Methodological Quality of Systematic Reviews Published in the Urological Literature from 1998 to 2012.

PURPOSE: Systematic reviews synthesize the current best evidence to address a clinical question. Given the growing emphasis on evidence-based clinical practice, systematic reviews are being increasingly sought after and published. We previously reported limitations in the methodological quality of 57 individual systematic reviews published from 1998 to 2008. We provide an update to our previous study, adding systematic reviews published from 2009 to 2012. MATERIALS AND METHODS: We systematically searched PubMed® and hand searched the table of contents of 4 major urological journals to identify systematic reviews related to questions of prevention and therapy. Two independent reviewers with prior formal evidence-based medicine training assessed the methodological quality using the validated 11-point AMSTAR (A Measurement Tool to Assess Systematic Reviews) instrument. We performed predefined statistical hypothesis testing for differences by publication period (1998 to 2008 vs 2009 to 2012) and journal of publication. We performed statistical testing using SPSS®, version 23.0 with a 2-sided α of 0.05 using the Student t-test, ANOVA and the chi-square test. RESULTS: A total of 113 systematic reviews published from 2009 to 2012 met study inclusion criteria. The most common topics were oncology (44 reviews or 38.9%), voiding dysfunction (26 or 23.0%) and stones/endourology (13 or 11.5%). The largest contributor was European Urology (46 reviews or 40.7%), followed by BJU International (31 or 27.4%) and The Journal of Urology® (22 or 19.5%). The mean ± SD AMSTAR score for the 2009 to 2012 period was 5.3 ± 2.3 compared to 4.8 ± 2.0 for 1998 to 2008 with a mean difference of 0.5 (95% CI 0.2 to 1.2, p = 0.133). CONCLUSIONS: While the number of systematic reviews published in the urological literature has increased substantially, the methodological quality of these studies remains suboptimal. Systematic review authors and editors should make every effort to adhere to well established methodological standards to enhance the impact of their research efforts.

Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence.

BACKGROUND: Transurethral radiofrequency collagen denaturation is a relatively novel, minimally invasive device-based intervention used to treat individuals with urinary incontinence (UI). No systematic review of the evidence supporting its use has been published to date. OBJECTIVES: To evaluate the efficacy of transurethral radiofrequency collagen denaturation, compared with other interventions, in the treatment of women with UI.Review authors sought to compare the following.• Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment.• Transurethral radiofrequency collagen denaturation versus conservative physical treatment.• Transurethral radiofrequency collagen denaturation versus mechanical devices (pessaries for UI).• Transurethral radiofrequency collagen denaturation versus drug treatment.• Transurethral radiofrequency collagen denaturation versus injectable treatment for UI.• Transurethral radiofrequency collagen denaturation versus other surgery for UI. SEARCH METHODS: We conducted a systematic search of the Cochrane Incontinence Group Specialised Register (searched 19 December 2014), EMBASE and EMBASE Classic (January 1947 to 2014 Week 50), Google Scholar and three trials registries in December 2014, along with reference checking. We sought to identify unpublished studies by handsearching abstracts of major gynaecology and urology meetings, and by contacting experts in the field and the device manufacturer. SELECTION CRITERIA: Randomised and quasi-randomised trials of transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI in women were eligible. DATA COLLECTION AND ANALYSIS: We screened search results and selected eligible studies for inclusion. We assessed risk of bias and analysed dichotomous variables as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous variables as mean differences (MDs) with 95% CIs. We rated the quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. MAIN RESULTS: We included in the analysis one small sham-controlled randomised trial of 173 women performed in the United States. Participants enrolled in this study had been diagnosed with stress UI and were randomly assigned to transurethral radiofrequency collagen denaturation (treatment) or a sham surgery using a non-functioning catheter (no treatment). Mean age of participants in the 12-month multi-centre trial was 50 years (range 22 to 76 years).Of three patient-important primary outcomes selected for this systematic review, the number of women reporting UI symptoms after intervention was not reported. No serious adverse events were reported for the transurethral radiofrequency collagen denaturation arm or the sham treatment arm during the 12-month trial. Owing to high risk of bias and imprecision, we downgraded the quality of evidence for this outcome to low. The effect of transurethral radiofrequency collagen denaturation on the number of women with an incontinence quality of life (I-QOL) score improvement ≥ 10 points at 12 months was as follows: RR 1.11, 95% CI 0.77 to 1.62; participants = 142, but the confidence interval was wide. For this outcome, the quality of evidence was also low as the result of high risk of bias and imprecision.We found no evidence on the number of women undergoing repeat continence surgery. The risk of other adverse events (pain/dysuria (RR 5.73, 95% CI 0.75 to 43.70; participants = 173); new detrusor overactivity (RR 1.36, 95% CI 0.63 to 2.93; participants = 173); and urinary tract infection (RR 0.95, 95% CI 0.24 to 3.86; participants = 173) could not be established reliably as the trial was small. Evidence was insufficient for assessment of whether use of transurethral radiofrequency collagen denaturation was associated with an increased rate of urinary retention, haematuria and hesitancy compared with sham treatment in 173 participants. The GRADE quality of evidence for all other adverse events with available evidence was low as the result of high risk of bias and imprecision.We found no evidence to inform comparisons of transurethral radiofrequency collagen denaturation with conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI. AUTHORS' CONCLUSIONS: It is not known whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of UI. Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment, and no evidence was found for comparison with any other method of treatment for UI.

Clinical practice guidelines on prostate cancer: a critical appraisal.

PURPOSE: Clinical practice guidelines are increasingly being used by leading organizations to promote high quality evidence-based patient care. However, the methodological quality of clinical practice guidelines developed by different organizations varies considerably. We assessed published clinical practice guidelines on the treatment of localized prostate cancer to evaluate the rigor, applicability and transparency of their recommendations. MATERIALS AND METHODS: We searched for English based clinical practice guidelines on treatment of localized prostate cancer from leading organizations in the 15-year period from 1999 to 2014. Clinical practice guidelines limited to early detection, screening, staging and/or diagnosis of prostate cancer were excluded from analysis. Four independent reviewers used the validated AGREE II instrument to assess the quality of clinical practice guidelines in 6 domains, including 1) scope and purpose, 2) stakeholder involvement, 3) rigor of development, 4) clarity of presentation, 5) applicability and 6) editorial independence. RESULTS: A total of 13 clinical practice guidelines met inclusion criteria. Overall the highest median scores were in the AGREE II domains of clarity of presentation, editorial independence, and scope and purpose. The lowest median score was for applicability (28.1%). Although the median score of editorial independence was high (85.4%), variability was also substantial (IQR 12.5-100). NICE and AUA clinical practice guidelines consistently scored well in most domains. CONCLUSIONS: Clinical practice guidelines from different organizations on treatment of localized prostate cancer are of variable quality and fall short of current standards in certain areas, especially in applicability and stakeholder involvement. Improvements in these key domains can enhance the impact and implementation of clinical practice guidelines.

Psychosocial interventions for men with prostate cancer: a Cochrane systematic review.

To evaluate the effectiveness of psychosocial interventions for men with prostate cancer in improving quality of life (QoL), self-efficacy and knowledge and in reducing distress, uncertainty and depression. We searched for trials using a range of electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO to October 2013, together with hand searching of journals and reference lists. Randomised controlled trials were eligible if they included psychosocial interventions that explicitly used one or a combination of the following approaches: cognitive behavioural, psycho-educational, supportive and counselling. Interventions had to be delivered or facilitated by trained or lay personnel. Our outcomes were an improvement in QoL, self-efficacy and knowledge and a reduction in distress, uncertainty and depression. Pairs of review authors independently extracted data and assessed risk of bias. We analysed data using standardised mean differences (SMDs), random-effects models and 95% confidence intervals (CIs). In all, 19 studies with a total of 3 204 men, with a diagnosis of prostate cancer, comparing psychosocial interventions vs usual care were included in this review. Men in the psychosocial intervention group had a small, statistically significant improvement in the physical component of general health-related QoL (GHQoL) at end of intervention (SMD 0.12, 95% CI 0.01-0.22) based on low quality evidence. There was no clear evidence of benefit associated with psychosocial interventions for the mental component of GHQoL at end of intervention (SMD -0.04, 95% CI -0.15 to 0.06) based on moderate quality evidence. At end of intervention, cancer-related QoL showed a small improvement after psychosocial interventions (SMD 0.21, 95% CI 0.04-0.39). For prostate cancer-specific and symptom-related QoL, the differences between intervention and control groups were not significant. There was no clear evidence that psychosocial interventions were beneficial in improving self-efficacy at end of intervention (SMD 0.16, 95% CI -0.05 to 0.38) based on very low quality evidence. Men in the psychosocial intervention group had a moderate increase in prostate cancer knowledge at end of intervention (SMD 0.51, 95% CI 0.32-0.71) based on very low quality evidence. A small increase in knowledge with psychosocial interventions was noted at 3 months after intervention (SMD 0.31, 95% CI 0.04-0.58). The results for uncertainty (SMD -0.05, 95% CI -0.35 to 0.26) and distress (SMD 0.02, 95% CI -0.11 to 0.15) at end of intervention were compatible with both benefit and harm based on very low quality evidence. Finally, there was no clear evidence of benefit associated with psychosocial interventions for depression at end of intervention (SMD -0.18, 95% CI -0.51 to 0.15) based on very low quality evidence. The overall risk of bias in the included studies was unclear or high, primarily as the result of performance bias. No data about stage of disease or treatment with androgen-deprivation therapy were extractable for subgroup analysis. Only one study addressed adverse effects. Overall, this review shows that psychosocial interventions may have small, short-term beneficial effects on certain domains of wellbeing, as measured by the physical component of GHQoL and cancer-related QoL when compared with usual care. Prostate cancer knowledge was also increased. However, this review failed to show a statistically significant effect on other domains such as symptom-related QoL, self-efficacy, uncertainty, distress or depression. Moreover, when beneficial effects were seen, it remained uncertain whether the magnitude of effect was large enough to be considered clinically important. The quality of evidence for most outcomes was rated as very low according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, reflecting study limitations, loss to follow-up, study heterogeneity and small sample sizes. We were unable to perform meaningful subgroup analyses based on disease stage or treatment method. Although some findings of this review are encouraging, they do not provide sufficiently strong evidence to permit meaningful conclusions about the effects of these interventions in men with prostate cancer. Additional well executed and transparently reported research studies are necessary to establish the role of psychosocial interventions in men with prostate cancer.

The impact of the extent of lymphadenectomy on oncologic outcomes in patients undergoing radical cystectomy for bladder cancer: a systematic review.

CONTEXT: Controversy exists regarding the therapeutic value of lymphadenectomy (LND) in patients undergoing radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC). OBJECTIVE: To systematically review the relevant literature assessing the impact of LND on oncologic and perioperative outcomes in patients undergoing RC for MIBC. EVIDENCE ACQUISITION: Medline, Medline In-Process, Embase, the Cochrane Central Register of Controlled Trials, and the Latin American and Caribbean Center on Health Sciences Information (LILACS) were searched up to December 2013. Comparative studies reporting on no LND, limited LND (L-LND), standard LND (S-LND), extended LND (E-LND), superextended LND (SE-LND), and oncologic and perioperative outcomes were included. Risk-of-bias and confounding assessments were performed. EVIDENCE SYNTHESIS: Twenty-three studies reporting on 19,793 patients were included. All but one study were retrospective. Planned meta-analyses were not possible because of study heterogeneity; therefore, data were synthesized narratively. There were high risks of bias and confounding across most studies as well as extreme heterogeneity in the definition of the anatomic boundaries of LND templates. All seven studies comparing LND with no LND favored LND in terms of better oncologic outcomes. Seven of 14 studies comparing (super)extended LND with L-LND or S-LND reported a beneficial outcome for (super)extended LND in at least a subset of patients. No difference in outcome was reported in two studies comparing E-LND and S-LND. The comparative harms of different extents of LND remain unclear. CONCLUSIONS: Although the quality of the data was poor, the available evidence indicates that any kind of LND is advantageous over no LND. Similarly, E-LND appears to be superior to lesser degrees of dissection, while SE-LND offered no additional benefits. It is hoped that data from ongoing randomized clinical trials will clarify remaining uncertainties. PATIENT SUMMARY: The current literature suggests that removal of lymph nodes in bladder cancer surgery is beneficial and might result in better outcomes in terms of prolonging survival; however, the quality of the available studies is poor, and high-quality studies are needed.

Low methodological and reporting quality of randomized, controlled trials of devices to treat urolithiasis.

PURPOSE: We assessed the methodological and reporting quality of randomized, controlled trials of stone disease management and determined whether the reporting quality of randomized, controlled trials improved with time. MATERIALS AND METHODS: We systematically searched the literature for randomized, controlled trials of urolithiasis treatment. We developed and pilot tested a data extraction checklist based on CONSORT (Consolidated Standards of Reporting Trials) criteria as well as a clinical checklist relevant to urolithiasis, each scored as 0 to 25. Our primary outcome measures were the mean differences in CONSORT and clinical summary scores with time. We performed statistical hypothesis testing using the Student t-test with 2-sided α = 0.05 to compare scores between 2002 to 2006 and 2007 to 2011. RESULTS: A total of 104 randomized, controlled trials met study inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (41.3%), ureteral stenting (28.8%) and shock wave lithotripsy (25.0%). Mean ± SE CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 0.7 (95% CI -0.3-1.6, p = 0.167). Mean clinical summary scores were 7.4 ± 0.5 and 9.3 ± 0.4 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 1.8 (95% CI 0.6-3.1, p = 0.004). CONCLUSIONS: While the number of randomized, controlled trials of urological devices used to treat stone disease substantially increased with time, methodological and clinical reporting quality remains suboptimal. This compromises their credibility and warrants efforts to promote appropriate performance of future endourological studies.

Psychosocial interventions for men with prostate cancer.

BACKGROUND: As the incidence and prevalence of prostate cancer continue to rise, the number of men needing help and support to assist them in coping with disease and treatment-related symptoms and their psychosocial effects is likely to increase. OBJECTIVES: To evaluate the effectiveness of psychosocial interventions for men with prostate cancer in improving quality of life (QoL), self-efficacy and knowledge and in reducing distress, uncertainty and depression. SEARCH METHODS: We searched for trials using a range of electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO to October 2013, together with handsearching of journals and reference lists. SELECTION CRITERIA: Randomised controlled trials of psychosocial interventions for men at any stage of prostate cancer. We included psychosocial interventions that explicitly used one or a combination of the following approaches: cognitive behavioural, psychoeducational, supportive and counselling. Interventions had to be delivered or facilitated by trained or lay personnel. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently extracted data and assessed risk of bias. We analysed data using standardised mean differences (SMDs), random-effects models and 95% confidence intervals (CIs). MAIN RESULTS: Nineteen studies comparing psychosocial interventions versus usual care in a total of 3204 men with prostate cancer were included in this review. All but three of these studies were conducted in the United States.Men in the psychosocial intervention group had a small, statistically significant improvement in the physical component of general health-related quality of life (GHQoL) at end of intervention (1414 participants, SMD 0.12, 95% CI 0.01 to 0.22) based on low-quality evidence. A small improvement in favour of psychosocial interventions (SMD 0.24, 95% CI 0.02 to 0.47) was also seen in the physical component of GHQoL at end of intervention for group-based interventions. No clear evidence of benefit was found for GHQoL scores at end of intervention with individual-based interventions compared with controls. Also, no clear evidence suggested that psychosocial interventions were beneficial in improving the physical component of GHQoL at four to six and at eight to 12 months post-intervention. In addition, no clear evidence showed benefit associated with psychosocial interventions for the mental component of GHQoL at end of intervention (1416 participants, SMD -0.04, 95% CI -0.15 to 0.06) based on moderate-quality evidence. Results for the mental component of GHQoL at four to six and at eight to 12 months post-intervention were compatible with benefit and harm. At end of intervention, cancer-related QoL showed a small improvement following psychosocial interventions (SMD 0.21, 95% CI 0.04 to 0.39), but at eight and 12 months, the effect was compatible with benefit and harm. For prostate cancer-specific and symptom-related QoL, the differences between groups were not significant.No clear evidence indicated that psychosocial interventions were beneficial in improving self-efficacy at end of intervention (337 participants, SMD 0.16, 95% CI -0.05 to 0.38) based on very low-quality evidence in three studies that assessed individual-based interventions. The results for self-efficacy at six to eight and at 12 months post-intervention were compatible with benefit and harm. Men in the psychosocial intervention group had a moderate increase in prostate cancer knowledge at end of intervention (506 participants, SMD 0.51, 95% CI 0.32 to 0.71) based on very low-quality evidence in two studies; this increase was also observed in the subgroups of group-based and individual-based interventions. A small increase in knowledge with psychosocial interventions was noted at three months post-intervention (SMD 0.31, 95% CI 0.04 to 0.58).The results for uncertainty (916 participants, SMD -0.05, 95% CI -0.35 to 0.26) and distress (916 participants, SMD 0.02, 95% CI -0.11 to 0.15) at end of intervention were compatible with both benefit and harm based on very low-quality evidence. No clear evidence suggests that psychosocial interventions were beneficial in reducing uncertainty and distress between groups at six to eight and at 12 months post-intervention. Finally, no clear evidence of benefit is associated with psychosocial interventions for depression at end of intervention (434 participants, SMD -0.18, 95% CI -0.51 to 0.15) based on very low-quality evidence. Individual-based interventions significantly reduced depression when compared with usual care groups. The results for depression at six and at 12 months post-intervention were compatible with benefit and harm.The overall risk of bias in the included studies was unclear or high, primarily as the result of performance bias.No data regarding stage of disease or treatment with androgen deprivation therapy (ADT) were extractable for subgroup analysis. Only one study addressed adverse effects. High attrition could indicate that some participants may not have been comfortable with the interventions. AUTHORS' CONCLUSIONS: Overall, this review shows that psychosocial interventions may have small, short-term beneficial effects on certain domains of well-being, as measured by the physical component of GHQoL and cancer-related QoL when compared with usual care. Prostate cancer knowledge was also increased. However, this review failed to demonstrate a statistically significant effect on other domains such as symptom-related QoL, self-efficacy, uncertainty, distress or depression. Moreover, when beneficial effects were observed, it remained uncertain whether the magnitude of effect was large enough to be considered clinically important. The quality of evidence for most outcomes was rated as very low according to GRADE, reflecting study limitations, loss to follow-up, study heterogeneity and small sample sizes. We were unable to perform meaningful subgroup analyses based on disease stage or treatment modality. Although some findings of this review are encouraging, they do not provide sufficiently strong evidence to permit meaningful conclusions about the effects of these interventions in men with prostate cancer. Additional well-done and transparently reported research studies are necessary to establish the role of psychosocial interventions in men with prostate cancer.

Screening for prostate cancer.

BACKGROUND: Any form of screening aims to reduce disease-specific and overall mortality, and to improve a person's future quality of life. Screening for prostate cancer has generated considerable debate within the medical and broader community, as demonstrated by the varying recommendations made by medical organizations and governed by national policies. To better inform individual patient decision-making and health policy decisions, we need to consider the entire body of data from randomised controlled trials (RCTs) on prostate cancer screening summarised in a systematic review. In 2006, our Cochrane review identified insufficient evidence to either support or refute the use of routine mass, selective, or opportunistic screening for prostate cancer. An update of the review in 2010 included three additional trials. Meta-analysis of the five studies included in the 2010 review concluded that screening did not significantly reduce prostate cancer-specific mortality. In the past two years, several updates to studies included in the 2010 review have been published thereby providing the rationale for this update of the 2010 systematic review. OBJECTIVES: To determine whether screening for prostate cancer reduces prostate cancer-specific mortality or all-cause mortality and to assess its impact on quality of life and adverse events. SEARCH METHODS: An updated search of electronic databases (PROSTATE register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CANCERLIT, and the NHS EED) was performed, in addition to handsearching of specific journals and bibliographies, in an effort to identify both published and unpublished trials. SELECTION CRITERIA: All RCTs of screening versus no screening for prostate cancer were eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: The original search (2006) identified 99 potentially relevant articles that were selected for full-text review. From these citations, two RCTs were identified as meeting the inclusion criteria. The search for the 2010 version of the review identified a further 106 potentially relevant articles, from which three new RCTs were included in the review. A total of 31 articles were retrieved for full-text examination based on the updated search in 2012. Updated data on three studies were included in this review. Data from the trials were independently extracted by two authors. MAIN RESULTS: Five RCTs with a total of 341,342 participants were included in this review. All involved prostate-specific antigen (PSA) testing, with or without digital rectal examination (DRE), though the interval and threshold for further evaluation varied across trials. The age of participants ranged from 45 to 80 years and duration of follow-up from 7 to 20 years. Our meta-analysis of the five included studies indicated no statistically significant difference in prostate cancer-specific mortality between men randomised to the screening and control groups (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.86 to 1.17). The methodological quality of three of the studies was assessed as posing a high risk of bias. The European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial were assessed as posing a low risk of bias, but provided contradicting results. The ERSPC study reported a significant reduction in prostate cancer-specific mortality (RR 0.84, 95% CI 0.73 to 0.95), whilst the PLCO study concluded no significant benefit (RR 1.15, 95% CI 0.86 to 1.54). The ERSPC was the only study of the five included in this review that reported a significant reduction in prostate cancer-specific mortality, in a pre-specified subgroup of men aged 55 to 69 years of age. Sensitivity analysis for overall risk of bias indicated no significant difference in prostate cancer-specific mortality when referring to the meta analysis of only the ERSPC and PLCO trial data (RR 0.96, 95% CI 0.70 to 1.30). Subgroup analyses indicated that prostate cancer-specific mortality was not affected by the age at which participants were screened. Meta-analysis of four studies investigating all-cause mortality did not determine any significant differences between men randomised to screening or control (RR 1.00, 95% CI 0.96 to 1.03). A diagnosis of prostate cancer was significantly greater in men randomised to screening compared to those randomised to control (RR 1.30, 95% CI 1.02 to 1.65). Localised prostate cancer was more commonly diagnosed in men randomised to screening (RR 1.79, 95% CI 1.19 to 2.70), whilst the proportion of men diagnosed with advanced prostate cancer was significantly lower in the screening group compared to the men serving as controls (RR 0.80, 95% CI 0.73 to 0.87). Screening resulted in a range of harms that can be considered minor to major in severity and duration. Common minor harms from screening include bleeding, bruising and short-term anxiety. Common major harms include overdiagnosis and overtreatment, including infection, blood loss requiring transfusion, pneumonia, erectile dysfunction, and incontinence. Harms of screening included false-positive results for the PSA test and overdiagnosis (up to 50% in the ERSPC study). Adverse events associated with transrectal ultrasound (TRUS)-guided biopsies included infection, bleeding and pain. No deaths were attributed to any biopsy procedure. None of the studies provided detailed assessment of the effect of screening on quality of life or provided a comprehensive assessment of resource utilization associated with screening (although preliminary analyses were reported). AUTHORS' CONCLUSIONS: Prostate cancer screening did not significantly decrease prostate cancer-specific mortality in a combined meta-analysis of five RCTs. Only one study (ERSPC) reported a 21% significant reduction of prostate cancer-specific mortality in a pre-specified subgroup of men aged 55 to 69 years. Pooled data currently demonstrates no significant reduction in prostate cancer-specific and overall mortality. Harms associated with PSA-based screening and subsequent diagnostic evaluations are frequent, and moderate in severity. Overdiagnosis and overtreatment are common and are associated with treatment-related harms. Men should be informed of this and the demonstrated adverse effects when they are deciding whether or not to undertake screening for prostate cancer. Any reduction in prostate cancer-specific mortality may take up to 10 years to accrue; therefore, men who have a life expectancy less than 10 to 15 years should be informed that screening for prostate cancer is unlikely to be beneficial. No studies examined the independent role of screening by DRE.

Diagnostic tests in urology: percentage of free prostate-specific antigen (PSA).

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Free to total PSA ratios are commonly used as an adjunct to total PSA levels to better define an individual's risk for prostate cancer; however, its strengths and weaknesses are not well understood. This article illustrates the use of likelihood ratios that can be generated from the reported sensitivities and specificities from given free to total PSA thresholds in either increasing or decreasing an individual patient's probability of prostate cancer. Understanding the strengths and limitations of free to total PSA testing will help clinicians anticipate whether its use is indicated or not.

Tumour-seeding: a rare complication of ablative therapy for clinically localised renal cell carcinoma.

Current evidence-based clinical practice guidelines identify surgical resection as the recommended treatment of small renal masses. Ablative approaches such as laparoscopic and percutaneous cryoablation and radiofrequency ablation offer the promise of complete tumour destruction by a less-invasive approach with regard to outcomes such as anaesthesia requirements, blood loss, length of stay and time to recovery, making them appealing to patients. However, evidence of therapeutic benefits, harms and costs for these methods remains limited. We report a case of applicator tract seeding by tumour following percutaneous cryoablation of renal cell carcinoma; a rare and potentially under-reported, yet catastrophic complication of ablative therapy.

A systematic review of the quality of evidence of ablative therapy for small renal masses.

PURPOSE: We critically assessed the methodological and reporting quality of published studies of ablative techniques for small renal masses. MATERIALS AND METHODS: We performed a systematic PubMed® and EMBASE® literature search from January 1966 to March 2010 to identify all full text, original research publications on ablative therapy for renal masses. Six reviewers working independently in 3 teams performed duplicate data abstraction using Strengthening the Reporting of Observational Studies in Epidemiology criteria, which were pilot tested in a separate sample. RESULTS: A total of 117 original research publications published in a 15-year period (1995 to 2009) met eligibility criteria. No randomized, controlled trials were identified. All studies were observational and 88.9% had 1 arm with no comparison group. Median sample size was 18 patients (IQR 5.5, 40.0) and 53.8% of studies included 20 or fewer patients. Median followup was 14.0 months (IQR 8.0, 23.8) and only 19.7% of studies had an average followup of greater than 24 months. Of the studies 20.5% mentioned the number of operators involved and only 6.0% provided information on their experience level. Of the studies 66.7% addressed the recurrence rate. Disease specific and overall survival was reported in only 15.4% and 16.2% of studies, respectively. CONCLUSIONS: The published literature on the therapeutic efficacy of ablative therapy for renal masses is largely limited to uncontrolled, 1-arm observational studies. In the absence of higher quality evidence ablative therapy outside research studies should be limited to select patients who are not candidates for surgical intervention.

Predictors of citations in the urological literature.

To assess the factors associated with increased citation rates in the urological literature by reviewing articles published in the four major urological journals to help authors improve the impact of their work. A random sample of 200 original research articles published between January and June 2004 was analysed from The Journal of Urology, Urology, European Urology and BJU International. Study information was abstracted by two independent reviewers and citation counts within 4 years of publication were collected using Web of Science(TM) . Study characteristics and citation rates were analysed using median and interquartile ranges (IQRs), and logistic regression analysis was used to evaluate which factors predicted greater citation rates. The overall median number of citations per published article was 6.0 (IQR 3-12). After univariate analysis, we found that study design, study topic, continent of origin and sample size were associated with greater median citation rates. In a multivariate linear regression model, study design and study topic (oncology) predicted increased citation rates. Randomized controlled trials were cited a median of 13.5 times and were the strongest predictor of citation rates with an odds ratio of 115.5 (95% confidence interval 9.4-1419.6). Citation rates are associated with study design and study topic in the urological literature. Authors may improve the impact of their work by designing clinical studies with greater methodological safeguards against bias.

Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To examine the evidence on the benefits and harms of screening for prostate cancer. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Electronic databases including Medline, Embase, CENTRAL, abstract proceedings, and reference lists up to July 2010. Review methods Included studies were randomised controlled trials comparing screening by prostate specific antigen with or without digital rectal examination versus no screening. Data abstraction and assessment of methodological quality with the GRADE approach was assessed by two independent reviewers and verified by the primary investigator. Mantel-Haenszel and inverse variance estimates were calculated and pooled under a random effects model expressing data as relative risks and 95% confidence intervals. RESULTS: Six randomised controlled trials with a total of 387 286 participants that met inclusion criteria were analysed. Screening was associated with an increased probability of receiving a diagnosis of prostate cancer (relative risk 1.46, 95% confidence interval 1.21 to 1.77; P<0.001) and stage I prostate cancer (1.95, 1.22 to 3.13; P=0.005). There was no significant effect of screening on death from prostate cancer (0.88, 0.71 to 1.09; P=0.25) or overall mortality (0.99, 0.97 to 1.01; P=0.44). All trials had one or more substantial methodological limitations. None provided data on the effects of screening on participants' quality of life. Little information was provided about potential harms associated with screening. CONCLUSIONS: The existing evidence from randomised controlled trials does not support the routine use of screening for prostate cancer with prostate specific antigen with or without digital rectal examination.