Publications by authors named "Philipp Dahm"

276 Publications

Interpreting and Appraising Noninferiority Trials: A Guide for Urologists and Clinicians.

Eur Urol Focus 2021 Mar 26. Epub 2021 Mar 26.

Department of Urology, Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche du CHUS, Sherbrooke, QC, Canada.

Noninferiority trials are increasingly used in urology. Understanding the methodology and assessment of such trials can be challenging for clinicians. We provide an approach to interpreting the results, validity, and applicability of noninferiority studies in clinical practice.
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http://dx.doi.org/10.1016/j.euf.2021.03.014DOI Listing
March 2021

Selective serotonin re-uptake inhibitors for premature ejaculation in adult men.

Cochrane Database Syst Rev 2021 03 21;3:CD012799. Epub 2021 Mar 21.

Urology Section, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA.

Background: Premature ejaculation (PE) is a common problem among men that occurs when ejaculation happens sooner than a man or his partner would like during sex; it may cause unhappiness and relationship problems. Selective serotonin re-uptake inhibitors (SSRIs), which are most commonly used as antidepressants are being used to treat this condition.

Objectives: To assess the effects of SSRIs in the treatment of PE in adult men.

Search Methods: We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, CINAHL), clinical trial registries, conference proceedings, and other sources of grey literature, up to 1 May 2020. We applied no restrictions on publication language or status.

Selection Criteria: We included only randomized controlled clinical trials (parallel group and cross-over trials) in which men with PE  were administered SSRIs or placebo. We also considered 'no treatment' to be an eligible comparator but did not find any relevant studies.

Data Collection And Analysis: Two review authors independently classified and abstracted data from the included studies. Primary outcomes were participant-perceived change with treatment, satisfaction with intercourse and study withdrawal due to adverse events. Secondary outcomes included self-perceived control over ejaculation, participant distress about PE, adverse events and intravaginal ejaculatory latency time (IELT). We performed statistical analyses using a random-effects model. We rated the certainty of evidence according to GRADE.

Main Results: We identified 31 studies in which 8254 participants were randomized to receiving either SSRIs or placebo. Primary outcomes: SSRI treatment probably improves self-perceived PE symptoms (defined as a rating of 'better' or 'much better') compared to placebo (risk ratio (RR) 1.92, 95% confidence interval (CI) 1.66 to 2.23; moderate-certainty evidence). Based on 220 participants per 1000 reporting improvement with placebo, this corresponds to 202 more men per 1000 (95% CI 145 more to 270 more) with improved symptoms with SSRIs.  SSRI treatment probably improves satisfaction with intercourse compared to placebo (defined as a rating of 'good' or 'very good'; RR 1.63, 95% CI 1.42 to 1.87; moderate-certainty evidence). Based on 278 participants per 1000 reporting improved satisfaction with placebo, this corresponds to 175 more (117 more to 242 more) per 1000 men with greater satisfaction with intercourse with SSRIs. SSRI treatment may increase treatment cessations due to adverse events compared to placebo (RR 3.80, 95% CI 2.61 to 5.51; low-certainty evidence). Based 11 study withdrawals per 1000 participants with placebo, this corresponds to 30 more men per 1000 (95% CI 17 more to 49 more) ceasing treatment due to adverse events with SSRIs.  Secondary outcomes: SSRI treatment likely improve participants' self-perceived control over ejaculation (defined as rating of 'good' or 'very good') compared to placebo (RR 2.29, 95% CI 1.72 to 3.05; moderate-certainty evidence). Assuming 132 per 1000 participants perceived at least good control, this corresponds to 170 more (95 more to 270 more) reporting at least good control with SSRIs.  SSRI probably lessens distress (defined as rating of 'a little bit' or 'not at all') about PE (RR 1.54, 95% CI 1.26 to 1.88; moderate-certainty evidence). Based on 353 per 1000 participants reporting low levels of distress, this corresponds to 191 more men (92 more to 311 more) per 1000 reporting low levels of distress with SSRIs.  SSRI treatment probably increases adverse events compared to placebo (RR 1.71, 95% CI 1.48 to 1.99; moderate-certainty evidence). Based on 243 adverse events per 1000 among men receiving placebo, this corresponds to 173 more (117 more to 241 more) men having an adverse event with SSRIs.  SSRI treatment may increase IELT compared to placebo (mean difference (MD) 3.09 minutes longer, 95% CI 1.94 longer to 4.25 longer; low-certainty evidence).

Authors' Conclusions: SSRI treatment for PE appears to substantially improve a number of outcomes of direct patient importance such as symptom improvement, satisfaction with intercourse and perceived control over ejaculation when compared to placebo. Undesirable effects are a small increase in treatment withdrawals due to adverse events as well as substantially increased adverse event rates. Issues affecting the certainty of evidence of outcomes were study limitations and imprecision.
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http://dx.doi.org/10.1002/14651858.CD012799.pub2DOI Listing
March 2021

Retzius-sparing versus standard robotic assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

BJU Int 2021 Mar 9. Epub 2021 Mar 9.

Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.

Objectives: To assess the effects of RS-RALP compared to standard RALP for the treatment of clinically localized prostate cancer.

Methods: We performed a systematic search in multiple databases and grey literature with no restrictions on the language of publication or publication status, up until June 2020. We included randomized controlled trials comparing Retzius-sparing robotic-assisted laparoscopic prostatectomy (RS-RALP) to standard robotic-assisted laparoscopic prostatectomy (S-RALP). We performed a meta-analysis using a random-effect model. The quality of evidence was assessed on outcome basis according to Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

Main Results: Our search identified six records of five unique randomized controlled trials, of which two were published studies, one was in press, and two were abstract proceedings. There were 571 randomized participants, of whom 502 completed the trials. Mean age of participants was 64.6 years and mean prostate-specific antigen was 6.9 ng/mL. About 54.2% of participants had cT1c disease, 38.6% had cT2a-b disease, and 7.1 % had cT2c disease. Primary outcomes: RS-RALP probably improves continence within one week after catheter removal (risk ratio (RR) 1.74, 95% confidence interval (CI) 1.41 to 2.14; I2 = 0%; studies = 4; participants = 410; moderate-certainty evidence). Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 248 more men per 1000 (137 more to 382 more) reporting continence recovery. RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I2 = 86%; studies = 5; participants = 526; low-certainty evidence). Assuming 750 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 224 more men per 1000 (41 more to 462 more) reporting continence recovery. We are very uncertain about the effects of RS-RALP on serious adverse events compared to standard RALP (RR 1.40, 95% CI 0.47 to 4.17; studies = 2; participants = 230; very low-certainty evidence).

Conclusions: Findings of this review indicate that RS-RALP may result in better continence outcomes than standard RALP up to six months after surgery. Continence outcomes at 12 months may be similar. Downsides of RS-RALP may be higher positive margin rates. We are very uncertain about the effect on BCRFS and potency outcomes. Longer-term oncologic and functional outcomes are lacking, and no preplanned subgroup analyses could be performed to explore the observed heterogeneity. Surgeons should discuss these trade-offs and the limitations of the evidence with their patients when considering this approach.
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http://dx.doi.org/10.1111/bju.15385DOI Listing
March 2021

A Systematic Review of Randomized Controlled Trials Comparing Buccal Mucosal Graft Harvest Site Non-Closure Closure in Patients Undergoing Urethral Reconstruction.

World J Mens Health 2021 Feb 15. Epub 2021 Feb 15.

Department of Urology, University of Minnesota, Minneapolis, MN, USA.

Purpose: To assess the effects of buccal mucosal graft site non-closure versus closure on postoperative oral morbidity for male undergoing augmentation urethroplasty for urethral stricture.

Materials And Methods: We included randomized controlled trials. Inclusion criteria were male over the age of 18 with urethral stricture disease requiring reconstruction with buccal mucosal graft harvest. Primary outcomes of the review were postoperative oral pain, need for secondary oral procedures and cosmetic defects.

Results: We included 5 studies with 346 randomized patients with urethral strictures, of whom 260 completed the trials. In terms of primary outcomes, non-closure graft site may reduce oral pain on postoperative day #1 (standard mean difference [SMD] 0.24 lower; 95% confidence interval [CI] 0.61 lower to 0.12 higher; low certainty evidence [CoE]) but we are uncertain how this impacts pain on postoperative days 3 to 6 (SMD 0.35; 95% CI 0.12 to 0.81 higher; very low CoE). We are also very uncertain as to how it affects the need for secondary oral procedures (risk ratio [RR] 0.22; 95% CI 0.01 to 4.28; very low CoE). Non-closure may increase the risk of cosmetic defects (RR 2.40; 95% CI 0.93 to 6.22; low CoE).

Conclusions: This review describes the trade-off for buccal mucosal graft site non-closure versus closure for various patient-important outcomes; decision-making will likely hinge on the relative value individual patients and surgeons place on them. The supporting evidence was rated as low and very low, thereby signaling substantial underlying uncertainty and the need for better trials.
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http://dx.doi.org/10.5534/wjmh.200175DOI Listing
February 2021

Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

Cochrane Database Syst Rev 2020 12 19;12:CD012867. Epub 2020 Dec 19.

Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.

Background: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach.

Objectives: To assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH.

Search Methods: We performed a comprehensive search using multiple databases (The Cochrane Library, MEDLINE, Embase, LILACS, Scopus, Web of Science, and Google Scholar), trials registries, other sources of grey literature, and conference proceedings with no restrictions on language of publication or publication status, up until 25 September 2020.

Selection Criteria: We included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.  DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies for inclusion or exclusion and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs.  MAIN RESULTS: We found data to inform two comparisons: PAE versus TURP (six RCTs and two NRSs), and PAE versus sham (one RCT). Mean age, IPSS, and prostate volume of participants were 66 years, 22.8, and 72.8 mL, respectively. This abstract focuses on the comparison of PAE versus TURP as the primary topic of interest. PAE versus TURP We included six RCTs and two NRSs with short-term (up to 12 months) follow-up and one RCT with long-term follow-up (13 to 24 months).  Short-term follow-up: based on RCT evidence, there may be little to no difference in urologic symptom score improvement (mean difference [MD] 1.55, 95% confidence interval [CI] -0.40 to 3.50; 369 participants; 6 RCTs; I² = 75%; low-certainty evidence) measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms. There may be little to no difference in quality of life (MD 0.16, 95% CI -0.37 to 0.68; 309 participants; 5 RCTs; I² = 56%; low-certainty evidence) as measured by the IPSS quality of life question on a scale from 0 to 6, with higher scores indicating worse quality of life between PAE and TURP, respectively. While we are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.71, 95% CI 0.16 to 3.10; 250 participants; 4 RCTs; I² = 26%; very low-certainty evidence), PAE may increase re-treatments (RR 3.64, 95% CI 1.02 to 12.98; 204 participants; 3 RCTs; I² = 0%; low-certainty evidence). Based on 18 re-treatments per 1000 men in the TURP group, this corresponds to 47 more (0 more to 214 more) per 1000 men undergoing PAE.   We are very uncertain about the effects on erectile function (MD -0.03, 95% CI -6.35 to 6.29; 129 participants; 2 RCTs; I² = 78%; very low-certainty evidence) measured by the International Index of Erectile Function at 5 on a scale from 1 to 25, with higher scores indicating better function. NRS evidence when available yielded similar results. Based on evidence from NRS, PAE may reduce the occurrence of ejaculatory disorders (RR 0.51, 95% CI 0.35 to 0.73; 260 participants; 1 NRS; low-certainty evidence). Longer-term follow-up: based on RCT evidence, we are very uncertain about the effects of PAE on urologic symptom scores (MD 0.30, 95% CI -3.17 to 3.77; 95 participants; very low-certainty evidence) compared to TURP. Quality of life may be similar (MD 0.20, 95% CI -0.49 to 0.89; 95 participants; low-certainty evidence). We are also very uncertain about major adverse events (RR 1.96, 95% CI 0.63 to 6.13; 107 participants; very low-certainty evidence). We did not find evidence on erectile function and ejaculatory disorders. Based on evidence from NRS, PAE may increase re-treatment rates (RR 1.51, 95% CI 0.43 to 5.29; 305 participants; low-certainty evidence); based on 56 re-treatments per 1000 men in the TURP group. this corresponds to 143 more (25 more to 430 more) per 1000 men in the PAE group.  AUTHORS' CONCLUSIONS: Compared to TURP up to 12 months (short-term follow-up), PAE may provide similar improvement in urologic symptom scores and quality of life. While we are very uncertain about major adverse events, PAE may increase re-treatment rates. We are uncertain about erectile function, but PAE may reduce ejaculatory disorders. Longer term (follow-up of 13 to 24 months), we are very uncertain as to how both procedures compare with regard to urologic symptom scores, but quality of life appears to be similar. We are very uncertain about major adverse events but PAE may increase re-treatments. We did not find longer term evidence on erectile function and ejaculatory disorders. Certainty of evidence for the main outcomes of this review was low or very low, signalling that our confidence in the reported effect size is limited or very limited, and that this topic should be better informed by future research.
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http://dx.doi.org/10.1002/14651858.CD012867.pub2DOI Listing
December 2020

Therapies for Clinically Localized Prostate Cancer: A Comparative Effectiveness Review.

J Urol 2021 Apr 22;205(4):967-976. Epub 2020 Dec 22.

Minneapolis VA Healthcare System, Minneapolis, Minnesota.

Purpose: We sought to identify new information evaluating clinically localized prostate cancer therapies.

Materials And Methods: Bibliographic databases (2013-January 2020), ClinicalTrials.gov and systematic reviews were searched for controlled studies of treatments for clinically localized prostate cancer with duration ≥5 years for mortality and metastases, and ≥1 year for harms.

Results: We identified 67 eligible references. Among patients with clinically, rather than prostate specific antigen, detected localized prostate cancer, watchful waiting may increase mortality and metastases but decreases urinary and erectile dysfunction vs radical prostatectomy. Comparative mortality effect may vary by tumor risk and age but not by race, health status, comorbidities or prostate specific antigen. Active monitoring probably results in little to no mortality difference in prostate specific antigen detected localized prostate cancer vs radical prostatectomy or external beam radiation plus androgen deprivation regardless of tumor risk. Metastases were slightly higher with active monitoring. Harms were greater with radical prostatectomy than active monitoring and mixed between external beam radiation plus androgen deprivation vs active monitoring. 3-Dimensional conformal radiation and androgen deprivation plus low dose rate brachytherapy provided small mortality reductions vs 3-dimensional conformal radiation and androgen deprivation but little to no difference on metastases. External beam radiation plus androgen deprivation vs external beam radiation alone may result in small mortality and metastasis reductions in higher risk disease but may increase sexual harms. Few new data exist on other treatments.

Conclusions: Radical prostatectomy reduces mortality vs watchful waiting in clinically detected localized prostate cancer but causes more harms. Effectiveness may be limited to younger men and those with intermediate risk disease. Active monitoring results in little to no mortality difference vs radical prostatectomy or external beam radiation plus androgen deprivation. Few new data exist on other treatments.
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http://dx.doi.org/10.1097/JU.0000000000001578DOI Listing
April 2021

Abiraterone acetate in combination with androgen deprivation therapy compared to androgen deprivation therapy only for metastatic hormone-sensitive prostate cancer.

Cochrane Database Syst Rev 2020 12 12;12:CD013245. Epub 2020 Dec 12.

Department of Urology, University Hospital Erlangen, Erlangen, Germany.

Background: Systemic androgen deprivation therapy (ADT), also referred to as hormone therapy,àhas long been the primary treatment for metastatic prostate cancer. Additional agents have been reserved for the castrate-resistant disease stage when ADT start becoming less effective. Abiraterone is an agent with an established role in that disease stage, which has only recently been evaluated in the hormone-sensitive setting.

Objectives: To assess the effects of early abiraterone acetate, in combination with systemic ADT, for newly diagnosed metastatic hormone-sensitive prostate cancer.

Search Methods: We searched CENTRAL, MEDLINE, Embase, six other databases, two trials registries, grey literature, and conference proceedings, up to 15 May 2020. We applied no restrictions on publication language or status.

Selection Criteria: We included randomized trials, in which men diagnosed with hormone-sensitive prostate cancer were administered abiraterone acetate and prednisolone with ADT or ADTàalone.

Data Collection And Analysis: Two review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model. We rated the quality of evidence according to the GRADE approach.

Main Results: The search identified two randomized controlled trials (RCT), with 2201 men, who were assigned to receive either abiraterone acetate 1000 mg once daily and low dose prednisone (5mg) in addition to ADT, or ADT alone. In the LATITUDE trial, the median age and range of men in the intervention group was 68 (38 to 89) years, and 67 (33 to 92) years in the control group. Nearly all of the men in thisàstudy (97.6%) had prostate cancer with a Gleason score of at least 8 (ISUP grade group 4). Primary outcomes The addition of abiraterone acetate to ADT reduces the probability of death from any cause compared to ADT alone (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.56 to 0.73; 2 RCTs, 2201 men; high certainty of evidence); this corresponds to 163 fewer deaths per 1000 men with hormone-sensitive metastaticàprostate cancerà(210 fewer to 115 fewer) at five years. Abiraterone acetate in addition to ADT probably results in little to no differenceàin quality of life compared to ADT alone, measured with the Functional Assessment of Cancer Therapy-prostate total score (FACT-P; range 0 to 156; higher values indicates better quality of life),àat 12 months (mean difference [MD] 2.90 points, 95% CI 0.11 to 5.60; 1 RCT, 838 men; moderate certainty of evidence). Secondary outcomes Abiraterone plus ADT increases the risk of grades III to V adverse events compared to ADT alone (risk ratio [RR] 1.34, 95% CI 1.22 to 1.47; 1 RCT, 1199 men; high certainty of evidence); this corresponds to 162 more grade III to Vàevents per 1000 men with hormone-sensitive metastaticàprostate cancerà(105 more to 224 more) at a median follow-up of 30àmonths. Abiraterone acetate in addition to ADT probably reduces the probability of death due to prostate cancer compared to ADT alone (HR 0.58, 95% CI 0.50 to 0.68; 2 RCTs, 2201 men; moderate certainty of evidence). This corresponds to 120 fewer death from prostate cancer per 1000 men with hormone-sensitive metastaticàprostate cancerà(95% CI 145 fewer to 90 fewer) afteràa median follow-up of 30 months. The addition of abiraterone acetate to ADT probably decreases the probability of disease progression compared to ADT alone (HR 0.35, 95%CI 0.26 to 0.49; 2 RCTs, 2097 men; moderate certainty of evidence). This corresponds to 369 fewer incidences of disease progression per 1000 men with hormone-sensitive metastaticàprostate cancerà(456 fewer to 256 fewer)àafter a median follow-up of 30 months. The addition of abiraterone acetate to ADT probably increases the risk of discontinuing treatment due to adverse events compared to ADT alone (RR 1.50, 95% CI 1.17 to 1.92; 1 RCT, 1199 men; moderate certainty of evidence). This corresponds to 51 more men (95% CI 17 more to 93 more) discontinuing treatment because of adverse events per 1000 men treated with abiraterone acetate and ADT compared to ADT alone afteràa median follow-up of 30 months.

Authors' Conclusions: The addition of abiraterone acetate to androgen deprivation therapy improves overall survival but probably not quality of life. Itàprobably also extends disease-specific survival, and delays disease progression compared to androgen deprivation therapy alone. However, the risk of grades III to V adverse events is increased, and probably, so is the risk of discontinuing treatment due to adverse events.
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http://dx.doi.org/10.1002/14651858.CD013245.pub2DOI Listing
December 2020

Alpha-blockers after shock wave lithotripsy for renal or ureteral stones in adults.

Cochrane Database Syst Rev 2020 11 12;11:CD013393. Epub 2020 Nov 12.

Urology Section, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA.

Background: Shock wave lithotripsy (SWL) is a widely used method to treat renal and ureteral stone. It fragments stones into smaller pieces that are then able to pass spontaneously down the ureter and into the bladder. Alpha-blockers may assist in promoting the passage of stone fragments, but their effectiveness remains uncertain.  OBJECTIVES: To assess the effects of alpha-blockers as adjuvant medical expulsive therapy plus usual care compared to placebo and usual care or usual care alone in adults undergoing shock wave lithotripsy for renal or ureteral stones.

Search Methods: We performed a comprehensive literature search of the Cochrane Library, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, several clinical trial registries and grey literature for published and unpublished studies irrespective of language. The date of the most recent search was 27 February 2020.

Selection Criteria: We included randomized controlled trials of adults undergoing SWL. Participants in the intervention group had to have received an alpha-blocker as adjuvant medical expulsive therapy plus usual care. For the comparator group, we considered studies in which participants received placebo.

Data Collection And Analysis: Two review authors independently selected studies for inclusion/exclusion, and performed data abstraction and risk of bias assessment. We conducted meta-analysis for the identified dichotomous and continuous outcomes using RevManWeb according to Cochrane methods using a random-effects model. We judged the certainty of evidence on a per outcome basis using GRADE.

Main Results: We included 40 studies with 4793 participants randomized to usual care and an alpha-blocker versus usual care alone. Only four studies were placebo controlled. The mean age of participants was 28.6 to 56.8 years and the mean stone size prior to SWL was 7.1 mm to 13.2 mm. The most widely used alpha-blocker was tamsulosin; others were silodosin, doxazosin, terazosin and alfuzosin.  Alpha-blockers may improve clearance of stone fragments after SWL (risk ratio (RR) 1.16, 95% confidence interval (CI) 1.09 to 1.23; I² = 78%; studies = 36; participants = 4084; low certainty evidence). Based on the stone clearance rate of 69.3% observed in the control arm, an alpha-blocker may increase stone clearance to 80.4%. This corresponds to 111 more (62 more to 159 more) participants per 1000 clearing their stone fragments. Alpha-blockers may reduce the need for auxiliary treatments after SWL (RR 0.67, 95% CI 0.45 to 1.00; I² = 16%; studies = 12; participants = 1251; low certainty evidence), but also includes the possibility of no effect. Based on a rate of auxiliary treatments in the usual care arm of 9.7%, alpha-blockers may reduce the rate to 6.5%. This corresponds 32 fewer (53 fewer to 0 fewer) participants per 1000 undergoing auxiliary treatments. Alpha-blockers may reduce major adverse events (RR 0.60, 95% CI 0.46 to 0.80; I² = 0%; studies = 7; participants = 747; low certainty evidence). Major adverse events occurred in 25.8% of participants in the usual care group; alpha-blockers would reduce this to 15.5%. This corresponds to 103 fewer (139 fewer to 52 fewer) major adverse events per 1000 with alpha-blocker treatment. None of the reported major adverse events appeared drug-related; most were emergency room visits or rehospitalizations. Alpha-blockers may reduce stone clearance time in days (mean difference (MD) -3.74, 95% CI -5.25 to -2.23; I² = 86%; studies = 14; participants = 1790; low certainty evidence). We found no evidence for the outcome of quality of life. For those outcomes for which we were able to perform subgroup analyses, we found no evidence of interaction with stone location, stone size or type of alpha-blocker. We were unable to conduct an analysis by lithotripter type. The results were also largely unchanged when the analyses were limited to placebo controlled studies and those in which participants explicitly only received a single SWL session.

Authors' Conclusions: Based on low certainty evidence, adjuvant alpha-blocker therapy following SWL in addition to usual care may result in improved stone clearance, less need for auxiliary treatments, fewer major adverse events and a reduced stone clearance time compared to usual care alone. We did not find evidence for quality of life. The low certainty of evidence means that our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.
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http://dx.doi.org/10.1002/14651858.CD013393.pub2DOI Listing
November 2020

The reporting quality of randomized controlled trials and experimental animal studies for urethroplasty.

World J Urol 2020 Nov 11. Epub 2020 Nov 11.

Urology Section, Minneapolis VA Health Care System, 112D, One Veterans Drive, Minneapolis, MN, 55417, USA.

Objectives: To assess the reporting quality of randomized controlled trials and experimental animal studies examining urethroplasty in reconstructive urological surgery literature.

Methods: We performed a comprehensive literature search to identify all urethroplasty-related RCTs examining humans as well as animal models. We used the Consolidated Standards of Reporting Trials (CONSORT) and the Animals in Research: Reporting in vivo Experiments (ARRIVE) guidelines to assess reporting quality. Two reviewers performed data abstraction independently and in duplicate. We then generated descriptive statistics including CONSORT (0-25) and ARRIVE (0-20) summary scores using the median and interquartile range.

Results: Twenty studies were ultimately included; 14 randomized controlled trials and 6 experimental animal studies. All studies were two-armed, parallel group studies. Median sample sizes (and interquartile range) of the human and animal studies were 48.5 (31.8-53.8) and 18 (15.3-27.5), respectively. The median CONSORT and ARRIVE scores were 10.0 (8.75-12.63) and 7.97 (6.79-8.64), respectively. Human randomized controlled trials did not consistently report the method of allocation concealment (6/14; 42.9%), blinding (2/14; 14.3%), or discuss the generalizability of the results (6/14; 42.9%). Animal studies infrequently reported why a given animal model was used (1/6; 16.7%), how they were allocated to groups (0/6; 0%) or what the experimental primary and secondary outcomes were (0/6; 0%).

Conclusions: Urethroplasty literature is marked by a paucity of both randomized controlled trials and experimental design animal studies. The existing studies are inconsistently reported and are therefore of uncertain methodological quality.
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http://dx.doi.org/10.1007/s00345-020-03501-8DOI Listing
November 2020

Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.

J Clin Epidemiol 2021 Jan 30;129:1-11. Epub 2020 Sep 30.

Department of Health Research Methods, Evidence, and Impact, McMaster University, McMaster University Medical Centre, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Objectives: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields.

Study Design And Setting: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group.

Results: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan.

Conclusion: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526592PMC
January 2021

The quality of physical activity guidelines, but not the specificity of their recommendations, has improved over time: a systematic review and critical appraisal.

Appl Physiol Nutr Metab 2021 Jan 29;46(1):34-45. Epub 2020 Sep 29.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada.

While numerous guidelines for the prescription of physical activity are released each year, the quality and practicability of these guidelines is unknown. We assessed the quality of 95 guidance documents published since 2000 that included recommendations about physical activity for the promotion of general health and prevention of cardiometabolic disease. We used 3 tools: Appraisal of Guidelines for Research and Evaluation (AGREE II), the National Academy of Medicine's (NAM) Standards for Trustworthy Clinical Practice Guidelines, and the Frequency, Intensity, Time, and Type (FITT) score. Average AGREE II domain scores ranged from 38%-84%, and the portion of criteria fulfilled per NAM domain ranged from 7%-39%. The average FITT score for all recommendations was 2.48 out of 4. While guidelines improved according to both AGREE II and the NAM standards over time, their practicability as assessed by FITT score did not improve. Guidelines produced by governmental agencies or other nonprofit organizations, using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, or fulfilling a higher number of NAM criteria tended to be of higher quality. Organizations producing physical activity guidelines can improve their quality by establishing and reporting processes for public representation, external review, and conflict of interest (COI) management. Future recommendations about physical activity should be more specific and include strategies to improve implementation. Registration no.: PROSPERO CRD42019126364. Most physical activity recommendations are not sufficiently specific to be practically implemented. The overall quality of guidelines has improved over time, but the specificity of recommendations has not. Improved public representation, external review, and COI disclosure and management processes would improve guideline quality.
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http://dx.doi.org/10.1139/apnm-2020-0378DOI Listing
January 2021

Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

Cochrane Database Syst Rev 2020 08 18;8:CD013641. Epub 2020 Aug 18.

Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.

Background: Robotic-assisted laparoscopic prostatectomy (RALP) is widely used to surgically treat clinically localized prostate cancer. It is typically performed using an approach (standard RALP) that mimics open retropubic prostatectomy by dissecting the so-called space of Retzius anterior to the bladder. An alternative, Retzius-sparing (or posterior approach) RALP (RS-RALP) has been described, which is reported to have better continence outcomes but may be associated with a higher risk of incomplete resection and positive surgical margins (PSM).

Objectives: To assess the effects of RS-RALP compared to standard RALP for the treatment of clinically localized prostate cancer.

Search Methods: We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to June 2020. We applied no restrictions on publication language or status.

Selection Criteria: We included trials where participants were randomized to RS-RALP or standard RALP for clinically localized prostate cancer.

Data Collection And Analysis: Two review authors independently classified and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery six and 12 months after surgery, potency recovery 12 months after surgery, positive surgical margins (PSM), biochemical recurrence-free survival (BCRFS), and urinary and sexual function quality of life. We performed statistical analyses using a random-effects model. We rated the certainty of evidence using the GRADE approach.

Main Results: Our search identified six records of five unique randomized controlled trials, of which two were published studies, one was in press, and two were abstract proceedings. There were 571 randomized participants, of whom 502 completed the trials. Mean age of participants was 64.6 years and mean prostate-specific antigen was 6.9 ng/mL. About 54.2% of participants had cT1c disease, 38.6% had cT2a-b disease, and 7.1 % had cT2c disease. Primary outcomes RS-RALP probably improves continence within one week after catheter removal (risk ratio (RR) 1.74, 95% confidence interval (CI) 1.41 to 2.14; I = 0%; studies = 4; participants = 410; moderate-certainty evidence). Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 248 more men per 1000 (137 more to 382 more) reporting continence recovery. RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I = 86%; studies = 5; participants = 526; low-certainty evidence). Assuming 750 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 224 more men per 1000 (41 more to 462 more) reporting continence recovery. We are very uncertain about the effects of RS-RALP on serious adverse events compared to standard RALP (RR 1.40, 95% CI 0.47 to 4.17; studies = 2; participants = 230; very low-certainty evidence). Secondary outcomes There is probably little to no difference in continence recovery at 12 months after surgery (RR 1.01, 95% CI 0.97 to 1.04; I = 0%; studies = 2; participants = 222; moderate-certainty evidence). Assuming 982 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 10 more men per 1000 (29 fewer to 39 more) reporting continence recovery.  We are very uncertain about the effect of RS-RALP on potency recovery 12 months after surgery (RR 0.98, 95% CI 0.54 to 1.80; studies = 1; participants = 55; very low-certainty evidence).  RS-RALP may increase PSMs (RR 1.95, 95% CI 1.19 to 3.20; I = 0%; studies = 3; participants = 308; low-certainty evidence) indicating a higher risk for prostate cancer recurrence. Assuming 129 per 1000 men undergoing standard RALP have positive margins, this corresponds to 123 more men per 1000 (25 more to 284 more) with PSMs. We are very uncertain about the effect of RS-RALP on BCRFS compared to standard RALP (hazard ratio (HR) 0.45, 95% CI 0.13 to 1.60; I = 32%; studies = 2; participants = 218; very low-certainty evidence).

Authors' Conclusions: Findings of this review indicate that RS-RALP may result in better continence outcomes than standard RALP up to six months after surgery. Continence outcomes at 12 months may be similar. Downsides of RS-RALP may be higher positive margin rates. We are very uncertain about the effect on BCRFS and potency outcomes. Longer-term oncologic and functional outcomes are lacking, and no preplanned subgroup analyses could be performed to explore the observed heterogeneity. Surgeons should discuss these trade-offs and the limitations of the evidence with their patients when considering this approach.
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http://dx.doi.org/10.1002/14651858.CD013641.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437391PMC
August 2020

Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020.

J Urol 2020 10 23;204(4):799-804. Epub 2020 Jul 23.

UCSD School of Medicine, La Jolla, California.

Purpose: The AUA Guideline panel provides evidence-based recommendations for the surgical management of male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Materials And Methods: The Panel amended the Guideline in 2020 to reflect additional literature published through September 2019. When sufficient evidence existed, the Panel assigned the body of evidence a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, the Panel provided additional information as Clinical Principles and Expert Opinions (See table 1[Table: see text]).

Results: Amendments to these Guidelines include: 1) an amended statement (Guideline 1) to include conducting a physical examination; 2) a new statement (Guideline 6) discussing concepts of treatment failure and retreatment; 3) an amended statement (Guideline 15) with updated supporting text for prostatic urethral lift (PUL); 4) an amended statement (Guideline 16) for PUL; 5) an amended statement (Guideline 17) with updated supporting text for transurethral microwave therapy (TUMT); 6) an amended statement (Guideline 18) with updated supporting text for water vapor thermal therapy; 7) updated supporting text for water vapor thermal therapy (Guideline 19); 8) an amended statement (Guideline 21) with updated supporting text for laser enucleation; 9) an amended statement (Guideline 22) with updated supporting text for Aquablation; and 10) an amended statement (Guideline 23) with updated supporting text for Prostate Artery Embolization (PAE).

Conclusions: These evidence-based updates to the AUA Guidelines further inform the surgical management of LUTS/BPH.
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http://dx.doi.org/10.1097/JU.0000000000001298DOI Listing
October 2020

Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer: Abridged summary of the Cochrane Review.

Investig Clin Urol 2020 07 29;61(4):349-354. Epub 2020 Jun 29.

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

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http://dx.doi.org/10.4111/icu.2020.61.4.349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7329645PMC
July 2020

Pharmacologic thromboprophylaxis in adult patients undergoing neurosurgical interventions for preventing venous thromboembolism.

Blood Adv 2020 06;4(12):2798-2809

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

The impact of pharmacologic prophylaxis for venous thromboembolism in patients undergoing neurosurgical intervention remains uncertain. We reviewed the efficacy and safety of pharmacologic compared with nonpharmacologic thromboprophylaxis in neurosurgical patients. Three databases were searched through April 2018, including those for randomized controlled trials (RCTs) and for nonrandomized controlled studies (NRSs). Independent reviewers assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Seven RCTs and 3 NRSs proved eligible. No studies reported on symptomatic proximal and distal deep vein thrombosis (DVT). Two RCTs reported on screening-detected proximal and distal DVTs. We used the findings of these 2 RCTs as the closest surrogate outcomes to inform the proximal and distal DVT outcomes. These 2 RCTs suggest that pharmacologic thromboprophylaxis may decrease the risk of developing asymptomatic proximal DVT (relative risk [RR], 0.50; 95% confidence interval [CI], 0.30-0.84; low certainty). Findings were uncertain for mortality (RR, 1.27; 95% CI, 0.57-2.86; low certainty), symptomatic pulmonary embolism (PE) (RR, 0.84; 95% CI, 0.03-27.42; very low certainty), asymptomatic distal DVT (RR, 0.54; 95% CI, 0.27-1.08; very low certainty), and reoperation (RR, 0.43; 95% CI, 0.06-2.84; very low certainty) outcomes. NRSs also reported uncertain findings for whether pharmacologic prophylaxis affects mortality (RR, 0.72; 95% CI, 0.46-1.13; low certainty) and PE (RR, 0.18; 95% CI, 0.01-3.76). For risk of bleeding, findings were uncertain in both RCTs (RR, 1.57; 95% CI, 0.70-3.50; low certainty) and NRSs (RR, 1.45; 95% CI, 0.30-7.12; very low certainty). In patients undergoing neurosurgical procedures, low certainty of evidence suggests that pharmacologic thromboprophylaxis confers benefit for preventing asymptomatic (screening-detected) proximal DVT with very low certainty regarding its impact on patient-important outcomes.
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http://dx.doi.org/10.1182/bloodadvances.2020002195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322965PMC
June 2020

Radical prostatectomy versus deferred treatment for localised prostate cancer.

Cochrane Database Syst Rev 2020 06 4;6:CD006590. Epub 2020 Jun 4.

Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, Netherlands.

Background: Prostate cancer is a common cancer but is oftentimes slow growing. When confined to the prostate, radical prostatectomy (RP), which involves removal of the prostate, offers potential cure that may come at the price of adverse events. Deferred treatment, involving observation and palliative treatment only (watchful waiting (WW)) or close monitoring and delayed local treatment with curative intent as needed in the setting of disease progression (active monitoring (AM)/surveillance (AS)) might be an alternative. This is an update of a Cochrane Review previously published in 2010.

Objectives: To assess effects of RP compared with deferred treatment for clinically localised prostate cancer.

Search Methods: We searched the Cochrane Library (including CDSR, CENTRAL, DARE, and HTA), MEDLINE, Embase, AMED, Web of Science, LILACS, Scopus, and OpenGrey. Additionally, we searched two trial registries and conference abstracts of three conferences (EAU, AUA, and ASCO) until 3 March 2020.

Selection Criteria: We included all randomised controlled trials (RCTs) that compared RP versus deferred treatment in patients with localised prostate cancer, defined as T1-2, N0, M0 prostate cancer.

Data Collection And Analysis: Two review authors independently assessed the eligibility of references and extracted data from included studies. The primary outcome was time to death from any cause; secondary outcomes were: time to death from prostate cancer; time to disease progression; time to metastatic disease; quality of life, including urinary and sexual function; and adverse events. We assessed the certainty of evidence per outcome using the GRADE approach.  MAIN RESULTS: We included four studies with 2635 participants (average age between 60 to 70 years). Three multicentre RCTs, from Europe and USA, compared RP with WW (n = 1537), and one compared RP with AM (n = 1098). Radical prostatectomy versus watchful waiting RP probably reduces the risk of death from any cause (hazard ratio (HR) 0.79, 95% confidence interval (CI) 0.70-0.90; 3 studies with 1537 participants; moderate-certainty evidence). Based on overall mortality at 29 years, this corresponds to 764 deaths per 1000 men in the RP group compared to 839 deaths per 1000 men in the WW group. RP probably also lowers the risk of death from prostate cancer (HR 0.57, 95% CI 0.44-0.73; 2 studies with 1426 participants; moderate-certainty evidence). Based on prostate cancer-specific mortality at 29 years, this corresponds to 195 deaths from prostate cancer per 1000 men in the RP group compared with 316 deaths from prostate cancer per 1000 men in the WW group. RP may reduce the risk of progression (HR 0.43, 95% CI 0.35-0.54; 2 studies with 1426 participants; I² = 54%; low-certainty evidence); at 19.5 years, this corresponds to 391 progressions per 1000 men for the RP group compared with 684 progressions per 1000 men for the WW group) and probably reduces the risk of developing metastatic disease (HR 0.56, 95% CI 0.46-0.70; 2 studies with 1426 participants; I² = 0%; moderate-certainty evidence); at 29 years, this corresponds to 271 metastatic diseases per 1000 men for RP compared with 431 metastatic diseases per 1000 men for WW. General quality of life at 12 years' follow-up is probably similar for both groups (risk ratio (RR) 1.0, 95% CI 0.85-1.16; low-certainty evidence), corresponding to 344  patients with high quality of life per 1000 men for the RP group compared with 344 patients with high quality of life per 1000 men for the WW group. Rates of urinary incontinence may be considerably higher (RR 3.97, 95% CI 2.34-6.74; low-certainty evidence), corresponding to 173 incontinent men per 1000 in the RP group compared with 44 incontinent men per 1000 in the WW group, as are rates of erectile dysfunction (RR 2.67, 95% CI 1.63-4.38; low-certainty evidence), corresponding to 389 erectile dysfunction events per 1000 for the RP group compared with 146 erectile dysfunction events per 1000 for the WW group, both at 10 years' follow-up. Radical prostatectomy versus active monitoring Based on one study including 1098 participants with 10 years' follow-up, there are probably no differences between RP and AM in time to death from any cause (HR 0.93, 95% CI 0.65-1.33; moderate-certainty evidence). Based on overall mortality at 10 years, this corresponds to 101 deaths per 1000 men in the RP group compared with 108 deaths per 1000 men in the AM group. Similarly, risk of death from prostate cancer probably is not different between the two groups (HR 0.63, 95% CI 0.21-1.89; moderate-certainty evidence). Based on prostate cancer-specific mortality at 10 years, this corresponds to nine prostate cancer deaths per 1000 men in the RP group compared with 15 prostate cancer deaths per 1000 men in the AM group. RP probably reduces the risk of progression (HR 0.39, 95% CI 0.27-0.56; moderate-certainty evidence; at 10 years, this corresponds to 86 progressions per 1000 men for RP compared with 206 progressions per 1000 men for AM) and the risk of developing metastatic disease (RR 0.39, 95% CI 0.21-0.73; moderate-certainty evidence; at 10 years, this corresponds to 24 metastatic diseases per 1000 men for the RP group compared with 61 metastatic diseases per 1000 men for the AM group).The general quality of life during follow-up was not different between the treatment groups. However, urinary function (mean difference (MD) 8.60 points lower, 95% CI 11.2-6.0 lower) and sexual function (MD 14.9 points lower, 95% CI 18.5-11.3 lower) on the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument, were worse in the RP group.

Authors' Conclusions: Based on long-term follow-up, RP compared with WW probably results in substantially improved oncological outcomes in men with localised prostate cancer but also markedly increases rates of urinary incontinence and erectile dysfunction. These findings are largely based on men diagnosed before widespread PSA screening, thereby limiting generalisability. Compared to AM, based on follow-up to 10 years, RP probably has similar outcomes with regard to overall and disease-specific survival yet probably reduces the risks of disease progression and metastatic disease. Urinary function and sexual function are probably decreased for the patients treated with RP.
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http://dx.doi.org/10.1002/14651858.CD006590.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270852PMC
June 2020

Methodology for the American Society of Hematology VTE guidelines: current best practice, innovations, and experiences.

Blood Adv 2020 05;4(10):2351-2365

Michael G. DeGroote Cochrane Canada Centre.

Background: Methods for the development of clinical guidelines have advanced dramatically over the past 2 decades to strive for trustworthiness, transparency, user-friendliness, and rigor. The American Society of Hematology (ASH) guidelines on venous thromboembolism (VTE) have followed these advances, together with application of methodological innovations.

Objective: In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development.

Methods: We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs.

Results: The complete set of VTE guidelines will include >250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects.

Conclusions: The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor.
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http://dx.doi.org/10.1182/bloodadvances.2020001768DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252554PMC
May 2020

Convective radiofrequency water vapour thermal therapy for lower urinary tract symptoms in men with benign prostatic hyperplasia.

Cochrane Database Syst Rev 2020 03 25;3:CD013251. Epub 2020 Mar 25.

Minneapolis VA Health Care System, Urology Section, One Veterans Drive, Mail Code 112D, Minneapolis, Minnesota, USA, 55417.

Background: New minimal invasive surgeries have been suggested as alternative options to transurethral resection of the prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Convective radiofrequency water vapour thermal therapy is a new technology that uses targeted, controlled water vapour energy (steam) to create necrotic tissue in the prostate.

Objectives: To assess the effects of convective radiofrequency water vapour thermal therapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

Search Methods: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Latin American and the Caribbean Health Sciences Literature, Scopus, Web of Science), trials registries, other sources of grey literature, and conference proceedings published up to 18 February 2020, with no restriction on the language or status of publication.

Selection Criteria: We included parallel-group randomised controlled trials (RCTs), cluster-RCTs, and non-randomised observational prospective studies with concurrent comparison groups, in which men with BPH underwent convective radiofrequency water vapour thermal therapy, another active therapy, or a sham procedure.

Data Collection And Analysis: Two review authors independently screened the literature, extracted data, and assessed risk of bias. We had planned to perform statistical analyses using a random-effects model, and interpret them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the certainty of the evidence according to the GRADE approach.

Main Results: We included a single, industry-sponsored RCT, with 197 randomised men, that compared convective radiofrequency water vapour thermal therapy to a sham procedure. The mean age 62.9 years, the International Prostate Symptom Score (IPSS) was 21.97, and the mean prostate volume was 45.4 mL. We only found short-term data, measured up to three months. Primary outcomes Convective radiofrequency water vapour thermal therapy may improve urologic symptom scores more than a sham procedure, measured on a IPSS scale (0 to 35; higher score represents worse urological symptoms) by a mean difference (MD) of -6.9 (95% confidence interval (CI) -9.06 to -4.74; 195 men; low-certainty evidence), and likely improves quality of life (QoL), measured on a IPSS-QoL scale (0 to 6; higher score represents worse QoL), by a MD of -1.2 (95% CI -1.66 to -0.74; 195 men; moderate-certainty evidence). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on major adverse events (risk ratio (RR) 6.79, 95% CI 0.39 to 117.00; 197 men; very low-certainty evidence) assessed by the Clavien-Dindo classification system of III, IV, and V complications. Secondary outcomes We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on retreatment (RR 1.36, 95% CI 0.06 to 32.86; 197 men; very low-certainty evidence). Convective radiofrequency water vapour thermal therapy may have little to no effect on erectile function (MD 0.4, 95% CI -1.91 to 2.71; 130 men; low-certainty evidence) and ejaculatory function (MD 0.5, 95% CI -0.83 to 1.83; 130 men; low-certainty evidence). Convective radiofrequency water vapour thermal therapy may increase minor adverse events assessed by the Clavien-Dindo classification system of Grade I and II complications (RR 1.89, 95% CI 1.15 to 3.11; 197 men; low-certainty evidence). This would correspond to 434 minor adverse events per 1000 men (95% CI 264 more to 714 more). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on acute urinary retention (RR 4.98, 95% CI 0.28 to 86.63; 197 men; very low-certainty evidence). It likely greatly increases the rate of men requiring indwelling urinary catheters (RR 35.58, 95% CI 15.37 to 82.36; 197 men; moderate-certainty evidence). We were unable to perform any of the predefined secondary analyses. We found no evidence for other comparisons, such as convective radiofrequency water vapour thermal therapy versus TURP or other minimal invasive procedures.

Authors' Conclusions: Compared to a sham procedure, urologic symptom scores and quality of life appear to improve with convective radiofrequency water vapour thermal therapy, but we are very uncertain about major adverse events. The certainty of evidence ranged from moderate to very low, with study limitations and imprecision being the most common reasons for rating down. These findings are based on a single industry-sponsored study, with three-month short-term follow-up. We did not find any studies comparing convective radiofrequency water vapour thermal therapy to any other active treatment form, such as TURP.
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http://dx.doi.org/10.1002/14651858.CD013251.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7093307PMC
March 2020

Guideline developers in the United States were inconsistent in applying criteria for appropriate Grading of Recommendations, Assessment, Development and Evaluation use.

J Clin Epidemiol 2020 08 4;124:193-199. Epub 2020 Mar 4.

Urology Section, Minneapolis Veterans Affairs Health Care System, Minneapolis, MN, USA; Department of Urology, University of Minnesota, Minneapolis, MN, USA. Electronic address:

Objectives: We assessed whether guidelines published by organizations based in the United States comply with published criteria for the use of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Study Design And Setting: We performed a cross-sectional study of all clinical practice guidelines that indicated the use of the GRADE approach, were published between 2011 and 2018, and listed in the National Guidelines Clearinghouse.

Results: We included 67 guideline documents from 44 of 135 (32.6%) US-based organizations that indicated the use of the GRADE approach. The majority (60/67, 89.6%) of guidelines defined the certainty of evidence consistent with GRADE, but only approximately 1 in 10 (7/67, 10.4%) explicitly reported consideration of all eight criteria to assess the certainty in the evidence for rating down and up. A majority of guidelines (36/67, 53.7%) provided a summary of the evidence, described explicit consideration of all four central domains (36/67, 53.7%), and rated the strength of recommendation consistent with GRADE (36/67, 53.7%).

Conclusion: Approximately one in three US-based organizations developing evidence-based guidelines report the use of GRADE, but adherence to published criteria is inconsistent. As uptake of the GRADE approach increases in the United States, continued efforts to train guideline methodologists and panel members are important.
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http://dx.doi.org/10.1016/j.jclinepi.2020.01.026DOI Listing
August 2020

Evidence-based medicine in urology.

World J Urol 2020 Mar;38(3):515-516

Department of Urology and Pediatric Urology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), University Hospital Erlangen, Krankenhausstrasse 12, 91054, Erlangen, Germany.

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http://dx.doi.org/10.1007/s00345-020-03139-6DOI Listing
March 2020

Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).

Eur Urol 2020 06 21;77(6):713-724. Epub 2020 Feb 21.

MDx Health, Irvine, CA, USA; Nanospectra Biosciences, Houston, TX, USA.

Background: Very long-term mortality in men with early prostate cancer treated with surgery versus observation is uncertain.

Objective: To determine long-term effects of surgery versus observation on all-cause mortality for men with early prostate cancer.

Design, Setting, And Participants: This study evaluated long-term follow-up of a randomized trial conducted at the US Department of Veterans Affairs and National Cancer Institute sites. The participants were men (n=731) ≤75yr of age with localized prostate cancer, prostate-specific antigen (PSA) <50ng/ml, life expectancy ≥10yr, and medically fit for surgery.

Intervention: Radical prostatectomy versus observation.

Outcome Measurements And Statistical Analysis: All-cause mortality was assessed in the entire cohort and patient and tumor subgroups. Intention-to-treat analysis was conducted using Kaplan-Meier methods with log-rank tests and Cox proportional hazard models; cumulative mortality incidence, between-group differences, and relative risks were also assessed at predefined time periods.

Results And Limitations: During 22.1yr (median follow-up for survivors=18.6yr; interquartile range: 16.6-20.0), 515 men died; 246 of 346 men (68%) were assigned to surgery versus 269 of 367 (73%) assigned to observation (hazard ratio 0.84 [95% confidence interval {CI}: 0.70-1.00]; p= 0.044 [absolute risk reduction = 5.7 percentage points, 95% CI: -0.89 to 12%]; relative risk: 0.92 [95% CI: 0.84-1.01]). The restricted mean survival in the surgical group was 13.6 yr (95% CI: 12.9-14.3) versus 12.6 yr (95% CI: 11.8-13.3) in the observation group; a mean of 1 life-year was gained with surgery. Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease. Results were not adjusted for multiple comparisons, and we could not assess outcomes other than all-cause mortality.

Conclusions: Surgery was associated with small very long-term reductions in all-cause mortality and increases in years of life gained. Absolute effects did not vary markedly by patient characteristics. Absolute effects and mean survival were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease.

Patient Summary: In this randomized study, we evaluated death from any cause in men with early prostate cancer treated with either surgery or observation. Overall, surgery may provide small very long-term reductions in death from any cause and increases in years of life gained. Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease. Strategies are needed to identify men needing and benefitting from surgery while reducing ineffective treatment and overtreatment.
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http://dx.doi.org/10.1016/j.eururo.2020.02.009DOI Listing
June 2020

A Longitudinal Assessment of the Reporting Quality of Randomized Controlled Trials for Surgical Interventions to Treat Nephrolithiasis Over 16 Years (2002 to 2017).

J Endourol 2020 04 24;34(4):502-508. Epub 2020 Mar 24.

Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.

Transparently reported, high-quality randomized controlled trials (RCTs) play a critical role in guiding evidence based clinical practice and informing evidence-based guidelines in patients with nephrolithiasis. Prior studies have found reporting quality to be low. We performed this study to assess whether the reporting of RCTs has improved over time. This study was governed by an protocol. We performed a systematic literature search for RCTs analyzing nephrolithiasis treatment. Selection of eligible studies and data abstraction were performed by two of three reviewers independently and in duplicate. We developed and pilot tested a data extraction checklist based on the Consolidated Standards of Reporting Trials (CONSORT) criteria on a scale of 0 to 25. Our primary outcome measure was the mean CONSORT score. We performed statistical hypothesis testing to compare scores between 2002-2006, 2007-2011, and 2012-2017. A total of 203 studies (2002-06: 38; 2007-11: 64; 2012-17: 101) met inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (35.1%), shockwave lithotripsy (25.4%), and ureteroscopy (22.9%). Asia contributed an increasing proportion of studies (25.6%, 44.6%, and 74.3%, respectively) in these three time periods. The main journals of publication were the (23.9%), the (19.5%), and (8.3%). The mean ± standard error of the CONSORT summary scores was 11.4 ± 0.4, (2002 to 2006), 12.1 ± 0.3, (2007 to 2011), and 13.3 ± 0.4 ( = 0.003) reflecting an increase by 1.92 (95% confidence interval: 0.86 - 2.98). The number of RCTs investigating the use of urologic devices to treat stone disease has substantially increased overtime. There has been a small improvement in reporting quality; however, this remains suboptimal overall. Increased efforts to promote the transparent reporting of RCTs in endourology are warranted.
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http://dx.doi.org/10.1089/end.2019.0649DOI Listing
April 2020

Guidelines about physical activity and exercise to reduce cardiometabolic risk factors: protocol for a systematic review and critical appraisal.

BMJ Open 2020 01 23;10(1):e032656. Epub 2020 Jan 23.

Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.

Introduction: Physical activity can prevent a wide range of diseases, including highly prevalent conditions such as heart disease, diabetes and associated cardiometabolic disorders. Numerous guidelines for the prescription of physical activity and exercise to promote general health and prevent disease are released each year, but the quality of these guidelines is currently unknown. This systematic review and critical appraisal of physical activity and exercise guidelines aims to summarise the current status and quality of these guidelines to provide suggestions to improve the development of future guidelines in this area.

Methods And Analysis: We will conduct a systematic review of guidelines in Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews and Scopus databases published from database 2000 through 23 October 2019, written in English for the use of physical activity and exercise for the prevention of cardiometabolic disease and related risk factors in otherwise healthy individuals. We will also search the grey literature for additional eligible documents. We will use the Appraisal of Guidelines for Research and Evaluation II tool to assess the quality of eligible recommendations from all included guidelines, as well as perform exploratory analyses on guideline development variables.

Ethics And Dissemination: As a protocol for the review and critical appraisal of published documents, no potential ethical considerations are discussed. The protocol will guide the development of the review, which will be disseminated to relevant journals for publication.

Prospero Registration Number: CRD42019126364.
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http://dx.doi.org/10.1136/bmjopen-2019-032656DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044951PMC
January 2020

Low Methodological Quality of Systematic Reviews Published in the Urological Literature (2016-2018).

Urology 2020 Apr 15;138:5-10. Epub 2020 Jan 15.

Minneapolis VA Medical Center, Urology Section, Minneapolis, MN; University of Minnesota, Department of Urology, Minneapolis, MN. Electronic address:

Objective: To investigate the methodological quality of systematic reviews (SRs) published in the urological literature.

Methods: PubMed was systematically searched for SRs related to questions of prevention and therapy published in 5 major urology journals (January, 2016 to December, 2018). Two reviewers followed a written a priori protocol to independently screen references in Rayyan and abstract data using a piloted form based on the 16 domains of AMSTAR-2. We performed preplanned statistical hypothesis testing by journal of publication in SPSS version 24.0.

Results: Our search identified 260 relevant references, 144 of which ultimately met inclusion criteria. The largest contributors by journal of publication were European Urology (53; 36.8%) followed by Urology (36; 25.0%), and BJU International (24; 16.6%). The most common clinical topics were oncology (64; 44.4%) and voiding dysfunction (32; 22.2%) followed by stones/endourology (14; 9.7%). Just over one-third (52; 36.2%) of reviews had a registered protocol. Nearly all studies (139; 96.5%) searched at least 2 databases. Less than one-third (46; 31.9%) also searched trial registries and one-fifth (30; 20.8%) consulted experts for additional trials. Few studies (14; 10.4%) provided a list of potentially relevant but excluded studies. Only 6 (4.2%) studies met all AMSTAR-2 critical domains as a prerequisite for high-quality reviews.

Conclusion: A large number of SRs are published in the urological literature each year, yet their quality is suboptimal. There is a need for educating authors, peer reviewers, and editors alike on established standards for high-quality SRs to ensure improvement in the future.
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http://dx.doi.org/10.1016/j.urology.2020.01.004DOI Listing
April 2020

Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer.

Cochrane Database Syst Rev 2020 01 8;1:CD011935. Epub 2020 Jan 8.

Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Institute for Evidence in Medicine, Breisacher Str. 153, Freiburg, Germany, D-79110.

Background: People with urothelial carcinoma of the bladder are at risk for recurrence and progression following transurethral resection of a bladder tumour (TURBT). Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) are commonly used, competing forms of intravesical therapy for intermediate- or high-risk non-muscle invasive (Ta and T1) urothelial bladder cancer but their relative merits are somewhat uncertain.

Objectives: To assess the effects of BCG intravesical therapy compared to MMC intravesical therapy for treating intermediate- and high-risk Ta and T1 bladder cancer in adults.

Search Methods: We performed a systematic literature search in multiple databases (CENTRAL, MEDLINE, Embase, Web of Science, Scopus, LILACS), as well as in two clinical trial registries. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The latest search was conducted in September 2019.

Selection Criteria: We included randomised controlled trials (RCTs) that compared intravesical BCG with intravesical MMC therapy for non-muscle invasive urothelial bladder cancer.

Data Collection And Analysis: Two review authors independently screened the literature, extracted data, assessed risk of bias and rated the quality of evidence according to GRADE per outcome. In the meta-analyses, we used the random-effects model.

Main Results: We identified 12 RCTs comparing BCG versus MMC in participants with intermediate- and high-risk non-muscle invasive bladder tumours (published from 1995 to 2013). In total, 2932 participants were randomised. Time to death from any cause: BCG may make little or no difference on time to death from any cause compared to MMC (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.79 to 1.20; participants = 1132, studies = 5; 567 participants in the BCG arm and 565 in the MMC arm; low-certainty evidence). This corresponds to 6 fewer deaths (40 fewer to 36 more) per 1000 participants treated with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Serious adverse effects: 12/577 participants treated with BCG experienced serious non-fatal adverse effects compared to 4/447 participants in the MMC group. The pooled risk ratio (RR) is 2.31 (95% CI 0.82 to 6.52; participants = 1024, studies = 5; low-certainty evidence). Therefore, BCG may increase the risk for serious adverse effects compared to MMC. This corresponds to nine more serious adverse effects (one fewer to 37 more) with BCG. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Time to recurrence: BCG may reduce the time to recurrence compared to MMC (HR 0.88, 95% CI 0.71 to 1.09; participants = 2616, studies = 11, 1273 participants in the BCG arm and 1343 in the MMC arm; low-certainty evidence). This corresponds to 41 fewer recurrences (104 fewer to 29 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations, imprecision and inconsistency. Time to progression: BCG may make little or no difference on time to progression compared to MMC (HR 0.96, 95% CI 0.73 to 1.26; participants = 1622, studies = 6; 804 participants in the BCG arm and 818 in the MMC arm; low-certainty evidence). This corresponds to four fewer progressions (29 fewer to 27 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Quality of life: we found very limited data for this outcomes and were unable to estimate an effect size.

Authors' Conclusions: Based on our findings, BCG may reduce the risk of recurrence over time although the Confidence Intervals include the possibility of no difference. It may have no effect on either the risk of progression or risk of death from any cause over time. BCG may cause more serious adverse events although the Confidence Intervals once again include the possibility of no difference. We were unable to determine the impact on quality of life. The certainty of the evidence was consistently low, due to concerns that include possible selection bias, performance bias, given the lack of blinding in these studies, and imprecision.
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http://dx.doi.org/10.1002/14651858.CD011935.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6956215PMC
January 2020

Efficacy and Safety of Testosterone Treatment in Men: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians.

Ann Intern Med 2020 01 7;172(2):105-118. Epub 2020 Jan 7.

Minneapolis VA Health Care System and University of Minnesota School of Medicine, Minneapolis, Minnesota (S.J.D., P.D., N.E., A.E., L.S.H., H.A.F., T.J.W.).

Background: Testosterone treatment rates in adult men have increased in the United States over the past 2 decades.

Purpose: To assess the benefits and harms of testosterone treatment for men without underlying organic causes of hypogonadism.

Data Sources: English-language searches of multiple electronic databases (January 1980 to May 2019) and reference lists from systematic reviews.

Study Selection: 38 randomized controlled trials (RCTs) of at least 6 months' duration that evaluated transdermal or intramuscular testosterone therapies versus placebo or no treatment and reported prespecified patient-centered outcomes, as well as 20 long-term observational studies, U.S. Food and Drug Administration review data, and product labels that reported harms information.

Data Extraction: Data extraction by a single investigator was confirmed by a second, 2 investigators assessed risk of bias, and evidence certainty was determined by consensus.

Data Synthesis: Studies enrolled mostly older men who varied in age, symptoms, and testosterone eligibility criteria. Testosterone therapy improved sexual functioning and quality of life in men with low testosterone levels, although effect sizes were small (low- to moderate-certainty evidence). Testosterone therapy had little to no effect on physical functioning, depressive symptoms, energy and vitality, or cognition. Harms evidence reported in trials was judged to be insufficient or of low certainty for most harm outcomes. No trials were powered to assess cardiovascular events or prostate cancer, and trials often excluded men at increased risk for these conditions. Observational studies were limited by confounding by indication and contraindication.

Limitation: Few trials exceeded a 1-year duration, minimum important outcome differences were often not established or reported, RCTs were not powered to assess important harms, few data were available in men aged 18 to 50 years, definitions of low testosterone varied, and study entry criteria varied.

Conclusion: In older men with low testosterone levels without well-established medical conditions known to cause hypogonadism, testosterone therapy may provide small improvements in sexual functioning and quality of life but little to no benefit for other common symptoms of aging. Long-term efficacy and safety are unknown.

Primary Funding Source: American College of Physicians. (PROSPERO: CRD42018096585).
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http://dx.doi.org/10.7326/M19-0830DOI Listing
January 2020

American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients.

Blood Adv 2019 12;3(23):3898-3944

Urology Section, Minneapolis VA Health Care System, Minneapolis, MN; and.

Background: Venous thromboembolism (VTE) is a common source of perioperative morbidity and mortality.

Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision making about preventing VTE in patients undergoing surgery.

Methods: ASH formed a multidisciplinary guideline panel balanced to minimize bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic reviews. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.

Results: The panel agreed on 30 recommendations, including for major surgery in general (n = 8), orthopedic surgery (n = 7), major general surgery (n = 3), major neurosurgical procedures (n = 2), urological surgery (n = 4), cardiac surgery and major vascular surgery (n = 2), major trauma (n = 2), and major gynecological surgery (n = 2).

Conclusions: For patients undergoing major surgery in general, the panel made conditional recommendations for mechanical prophylaxis over no prophylaxis, for pneumatic compression prophylaxis over graduated compression stockings, and against inferior vena cava filters. In patients undergoing total hip or total knee arthroplasty, conditional recommendations included using either aspirin or anticoagulants, as well as for a direct oral anticoagulant over low-molecular-weight heparin (LMWH). For major general surgery, the panel suggested pharmacological prophylaxis over no prophylaxis, using LMWH or unfractionated heparin. For major neurosurgery, transurethral resection of the prostate, or radical prostatectomy, the panel suggested against pharmacological prophylaxis. For major trauma surgery or major gynecological surgery, the panel suggested pharmacological prophylaxis over no prophylaxis.
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http://dx.doi.org/10.1182/bloodadvances.2019000975DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963238PMC
December 2019

The fate of urological systematic reviews registered in PROSPERO.

World J Urol 2020 Nov 29;38(11):2981-2986. Epub 2019 Nov 29.

Department of Urology, University of Minnesota, Minneapolis, MN, USA.

Purpose: To identify urologic systematic reviews (SRs) registered to PROSPERO that resulted in a publication, and to evaluate their methodological quality and concordance with their stated a priori protocols.

Methods: We searched PubMed to identify urologic SR protocols registered in PROSPERO that resulted in a publication and assessed their methodological quality and protocols in relation to their stated a priori protocols in PROSPERO.

Results: Of the 576 urologic SR protocols registered in PROSPERO up to December 2017, 201 (34.9%) resulted in a full SR publication, but only 40 (17.7%) updated their registration record accordingly. Publications were spread over 100 different journals, with a median time-to-publication of 29 months (95% CI 25.0-33.0). The most common topic by far was prostate cancer (59.7%), followed by voiding issues (15.3%), and renal transplantation (15.3%). Only little over half the reviews (52.74%) explicitly stated primary outcome(s) that matched the primary outcome of their corresponding PROSPERO protocol. Notable methodologic deviations from registered protocols included planned restriction on study design (33%), heterogeneity analysis (42%) and planned risk of bias analysis (65.2%).

Conclusion: SR authors in urology are increasingly using PROSPERO to register their titles, but our findings indicate that registration alone is not a guarantor of a high-quality SR product. There appears to be a critical need to raise the bar for review authors registering protocols in PROSPERO, with an emphasis on transparency in their publication status updates as well as deviations from their a priori protocols.
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http://dx.doi.org/10.1007/s00345-019-03032-xDOI Listing
November 2020