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Article of the Week: Muscolofascial Reconstruction after RP

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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 Dr. Francesco Alessandro Mistretta, discussing his paper.

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

Posterior musculofascial reconstruction after radical prostatectomy: an updated systematic review and a meta-analysis

 

Angelica A.C. Grasso*, Francesco A. Mistretta*, Marco Sandri†, Gabriele Cozzi*, Elisa De Lorenzis*, Marco Rosso*, Giancarlo Albo*, Franco Palmisano*, Alex Mottrie‡, Alexander Haese§, Markus Graefen§, Rafael Coelho, Vipul R. Patel¶ and Bernardo Rocco*

 

*Department of Urology, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, †DMS StatLab, Data Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy, ‡OLV Robotic Surgery Institute, Aalst, Belgium, §Martini Clinic Prostate Cancer Center, University Clinic Eppendorf, Hamburg, Germany, and Global Robotics Institute, Florida Hospital-Celebration Health Celebration, University of Central Florida School of Medicine, Orlando, FL, USA

 

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To evaluate the influence of posterior musculofascial plate reconstruction (PR) on early return of continence after radical prostatectomy (RP); an updated systematic review of the literature. A systematic review of the literature was performed in June 2015, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and searching Medline, Embase, Scopus and Web of Science databases. We searched the terms posterior reconstruction prostatectomy, double layer anastomosis prostatectomy across the ‘Title’ and ‘Abstract’ fields of the records, with the following limits: humans, gender (male), and language (English). The authors reviewed the records to identify studies comparing cohorts of patients who underwent RP with or without restoration of the posterior aspect of the rhabdosphincter. A meta-analysis of the risk ratios estimated using data from the selected studies was performed. In all, 21 studies were identified, including three randomised controlled trials. The overall analysis of comparative studies showed that PR improved early continence recovery at 3–7, 30, and 90 days after catheter removal, while the continence rate at 180 days was statistically but not clinically affected. Statistically significantly lower anastomotic leakage rates were described after PR. There were no significant differences for positive surgical margins rates or for complications such as acute urinary retention and bladder neck stricture. The analysis confirms the benefits at 30 days after catheter removal already discussed in the review published in 2012, but also shows a significant advantage in terms of urinary continence recovery in the first 90 days. A multicentre prospective randomised controlled trial is currently being conducted in several institutions around the world to better assess the effectiveness of PR in facilitating an earlier recovery of postoperative urinary continence.

 

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Editorial: The Jury on Posterior Muscolofascial Reconstruction is still out

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In their systematic review and meta-analysis, Grasso et al. [1] address the question of whether posterior muscolofascial reconstruction (PMR), the so-called Rocco stitch, positively affects urinary continence after radical prostatectomy. The relevance of the question to this structured form of inquiry is that individual studies to date have been inconclusive. We recognize Sir Archie Cochrane, who gave his name to the Cochrane Collaboration that pioneered the methods for conducting systematic reviews, for emphasizing the critical importance of looking at the entire body of evidence in a structured manner when seeking to answer a clinical question [2]. In the present study, which included both randomized controlled trials (RCTs) and observational studies of variable methodological quality, a favourable impact of PMR across all postoperative time points (3–7 days, 30 days, 3 and 6 months) was observed. The effect was most pronounced early on at the time of catheter removal, when the patients undergoing PMR were nearly twice as likely as the control group (risk ratio 1.9; 95% CI 1.3–2.9) to be continent, thereby suggesting a major benefit of this approach. It should be noted, however, that this analysis was dominated by the observational studies, particularly retrospective observational studies, which offer the least degree of methodological rigor.

Even more important, therefore, than the act of pooling across studies is the rating of the quality of evidence for the body of evidence on an outcome-specific basis. Based on the GRADE approach, which has become the most widely endorsed framework for rating the quality of evidence, we would initially place a high and low level of confidence in a body of evidence drawn from RCTs and observational studies, respectively [3]. As a result, one might plan a separate analysis of those two groups of studies first, and only move to pool them if their results were similar. In this case, the results from the RCTs and observational studies were different, with prospective and retrospective studies reporting larger, probably exaggerated effect sizes; however, it is also understood that other aspects such as study limitation (risk of bias), inconsistency, impression, indirectness and risk publication bias may lower our confidence in the effect estimates from RCTs [4]. Focusing on the body of evidence from RCTs alone (Table 1) we have ‘moderate’ confidence that PMR may not improve early continence at the time of catheter removal. Similarly, the few RCTs that contributed to the assessment of continence at later timepoints do not provide evidence that continence is affected favourably, although our confidence for those outcomes is only ‘low’ or ‘very low’, suggesting that future trials may change these estimates of effect. Meanwhile, it should be noted that none of the RCTs appeared to provide information on the potential downsides of PMR, such as rates of urinary retention or bladder neck contracture. As a result, enough uncertainty remains to state that the jury on PMR is still out; this is consistent with the authors’ call for a future high-quality trial, which is reportedly ongoing. While PMR is already widely used by open and robot-assisted prostatectomy surgeons around the globe, this example sheds light on current evidentiary standards of surgical innovation. Following the IDEAL recommendations, it would be much preferred if the urological community committed to well designed trials for novel surgical approaches and device-dependent interventions up front, before moving to widespread dissemination [5].

JulEOTW2

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Philipp Dahm
Department of Urology, Minneapolis VA Health Care System, Urology Section 112D and University of Minnesota, Minneapolis, MN, USA

 

References

 

1 Grasso AAC, Mistretta FA, Sandri M et al. Posterior musculofascial reconstruction after radical prostatectomy: an updated systematic review and a meta-analysis. BJU Int 2016; 118: 20–34.

 

2 Hajebrahimi S, Dahm P, Buckingham J. Evidence-based urology in practice: the cochrane library. BJU Int 2009; 104: 1048–9

 

3 Canfield SE, Dahm P. Rating the quality of evidence and the strength of recommendations using GRADE. World J Urol 2011; 29: 311–7

 

4 Guyatt GH, Oxman AD, Vist GE et al. GRADE: what is “quality of evidence” and why is it important to clinicians? BMJ 2008; 336: 995–8

 

5 McCulloch P. The IDEAL recommendations and urological innovation. World J Urol 2011; 29: 331–6

 

Video: Posterior Muscolofascial Reconstruction after RP

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Posterior musculofascial reconstruction after radical prostatectomy: an updated systematic review and a meta-analysis

Angelica A.C. Grasso*, Francesco A. Mistretta*, Marco Sandri†, Gabriele Cozzi*, Elisa De Lorenzis*, Marco Rosso*, Giancarlo Albo*, Franco Palmisano*, Alex Mottrie‡, Alexander Haese§, Markus Graefen§, Rafael Coelho, Vipul R. Patel¶ and Bernardo Rocco*

 

*Department of Urology, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, †DMS StatLab, Data Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy, ‡OLV Robotic Surgery Institute, Aalst, Belgium, §Martini Clinic Prostate Cancer Center, University Clinic Eppendorf, Hamburg, Germany, and Global Robotics Institute, Florida Hospital-Celebration Health Celebration, University of Central Florida School of Medicine, Orlando, FL, USA

 

Read the full article
To evaluate the influence of posterior musculofascial plate reconstruction (PR) on early return of continence after radical prostatectomy (RP); an updated systematic review of the literature. A systematic review of the literature was performed in June 2015, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and searching Medline, Embase, Scopus and Web of Science databases. We searched the terms posterior reconstruction prostatectomy, double layer anastomosis prostatectomy across the ‘Title’ and ‘Abstract’ fields of the records, with the following limits: humans, gender (male), and language (English). The authors reviewed the records to identify studies comparing cohorts of patients who underwent RP with or without restoration of the posterior aspect of the rhabdosphincter. A meta-analysis of the risk ratios estimated using data from the selected studies was performed. In all, 21 studies were identified, including three randomised controlled trials. The overall analysis of comparative studies showed that PR improved early continence recovery at 3–7, 30, and 90 days after catheter removal, while the continence rate at 180 days was statistically but not clinically affected. Statistically significantly lower anastomotic leakage rates were described after PR. There were no significant differences for positive surgical margins rates or for complications such as acute urinary retention and bladder neck stricture. The analysis confirms the benefits at 30 days after catheter removal already discussed in the review published in 2012, but also shows a significant advantage in terms of urinary continence recovery in the first 90 days. A multicentre prospective randomised controlled trial is currently being conducted in several institutions around the world to better assess the effectiveness of PR in facilitating an earlier recovery of postoperative urinary continence.

 

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Article of the Month: Further Evidence that Bladder Cancer Patients should Stop Smoking

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Every Month the Editor-in-Chief selects an Article of the Month 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. Smoking in a daily basis can affect your lungs, make sure to improve your indoor air quality just by checking out the latest blaux portable ac reviews.

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.

Trends in the risk of second primary cancer among bladder cancer survivors: a population-based cohort of 10 047 patients

Joris Muller*,†, Pascale Grosclaude‡,§, Benedicte Lapotre-Ledoux§,, Anne-Sophie Woronoff§,**, Anne-Valerie Guizard§,††, Simona Bara§,‡‡, Marc Colonna§,§§, Xavier Troussard§,¶¶, Veronique Bouvier§,***, Brigitte Tretarre§,†††, Michel Velten*,†,§,‡‡‡ and Jeremie Jegu*,†,§
*Bas-Rhin Cancer Registry, EA 3430, FMTS, University of Strasbourg, †Department of Public Health, University Hospital of Strasbourg, Strasbourg, ‡Tarn Cancer Registry, Albi, §
Francim: Reseau francais des registres des cancers, Toulouse, Somme Cancer Registry, Department of Hygiene and Public Health, University Hospital of Amiens, Amiens, **Doubs and Belfort Territory Cancer Registry, University Hospital of Besancon, Besancon, ††Calvados General Cancer Registry, Cancers & Preventions, U 1086 Inserm, Francois Baclesse Centre, Caen, ‡‡Manche Cancer Registry, Cotentin Hospital, Cherbourg-Octeville, §§Isere Cancer Registry, University Hospital of Grenoble, Grenoble, ¶¶Basse-Normandie Haematological Malignancies Cancer Registry, University Hospital of Caen, ***Calvados Digestive Cancer Registry, Cancers & Preventions, U 1086 Inserm, Francois Baclesse Centre, Caen, †††Herault Cancer Registry, Research Center, Montpellier , and ‡‡‡Department of Epidemiology and Biostatistics, Paul Strauss Center, Strasbourg, France
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Objectives

To determine whether the risk of second primary cancer (SPC) among patients with bladder cancer (BCa) has changed over past years.

Materials and Methods

Data from 10 French population-based cancer registries were used to establish a cohort of 10 047 patients diagnosed with a first invasive (≥T1) BCa between 1989 and 2004 and followed up until 2007. An SPC was defined as the first subsequent primary cancer occurring at least 2 months after a BCa diagnosis. Standardized incidence ratios (SIRs) of metachronous SPC were calculated. Multivariate Poisson regression models were used to assess the direct effect of the year of BCa diagnosis on the risk of SPC.

JulAOTW1Results

Results

The risk of new malignancy among BCa survivors was 60% higher than in the general population (SIR 1.60, 95% confidence interval [CI] 1.51–1.68). Male patients presented a high risk of SPC of the lung (SIR 3.12), head and neck (SIR 2.19) and prostate (SIR 1.54). In multivariate analyses adjusted for gender, age at diagnosis and follow-up, a significant increase in the risk of SPC of the lung was observed over the calendar year of BCa diagnosis (P for linear trend 0.010), with an SIR increasing by 3.7% for each year (95% CI 0.9–6.6%); however, no particular trend was observed regarding the risk of SPC of the head and neck (P = 0.596) or the prostate (P = 0.518).

Conclusions

As the risk of SPC of the lung increased between 1989 and 2004, this study contributes more evidence to support the promotion of tobacco smoking cessation interventions among patients with BCa.

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Editorial: Analysis of Genetics to Identify Susceptibility to Secondary Malignancies in Patients with BCa

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A study by Muller et al. [1] evaluated a cohort of 10 047 patients diagnosed with a first invasive (≥T1) bladder cancer and found that independent of gender and age, the risk of subsequent lung cancer was increased. This is not surprising considering the strong association of both bladder and lung cancer with tobacco, which is the main risk factor for both malignancies. While the authors limited their analysis to patients with invasive disease, the same association of bladder and lung cancer probably holds true for patients with non-invasive disease. An important question this raises is whether urologists should be more proactive in screening for lung cancer in their patients with bladder cancer. While chest radiographs are commonly used to monitor patients who undergo cystectomy, they are not routinely used for patients with non-invasive disease. Furthermore, the recommendations for screening for lung cancer based on the National Lung Cancer Screening Trial (NLST) involve use of low-dose chest CT, which is rarely done routinely by urologists [2]. In the Muller et al. [1] study, despite the large cohort and median follow-up of 3.1 years, there were still only 295 cases of lung cancer. This was three-times the expected incidence but overall a low rate.

One interesting consideration is whether use of genetic factors may be useful to identify which patients might be at higher risk at baseline for subsequent secondary cancers. Currently, single nucleotide polymorphism (SNP) analysis is not used clinically in screening but other genetic abnormalities such as BRCA (BReast Cancer gene) mutations and Lynch syndrome have been used to identify secondary malignancies. However, identifying individuals at higher risk of developing cancer may inform clinicians and allow for a more targeted screening strategy, even in patients of increased baseline risk.

The USA National Cancer Institute performed genome-wide association studies (GWAS) for 49 492 patients with cancer and 34 131 controls to estimate the heritability of individual cancers, as well as the proportion of heritability attributable to cigarette smoking in smoking-related cancers, and the genetic correlation between pairs of cancers [3]. They calculated that at least 24% and 7% of the heritability for lung and bladder cancer, respectively, can be attributed to genetic determinants of smoking. Only four pairs of cancers had marginally statistically significant correlations including bladder and lung.

While tobacco is the major cause of lung cancer, only ≈10% of smokers develop lung cancer in their lifetime indicating there is significant individual variation in susceptibility to lung cancer. The International Lung Cancer Consortium pooled genotype data for SNPs at chromosomes 15q25 (rs16969968, rs8034191), 5p15 (rs2736100, rs402710), and 6p21 (rs2256543, rs4324798) from 21 case-control studies for 11 645 patients with lung cancer and 14 954 control subjects [4]. Associations between 15q25 and the risk of lung cancer were replicated in White ever-smokers (rs16969968) but there was no association in never-smokers or in Asians between either of the 15q25 variants and the risk of lung cancer. For the chromosome 5p15 region, they confirmed statistically significant associations in Whites for both rs2736100 and rs402710 and identified similar associations in Asians. Zhang et al. [5] undertook a gene–smoking interaction analysis in a GWAS of lung cancer in Han Chinese population of 5 408 subjects (2 331 patients and 3 077 controls) using a two-phase designed case-control study. They identified two SNPs associated with lung cancer and smoking, including one with a synergistic interaction (rs4589502) and one with an antagonistic interaction (rs131629).

There have also been several studies evaluating SNPs and risk of bladder cancer. A study of 1 595 patients and 1 760 controls, stratified for smoking habits, found that different SNP combinations were relevant in smokers and non-smokers [6]. In smokers, polymorphisms involved in detoxification of cigarette smoke carcinogens were most relevant (GSTM1 [glutathione S-transferase μ1], rs11892031), in contrast to those in non-smokers where MYC (v-myc avian myelocytomatosis viral oncogene homolog) and APOBEC3A (apolipoprotein B mRNA editing enzyme, catalytic polypeptide-like 3A) near polymorphisms (rs9642880, rs1014971) were the most influential. A study of genome-wide interaction of smoking and bladder cancer risk based on data from 3 002 patients and 4 411 controls with validation in a separate dataset identified 10 SNPs that showed association in a consistent manner with the initial dataset and in the combined dataset, providing evidence of interaction with tobacco use [7]. These studies of genetic polymorphisms add evidence regarding the impact of gene–environment interactions, which influence the detrimental effects of tobacco on risk of bladder cancer.

There are other genetic polymorphisms that have been found to increase risk of tobacco-related malignancies. A study of polymorphisms inNAT2 (N-acetyltransferase 2 [arylamine N-acetyltransferase]), GSTM1, NAT1, GSTT1 (GST θ1), GSTM3, and GSTP1 (GST π1) in 1 150 patients with bladder cancer and 1 149 controls found that compared with NAT2 rapid or intermediate acetylators, NAT2 slow acetylators had an increased overall risk of bladder cancer (odds ratio 1.4, 95% CI 1.2–1.7), which was stronger for cigarette smokers than for never smokers. No significant associations were found with the other polymorphisms [8]. The overall association for GSTM1 was also robust (P < 0.001) but was not modified by smoking status (P = 0.86).

While it may be too early to apply GWAS to all patients who smoke, a trial focusing on those with other tobacco-related malignancies may identify cohorts where screening for other malignancies is not only effective but also practical.

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Yair Lotan, Professor of Urology
Department of Urology, UT Southwestern Medical Center at Dallas, Dallas, TX, USA

 

References

 

1 Muller J, Grosclaude P, Lapotre-Ledoux B et al. Trends in the risk of second primary cancer among bladder cancer survivors: a population-based cohort of 10 047 patients. BJU Int 2016; 118: 53–9

 

2 National Lung Screening Trial Research Team, Aberle DR, Adams AM et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; 365: 395–409

 

3 Sampson JN, Wheeler WA, Yeager M et al. Analysis of heritability and shared heritability based on genome-wide association studies for thirteen cancer types. J Natl Cancer Inst 2015; 107: pii: djv279. doi: 10.1093/jnci/djv279

 

4 Truong T, Hung RJ, Amos CI et al. Replication of lung cancer susceptibility loci at chromosomes 15q25, 5p15, and 6p21: a pooled analysis from the International Lung Cancer Consortium. J Natl Cancer Inst 2010; 102: 959–71

 

5 Zhang R, Chu M, Zhao Y et al. A genome-wide gene-environment interaction analysis for tobacco smoke and lung cancer susceptibility. Carcinogenesis 2014; 35: 1528–35

 

6 Schwender H, Selinski S, Blaszkewicz M et al. Distinct SNP combinations confer susceptibility to urinary bladder cancer in smokers and non-smokers. PLoS One 2012; 7: e51880

 

7 Figueroa JD, Han SS, Garcia-Closas M et al. Genome-wide interaction study of smoking and bladder cancer risk. Carcinogenesis 2014; 35: 1737–44

 

8 Garcia-Closas M, Malats N, Silverman D et al. NAT2 slow acetylation, GSTM1 null genotype, and risk of bladder cancer: results from the Spanish Bladder Cancer Study and meta-analyses. Lancet 2005; 366: 649–59

 

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

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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 Porena8, Vincenzo 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 Paula24, Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana d’Urologia)

 

1 Department of Urology, University of Catania, Catania, 2 Department of Urology, Sant’ Andrea Hospital, ‘La Sapienza’ University of Roma, Roma, 3 S.O. Oncologia Radioterapica, Pordenone, 4 Urology, Presidio Ospedaliero Gradenigo, Torino, 5 Radiotherapy, IRCC Candiolo, Torino, 6 Radiotherapy, A.O. Santa Maria, Terni, 7 Department of Urology, University of Padova, Padova, 8 Department of Urology, University of Perugia, Perugia, 9 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, 13 Radiotherapy, 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

 

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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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Editorial: EAU guidelines – do we care? Reflections from the EAU Impact Assessment of Guidelines Implementation and Education group

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There is increasing evidence in the literature that androgen deprivation therapy (ADT) is overused among practising urologists in the setting of localized, and even locally advanced, prostate cancer (PCa) [1, 2]. Morgia et al. [1] report a misuse of ADT prescriptions among Italian urologists in roughly a quarter of cases, mainly in the setting of low-risk/localized disease where ADT may harm patients without proven benefit with regard to disease-specific outcomes [3]. Such clinical practice behaviours are even more unjustifiable given the high level of evidence upon which the current European Association of Urology (EAU) guidelines recommendations on ADT use are based [4].

Morgia et al. [1] should be congratulated for highlighting the magnitude of the problems the urological community currently face in terms of the gap between evidence and practice. Unfortunately, while the authors report significant geographical differences in ADT prescriptions within the same country (Italy), the methods they used in their study do not allow an understanding of the reasons for the discrepancy. It is currently unknown whether the gap between evidence and practice is attributable to physician or patient attitude or to the national health system structure. The inclusion of qualitative methods, such as semi-structured interviews, would have been ideal to probe clinician reasoning for discordant adherence. This is crucial because knowledge of possible barriers to the application of guidelines represents a key step in their implementation process. Indeed, once the issue is raised, the next logical questions to pose would be: how can we reduce such variation in urological practice especially where there is a real risk of causing harm to patients and how can we improve and implement the use of guideline recommendations when clearly underpinned by high-quality evidence?

It is indeed intuitive that any huge evidence–practice gap may have profound implications not only in the process of patient care optimization but also in the context of national healthcare efficiency.

Certainly the issue of ADT overuse raised by Morgia et al. [1] can be considered the perfect setting to scale up and prioritize efforts aimed at improving current urological practice for three main reasons: (i) the high prevalence of the disease studied (namely, PCa); (ii) the availability of an up-to-date evidence-based guideline showing the impact of ADT in terms of patient side effects and costs; and (iii) the now known gap between evidence and practice patterns.

Given this setting, it should then be mandatory to promote ways not only to assess the use of guideline recommendations but also to increase dissemination among users (not only healthcare professionals, but also patients and policy makers) and to evaluate their impact. The aim of this highly articulated process of knowledge translation is eventually to move research findings into clinical practice. Ideally, this approach should be based on the following five crucial questions: (i) What should be transferred? (ii) To whom should research knowledge be transferred? (iii) By whom should research knowledge be transferred? (iv) How should research knowledge be transferred? and (v) To what effect should research knowledge be transferred? [5]. Each of these questions represents a crucial step in any knowledge translation process. To optimize this approach, it is critical to identify barriers to knowledge implementation and to choose the optimum interventions to limit or to overcome them. This ‘global process’ is much more complicated than commonly thought, given the significant cultural, social, economic and health system differences not only between countries but also within the same country, as shown by Morgia et al. [1]. It is likely, therefore, that any knowledge implementation approach should be tailored according to each country and should be based on key steps, such as: selection of a credible ‘messenger’; development of the appropriate technological and organizational instruments to facilitate access to disseminate and use existing high-quality evidence; and the setting up of education programmes to improve clinical research literacy skills.

Finally, we believe that the paper by Morgia et al. [1] strongly supports the notion that ‘evidence-based medicine should be complemented by evidence-based implementation’ [6]. It is indeed likely that creating a knowledge translation setting where the gap between evidence and practice is eventually bridged is as important as producing accurate, scientifically sound and meticulous guidelines that can be trusted by all stakeholders.

Tackling the crucially important problem of discordant guideline adherence is the remit of the recently established EAU Guidelines Office ‘IMAGINE’ project (IMpact Assessment of Guidelines Implementation and Education) which aims to: ascertain adherence to prioritized guideline recommendations; elucidate the barriers and facilitators to change; design bespoke knowledge transfer interventions; and evaluate the impact of the EAU guidelines, thereby optimizing adherence, with the ultimate goal of improving patient care.

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Alberto Briganti*, Steven MacLennan†, Lorenzo Marconi‡, Karin Plass§ and James N’Dow †on behalf of EAU Guidelines Office ‘IMAGINE’ project
*Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy, †Academic Urology Unit, University of Aberdeen, Aberdeen, UK, ‡Department of Urology, Coimbra University Hospital, Coimbra, Portugal and §EAU Central Office, Guidelines Office, Arnhem, The Netherlands

 

References

 

1 Morgia G, Russo GI, Tubaro A et al. 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. BJU Int 2016; 117: 867–73

 

2 Lycken M, Garmo H, Adolfsson J, Stattin P, Holmberg L, Bill-Axelson A. Patterns of androgen deprivation therapies among men diagnosed with localised prostate cancer: a population-based study. Eur J Cancer 2014; 50: 1789–98

 

3 Lu-Yao GL, Albertsen PC, Moore DF et al. Survival following primary androgen deprivation therapy among men with localized prostate cancer. JAMA 2008; 300: 173–81

 

4 Heidenreich A, Bastian PJ, Bellmunt J et al. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2014; 65: 467–79

 

5 Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Suires JE. Knowledge translation of research findings. Implement Sci 2012; 7: 50

 

6 Grol R. Beliefs and evidence in changing clinical practice. BMJ 1997; 315: 418–21

 

Video: Patterns of prescription and adherence to EAU guidelines on ADT in PCa

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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 Porena8, Vincenzo 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 Paula24, Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana d’Urologia)

 

1 Department of Urology, University of Catania, Catania, 2 Department of Urology, Sant’ Andrea Hospital, ‘La Sapienza’ University of Roma, Roma, 3 S.O. Oncologia Radioterapica, Pordenone, 4 Urology, Presidio Ospedaliero Gradenigo, Torino, 5 Radiotherapy, IRCC Candiolo, Torino, 6 Radiotherapy, A.O. Santa Maria, Terni, 7 Department of Urology, University of Padova, Padova, 8 Department of Urology, University of Perugia, Perugia, 9 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, 13 Radiotherapy, 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

 

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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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Article of the Week: NSS Across a Nation

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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 Archie Fernando and Tim O’Brien, discussing their paper.

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

Nephron-sparing surgery across a nation – outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit

Archie Fernando*†, Sarah Fowler* and Tim O’Brien*†, on behalf of the British
Association of Urological Surgeons (BAUS) 

 

*BAUS, The Royal College of Surgeons of England, and †The Urology Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK

 

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BAUS-2012-national-partial-nephrectomy-audit-infographic-clipped

 

Click on image for full size infographic

 

Objective

To determine the scope and outcomes of nephron-sparing surgery (NSS), i.e. partial nephrectomy, across the UK and in so doing set a realistic benchmark and identify fresh contemporary challenges in NSS.

Patients and Methods

In 2012 reporting of outcomes of all types of nephrectomy became mandatory in the UK. In all, 148 surgeons in 86 centres prospectively entered data on 6 042 nephrectomies undertaken in 2012. This study is a retrospective analysis of the NSS procedures in the dataset.

Results

A total of 1 044 NSS procedures were recorded and the median (range) surgical volume was 4 (1–39) per consultant and 8 (1–59) per centre. In all, 36 surgeons and 10 centres reported on only one NSS. The indications for NSS were: elective with a tumour of ≤4.5 cm in 59%, elective with a tumour of >4.5 cm in 10%, relative in 7%, imperative in 12%, Von Hippel–Lindau in 1%, and unknown in 11%. The median (range) tumour size was 3.4 (0.8–30) cm. The technique used was minimally invasive surgery in 42%, open in 58%, with conversions in 4%. The histology results were: malignant in 80%, benign in 18%, and unknown in 2%. In patients aged <40 years 36% (36/101) had benign histology vs 17% (151/874) of those aged ≥40 years (P < 0.01). In patients with tumours of <2.5 cm 29% (69/238) had benign histology vs 14% (57/410) with tumours of 2.5–4 cm vs 8% (16/194) with tumours of ≥4 cm (P = 0.02). In patients aged <40 years with of tumours of <2.5 cm 44% (15/34) were benign. The 30-day mortality was 0.1% (1/1 044). There were major complications (Clavien–Dindo grade of ≥IIIa) in 5% (53/1 044). There was an increased risk of complications after extended elective NSS of 19% (19/101) vs elective at 12% (76/621) (relative risk [RR] 1.54; P < 0.01). Margins were recorded in 68% (709/1 044) of the patients, with positive margins identified in 7% (51/709). Positive surgical margins after NSS for pathological T3 (pT3) tumours were found in 47.8% (11/23) vs 6.1% (32/523) for pT1a, tumours (RR 5.61; P < 0.01). In all, 14% (894/6 042) of the patients underwent surgery for T1a tumours: 55% (488/894) by NSS, 42% (377/894) by radical nephrectomy (RN), and in 3% (29/894) the procedure used was unknown. Major complications after occurred in 4.9% (24/488) of NSS vs 1.3% (5/377) of RN (P < 0.01). Limitations included poor reporting of renal function data and no data on tumour complexity.

Conclusions

In its first year, mandatory national reporting has provided several challenging contemporary insights into NSS.

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Editorial: SRMs – Where is the Wisdom We Have Lost in Knowledge?

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The perceived wisdom that a small enhancing mass in the kidney represents a surgical lesion that automatically requires excision without the need for a preoperative biopsy has been challenged by Fernando et al. [1] in this issue of BJUI.

The authors are to be congratulated in bringing these data to publication to provoke debate on the treatment paradigm for small renal masses (SRMs) by reviewing nationally collected data on the main therapeutic surgical option: nephron-sparing surgery. As anyone who has attended a renal multidisciplinary meeting can testify, the predominant presentation of renal cancer is the incidentally detected SRM, often in elderly patients with significant comorbidity.

As the authors emphasize, these data are unique in representing a national picture encompassing both high- and low-volume centres, as opposed to the majority of the studies in the literature, which report data from high-volume tertiary referral centres.

Drawing conclusions from data requires a clear understanding of the source and quality. Most importantly, as these data only refer to patients undergoing nephron-sparing surgery, we need to be cautious about extrapolating to infer information on the management of SRMs in general.

For instance, a striking finding of the present study is the high incidence of benign lesions in the younger age groups. We have no knowledge of the numbers of patients with SRMs within the study period who had biopsy-proven benign disease and thus avoided surgery. It is probable that the true incidence of benign disease would be even higher if these cases had been recorded and included in the analysis.

An inherent difficulty with self-reported data is the issue of compliance, and this is clearly evident in the present study, with, for example, almost a third of cases missing data on surgical margin results. It would perhaps be helpful for future audits if the BAUS dataset had a clear definition of positive surgical margin in recognition of the surgical drift to enucleation rather than excision with a margin of renal parenchyma.

The variation in caseload between reporting centres raises important questions, as does the finding that two fifths of patients with T1a tumours underwent radical nephrectomies. As the authors concede, with the numbers involved and the absence of any measure of tumour complexity, it is difficult to draw firm conclusions; however, the study does highlight the need to examine this issue in future analyses and to consider including some form of renal scoring system in future audits.

Where do we go from here and what can we do with this information? First, we need to rethink our discussion with patients with SRMs. Can we justify performing major surgery with a one in 20 chance of a significant complication for a possible benign lesion without at least a pragmatic discussion of the role of renal biopsy with the patient? Indeed, one may argue, could it really be an ‘informed’ decision without it?

Second, we need to improve the quality of the data by encouraging robust data reporting, increasing the completion rate and considering adding data fields which will allow us to draw clearer conclusions on surgical margin and surgical outcome and volume relationships.

Third, we need to recognize that nephron-sparing surgery is only one component of the management of SRMs, which represents a major contemporary challenge in terms of health resources and, most importantly, in deciding the best treatment paradigm for our patients. If BAUS can carry out this audit, could we not extend this to all patients with SRMs, whether they have surgery, ablation or surveillance, and establish greater clarity on these treatment methods?

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Michael Aitchison, Consultant Urological Surgeon and Maxine Tran, Senior Lecturer in Renal Cancer Surgery and Honorary Consultant Urological Surgeon

 

Renal Cancer Service, Royal Free NHS Foundation Trust, London, UK

 

Reference
1 Fernando A, Fowler S, O’Brien T. Nephron-sparing surgery across a nation—outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit. BJU Int 2016; 117: 874–82

 

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