in the absence of potential benign aetiologies, with the evaluation including cystoscopy and upper urinary tract imaging. Existing guidelines vary in their definition of AMH (role of urine dipstick vs urine microscopy), the age threshold for recommending evaluation, and the optimal imaging method (computed tomography vs ultrasonography). Of the reviewed guidelines, none recommended the use of urine cytology or urine markers during the initial AMH evaluation. Patients should have ongoing follow-up after a negative initial AMH evaluation. Significant variation exists among current guidelines for AMH with respect to who should be evaluated and in what manner. Given the patient and health system implications of balancing appropriately focused and effective diagnostic evaluation, AMH represents a valuable future research opportunity.

NICE Guidance: Routine preoperative tests for elective surgery

Overview

This guideline covers routine preoperative tests for people aged over 16 who are having elective surgery. It aims to reduce unnecessary testing by advising which tests to offer people before minor, intermediate and major or complex surgery, taking into account specific comorbidities (cardiovascular, renal and respiratory conditions and diabetes and obesity). It does not cover pregnant women or people having cardiothoracic procedures or neurosurgery. To Get accurate insights into your health with an at-home blood test visit https://www.numan.com/blood-tests.

Who is it for?

  • Healthcare professionals
  • People having elective surgery, their families and carers

This guideline updates and replaces NICE guideline CG3 (published June 2003).

Recommendations

People have the right to be involved in discussions and make informed decisions about their care, as described in your care [https://www.nice.org.uk/about/nice-communities/public-involvement/your-care].

We expect you to take our guidance into account. But you should always base decisions on the person you are working with.

Making decisions using NICE guidelines [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/using-NICE-guidelines-to-make-decisions] explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Guidance on consent for young people aged 16–17 is available from the reference guide to consent for examination or treatment [https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition] (Department of Health).

The tests covered by this guideline are:

  • chest X-ray
  • echocardiography (resting)
  • electrocardiography (ECG; resting)
  • full blood count (haemoglobin, white blood cell count and platelet count)
  • glycated haemoglobin (HbA1c) testing
  • haemostasis tests
  • kidney function (estimated glomerular filtration rate, electrolytes, creatinine and sometimes urea levels)
  • lung function tests (spirometry, including peak expiratory flow rate, forced vital capacity and forced expiratory volume) and arterial blood gas analysis
  • polysomnography
  • pregnancy testing
  • sickle cell disease/trait tests
  • urine tests.

The recommendations were developed in relation to the following comorbidities:

  • cardiovascular
  • diabetes
  • obesity
  • renal
  • respiratory.

Recommendations relevant for all types of surgery

A colour poster version of these recommendations can be downloaded from tools and resources [https://www.nice.org.uk/guidance/ng45/resources].

  • 1.1

    Communication

    • 1.1.1
      When offering tests before surgery, give people information in line with recommendations (including those on consent and capacity) made in the NICE guideline on patient experience in adult NHS services [https://www.nice.org.uk/guidance/cg138].
    • 1.1.2
      Ensure that the results of any preoperative tests undertaken in primary care are included when referring people for surgical consultation.
  • 1.2

    Considering existing medicines

    • 1.2.1
      Take into account any medicines people are taking when considering whether to offer any preoperative test.
  • 1.3

    Pregnancy tests

    • 1.3.1
      On the day of surgery, sensitively ask all women of childbearing potential whether there is any possibility they could be pregnant.
    • 1.3.2
      Make sure women who could possibly be pregnant are aware of the risks of the anaesthetic and the procedure to the fetus.
    • 1.3.3
      Document all discussions with women about whether or not to carry out a pregnancy test.
    • 1.3.4
      Carry out a pregnancy test with the woman’s consent if there is any doubt about whether she could be pregnant.
    • 1.3.5
      Develop locally agreed protocols for checking pregnancy status before surgery.
    • 1.3.6
      Make sure protocols are documented and audited, and in line with statutory and professional guidance.
  • 1.4

    Sickle cell disease or sickle cell trait tests

    • 1.4.1
      Do not routinely offer testing for sickle cell disease or sickle cell trait before surgery.
    • 1.4.2
      Ask the person having surgery if they or any member of their family have sickle cell disease.
    • 1.4.3
      If the person is known to have sickle cell disease and has their disease managed by a specialist sickle cell service, liaise with this team before surgery.
  • 1.5

    HbA1c testing for people without diagnosed diabetes

    • 1.5.1
      Do not routinely offer HbA1c testing before surgery to people without diagnosed diabetes.
  • 1.6

    HbA1c testing for people with diabetes

    • 1.6.1
      People with diabetes who are being referred for surgical consultation from primary care should have their most recent HbA1c test results included in their referral information.
    • 1.6.2
      Offer HbA1c testing to people with diabetes having surgery if they have not been tested in the last 3 months.
  • 1.7

    Urine tests

    • 1.7.1
      Do not routinely offer urine dipstick tests before surgery.
    • 1.7.2
      Consider microscopy and culture of midstream urine sample before surgery if the presence of a urinary tract infection would influence the decision to operate.
  • 1.8

    Chest X-ray

    • 1.8.1
      Do not routinely offer chest X-rays before surgery.
  • 1.9

    Echocardiography

    • 1.9.1
      Do not routinely offer resting echocardiography before surgery.
    • 1.9.2

      Consider resting echocardiography if the person has:

      • a heart murmur and any cardiac symptom (including breathlessness, pre-syncope, syncope or chest pain) or
      • signs or symptoms of heart failure.

Before ordering the resting echocardiogram, carry out a resting electrocardiogram (ECG) and discuss the findings with an anaesthetist.

Recommendations for specific surgery grades (minor, intermediate, and major or complex) and ASA grades

The following recommendations are specific to surgery grade and ASA grade.

Surgery grades
Surgery grades Examples
Minor
  • excising skin lesion
  • draining breast abscess
Intermediate
  • primary repair of inguinal hernia
  • excising varicose veins in the leg
  • tonsillectomy or adenotonsillectomy
  • knee arthroscopy
Major or complex
  • total abdominal hysterectomy
  • endoscopic resection of prostate
  • lumbar discectomy
  • thyroidectomy
  • total joint replacement
  • lung operations
  • colonic resection
  • radical neck dissection
ASA grades

The ASA (American Society of Anesthesiologists) Physical Status Classification System [https://www.asahq.org/resources/clinical-information/asa-physical-status-classification-system] is a simple scale describing fitness to undergo an anaesthetic. The ASA states that it does not endorse any elaboration of these definitions. However, anaesthetists in the UK often qualify (or interpret) these grades as relating to functional capacity – that is, comorbidity that does not (ASA 2) or that does (ASA 3) limit a person’s activity.

ASA 1 A normal healthy patient
ASA 2 A patient with mild systemic disease
ASA 3 A patient with severe systemic disease
ASA 4 A patient with severe systemic disease that is a constant threat to life
Key to recommendations in tables

[Yes] Offer the test

[Not routinely] Do not routinely offer the test

[Consider] Consider the test (the value of carrying out the test may depend on specific patient characteristics)

Table 1. Minor surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4
  1. AKI, acute kidney injury. 1See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].

Full blood count Not routinely Not routinely Not routinely
Haemostasis Not routinely Not routinely Not routinely
Kidney function Not routinely Not routinely Consider in people at risk of AKI1
ECG Not routinely Not routinely Consider if no ECG results available from past 12 months
Lung function/arterial blood gas Not routinely Not routinely Not routinely
Table 2. Intermediate surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4
  1. AKI, acute kidney injury. 1Note that currently the effects of direct oral anticoagulants (DOACs) cannot be measured by routine testing. 2See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].

Full blood count Not routinely Not routinely Consider for people with cardiovascular or renal disease if any symptoms not recently investigated
Haemostasis Not routinely Not routinely Consider in people with chronic liver disease

  • If people taking anticoagulants need modification of their treatment regimen, make an individualised plan in line with local guidance
  • If clotting status needs to be tested before surgery (depending on local guidance) use point-of-care testing1
Kidney function Not routinely Consider in people at risk of AKI2 Yes
ECG Not routinely Consider for people with cardiovascular, renal or diabetes comorbidities Yes
Lung function/arterial blood gas Not routinely Not routinely Consider seeking advice from a senior anaesthetist as soon as possible after assessment for people who are ASA grade 3 or 4 due to known or suspected respiratory disease
Table 3. Major or complex surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4
  1. AKI, acute kidney injury. 1Note that currently the effects of direct oral anticoagulants (DOACs) cannot be measured by routine testing. 2See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].

Full blood count Yes Yes Yes
Haemostasis Not routinely Not routinely Consider in people with chronic liver disease

  • If people taking anticoagulants need modification of their treatment regimen, make an individualised plan in line with local guidance
  • If clotting status needs to be tested before surgery (depending on local guidance) use point-of-care testing1
Kidney function Consider in people at risk of AKI2 Yes Yes
ECG Consider for people aged over 65 if no ECG results available from past 12 months Yes Yes
Lung function/arterial blood gas Not routinely Not routinely Consider seeking advice from a senior anaesthetist as soon as possible after assessment for people who are ASA grade 3 or 4 due to known or suspected respiratory disease
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Residents’ Podcast: When to Perform Preoperative Chest CT for RCC Staging

Jesse Ory, Kyle Lehmann and Jeff Himmelman

Department of Urology, Dalhousie University, Halifax, NS, Canada

 

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Abstract

Objectives

To provide objective criteria for preoperative staging chest computed tomography (CT) in patients diagnosed with renal cell carcinoma (RCC) because, in the absence of established indications, the decision for preoperative chest CT remains subjective.

Patients and Methods

A total of 1 946 patients undergoing surgical treatment of RCC, whose data were collected in a prospective institutional database, were assessed. The outcome of the study was presence of pulmonary metastases at staging chest CT. A multivariable logistic regression model predicting positive chest CT was fitted. Predictors consisted of preoperative clinical tumour (cT) and nodal (cN) stage, presence of systemic symptoms and platelet count (PLT)/haemoglobin (Hb) ratio.

Results

The rate of positive chest CT was 6% (n = 119). At multivariable logistic regression, ≥cT1b, cN1, systemic symptoms and Hb/PLT ratio were all associated with higher risk of positive chest CT (all P < 0.001). After 2000-sample bootstrap validation, the concordance index was found to be 0.88. At decision-curve analysis, the net benefit of the proposed strategy was superior to the select-all and select-none strategies. Accordingly, if chest CT had been performed when the risk of a positive result was >1%, a negative chest CT would have been spared in 37% of the population and a positive chest CT would have been missed in 0.2% of the population only.

Conclusions

The proposed strategy estimates the risk of positive chest CT at RCC staging with optimum accuracy and the results were statistically and clinically relevant. The findings of the present study support a recommendation for chest CT in patients with ≥cT1b, cN1, systemic symptoms or anaemia and thrombocythemia. Conversely, in patients with cT1a, cN0 without systemic symptoms, anaemia and thrombocythemia, chest CT could be omitted.

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Article of the Week: When to Perform Preoperative Chest CT for RCC Staging

Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

When to perform preoperative chest computed tomography for renal cancer staging

Alessandro Larcher*, Paolo DellOglio*, Nicola Fossati*, Alessandro Nini*Fabio Muttin*, Nazareno Suardi*, Francesco De Cobelli, Andrea Salonia*Alberto Briganti*, Xu Zhang§, Francesco Montorsi*, Roberto Bertini*† and Umberto Capitanio*

 

*Division of Experimental Oncology, URI – Urological Research Institute, Unit of Urology, Vita-Salute San Raffaele University, Unit of Radiology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy, and § Clinical Division of Surgery, Department of Urology, Chinese PLA General Hospital, Beijing, China

 

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Abstract

Objectives

To provide objective criteria for preoperative staging chest computed tomography (CT) in patients diagnosed with renal cell carcinoma (RCC) because, in the absence of established indications, the decision for preoperative chest CT remains subjective.

Patients and Methods

A total of 1 946 patients undergoing surgical treatment of RCC, whose data were collected in a prospective institutional database, were assessed. The outcome of the study was presence of pulmonary metastases at staging chest CT. A multivariable logistic regression model predicting positive chest CT was fitted. Predictors consisted of preoperative clinical tumour (cT) and nodal (cN) stage, presence of systemic symptoms and platelet count (PLT)/haemoglobin (Hb) ratio.

Results

The rate of positive chest CT was 6% (n = 119). At multivariable logistic regression, ≥cT1b, cN1, systemic symptoms and Hb/PLT ratio were all associated with higher risk of positive chest CT (all P < 0.001). After 2000-sample bootstrap validation, the concordance index was found to be 0.88. At decision-curve analysis, the net benefit of the proposed strategy was superior to the select-all and select-none strategies. Accordingly, if chest CT had been performed when the risk of a positive result was >1%, a negative chest CT would have been spared in 37% of the population and a positive chest CT would have been missed in 0.2% of the population only.

Conclusions

The proposed strategy estimates the risk of positive chest CT at RCC staging with optimum accuracy and the results were statistically and clinically relevant. The findings of the present study support a recommendation for chest CT in patients with ≥cT1b, cN1, systemic symptoms or anaemia and thrombocythemia. Conversely, in patients with cT1a, cN0 without systemic symptoms, anaemia and thrombocythemia, chest CT could be omitted.

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Editorial: Do all patients with renal cell carcinoma need a chest computed tomography?

While all patients with RCC need chest imaging for staging evaluation, the answer to the question in the title is ‘No’, and, in fact, many patients would be adequately staged with a chest X-ray, albeit with reduced accuracy. Evidence to support this assertion is provided by Larcher et al. [1] in this issue of BJUI, who retrospectively evaluated 1946 patients with a solitary and sporadic RCC mass. While excluding patients who did not have surgery and those with visceral metastases seen on abdominal imaging, the authors observed pulmonary metastases in 6% (119 patients) of their population. In a multivariable analysis, features associated with a positive chest CT included cT1b+, cN1, systemic symptoms, anaemia, and thrombocytosis. Incorporating these features into a predictive model, the authors report a robust concordance index of 0.88, with the effect of each feature demonstrated in a nomogram. Further, the authors report that if a chest CT is only performed when the risk of a positive result is >1%, 37% of their population could have been spared a chest CT while missing a positive result in only 0.2% (four patients). Patient factors that predict for a <1% risk of a positive chest CT essentially include those with cT1aN0 RCC without systemic symptoms, anaemia, or thrombocytosis. Thus, the authors conclude that in these low-risk patients, a chest CT can be omitted, while any patient that is cT1b+, cN1, or with systemic symptoms, anaemia, or thrombocytosis warrants a dedicated chest CT at diagnosis.

The finding that patients with RCC with smaller tumours (cT1a or ≤4 cm) were unlikely to harbour pulmonary metastases is consistent with prior literature. Observations from the Memorial Sloan-Kettering Cancer Center (MSKCC) [2], and subsequently validated by our group at Mayo Clinic [3], suggested that among surgically treated patients with RCC, risk of M1 disease (at any location) at diagnosis was non-existent for tumours of <2 cm, was <1% for tumours of 2–3 cm, and was only 1–2% for tumours of 3-4 cm in size. Given that it is rare for patients with small renal masses to endorse systemic symptoms or have paraneoplastic symptoms related to the tumour, these prior observations suggest a lack of utility for chest CT for patients with small renal masses supporting the findings from Larcher et al. [1].

In patients with RCC with synchronous metastases, lung is the most common site of spread and guidelines uniformly recommend chest imaging at diagnosis. However, a ‘select-all’ strategy for chest CT in patients with renal masses leads to unnecessary findings in those with a benign primary tumour, increased use of healthcare resources, and relatively frequent findings of indeterminate lesions. In fact, contemporary observations from the MSKCC found that about half of patients with RCC undergoing surgery had indeterminate pulmonary nodules on chest CT that required either additional evaluation or subsequent chest CT to document stability [4]. Further, the presence of indeterminate pulmonary nodules was not associated with distant metastases or death from RCC after surgery unless they were >1 cm, which only represented a small portion (4%) of the entire cohort [4]. Thus, the analysis from Larcher et al. [1] in this issue of BJUI has meaningful clinical relevance; that is, patients with cT1aN0 RCC without symptoms or laboratory abnormalities do not require a chest CT for screening of their lungs.

R. Houston Thompson
Department of Urology, Mayo Clinic, Rochester, MN, USA

 

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References

 

1 Larcher A, DellOglio P, Fossati N et al. When to perform preoperative chest computed tomography for renal cancer staging. BJU Int 2017; 120: 4906

 

2 Thompson RH, Hill JR, Babayev Y et al. Metastatic renal cell carcinoma risk according to tumor size. J Urol 2009; 182: 415

 

3 Umbreit EC, Shimko MS, Childs MA et al. Metastatic potential of renal mass according to original tumour size at presentation. BJU Int 2011; 109: 1904

 

 

NICE Guidance: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

Overview

Evidence-based recommendations on enzalutamide (Xtandi) for treating metastatic, hormone-relapsed prostate cancer for people in whom chemotherapy is not yet clinically indicated.

Summary of Appraisal Committee’s Key Conclusions

TA377 Appraisal title: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is clinically indicated Section
Key conclusion

Enzalutamide is recommended, within its marketing authorisation, as an option for treating metastatic hormone-relapsed prostate cancer:

  • in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated
  • and only when the company provides it with the discount agreed in the patient access scheme.

The Committee concluded that, with its preferred assumptions, the resulting incremental cost-effectiveness ratio (ICER) for enzalutamide compared with best supportive care was likely to be between £31,600 and £34,800 per quality-adjusted life year (QALY) gained. This range was dependent on the method used to adjust survival estimates for active treatments not used in the NHS. Furthermore, it was likely to be nearer to the lower end of this range.

The Committee concluded that enzalutamide is innovative, and that taking into account factors, which had not been fully accounted for in the modelling, agreed that the ICER for enzalutamide compared with best supportive care was below £30,000 per QALY gained, and enzalutamide could be considered a cost-effective use of NHS resources.

1.1, 4.15, 4.18, 4.19
Current practice
Clinical need of patients, including the availability of alternative treatments

Enzalutamide is a well-tolerated treatment, and people welcome having more treatment options to delay cytotoxic chemotherapy.

Enzalutamide and abiraterone (taken before chemotherapy is clinically indicated) are currently available through the Cancer Drugs Fund. Although abiraterone before docetaxel is available to some people, it is not embedded within current NHS funding arrangements because its future is not guaranteed. It was therefore not considered as a comparator.

There are some people who can have enzalutamide but not abiraterone in clinical practice (people who can’t take corticosteroids, people with visceral disease and people with severe liver disease).

4.4, 4.1, 4.2, 4.18
The technology

Proposed benefits of the technology

How innovative is the technology in its potential to make a significant and substantial impact on health-related benefits?

Enzalutamide is the preferred treatment option for people with visceral disease and liver dysfunction, in whom abiraterone is contraindicated at this position in the treatment pathway, or for people who can’t take corticosteroids. Although enzalutamide is not a new treatment, it is the only treatment that can give these benefits at this position in the treatment pathway and so is innovative. 4.18
What is the position of the treatment in the pathway of care for the condition? Enzalutamide is indicated for people with metastatic hormone-relapsed prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy, before chemotherapy is indicated. 4.1
Adverse reactions Enzalutamide is a well-tolerated treatment. 4.4
Evidence for clinical effectiveness
Availability, nature and quality of evidence The efficacy estimates for enzalutamide came from PREVAIL. Enzalutamide increased overall survival (OS) compared with placebo. The Committee considered that adjusting the OS estimated from the trial for subsequent life-extending treatments taken by people in the trial, but which are not available in the UK, was appropriate. 4.6
Relevance to general clinical practice in the NHS The Committee was aware that in PREVAIL, once the disease progressed, people on enzalutamide could move on to subsequent treatments. It was also aware that the company considered that some of these treatments (such as abiraterone, enzalutamide, cabazitaxel, sipuleucel-T, cytotoxic chemotherapy other than docetaxel and investigational treatments) would not be used in England at this position in the treatment pathway. The Committee agreed that it was appropriate to adjust the survival estimates for people having these treatments. 4.6
Uncertainties generated by the evidence The extent of adjustment needed to the OS estimates (to account for subsequent treatments that people had in PREVAIL that are not available in clinical practice in England) was uncertain. It was unclear which of the methods the company had used for adjustment (the Inverse Probability of Censoring Weights or the two-stage method) was better, however IPCW was associated with fewer assumptions. 4.7
Are there any clinically relevant subgroups for which there is evidence of differential effectiveness? None identified.
Estimate of the size of the clinical effectiveness including strength of supporting evidence Enzalutamide increased OS compared with placebo, but the extent of the difference was uncertain because some people went on to have further active treatments in both study arms. The company tried to adjust for this but there was uncertainty about which method of adjustment was appropriate. 4.6, 4.7
Evidence for cost effectiveness
Availability and nature of evidence The company developed a new model and needed to extrapolate OS and time to treatment discontinuation from the trial data in its model. 4.9. 4.11, 4.12
Uncertainties around and plausibility of assumptions and inputs in the economic model

The model structure was appropriate in terms of the sequence of treatments people would have in clinical practice in England, but there was uncertainty about whether time spent on treatments after enzalutamide reflected clinical practice.

The Committee was concerned that that the company had not further checked the validity of the extrapolated data. This was particularly important because of the immaturity of the trial data and because of the small population at risk at the end of the trial follow-up (those who had not died or had been otherwise censored). This meant that a large proportion of the estimated survival benefit was based on the extrapolated period rather than the trial data.

4.9, 4.11

Incorporation of health-related quality-of-life benefits and utility values

Have any potential significant and substantial health-related benefits been identified that were not included in the economic model, and how have they been considered?

The Committee considered whether the model captured the benefits of delaying chemotherapy, which is important to patients. The Committee agreed that the model predicted that people having enzalutamide had more time with better utility than people on best supportive care, but it was unclear whether the benefit of delaying chemotherapy had been fully captured by the utility values included in the modelling. The Committee concluded that enzalutamide is innovative. 4.18, 4.19
Are there specific groups of people for whom the technology is particularly cost effective? None.
What are the key drivers of cost effectiveness? The data cut-offs from PREVAIL that are used in the modelling and the utility value estimates. 4.11, 4.12, 4.13
Most likely cost-effectiveness estimate (given as an ICER) The most plausible ICER for enzalutamide compared with best supportive care was nearer to £31,600 than to £34,800 per QALY gained. The Committee also concluded that enzalutamide is innovative and taking into account factors, which had not been fully accounted for in the modelling, agreed that the ICER for enzalutamide compared with best supportive care was below £30,000 per QALY gained. 4.15, 4.18, 4.19
Additional factors taken into account
Patient access schemes (PPRS)

The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.

The company revised its patient access scheme over the course of this appraisal to increase the discount to the cost of enzalutamide for the NHS.

2.3, 4.14
End-of-life considerations

The company did not make a case for enzalutamide meeting end-of-life criteria.

The Committee considered that the first criterion for end of life (the treatment is indicated for patients with a short life expectancy, normally <24 months) had not been met. Therefore, the Committee did not consider the other criteria and concluded that enzalutamide did not meet end-of-life criteria for treating metastatic hormone-relapsed prostate cancer in people for whom chemotherapy is not yet indicated.

4.17
Equalities considerations and social value judgements No equality issues were raised.

 

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Guideline of guidelines: non-muscle-invasive bladder cancer

Abstract

Non-muscle-invasive bladder cancer (NMIBC) represents the vast majority of bladder cancer diagnoses, but this definition represents a spectrum of disease with a variable clinical course, notable for significant risk of recurrence and potential for progression. Management involves risk-adapted strategies of cystoscopic surveillance and intravesical therapy with the goal of bladder preservation when safe to do so. Multiple organizational guidelines exist to help practitioners manage this complicated disease process, but adherence to management principles among practising urologists is reportedly low. We review four major organizational guidelines on NMIBC: the American Urological Association (AUA)/Society of Urologic Oncology (SUO), European Association of Urology (EAU), National Comprehensive Cancer Network (NCCN), and National Institute for Health and Care Excellence (NICE) guidelines.

gog-nmibc

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Video: International Consultation on Urological Diseases and European Association of Urology International Consultation on Minimally Invasive Surgery in Urology: laparoscopic and robotic adrenalectomy

International Consultation on Urological Diseases and European Association of Urology International Consultation on Minimally Invasive Surgery in Urology: laparoscopic and robotic adrenalectomy

Mark W. Ball*, Ashok K. Hemal† and Mohamad E. Allaf*

 

*James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, and Department of Urology, Wake Forest School of Medicine, Winston-Salem, NC, USA

 

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Abstract

The aim of this study was to provide an evidence-based systematic review of the use of laparoscopic and robotic adrenalectomy in the treatment of adrenal disease as part of the International Consultation on Urological Diseases and European Association of Urology consultation on Minimally Invasive Surgery in Urology. A systematic literature search (January 2004 to January 2014) was conducted to identify comparative studies assessing the safety and efficacy of minimally invasive adrenal surgery. Subtopics including the role of minimally invasive surgery for pheochromocytoma, adrenocortical carcinoma (ACC) and large adrenal tumours were examined. Additionally, the role of transperitoneal and retroperitoneal approaches, as well as laparoendoscopic single-site (LESS) and robotic adrenalectomy were reviewed. The major findings are presented in an evidence-based fashion. Large retrospective and prospective data were analysed and a set of recommendations provided by the committee was produced. Laparoscopic surgery should be considered the first-line therapy for benign adrenal masses requiring surgical resection and for patients with pheochromocytoma. While a laparoscopic approach may be feasible for selected cases of ACC without adjacent organ involvement, an open surgical approach remains the ‘gold standard’. Large adrenal tumours without preoperative or intra-operative suspicion of ACC may be safely resected via a laparoscopic approach. Both transperitoneal and retroperitoneal approaches to laparoscopic adrenalectomy are safe. The approach should be chosen based on surgeon training and experience. LESS and robotic adrenalectomy should be considered as alternatives to laparoscopic adrenalectomy but require further study.

 

aotwjan3-reults
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Guideline of guidelines: priapism

gog-priapism

Introduction

Priapism is defined as a prolonged penile erection lasting for >4 h in the absence of sexual stimulation and remains despite orgasm. Current guidelines for priapism have been published after a comprehensive literature review and expert consensus by the AUA and by an evidence review according to the Oxford Centre for Evidence-Based Medicine (OCEBM) by the European Association of Urology (EAU). Although there are both local and regional guidelines available throughout the UK, these tend to be adaptations of guidelines from larger urology organisations and there are currently no guidelines available from the BAUS. However, in the UK the management of complex cases is increasingly undertaken in specialist centres with the basic management following existing guidelines.

As priapism is a urological emergency, which requires immediate detumescence, the condition does not lend itself to randomised controlled trials and the EAU guidelines are based, at best, on Level 3 evidence.

gog-priapism-key-points

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Article of the Week: Patterns of prescription and adherence to EAU guidelines on ADT in PCa

Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Giuseppe Morgia and Giorgio Ivan Russo, discussing their paper.

If you only have time to read one article this week, it should be this one.

Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study

Giuseppe Morgia1, Giorgio Ivan Russo1, Andrea Tubaro2, Roberto Bortolus3, Donato Randone4, Pietro Gabriele5, Fabio Trippa6, Filiberto Zattoni7, Massimo Porena8Vincenzo Mirone9, Sergio Serni10, Alberto Del Nero11, Giancarlo Lay12 , Umberto Ricardi13, Francesco Rocco14, Carlo Terrone15, Arcangelo Pagliarulo16, Giuseppe Ludovico17, Giuseppe Vespasiani18, Maurizio Brausi19, Claudio Simeone20, Giovanni Novella21, Giorgio Carmignani22, Rosario Leonardi23, Paola Pinnaro5, Ugo De Paula24Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana dUrologia)

 

Department of Urology, University of Catania, Catania, Department of Urology, Sant Andrea Hospital, La Sapienza’ University of Roma, Roma, S.O. Oncologia Radioterapica, Pordenone, Urology, Presidio Ospedaliero Gradenigo, Torino, Radiotherapy, IRCC Candiolo, Torino, Radiotherapy, A.O. Santa Maria, Terni, Department of Urology, University of Padova, Padova, Department of Urology, University of Perugia, Perugia, Department of Urology, Universita Federico II of Napoli, Napoli,
10 Department of Urology, University of Firenze, Firenze, 11 Urologia I, Azienda Ospedaliera San Paolo, Milano, 12 Radiotherapy, ASL of Cagliari, Cagliari, 1Radiotherapy, AOU University S. Giovanni Battista Molinette, Torino, 14 Department of Urology, University of Milano, Milano, 15Urology, University Hospital Maggioredella Carita, Novara,16 Urology, University of Bari, Bari, 17 Urology, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, 18 Department of Urology, University Tor Vergata, Roma, 19 Urology, Ospedale Civile Ramazzini, Carpi, 20 Department of Urology, University of Brescia, Brescia, 21 Department of Surgery, Urology Clinic, AOUI Verona, Verona, 22 Department of Urology, University of Genova, Genova, 23 Urology, Centro Uro-Andrologico La CURA, Acireale, 24 Radiotherapy, AO S. Giovanni Addolorata, Roma, 25 Radiotherapy, Istituto Nazionale per la Ricerca, Genova, 26 Department of Urology, University of Chieti, Chieti, 27 Department of Urology, University of Trieste, Trieste, 28 Radiotherapy, Policlinico Universitario Agostino Gemelli, Roma, 29 Department of Surgical Sciences, Città della Salutee della Scienza, University of Torino, Torino, 30 Urology, Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalù, and 31 Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy

 

Read the full article

Objective

To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription.

Methods

The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B).

AOTWJun5Results

Results

The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D’Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT.

Conclusion

EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

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