Dionysios Mitropoulos

Reporting and Grading of Complications After Urologic Surgical Procedures: An ad hoc EAU Guidelines Panel Assessment and Recommendations

CONTEXT The incidence of postoperative complications is still the most frequently used surrogate marker of quality in surgery, but no standard guidelines or criteria exist for reporting surgical complications in the area of urology. OBJECTIVE To review the available reporting systems used for urologic surgical complications, to establish a possible change in attitude towards reporting of complications using standardised systems, to assess systematically the Clavien-Dindo system when used for the reporting of complications related to urologic surgical procedures, to identify shortcomings in reporting complications, and to propose recommendations for the development and implementation of future reporting systems that are focused on patient-centred outcomes. EVIDENCE ACQUISITION Standardised systems for reporting and classification of surgical complications were identified through a systematic review of the literature. To establish a possible change in attitude towards reporting of complications related to urologic procedures, we performed a systematic literature search of all papers reporting complications after urologic surgery published in European Urology, Journal of Urology, Urology, BJU International, and World Journal of Urology in 1999-2000 and 2009-2010. Data identification for the systematic assessment of the Clavien-Dindo system currently used for the reporting of complications related to urologic surgical interventions involved a Medline/Embase search and the search engines of individual urologic journals and publishers using Clavien, urology, and complications as keywords. All selected papers were full-text retrieved and assessed; analysis was done based on structured forms. EVIDENCE SYNTHESIS The systematic review of the literature for standardised systems used for reporting and classification of surgical complications revealed five such systems. As far as the attitude of urologists towards reporting of complications, a shift could be seen in the number of studies using most of the Martin criteria, as well as in the number of studies using either standardised criteria or the Clavien-Dindo system. The latter system was not properly used in 72 papers (35.3%). CONCLUSIONS Uniformed reporting of complications after urologic procedures will aid all those involved in patient care and scientific publishing (authors, reviewers, and editors). It will also contribute to the improvement of the scientific quality of papers published in the field of urologic surgery. When reporting the outcomes of urologic procedures, the committee proposes a series of quality criteria.

Treatment of patients with metastatic urothelial carcinoma and impaired renal function with single-agent docetaxel

OBJECTIVES To evaluate the efficacy and toxicity of single-agent docetaxel in patients with metastatic urothelial carcinoma and impaired renal function. METHODS Eleven consecutive patients previously untreated for metastatic disease with renal impairment (median serum creatinine level of 2.6 mg/dL) were treated with intravenous docetaxel 100 mg/m2 for 1 hour every 21 days. Granulocyte colony-stimulating factor was administered at a dose of 5 microg/kg/day subcutaneously from days 5 to 14. RESULTS Five of 11 patients achieved a partial response, with time to progression of responding patients ranging from 5 to 22 months or more. The median overall survival rate was 11 months. Renal function improved in 5 of 8 patients with tumor-related renal impairment. Toxicity was primarily hematologic, with 5 patients developing grade 3 or 4 neutropenia; nonhematologic toxicities were manageable. CONCLUSIONS Our preliminary data indicate that single-agent docetaxel therapy may represent an effective therapeutic alternative for patients with advanced urothelial carcinoma and renal insufficiency precluding cisplatin-based combination chemotherapy.

Notificación y clasificación de complicaciones después de procedimientos quirúrgicos urológicos: una evaluación y recomendaciones del panel de guías clínicas de la EAU

CONTEXT The incidence of postoperative complications is still the most frequently used surrogate marker of quality in surgery, but no standard guidelines or criteria exist for reporting surgical complications in the area of urology. OBJECTIVE To review the available reporting systems used for urologic surgical complications, to establish a possible change in attitude towards reporting of complications using standardised systems, to assess systematically the Clavien-Dindo system when used for the reporting of complications related to urologic surgical procedures, to identify shortcomings in reporting complications, and to propose recommendations for the development and implementation of future reporting systems that are focused on patient-centred outcomes. EVIDENCE ACQUISITION Standardised systems for reporting and classification of surgical complications were identified through a systematic review of the literature. To establish a possible change in attitude towards reporting of complications related to urologic procedures, we performed a systematic literature search of all papers reporting complications after urologic surgery published in European Urology, Journal of Urology, Urology, BJU International, and World Journal of Urology in 1999-2000 and 2009-2010. Data identification for the systematic assessment of the Clavien-Dindo system currently used for the reporting of complications related to urologic surgical interventions involved a Medline/Embase search and the search engines of individual urologic journals and publishers using Clavien, urology, and complications as keywords. All selected papers were full-text retrieved and assessed; analysis was done based on structured forms. EVIDENCE SYNTHESIS The systematic review of the literature for standardised systems used for reporting and classification of surgical complications revealed five such systems. As far as the attitude of urologists towards reporting of complications, a shift could be seen in the number of studies using most of the Martin criteria, as well as in the number of studies using either standardised criteria or the Clavien-Dindo system. The latter system was not properly used in 72 papers (35.3%). CONCLUSIONS Uniformed reporting of complications after urologic procedures will aid all those involved in patient care and scientific publishing (authors, reviewers, and editors). It will also contribute to the improvement of the scientific quality of papers published in the field of urologic surgery. When reporting the outcomes of urologic procedures, the committee proposes a series of quality criteria.

Quality Assessment of Partial Nephrectomy Complications Reporting Using EAU Standardised Quality Criteria

CONTEXT A standardised system to report outcomes and complications of urologic procedures has recently been proposed by an ad hoc European Association of Urology (EAU) Guidelines panel. To date, no studies have used these criteria to evaluate the quality of reports of outcomes and complications after partial nephrectomy (PN). OBJECTIVE To address the quality of reporting of PN complications. DESIGN, SETTING, AND PARTICIPANTS A systematic review of papers reporting outcomes of PN was conducted through the electronic search of databases, including Medline, PubMed, Embase, Scopus, and the Cochrane Database of Systematic Reviews. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Analysis was carried out on structured forms. The quality criteria that the EAU Working Group proposed for reporting complications were recorded for each paper, and adherence to the Martin criteria was assessed. RESULTS AND LIMITATIONS Standardised criteria to report and grade complications were used in 71 out of 204 evaluable studies (34.8%). Only six studies (2.9%) fulfilled all criteria that the EAU Guidelines Office ad hoc panel proposed. The mean number did not change significantly by time or by surgical approach used. The most underreported criteria (in <50% of the studies) were who collected the data (18.6%), whether he or she were involved in the treatment (13.7%), duration of follow-up (47.1%), mortality data and causes of death (33.8%), definition of procedure-specific complications (39.2), separate reporting of intra- and postoperative complications (45.1%), complication severity or grade (32.4%), risk factors analysis (44.1%), readmission rates (12.7%), and percentage of patients lost to follow-up (6.9%). The mean number fulfilled was 6.5 ± 2.9 (mean plus or minus standard deviation) and did not change significantly by time or by surgical approach used. CONCLUSIONS The only way to improve the quality of the surgical scientific literature and to allow sound comparisons among different approaches, especially with the lack of randomised trials, is the use of more rigorous methodology than the one recently proposed to report outcomes and complications. PATIENT SUMMARY A rigorous methodology is mandatory when surgeons report about complications after surgery. Otherwise, the rate of adverse events is underestimated.

Does free to total ratio of prostate-specific antigen alter decision-making on prostatic biopsy?

OBJECTIVES For patients with prostate specific antigen (PSA) values of 4-10 ng/mL, some urologists perform prostatic biopsies depending upon the findings of digital rectal examination (DRE) and transrectal ultrasonography (TRUS), and others perform biopsies on most of these men regardless of the findings of DRE and TRUS. The purpose of this study was to examine whether the information given by the measurement of the ratio of free to total (F/T) PSA can alter decision-making on prostatic biopsy. METHODS One hundred and two (102) men with PSA values between 4 and 10 ng/mL, were included in this study. All men were examined with DRE and TRUS; a F/T PSA ratio was also measured, and six prostatic biopsies were taken from each patient. RESULTS In 102 men who were biopsied, 22 (21.5%) prostatic carcinomas were identified. Among these 22 cancer patients, 13 had abnormal findings in DRE and/or TRUS and would have been biopsied and diagnosed anyway. If we use only the F/T PSA ratio (cut-off value 0.20) to decide whom to biopsy, we would have diagnosed 16/22 cancers; the difference between these two procedures was not statistically significant (P = 0.17). If we decide to biopsy those patients who have abnormal findings in DRE and/or TRUS and those who have a F/T PSA ratio < 0.20, we would diagnose 20/22 cancers (P = 0.05) and at the same time, reduce the unnecessary biopsies from 80 to 41 (48%). With a PSA value between 4 and 10 ng/mL and no findings in DRE and TRUS and at the same time with a F/T PSA ratio > or = 0.20, we would have to perform biopsies in 20.5 men to find one cancer. On the other hand, in patients with suspicious findings in DRE and/or TRUS and a F/T PSA ratio < 0.20, in every two men that we biopsy we would find one cancer. CONCLUSION We believe that among patients with PSA values between 4 and 10 ng/mL after performing DRE and TRUS, the additional information of F/T PSA ratio can help since it increases the number of cancers detected and reduces the number of unnecessary biopsies.

The European Association of Urology (EAU) Guidelines Methodology: A Critical Evaluation

OBJECTIVES Guidelines can be produced and written in numerous ways. The aim of the present article is to describe and evaluate the method currently used to produce the European Association of Urology (EAU) guidelines. DESIGN, SETTING, AND PARTICIPANTS The methodology is described in detail, compared to other urologic guidelines by members of the EAU Guidelines Office Board. MEASUREMENTS The new methodology is evaluated by the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. RESULTS AND LIMITATIONS The currently used methodology is adapted to the aims and objectives as established by the EAU for their guidelines; wide coverage (essentially all fields of urology) and useful to urologists all over Europe. The frequent updates are easily accessible in a printed and electronic format. The AGREE instrument supports these strong points, but also identifies potentially weak points, such as no patient involvement, no formal validation of the guidelines texts prior to publication, and lack of discussion of organisational barriers and cost implications. CONCLUSION The currently used methodology for the production of EAU guidelines fulfils the associations main objectives related to their guidelines, but the texts will benefit from the inclusion of country-specific cost and organisational data. For the practising clinician, these guidelines will help to take science into clinical practice.

Bcl-2 protein and DNA ploidy in renal cell carcinoma: Do they affect patient prognosis?

Abstract  Aim:  The aim of the present study was to correlate bcl‐2 protein expression and DNA‐ploidy status with established prognostic parameters in renal cell carcinoma (RCC) and to examine their impact on disease progression and patient survival.

Current Clinical Practice Guidelines for the Treatment of Renal Cell Carcinoma: A Systematic Review and Critical Evaluation

The landscape of local and systemic therapy of renal cell carcinoma (RCC) is rapidly changing. The increase in the incidental finding of small renal tumors has increased the application of nephron-sparing procedures, while ten novel agents targeting the vascular endothelial growth factor (VEGF) or the mammalian target of rapamycin pathways, or inhibiting the interaction of the programmed death 1 receptor with its ligand, have been approved since 2006 and have dramatically improved the prognosis of metastatic RCC (mRCC). These rapid developments have resulted in continuous changes in the respective Clinical Practice Guidelines/Expert Recommendations. We conducted a systematic review of the existing guidelines in MEDLINE according to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement, aiming to identify areas of agreement and discrepancy among them and to evaluate the underlying reasons for such discrepancies. Data synthesis identified selection criteria for nonsurgical approaches in renal masses; the role of modern laparoscopic techniques in the context of partial nephrectomy; selection criteria for cytoreductive nephrectomy and metastasectomy in mRCC; systemic therapy of metastatic non-clear-cell renal cancers; and optimal sequence of available agents in mRCC relapsed after anti-VEGF therapy as the major areas of uncertainty. Agreement or uncertainty was not always correlated with the availability of data from phase III randomized controlled trials. Our review suggests that the combination of systematic review and critical evaluation can define practices of wide applicability and areas for future research by identifying areas of agreement and uncertainty among existing guidelines. IMPLICATIONS FOR PRACTICE Currently, there is uncertainity on the role of surgery in MRCC and on the choice of available guidelines in relapsed RCC. The best practice is individualization of targeted therapies. Systematic review of guidelines can help to identify unmet medical needs and areas of future research.

Outcome of patients with nonmetastatic muscle‐invasive bladder cancer not undergoing cystectomy after treatment with noncisplatin‐based chemotherapy and/or radiotherapy: a retrospective analysis

Transurethral resection of bladder tumor (TURBT), radiotherapy, chemotherapy, or combinations can be used in patients with muscle‐invasive bladder cancer (MIBC) not undergoing cystectomy. Nevertheless, unfitness for cystectomy is frequently associated with unfitness for other therapeutic modalities. We report the outcome of patients with MIBC who did not undergo cystectomy and did not receive cisplatin‐based chemotherapy. Selection criteria for the study were nonmetastatic MIBC, no cystectomy, no cisplatin‐based chemotherapy. Chemotherapy and/or radiotherapy should have been used aside from TURBT. Forty‐nine patients (median age 79), managed between April 2001 and January 2012, were included in this analysis. Median Charlson Comorbidity Index was 5, while 76% were unfit for cisplatin. Treatment included radiotherapy (n = 7), carboplatin‐based chemotherapy (n = 25), carboplatin‐based chemotherapy followed by radiotherapy (n = 10), and radiochemotherapy (n = 7). Five‐year event‐free rate was 26% (standard error [SE] = 7) for overall survival, 23% (SE = 7) for progression‐free survival, and 30 (SE = 8) for cancer‐specific survival (CSS). Patients who were treated with combination of radiotherapy and chemotherapy had significantly longer CSS compared to those treated with radiotherapy or chemotherapy only (5‐year CSS rate: 16% [SE 8] vs. 63% [SE 15], P = 0.053). Unfit‐for‐cystectomy patients frequently receive suboptimal nonsurgical treatment. Their outcome was poor. Combining chemotherapy with radiotherapy produced better outcomes and should be prospectively evaluated.

A Cough Deteriorating Gross Hematuria: A Clinical Sign of a Forthcoming Life-Threatening Rupture of an Intraparenchymal Aneurysm of Renal Artery (Wunderlich's Syndrome)

Macroscopic hematuria regards the 4% to 20% of all urological visits. Renal artery aneurysms (RAAs) are detected in approximately 0.01%–1% of the general population, while intraparenchymal renal artery aneurysms (IPRAAs) are even more rarely detected in less than 10% of patients with RAAs. We present a case of a 58-year-old woman that came into the emergency room (ER) complaining of a gross hematuria during the last four days. Although in the ER room the first urine sample was clear after a cough episode, a severe gross hematuria began which led to a hemodynamically unstable patient. Finally, a radical nephrectomy was performed, and an IPRAA was the final diagnosis. A cough deteriorating hematuria could be attributed to a ruptured intraparenchymal renal artery aneurysm, which even though constitutes a rare entity, it is a life-threatening medical emergency.