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Article of the Month: PROMs in the ProtecT trial of PCa treatments

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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.

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 discussing the paper.

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

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Athene Lane*,†, Chris Metcalfe*,†, Grace J. Young*,†, Tim J. Peters‡,§, Jane Blazeby*, Kerry N. L. Avery*, Daniel Dedman, Liz Down*, Malcolm D. Mason**, David E. Neal††, Freddie C. Hamdy†† and Jenny L. Donovan*,§ for the ProtecT Study group

 

*School of Social and Community Medicine, University of Bristol, Bristol, †Bristol Randomised Trials Collaboration, University of Bristol, Bristol, ‡School of Clinical Sciences, University of Bristol, Bristol, §Collaboration for Leadership in Applied Health Research and Care West, United Hospitals Bristol, Bristol, Clinical Practice Research Datalink Group, Medicines and Healthcare Products Regulatory Agency, London, **School of Medicine, Cardiff University, Cardiff, and ††Nuffield Department of Surgery, University of Oxford, Oxford, UK
Read the full article

Objectives

To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.

Materials and Methods

A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men’s age at biopsy and PSA testing time points for selected measures.

aotmdec1

Results

A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.

Conclusion

The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Read more articles of the week

Editorial: ‘Killing Two Birds With One Stone’ – PROMS from the ProtecT Trial

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Very few areas of medicine generate more controversy than the management of clinically localised prostate cancer. This is in large part due to the somewhat conflicting nature of the scant level I evidence that exists on the subject. Whereas the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) demonstrated a clinically meaningful and durable survival advantage for surgery when compared to watchful waiting in a predominantly White Scandinavian population of patients with clinically palpable yet localised prostate cancer [1], the Radical Prostatectomy Versus Observation for Localized Prostate Cancer (PIVOT) trial reported a mostly null effect of surgery in a predominantly older, less healthy population of American patients with clinically indolent disease [2]. Neither trial addresses the effect of radiotherapy on prostate cancer survival and both may lack relevance in contemporary prostate cancer practice.

For these reasons and a myriad of others, the medical community eagerly awaits the results of the Prostate Testing for Cancer and Treatment (ProtecT) trial [3]. With a fastidiously designed protocol that involves 337 primary care centres across nine cities in the UK, the use of dedicated study nurses, the successful enrolment of pre-specified sample size targets, and the inclusion of patient-reported quality-of-life measures, the ProtecT trial is poised to make enormous inroads for men with prostate cancer and the providers who care for them.

In this issue of the BJUI, the investigators from the ProtecT trial publish baseline patient-reported outcome measures (PROMs) from the ProtecT trial [4]. While others have previously reported baseline PROMs in large comparative effectiveness studies [5], the findings from this study are notable for several reasons. First, this is the first randomised trial comparing the effect of surgery, radiation, and active monitoring on PROMs. While several high-quality prospective observational cohort studies have reported long-term quality-of-life outcomes after prostate cancer treatment [6, 7], ProtecT will offer randomised comparisons that minimise confounding and selection bias from the outset. Second, the ProtecT trial will not only measure disease-specific health-related quality of life through the use of psychometrically validated survey instruments, such as the Expanded Prostate Index Composite, but also general health-related quality of life through the use of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30 (as well as depression and anxiety through the use of the Hospital Anxiety and Depression Scale). Finally, and perhaps most importantly, the investigators collected baseline PROMs at the time of the first biopsy before cancer diagnosis, which will offer distinct advantages when modelling patient-reported function over time, as well as avoiding recall bias associated with retrospective collection of baseline patient-reported outcomes.

In the absence of the long-term survival data from randomised trials comparing surgery and radiation, previous studies have rightly focused on understanding how the effect of prostate cancer treatments differ with respect to PROMs. With the ProtecT trial, we will not only start to have answers to longstanding questions about how surgery, radiation and active surveillance compare with respect to clinical outcomes, such as survival and cancer control, but also with respect to PROMs. By addressing both of these domains, the ProtecT investigators are in position to ‘kill two birds with one stone’ and in so doing will undoubtedly make large strides in facilitating data-driven decision-making for patients with prostate cancer worldwide.

Read the full article
Mark D. Tyson* and David F. Penson*,†,‡

 

Departments of *Urologic Surgery and †Health Policy, Vanderbilt University Medical Center, and‡ Geriatric, Research, and Educational Center, Veterans Affairs Tennessee Valley Health Care System, Nashville, TN, USA

 

References

 

1 Bill-Axelson A, Holmberg L, Garmo H et al. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med 2014; 370: 932–42

 

2 Wilt TJ, Brawer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203–13

 

3 Lane JA, Donovan JL, Davis M et al. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncol 2014; 15: 1109–18

 

4 Lane A, Metcalfe C, Young GJ et al. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. BJU Int 2016; 118: 869–79

 

5 Resnick MJ, Barocas DA, Morgans AK et al. Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: defining the population at risk for harms of prostate cancer treatment. Cancer 2014; 120: 1263–71

 

6 Sanda MG, Dunn RL, Michalski J et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008; 358: 1250–61

 

7 Resnick MJ, Koyama T, Fan KH et al. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med 2013; 368: 436–45

 

Video: PROMs in the ProtecT trial of PCa treatments

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Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Athene Lane*,†, Chris Metcalfe*,†, Grace J. Young*,†, Tim J. Peters‡,§, Jane Blazeby*, Kerry N. L. Avery*, Daniel Dedman, Liz Down*, Malcolm D. Mason**, David E. Neal††, Freddie C. Hamdy†† and Jenny L. Donovan*,§ for the ProtecT Study group

 

*School of Social and Community Medicine, University of Bristol, Bristol, †Bristol Randomised Trials Collaboration, University of Bristol, Bristol, ‡School of Clinical Sciences, University of Bristol, Bristol, §Collaboration for Leadership in Applied Health Research and Care West, United Hospitals Bristol, Bristol, Clinical Practice Research Datalink Group, Medicines and Healthcare Products Regulatory Agency, London, **School of Medicine, Cardiff University, Cardiff, and ††Nuffield Department of Surgery, University of Oxford, Oxford, UK
Read the full article

Objectives

To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.

Materials and Methods

A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men’s age at biopsy and PSA testing time points for selected measures.

aotmdec1

Results

A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.

Conclusion

The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Read more articles of the week

Article of the Month: The Effect of Smoking on Sperm Functional Quality and Seminal Plasma Proteomic Profile

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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.

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.

Analysis of the functional aspects and seminal plasma proteomic profile of sperm from smokers

Mariana Pereira Antoniassi*, Paula Intasqui*, Mariana Camargo*, Daniel Suslik
Zylbersztejn*, Valdemir Melechco Carvalho†, Karina H. M. Cardozo† and Ricardo
Pimenta Bertolla*‡

 

*Department of Surgery, Division of Urology, Human Reproduction Section, Sao Paulo Federal University, †Fleury Group, and ‡Hospital Sao Paulo, Sao Paulo, Brazil

 

Read the full article

Objective

To evaluate the effect of smoking on sperm functional quality and seminal plasma proteomic profile.

Patients and Methods

Sperm functional tests were performed in 20 non-smoking men with normal semen quality, according to the World Health Organization (2010) and in 20 smoking patients. These included: evaluation of DNA fragmentation by alkaline Comet assay; analysis of mitochondrial activity using DAB staining; and acrosomal integrity evaluation by PNA binding. The remaining semen was centrifuged and seminal plasma was used for proteomic analysis (liquid chromatography-tandem mass spectrometry). The quantified proteins were used for Venn diagram construction in Cytoscape 3.2.1 software, using the PINA4MS plug-in. Then, differentially expressed proteins were used for functional enrichment analysis of Gene Ontology categories, Kyoto Encyclopedia of Genes and Genomes and Reactome, using Cytoscape software and the ClueGO 2.2.0 plug-in.

aotm-nov-1-results

Results

Smokers had a higher percentage of sperm DNA damage (Comet classes III and IV; P < 0.01), partially and fully inactive mitochondria (DAB classes III and IV; P = 0.001 and P = 0.006, respectively) and non-intact acrosomes (P < 0.01) when compared with the control group. With respect to proteomic analysis, 422 proteins were identified and quantified, of which one protein was absent, 27 proteins were under-represented and six proteins were over-represented in smokers. Functional enrichment analysis showed the enrichment of antigen processing and presentation, positive regulation of prostaglandin secretion involved in immune response, protein kinase A signalling and arachidonic acid secretion, complement activation, regulation of the cytokine-mediated signalling pathway and regulation of acute inflammatory response in the study group (smokers).

Conclusion

In conclusion, cigarette smoking was associated with an inflammatory state in the accessory glands and in the testis, as shown by enriched proteomic pathways. This state causes an alteration in sperm functional quality, which is characterized by decreased acrosome integrity and mitochondrial activity, as well as by increased nuclear DNA fragmentation.

Read more articles of the week

Reference: Grey Haze.

Editorial: Semen Proteome Alterations in the Smoking Male

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Infertility affects 15% of couples, with male factor infertility influencing half of such couples [1]. Multiple environmental risk factors for male infertility have been identified, including: diet, exposure to pollution, and multiple substance abuses, e.g. alcohol, tobacco, marijuana, opiates [2].

In this issue of BJUI, the study of Antoniassi et al. [3] makes an important contribution to the literature regarding the impact of a particular environmental factor, smoking, on male factor infertility. Standard semen analysis does not have strong sensitivity or specificity for male factor infertility given that it only examines sperm. Guzick et al. [4] demonstrated this in a study that showed extensive overlap in the sperm motility, concentration, and morphology in the male partners of fertile and infertile couples. Given this, multiple aspects of functional sperm testing have been added to standard semen analysis. Proteins added to the semen by the male accessory sex organs play a vital role in male reproductive capacity, providing nourishment and protection to spermatozoa. Batruch et al. [5] identified >2300 proteins in the semen of both fertile and infertile men using mass spectrometry. The physiological role of most of these proteins is unknown. Proteomics identifies the protein complement present in the semen using mass spectrometry. Sharma et al. [6] reported that the proteome of men with reactive oxygen species present is altered and that the absence of certain proteins may impair the neutralization of oxidative stress in semen. Prior studies have shown that the protein complement of the semen is different in men with clinical varicocoeles [7].

While the concern about the impact of smoking on male reproductive health is well documented, the effect that it has on the semen proteome is unknown. Antoniassi et al. [3] compared the semen proteome in both non-smoking and smoking men who presented to their laboratory for semen analysis. Given that patients rather than volunteers were used in this study, one cannot easily generalize the study findings to the general male population. After testing the samples for mitochondrial activity, acrosome function, and DNA integrity, the samples underwent liquid chromatography/mass spectroscopy to analyze the proteome. Sperm from smokers showed lesser sperm integrity, higher DNA fragmentation rates, and a lower percentage of intact mitochondria. The investigators demonstrated that smoking causes changes in the semen proteome. In smoking men one protein was absent, 27 proteins were under-represented, and six were over-represented. This study [3] provides some insight into how certain proteins may impact fertility. The protein S100A9 is overexpressed in smoking men and is associated with chronic inflammation, which corresponds with the fact that smokers frequently exhibit leukocytospermia. Mammoglobin B, the protein absent in men who smoke, is involved in the binding of steroid hormones; therefore, it is conceivable that its absence inhibits the ability of sperm to respond to sex hormones. you can find more info on Theihcc.com around these and other steroids.

This study [3] establishes that, among men who present for fertility evaluation, smokers have an altered proteome compared to non-smokers. This highlights the need for a greater understanding of how the semen proteome interacts with cellular elements. Further studies that examine the proteome of smokers and non-smokers with no history of infertility are warranted.

Read the full article

 

Kenneth J. DeLay and Wayne J.G. Hellstrom

 

Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA

 

References

 

1 Sabanegh E Jr, Agarwal A. Male infertility. In Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA eds, Campbell-Walsh Urology, 10th edn, Philadelphia, PA: Elsevier Saunders: 2011

 

2 Barazani Y, Katz BF, Nagler HM, Stember DS. Lifestyle, environment, and male reproductive health. Urol Clin North Am 2014; 41: 55–66

 

3 AntoniassiMP, Intasqui P, Camargo M et al.Analysisofthefunctional aspects and seminal plasma proteomic profileofspermfromsmokers. BJU Int 2016; 118: 814–22

 

4 GuzickDS, Overstreet JW, Factor-Litvak P et al.Spermmorphology, motility, and concentration in fertile and infertile men. NEnglJMed2001; 345: 1388–93

 

5 Batruch I, Lecker I, Kagedan D et al. Proteomic analysis of seminal plasma from normal volunteers and post-vasectomy patients identifies over 2000 proteins and candidate biomarkers of the urogenital system. J Proteome Res 2011; 10: 941–53

 

6 Sharma R, Agarwal A, Mohanty G et al. Proteomic analysis of seminal fluid from men exhibiting oxidative stress. Reprod Biol Endocrinol 2013; 11: 85.

 

7 Zylbersztejn DS, Andreoni C, Del Giudice PT et al. Proteomic analysis of seminal plasma in adolescents with and without varicocele. Fertil Steril 2013; 99: 92–8

 

Video: The Effect of Smoking on Sperm Functional Quality and Seminal Plasma Proteomic Profile

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Analysis of the functional aspects and seminal plasma proteomic profile of sperm from smokers

Mariana Pereira Antoniassi*, Paula Intasqui*, Mariana Camargo*, Daniel Suslik
Zylbersztejn*, Valdemir Melechco Carvalho†, Karina H. M. Cardozo† and Ricardo
Pimenta Bertolla*‡
*Department of Surgery, Division of Urology, Human Reproduction Section, Sao Paulo Federal University, †Fleury Group, and ‡Hospital Sao Paulo, Sao Paulo, Brazil
Read the full article

Objective

To evaluate the effect of smoking on sperm functional quality and seminal plasma proteomic profile.

Patients and Methods

Sperm functional tests were performed in 20 non-smoking men with normal semen quality, according to the World Health Organization (2010) and in 20 smoking patients. These included: evaluation of DNA fragmentation by alkaline Comet assay; analysis of mitochondrial activity using DAB staining; and acrosomal integrity evaluation by PNA binding. The remaining semen was centrifuged and seminal plasma was used for proteomic analysis (liquid chromatography-tandem mass spectrometry). The quantified proteins were used for Venn diagram construction in Cytoscape 3.2.1 software, using the PINA4MS plug-in. Then, differentially expressed proteins were used for functional enrichment analysis of Gene Ontology categories, Kyoto Encyclopedia of Genes and Genomes and Reactome, using Cytoscape software and the ClueGO 2.2.0 plug-in.

aotm-nov-1-results

Results

Smokers had a higher percentage of sperm DNA damage (Comet classes III and IV; P < 0.01), partially and fully inactive mitochondria (DAB classes III and IV; P = 0.001 and P = 0.006, respectively) and non-intact acrosomes (P < 0.01) when compared with the control group. With respect to proteomic analysis, 422 proteins were identified and quantified, of which one protein was absent, 27 proteins were under-represented and six proteins were over-represented in smokers. Functional enrichment analysis showed the enrichment of antigen processing and presentation, positive regulation of prostaglandin secretion involved in immune response, protein kinase A signalling and arachidonic acid secretion, complement activation, regulation of the cytokine-mediated signalling pathway and regulation of acute inflammatory response in the study group (smokers).

Conclusion

In conclusion, cigarette smoking was associated with an inflammatory state in the accessory glands and in the testis, as shown by enriched proteomic pathways. This state causes an alteration in sperm functional quality, which is characterized by decreased acrosome integrity and mitochondrial activity, as well as by increased nuclear DNA fragmentation.

Read more articles of the week

Article of the Month: Recent advances in immuno-oncology and its application to urological cancers

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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.

In addition to the article itself, there is an accompanying comment 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.

Recent advances in immuno-oncology and its application to urological cancers

Jennifer M. Mataraza and Philip Gotwals

 

Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research, Cambridge, MA, USA

 

Read the full article

Abstract

Recent advances in immuno-oncology have the potential to transform the practice of medical oncology. Antibodies directed against negative regulators of T-cell function (checkpoint inhibitors), engineered cell therapies and innate immune stimulators, such as oncolytic viruses, are effective in a wide range of cancers. Immune‘based therapies have had a clinically meaningful impact on the treatment of advanced melanoma, and the lessons regarding use of single agents and combinations in melanoma may be applicable to the treatment of urological cancers. Checkpoint inhibitors, cytokine therapy and therapeutic vaccines are already showing promise in urothelial bladder cancer, renal cell carcinoma and prostate cancer. Critical areas of future immuno-oncology research include the prospective identification of patients who will respond to current immune-based cancer therapies and the identification of new therapeutic agents that promote immune priming in tumours, and increase the rate of durable clinical responses.

oct-aotm-results

Read more articles of the week

Article of the Month: Guideline of Guidelines – Thromboprophylaxis for Urological Surgery

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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.

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 Kari Tikkinen, discussing his paper.

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

Guideline of guidelines: thromboprophylaxis for urological surgery

Philippe D. Violette*, Rufus Cartwright†‡, Matthias Briel§, Kari A.O. Tikkinen¶ and Gordon H. Guyatt**,††

 

*Division of Urology, Department of Surgery, Woodstock Hospital, Woodstock, ON, Canada, † Department of Epidemiology and Biostatistics, Imperial College London, London, UK, ‡Department of Urogynaecology, St. Mary’s Hospital, London, UK, §Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland, Departments of Urology and Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland, **Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada, and ††Department of Medicine, McMaster University, Hamilton, ON, Canada

 

Read the full article

 

Decisions regarding thromboprophylaxis in urologic surgery involve a trade-off between decreased risk of venous thromboembolism (VTE) and increased risk of bleeding. Both patient- and procedure-specific factors are critical in making an informed decision on the use of thromboprophylaxis. Our systematic review of the literature revealed that existing guidelines in urology are limited. Recommendations from national and international guidelines often conflict and are largely based on indirect as opposed to procedure-specific evidence. These issues have likely contributed to large variation in the use of VTE prophylaxis within and between countries. The majority of existing guidelines typically suggest prolonged thromboprophylaxis for high-risk abdominal or pelvic surgery, without clear clarification of what these procedures are, for up to 4 weeks post-discharge. Existing guidance may result in the under-treatment of procedures with low risk of bleeding and the over-treatment of oncological procedures with low risk of VTE. Guidance for patients who are already anticoagulated are not specific to urological procedures but generally involve evaluating patient and surgical risks when deciding on bridging therapy. The European Association of Urology Guidelines Office has commissioned an ad hoc guideline panel that will present a formal thromboprophylaxis guideline for specific urological procedures and patient risk factors.

AOTM Key Points

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Editorial: Optimal Thromboprophylaxis Remains a Challenge

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The ‘Guideline of guidelines: thromboprophylaxis for urological surgery’, published in this month’s issue of BJUI by Violette et al. [1], addresses a critical issue in urological practice and offers a comprehensive overview of available guidelines. Many urological surgeries, especially cancer surgeries, present a significant risk of thromboembolism, as well as bleeding. Therefore, urological surgeons should be well educated in the matter in order to be able to offer optimal prophylaxis to patients. Reading through the current recommendations and guidelines, one realises the wide variety of possible ways to risk stratify a patient, but also the large differences in opinions on how and when to offer prophylaxis. Consequently, even members within the same national society treat their patients in completely different ways.

The ideal recommendation will have to be individualised, taking thromboembolic and bleeding risk into account for each individual patient and specific surgery type. This stratification of patients not only presents a challenge in clinical practice but also for the design of meaningful clinical trials. As many medical questions regarding thromboprophylaxis remain unanswered, the currently available recommendations are based on our pathophysiological understanding and remain eminence-based, rather than evidence-based.

For many years, the ‘Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines’ [2] were viewed as the most respected guidelines in surgery. They include recommendations for a wide variety of surgical procedures, including urological surgeries. With an ageing population, our patients will more often be on anticoagulant treatment before surgery. While most guidelines still recommend stopping the anticoagulant treatment and bridging with heparin, new evidence from randomised controlled trials [3, 4] indicate that bridging by heparin significantly increases the risk for major bleeding without reducing the thromboembolic risk in most patients. Despite a recent appeal by internists and cardiologists [5], revised guidelines from the American College of Chest Physicians to replace the partially outdated recommendations have yet to be published. As mentioned by Violette et al. [1] in their current review, bridging should probably only be offered to a limited number of patients with a very high risk of thromboembolic complications.

Whether the recommendations for acetylsalicylic acid prophylaxis will be changed similarly (to stopping perioperatively in all but high-risk patients) is less clear [6]. More clinical evidence is needed here.

The European Association of Urology has recognised the problem and presented the prospect of providing a guideline on thromboprophylaxis for urological procedures later this year. Looking at the landscape of available high-quality publications it will still be highly challenging to provide clear recommendations for urological surgeries. The key to a comprehensive application will be the clinical practicality. With this review, the authors have set the stage to a critical review of the recommendations from a urological point of view.

Read the full article

 

Daniel Eberli
University and University Hospital of Zurich, Zurich, Switzerland

 

References

 

1 Violette PD, Cartwright R, Briel M, Tikkinen KAO, Guyatt GH. Guideline of guidelines: thromboprophylaxis for urological surgery. BJU Int 2016; 118: 351–58

 

2 Douketis JD, Spyropoulos AC, Spencer FA et al. Perioperative management of antithrombotic therapy: antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl.): e326S–50S

 

3 Steinberg BA, Peterson ED, Kim S et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation 2015; 131: 488–94

 

4 Douketis JD, Spyropoulos AC, Kaatz S et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med 2015; 373: 823–33

 

5 Rose AJ, Allen AL, Minichello T. A call to reduce the use of bridging anticoagulation. Circ Cardiovasc Qual Outcomes 2016; 9: 64–7

 

6 Devereaux PJ, Mrkobrada M, Sessler DI et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med 2014; 370: 1494–503

 

Video: Guideline of Guidelines – Thromboprophylaxis for Urological Surgery

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Guideline of guidelines: thromboprophylaxis for urological surgery

Philippe D. Violette*, Rufus Cartwright†‡, Matthias Briel§, Kari A.O. Tikkinen¶ and Gordon H. Guyatt**,††

 

*Division of Urology, Department of Surgery, Woodstock Hospital, Woodstock, ON, Canada, † Department of Epidemiology and Biostatistics, Imperial College London, London, UK, ‡Department of Urogynaecology, St. Mary’s Hospital, London, UK, §Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland, Departments of Urology and Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland, **Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada, and ††Department of Medicine, McMaster University, Hamilton, ON, Canada
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Decisions regarding thromboprophylaxis in urologic surgery involve a trade-off between decreased risk of venous thromboembolism (VTE) and increased risk of bleeding. Both patient- and procedure-specific factors are critical in making an informed decision on the use of thromboprophylaxis. Our systematic review of the literature revealed that existing guidelines in urology are limited. Recommendations from national and international guidelines often conflict and are largely based on indirect as opposed to procedure-specific evidence. These issues have likely contributed to large variation in the use of VTE prophylaxis within and between countries. The majority of existing guidelines typically suggest prolonged thromboprophylaxis for high-risk abdominal or pelvic surgery, without clear clarification of what these procedures are, for up to 4 weeks post-discharge. Existing guidance may result in the under-treatment of procedures with low risk of bleeding and the over-treatment of oncological procedures with low risk of VTE. Guidance for patients who are already anticoagulated are not specific to urological procedures but generally involve evaluating patient and surgical risks when deciding on bridging therapy. The European Association of Urology Guidelines Office has commissioned an ad hoc guideline panel that will present a formal thromboprophylaxis guideline for specific urological procedures and patient risk factors.
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