observation study

观察研究
  • 文章类型: Journal Article
    背景:可穿戴生理监测设备是用于远程监测和早期检测感兴趣的潜在健康变化的有前途的工具。这种方法在社区和长时间内的广泛采用将需要一个自动化的数据收集平台,processing,并分析相关健康信息。
    目的:在本研究中,我们探索通过自动数据收集对个人健康的前瞻性监测,提取度量,和健康异常分析管道在自由生活条件下连续监测几个月,重点是病毒性呼吸道感染,如流感或COVID-19。
    方法:共有59名参与者在8个月的时间内每天提供智能手表数据以及健康症状和疾病报告。来自光电体积描记术传感器的生理和活动数据,包括高分辨率跳间间隔(IBI)和步数,直接从GarminFenix6智能手表上传,并使用独立设备在云中自动处理,开源分析引擎。根据心率和心率变异性指标与每个人的活动匹配基线值的偏差计算健康风险评分。并检查超过预定阈值的分数是否有相应的症状或疾病报告.相反,健康调查回复中的病毒性呼吸道疾病报告也被检查健康风险评分的相应变化,以定性评估作为急性呼吸道健康异常指标的风险评分.
    结果:每天提供的指示智能手表佩戴合规性的传感器数据的中位数平均百分比为70%,调查答复表明健康报告依从性为46%。共检测到29个升高的健康风险评分,其中12人(41%)同时有调查数据,并表示有健康症状或疾病。研究参与者共报告了21种流感或COVID-19疾病;这些报告中有9种(43%)同时包含智能手表数据,其中6人(67%)的健康风险评分增加.
    结论:我们演示了数据收集的协议,提取心率和心率变异性指标,和前瞻性分析,与使用可穿戴传感器进行连续监测的近实时健康评估兼容。用于数据收集和分析的模块化平台允许选择不同的可穿戴传感器和算法。这里,我们展示了其在自由生活条件下个人佩戴的GarminFenix6智能手表的高保真IBI数据收集中的实施,和潜在的,近实时的数据分析,最终计算健康风险分数。据我们所知,这项研究首次证明了使用智能手表近实时测量高分辨率心脏IBI和步数以在自由生活条件下长期监测期间进行呼吸系统疾病检测的可行性.
    BACKGROUND: Wearable physiological monitoring devices are promising tools for remote monitoring and early detection of potential health changes of interest. The widespread adoption of such an approach across communities and over long periods of time will require an automated data platform for collecting, processing, and analyzing relevant health information.
    OBJECTIVE: In this study, we explore prospective monitoring of individual health through an automated data collection, metrics extraction, and health anomaly analysis pipeline in free-living conditions over a continuous monitoring period of several months with a focus on viral respiratory infections, such as influenza or COVID-19.
    METHODS: A total of 59 participants provided smartwatch data and health symptom and illness reports daily over an 8-month window. Physiological and activity data from photoplethysmography sensors, including high-resolution interbeat interval (IBI) and step counts, were uploaded directly from Garmin Fenix 6 smartwatches and processed automatically in the cloud using a stand-alone, open-source analytical engine. Health risk scores were computed based on a deviation in heart rate and heart rate variability metrics from each individual\'s activity-matched baseline values, and scores exceeding a predefined threshold were checked for corresponding symptoms or illness reports. Conversely, reports of viral respiratory illnesses in health survey responses were also checked for corresponding changes in health risk scores to qualitatively assess the risk score as an indicator of acute respiratory health anomalies.
    RESULTS: The median average percentage of sensor data provided per day indicating smartwatch wear compliance was 70%, and survey responses indicating health reporting compliance was 46%. A total of 29 elevated health risk scores were detected, of which 12 (41%) had concurrent survey data and indicated a health symptom or illness. A total of 21 influenza or COVID-19 illnesses were reported by study participants; 9 (43%) of these reports had concurrent smartwatch data, of which 6 (67%) had an increase in health risk score.
    CONCLUSIONS: We demonstrate a protocol for data collection, extraction of heart rate and heart rate variability metrics, and prospective analysis that is compatible with near real-time health assessment using wearable sensors for continuous monitoring. The modular platform for data collection and analysis allows for a choice of different wearable sensors and algorithms. Here, we demonstrate its implementation in the collection of high-fidelity IBI data from Garmin Fenix 6 smartwatches worn by individuals in free-living conditions, and the prospective, near real-time analysis of the data, culminating in the calculation of health risk scores. To our knowledge, this study demonstrates for the first time the feasibility of measuring high-resolution heart IBI and step count using smartwatches in near real time for respiratory illness detection over a long-term monitoring period in free-living conditions.
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  • 文章类型: Journal Article
    背景:这项前瞻性真实世界研究旨在评估艾日布林在中国治疗晚期乳腺癌(ABC)的临床实践中的疗效和安全性。
    方法:在本研究中,纳入符合条件的不能手术的局部晚期或转移性乳腺癌患者,这些患者先前经历过蒽环类/紫杉烷类新/辅助治疗或姑息治疗失败.每3周在第1天和第8天静脉内输注Eribulin(1.4mg/m2),直到疾病进展或发生不可耐受的毒性。无进展生存期(PFS),总反应率(ORR),疾病控制率(DCR),并对治疗的安全性进行了评估.
    结果:纳入了一百三十四名患者。中位PFS(mPFS)为4.3个月(95%CI:0.3-15.4)。ORR和DCR分别为32.1%和79.1%,分别。接受eribulin一线或二线治疗的患者的mPFS明显优于接受eribulin≥3线治疗的患者(6.9个月[95%CI:3.2-8.8]vs.4.0个月[95%CI:3.4-4.6],p=0.006)。三阴性患者的mPFS,HER2阳性,HER2(-)/HR(+)为3.4(95%CI:2.7-4.1),6.2(95%CI:2.3-10.1)和5.0个月(95%CI:4.1-5.9),分别。HER2(+)患者的PFS明显长于TNBC患者(p=0.022)。接受联合治疗的患者的mPFS明显长于接受艾瑞布林单一治疗的患者(5.0个月[95%CI3.6-6.3]vs.4.0个月[95%CI:3.3-4.7][p=0.016])。多因素分析显示,非TNBC分子分型的MBC患者接受艾瑞布林≤2线治疗和联合治疗,其疾病进展风险较低。中性粒细胞减少症(33.58%),白细胞减少症(11.94%),血小板减少症(4.48%)是最常见的治疗相关不良事件.
    结论:在现实世界中,Eribulin在中国ABC患者中表现出有效的临床活性和良好的耐受性。疗效和安全性与以前的随机3期试验报告一致。
    BACKGROUND: This prospective real-world study aimed to assess the efficacy and safety of eribulin in the clinical practice against advanced breast cancer (ABC) in China.
    METHODS: In this study, eligible patients with inoperable locally advanced or metastatic breast cancer who had experienced prior neo-/adjuvant or failed the palliative treatment with anthracycline/taxanes were included. Eribulin (1.4 mg/m2) was infused intravenously on Day 1 and Day 8 every 3 weeks until disease progression or intolerable toxicity occurred. The progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and safety of the treatment were assessed.
    RESULTS: One hundred and thirty-four patients were enrolled. The median PFS (mPFS) was 4.3 months (95% CI: 0.3-15.4). The ORR and DCR was 32.1% and 79.1%, respectively. The mPFS of patients who received eribulin as first- or second-line treatment was significantly better than those who received eribulin as ≥3-line treatment (6.9 months [95% CI: 3.2-8.8] vs. 4.0 months [95% CI: 3.4-4.6], p = 0.006). The mPFS of patients with triple-negative, HER2-positive, and HER2(-)/HR(+) was 3.4 (95% CI: 2.7-4.1), 6.2 (95% CI: 2.3-10.1) and 5.0 months (95% CI: 4.1-5.9), respectively. HER2(+) patients had significantly longer PFS than TNBC patients (p = 0.022). Patients received combination therapy had a significantly longer mPFS than those who received eribulin monotherapy (5.0 months [95% CI 3.6-6.3] vs. 4.0 months [95% CI: 3.3-4.7] [p = 0.016]). Multivariate analysis revealed that MBC patients with a molecular typing of non-TNBC receiving eribulin as ≤2-line therapy and combination therapy had a low risk of disease progression. Neutropenia (33.58%), leukopenia (11.94%), and thrombocytopenia (4.48%) were the most common treatment-related adverse events.
    CONCLUSIONS: Eribulin demonstrated effective clinical activity and a favorable tolerability profile in Chinese patients with ABC in the real-world. The efficacy and safety profile were consistent with those reported in previous randomized phase 3 trials.
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  • 文章类型: Journal Article
    未来的空域预计将变得更加拥挤,额外的服务货运和商业航班。在这样的环境下,飞行员将面临额外的负担,鉴于他们在完成工作活动时必须同时考虑的因素越来越多。因此,必须注意和注意操作飞行员所经历的心理工作量(MWL)。如果没有地址,精神超负荷状态可能会影响飞行员以安全和正确的方式完成其工作活动的能力。本研究检查了两种不同的驾驶舱显示接口(CDI)的影响,蒸汽量规面板和G1000玻璃面板,在基于飞行模拟器的环境中,新手飞行员的MWL和态势感知(SA)。在这项研究中,使用客观(EEG和HRV)和主观(NASA-TLX)评估的组合来评估新手飞行员的认知状态。我们的结果表明,CDI的量规设计会影响新手飞行员的SA和MWL,与G1000玻璃面板更有效地降低MWL和改善SA相比,蒸汽量规面板。这项研究的结果对未来飞行甲板接口的设计和未来飞行员的培训具有重要意义。
    Future airspace is expected to become more congested with additional in-service cargo and commercial flights. Pilots will face additional burdens in such an environment, given the increasing number of factors that they must simultaneously consider while completing their work activities. Therefore, care and attention must be paid to the mental workload (MWL) experienced by operating pilots. If left unaddressed, a state of mental overload could affect the pilot\'s ability to complete his or her work activities in a safe and correct manner. This study examines the impact of two different cockpit display interfaces (CDIs), the Steam Gauge panel and the G1000 Glass panel, on novice pilots\' MWL and situational awareness (SA) in a flight simulator-based setting. A combination of objective (EEG and HRV) and subjective (NASA-TLX) assessments is used to assess novice pilots\' cognitive states during this study. Our results indicate that the gauge design of the CDI affects novice pilots\' SA and MWL, with the G1000 Glass panel being more effective in reducing the MWL and improving SA compared with the Steam Gauge panel. The results of this study have implications for the design of future flight deck interfaces and the training of future pilots.
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  • 文章类型: Journal Article
    背景:在筛查时发现了一些乳腺癌,尤其是导管原位癌,可能进展为有症状疾病的可能性有限。确定非进展是一个挑战,但是如果所有筛查检测到的乳腺肿瘤最终达到临床阶段,对于有或没有筛查的女性,在相当高的年龄累积发病率是相似的,以女人活着为条件。
    方法:使用高质量的人口数据,并从逐步引入的BreastScreen挪威计划进行了24年的随访,我们研究了在50-69岁的乳房X线摄影筛查中发现的所有乳腺癌是否会在85岁内发展为临床症状.首先,我们估计了在有或没有筛查的情况下,乳腺癌的发病率按年龄划分,基于延长的年龄-时间段-队列发病率模型。接下来,我们估计了筛查检测到的病例中非进展性肿瘤的频率,通过计算85岁时筛查和非筛查方案之间的乳腺癌累积率差异。
    结果:在50至69岁参加BreastScreen挪威的女性中,我们估计,1.1%的参与者在85岁时被诊断出患有乳腺癌,但没有可能进展为有症状的疾病.潜在非进展性肿瘤的这一比例相当于筛查时检测到的乳腺癌的15.7%[95%CI3.3,27.1]。
    结论:我们的研究结果表明,在筛查中发现的乳腺癌中,六分之一可能是非进行性的。
    Some breast carcinomas detected at screening, especially ductal carcinoma in situ, may have limited potential for progression to symptomatic disease. To determine non-progression is a challenge, but if all screening-detected breast tumors eventually reach a clinical stage, the cumulative incidence at a reasonably high age would be similar for women with or without screening, conditional on the women being alive.
    Using high-quality population data with 24 years of follow-up from the gradually introduced BreastScreen Norway program, we studied whether all breast carcinomas detected at mammography screening 50-69 years of age would progress to clinical symptoms within 85 years of age. First, we estimated the incidence rates of breast carcinomas by age in scenarios with or without screening, based on an extended age-period-cohort incidence model. Next, we estimated the frequency of non-progressive tumors among screening-detected cases, by calculating the difference in the cumulative rate of breast carcinomas between the screening and non-screening scenarios at 85 years of age.
    Among women who attended BreastScreen Norway from the age of 50 to 69 years, we estimated that 1.1% of the participants were diagnosed with a breast carcinoma without the potential to progress to symptomatic disease by 85 years of age. This proportion of potentially non-progressive tumors corresponded to 15.7% [95% CI 3.3, 27.1] of breast carcinomas detected at screening.
    Our findings suggest that nearly one in six breast carcinomas detected at screening may be non-progressive.
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  • 文章类型: Multicenter Study
    背景:这项研究检查了从英国14家医院收集的接受eribulin治疗转移性乳腺癌(MBC)的患者的真实数据。
    方法:回顾性收集接受艾瑞布林治疗的MBC患者的匿名数据。数据包括激素受体状态,组织学诊断,年龄,先前的化疗,对eribulin的反应,无进展生存期(PFS),总生存率(OS)。
    结果:在577名患者中进行了分析,中位年龄为56岁,大多数患者(73%)为雌激素受体阳性.中位OS为288天(95%置信区间[CI]:261-315),PFS为117天(95%CI:105-129)。老年患者的中位OS较高(≥65vs.<65岁:325天[95%CI:264-385]vs.285天[95%CI:252-317];p=0.028)。在先前化疗行较少后接受eribulin的患者中,中位OS也较高(≤2vs.>2之前:328天[95%CI:264-385]vs.264天[95%CI:229-298];p=0.042)。
    结论:这些回顾性数据表明艾瑞布林可以成功用于老年MBC患者。Eribulin治疗在早期行设置中更有效,which,虽然可预测,支持考虑将eribulin作为二线治疗方案。
    BACKGROUND: This study examined real-world data from patients who received eribulin for metastatic breast cancer (MBC) collected from 14 hospitals across the UK.
    METHODS: Anonymized data were collected retrospectively from patients with MBC who had received eribulin. The data included the hormone-receptor status, histological diagnosis, age, prior chemotherapy, response to eribulin, progression-free survival (PFS), and overall survival (OS).
    RESULTS: Among 577 patients analyzed, the median age was 56 years, and most patients (73%) were estrogen-receptor positive. The median OS was 288 days (95% confidence interval [CI]: 261-315), and the PFS was 117 days (95% CI: 105-129). The median OS was higher among older patients (≥65 vs. <65 years: 325 days [95% CI: 264-385] vs. 285 days [95% CI: 252-317]; p = 0.028). The median OS was also higher in patients who received eribulin after fewer prior lines of chemotherapy (≤2 vs. >2 prior: 328 days [95% CI: 264-385] vs. 264 days [95% CI: 229-298]; p = 0.042).
    CONCLUSIONS: These retrospective data suggest that eribulin can be successfully used in older patients with MBC. Eribulin treatment was more effective in earlier-line settings, which, while predictable, supports consideration of eribulin as a second-line treatment option.
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  • 文章类型: Journal Article
    放射治疗期间的闪光和气味是众所周知的现象。两项前瞻性观察性研究表明,55%的患者在视网膜照射期间观察到闪光,而27%的患者在鼻腔放疗期间感觉到气味。我们对2019年1月至2021年10月期间接受全身照射(TBI)的所有患者进行了一项前瞻性观察性研究。使用与先前研究中使用的方法相同的方法检查TBI期间的闪光和气味。在研究期间共有32名患者接受TBI。患者的中位年龄为41(18-60)岁,包括20名男性和12名女性。调查清单显示,在TBI期间,有14名患者(44%)感觉到光,有14名患者(44%)感觉到气味,.照射时的光颜色为黄色的有6例,白人在四种情况下,和蓝色在四个案例中。光的强度为2-5(中位数3,1非常弱,5非常强),感觉到闪光的时间为4-60s(中位数10s)。两个病人都感觉到塑料的味道,臭氧和漂白剂,其他人都感觉到了一种气味。气味的强度为1-4(中位数3,1非常弱,5非常强),感觉到气味的时间为1-25s(中位数3s)。我们得出的结论是,在TBI期间,44%的患者都能感觉到闪光和气味。本研究报告了各种类型的闪光和气味。
    Light flash and odor during radiotherapy are well-known phenomena. Two prospective observational studies have indicated that 55% of patients observed a light flash during irradiation of the retina and 27% of patients sensed an odor during radiotherapy for the nasal cavity. A prospective observational study was performed in all patients at our hospital who received total body irradiation (TBI) between January 2019 to October 2021. Light flash and odor during TBI were examined using the same method as that used in previous studies. A total of 32 patients received TBI during the study period. The patients had a median age of 41 (18-60) years, and included 20 males and 12 females. A survey checklist showed that 14 patients (44%) sensed light and 14 patients (44%) sensed odor during TBI,. The color of the light during irradiation was yellow in six cases, white in four cases, and blue in four cases. The intensity of the light was 2-5 (median 3, 1 is very weak, 5 is very strong) and the time over which the light flash was felt was 4-60 s (median 10 s). Two patients each sensed smells of plastic, ozone and bleach, and others sensed one smell each. The intensity of the odor was 1-4 (median 3, 1 is very weak, 5 is very strong) and the time over which the odor was sensed was 1-25 s (median 3 s). We conclude that light flashes and odors are each sensed by 44% of patients during TBI. Various types of light flashes and odors were reported in this study.
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  • 文章类型: Journal Article
    建筑工程中的职业安全和健康(OSH)仍然是一个有问题的问题,OSH协调员是欧盟改善这一状况的关键举措。然而,没有关于(OSH)协调员在建筑中的影响的研究。本研究将控制层次结构(HOC)概念化为可视化和评估OSH协调员工作影响的一种手段。该研究基于与12名成功的OSH协调员进行的107天观察的实地考察记录,使用了大量的观察材料。分析显示,在这107个观察日,协调员实施了280项OSH措施,并被阻止实施71次。大多数实施的措施是在行政(53.6%)和工程(35%)控制。这可能部分解释了为什么对OSH协调的日益关注并未转化为结构中OSH结果的改善。该研究为OSH协调员和寻求提高其工作知名度和合法性的专业人员提供了见解。此外,对于有兴趣确保其组织OSH实践有效性的组织可能是有益的。该研究还为更多基于研究的实践奠定了基础,教育,以及职业安全和健康协调员的职业化。
    Occupational safety and health (OSH) in construction work continues to be a problematic issue, and OSH coordinators are a pivotal initiative for improving this in the EU. However, no studies on the impact of (OSH) coordinators in construction exists. This study conceptualizes the hierarchy of controls (HOC) as a means for visualizing and evaluating the impact of OSH coordinators\' work. The study engages with a large observational material based on fieldwork notes from 107 days of observations with 12 successful OSH coordinators. The analysis shows that during the 107 observation days, the coordinators implemented 280 OSH measures and were prevented 71 times from implementing measures. Most of the implemented measures were in the administrative (53.6%) and engineering (35%) controls. This may provide part of the explanation of why an increasing focus on OSH coordination has not translated into improved OSH outcomes in construction. The study contributes with insights for OSH coordinators and professionals seeking to improve the visibility and legitimacy of their work. In addition, it may be beneficial to organizations interested in ensuring the effectiveness of their organizational OSH practices. The study also creates foundations for more research-based practices, education, and professionalization of OSH coordinators as a profession.
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  • 文章类型: Journal Article
    Data harmonization is the process by which each of the variables from different research studies are standardized to similar units resulting in comparable datasets. These data may be integrated for more powerful and accurate examination and prediction of outcomes for use in the intelligent and smart electronic health software programs and systems. Prospective harmonization is performed when researchers create guidelines for gathering and managing the data before data collection begins. In contrast, retrospective harmonization is performed by pooling previously collected data from various studies using expert domain knowledge to identify and translate variables. In nutritional epidemiology, dietary data harmonization is often necessary to construct the nutrient and food databases necessary to answer complex research questions and develop effective public health policy. In this paper, we review methods for effective data harmonization, including developing a harmonization plan, which common standards already exist for harmonization, and defining variables needed to harmonize datasets. Currently, several large-scale studies maintain harmonized nutrient databases, especially in Europe, and steps have been proposed to inform the retrospective harmonization process. As an example, data harmonization methods are applied to several U.S longitudinal diet datasets. Based on our review, considerations for future dietary data harmonization include user agreements for sharing private data among participating studies, defining variables and data dictionaries that accurately map variables among studies, and the use of secure data storage servers to maintain privacy. These considerations establish necessary components of harmonized data for smart health applications which can promote healthier eating and provide greater insights into the effect of dietary patterns on health.
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  • 文章类型: Journal Article
    背景:接受放射治疗的患者有时会在照射过程中抱怨闪光。这种光的特性的细节没有描述。
    目的:评估光子和质子放射治疗过程中的闪光。
    方法:对2019年1月至2020年8月在两个中心接受光子和质子治疗的所有成年患者(≥20岁)进行了一项前瞻性观察性研究,但无法沟通的患者和视觉异常的患者除外。对存在或不存在闪光进行评估,光明黑暗(7级),光强度(5级),频率,光运动,灯闪烁,和时间看到光,使用每周检查表。
    结果:共检查了621例患者的650个疗程,其中416人接受了光子放射治疗,205人接受了质子束治疗。检查表显示,有88名患者(16.1%)在光子或质子放射治疗期间感觉到光。在多变量逻辑回归分析中,与闪光显著相关的因素是较高的视网膜剂量和较年轻的年龄(p<0.001).只有35/524例患者(6.7%)未照射视网膜,但是到13/33(39.4%)和41/64(64.1%),视网膜的最大等剂量线分别为10-50%和60-100%,分别。感觉到蓝色的患者数量,紫色,黄色,红色,白色和其他颜色分别为52、15、15、9、16和8(可能有多种选择)。52例患者(59%)观察到光运动。灯的位置被定义为近,远,中间有70、13和5名患者,分别。看到光的中位时间为10s。
    结论:许多患者在放疗期间感觉到闪光。视网膜剂量和年龄较小与闪光频率显着相关。
    BACKGROUND: Patients who receive radiation therapy sometimes complain of a light flash during irradiation. The details of the characteristics of this light have not been described.
    OBJECTIVE: To evaluate light flashes during photon and proton radiotherapy.
    METHODS: A prospective observational study was performed in all adult patients (≥20 years old) who received photon and proton therapy at two centers between January 2019 and August 2020, except for patients who could not communicate and those with visual abnormality. Evaluations were obtained for the presence or absence of light flashes, light darkness (7 levels), light intensity (5 levels), frequency, light movement, light flashing, and time seeing the light, using a weekly checklist.
    RESULTS: A total of 650 courses were examined for 621 patients, of whom 416 received photon radiotherapy and 205 received proton beam therapy. The checklist indicated that 88 patients (16.1%) sensed light during photon or proton radiotherapy. In multivariate logistic regression analysis, the factors that were significantly associated with a light flash were a higher retina dose and younger age (p < 0.001). Light flashes were seen by only 35/524 patients (6.7%) for whom the retina was not irradiated, but by 13/33 (39.4%) and 41/64 (64.1%) with maximum isodose lines for the retina of 10-50% and 60-100%, respectively. The numbers of patients who sensed blue, purple, yellow, red, white and other colors were 52, 15, 15, 9, 16 and 8, respectively (multiple selections possible). Light movement was observed by 52 patients (59%). The location of the light was defined as near, far, and middle by 70, 13, and 5 patients, respectively. The median time the light was seen was 10 s.
    CONCLUSIONS: Many patients sense light flashes during radiotherapy. The retina dose and a younger age were significantly associated with the frequency of light flashes.
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  • 文章类型: Journal Article
    轮状病毒感染已被认为是乳糜泻(CD)和1型糖尿病(T1D)的危险因素。英国在2013年推出了婴儿轮状病毒疫苗接种。我们之前已经表明,轮状病毒疫苗接种可以对综合征产生有益的脱靶效应,如住院癫痫发作。因此,我们调查了英国轮状病毒疫苗接种是否可以预防CD和T1D。
    使用临床实践研究数据链的初级保健记录对2010年至2015年出生的儿童进行了一项队列研究。患儿随访6个月至7岁,对结果进行审查,死亡或离开实践。CD被定义为CD的诊断或无麸质产品的处方。T1D被定义为T1D诊断。暴露是轮状病毒疫苗接种,定义为一个或多个剂量。混合效应Cox回归用于估计风险比(HR)和95%置信区间(CI)。针对潜在的混杂因素调整了模型,并包括用于一般实践的随机截获。
    队列中有880,629名儿童(48.8%为女性)。共有343,113名(39.0%)参与者接种了轮状病毒疫苗;在引入轮状病毒疫苗后出生的人中,93.4%接种了疫苗。研究参与者贡献了4,388,355人年,中位随访时间为5.66人年。有1657个CD案例,每100,000人年的发病率为38.0例。与未接种疫苗的儿童相比,对于接种疫苗的儿童,CD的校正HR为1.05(95%CI0.86-1.28).女性的危害比男性高40%。记录了733名参与者的T1D,每100,000人年的发病率为17.1例。在调整后的分析中,轮状病毒疫苗接种与T1D风险无关(HR=0.89,95%CI0.68-1.19).
    自2006年获得许可以来,轮状病毒疫苗接种大大降低了腹泻病的发病率和死亡率。我们在这项大型队列研究中的发现没有提供证据表明轮状病毒疫苗可以预防CD或T1D。也不会增加风险,提供轮状病毒疫苗安全性的进一步证据。
    Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK.
    A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices.
    There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86-1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68-1.19).
    Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.
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