Prospective studies

前瞻性研究
  • 文章类型: Journal Article
    早产的儿童有长期神经发育后遗症的风险。出生后不久预防性大剂量重组人促红细胞生成素(rhEpo)并未显示出改善认知功能,电机,和行为发展在2年和5年。
    调查早期高剂量rhEpo是否与更好的执行功能和处理速度-晚期-成熟的认知功能-在早产的学龄儿童中。
    这项单中心队列研究是一项前瞻性研究,多中心新生儿临床试验的观察性随访研究;365名早产儿童(平均胎龄,29.3周[范围,26.0-31.9周])在2005年至2012年出生时参加了瑞士EPO神经保护试验,并在2年时被纳入主要结局分析,在2017年至2021年之间,当他们在学龄时,他们有资格被招募参加EpoKids研究。另外招募足月出生的儿童并将其纳入对照组。数据在2022年5月至9月之间进行了分析。
    施用rhEpo(3000IU/kg)或安慰剂(生理盐水,0.9%)作为瑞士EPO神经保护试验的一部分,在生命的前2天内静脉注射3次。
    全面的神经心理学测试电池评估了执行功能和处理速度,父母报告了孩子在日常生活中的执行功能,以检验早期高剂量rhEpo给药与学龄儿童更好的认知结果相关的假设。
    在EpoKids研究中,214名早产儿童(符合条件的队列中365名儿童中的58.6%)的平均年龄为10.4岁(范围,6.9-13.4岁);男孩117人(54.7%)。在15项执行功能和处理速度测试中,没有证据表明接受rhEpo的117名儿童与接受安慰剂的97名儿童不同,在父母评估的执行功能中也是如此(估计值范围为-0.138至0.084,所有95%CI均包括0).不考虑rhEpo或安慰剂分配,非常早产的儿童在15项执行功能和处理速度测试中的11项得分低于足月出生的同龄人(估计值在0.112~0.255之间,95%CI不包括0).
    这项研究没有发现预防性早期高剂量rhEpo给药与早产后的长期神经发育结果之间存在正相关的证据。这些结果表明,一个全面的方法,包括药物和非药物预防和干预策略,需要支持这些孩子的神经发育结果。
    UNASSIGNED: Children born very preterm are at risk for long-term neurodevelopmental sequelae. Prophylactic high-dose recombinant human erythropoietin (rhEpo) shortly after birth has not been shown to improve cognitive, motor, and behavioral development at 2 and 5 years.
    UNASSIGNED: To investigate whether early high-dose rhEpo is associated with better executive functions and processing speed-late-maturing cognitive functions-in school-aged children born very preterm.
    UNASSIGNED: This single-center cohort study was a prospective, observational follow-up study of a multicenter neonatal clinical trial; 365 children born very preterm (mean gestational age, 29.3 weeks [range, 26.0-31.9 weeks]) who had been enrolled in the Swiss EPO Neuroprotection Trial at birth between 2005 and 2012, and who were included in the primary outcome analyses at 2 years, were eligible to be recruited for the EpoKids study between 2017 and 2021 when they were at school age. Term-born children were additionally recruited and included in a control group. Data were analyzed between May and September 2022.
    UNASSIGNED: Administration of rhEpo (3000 IU/kg) or placebo (saline, 0.9%) intravenously 3 times within the first 2 days of life as part of the Swiss EPO Neuroprotection Trial.
    UNASSIGNED: A comprehensive neuropsychological test battery assessed executive functions and processing speed, and parents reported on their child\'s executive functions in everyday life to test the hypothesis that early high-dose rhEpo administration is associated with better cognitive outcomes at school age.
    UNASSIGNED: In the EpoKids study, 214 children born very preterm (58.6% of 365 children in eligible cohort) were assessed at a mean age of 10.4 years (range, 6.9-13.4 years); 117 (54.7%) were boys. There was no evidence that the 117 children who had received rhEpo differed from the 97 children who had received placebo in any of the 15 executive function and processing speed tests, nor in parent-rated executive functions (estimates ranged from -0.138 to 0.084, all 95% CIs included 0). Irrespective of rhEpo or placebo allocation, children born very preterm scored lower on 11 of 15 executive function and processing speed tests than term-born peers (estimates ranged from 0.112 to 0.255, 95% CIs did not include 0).
    UNASSIGNED: This study found no evidence for a positive association between prophylactic early high-dose rhEpo administration and long-term neurodevelopmental outcomes after very preterm birth. These results suggest that a comprehensive approach, including pharmacological and nonpharmacological prevention and intervention strategies, is needed to support these children\'s neurodevelopmental outcome.
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  • 文章类型: Journal Article
    精神分裂症与大多数自然原因导致的过早死亡有关。认知功能下降已被确定为一般人群死亡率的决定因素。然而,对精神分裂症患者这一问题的前瞻性研究很少。
    研究认知功能低下是否是精神分裂症患者自然死亡的危险因素。
    这项前瞻性队列研究包括在1999年2月1日至2022年12月31日之间在巴尔的摩的非营利性精神病系统中注册的精神分裂症或分裂情感障碍患者。马里兰。使用可重复电池评估神经心理学状态(RBANS)和其他临床措施对参与者进行评估。
    自然原因死亡率。
    认知功能的关联,肥胖,吸烟,使用Cox比例风险回归模型评估具有自然原因死亡率的医疗条件.
    在844名参与者中(平均[SD]年龄,39.6[12.1]岁;533名男性[63.2%]),158人(18.7%)在14.4年的中位随访期间死于自然原因(范围,7.0天至23.9年)。与死亡率相关的最重要因素是RBANS测量的认知功能降低(Cox系数,-0.04;95%CI,-0.05至-0.03;z=-5.72;调整后P<.001)。与死亡率独立相关的其他因素包括自身免疫性疾病的诊断(风险比[HR],2.86;95%CI,1.83-4.47;z=4.62;调整后P<.001),吸烟(HR,2.26;95%CI,1.55-3.30;z=4.23;调整后P<.001),慢性阻塞性肺疾病的诊断(HR,3.31;95%CI,1.69-6.49;z=3.48;调整后P=.006),作为连续变量的体重指数(HR,1.06;95%CI,1.02-1.09;z=3.30;调整后P=0.01),心律紊乱的诊断(HR,2.56;95%CI,1.40-4.69;z=3.06;调整后P=.02),离婚或分居(HR,1.80;95%CI,1.22-2.65;z=2.97;调整后P=.02)。低于第50百分位数的RBANS分数显示出与吸烟者的联合关联,体重指数升高,并被诊断为自身免疫性或心脏节律紊乱。
    在这项前瞻性队列研究中,认知功能低下是精神分裂症患者自然死亡的危险因素.应该努力改善认知功能的方法,特别是在有额外风险因素的个体中。
    UNASSIGNED: Schizophrenia is associated with premature mortality from mostly natural causes. Decreased cognitive functioning has been identified as a determinant of mortality in the general population. However, there have been few prospective studies of this issue in persons with schizophrenia.
    UNASSIGNED: To examine whether lower cognitive functioning is a risk factor for natural cause mortality in schizophrenia.
    UNASSIGNED: This prospective cohort study included persons with schizophrenia or schizoaffective disorder enrolled between February 1, 1999, and December 31, 2022, at a nonprofit psychiatric system in Baltimore, Maryland. Participants were evaluated using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and other clinical measures.
    UNASSIGNED: Natural cause mortality.
    UNASSIGNED: Associations of cognitive function, obesity, tobacco smoking, and medical conditions with natural cause mortality were evaluated using Cox proportional hazards regression models.
    UNASSIGNED: Of the 844 participants enrolled (mean [SD] age, 39.6 [12.1] years; 533 male [63.2%]), 158 (18.7%) died of natural causes during a median follow-up of 14.4 years (range, 7.0 days to 23.9 years). The most significant factor associated with mortality was lower cognitive functioning as measured by the RBANS (Cox coefficient, -0.04; 95% CI, -0.05 to -0.03; z = -5.72; adjusted P < .001). Additional factors independently associated with mortality included the diagnosis of an autoimmune disorder (hazard ratio [HR], 2.86; 95% CI, 1.83-4.47; z = 4.62; adjusted P < .001), tobacco smoking (HR, 2.26; 95% CI, 1.55-3.30; z = 4.23; adjusted P < .001), diagnosis of chronic obstructive pulmonary disease (HR, 3.31; 95% CI, 1.69-6.49; z = 3.48; adjusted P = .006), body mass index as a continuous variable (HR, 1.06; 95% CI, 1.02-1.09; z = 3.30; adjusted P = .01), diagnosis of a cardiac rhythm disorder (HR, 2.56; 95% CI, 1.40-4.69; z = 3.06; adjusted P = .02), and being divorced or separated (HR, 1.80; 95% CI, 1.22-2.65; z = 2.97; adjusted P = .02). An RBANS score below the 50th percentile displayed a joint association with being a smoker, having an elevated body mass index, and having a diagnosis of an autoimmune or a cardiac rhythm disorder.
    UNASSIGNED: In this prospective cohort study, lower cognitive functioning was a risk factor for natural cause mortality in schizophrenia. Efforts should be directed at methods to improve cognitive functioning, particularly among individuals with additional risk factors.
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  • 文章类型: Journal Article
    目的:传统的禁食会引起相当大的不适,而没有增加安全性的保证,而口服碳水化合物饮料提供了改善医疗体验的替代方案。本研究旨在探讨无痛双向内镜检查前不同类型和剂量的口腔液体负荷对胃排空和健康的影响。
    方法:将180例患者安排在静脉麻醉下进行双向内镜检查:对照组(C组)符合标准禁食;200mL碳水化合物组(P1组),400mL碳水化合物组(P2组),200mL水组(W1组)和400mL水组(W2组)在手术前2h分别消耗200mL或400mL相应的澄清液体。超声下的胃排空指标,主观舒适度指标,组间比较围手术期血糖和生命体征。
    结果:在包括CSA(横截面积)在内的胃排空中没有检测到显着差异,GV(胃容量),cGV(校正胃容量)和组间三点分级系统,麻醉前cGV均>1.5mL/kg。P2组的参与者经历了较少的术前口渴和口腔干燥,所以作为程序后的渴望,口腔干燥和饥饿。各组围手术期血糖和MAP趋势相似。低血压的发生,心动过缓,缺氧,两组之间所需的去甲肾上腺素具有可比性。
    结论:在无痛双向内窥镜检查前2小时,可以安全地使用200mL或400mL口服饮料,而不会增加胃体积。400mL碳水化合物溶液有效地缓解了不适并且可以作为考虑因素。
    背景:于2023年12月5日在中国临床试验注册中心注册(ChiCTR2300078319)。
    OBJECTIVE: Traditional fasting causes considerable discomfort without added assurance of security, whereas oral carbohydrate beverage offers an alternative to improve medical experience. This study aims to explore the impact of different types and dosages of oral fluids loading before painless bidirectional endoscopy on the gastric emptying and wellbeing.
    METHODS: 180 patients arranged for bidirectional endoscopy with intravenous anesthesia were randomized: patients in the control group (Group C) obeyed standard fasting; the 200 mL carbohydrate group (Group P1), 400 mL carbohydrate group (Group P2), 200 mL water group (Group W1) and 400 mL water group (Group W2) respectively consumed 200 mL or 400 mL corresponding clear liquids 2 h before the procedure. Gastric emptying metrics under ultrasound, subjective comfort indexes, periprocedural blood glucose and vital signs were contrasted among the groups.
    RESULTS: No significant differences were detected in the gastric emptying including CSA (cross-sectional area), GV (gastric volume), cGV (corrected gastric volume) and the three-point grading system among groups, and none had a cGV > 1.5 mL/kg before anesthesia. Participants in Group P2 experienced less preprocedural thirst and mouth dryness, so as the postprocedural thirst, mouth dryness and hunger. Periprocedural blood glucose and MAP had the similar trend in all groups. The occurrence of hypotension, bradycardia, hypoxia, and the required norepinephrine was comparable among the groups.
    CONCLUSIONS: Oral beverage loading with 200 mL or 400 mL can be safely applicated 2 h before painless bidirectional endoscopy without increasing the gastric volume. 400 mL carbohydrate solution effectively relieves the discomfort and could serve as a consideration.
    BACKGROUND: Registered in the Chinese Clinical Trial Registry on December 5, 2023 (ChiCTR2300078319).
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  • 文章类型: Journal Article
    背景:本研究的目的是探讨慢性肾脏病(CKD)患者全身免疫炎症指数(SII)与全因死亡率之间的关系。
    方法:这项前瞻性队列研究是在1999年至2018年的国家健康和营养检查调查周期的9303名CKD参与者中进行的。死亡率数据是通过将参与者记录与截至2019年12月31日的国家死亡指数联系起来确定的。采用复杂抽样加权多变量Cox比例风险模型来估计SII水平与全因死亡率之间的关联。提供风险比(HR)和95%置信区间(CI)。进行了有限的三次样条分析以探索潜在的非线性相关性。还进行了亚组分析和敏感性分析。
    结果:在86个月的中位随访期间,记录了3400例(36.54%)全因死亡。在CKD患者中发现SII水平与全因死亡率之间存在独特的“J”形关系,在第二个四分位数内的SII水平478.93处观察到的最低点。在调整潜在协变量后,SII每增加一个标准差,全因死亡风险就会上升13%,一旦SII超过478.93(HR=1.13;95%CI=1.08-1.18)。在CKD患者中,SII升高与全因死亡率风险增加相关(Q4与Q2:HR=1.23;95%CI=1.01-1.48)。亚组分析表明,SII与CKD死亡率之间的相关性在60岁以上的参与者和糖尿病患者中尤为明显。敏感性分析显示,在消除了SII的极端5%异常值之后,SII与全因死亡率之间呈线性正相关。
    结论:在CKD患者中发现了SII水平与全因死亡率之间的特殊关系。需要进一步的研究来验证和扩展这些发现。
    BACKGROUND: The aim of this study was to investigate the association between systemic immune-inflammation index (SII) and all-cause mortality in individuals with chronic kidney disease (CKD).
    METHODS: This prospective cohort study was carried out among 9303 participants with CKD from the National Health and Nutrition Examination Survey cycles spanning 1999 to 2018. The mortality data were ascertained by linking participant records to the National Death Index up to December 31, 2019. Complex sampling-weighted multivariate Cox proportional hazards models were employed to estimate the association between SII level and all-cause mortality, providing hazard ratios (HR) and 95% confidence intervals (CI). A restricted cubic spline analysis was conducted to explore potential nonlinear correlation. Subgroup analyses and sensitivity analyses were also conducted.
    RESULTS: During a median follow-up period of 86 months, 3400 (36.54%) all-cause deaths were documented. A distinctive \"J\"-shaped relationship between SII level and all-cause mortality was discerned among individuals with CKD, with the nadir observed at an SII level of 478.93 within the second quartile. After adjusting for potential covariates, the risk of all-cause mortality escalated by 13% per increment of one standard deviation of SII, once SII exceeded 478.93 (HR = 1.13; 95% CI = 1.08-1.18). An elevated SII was associated with an increased risk of all-cause mortality among patients with CKD (Q4 vs. Q2: HR = 1.23; 95% CI = 1.01-1.48). Subgroup analyses indicated that the correlation between SII and CKD mortality was particularly pronounced among participants over 60 years old and individuals with diabetes. Sensitivity analyses revealed a linear positive association between SII and all-cause mortality after removing the extreme 5% outliers of SII.
    CONCLUSIONS: A distinctive \"J\"-shaped relationship between SII level and all-cause mortality was identified among individuals with CKD. Further research is warranted to validate and expand upon these findings.
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  • 文章类型: Journal Article
    背景美国剪切波弹性成像(SWE)和振动控制瞬时弹性成像(VCTE)能够评估肝脏硬度,纤维化严重程度的指标。然而,有限的可重复性数据限制了它们在临床试验中的使用.目的评估非酒精性脂肪性肝病(NAFLD)在系统内和系统间的SWE和VCTE测量变异性,以支持临床试验诊断富集和纵向肝脏硬度的临床解释。材料和方法本前瞻性,观察,横断面研究(2021年3月至2021年11月)纳入患有NAFLD的成年人,根据纤维化-4(FIB-4)指数(≤1.3,>1.3和<2.67,≥2.67)分层,在两个站点评估SWE与五个美国系统和VCTE与一个系统。每位参与者在一周内的两天内接受了12次弹性成像检查,每天由不同的操作员进行的检查。VCTE和SWE测量以米/秒为单位报告。主要终点是不同的一天,SWE和VCTE跨系统汇集不同运营商再现系数(RDCDDDO)。次要终点包括系统特定的RDCDDDO,同一天,相同操作员重复性系数(RCSDSO),和系统之间的同一天,同算子再现系数。计划的样本提供了80%的能力来检测小于35%的合并RDCDDDO,预先指定的性能阈值。结果共有40名参与者(平均年龄,60岁±10[SD];24名女性)低(n=17),中间(n=15),和高(n=8)FIB-4评分入组。RDCDDDO为30.7%(95%上限,SWE的34.4%)和35.6%(95%上限,43.9%)为VCTE。SWE系统特定的RDCDDDO从24.2%到34.3%不等。SWE的RCSDSO为21.0%(范围,13.9%-35.0%),VCTE为19.6%。系统间的SWE当天,相同操作者再现系数为52.7%.结论SWE达到预定阈值,RDCDDDO低于35%,VCTE具有较高的RDCDDDO。不同系统之间的SWE变异性较高。这些估计通过(a)定义预期的变异性来推进基于US的肝脏非侵入性测试资格(b)确定使用相同系统进行的系列检查变异性较低,和(c)告知临床试验设计。ClinicalTrials.gov标识符NCT04828551©RSNA,2024补充材料可用于本文。
    Background US shear-wave elastography (SWE) and vibration-controlled transient elastography (VCTE) enable assessment of liver stiffness, an indicator of fibrosis severity. However, limited reproducibility data restrict their use in clinical trials. Purpose To estimate SWE and VCTE measurement variability in nonalcoholic fatty liver disease (NAFLD) within and across systems to support clinical trial diagnostic enrichment and clinical interpretation of longitudinal liver stiffness. Materials and Methods This prospective, observational, cross-sectional study (March 2021 to November 2021) enrolled adults with NAFLD, stratified according to the Fibrosis-4 (FIB-4) index (≤1.3, >1.3 and <2.67, ≥2.67), at two sites to assess SWE with five US systems and VCTE with one system. Each participant underwent 12 elastography examinations over two separate days within 1 week, with each day\'s examinations conducted by a different operator. VCTE and SWE measurements were reported in units of meters per second. The primary end point was the different-day, different-operator reproducibility coefficient (RDCDDDO) pooled across systems for SWE and individually for VCTE. Secondary end points included system-specific RDCDDDO, same-day, same-operator repeatability coefficient (RCSDSO), and between-system same-day, same-operator reproducibility coefficient. The planned sample provided 80% power to detect a pooled RDCDDDO of less than 35%, the prespecified performance threshold. Results A total of 40 participants (mean age, 60 years ± 10 [SD]; 24 women) with low (n = 17), intermediate (n = 15), and high (n = 8) FIB-4 scores were enrolled. RDCDDDO was 30.7% (95% upper bound, 34.4%) for SWE and 35.6% (95% upper bound, 43.9%) for VCTE. SWE system-specific RDCDDDO varied from 24.2% to 34.3%. The RCSDSO was 21.0% for SWE (range, 13.9%-35.0%) and 19.6% for VCTE. The SWE between-system same-day, same-operator reproducibility coefficient was 52.7%. Conclusion SWE met the prespecified threshold, RDCDDDO less than 35%, with VCTE having a higher RDCDDDO. SWE variability was higher between different systems. These estimates advance liver US-based noninvasive test qualification by (a) defining expected variability, (b) establishing that serial examination variability is lower when performed with the same system, and (c) informing clinical trial design. ClinicalTrials.gov Identifier NCT04828551 © RSNA, 2024 Supplemental material is available for this article.
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  • 文章类型: Journal Article
    缺乏用于肺移植受者定期监测的超低剂量(ULD)CT方案的诊断准确性的背景数据。目的评估使用ULD光子计数CT(PCT)在重复CT随访期间检测肺移植受体的肺异常以降低辐射剂量的潜力。材料和方法前瞻性纳入2023年3月至2023年5月连续接受同一天标准护理低剂量(LD)和ULDPCT的肺移植成人受体。ULD方案以包含20%的两个目标有效剂量进行(下文,ULD1)和10%(以下,ULD2)的标准LD协议。三位读者对1mm重建进行了审查。主观图像质量,某些解剖结构的可见性(使用五点李克特量表),并独立评估肺部异常的存在。使用χ2或t检验来评估ULD1和ULD2方案之间的差异。结果共有82名参与者(中位年龄,64年[IQR,54-69岁];47名男性)包括在内(每个ULD方案41名参与者)。LD的平均有效剂量为1.41mSv±0.44(SD),ULD1为0.26mSv±0.08,ULD2为0.17mSv±0.04。根据三位读者的说法,在39-40(ULD1)和40-41(ULD2)参与者中,ULD图像的主观图像质量被认为是诊断(Likert评分≥3),33-41(ULD1)和34-41(ULD2)参与者的解剖结构可以充分可视化(Likert评分≥3)。对于两种ULD方案,单个肺部异常的检测准确性均超过70%,除了阅读器1和3检测近端支气管扩张和阅读器3检测支气管壁增厚和空气滞留。没有证据表明噪声有统计学上的显著差异(P=0.96),信噪比(P=.77),在ULD方案之间注意到或读数准确性(所有P≥.05)。结论ULDPCT检测肺移植术后肺部异常是可行的。辐射剂量减少十倍。©RSNA,2024补充材料可用于本文。另见本期Ciet的社论。
    Background Data on the diagnostic accuracy of ultralow-dose (ULD) CT protocols for periodic surveillance in recipients of lung transplant are lacking. Purpose To assess the potential for radiation dose reduction using ULD photon-counting CT (PCT) to detect lung abnormalities in recipients of lung transplant during repeat CT follow-up. Materials and Methods Consecutive adult recipients of lung transplant undergoing same-day standard-of-care low-dose (LD) and ULD PCT from March 2023 to May 2023 were prospectively included. The ULD protocols were performed with two target effective doses comprising 20% (hereafter, ULD1) and 10% (hereafter, ULD2) of the standard LD protocol. The 1-mm reconstructions were reviewed by three readers. Subjective image quality, the visibility of certain anatomic structures (using a five-point Likert scale), and the presence of lung abnormalities were independently assessed. The χ2 or t tests were used to evaluate differences between the ULD1 and ULD2 protocols. Results A total of 82 participants (median age, 64 years [IQR, 54-69 years]; 47 male) were included (41 participants for each ULD protocol). The mean effective doses per protocol were 1.41 mSv ± 0.44 (SD) for LD, 0.26 mSv ± 0.08 for ULD1, and 0.17 mSv ± 0.04 for ULD2. According to three readers, the subjective image quality of the ULD images was deemed diagnostic (Likert score ≥3) in 39-40 (ULD1) and 40-41 (ULD2) participants, and anatomic structures could be adequately visualized (Likert score ≥3) in 33-41 (ULD1) and 34-41 (ULD2) participants. The detection accuracy for individual lung anomalies exceeded 70% for both ULD protocols, except for readers 1 and 3 detecting proximal bronchiectasis and reader 3 detecting bronchial wall thickening and air trapping. No evidence of a statistically significant difference in noise (P = .96), signal-to-noise ratio (P = .77), or reader accuracy (all P ≥ .05) was noted between the ULD protocols. Conclusion ULD PCT was feasible for detecting lung abnormalities following lung transplant, with a tenfold radiation dose reduction. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Ciet in this issue.
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  • 文章类型: Journal Article
    背景对比增强超声(CEUS)可用于术前评估膀胱癌的肌肉浸润,这对于确定适当的治疗很重要。然而,在CEUS进行评估的诊断标准尚未标准化.目的开发并验证用于评估膀胱癌肌肉浸润的CEUS膀胱成像报告和数据系统(VI-RADS)。材料与方法这项单中心前瞻性研究连续纳入疑似膀胱癌患者。参与者在2021年7月至2023年5月期间接受了经腹或腔内CEUS。根据注册的时间顺序,参与者以2:1的比例分为训练集和验证集。训练集用于识别主要成像特征,包括在CEUSVI-RADS中,使用病理参考标准确定每个类别的肌肉侵入可能性。使用最大Youden指数确定了肌肉入侵的最佳VI-RADS类别截止值。验证集由新手和专家读者评估,并用于验证所开发系统的诊断性能和互读协议。总体结果,126名参与者(平均年龄,64年[IQR,57-71岁];107名男性)和67名参与者(平均年龄,64年[IQR,56-69岁];49名男性)被纳入训练和验证集,分别。在训练集中,肌肉侵袭的最佳CEUSVI-RADS类别截止值为VI-RADS4或更高(Youden指数,0.77)。在验证集中,CEUSVI-RADS为新手和专家读者实现了良好的性能(接收器工作特性曲线下的区域,0.80[95%CI:0.70,0.90]vs0.88[95%CI:0.80,0.97];P=.09)。对于新手读者,关于CEUSVI-RADS类别评估的读者协议为0.77(95%CI:0.65,0.85),0.87(95%CI:0.79,0.92),适用于专家读者,所有读者均为0.78(95%CI:0.70,0.84)。结论开发的CEUSVI-RADS在评估膀胱癌肌肉浸润方面显示出良好的性能和相互一致性。中国临床试验登记号.ChiCTR2100049435©RSNA,2024补充材料可用于本文。另请参阅本期Morrell的社论。
    Background Contrast-enhanced US (CEUS) can be used preoperatively for evaluating muscle invasion in bladder cancer, which is important for determining appropriate treatment. However, diagnostic criteria for assessing this at CEUS have not been standardized. Purpose To develop and validate a CEUS Vesical Imaging Reporting and Data System (VI-RADS) for evaluating muscle invasion in bladder cancer. Materials and Methods This single-center prospective study consecutively enrolled patients with suspected bladder cancer. Participants underwent transabdominal or intracavity CEUS between July 2021 and May 2023. Participants were divided into a training set and a validation set at a 2:1 ratio based on the chronologic order of enrollment. The training set was used to identify major imaging features to include in CEUS VI-RADS, and the likelihood of muscle invasion per category was determined using a pathologic reference standard. The optimal VI-RADS category cutoff for muscle invasion was determined with use of the maximum Youden index. The validation set was assessed by novice and expert readers and used to validate the diagnostic performance and interreader agreement of the developed system. Results Overall, 126 participants (median age, 64 years [IQR, 57-71 years]; 107 male) and 67 participants (median age, 64 years [IQR, 56-69 years]; 49 male) were included in the training and validation set, respectively. In the training set, the optimal CEUS VI-RADS category cutoff for muscle invasion was VI-RADS 4 or higher (Youden index, 0.77). In the validation set, CEUS VI-RADS achieved good performance for both novice and expert readers (area under the receiver operating characteristic curve, 0.80 [95% CI: 0.70, 0.90] vs 0.88 [95% CI: 0.80, 0.97]; P = .09). The interreader agreement regarding the evaluation of CEUS VI-RADS category was 0.77 (95% CI: 0.65, 0.85) for novice readers, 0.87 (95% CI: 0.79, 0.92) for expert readers, and 0.78 (95% CI: 0.70, 0.84) for all readers. Conclusion The developed CEUS VI-RADS showed good performance and interreader agreement for the assessment of muscle invasion in bladder cancer. Chinese Clinical Trial Registry no. ChiCTR2100049435 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Morrell in this issue.
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  • DOI:
    文章类型: Journal Article
    背景:局部麻醉药用于各种部位和机制,以最大程度地提高围手术期的镇痛效果并减少阿片类药物的使用和副作用。减肥环境中的疼痛管理具有挑战性,术中局部麻醉药的疗效目前正在评估中。
    目的:确定在腹腔镜减肥手术中进行的一种新的腹内麻醉技术的安全性和有效性:内脏阻滞。
    方法:在这项前瞻性随机双盲试验研究中,16例接受减肥手术的患者接受了罗哌卡因在食管胃前交界处脂肪注射治疗,15例注射生理盐水作为对照。
    结果:该手术被证明是安全的,并且没有遇到不良事件或副作用。在术后第一个小时内,使用非阿片类药物镇痛的趋势无统计学意义。
    结论:内脏阻滞是一种安全可行的术中操作。其功效的趋势值得未来进行更大规模的研究。
    BACKGROUND: Local anesthetics are used in various sites and mechanisms to maximize perioperative analgesia and reduce opioid use and side effects. Pain management in the bariatric setting is challenging and the efficacy of local anesthetics intraoperatively is under current evaluation.
    OBJECTIVE: To determine the safety and efficacy of a new intra-abdominal anesthetic technique performed during laparoscopic bariatric operations: visceral block.
    METHODS: During this prospective randomized double-blinded pilot study, 16 patients undergoing bariatric surgery were treated with the injection of ropivacaine to the anterior esophagogastric junction fat, and 15 were injected with saline as control.
    RESULTS: The procedure was shown to be safe, and no adverse events nor side effects were encountered. A non-statistically significant trend toward the use of a non-opioid analgesia was documented during the first postoperative hours.
    CONCLUSIONS: Visceral block is a safe and feasible intraoperative procedure. A trend toward its efficacy warrants future larger scale studies.
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  • 文章类型: Journal Article
    现有的研究表明,在一个人的一生中,特别是童年的创伤和虐待,是成年后虐待和再次受害的危险因素,尽管纵向证据很少。使用一项为期30年的关于儿童虐待的长期后果的纵向研究的数据,本文描述了童年虐待在成年后两个时间点预测随后的受害和伴侣暴力受害的程度。数据是从一项前瞻性队列设计研究中获得的,在该研究中,有法庭证实的虐待病例(0-11岁)和人口统计学上匹配的对照的儿童被追踪到成年期,并进行了几波采访。儿童虐待是通过1967年至1971年在美国中西部县地区的青少年和成人法庭记录进行评估的。对2000年至2002年(Mage=39.5岁)和2009年至2010年(Mage=47.5)的受害经历进行了评估,其中包括基于终生创伤和受害历史工具的信息以及有关过去一年伴侣暴力受害的问题的两种类型。与39.5岁的对照组相比,有童年虐待史的人更有可能报告身体和性侵犯,绑架和跟踪受害。相比之下,两组在47.5岁时的后期评估中没有差异,但虐待者报告的性侵犯/性虐待风险高于对照组.对于39.5岁的亲密伴侣暴力受害,虐待组和对照组仅在涉及伤害的受害方面有所不同。成年后,与对照组相比,更多有儿童虐待史的个体报告伴侣身体暴力受害.尽管这些纵向研究结果表明,在两个时间点,受害经历普遍下降,这些结果表明,儿童虐待会增加成年中期随后再次受害的风险,特别适用于性侵犯/虐待和亲密伴侣身体暴力受害。这些发现对针对虐待儿童的预防和干预工作具有重要意义。
    Existing research suggests that prior victimizations during a person\'s lifetime, particularly childhood traumas and maltreatment, are risk factors for abuse and revictimization in adulthood, although longitudinal evidence is sparse. Using data from a 30-year ongoing longitudinal study of the long-term consequences of childhood maltreatment, this paper describes the extent to which childhood maltreatment predicts subsequent victimization and partner violence victimization at two time points in adulthood. Data were obtained from a prospective cohort design study in which children with court-substantiated cases of maltreatment (ages 0-11 years) and demographically matched controls were followed into adulthood and interviewed over several waves. Childhood maltreatment was assessed through juvenile and adult court records from 1967 to 1971 in a midwestern county area in the United States. Victimization experiences were assessed from 2000 to 2002 (Mage = 39.5 years) and 2009 to 2010 (Mage = 47.5) and included two types based on information from the lifetime trauma and victimization history instrument and questions about past year partner violence victimization. Individuals with histories of childhood maltreatment were more likely to report physical and sexual assaults and kidnapping and stalking victimization than controls through age 39.5. In contrast, the two groups did not differ at the later assessment at age 47.5, except maltreated individuals reported greater risk for sexual assault/abuse than controls. For intimate partner violence victimization at age 39.5, maltreated and control groups differed only in terms of victimization involving injury. Later in adulthood, more individuals with histories of childhood maltreatment reported partner physical violence victimization compared to controls. Although these longitudinal findings showed a general decline in victimization experiences over the two time points, these results demonstrate that childhood maltreatment increases risk for subsequent revictimization in middle adulthood, specifically for sexual assault/abuse and intimate partner physical violence victimization. These findings have implications for prevention and intervention efforts targeting maltreated children.
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  • 文章类型: Journal Article
    为了研究新型小孔径设备的可行性和安全性,植入人工晶状体的顶部。
    对7例患者的双眼进行了规则性白内障手术。在非优势眼中,在手术结束时,还将一个小孔径装置(VisionXtender;Morcher)植入囊袋内.面罩的内径为1.4mm。术后3个月和2年进行可行性和安全性研究。
    在所有情况下,该装置成功定位在囊袋内,没有任何术中并发症.在3个月的随访中没有观察到炎症。所有患者取得的双眼未矫正远距视力为0的最小分辩角对数(log-MAR)或更好。此外,在非优势眼测量到0.1logMAR或更高的距离校正中间视力。术后两年,对3例双眼进行了Nd:YAG囊切开术。
    这项临床可行性试验表明,使用新型小孔径装置既容易又安全。未报告术中或术后并发症。所有患者达到满意的距离,中间,和接近视力。当与不同的人工晶状体结合使用时,该装置显示出显着的潜力(例如,复曲面)。在未来,不同的开口形状似乎是可能的。[JRefractSurg.2024;40(9):e662-e666。].
    UNASSIGNED: To investigate the feasibility and safety of a new small-aperture device, which is implanted on top of the intraocular lens.
    UNASSIGNED: Regular cataract surgery was performed in both eyes in 7 patients. In the non-dominant eye, a small-aperture device (VisionXtender; Morcher) was additionally implanted into the capsular bag at the end of the surgery. The mask had an inner diameter of 1.4 mm. Feasibility and safety were investigated 3 months and 2 years after surgery.
    UNASSIGNED: In all cases, the device was successfully positioned in the capsular bag without any intraoperative complications. No inflammation was observed at the 3-month follow-up visit. All patients achieved binocular uncorrected distance visual acuity of 0 logarithm of the minimum angle of resolution (log-MAR) or better. Additionally, distance-corrected intermediate visual acuity of 0.1 logMAR or better was measured in the non-dominant eye. Two years postoperatively, Nd:YAG capsulotomy was performed in three patients in both eyes.
    UNASSIGNED: This clinical feasibility trial demonstrates that the use of the new small-aperture device is both easy and safe. No intraoperative or postoperative complications were reported. All patients attained satisfactory distance, intermediate, and near visual acuity. The device shows significant potential when used in combination with different intraocular lenses (eg, toric). In the future, different opening shapes seem to be possible. [J Refract Surg. 2024;40(9):e662-e666.].
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