Humans

人类
  • 文章类型: Journal Article
    乳酸菌是“健康”女性泌尿和阴道社区的常见居民,通常与两个解剖部位缺乏症状有关。鉴于先前对两个群落中相似细菌物种的研究的鉴定,据推测,这两种微生物实际上是相连的。这里,我们对49株乳酸菌进行了全基因组测序,包括来自同一参与者的16个配对的泌尿生殖器样本。这些菌株代表了五种不同的乳杆菌:L.crispatus,L.Gasseri,L.iners,L.jensenii,还有L.paragasseri.平均核苷酸同一性(ANI),对齐,单核苷酸多态性(SNP),和CRISPR比较来自同一参与者的菌株。我们进行了基因组组装和ANI比较的模拟,并提出了一种统计方法来区分不相关的,相关,和相同的菌株。我们发现配对的样本中有50%具有相同的菌株,有证据表明泌尿和阴道是有联系的.此外,我们发现了菌株有共同祖先的证据.这些结果确定泌尿道和阴道之间的微生物共享不限于尿病原体。知道这两个解剖部位可以在女性中共享乳杆菌可以为未来的临床方法提供信息。
    Lactobacillus species are common inhabitants of the \'healthy\' female urinary and vaginal communities, often associated with a lack of symptoms in both anatomical sites. Given identification by prior studies of similar bacterial species in both communities, it has been hypothesized that the two microbiotas are in fact connected. Here, we carried out whole-genome sequencing of 49 Lactobacillus strains, including 16 paired urogenital samples from the same participant. These strains represent five different Lactobacillus species: L. crispatus, L. gasseri, L. iners, L. jensenii, and L. paragasseri. Average nucleotide identity (ANI), alignment, single-nucleotide polymorphism (SNP), and CRISPR comparisons between strains from the same participant were performed. We conducted simulations of genome assemblies and ANI comparisons and present a statistical method to distinguish between unrelated, related, and identical strains. We found that 50 % of the paired samples have identical strains, evidence that the urinary and vaginal communities are connected. Additionally, we found evidence of strains sharing a common ancestor. These results establish that microbial sharing between the urinary tract and vagina is not limited to uropathogens. Knowledge that these two anatomical sites can share lactobacilli in females can inform future clinical approaches.
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  • 文章类型: Journal Article
    同胞物种之间的时空关联支撑了生物相互作用,结构生态组合,维持生态系统的功能和稳定。然而,种间时空关联对人类活动的复原力仍然知之甚少,特别是在山区森林中,人为影响通常很普遍。这里,我们将上下文相关的联合物种分布模型应用于喜马拉雅东部全球生物多样性热点的系统相机陷阱调查数据集,以了解山区森林中突出的人类活动如何影响陆地哺乳动物群落中的物种关联。在43,163个相机天的努力中,我们从322个站点获得了10,388个独立的17个重点物种(12个食肉动物和5个有蹄类动物)的独立检测。我们发现,与人类修饰水平较高(87%)和人类存在(83%)的栖息地相比,人类修饰水平较高(64%)和人类存在(65%)的栖息地的正相关发生率更高。我们还发现,在人类干扰水平增加时,成对相遇时间显着减少,对应于物种对之间更频繁的相遇。我们的发现表明,人类活动可以将哺乳动物推到更频繁的相遇和联想中,这可能会影响野生动物的共存和持久性,具有潜在的深远的生态后果。
    Spatial and temporal associations between sympatric species underpin biotic interactions, structure ecological assemblages, and sustain ecosystem functioning and stability. However, the resilience of interspecific spatiotemporal associations to human activity remains poorly understood, particularly in mountain forests where anthropogenic impacts are often pervasive. Here, we applied context-dependent Joint Species Distribution Models to a systematic camera-trap survey dataset from a global biodiversity hotspot in eastern Himalayas to understand how prominent human activities in mountain forests influence species associations within terrestrial mammal communities. We obtained 10,388 independent detections of 17 focal species (12 carnivores and five ungulates) from 322 stations over 43,163 camera days of effort. We identified a higher incidence of positive associations in habitats with higher levels of human modification (87%) and human presence (83%) compared to those located in habitats with lower human modification (64%) and human presence (65%) levels. We also detected a significant reduction of pairwise encounter time at increasing levels of human disturbance, corresponding to more frequent encounters between pairs of species. Our findings indicate that human activities can push mammals together into more frequent encounters and associations, which likely influences the coexistence and persistence of wildlife, with potential far-ranging ecological consequences.
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  • 文章类型: Journal Article
    背景:虚拟现实(VR)是一种经过充分研究的数字干预措施,已用于管理接受各种医疗程序的儿科患者的急性疼痛和焦虑。这项研究的重点是调查独特的患者特征和VR沉浸水平对VR在静脉穿刺期间管理儿科疼痛和焦虑的有效性的作用。
    目的:本研究的目的是确定VR干预期间特定患者特征和沉浸水平如何影响接受静脉穿刺手术的儿科患者的焦虑和疼痛水平。
    方法:本研究是对2种组合的二次数据分析,先前发表的随机对照试验在洛杉矶儿童医院于2017年4月12日至2019年7月24日对252名10-21岁的儿科患者进行了观察.在3种临床环境中进行了一项随机临床试验,检查了周围静脉导管的放置(放射学和输液中心)和抽血(静脉切开术)。使用条件过程分析进行适度和调解分析,以评估VR干预期间沉浸水平的影响。
    结果:在预测术后焦虑时,沉浸水平和焦虑敏感性之间存在显著的缓和(P=0.01)。在护理标准范围内表现出最高焦虑敏感度的患者,相对于高沉浸水平的个体,术后焦虑升高为1.9(95%CI0.9-2.8;P<.001)。没有发现其他重要因素可以介导或减轻沉浸对术后焦虑或疼痛的影响。
    结论:VR对于焦虑敏感性较高的患者最有效,他们报告感觉高度沉浸。年龄,程序的位置,和患者的性别未发现显著影响VR成功管理术后疼痛或焦虑水平,这表明沉浸式VR可能是广泛的儿科人群的有益干预措施。
    背景:ClinicalTrials.govNCT04268901;https://clinicaltrials.gov/study/NCT04268901。
    BACKGROUND: Virtual reality (VR) is a well-researched digital intervention that has been used for managing acute pain and anxiety in pediatric patients undergoing various medical procedures. This study focuses on investigating the role of unique patient characteristics and VR immersion level on the effectiveness of VR for managing pediatric pain and anxiety during venipuncture.
    OBJECTIVE: The purpose of this study is to determine how specific patient characteristics and level of immersion during a VR intervention impact anxiety and pain levels for pediatric patients undergoing venipuncture procedures.
    METHODS: This study is a secondary data analysis of 2 combined, previously published randomized control trials on 252 pediatric patients aged 10-21 years observed at Children\'s Hospital Los Angeles from April 12, 2017, to July 24, 2019. One randomized clinical trial was conducted in 3 clinical environments examining peripheral intravenous catheter placement (radiology and an infusion center) and blood draw (phlebotomy). Conditional process analysis was used to conduct moderation and mediation analyses to assess the impact of immersion level during the VR intervention.
    RESULTS: Significant moderation was found between the level of immersion and anxiety sensitivity when predicting postprocedural anxiety (P=.01). Patients exhibiting the highest anxiety sensitivity within the standard of care yielded a 1.9 (95% CI 0.9-2.8; P<.001)-point elevation in postprocedural anxiety relative to individuals with high immersion levels. No other significant factors were found to mediate or moderate the effect of immersion on either postprocedural anxiety or pain.
    CONCLUSIONS: VR is most effective for patients with higher anxiety sensitivity who report feeling highly immersed. Age, location of the procedure, and gender of the patient were not found to significantly impact VR\'s success in managing levels of postprocedural pain or anxiety, suggesting that immersive VR may be a beneficial intervention for a broad pediatric population.
    BACKGROUND: ClinicalTrials.gov NCT04268901; https://clinicaltrials.gov/study/NCT04268901.
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  • DOI:
    文章类型: Journal Article
    静脉内给药的人免疫球蛋白产品(IVIG)中抗D抗体的水平由欧洲药典规定的直接血凝方法控制(Ph。欧尔.)需要2种对照参考试剂。世界卫生组织(WHO)阳性对照国际参考试剂(IRR;02/228)的标称滴度为8,定义了最高可接受滴度,而阴性对照制剂(02/226)的标称滴度<2。工作参考制剂(04/132和04/140)随后被确立为用于Ph的生物参考制剂(BRP)。欧尔.,并由美国食品和药物管理局(USFDA)和国家生物标准与控制研究所(NIBSC)分发。由于3家机构的这些工作参考准备工作的库存减少,组织了一项联合国际研究,以建立统一的替代批次。16个实验室为研究提供了数据,以评估阳性和阴性候选替代批次(分别为13/148和12/300)与WHO阳性和阴性对照IRR以及当前的工作参考制剂(BRP)。结果表明,候选参考制剂(13/148和12/300)与相应的IRR和当前的BRP没有区别。候选制剂13/148和12/300由博士通过。欧尔.作为免疫球蛋白(抗D抗体测试)BRP批次2和免疫球蛋白(抗D抗体测试阴性对照)BRP批次2,标称血凝滴度分别为8和<2。同样的材料也被采用作为NIBSC和美国FDA的参考制剂,从而确保全面协调。
    The level of anti-D antibodies in human immunoglobulin products for intravenous administration (IVIG) is controlled by the direct haemagglutination method prescribed by the European Pharmacopoeia (Ph. Eur.) that requires 2 control reference reagents. The World Health Organization (WHO) positive control International Reference Reagent (IRR; 02/228) with a nominal titre of 8 defines the highest acceptable titre, while the negative control preparation (02/226) has a nominal titre of <2. Working reference preparations (04/132 and 04/140) were subsequently established as Biological Reference Preparations (BRPs) for the Ph. Eur., and for distribution by the United States Food and Drug Administration (US FDA) and the National Institute for Biological Standards and Control (NIBSC). Due to diminishing stocks of these working reference preparations across the 3 institutions, a joint international study was organised to establish harmonised replacement batches. Sixteen laboratories contributed data to the study to evaluate positive and negative candidate replacement batches (13/148 and 12/300, respectively) against the WHO positive and negative control IRRs and the current working reference preparations (BRPs). The results show that the candidate reference preparations (13/148 and 12/300) are indistinguishable from the corresponding IRRs and current BRPs. The candidate preparations 13/148 and 12/300 were adopted by the Ph. Eur. Commission as Immunoglobulin (anti-D antibodies test) BRP batch 2 and Immunoglobulin (anti-D antibodies test negative control) BRP batch 2 with nominal haemagglutination titres of 8 and <2, respectively. The same materials were also adopted as NIBSC and US FDA reference preparations, thus ensuring full harmonisation.
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  • 文章类型: Journal Article
    这项研究比较了在短臂人体离心机(SAHC)上在直立(自然重力)位置和仰卧位置进行的前蹲(FS)之间的联合运动学。先前没有在离心机上锻炼经验的男性参与者(N=12)在暴露于人工重力(AG)的同时在SAHC上进行的FS锻炼之前(PRE)和之后(POST)完成了直立位置的FS。参与者完成,按照随机顺序,三组六次重复,负荷等于体重或直立下蹲的1.25倍体重,AG的重心(COG)为1g和1.25g。在陆地深蹲期间,负载是用杠铃施加的。用一组惯性测量单元记录膝(左/右)和髋(左/右)屈曲角度。AG降低了膝盖和臀部的最大屈曲角度(MAX)以及运动范围(ROM),1和1.25g。在AG中进行的第一次和最后一次重复之间观察到轻微的适应。AG通过降低MAX影响幼稚参与者的FS能力,MIN和ROM的膝盖和臀部。
    This study compared the joint kinematics between the front squat (FS) conducted in the upright (natural gravity) position and in the supine position on a short arm human centrifuge (SAHC). Male participants (N = 12) with no prior experience exercising on a centrifuge completed a FS in the upright position before (PRE) and after (POST) a FS exercise conducted on the SAHC while exposed to artificial gravity (AG). Participants completed, in randomized order, three sets of six repetitions with a load equal to body weight or 1.25 × body weight for upright squats, and 1 g and 1.25 g at the center of gravity (COG) for AG. During the terrestrial squats, the load was applied with a barbell. Knee (left/right) and hip (left/right) flexion angles were recorded with a set of inertial measurement units. AG decreased the maximum flexion angle (MAX) of knees and hips as well as the range of motion (ROM), both at 1 and 1.25 g. Minor adaptation was observed between the first and the last repetition performed in AG. AG affects the ability to FS in naïve participants by reducing MAX, MIN and ROM of the knees and hip.
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  • 文章类型: Journal Article
    背景:尽管玻璃离聚物水泥(GIC)在治疗白斑病变(WSL)方面优于复合材料,人们仍然担心它们的预防和抗菌性能。已经做出了努力来提高它们与去矿质牙釉质的结合强度,壳聚糖纳米粒子的氟释放和抗菌性能,这似乎是一个很有希望的方法。
    目的:本研究的目的是评估抗菌作用,WSL区域与牙釉质的微剪切粘结强度(μSBS),以及用不同的纳米壳聚糖体积改性传统GIC的聚丙烯酸液相后的氟化物和纳米壳聚糖的释放。
    方法:共制备了120个样品,然后分为4组(n=30):G1-未修饰的GIC,作为对照组,而G2、G3和G4用不同的纳米壳聚糖体积(50%,100%和150%,分别)。在蒸馏水中储存24小时后,使用通用试验机(UTM)评估微剪切粘结强度。在不同时间点使用分光光度计测量氟化物和纳米壳聚糖的释放(最初,在1小时,24h,48h,72小时,1周,2周,3周,和6周)在蒸馏水中储存后。用琼脂扩散试验评估对金黄色链球菌菌株的抗菌作用。对数据进行统计学分析。
    结果:储存24小时后,G2记录了轻微的,但不重要,与G1(3.9±1.30MPa)相比,μSBS值(4.1±0.94MPa)增加。关于氟化物的释放,在24小时储存期结束时,G1的记录量(0.70±0.30μmf/cm2)明显大于改性纳米壳聚糖GIC组;G1之后是G4(0.54±0.34μmf/cm2)。对于G3,在24小时储存后纳米壳聚糖释放量最高(0.85±0.00μmf/cm2)。记录到G2的最高抑制区值。
    结论:用50%纳米壳聚糖改性的玻璃离聚物水泥显示出积极影响μSBS和抗菌作用,而150%纳米壳聚糖改性显著增加氟释放。
    BACKGROUND: Despite the superiority of glass-ionomer cements (GICs) over composites in treating white spot lesions (WSLs), there is still a concern about their preventive and antibacterial properties. Efforts have been made to improve the strength of their bond to demineralized enamel, fluoride release and antibacterial properties by adding nanoparticles of chitosan, which seems to be a promising method.
    OBJECTIVE: The aim of the present study was to assess the antibacterial effect, the microshear bond strength (μSBS) to enamel at the WSL area, and the fluoride and nano-chitosan release after modifying the polyacrylic acid liquid phase of a traditional GIC with different nano-chitosan volumes.
    METHODS: A total of 120 samples were prepared, and then divided into 4 groups (n = 30): G1 - non-modified GIC, which served as a control group, while G2, G3 and G4 were modified with different nano-chitosan volumes (50%, 100% and 150%, respectively). Microshear bond strength was assessed using a universal testing machine (UTM) after storage in distilled water for 24 h. Fluoride and nanochitosan release was measured with the use of spectrophotometers at different time points (initially, and at 1 h, 24 h, 48 h, 72 h, 1 week, 2 weeks, 3 weeks, and 6 weeks) after storage in distilled water. The antibacterial effect against the Streptococcus aureus strain was assessed with the agar diffusion test. The data was statistically analyzed.
    RESULTS: After 24-hour storage, G2 recorded a slight, yet non-significant, increase in the μSBS values (4.1 ±0.94 MPa) as compared to G1 (3.9 ±1.30 MPa). With regard to fluoride release, the amount recorded for G1 was significantly greater at the end of the 24-hour storage period (0.70 ±0.30 μmf/cm2) than modified nano-chitosan GIC groups; G1 was followed by G4 (0.54 ±0.34 μmf/cm2). The highest amount of nano-chitosan release after 24-hour storage was noted for G3 (0.85 ±0.00 μmf/cm2). The highest inhibition zone value was recorded for G2.
    CONCLUSIONS: Glass-ionomer cement modified with 50% nano-chitosan was shown to positively affect μSBS and the antibacterial effect, while modification with 150% nano-chitosan significantly increased fluoride release.
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  • 文章类型: Journal Article
    背景:炎症性肠病(IBD)患者血栓形成的风险增加。他们通常需要肠胃外营养(PN),需要长时间静脉进入。我们评估了接受家庭PN(HPN)的IBD患者与外周中心静脉导管(PICC)和隧道导管相关的深静脉血栓形成(DVT)的风险。
    方法:使用克利夫兰诊所HPN注册表,我们回顾性研究了2019年6月30日至2023年1月1日期间接受HPN治疗的IBD成人队列.我们收集了人口统计,导管类型,和导管相关DVT(CADVT)数据。我们进行了描述性统计和泊松检验,以比较感兴趣的参数之间的CADVT率。我们生成了Kaplan-Meier图来说明无CADVT生存的寿命和Cox比例风险模型来计算与CADVT相关的风险比。
    结果:我们收集了407名患者的数据,其中,276(68%)接受隧道导管,131(32%)接受PICC作为初始导管。有17例CADVT,总发生率为0.08/1000导管天,而PICC和隧道导管的DVT个体比率为0.16和0.05/1000导管天,分别(P=0.03)。在调整了年龄之后,性别,和合并症,与隧道导管相比,PICC的CADVT风险明显更高,调整后的风险比为2.962(95%CI=1.140-7.698;P=0.025),调整后的发生率比为3.66(95%CI=2.637-4.696;P=0.013)。
    结论:我们的研究表明,与隧道导管相比,PICC的CADVT风险高出近三倍。对于需要输注HPN超过30天的IBD患者,我们建议放置隧道导管。
    BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk of thrombosis. They often need parenteral nutrition (PN) requiring intravenous access for prolonged periods. We assessed the risk of deep vein thrombosis (DVT) associated with peripherally inserted central catheters (PICCs) and tunneled catheters for patients with IBD receiving home PN (HPN).
    METHODS: Using the Cleveland Clinic HPN Registry, we retrospectively studied a cohort of adults with IBD who received HPN between June 30, 2019 and January 1, 2023. We collected demographics, catheter type, and catheter-associated DVT (CADVT) data. We performed descriptive statistics and Poisson tests to compare CADVT rates among parameters of interest. We generated Kaplan-Meier graphs to illustrate longevity of CADVT-free survival and a Cox proportional hazard model to calculate the hazard ratio associated with CADVT.
    RESULTS: We collected data on 407 patients, of which, 276 (68%) received tunneled catheters and 131 (32%) received PICCs as their initial catheter. There were 17 CADVTs with an overall rate of 0.08 per 1000 catheter days, whereas individual rates of DVT for PICCs and tunneled catheters were 0.16 and 0.05 per 1000 catheter days, respectively (P = 0.03). After adjusting for age, sex, and comorbidity, CADVT risk was significantly higher for PICCs compared with tunneled catheters, with an adjusted hazard ratio of 2.962 (95% CI=1.140-7.698; P = 0.025) and adjusted incidence rate ratio of 3.66 (95% CI=2.637-4.696; P = 0.013).
    CONCLUSIONS: Our study shows that CADVT risk is nearly three times higher with PICCs compared with tunneled catheters. We recommend tunneled catheter placement for patients with IBD who require HPN infusion greater than 30 days.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    与早期夹线(ECC)相比,脐带挤奶(UCM)减少分娩室心肺支持,缺氧缺血性脑病,和治疗性低温在无活力的近月和足月婴儿。然而,UCM出院后结果未知。
    在无活力婴儿挤奶(MINVI)试验中,确定出生时随机接受UCM或ECC治疗的儿童的2年结局。
    从2021年1月9日至2023年9月25日进行了二次分析,以评估集群随机交叉试验的长期结果。初步试验在美国的10个医疗中心进行,加拿大,和波兰从2019年1月5日至2021年6月1日,并假设与ECC相比,UCM将减少新生儿重症监护病房的入院;随访于2023年9月26日结束。该人群包括出生时年龄在35至42周的近月和足月婴儿,他们没有活力;家庭同意完成2岁以下的发育筛查问卷。
    UCM和ECC。
    年龄和阶段问卷,第三版(ASQ-3)和改良的幼儿自闭症清单,修订/随访(M-CHAT-R/F)调查问卷,年龄在22至26个月。使用意向治疗分析和符合方案分析。
    在初审的1730名新生儿中,在2岁时可获得ASQ-3评分或2岁前死亡的971名儿童(81%)和M-CHAT-R/F评分或2岁前死亡的927名儿童(77%)中,我们评估了长期结局.治疗组产妇和新生儿特征相似,中位出生胎龄为39岁(IQR,两组均为38-40周;UCM组中有224名婴儿(45%),ECC组中有201名婴儿(43%)为女性。ASQ-3总分中位数相似(UCM:255[IQR,225-280]vsECC:255[IQR,230-280];P=.87),在ASQ-3子域中没有显着差异。中高风险M-CHAT-R/F评分也相似(UCM,9%[486人中的45人]与ECC,8%[441个中的37个];P=0.86)。
    在这项对出生时活力不足的近期晚期和足月婴儿的随机临床试验的二次分析中,2岁时的ASQ-3评分在UCM组和ECC组之间没有显着差异。结合先前报告的重要短期利益,这项后续研究表明UCM是可行的,无成本干预没有长期神经发育风险的非剧烈近期和足月新生儿脐带挤奶。
    ClinicalTrials.gov标识符:NCT03631940。
    UNASSIGNED: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known.
    UNASSIGNED: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial.
    UNASSIGNED: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks\' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years.
    UNASSIGNED: UCM and ECC.
    UNASSIGNED: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used.
    UNASSIGNED: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86).
    UNASSIGNED: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns.
    UNASSIGNED: ClinicalTrials.gov Identifier: NCT03631940.
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  • 文章类型: Journal Article
    引发患者价值观的严重疾病对话(SIC),目标,和护理偏好减少焦虑和抑郁,提高生活质量,但癌症患者很少发生。针对临床医生和/或患者的行为经济实施策略(轻推)可能会增加SIC完成。
    测试临床医生和患者轻推对SIC完成的独立和综合影响。
    A2×2阶乘,本研究于2021年9月7日至2022年3月11日在宾夕法尼亚州和新泽西州大型学术卫生系统内的4家医院和6个社区中心的肿瘤科诊所进行,纳入163名内科和妇科肿瘤临床医师和4450名具有高死亡风险(180日死亡率风险≥10%)的癌症患者中.
    临床医师集群和患者被独立随机分配接受常规治疗和轻推,产生4个武器:(1)主动控制,在试验开始前运行2年,由临床医生短信提醒组成,以完成高死亡率风险患者的SIC;(2)仅临床医生轻推,包括主动控制加上每周同行比较临床医生水平的SIC完成率;(3)仅患者微动,由主动控制和临床前电子通信组成,旨在为患者提供SIC;(4)结合临床医生和患者的轻推。
    主要结果是参与者在随机分组后首次就诊后6个月内电子健康记录中记录的SIC。在患者水平的意向治疗基础上进行分析。
    该研究累积了4450名患者(中位年龄,67年[IQR,59-75岁];163名临床医生观察到2352名女性[52.9%],随机分为主动对照(n=1004),临床医生轻推(n=1179),患者轻推(n=997),或组合推动(n=1270)。主动控制臂的6个月SIC完成的总体患者水平率为11.2%(1004个中的112个),临床医生推臂的11.5%(1179个中的136个),11.5%的患者推臂(115/997),和14.1%的组合推动臂(1270个中的179个)。与主动控制相比,综合推动与SIC率的增加相关(风险比[rHR],1.55[95%CI,1.00-2.40];P=0.049),而临床医生轻推(HR,0.95[95%CI,0.64-1.41;P=0.79)和患者轻推(HR,0.99[95%CI,0.73-1.33];P=.93)没有。
    在这项整群随机试验中,与主动对照相比,结合临床医生同伴比较和患者启动问卷的轻推与记录在案的SIC略有增加相关。结合临床和患者指导的轻推可能有助于在常规癌症护理中促进SIC。
    ClinicalTrials.gov标识符:NCT04867850。
    UNASSIGNED: Serious illness conversations (SICs) that elicit patients\' values, goals, and care preferences reduce anxiety and depression and improve quality of life, but occur infrequently for patients with cancer. Behavioral economic implementation strategies (nudges) directed at clinicians and/or patients may increase SIC completion.
    UNASSIGNED: To test the independent and combined effects of clinician and patient nudges on SIC completion.
    UNASSIGNED: A 2 × 2 factorial, cluster randomized trial was conducted from September 7, 2021, to March 11, 2022, at oncology clinics across 4 hospitals and 6 community sites within a large academic health system in Pennsylvania and New Jersey among 163 medical and gynecologic oncology clinicians and 4450 patients with cancer at high risk of mortality (≥10% risk of 180-day mortality).
    UNASSIGNED: Clinician clusters and patients were independently randomized to receive usual care vs nudges, resulting in 4 arms: (1) active control, operating for 2 years prior to trial start, consisting of clinician text message reminders to complete SICs for patients at high mortality risk; (2) clinician nudge only, consisting of active control plus weekly peer comparisons of clinician-level SIC completion rates; (3) patient nudge only, consisting of active control plus a preclinic electronic communication designed to prime patients for SICs; and (4) combined clinician and patient nudges.
    UNASSIGNED: The primary outcome was a documented SIC in the electronic health record within 6 months of a participant\'s first clinic visit after randomization. Analysis was performed on an intent-to-treat basis at the patient level.
    UNASSIGNED: The study accrued 4450 patients (median age, 67 years [IQR, 59-75 years]; 2352 women [52.9%]) seen by 163 clinicians, randomized to active control (n = 1004), clinician nudge (n = 1179), patient nudge (n = 997), or combined nudges (n = 1270). Overall patient-level rates of 6-month SIC completion were 11.2% for the active control arm (112 of 1004), 11.5% for the clinician nudge arm (136 of 1179), 11.5% for the patient nudge arm (115 of 997), and 14.1% for the combined nudge arm (179 of 1270). Compared with active control, the combined nudges were associated with an increase in SIC rates (ratio of hazard ratios [rHR], 1.55 [95% CI, 1.00-2.40]; P = .049), whereas the clinician nudge (HR, 0.95 [95% CI, 0.64-1.41; P = .79) and patient nudge (HR, 0.99 [95% CI, 0.73-1.33]; P = .93) were not.
    UNASSIGNED: In this cluster randomized trial, nudges combining clinician peer comparisons with patient priming questionnaires were associated with a marginal increase in documented SICs compared with an active control. Combining clinician- and patient-directed nudges may help to promote SICs in routine cancer care.
    UNASSIGNED: ClinicalTrials.gov Identifier: NCT04867850.
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