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BACKGROUND: Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior therapies in clinical practice. With the abundance of novel therapies, NI trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality. We conducted a systematic review without restriction to journal type, journal impact factor, disease state or intervention to evaluate the quality of NI trials, including a comprehensive risk of bias assessment and comparison of quality over time. METHODOLOGY: We searched PubMed and Cochrane Library databases for NI trials published in English in 2014 and 2019. They were assessed for: study design and NI margin characteristics, primary results, and risk of bias for blinding, concealment, analysis method and missing outcome data. RESULTS: We included 823 studies. Between 2014 and 2019, a shift from publication in specialty to general journals (15% vs 28%, p < 0.001) and from pharmacological to non-pharmacological interventions (25% vs 38%, p = 0.025) was observed. The NI margin was specified in most trials for both years (94% vs 95%). Rationale for the NI margin increased (36% vs 57%, p < 0.001), but remained low, with clinical judgement the most common rationale (30% vs 23%), but more 2019 articles incorporating patient values (0.3% vs 21%, p < 0.001). Over 50% of studies were open-label for both years. Gold standard method of analyses (both per protocol + (modified) intention to treat) declined over time (43% vs 36%, p < 0.001). DISCUSSION: The methodological quality and reporting of NI trials remains inadequate although improving in some areas. Improved methods for NI margin justification, blinding, and analysis method are warranted to facilitate clinical decision-making.
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ABSTRACT: This retrospective cohort study drawing data from 48 major tertiary children's hospitals found heterogeneity in the diagnosis and management of congenital syphilis (CS) despite CDC guideline recommendations. The noted overall rise in the number of congenital syphilis cases mirrors the nationwide increase.
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PURPOSE: Transrectal ultrasound (US) imaging is paramount to the successful completion of prostate biopsies. Certain US features have been associated with prostate cancer (PCa), but their utility remains controversial. We explored the role of multiparametric US (mpUS) in the detection of clinically significant PCa. METHODS: We performed a retrospective cohort study to contrast the findings of prostate MRI and mpUS. Patients who underwent MRI, US and biopsy between 2015 and 2021 were included. Biopsies were performed using a systematic approach (12 cores), as well as with MRI (4 cores/lesion) and US (1 core/lesion) targeting. The US features analyzed consisted of: calcifications, hypoechoic lesions and power or color Doppler positivity. Gleason 3 + 4 or higher was used as to define true positives. Measures of diagnostic accuracy were calculated for the different imaging modalities. RESULTS: The final cohort included 74 patients, of which 24 (32.4%) had clinically significant PCa. The concordance between MRI and US was 63.5%. Seven individuals with discordant results had clinically significant PCa. MRI alone was more sensitive (87.5% vs 75%) but less specific (28% vs 32%) than US alone. An all-inclusive approach considering any suspicious US or MRI finding had a sensitivity of 95.8%. A more restrictive approach, targeting lesions noted in both US and MRI, yielded the highest specificity (50.0%) and accuracy (55.4%). CONCLUSION: Biopsy targeting based on US findings can provide additional diagnostic information that may increase sensitivity or specificity. Additional research into this topic could open the door to a more personalized approach to prostate biopsy.
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Biópsia Guiada por Imagem , Neoplasias da Próstata , Masculino , Humanos , Estudos Retrospectivos , Biópsia Guiada por Imagem/métodos , Neoplasias da Próstata/patologia , Próstata/diagnóstico por imagem , Próstata/patologia , Imageamento por Ressonância Magnética/métodosRESUMO
PURPOSE: To compare 5-year health-related quality of life (HRQoL) outcomes between prostate cancer (CaP) patients who underwent robotic-assisted laparoscopic radical prostatectomy (RALP) versus open radical retropubic prostatectomy (RRP) and assess for racial disparities between Caucasian American (CA) and African American (AA) men undergoing surgery. METHODS: A prospective cohort study of HRQoL data was conducted on patients diagnosed with CaP from 2007 to 2017 and enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database. Using the EPIC and SF-36 instruments, changes in urinary, sexual, bowel, and hormonal domains, as well as physical and mental component summary scores were compared across surgery type (RALP versus RRP) at pre-treatment ("baseline"), and annually for 5 years. We further compared HRQoL outcomes in CA and AA men undergoing surgery. Longitudinal HRQoL patterns were modeled using generalized estimating equations (GEE), adjusting for baseline HRQoL and other characteristics. RESULTS: 448 CaP patients (22% AA) met study inclusion criteria, 66% underwent RALP and 34% underwent RRP. At baseline, HRQoL domains were comparable across treatment group (RALP vs. RRP). In the adjusted low-risk cohort, there were only three time points that met a statistically significant HRQoL difference in EPIC scores between RALP and RRP. Urinary function score during year 4 of follow-up showed a 7.5 (95% CI 3.1-11.9, P = 0.01) points difference in favor of RRP. Bowel bother scores favored RRP in year 1 with a difference of 3.1 (95% CI 0.7-5.4, P = 0.04) points, and in year 5 with a difference of 3.8 (95% CI 1.1-6.4, P = 0.03) points. In the intermediate/high-risk cohort, there were no statistically significant differences in any of the domain scores between RALP and RRP during follow-up. CONCLUSIONS: The robotic and open approach to radical prostatectomy led to comparable HRQoL outcomes at a follow-up length of 60 months. No HRQoL racial disparities were found between AA and CA men during long-term follow-up.
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Laparoscopia , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Humanos , Laparoscopia/métodos , Masculino , Estudos Prospectivos , Próstata , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Qualidade de Vida , Procedimentos Cirúrgicos Robóticos/métodos , Resultado do TratamentoRESUMO
Objectives/Introduction Neoadjuvant chemotherapy (NAC) prior to radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC) is associated with survival benefit across patients of all ages, yet it is not offered to many elderly patients. We aimed to evaluate age-based disparity in treatment and outcomes of MIBC. Methods Using the National Cancer Database, we identified patients with MIBC from 2006 to 2017. Use of treatment modalities was compared between age groups. A second analysis compared perioperative outcomes and overall survival (OS) in elderly patients (70 years or older) undergoing RC with NAC vs no NAC. Propensity score weighting (PSW) was used for each analysis. Results In 70,911 patients, use of NAC with RC was lower in patients 70 years or older (7.2% vs 20.9%; P < .001). In patients 70 years or older undergoing RC, NAC was associated with shorter inpatient stay (8.5 vs 9.6 days; P < .001), decreased 30-day readmission (8.6% vs 10.6%; P <.001), and lower 30- and 90-day mortality (1.5% vs 3.1%; P = .01; and 4.9% vs 7.7%; P = .003, respectively). On weighted multivariate regressions, NAC predicted shorter length of stay and lower 30-and 90-day mortality. Elderly patients receiving NAC had improved OS compared with RC alone (P = .0011, 2010-2013; P < .001, 2014-2016). Conclusions Despite increased omission of NAC in patients 70 years or older, elderly patients receiving NAC and RC had improved perioperative outcomes and OS compared with those undergoing RC alone. There may be selection bias unaccounted for with our PSW; however, our results provide compelling evidence that NAC does not compromise surgical outcomes in appropriately selected elderly patients. Patients of advanced age who are candidates for RC should be offered NAC.
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Neoplasias Musculares/etiologia , Neoplasias Musculares/terapia , Neoplasias da Bexiga Urinária/terapia , Idoso , Quimioterapia Adjuvante/métodos , Cistectomia/métodos , Bases de Dados Factuais , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Neoplasias Musculares/tratamento farmacológico , Neoplasias Musculares/cirurgia , Terapia Neoadjuvante/métodos , Invasividade Neoplásica , Estudos Retrospectivos , Fatores de Tempo , Bexiga Urinária/patologia , Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/complicações , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgiaRESUMO
Background: A high incidence of acute kidney injury (AKI) has been reported in coronavirus disease 2019 (COVID-19) patients in critical care units and those undergoing invasive mechanical ventilation (IMV). The introduction of dexamethasone (DXM) as treatment for severe COVID-19 has improved mortality, but its effects in other organs remain under study. Objective: The objective of this study was to evaluate the association between DXM and AKI in COVID-19. Methods: In this prospective observational cohort study, we evaluated the incidence of AKI in critically ill COVID-19 patients undergoing mechanical ventilation, and the association of DXM treatment with the incidence, severity, and outcomes of AKI. The association between DXM treatment and AKI was evaluated by multivariable logistic regression. The association of the combination of DXM treatment and AKI on mortality was evaluated by Cox-regression analysis. Results: We included 552 patients. AKI was diagnosed in 311 (56%), of which 196 (63%) corresponded to severe (stage 2 or 3) AKI, and 46 (14.8%) received kidney replacement therapy. Two hundred and sixty-seven (48%) patients were treated with DXM. This treatment was associated to lower incidence of AKI (Odds Radio 0.34, 95% Confidence intervals [CI] 0.22-0.52, p < 0.001) after adjusting for age, body mass index, laboratory parameters, SOFA score, and vasopressor use. DXM treatment significantly reduced mortality in patients with severe AKI (HR 0.63, 95%CI 0.41-0.96, p = 0.032). Conclusions: The incidence of AKI is high in COVID-19 patients under IMV. DXM treatment is associated with a lower incidence of AKI and a lower mortality in the group with severe AKI.
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Injúria Renal Aguda , COVID-19 , Humanos , COVID-19/complicações , Respiração Artificial , Estudos Prospectivos , Tratamento Farmacológico da COVID-19 , Cuidados Críticos , Unidades de Terapia Intensiva , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/prevenção & controle , Estado Terminal , Dexametasona , Estudos Retrospectivos , Fatores de RiscoRESUMO
Stigma remains a leading barrier to HIV care. To determine the influence of disclosure stigma (DS), fear of disclosing one's serostatus, on virologic suppression, a cross-sectional study was performed at the largest publicly-funded HIV clinic in South Texas. A survey was administered to participants who were: ≥18 years old, living with HIV, and receiving antiretroviral therapy. Surveys included demographics, adherence questionnaire, and a validated HIV-stigma scale with DS as the sum of 10 items ranked 0-3, with score of 30 indicating highest stigma. The primary outcome was lack of virologic suppression (LOVS): most recent HIV-1 RNA > 20 copies/ml. A bivariate analyses examined predictors of DS, dichotomized at the median. Depression score, perceived stress, and lack of friend/family support were associated with DS. Logistic regression models examined the relationship between DS, as a continuous variable, and LOVS. For 275 participants (69% Hispanic), median DS score was 18.5. DS was significantly inversely associated with LOVS (aOR 0.94 per 1 scale point; CI 0.89, 0.99) after adjustment for age, gender/sexual orientation, race/ethnicity, and drug use. The unanticipated inverse association between DS and LOVS highlights the complexity of this relationship. However, the balance of data in this cohort demonstrate an overall negative impact of DS.
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Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Revelação , Infecções por HIV/tratamento farmacológico , Adesão à Medicação/psicologia , Estigma Social , Carga Viral/efeitos dos fármacos , Adolescente , Adulto , Estudos Transversais , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Infecções por HIV/virologia , HIV-1/genética , Humanos , Masculino , Pessoa de Meia-Idade , Discriminação Social , Texas/epidemiologia , Adulto JovemRESUMO
Prescription opioid misuse is a rising epidemic in the U.S., and people living with HIV are at increased risk. We assessed the association between prescription opioid use and virologic failure in HIV+ patients in the South Texas HIV Cohort. We found prescription opioid use was significantly associated with virologic failure, after adjustment for age, race, gender, insurance status, years living with HIV, reported HIV risk factor, chronic hepatitis C virus infection, current substance abuse, and care engagement. These findings suggest that opioid analgesic use may have negative consequences beyond misuse in people living with HIV.
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Analgésicos Opioides/efeitos adversos , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Transtornos Relacionados ao Uso de Opioides/complicações , Uso Indevido de Medicamentos sob Prescrição/efeitos adversos , Medicamentos sob Prescrição/efeitos adversos , Carga Viral/efeitos dos fármacos , Adolescente , Adulto , Analgésicos Opioides/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Uso Indevido de Medicamentos sob Prescrição/estatística & dados numéricos , Medicamentos sob Prescrição/uso terapêutico , Estudos Retrospectivos , Texas , Falha de Tratamento , Adulto JovemRESUMO
[This corrects the article DOI: 10.1016/j.pmedr.2023.102496.].
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Retention in care for people living with HIV (PLWH) is important for individual and population health. Preemptive identification of PLWH at high risk of lapsing in care may improve retention efforts. We surveyed providers at nine institutions throughout Chicago about their perspectives on using an electronic health record (EHR) tool to predict the risk of lapsing in care. Sixty-three percent (20/32) of providers reported currently assessing patients' risk for lapsing in care, and 91% (29/32) reported willingness to implement an EHR tool. When compared to those with other job roles, prescribers agreed (vs. neutral) that the tool would be less biased than personal judgment (OR 13.33, 95% CI 1.05, 169.56). Prescribers were also more likely to identify community health workers as persons who should deliver these interventions (OR 10.50, 95% CI 1.02, 108.58). Transportation, housing, substance use, and employment information were factors that providers wanted to be included in an EHR-based tool. Social workers were significantly more likely to indicate the inclusion of employment information as important (OR 10.50, 95% CI 1.11, 98.87) when compared to other participants. Acceptability of an EHR tool was high; future research should investigate barriers and evaluate the effectiveness of such a tool.
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Registros Eletrônicos de Saúde , Infecções por HIV , Humanos , Infecções por HIV/tratamento farmacológico , Masculino , Feminino , Chicago , Estudos de Viabilidade , Adulto , Pessoal de Saúde/psicologia , Pessoa de Meia-Idade , Retenção nos Cuidados/estatística & dados numéricos , Atitude do Pessoal de SaúdeRESUMO
OBJECTIVE: The objective of this study is to use GPS technology to determine if violent and property crime exposure to participants activity spaces affect outcomes of the HIV prevention and care continuum (PCC) among Young black sexually minoritized men (YBSMM) and transgender women (TGW), a subgroup at high vulnerability for new HIV diagnoses. Exposure to violent and property crime adversely affects a variety of acute and chronic medical conditions; however, the relationship between exposure to violent and property crime and HIV risk [e.g. preexposure prophylaxis (PrEP) nonuse] is unknown. Spatial analytic analysis using dynamic Global Position Systems (GPS) technology can accurately detect geospatial associations between the crime exposure and objective HIV-related outcomes. METHODS: With the Neighborhoods and Networks (N2) Cohort Study, GPS technology to identify the activity space of 286 [123 people with HIV (PWH) and 163 people without HIV (PWoH)] YBSMM and TGW living in Chicago, Illinois, to identified spatial associations between violent and property crime exposures with HIV PCC outcomes. RESULTS: We found that YBSMM and TGW with higher exposure areas with higher levels of violent crime were less likely to use HIV PrEP therapy [adjusted odds ratio (aOR) 0.76, 95% confidence interval (CI) 0.63-0.91, P â=â0.03]. CONCLUSION: This study demonstrates the importance of clinical providers to consider violent crime as a potential sociostructural barrier that may impact medication adherence and healthcare outcomes among vulnerable populations. Additionally, GPS technology offers an alternative data analytic process that may be used in future studies to assist in identifying barriers to ending the HIV epidemic.
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Crime , Infecções por HIV , Profilaxia Pré-Exposição , Características de Residência , Pessoas Transgênero , Humanos , Masculino , Infecções por HIV/prevenção & controle , Feminino , Pessoas Transgênero/estatística & dados numéricos , Adulto Jovem , Chicago , Profilaxia Pré-Exposição/estatística & dados numéricos , Adulto , Crime/estatística & dados numéricos , Estudos de Coortes , Adolescente , Sistemas de Informação Geográfica , Negro ou Afro-Americano/estatística & dados numéricos , Análise EspacialRESUMO
Fibrosing mediastinitis (FM) is a rare, potentially progressive disease resulting from an idiosyncratic immune response to a variety of stimuli that lead to fibrous infiltration of the mediastinum and possible narrowing of the bronchovascular structures. We report an unusual case of FM in a pediatric patient presenting as myopericarditis and progressing to pericardial thickening and encasement of the mediastinal vascular structures needing surgical intervention. Imaging, including transthoracic echocardiography, cardiac computed tomography, and cardiac magnetic resonance played a crucial role in the diagnosis, assessment, and follow-up. Contrast-enhanced computed tomography can be especially helpful to demonstrate potential findings associated with FM.
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BACKGROUND: Since May, 2022, a large global outbreak of human mpox (formerly known as monkeypox) has predominantly affected men who have sex with men. The strain responsible, Clade IIb, has mutated substantially from precursors originating from the 2017-18 outbreak in Nigeria. Immunity to smallpox, another orthopoxvirus, via previous infection or vaccination provides lifelong immunity. However, since the 2022 mpox outbreak, recent clusters were described in individuals with presumed immunity through recent infection or vaccination. We aim to describe the epidemiological and clinical characteristics of mpox in individuals with past infection or vaccination to improve the understanding of this disease in the setting of previous immunity. METHODS: In this global case series, international collaborators from nine countries provided data on individuals with PCR-confirmed mpox after documented previous infection or vaccination between May 11, 2022, and June 30, 2023. We excluded cases that could not confirm vaccination status or cases with partial immunisation or any doses received before the current multi-national mpox outbreak (cutoff date May 1, 2022). Data were collected via a case report spreadsheet that reported on dates of infection and vaccination, route of immunisation, demographic characteristics, clinical findings, HIV status, concomitant sexually transmitted infections, and markers of disease severity (mpox severity score system). We describe case epidemiology, clinical course, and mpox severity scores; all analyses were descriptive. FINDINGS: We report mpox infections in 37 gay and bisexual men who have sex with men: seven individuals had mpox reinfections, 29 individuals had mpox infections that occurred after two appropriately spaced Modified Vaccinia Ankara-Bavarian Nordic vaccine courses, and one individual had an infection that met the criteria for both reinfection and infection after vaccination. The median age of individuals was 36 years (IQR 30-45; range 21-58). Those with natural immunity after initial infection had a shorter disease course with less mucosal disease upon reinfection than with their initial infection. Infections post-vaccination were characterised by few lesions, little mucosal disease, and minimal analgesia requirements; two people received oral tecovirimat. Overall, there were no deaths, no bacterial superinfections, and all individuals were managed in the ambulatory clinic with one hospital admission for a necrotising neck lesion. INTERPRETATION: The epidemiology of people with mpox reinfection or infection post-vaccination was similar to other published cohorts during the 2022 outbreak-predominantly young, sexually active gay and bisexual men who have sex with men. Clinical features and outcomes of repeat infection and infection after vaccination appear to be less clinically severe than those described in 2022 case literature. Specifically, compared with the 2022 case series, these individuals in the present study had fewer confluent lesions, less mucosal involvement, reduced analgesia requirement, and fewer admissions. Natural immunity and vaccine-induced immunity are not fully protective against mpox infection. However, in this small series both disease duration and severity appear to be reduced. FUNDING: None.
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Mpox , Minorias Sexuais e de Gênero , Vacinas , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Homossexualidade Masculina , Reinfecção , VacinaçãoRESUMO
This study seeks to understand the general adult population's knowledge, attitudes, and stigma towards methamphetamine use and people with a history of methamphetamine use utilizing a cross-sectional national survey. We analyzed data from a cross-sectional survey drawn from AmeriSpeak®, a probability-based ongoing panel of over 35,000 households representative of the U.S. household population. We developed a 10-item social stigma scale, and estimated a multivariable generalized linear regression model for public stigma towards methamphetamine use as our dependent variable and a series of covariates. Six adjusted independent variables were noted to be significantly associated with higher stigma towards methamphetamine use: older age, higher household income, married status, Republican party affiliation, no history of methamphetamine use, and higher racism score. Sex assigned at birth, race (with Black as reference category), education level, and history of arrest or incarceration showed no statistical significance in stigma scores. In a separate regression model limited to people with a history of methamphetamine use (n = 727), notably White respondents had lower stigma compared to Black respondents. Our large population-based survey identified several factors associated with higher stigma towards those who use methamphetamines, including higher racist attitudes which was associated with a higher stigma score and higher internalized stigma amongst Black respondents with a history of methamphetamine use. Given the scope of methamphetamine use in the U.S., addressing stigma, in particular in regard to race, may impact the nation's public health efforts to reduce methamphetamine-associated adverse outcomes.
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BACKGROUND: Patients with high-risk (HR) prostate cancer (PCa) represent a heterogeneous group, however, current treatment guidelines do not consider their specific features. The objective of this study was to evaluate treatment trends and outcomes in HR patients defined by PSA alone and otherwise low-risk features. METHODS: Using the National Cancer Database, we identified patients diagnosed with HR PCa between 2010 and 2016. A study group of patients defined by PSA >20 ng/ml alone and otherwise low-risk features, was compared to a group of HR patients defined by Gleason score or stage. We compared treatment rates over time, the use of concomitant androgen deprivation therapy (ADT), and overall survival (OS). Examination of treatment trends was done using a Z-test analysis. A Kaplan-Meier survival analysis was used to determine 5-year OS with the Log-rank test for comparison. Statistical analyses were completed using R Version 3.5.2. RESULTS: We identified 5,652 patients in the study group and 71,922 in the comparison group. Only 6.8% of the study group had disease ≥cT2, compared to 43.7% in the comparison group. In the study group, 12.5% (709), underwent active surveillance (AS), 36.4% (2,055) radiation therapy (EBRT) and 51.1% (2,888) radical prostatectomy (RP), while the rate of AS, EBRT, and RP in the comparison group were 0.3% (191), 43.0% (30,928), and 56.7% (40,803), respectively. Over the study period, adoption of AS increased from 6.2% in 2010 to 25.0% in 2016 in the study group (P< 0.001), but not in the comparison group. In patients undergoing EBRT, ADT treatment increased from 2010 to 2016 in both groups, though by 2016 only 45.3% of patients in the study group and 86.3% in the comparison group received ADT. The 5-year OS was 93.7% (95% CI 92.8-94.6) in the study group and 89.7% (95% CI 89.2-90.1) in the comparison group (P< 0.001). CONCLUSIONS: Men with HR PCa defined by PSA with otherwise low risk features present at an earlier stage and receive less aggressive therapy than other HR patients. Despite increased rates of AS and decreased use of ADT, these patients appear to have improved survival when compared to other HR patients. These findings suggest that not all HR patients will benefit from aggressive definitive treatment.
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Antígeno Prostático Específico , Neoplasias da Próstata , Masculino , Humanos , Antagonistas de Androgênios/uso terapêutico , Estudos Retrospectivos , Próstata , ProstatectomiaRESUMO
INTRODUCTION: Racial differences in Health-Related Quality of Life (HRQoL) after treatment of prostate cancer (PCa) are not well studied. We compared treatment patterns and HRQoL in African American (AA) and non-AA men undergoing active surveillance (AS), radical prostatectomy (RP), or radiation (XRT). METHODS: Men diagnosed with PCa from 2007-2017 in the Center for Prostate Disease Research Database were identified. HRQoL was evaluated using Expanded PCa Index Composite and SF-36 Health Survey. RESULTS: In 1006 men with localized PCa, 223 (22.2%) were AA (mean follow up 5.2 yrs). AA men with low-risk disease were less likely to undergo AS (28.5 vs. 38.8%) and more likely to undergo XRT (22.3 vs. 10.6%) than non-AA men, p < 0.001. In intermediate-risk disease, AA received more XRT (43.0 vs. 26.9%) and less RP (50.5 vs 66.8%), p = 0.016. In all men, RP resulted in worse urinary function and sexual HRQoL compared to AS and XRT. Bowel HRQoL did not vary by treatment in AA men, however, in non-AA men, XRT resulted in worse bowel scores than AS and RP. HRQoL was then compared for each treatment modality. AA men had worse sexual bother (p = 0.024) after RP than non-AA men, No racial differences were found in urinary, bowel, hormonal, or SF-36 scores for men undergoing AS, RP or XRT. CONCLUSION: AA men are less often treated with AS for low-risk disease and are more likely to undergo XRT. AA men experience worse sexual bother after RP, however, the effect of XRT on bowel symptoms is worse in non-AA men.
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Negro ou Afro-Americano , Neoplasias da Próstata , Qualidade de Vida , Humanos , Masculino , Prostatectomia/métodos , Neoplasias da Próstata/etnologia , Neoplasias da Próstata/cirurgia , Resultado do Tratamento , Disparidades em Assistência à SaúdeRESUMO
Aim: The EMulate Therapeutics Voyager™ is a simple, wearable, home-use device that uses an alternating electromagnetic field to alter biologic signaling within cells. Objective: To assess the safety/feasibility of the Voyager in the treatment of recurrent glioblastoma (rGBM). Methods: In this study, patients with rGBM were treated with Voyager as monotherapy or in combination with standard chemotherapy at the Investigator's discretion. Safety was assessed by incidence of adverse events associated with the Voyager. Patients were followed until death. Results: A total of 75 patients were enrolled and treated for at least one day with the Voyager (safety population). Device-related adverse events were uncommon and generally did not result in interruption or withdrawal from treatment. There were no serious adverse events associated with Voyager. A total of 60 patients were treated for at least one month (clinical utility population). The median progression-free survival (PFS) was 17 weeks (4.3 months) in the Voyager only group (n = 24) and 21 weeks (5.3 months) in the Voyager + concurrent therapy group (n = 36). The median overall survival (OS) was 7 months in the Voyager only group and 9 months in the Voyager + concurrent therapy group. In patients treated with Voyager + concurrent therapy, the median OS for patients enrolled with their 1st or 2nd recurrence (n = 26) was 10 months, while in patients enrolled with their 3rd or 4th recurrence (n = 10) OS was 7 months. Conclusion: The data support the safety and feasibility of the Voyager for the treatment of rGBM. Further prospective study of the device is warranted. Trial Registration Number: NCT02296580 (ClinicalTrials.gov).
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Neoplasias Encefálicas , Glioblastoma , Humanos , Neoplasias Encefálicas/tratamento farmacológico , Estudos de Viabilidade , Glioblastoma/tratamento farmacológico , Recidiva Local de Neoplasia , Estudos ProspectivosRESUMO
Background: Localized prostate cancer (PCa) treatment is associated with reduced health-related quality of life (HRQoL). Current literature is limited by short-term follow-up. Objective: To prospectively evaluate the 5-yr HRQoL outcomes in men undergoing radical prostatectomy (RP), external beam radiotherapy (EBRT), or active surveillance (AS). Design setting and participants: We prospectively evaluated HRQoL in patients with low-risk/favorable intermediate-risk PCa enrolled in the Center for Prostate Disease Research multicenter database between 2007 and 2017. Intervention: Of 1012 patients included in the study, 252 (24.9%) underwent AS, 557 (55.0%) RP, and 203 (20.0%) EBRT. Patients complete the Expanded Prostate Cancer Index Composite and the 36-item Medical Outcomes Study Short Form at baseline and thereafter each year up to 5 yr after treatment. Outcome measurements and statistical analysis: Temporal changes in HRQoL were compared between treatments and were modeled using linear regression models adjusted for baseline HRQoL, demographic, and clinical characteristics. Results and limitations: RP showed the least irritative symptoms and worse incontinence in comparison with AS (p < 0.001 for both subdomains) or EBRT (p < 0.001 for both subdomains) at all time points. RP sexual domain score was worse than the scores of AS (mean difference 22.3 points, 95% confidence interval [CI] 10.5-27.8, p < 0.001) and EBRT (mean difference 16.9 points, 95% CI 12.5-20.3, p < 0.001) during years 1-3 and not different from that of EBRT (mean difference 2.9 points, 95% CI -4.8 to 8.3, p = 0.3) at years 4 and 5. Bowel function and bother were worse for EBRT than for AS (p < 0.001 for both subdomains) and RP (p < 0.001 for both subdomains) at all time points. During the 3-5-yr period, AS demonstrated the worst decline in all mental health domains (p < 0.001 in comparison with both EBRT and RP). Conclusions: RP results in worse long-term urinary function and incontinence, but in less irritative and obstructive symptoms than EBRT and AS. Sexual domain scores were least affected by AS, while RP shows similar scores to EBRT at long term. Long-term HRQoL changes are critical for advising patients. Patient summary: We evaluated long-term health-related quality of life (HRQoL) in a large US population treated for localized prostate cancer. HRQoL outcomes varied according to treatment modality and time. These changes should inform patients about their expected outcomes following treatment.