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PURPOSE: Psychological distress has been associated with an impaired immune response and poor wound healing. We hypothesized that preoperative patient reported mental health would be associated with high grade 30-day complications after radical cystectomy. MATERIALS AND METHODS: We retrospectively identified patients who underwent radical cystectomy for bladder cancer who completed Short Form 12 (SF-12) surveys for self-assessment of health status less than 6 months before surgery. Median physical and mental composite scores were calculated. An expert model including known predictors of postoperative high grade complications was developed, and SF-12 physical composite score and mental composite score were added to determine their association with this end point. RESULTS: From January 2010 to August 2014, 472 patients underwent radical cystectomy for bladder cancer, of whom 274 (58.1%) completed preoperative SF-12 questionnaires. Responders were more likely to be white (p=0.024), have higher preoperative albumin (p=0.037), receive neoadjuvant chemotherapy (p=0.002), have pT3/T4 disease (p=0.044) and have positive soft tissue surgical margins (p=0.006). Median SF-12 physical composite score was 43.1 (IQR 33.0-51.5) and mental composite score was 48.5 (IQR 39.5-54.7) in responders. Overall 46 (16.8%) responders experienced a high grade 30-day complication. Patients with a high grade complication had a lower preoperative median SF-12 mental composite score (44.8 vs 49.8, p=0.004) but no difference in physical composite score (39.2 vs 43.8, p=0.06). SF-12 mental composite score was also a significant predictive variable when added to our expert model (p=0.01). CONCLUSIONS: Preoperative patient reported mental health was independently associated with high grade complications after radical cystectomy. Therefore, patient self-assessment of health status before surgery through validated questionnaires may provide additional information useful in predicting short-term postoperative outcomes.
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Cistectomia , Transtornos Mentais/complicações , Complicações Pós-Operatórias/etiologia , Neoplasias da Bexiga Urinária/complicações , Neoplasias da Bexiga Urinária/cirurgia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Estudos Retrospectivos , Índice de Gravidade de Doença , Bexiga UrináriaRESUMO
INTRODUCTION: Based on 2010 American Urological Association recommendations our practice transitioned from sterile to high level disinfection flexible cystoscope reprocessing and from sterile to clean handling practices. We examined symptomatic urinary tract infection rate and cost before and after policy implementation. METHODS: We retrospectively reviewed 30-day outcomes following 1,888 simple cystoscopy encounters that occurred from 2007 to 2010 (sterile, 905) and 2012 to 2015 (high level disinfection, 983) at the Malcom Randall Veterans Affairs Medical Center. We excluded veterans who had recent instrumentation, active or recent urinary tract infection, performed intermittent catheterization, or had complicated cystoscopy (dilation, biopsy etc). Patient/procedural factors and cost were collected and compared between groups. RESULTS: Both cohorts had similar age (mean 68 years), race (Caucasian, 82%), comorbidities (cancer history, 62%; diabetes mellitus, 36%; tobacco use, 24.5%), and cystoscopy procedural indications (cancer surveillance, 50%; hematuria, 34%). Urological complication rate was low between groups (1.43%) with no significant difference in symptomatic urinary tract infection events (0.99% sterile vs 0.51% high level disinfection, p=0.29) or unplanned clinic/emergency department visits (0.66% sterile vs 0.71% high level disinfection, p=0.91). Roughly 95% of the cohorts were given prophylactic antibiotics, most commonly fluoroquinolones (91%). High level disinfection was $82 cheaper per procedure than sterile with most cost disparity stemming from reprocessing. Total savings for our facility by switching to high level disinfection was more than $100,000 annually. CONCLUSIONS: In an older, morbid veteran population receiving centralized care and prophylactic antibiotics we found no difference in symptomatic urinary tract infection or unplanned visits between sterile or high level disinfection techniques. However, high level disinfection was associated with a sizable cost savings, improved clinic workflow, and reduced use of personal protective equipment.
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Background: Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events. Methods: Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal. Results: Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ. Conclusions: HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.