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OBJECTIVES: To assess human in vivo intrarenal pressure (IRP) and peristaltic activity at baseline and after ureteric stent placement, using a narrow calibre pressure guidewire placed retrogradely in the renal pelvis. PATIENTS AND METHODS: A prospective, multi-institutional study recruiting consenting patients undergoing ureteroscopy was designed with ethical approval. Prior to ureteroscopy, the urinary bladder was emptied and the COMET™ II pressure guidewire (Boston Scientific) was advanced retrogradely via the ureteric orifice to the renal pelvis. Baseline IRPs were recorded for 1-2 min. At procedure completion, following ureteric stent insertion, IRPs were recorded for another 1-2 min. Statistical analysis of mean baseline IRP, peristaltic waveforms and frequency of peristaltic contractions was performed, thereby analysing the influence of patient variables and ureteric stenting. RESULTS: A total of 100 patients were included. Baseline mean (±SD) IRP was 16.76 (6.4) mmHg in the renal pelvis, with maximum peristaltic IRP peaks reaching a mean (SD) of 25.75 (17.9) mmHg. Peristaltic activity generally occurred in a rhythmic, coordinated fashion, with a mean (SD) interval of 5.63 (3.08) s between peaks. On univariate analysis, higher baseline IRP was observed with male sex, preoperative hydronephrosis, and preoperative ureteric stenting. On linear regression, male sex was no longer statistically significant, whilst the latter two variables remained significant (P = 0.004; P < 0.001). The mean (SD) baseline IRP in the non-hydronephrotic, unstented cohort was 14.19 (4.39) mmHg. Age, α-blockers and calcium channel blockers did not significantly influence IRP, and no measured variables influenced peristaltic activity. Immediately after ureteric stent insertion, IRP decreased (mean [SD] 15.18 [5.28] vs 16.76 [6.4] mmHg, P = 0.004), whilst peristaltic activity was maintained. CONCLUSIONS: Human in vivo mean (SD) baseline IRP is 14.19 (4.39) mmHg in normal kidneys and increases with both hydronephrosis and preoperative ureteric stenting. Mean (SD) peristaltic peak IRP values of 25.75 (17.9) mmHg are reached in the renal pelvis every 3-7 s and maintained in the early post-stent period.
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Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology. A significant number of questions were related to the pediatric population and/or rare diseases. A total of 27 regulatory-led RWD studies have been conducted. Most studies were descriptive and aimed at estimating incidence and prevalence rates of clinical outcomes including adverse events or to evaluate medicines utilization. The review highlights key learnings to guide further efforts to enable the use and establish the value of real-world evidence (RWE) for regulatory decisions. For instance, there is a need to access additional fit-for-purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines. The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question is equally important. Finally, the review provides our perspective on the way forward to maximize the potential of regulatory-led RWE generation.
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BACKGROUND: The aim was to ascertain the impact of irrigation technique on human intrarenal pressure during retrograde intrarenal surgery. METHODS: A parallel randomized trial recruited patients across three hospital sites. Patients undergoing retrograde intrarenal surgery for renal stone treatment with an 11/13-Fr ureteral access sheath were allocated randomly to 100 mmHg pressurized-bag (PB) or manual hand-pump (HP) irrigation. The primary outcome was mean procedural intrarenal pressure. Secondary outcomes included maximum intrarenal pressure, variance, visualization, HP force of usage, procedure duration, stone clearance, and clinical outcomes. Live intrarenal pressure monitoring was performed using a COMETTMII pressure guidewire, deployed cystoscopically to the renal pelvis. The operating team was blinded to the intrarenal pressure. RESULTS: Thirty-eight patients were randomized between July and November 2023 (trial closure). The final analysis included 34 patients (PB 16; HP 18). Compared with PB irrigation, HP irrigation resulted in significantly higher mean intrarenal pressure (mean(s.d.) 62.29(27.45) versus 38.16(16.84) mmHg; 95% c.i. for difference in means (MD) 7.97 to 40.29 mmHg; P = 0.005) and maximum intrarenal pressure (192.71(106.23) versus 68.04(24.16) mmHg; 95% c.i. for MD 70.76 to 178.59 mmHg; P < 0.001), along with greater variance in intrarenal pressure (log transformed) (6.23(1.59) versus 4.60(1.30); 95% c.i. for MD 0.62 to 2.66; P = 0.001). Surgeon satisfaction with procedural vision reported on a scale of 10 was higher with PB compared with HP irrigation (mean(s.d.) 8.75(0.58) versus 6.28(1.27); 95% c.i. for MD 1.79 to 3.16; P < 0.001). Subjective HP usage force did not correlate significantly with transmitted intrarenal pressure (Pearson R = -0.15, P = 0.57). One patient (HP arm) developed urosepsis. CONCLUSION: Manual HP irrigation resulted in higher and more fluctuant intrarenal pressure trace (with inferior visual clarity) than 100-mmHg PB irrigation. REGISTRATION NUMBER: osf.io/jmg2h (https://osf.io/).
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Cálculos Renales , Presión , Irrigación Terapéutica , Humanos , Irrigación Terapéutica/métodos , Femenino , Masculino , Persona de Mediana Edad , Cálculos Renales/cirugía , Adulto , Anciano , Resultado del TratamientoRESUMEN
PURPOSE: Prostate biopsy is central to the accurate histological diagnosis of prostate cancer. In current practice, the biopsy procedure can be performed using a transrectal or transperineal route with different technologies available for targeting of lesions within the prostate. Historically, the biopsy procedure was performed solely by urologists, but with the advent of image-guided techniques, the involvement of radiologists in prostate biopsy has become more common. Herein, we discuss the pros, cons and future considerations regarding their ongoing role. METHODS: A narrative review regarding the current evidence was completed. PubMed and Cochrane central register of controlled trials were search until January 2024. All study types were of consideration if published after 2000 and an English language translation was available. RESULTS: There are no published studies that directly compare outcomes of prostate biopsy when performed by a urologist or radiologist. In all published studies regarding the learning curve for prostate biopsy, the procedure was performed by urologists. These studies suggest that the learning curve for prostate biopsy is between 10 and 50 cases to reach proficiency in terms of prostate cancer detection and complications. It is recognised that many urologists are poorly able to accurately interpret multi parametric (mp)-MRI of the prostate. Collaboration between the specialities is of importance with urology offering the advantage of being involved in prior and future care of the patient while radiology has the advantage of being able to expertly interpret preprocedure MRI. CONCLUSION: There is no evidence to suggest that prostate biopsy should be solely performed by a specific specialty. The most important factor remains knowledge of the relevant anatomy and sufficient volume of cases to develop and maintain skills.
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Predicción , Biopsia Guiada por Imagen , Próstata , Neoplasias de la Próstata , Urología , Masculino , Humanos , Biopsia Guiada por Imagen/métodos , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Próstata/patología , Próstata/diagnóstico por imagenRESUMEN
BACKGROUND: Xanthogranulomatous pyelonephritis (XGP) is a rare chronic inflammatory condition of the kidney, associated with high patient morbidity, often requiring targeted antibiotic therapy and surgical removal of the affected kidney. AIM: We report the outcomes of patients undergoing nephrectomy for XGP in our institution over a 12-year period. METHODS: Following ethical approval, a retrospective review of histological samples of renal tissue demonstrating features of XGP from June 2010 to 2022 was conducted. Laboratory, imaging, and clinical data of included participants were collected. RESULTS: Eleven patients were included (8 women, 3 men), mean age of 58.1 (35-81). Recurrent urinary tract infection was the most common clinical presentation (55%, n = 6). Other presentations included flank pain (36%, n = 4), collection/ abscess (45%, n = 5), and nephro-cutaneous fistulae (9%, n = 1). The majority of patients had bacteriuria (91%, n = 10), and Escherichia coli was the most common bacteria isolated (55%, n = 6). Antibiotic resistance was seen in 60% of positive urine samples (n = 6). An open nephrectomy was performed in all but one case (91%, n = 10). A postoperative complication occurred in 73% (n = 8), with 50% (n = 4) of complications Clavien Dindo grade 3 or higher, including one patient mortality. CONCLUSIONS: XGP is a difficult and complex condition to treat. All patients in this series presented with infection or associated sequelae thereof. Complex XGP cases therefore often require open nephrectomy and have high rates of postoperative complications. Careful consideration of antibiotic and operative intervention is therefore essential to ensure the best outcome for these patients.
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Pielonefritis Xantogranulomatosa , Infecciones Urinarias , Masculino , Humanos , Femenino , Persona de Mediana Edad , Pielonefritis Xantogranulomatosa/cirugía , Pielonefritis Xantogranulomatosa/complicaciones , Diagnóstico por Imagen , Estudios Retrospectivos , Nefrectomía/métodos , Infecciones Urinarias/tratamiento farmacológico , Complicaciones Posoperatorias , Antibacterianos/uso terapéuticoRESUMEN
INTRODUCTION: The physical health of individuals with severe mental illness (SMI) is a cause for concern. While the purpose of inpatient mental health settings is rehabilitation and treatment, the physical health of hospitalised patients commonly deteriorates. Physical activity (PA) has been identified as an appropriate intervention to help improve the psychological and physical health of inpatients. We aim to address the gaps in the current literature by exploring how, why, for whom and in what contexts PA interventions help patients with SMI, who receive inpatient treatment, to increase their PA engagement. METHODS AND ANALYSIS: Realist synthesis: Six steps will be followed: (1) identification of the review question and scope of the review; (2) searching for evidence; (3) screening and appraisal; (4) extraction of data; (5) synthesis of the data and (6) dissemination. Five databases will be searched: Web of Science, PubMed, PsycINFO, PsychArticles and EmBase. A total of 10-15 stakeholders made up of academics and people living with SMI, sport and exercise therapists, psychiatrists, physiotherapists of low, medium and highly secure inpatient settings, will form an expert advisory group. They will provide their insight and knowledge of the secure setting contexts and perceived principles of how PA initiatives being undertaken in their hospitals for patients with SMI work, or not. The results will be published in accordance with the Realist And Meta-narrative Evidence Syntheses-Evolving Standards publication standards. ETHICS AND DISSEMINATION: Ethical approval has been granted. The review will produce context-specific guidance for Clinical Commissioning Groups and practitioners on how to optimise the provision of PA interventions for people with SMI in inpatient settings.
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Trastornos Mentales , Psiquiatría , Humanos , Salud Mental , Pacientes Internos , Trastornos Mentales/terapia , Ejercicio FísicoRESUMEN
Objectives: To explore beliefs and practice patterns of urologists regarding intrarenal pressure (IRP) during ureteroscopy (URS). Methods: A customized questionnaire was designed in a 4-step iterative process incorporating a systematic review of the literature and critical analysis of topics/questions by six endourologists. The 19-item questionnaire interrogated perceptions, practice patterns, and key areas of uncertainty regarding ureteroscopic IRP, and was disseminated via urologic societies, networks, and social media to the international urologic community. Consultants/attendings and trainees currently practicing urology were eligible to respond. Quantitative responses were compiled and analyzed using descriptive statistics and chi-square test, with subgroup analysis by procedure volume. Results: Responses were received from 522 urologists, practicing in six continents. The individual question response rate was >97%. Most (83.9%, 437/515) respondents were practicing at a consultant/attending level. An endourology fellowship incorporating stone management had been completed by 59.2% (307/519). The vast majority of respondents (85.4%, 446/520) scored the perceived clinical significance of IRP during URS ≥7/10 on a Likert scale. Concern was uniformly reported, with no difference between respondents with and without a high annual case volume (p = 0.16). Potential adverse outcomes respondents associated with elevated ureteroscopic IRP were urosepsis (96.2%, 501/520), collecting system rupture (80.8%, 421/520), postoperative pain (67%, 349/520), bleeding (63.72%, 332/520), and long-term renal damage (26.1%, 136/520). Almost all participants (96.2%, 501/520) used measures aiming to reduce IRP during URS. Regarding the perceived maximum acceptable threshold for mean IRP during URS, 30 mm Hg (40 cm H2O) was most frequently selected [23.2% (119/463)], with most participants (78.2%, 341/463) choosing a value ≤40 mm Hg. Conclusions: This is the first large-scale analysis of urologists' perceptions of ureteroscopic IRP. It identifies high levels of concern among the global urologic community, with almost unanimous agreement that elevated IRP is associated with adverse clinical outcomes. Equipoise remains regarding appropriate IRP limits intraoperatively and the most appropriate technical strategies to ensure adherence to these.
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Ureteroscopía , Urología , Humanos , Ureteroscopía/métodos , Estudios Transversales , Urólogos , RiñónRESUMEN
BACKGROUND: Clozapine is the most effective antipsychotic but requires careful titration to therapeutic blood levels. Methods to predict therapeutic doses are based on population data. AIMS: We aimed to construct a model based on genetic variants which accurately predicted plasma levels for clozapine. METHOD: We measured clozapine plasma levels in patients on a stable dose of clozapine who were known to be fully compliant. Measured plasma levels were adjusted for sampling time and dose. Hepatic enzyme variants were analysed and models were constructed to predict the required dose. These predictions were compared with a standard population-based algorithm. RESULTS: We measured plasma clozapine concentrations in 18 adherent patients on stable doses of clozapine and recorded the exact timing of sampling. For the algorithm-predicted dose, the mean difference was -49.9 mg/day ((SD 155.9), r = 0.36) from the actual dose required to give a plasma concentration of 0.35 ng/ml. The gene variant activity score predicted a dose for which the mean difference was -43.5 mg/day ((SD 140.1), r = 0.55). For the gene variant activity score with omeprazole correction predicted dose, the mean difference was -31.0 mg/day ((SD 140.8), r = 0.54), and with the gene variant CYP1A2 inducibility predicted dose the mean difference was 44.9 mg/day ((SD 160.8), r = 0.32). CONCLUSION: Our gene variant activity score with omeprazole correction gave the best estimate of the clozapine dose required to achieve a minimum therapeutic plasma concentration. The use of this model will allow safer titration of clozapine and may reduce the need for plasma-level monitoring during titration.
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Antipsicóticos , Clozapina , Esquizofrenia , Humanos , Clozapina/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Esquizofrenia/genética , Antipsicóticos/uso terapéutico , Omeprazol/uso terapéutico , AlgoritmosRESUMEN
Importance: Postoperative urinary retention (POUR) is a well-recognized complication of inguinal hernia repair (IHR). A variable incidence of POUR has previously been reported in this context, and contradictory evidence surrounds potential risk factors. Objective: To ascertain the incidence of, explore risk factors for, and determine the health service outcomes of POUR following elective IHR. Design, Setting, and Participants: The Retention of Urine After Inguinal Hernia Elective Repair (RETAINER I) study, an international, prospective cohort study, recruited participants between March 1 and October 31, 2021. This study was conducted across 209 centers in 32 countries in a consecutive sample of adult patients undergoing elective IHR. Exposure: Open or minimally invasive IHR by any surgical technique, under local, neuraxial regional, or general anesthesia. Main Outcomes and Measures: The primary outcome was the incidence of POUR following elective IHR. Secondary outcomes were perioperative risk factors, management, clinical consequences, and health service outcomes of POUR. A preoperative International Prostate Symptom Score was measured in male patients. Results: In total, 4151 patients (3882 male and 269 female; median [IQR] age, 56 [43-68] years) were studied. Inguinal hernia repair was commenced via an open surgical approach in 82.2% of patients (n = 3414) and minimally invasive surgery in 17.8% (n = 737). The primary form of anesthesia was general in 40.9% of patients (n = 1696), neuraxial regional in 45.8% (n = 1902), and local in 10.7% (n = 446). Postoperative urinary retention occurred in 5.8% of male patients (n = 224), 2.97% of female patients (n = 8), and 9.5% (119 of 1252) of male patients aged 65 years or older. Risk factors for POUR after adjusted analyses included increasing age, anticholinergic medication, history of urinary retention, constipation, out-of-hours surgery, involvement of urinary bladder within the hernia, temporary intraoperative urethral catheterization, and increasing operative duration. Postoperative urinary retention was the primary reason for 27.8% of unplanned day-case surgery admissions (n = 74) and 51.8% of 30-day readmissions (n = 72). Conclusions: The findings of this cohort study suggest that 1 in 17 male patients, 1 in 11 male patients aged 65 years or older, and 1 in 34 female patients may develop POUR following IHR. These findings could inform preoperative patient counseling. In addition, awareness of modifiable risk factors may help to identify patients at increased risk of POUR who may benefit from perioperative risk mitigation strategies.
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Hernia Inguinal , Laparoscopía , Retención Urinaria , Adulto , Humanos , Masculino , Femenino , Persona de Mediana Edad , Retención Urinaria/epidemiología , Retención Urinaria/etiología , Retención Urinaria/cirugía , Hernia Inguinal/cirugía , Hernia Inguinal/complicaciones , Estudios de Cohortes , Incidencia , Estudios Prospectivos , Estudios Retrospectivos , Herniorrafia/efectos adversos , Herniorrafia/métodos , Laparoscopía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Factores de Riesgo , Anestesia GeneralRESUMEN
BACKGROUND: Adolescents in secure psychiatric care typically report high obesity rates. However, longitudinal research exploring the rate and extent of change is sparse. This study aimed to analyse sex differences in longitudinal body mass index (BMI) change for adolescents receiving treatment in a secure psychiatric hospital. METHODS: The sample comprised 670 adolescents in secure psychiatric care. BMI trajectories from admission to 50 months of hospitalisation were produced using sex-stratified multilevel models. Systematic difference in mean BMI trajectories according to age at admission (14, 15, 16, or 17 years), medication (Olanzapine or Sodium Valproate), and primary diagnosis (Psychotic, non-Psychotic or Functional/behavioural disorders) were investigated. RESULTS: Together, males and females experienced a mean BMI increase of 2.22 m/kg2 over the 50-month period. For females, BMI increased from 25.69 m/kg2 to 30.31 m/kg2 , and for males, reduced from 25.01 m/kg2 to 23.95 m/kg2 . From 30 to 50 months, a plateau was observed for females and a reduction in BMI observed for males. Psychotic disorders in males (ß 3.87; CI 1.1-6.7) were associated with the greatest rate of BMI change. For medication, Olanzapine in females was associated with the greatest rate of change (ß1.78; CI -.89-4.47). CONCLUSIONS: This is the first longitudinal study exploring longitudinal BMI change for adolescent inpatients. Results highlight that individual differences in adolescent inpatients result in differing levels of risk to weight gain in secure care. Specifically, males with psychotic disorders and females taking Olanzapine present the greatest risk of weight gain. This has implications for the prioritisation of interventions for those most at risk of weight gain.
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Pacientes Internos , Aumento de Peso , Adolescente , Femenino , Humanos , Masculino , Índice de Masa Corporal , Olanzapina/uso terapéutico , Estudios LongitudinalesRESUMEN
BACKGROUND: Upfront chemotherapy prolongs overall survival for men with metastatic, hormone-sensitive prostate cancer (mHSPC) based on data from clinical trials. We sought to assess the association between upfront chemotherapy and overall survival in men with mHSPC in a real-world cohort. METHODS: We performed a retrospective cohort study of men with de novo, treatment-naïve metastatic prostate cancer from a large, national cancer database in the United States (2014-2015). Men in the upfront chemotherapy group received chemotherapy within 4 months of diagnosis (n = 1033, 28%) versus no chemotherapy or chemotherapy later than 12 months after diagnosis (controls; n = 2704, 72%). Overall survival was assessed using Kaplan-Meier estimates and compared using multivariable Cox regression analysis. RESULTS: After a median follow-up of 23 months, median overall survival was 35.7 months in the upfront chemotherapy group and 32.5 months for controls (log-rank p < 0.001). After adjusting for patient and clinical variables, upfront chemotherapy was associated with longer overall survival (hazard ratio 0.78, 95% confidence interval 0.68-0.89, p < 0.001). In exploratory analyses, the association between upfront chemotherapy and overall survival did not differ by age groups, race, or number of comorbidities (all interaction p > 0.2). CONCLUSIONS: In this real-world cohort, upfront chemotherapy for mHSPC was associated with longer overall survival. These data support the continued use of chemotherapy for men with mHSPC regardless of race or age if they are fit for chemotherapy and underscore the importance of evaluating cancer therapeutics outside of clinical trials to demonstrate treatment efficacy in populations that may be underrepresented in clinical trials.
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Antineoplásicos/uso terapéutico , Neoplasias de la Próstata/mortalidad , Anciano , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Neoplasias de la Próstata/tratamiento farmacológico , Neoplasias de la Próstata/secundario , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
OBJECTIVES: To determine the use of surgical resection of metastatic disease in a large national sample and its association with overall survival. METHODS: The National Cancer Database was queried for patients with metastatic bladder cancer (2004-2016). Overall survival was assessed using Kaplan-Meier and multivariable Cox analyses. The associations between covariates and use of metastasectomy were assessed with multivariable logistic regression. RESULTS: Of the 16 382 patients with metastatic bladder cancer included, 6.8% underwent metastasectomy. Its use increased over time (4.7% in 2004 to 6.6% in 2016; per year odds ratio 1.02, 95% confidence interval 1.00-1.04, P = 0.019). Median survival was 7.0 months for patients who received metastasectomy and 5.1 months for those who did not (hazard ratio 0.85, 95% confidence interval 0.79-0.91, P < 0.001). In subgroup analyses, metastasectomy predicted longer survival in patients with lung (hazard ratio 0.73, 95% confidence interval 0.61-0.88, P = 0.001) or brain metastases (hazard ratio 0.58, 95% confidence interval 0.35-0.96, P = 0.035) and in patients with variant histology (hazard ratio 0.80, 95% confidence interval 0.69-0.93, P = 0.003). CONCLUSIONS: In a national sample, the use of metastasectomy for bladder cancer is low. Furthermore, metastasectomy is associated with longer survival overall and in multiple subgroups. However, these results should be validated in future studies.
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Neoplasias Pulmonares , Metastasectomía , Neoplasias de la Vejiga Urinaria , Estudios de Cohortes , Humanos , Neoplasias Pulmonares/cirugía , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
INTRODUCTION: Few studies investigate significant perioperative predictors for long-term renal allograft survival after second kidney transplant (SKT). We compared long-term survival following SKT with primary kidney transplant and determined predictors of renal allograft failure after SKT. METHODS: Outcomes of all primary or second kidney transplant recipients at a national kidney transplant center between 1993 and 2017 were reviewed. The primary outcomes measurements were renal allograft survival for both first and second kidney transplants. Secondary outcome measurements were incidence of delayed graft function (DGF), incidence of acute rejection (AR), and predictors for renal allograft survival in SKT recipients. RESULTS: In total, there were 392 SKTs and 2748 primary kidney transplants performed between 1993 and 2017. The 1-, 5-, and 10-year death-censored graft survival for deceased-donor recipients was 95.3%, 88.7%, and 78.2% for primary kidney transplant and 94.9%, 87.1%, and 74.9% for SKT (P = .0288). Survival of primary renal allograft <6 years (HR 0.6, P = .017), AR episodes (HR 1.6, P = .031), DGF (HR 2.0, P = .005), and HLA-DR MM (HR 1.7, P = .018) was independent predictors of long-term renal allograft failure after SKT. CONCLUSION: These findings may provide important information on long-term survival outcomes after SKT and for identifying patients at risk for long-term renal allograft failure after SKT.
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Trasplante de Riñón , Aloinjertos , Rechazo de Injerto/etiología , Supervivencia de Injerto , Humanos , Riñón , Estudios Retrospectivos , Factores de RiesgoRESUMEN
INTRODUCTION: Ureteric stents are frequently placed following endo-urological procedures. These stents cause significant morbidity for patients. Standard ureteric stents are removed by flexible cystoscopy. This procedure can be unpleasant for patients and requires additional resources. A newly designed magnetic stent allows removal in an outpatient setting. The aim of our study is to compare the magnetic stent and standard ureteric stents with regard to morbidity, pain on stent removal and cost-effectiveness. METHODS: This study was carried out across two sites between September 2016 and July 2017. In site A, a magnetic stent (Urotech, Black-Star®) is removed by magnetic retrieval device. Fifty consecutive patients completed the validated Ureteric Stent Symptom Questionnaire (USSQ) and visual analogue scale (VAS) at the time of stent removal. On site B, a soft polyurethane stent (Cook Universa) was removed by flexible cystoscopy. Fifty patients were identified retrospectively and completed questionnaires by post. Cost analysis was also performed. RESULTS: One hundred questionnaires were included for analysis. No significant difference in stent morbidity as assessed by the USSQ was shown between both groups. Median duration of stenting was significantly shorter in the magnetic stent group (5.5 versus 21.5 days, p < 0.001). Mean pain on stent removal was significantly less with magnetic retrieval (2.9 versus 3.9, p < 0.05). Complication rates were similar in both groups. Cost analysis showed a cost saving of 203 per patient with the magnetic stent group. CONCLUSION: Magnetic stents cause similar morbidity for patients compared with standard stents removed by flexible cystoscopy; they are associated with less pain at removal and are cost saving.
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Remoción de Dispositivos/métodos , Fenómenos Magnéticos , Stents/efectos adversos , Uréter/cirugía , Femenino , Humanos , Masculino , Estudios RetrospectivosRESUMEN
INTRODUCTION: Transperineal template prostate biopsy (TTPB) is reported to have higher cancer detection and lower complication rate compared to transrectal ultrasound guided prostate biopsy (TRUSPB).However, there is no report of the same patient's experience with both types of biopsy.To compare the patient reported experience in the same cohort of patients who underwent both TRUSPB and TTPB, using validated questionnaires. MATERIAL AND METHODS: We retrospectively utilised the Patient Reported Outcome Methods (PROM) tool validated for TRUSPB and the International Index of Erectile Function (IIEF-5) questionnaire to collect longitudinal data at follow-up in the same cohort of patients who underwent both TTPB and TRUSPB between January 2015 and February 2016. RESULTS: Out of 44 TTPB performed during the period, 35 patients had undergone both TRUSPB and TTPB. Patient reported pain post biopsy was significantly higher with TRUSPB (86% vs. 61%; p = 0.01). Post-biopsy urinary retention rates were significantly higher in the TTPB group (16.7% vs. 5.7%; p = 0.05, t test). Furthermore, the incidence of patient reported sexual dysfunction rates based on the IIEF-5 was significantly higher in the TTPB group (p = 0.001, t test). CONCLUSIONS: Although overall TTPB was better tolerated in this cohort of patients with lower risk of health care contact, patients reported higher incidence of urinary retention and sexual dysfunction after TTPB compared to TRUSPB. Thus, patients should be adequately informed about potential risks with each biopsy as they may have significant impact on quality of life.
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BACKGROUND: Between 20% and 35% of prostate cancer (PCa) patients who undergo treatment with curative intent (ie, surgery or radiation therapy) for localized disease will experience biochemical recurrence (BCR). Alterations in the insulin-like growth factor (IGF) axis and PTEN expression have been implicated in the development and progression of several human tumors including PCa. We examined the expression of the insulin receptor (INSR), IGF-1 receptor (IGF-1R), PTEN, and AKT in radical prostatectomy tissue of patients who developed BCR post-surgery. METHODS: Tissue microarrays (TMA) of 130 patients post-radical prostatectomy (65 = BCR, 65 = non-BCR) were stained by immunohistochemistry for INSR, IGF-1R, PTEN, and AKT using optimized antibody protocols. INSR, IGF1-R, PTEN, and AKT expression between benign and cancerous tissue, and different Gleason grades was assessed. Kaplan-Meier survival curves were used to examine the relationship between proteins expression and BCR. RESULTS: INSR (P < 0.001), IGF-1R (P < 0.001), and AKT (P < 0.05) expression was significantly increased and PTEN (P < 0.001) was significantly decreased in cancerous versus benign tissue. There was no significant difference in INSR, IGF-1R, or AKT expression in the cancerous tissue of non-BCR versus BCR patients (P = 0.149, P = 0.990, P = 0.399, respectively). There was a significant decrease in PTEN expression in the malignant tissue of BCR versus non-BCR patients (P = 0.011). Combinational analysis of the tissue proteins identified a combination of decreased PTEN and increased AKT or increased INSR was associated with worst outcome. We found that in each case, our hypothesized worst group was most likely to experience BCR and this was significant for combinations of PTEN+INSR and PTEN+AKT but not PTEN+IGF-1R (P = 0.023, P = 0.028, P = 0.078, respectively). CONCLUSIONS: Low PTEN is associated with BCR and this association is strongly modified by high INSR and high AKT expression. Measurement of these proteins could help inform appropriate patient selection for postoperative adjuvant therapy and prevent BCR.
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Biomarcadores de Tumor/biosíntesis , Recurrencia Local de Neoplasia/metabolismo , Fosfohidrolasa PTEN/biosíntesis , Prostatectomía/tendencias , Neoplasias de la Próstata/metabolismo , Receptor IGF Tipo 1/biosíntesis , Adulto , Anciano , Estudios de Cohortes , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Valor Predictivo de las Pruebas , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Proteínas Proto-Oncogénicas c-akt/biosíntesis , Receptor de Insulina/biosíntesisRESUMEN
INTRODUCTION: The aim of our study was to determine the contemporary practice in the utilization of life expectancy (LE) calculations among urological clinicians. MATERIAL AND METHODS: Members of the Irish Society of Urology (ISU) and the British Association of Urological Surgeons (BAUS) completed a questionnaire on LE utilization in urological practice. RESULTS: The survey was delivered to 1251 clinicians and the response rate was 17% (n = 208/1251). The majority (61%, n = 127) of urologists were aware of methods available for estimated LE calculation.Seventy-one percent (n = 148) had never utilized LE analysis in clinical practice and 81% (n = 170) routinely used 'eyeballing' (empiric prediction) for estimating LE. Life expectancy tables were utilized infrequently (12%, n = 25) in making the decision for treatment in the setting of multi-disciplinary meetings. CONCLUSIONS: LE is poorly integrated into treatment decision-making; not only for the management of urological patients but also in the multidisciplinary setting. Further education and awareness regarding the importance of LE is vital.
RESUMEN
Parkinson's disease is a complex heterogeneous disorder with urgent need for disease-modifying therapies. Progress in successful therapeutic approaches for PD will require an unprecedented level of collaboration. At a workshop hosted by Parkinson's UK and co-organized by Critical Path Institute's (C-Path) Coalition Against Major Diseases (CAMD) Consortiums, investigators from industry, academia, government and regulatory agencies agreed on the need for sharing of data to enable future success. Government agencies included EMA, FDA, NINDS/NIH and IMI (Innovative Medicines Initiative). Emerging discoveries in new biomarkers and genetic endophenotypes are contributing to our understanding of the underlying pathophysiology of PD. In parallel there is growing recognition that early intervention will be key for successful treatments aimed at disease modification. At present, there is a lack of a comprehensive understanding of disease progression and the many factors that contribute to disease progression heterogeneity. Novel therapeutic targets and trial designs that incorporate existing and new biomarkers to evaluate drug effects independently and in combination are required. The integration of robust clinical data sets is viewed as a powerful approach to hasten medical discovery and therapies, as is being realized across diverse disease conditions employing big data analytics for healthcare. The application of lessons learned from parallel efforts is critical to identify barriers and enable a viable path forward. A roadmap is presented for a regulatory, academic, industry and advocacy driven integrated initiative that aims to facilitate and streamline new drug trials and registrations in Parkinson's disease.
Asunto(s)
Ensayos Clínicos como Asunto/normas , Descubrimiento de Drogas/normas , Difusión de la Información , Enfermedad de Parkinson/tratamiento farmacológico , Biomarcadores , Humanos , Proyectos de InvestigaciónRESUMEN
OBJECTIVE: To determine the yield of follow-up imaging in patients sustaining renal trauma at our level-1 trauma center and hence, whether the 2013 European Association of Urology guidelines are clinically applicable. METHODS: All patients who attended Cork University Hospital with a diagnosis of renal injury from 2000-2012 were identified. Review of all medical records and radiologic imaging was undertaken. Injuries were graded using the American Association for the Surgery of Trauma Organ Injury Scale and were grouped as low-grade injuries (I, II, and III) or high-grade injuries (IV and V). RESULTS: One hundred and two patients (105 renal units) were identified with a median age of 23 years (interquartile range, 18-39 years). The mechanism of injury was blunt force in 98 of 102 cases (96%). Injuries were diagnosed at the time of admission using contrast-enhanced computed tomography (CT) imaging. Low-grade injuries accounted for 78 of 102 cases (77%); all were managed conservatively with a complication rate of 2 of 78 (3%). Twenty-four patients (23%) had high-grade injuries; 2 cases required nephrectomy, 22 of 24 (92%) were managed conservatively with a complication rate of 5 of 24 (21%). All patients with complications were symptomatic, prompting repeat imaging. Overall, 38 of 102 patients (37%) underwent at least 1 follow-up CT: 20 of 78 (25%) of low-grade injuries and 18 of 24 (75%) of high-grade injuries. Concurrent thoracoabdominal injuries mandated the need for repeat CT evaluation in 21 of 38 patients (55%). Thirty-one (30%) patients were reimaged by renal ultrasonography. CONCLUSION: Selective reimaging of renal injuries based on clinical and laboratory criteria would have detected all complications. The 2013 European Association of Urology guidelines on urologic trauma are clinically appropriate in a major tertiary-trauma unit.
Asunto(s)
Riñón/diagnóstico por imagen , Riñón/lesiones , Tomografía Computarizada por Rayos X/estadística & datos numéricos , Heridas no Penetrantes/diagnóstico por imagen , Adolescente , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Retrospectivos , Centros Traumatológicos , Procedimientos Innecesarios/estadística & datos numéricos , Adulto JovenRESUMEN
PURPOSE: Caring for a patient with Parkinson's disease (PD) is stressful and has a significant impact on the carer's physical and mental health. This article is aimed at assessing which characteristics are most frequently associated with the stress symptoms of PD carers. METHOD: Data from the Parkinson's UK Members' Survey were drawn from 1881 valid self-completion surveys, filled in by carers of a patient with PD. RESULTS: The carers, 95.6% of whom were a first-degree relative, reported an average of 2.7 ± 3.1 stress-related symptoms. In multiple regression analysis, a greater number of symptoms were associated (p < 0.01) with: the more tasks that the carer carried out (ß = 0.35), an increased number of carer's co-morbidities (0.22) and worsening financial status (0.16). CONCLUSIONS: It is important to consider the health of both the patient with PD as well as that of the family carer to reduce the impact of caring activity on the carer's stress.