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1.
World J Urol ; 40(4): 999-1004, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35037963

RESUMO

PURPOSE: The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). METHODS: A pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ. Patients were randomized 1:1 to receive intravesical BCG for 1 year (once weekly for 6 weeks plus subsequent maintenance) or HIVEC with 40 mg MMC, administered using the Combat BRS system (once weekly instillations were given for 6 weeks, followed by once monthly instillation for 6 months). Total recirculating dwell time for HIVEC was 60 min at a target temperature of 43° ± 0.5 °C. Primary endpoint was recurrence-free survival. Secondary endpoints were time to recurrence, progression-free survival, cancer-specific survival, and overall survival at 24 months. Adverse events were routinely assessed. RESULTS: Fifty patients were enrolled. Mean age was 73.5 years. Median follow-up was 33.7 months. Recurrence-free survival at 24 months was 86.5% for HIVEC and 71.8% for BCG (p = 0.184) in the intention-to-treat analysis and 95.0% for HIVEC and 75.1% for BCG (p = 0.064) in the per protocol analysis. Time to recurrence was 21.5 and 16.1 months for HIVEC and BCG, respectively. Progression-free survival for HIVEC vs BCG was 95.7% vs 71.8% (p = 0.043) in the intention-to-treat analysis and 100% vs 75.1% (p = 0.018) in the per protocol analysis, respectively. Cancer-specific survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG. CONCLUSION: HIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages. TRIAL REGISTRATION: EudraCT 2016-001186-85. Date of registration: 17 March 2016.


Assuntos
Hipertermia Induzida , Neoplasias da Bexiga Urinária , Adjuvantes Imunológicos/uso terapêutico , Administração Intravesical , Idoso , Vacina BCG/uso terapêutico , Humanos , Mitomicina/uso terapêutico , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias da Bexiga Urinária/tratamento farmacológico
2.
Am J Emerg Med ; 44: 137-142, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33618037

RESUMO

OBJECTIVES: To propose a clear definition and management pathway of patients with analgesic refractory colic pain (ARCP). PATIENTS AND METHODS: Prospective cohort study from February 2018 to February 2019 including patients with ARCP defined as ongoing renal colic pain after one dose of IV NSAID, IV paracetamol, and a parenteral opioid, given sequentially in that order. Patients were observed in-hospital under full parenteral analgesic management for 8-12 h, whenever patients had minimal or absent pain after conservative management (CM) they were discharged, and followed-up with new imaging within four weeks. If the pain was not controlled after CM, surgical management (double-J stent or ureteroscopy) was performed. We excluded patients with any other indication for urgent intervention or in cases where CM was deemed inappropriate (sepsis, acute renal failure, stones >10 mm in size, suspected concomitant urinary tract infection, bilateral ureteral stones, pregnancy, patients with a single kidney, kidney transplant recipients, difficult access to medical care or refusal to undergo CM). RESULTS: Data from 60 patients was collected. The only variable associated with an increased risk of failed CM was a history of previous renal colic (OR 3.98 [95% CI 1.14-13.84], p = 0.02). Neither gender, age, stone size, location, or hydronephrosis grade were able to predict CM failure. 41.6% of patients were successfully managed conservatively and only 8% of them required scheduled surgical management at follow-up. CONCLUSION: Our results show that a high proportion of patients with ARCP may be successfully managed conservatively with an extended observation period without complications at follow-up. These results should be replicated in a randomized controlled trial to confirm them.


Assuntos
Analgésicos/uso terapêutico , Cólica/tratamento farmacológico , Tratamento Conservador , Manejo da Dor/métodos , Acetaminofen/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Estudos Prospectivos
3.
Andrologia ; 52(8): e13717, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32596939

RESUMO

There is an increasing use of the procedure, anatomical endoscopic enucleation of the prostate, as an alternative to conventional transurethral resection of prostate for surgical treatment of benign prostatic hyperplasia. However, barriers to adoption of this procedure remain and no prior studies explored this important aspect till date. The aim of this study is to identify the predictors and barriers of surgeon-related practices in this area. The study findings may also provide valuable insight into current practice trends worldwide. To achieve the objectives, we conducted an online, cross-sectional, questionnaire-based study between 1st September 2019 and 5th October 2019 to investigate the knowledge, attitudes and practices among urologists worldwide. Our findings showed that the main barriers for adoption of the procedure were lack of mentorship, a steep learning curve, and unavailability of morcellator, bipolar or laser energy sources. Fear of urinary incontinence, bleeding and bladder injury were not major hindrance to adoption of this technique. The results also demonstrated that there will be continued increase in utility of the procedure in the future.


Assuntos
Terapia a Laser , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Estudos Transversais , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Hiperplasia Prostática/cirurgia , Inquéritos e Questionários , Resultado do Tratamento , Urologistas
4.
Int Braz J Urol ; 46(suppl.1): 120-124, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32550706

RESUMO

Never before in human history has it been possible to communicate so quickly during a pandemic, social media platforms have been a key piece for the dissemination of information; however, there are multiple advantages and disadvantages that must be considered. Responsible use of these tools can help quickly disseminate important new information, relevant new scientific findings, share diagnostic, treatment, and follow-up protocols, as well as compare different approaches globally, removing geographic boundaries for the first time in history. In order to use these tools in a responsible and useful way, it is recommended to follow some basic guidelines when sharing information on social networks in the COVID-19 era. In this paper, we summarize the most relevant information on the influence, and advantages, and disadvantages of the use of social networks during the COVID-19 pandemic.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Disseminação de Informação , Pandemias , Pneumonia Viral , Mídias Sociais , COVID-19 , Informação de Saúde ao Consumidor , Infecções por Coronavirus/epidemiologia , Humanos , Pneumonia Viral/epidemiologia , SARS-CoV-2
5.
J Urol ; : 101097JU0000000000004062, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38848550
6.
Int J Urol ; 26(11): 1054-1058, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31475394

RESUMO

OBJECTIVES: To assess the impact of transrectal versus transperineal prostate biopsy on erectile function. METHODS: This was a single-center, observational, prospective study of consecutive patients who underwent a prostate biopsy (transrectal or transperineal/fusion biopsy). Study participants completed the International Index of Erectile Function-5 questionnaire before the procedure, and 3 and 6 months after. Prostatic biopsies were carried out following the standard procedure for both techniques. RESULTS: The study included 135 male patients with a mean age of 63.5 years. At baseline, 28 patients (21%) presented normal erectile function, whereas 107 patients (82%) presented erectile dysfunction, which was severe in four (3%), moderate in 49 (36%) and mild in 54 (40%), with an overall mean International Index of Erectile Function-5 score of 17.70. After 3 months, the rates were 29%, 3%, 27% and 38%, respectively (mean International Index of Erectile Function-5 score 17.95). At 6 months, the rates were 30%, 6%, 28% and 34%, respectively (mean International Index of Erectile Function-5 score of 17.77). No significant differences between pre- and post-biopsy International Index of Erectile Function-5 scores at 3 and 6 months were observed, even when analyzing transrectal and transperineal separately. The number of biopsy cores and number of previous biopsies did not influence the International Index of Erectile Function-5 scores. CONCLUSIONS: Our findings suggest that prostate biopsy technique, number of biopsy cores and history of previous biopsy do not significantly impact erectile function in the medium term up to 6 months.


Assuntos
Disfunção Erétil/etiologia , Doenças Prostáticas/diagnóstico , Procedimentos Cirúrgicos Urogenitais/efeitos adversos , Idoso , Biópsia/efeitos adversos , Biópsia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
9.
Cochrane Database Syst Rev ; 11: CD011296, 2018 11 29.
Artigo em Inglês | MEDLINE | ID: mdl-30488948

RESUMO

BACKGROUND: Diabetes mellitus is a metabolic disorder resulting from a defect in insulin secretion, function, or both. Hyperglycaemia in non-critically ill hospitalised people is associated with poor clinical outcomes (infections, prolonged hospital stay, poor wound healing, higher morbidity and mortality). In the hospital setting people diagnosed with diabetes receive insulin therapy as part of their treatment in order to achieve metabolic control. However, insulin therapy can be provided by different strategies (sliding scale insulin (SSI), basal-bolus insulin, and other modalities). Sliding scale insulin is currently the most commonly used method, however there is uncertainty about which strategy provides the best patient outcomes. OBJECTIVES: To assess the effects of SSI for non-critically ill hospitalised adults with diabetes mellitus. SEARCH METHODS: We identified eligible trials by searching MEDLINE, Embase, LILACS, and the Cochrane Library. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov trial registers. The date of the last search for all databases was December 2017. We also examined reference lists of identified randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors. SELECTION CRITERIA: We included RCTs comparing SSI with other strategies for glycaemic control in non-critically ill hospitalised adult participants of any sex with diabetes mellitus. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data, assessed trials for risk of bias, and evaluated the overall certainty of evidence utilising the GRADE instrument. We synthesised data using a random-effects model meta-analysis with 95% prediction intervals, if possible, or descriptive analysis, as appropriate. MAIN RESULTS: Of 720 records screened, we included eight trials that randomised 1048 participants with type 2 diabetes (387 SSI participants and 615 participants in comparator groups were available for final analysis). We included non-critically ill medical and surgical adults with the diagnosis of diabetes mellitus. The mean follow-up time was measured by the mean length of hospital stay and ranged between five and 24 days. The mean age of participants was 44.5 years to 71 years.Overall, we judged the risk of bias on the trial level as unclear for selection bias, high for outcome-related performance and detection bias with regard to hypoglycaemic episodes, other adverse events, and mean glucose levels, and low for all-cause mortality and length of hospital stay. Attrition bias was low for all outcome measures.Six trials compared SSI with a basal-bolus insulin scheme, three of which investigating 64% of all participants in this category also applying an SSI approach in the bolus comparator part. One trial had a basal insulin-only comparator arm, and the remaining trial used continuous insulin infusion as the comparator. For our main comparison of SSI versus basal-bolus insulin, the results were as follows. Four trials reported mortality data. One out of 268 participants in the SSI group (0.3%) compared with two out of 334 participants in the basal-bolus group (0.6%) died (low-certainty evidence). Severe hypoglycaemic episodes, defined as blood glucose levels below 40 mg/dL (2.2 mmol/L), showed a risk ratio (RR) of 0.22, 95% confidence interval (CI) 0.05 to 1.00; P = 0.05; 5 trials; 667 participants; very low-certainty evidence. The 95% prediction interval ranged between 0.02 and 2.57. All nine severe hypoglycaemic episodes were observed among the 369 participants on basal-bolus insulin (2.4%). The mean length of hospital stay was 0.5 days longer for the SSI group, 95% CI -0.5 to 1.4; P = 0.32; 6 trials; 717 participants; very low-certainty evidence. The 95% prediction interval ranged between -1.7 days and 2.7 days. Adverse events other than hypoglycaemic episodes, such as postoperative infections, showed a RR of 1.16, 95% CI 0.25 to 5.37; P = 0.85; 3 trials; 481 participants; very low-certainty evidence. The mean blood glucose levels ranged across basal-bolus groups from 156 mg/dL (8.7 mmol/L) to 221 mg/dL (12.3 mmol/L). The mean blood glucose level in the SSI groups was 14.8 mg/dL (0.8 mmol/L) higher (95% CI 7.8 (0.4) to 21.8 (1.2); P < 0.001; 6 trials; 717 participants; low-certainty evidence). The 95% prediction interval ranged between -3.6 mg/dL (-0.2 mmol/L) and 33.2 mg/dL (1.8 mmol/L). No trial reported on diabetes-related mortality or socioeconomic effects. AUTHORS' CONCLUSIONS: We are uncertain which insulin strategy (SSI or basal-bolus insulin) is best for non-critically hospitalised adults with diabetes mellitus. A basal-bolus insulin strategy in these patients might result in better short-term glycaemic control but could increase the risk for severe hypoglycaemic episodes. The certainty of the body of evidence comparing SSI with basal-bolus insulin was low to very low and needs to be improved by adequately performed, well-powered RCTs in different hospital environments with well-educated medical staff using identical short-acting insulins in both intervention and comparator arms to compare the rigid SSI approach with flexible insulin application strategies.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Pacientes Internados , Insulina/administração & dosagem , Adulto , Idoso , Causas de Morte , Diabetes Mellitus Tipo 2/mortalidade , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Urol Int ; 98(4): 442-448, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28355599

RESUMO

BACKGROUND: Infections related to catheters in the upper urinary tract (CUUT) are associated with specific characteristics. METHODS: A prospective observational study was carried out from 2012 to 2015 to evaluate infections in patients with CUUT. RESULTS: A total of 209 infections were included (99 with double-J, 81 with nephrostomy, and 29 with internal/external nephroureteral stents). Among nephrostomy tube carriers, the most frequently isolated microorganisms were Pseudomonas and Enterococcus. In those with an internal/external nephroureteral stent, Klebsiella was the most common, and 57.1% were extended-spectrum beta-lactamase-producing Klebsiella. In double-J carriers, Escherichia coli and Enterococcus were the most common microorganisms. Multiple-drug resistance (MDR) microorganisms were isolated in 28.6, 47.1, and 58.3% of patients with double-J, nephrostomy, and internal-external nephroureteral stents. A percutaneous CUUT (p = 0.005) and immunosuppression (p = 0.034) were risk factors for MDR microorganisms. CONCLUSIONS: Non-E. coli bacteria are commonly isolated in patients with CUUT. MDR microorganisms are frequent, mainly in percutaneous approach or immunosuppression.


Assuntos
Catéteres , Farmacorresistência Bacteriana Múltipla , Infecções Urinárias/microbiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecção Hospitalar/microbiologia , Enterococcus , Escherichia coli , Feminino , Humanos , Hospedeiro Imunocomprometido , Terapia de Imunossupressão , Klebsiella , Masculino , Pessoa de Meia-Idade , Nefrostomia Percutânea , Nefrotomia , Estudos Prospectivos , Pseudomonas , Fatores de Risco , Sistema Urinário/microbiologia , beta-Lactamases/uso terapêutico
11.
Cochrane Database Syst Rev ; (1): CD011281, 2016 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-26798030

RESUMO

BACKGROUND: Diabetic ketoacidosis (DKA) is an acute, life-threatening complication of uncontrolled diabetes that mainly occurs in individuals with autoimmune type 1 diabetes, but it is not uncommon in some people with type 2 diabetes. The treatment of DKA is traditionally accomplished by the administration of intravenous infusion of regular insulin that is initiated in the emergency department and continued in an intensive care unit or a high-dependency unit environment. It is unclear whether people with DKA should be treated with other treatment modalities such as subcutaneous rapid-acting insulin analogues. OBJECTIVES: To assess the effects of subcutaneous rapid-acting insulin analogues for the treatment of diabetic ketoacidosis. SEARCH METHODS: We identified eligible trials by searching MEDLINE, PubMed, EMBASE, LILACS, CINAHL, and the Cochrane Library. We searched the trials registers WHO ICTRP Search Portal and ClinicalTrials.gov. The date of last search for all databases was 27 October 2015. We also examined reference lists of included randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors. SELECTION CRITERIA: We included trials if they were RCTs comparing subcutaneous rapid-acting insulin analogues versus standard intravenous infusion in participants with DKA of any age or sex with type 1 or type 2 diabetes, and in pregnant women. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data, assessed studies for risk of bias, and evaluated overall study quality utilising the GRADE instrument. We assessed the statistical heterogeneity of included studies by visually inspecting forest plots and quantifying the diversity using the I² statistic. We synthesised data using random-effects model meta-analysis or descriptive analysis, as appropriate. MAIN RESULTS: Five trials randomised 201 participants (110 participants to subcutaneous rapid-acting insulin analogues and 91 to intravenous regular insulin). The criteria for DKA were consistent with the American Diabetes Association criteria for mild or moderate DKA. The underlying cause of DKA was mostly poor compliance with diabetes therapy. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Four trials evaluated the effects of the rapid-acting insulin analogue lispro, and one the effects of the rapid-acting insulin analogue aspart. The mean follow-up period as measured by mean hospital stay ranged between two and seven days. Overall, risk of bias of the evaluated trials was unclear in many domains and high for performance bias for the outcome measure time to resolution of DKA.No deaths were reported in the included trials (186 participants; 3 trials; moderate- (insulin lispro) to low-quality evidence (insulin aspart)). There was very low-quality evidence to evaluate the effects of subcutaneous insulin lispro versus intravenous regular insulin on the time to resolution of DKA: mean difference (MD) 0.2 h (95% CI -1.7 to 2.1); P = 0.81; 90 participants; 2 trials. In one trial involving children with DKA, the time to reach a glucose level of 250 mg/dL was similar between insulin lispro and intravenous regular insulin. There was very low-quality evidence to evaluate the effects of subcutaneous insulin aspart versus intravenous regular insulin on the time to resolution of DKA: MD -1 h (95% CI -3.2 to 1.2); P = 0.36; 30 participants; 1 trial. There was low-quality evidence to evaluate the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin on hypoglycaemic episodes: 6 of 80 insulin lispro-treated participants compared with 9 of 76 regular insulin-treated participants reported hypoglycaemic events; risk ratio (RR) 0.59 (95% CI 0.23 to 1.52); P = 0.28; 156 participants; 4 trials. For insulin aspart compared with regular insulin, RR for hypoglycaemic episodes was 1.00 (95% CI 0.07 to 14.55); P = 1.0; 30 participants; 1 trial; low-quality evidence. Socioeconomic effects as measured by length of mean hospital stay for insulin lispro compared with regular insulin showed a MD of -0.4 days (95% CI -1 to 0.2); P = 0.22; 90 participants; 2 trials; low-quality evidence and for insulin aspart compared with regular insulin 1.1 days (95% CI -3.3 to 1.1); P = 0.32; low-quality evidence. Data on morbidity were limited, but no specific events were reported for the comparison of insulin lispro with regular insulin. No trial reported on adverse events other than hypoglycaemic episodes, and no trial investigated patient satisfaction. AUTHORS' CONCLUSIONS: Our review, which provided mainly data on adults, suggests on the basis of mostly low- to very low-quality evidence that there are neither advantages nor disadvantages when comparing the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin for treating mild or moderate DKA.


Assuntos
Cetoacidose Diabética/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina de Ação Curta/uso terapêutico , Adulto , Criança , Humanos , Hipoglicemiantes/efeitos adversos , Injeções Subcutâneas , Insulina/uso terapêutico , Insulina Aspart/uso terapêutico , Insulina Lispro/uso terapêutico , Insulina de Ação Curta/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
12.
Eur Urol ; 85(1): 1-2, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37244815

RESUMO

While PARP inhibitors such as rucaparib and olaparib have shown activity in metastatic castration-resistant prostate cancer, they have failed to show a clear improvement in hard outcomes such as overall survival or quality of life. Because of methodological limitations, we suggest caution before implementing these treatments in routine clinical practice; offering them to patients without a BRCA1/2 mutation is probably inappropriate.


Assuntos
Inibidores de Poli(ADP-Ribose) Polimerases , Neoplasias de Próstata Resistentes à Castração , Masculino , Humanos , Inibidores de Poli(ADP-Ribose) Polimerases/uso terapêutico , Inibidores de Poli(ADP-Ribose) Polimerases/farmacologia , Proteína BRCA1 , Qualidade de Vida , Neoplasias de Próstata Resistentes à Castração/patologia , Proteína BRCA2
13.
Eur Urol Oncol ; 2024 02 13.
Artigo em Inglês | MEDLINE | ID: mdl-38355375

RESUMO

BACKGROUND: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial. OBJECTIVE: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. DESIGN, SETTING, AND PARTICIPANTS: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes. RESULTS AND LIMITATION: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2). CONCLUSIONS: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy. PATIENT SUMMARY: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.

14.
Eur Urol Focus ; 9(5): 708-710, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37872080

RESUMO

Certainty of evidence (formerly known as quality of evidence) is defined as the extent to which our confidence in an estimate of the effect is correct or our certainty that such estimate supports a particular recommendation for a clinical practice guideline. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) is a structured and reproducible framework for assigning a level of certainty on a per-outcome basis for evidence derived from randomized and nonrandomized studies. The level of certainty starts as high or low and can be increased or decreased after considering several criteria (eg, risk of bias, inconsistency of results, publication bias, dose-response gradient, large magnitude of effect, among others). Here we describe in brief the GRADE process for summarizing and assigning a certainty rating for evidence. PATIENT SUMMARY: The GRADE framework is a way to work out how much we can trust results from medical research studies. This helps doctors in making informed decisions with their patients.


Assuntos
Pesquisa Biomédica , Medicina Baseada em Evidências , Humanos , Viés , Tomada de Decisões
15.
Urology ; 172: 157-164, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36436672

RESUMO

OBJECTIVE: To assess clinical outcomes of patients who underwent simultaneous radical cystectomy (RC) and radical nephroureterectomy (RNU) for panurothelial carcinoma (PanUC). MATERIALS AND METHODS: A retrospective analysis of 67 patients who underwent simultaneous RC and unilateral RNU for PanUC, from 1996 to 2017. Kaplan-Meier estimates for remnant urothelium recurrence-free survival, metastasis-free survival, overall survival (OS), and cancer-specific survival (CSS) were performed. Cox multivariate models were constructed. RESULTS: The median follow-up was 38 months, 29.8% of patients had a recurrence, 34.3% had metastasis, 67.2% of patients died from any cause, and 37.3% died from urothelial carcinoma. Overall survival and CSS rates at 5 years were 44% and 61%, respectively. In multivariate analysis, progression to muscle-invasive bladder cancer before surgery, presence of muscle-invasive stages at RC and/or RNU, and prostatic urethra involvement were predictors for worse metastasis-free survival and CSS. Forty-one patients (61.2%) had an estimated glomerular filtration rate (eGFR) <60 mL/min before surgery and the number rose to 56 (83.5%) after surgery; 29.8% patients needed renal function replacement therapy after surgery (16 haemodialysis and 4 renal transplant). CONCLUSION: Patients with PanUC who undergo simultaneous surgery have adverse oncological (only 4 out of every 10 remain alive at 5 years) and functional outcomes (1 out of 3 will need renal function replacement therapy after surgery). Up to a third of the patients had a recurrence (urethra or contralateral kidney) within 18 months, justifying close surveillance or considering prophylactic urethrectomy. These data should help in counsel on morbidity and life expectancy.


Assuntos
Carcinoma de Células de Transição , Neoplasias da Bexiga Urinária , Humanos , Nefroureterectomia/efeitos adversos , Carcinoma de Células de Transição/patologia , Neoplasias da Bexiga Urinária/patologia , Cistectomia/efeitos adversos , Estudos Retrospectivos , Rim/patologia , Resultado do Tratamento
16.
Bladder Cancer ; 8(4): 379-393, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-38994184

RESUMO

INTRODUCTION: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette-Guérin. Chemohyperthermia therapy (CHT) may be a novel alternative therapy for the treatment of NMIBC. OBJECTIVE: To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC. METHODS: This was a prospective multi-institutional study of 1,028 consecutive patients with NMIBC undergoing CHT between 2012 and 2020. A total of 835 patients were treated with CHT with Mitomycin C (MMC). Disease was confirmed on transurethral resection of bladder tumor (TURBT) prior to starting CHT. Follow-up included cystoscopy and subsequent TURBT if recurrence/progression was suspected. The primary endpoint was RFS. Secondary endpoints were progression-free survival (PFS) and adverse events from CHT. RESULTS AND LIMITATIONS: Median follow up was 22.4 months (Interquartile range (IQR): 12.8 -35.8). Median age was 70.4 years (IQR: 62.1 -78.6). A total of 557 (66.7%), 172 (20.6) and 74 (8.9%) of patients were classified to BCG naïve, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naïve was 87.6% (95% CI 85.0% - 90.4%) and 75.0% (95% CI 71.3% - 78.8%), respectively. The RFS at 12 months and 24 months for BCG unresponsive cohort was 78.1% (95% CI 72.0% - 84.7%) and 57.4% (95% CI 49.7% - 66.3%), respectively. The RFS at 24 months for the BCG unresponsive cohort for CIS with/without papillary disease and papillary only disease were 43.6% (95% CI 31.4% -60.4%) and 64.5% (95% CI 55.4% - 75.1%), respectively. Minor adverse events occurred in 216 (25.6%) patients and severe events occurred in 17 (2.0%) patients. CONCLUSIONS: CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.

17.
Eur Urol Open Sci ; 45: 44-49, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36353659

RESUMO

Background: Evidence-based medicine (EBM) was introduced as a concept in the early 1990s as an integration of the best available evidence with clinical expertise and patient values. Objective: To evaluate the current status of EBM training and EBM perception, attitudes, and self-perceived skills among European urology residents. Design setting and participants: Our online open survey comprised 28 multiple-choice items, including ten questions with responses on a five-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree. The survey was distributed via the mailing lists and social media accounts of the European Society of Residents in Urology, German Society of Residents in Urology, French Society of Urologists in Training, Spanish Urology Residents Working Group, Italian Society of Residents in Urology, and the Urology Social Media Working Group in two rounds (May-July 2019 and July 2020). We excluded responses from non-European countries. Outcome measurements and statistical analysis: The online open survey comprised 28 multiple-choice items. These included ten questions with answers on a five-point Likert scale with response items ranging from strongly disagree (score of 1) to strongly agree (score of 5). Results and limitations: We received 210 responses, of which 181 from 23 European countries were eligible. Approximately three-quarters (73.7%) of the respondents were male, with a mean age of 31 yr. Only 28.2% reported EBM training as part of their urology curriculum and 19.3% felt that the training they received was sufficient to guide their daily practice. An overwhelming majority (91.5%) stated that they would be interested in more formalized EBM training or additional training. There was a strong level of agreement (median score 5, interquartile range 4-5) that EBM is important for daily medical and surgical practice and that it improves patient care. Overall, the mean self-perceived understanding of basic EBM concepts was good. Limitations include concerns about generalizability given its internet-based format, the inability to calculate a response rate, poor representation from some European regions, and limited sample size. Conclusions: Our survey suggests that European urology residents receive a limited amount of EBM training despite considerable appreciation, interest, and self-perceived deficits for more advanced concepts. Formal integration of EBM teaching in all European residency programs should be considered. Patient summary: We performed an online survey of urology residents in Europe. We found that residents have positive perceptions of and attitudes to evidence-based medicine but most programs lack formal training in this area.

18.
Urol Oncol ; 40(11): 491.e11-491.e19, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35851185

RESUMO

PURPOSE: Non-muscle-invasive bladder cancers (NMIBC) constitute 3-quarters of all primary diagnosed bladder tumors. For risk-adapted management of patients with NMIBC, different risk group systems and predictive models have been developed. This study aimed to externally validate EORTC2016, CUETO and novel EAU2021 risk scoring models in a multi-institutional retrospective cohort of patients with high-grade NMIBC who were treated with an adequate BCG immunotherapy. METHODS: The Kaplan-Meier estimates for recurrence-free survival and progression-free survival were performed, predictive abilities were assessed using the concordance index (C-index) and area under the curve (AUC). RESULTS: A total of 1690 patients were included and the median follow-up was 51 months. For the overall cohort, the estimates recurrence-free survival and progression-free survival rates at 5-years were 57.1% and 82.3%, respectively. The CUETO scoring model had poor discrimination for disease recurrence (C-index/AUC for G2 and G3 grade tumors: 0.570/0.493 and 0.559/0.492) and both CUETO (C-index/AUC for G2 and G3 grade tumors: 0.634/0.521 and 0.622/0.525) EAU2021 (c-index/AUC: 0.644/0.522) had poor discrimination for disease progression. CONCLUSION: Both the CUETO and EAU2021 scoring systems were able to successfully stratify risks in our population, but presented poor discriminative value in predicting clinical events. Due to the lack of data, model validation was not possible for EORTC2016. The CUETO and EAU2021 systems overestimated the risk, especially in highest-risk patients. The risk of progression according to EORTC2016 was slightly lower when compared with our population analysis.


Assuntos
Carcinoma de Células de Transição , Neoplasias da Bexiga Urinária , Humanos , Neoplasias da Bexiga Urinária/patologia , Estudos Retrospectivos , Vacina BCG/uso terapêutico , Recidiva Local de Neoplasia/patologia , Invasividade Neoplásica , Progressão da Doença , Medição de Risco , Carcinoma de Células de Transição/patologia
19.
Eur Urol Focus ; 7(6): 1230-1233, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34598913

RESUMO

Grading of Recommendations Assessment, Development, and Evaluation (GRADE) is a methodologically rigorous and transparent framework for grading the certainty of evidence and moving from evidence to recommendations in guidelines. Certainty of evidence can be rated as high, moderate, low, or very low, and some domains may lead to an increase or decrease in the certainty of evidence. Once evidence is summarized, the certainty, balance of desirable and undesirable outcomes, patients' values and preferences, equity, acceptability, and feasibility are taken into consideration in order to give a strong or weak recommendation for or against an intervention. In this review we summarize the GRADE approach using urology-related examples. PATIENT SUMMARY: GRADE is a well-established system for determining how much confidence we can place in research evidence and how guideline panels can make recommendations for patient care and health care policy. Recommendations can be strong or weak for or against a treatment strategy. Guideline developers should consider the certainty of the evidence, the balance of desirable and undesirable outcomes, patients' values and preferences, and resource use.


Assuntos
Abordagem GRADE , Urologia , Medicina Baseada em Evidências , Humanos
20.
Can Urol Assoc J ; 15(12): 407-411, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34171212

RESUMO

INTRODUCTION: Negative ureteroscopy (NURS) is "a ureteroscopy in which no stone is found during the procedure." We aimed to determine the association between the surgical waiting list time (WLT) and the NURS rate. METHODS: We retrospectively analyzed all patients scheduled for ureteroscopy in our center between January 2017 and July 2019. The inclusion criterion was unilateral, semirigid ureteroscopy for a single ureteral stone; exclusion criteria were renal-only stones, incomplete ureteroscopy, and stones >10 mm. We analyzed age; gender; body mass index; stone size, density, and location; presence of a temporary double-J (DJ) stent; use of medical expulsive therapy; and WLT. Complications while waiting for surgery were also collected and analyzed. RESULTS: We included 219 patients, 41 (18.7%) of whom had NURS. The median WLT was 74 days (interquartile range [IQR] 45-127). Variables protective against NURS were large stone size (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.66-0.93), presence of a temporary DJ stent (OR 0.43, 95% CI 0.2-0.8), and radiopaque stones (OR 0.44, 95% CI 0.21-0.88). A long WLT ((≥60 days) increased the risk of NURS (OR 2.18, 95% CI 1.02-4.61). Complications requiring emergency department visits while waiting for surgery were documented in 58/137 (42.3%) patients with indwelling DJ stents; nonetheless, a WLT greater than the median was not associated with an increased risk of complications (p=0.38). CONCLUSIONS: Long WLT has an independent, direct, and linear correlation with NURS rates. Patients at higher risk of NURS, may be offered preoperative re-evaluation with a computed tomography scan in a resource-limited setting.

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