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Clustering of physical health multimorbidity in people with severe mental illness: An accumulated prevalence analysis of United Kingdom primary care data. 严重精神疾病患者身体健康多病的聚类:英国初级保健数据的累积流行分析
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-20 eCollection Date: 2022-04-01 DOI: 10.1371/journal.pmed.1003976
Naomi Launders, Joseph F Hayes, Gabriele Price, David Pj Osborn

Background: People with severe mental illness (SMI) have higher rates of a range of physical health conditions, yet little is known regarding the clustering of physical health conditions in this population. We aimed to investigate the prevalence and clustering of chronic physical health conditions in people with SMI, compared to people without SMI.

Methods and findings: We performed a cohort-nested accumulated prevalence study, using primary care data from the Clinical Practice Research Datalink (CPRD), which holds details of 39 million patients in the United Kingdom. We identified 68,783 adults with a primary care diagnosis of SMI (schizophrenia, bipolar disorder, or other psychoses) from 2000 to 2018, matched up to 1:4 to 274,684 patients without an SMI diagnosis, on age, sex, primary care practice, and year of registration at the practice. Patients had a median of 28.85 (IQR: 19.10 to 41.37) years of primary care observations. Patients with SMI had higher prevalence of smoking (27.65% versus 46.08%), obesity (24.91% versus 38.09%), alcohol misuse (3.66% versus 13.47%), and drug misuse (2.08% versus 12.84%) than comparators. We defined 24 physical health conditions derived from the Elixhauser and Charlson comorbidity indices and used logistic regression to investigate individual conditions and multimorbidity. We controlled for age, sex, region, and ethnicity and then additionally for health risk factors: smoking status, alcohol misuse, drug misuse, and body mass index (BMI). We defined multimorbidity clusters using multiple correspondence analysis (MCA) and K-means cluster analysis and described them based on the observed/expected ratio. Patients with SMI had higher odds of 19 of 24 conditions and a higher prevalence of multimorbidity (odds ratio (OR): 1.84; 95% confidence interval [CI]: 1.80 to 1.88, p < 0.001) compared to those without SMI, particularly in younger age groups (males aged 30 to 39: OR: 2.49; 95% CI: 2.27 to 2.73; p < 0.001; females aged 18 to 30: OR: 2.69; 95% CI: 2.36 to 3.07; p < 0.001). Adjusting for health risk factors reduced the OR of all conditions. We identified 7 multimorbidity clusters in those with SMI and 7 in those without SMI. A total of 4 clusters were common to those with and without SMI; while 1, heart disease, appeared as one cluster in those with SMI and 3 distinct clusters in comparators; and 2 small clusters were unique to the SMI cohort. Limitations to this study include missing data, which may have led to residual confounding, and an inability to investigate the temporal associations between SMI and physical health conditions.

Conclusions: In this study, we observed that physical health conditions cluster similarly in people with and without SMI, although patients with SMI had higher burden of multimorbidity, particularly in younger age groups. While interventions aimed at the general population may also be appropriate for those with SMI, t

背景严重精神疾病(SMI)患者的一系列身体健康状况发生率较高,但对该人群中身体健康状况的聚集性知之甚少。我们旨在调查SMI患者与非SMI患者慢性身体健康状况的患病率和聚集性。方法和发现我们使用来自临床实践研究数据链(CPRD)的初级保健数据进行了一项队列嵌套累积患病率研究,该数据链包含了英国3900万患者的详细信息。从2000年到2018年,我们确定了68783名初级保健诊断为SMI(精神分裂症、双相情感障碍或其他精神病)的成年人,根据年龄、性别、初级保健实践和在该机构注册的年份,匹配了1:4至274684名未经SMI诊断的患者。患者的初级保健观察中位数为28.85年(IQR:19.10至41.37)。SMI患者的吸烟率(27.65%对46.08%)、肥胖率(24.91%对38.09%)、酗酒率(3.66%对13.47%)和药物滥用率(2.08%对12.84%)高于对照组。我们根据Elixhauser和Charlson共病指数定义了24种身体健康状况,并使用逻辑回归来研究个体状况和多发病率。我们控制了年龄、性别、地区和种族,此外还控制了健康风险因素:吸烟状况、酗酒、药物滥用和体重指数(BMI)。我们使用多重对应分析(MCA)和K-means聚类分析定义了多发病率聚类,并根据观察/预期比率对其进行了描述。SMI患者在24种情况中有19种情况的发生率较高,多发病率较高(比值比(OR):1.84;95%置信区间[CI]:1.80至1.88,p<0.001),尤其是在年轻组(30至39岁的男性:OR:2.49;95%置信区间:2.27至2.73;p<0.001;18至30岁的女性:OR:2.69;95%可信区间:2.36至3.07;p<0.001)。调整健康风险因素可降低所有情况的OR。我们在患有SMI的患者中确定了7个多发病簇,在没有SMI的人群中确定了七个多发病集群。总共有4个集群对于有SMI和没有SMI的集群是常见的;而1,心脏病,在SMI患者中表现为一个聚类,在对照组中表现为3个不同的聚类;2个小集群是SMI队列所特有的。这项研究的局限性包括数据缺失,这可能导致了残余的混淆,以及无法调查SMI与身体健康状况之间的时间相关性。结论在这项研究中,我们观察到患有和没有SMI的人的身体健康状况相似,尽管患有SMI的患者有更高的多发病负担,尤其是在年轻群体中。虽然针对普通人群的干预措施可能也适用于SMI患者,但有必要采取干预措施,更好地管理年轻多发性疾病,并采取针对年轻疾病的预防措施,减少健康风险因素。
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引用次数: 0
Evaluation of the Mexican warning label nutrient profile on food products marketed in Mexico in 2016 and 2017: A cross-sectional analysis. 2016年和2017年在墨西哥销售的食品中墨西哥警告标签营养概况的评估:横断面分析
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2022-04-20 eCollection Date: 2022-04-01 DOI: 10.1371/journal.pmed.1003968
Alejandra Contreras-Manzano, Carlos Cruz-Casarrubias, Ana Munguía, Alejandra Jáuregui, Jorge Vargas-Meza, Claudia Nieto, Lizbeth Tolentino-Mayo, Simón Barquera

Background: Different nutrient profiles (NPs) have been developed in Latin America to assess the nutritional quality of packaged food products. Recently, the Mexican NP was developed as part of the new warning label regulation implemented in 2020, considering 5 warning octagons (calories, sugar, sodium, saturated fats, and trans fats) and 2 warning rectangles (caffeine and non-nutritive sweeteners). The objective of this cross-sectional study was to evaluate the Mexican NP and other NPs proposed or used in Latin America against the Pan American Health Organization (PAHO) model.

Methods and findings: Nutrition content data of 38,872 packaged food products available in the Mexican market were collected in 2016 and 2017. The evaluation of the Mexican NP, including its 3 implementation phases of increasing stringency (2020, 2023, and 2025), was conducted by comparing the percentage of products classified as "healthy" (without warnings) or "less healthy" (with 1 or more warnings), as well as the number and type of warnings assigned to food products, against the PAHO NP. Using the calibration method, we compared the classifications produced by the PAHO model against those produced by the NP models of Ecuador, Chile (3 phases), Peru (2 phases), Uruguay, and Brazil. Kappa coefficients and Pearson correlations were estimated, and proportion tests were performed. We found that the 3 implementation phases of the Mexican NP had near to perfect agreement in the classification of healthy foods (Mexico NP models: 19.1% to 23.8%; PAHO model: 19.7%) and a strong correlation (>91.9%) with the PAHO model. Other NPs with high agreement with the PAHO model were the Ecuador (89.8%), Uruguay (82.5%), Chile Phase 3 (82.3%), and Peru Phase 2 (84.2%) NPs. In contrast, the Peru Phase 1, Brazil, and Chile Phase 1 NP models had the highest percentage of foods classified as healthy (49.2%, 47.1%, and 46.5%, respectively) and the lowest agreement with the PAHO model (69.9%, 69.3%, and 73%, respectively). Study limitations include that warnings considered by the Mexican NP models were evaluated as if all the warnings were octagon seals, while 2 out of the 7 were rectangular warnings (caffeine and non-nutritive sweeteners), and that our data are limited by the quality of the information reported in the list of ingredients and the nutrition facts table of the products.

Conclusions: The 3 implementation phases of the Mexican NP were useful to identify healthy food products. In contrast, the Peru Phase 1, Brazil, and Chile Phase 1 NP models may have limited usefulness for the classification of foods according to the content of ingredients of concern. The results of this study may inform countries seeking to adapt and evaluate existing NP models for use in population-specific applications.

拉丁美洲已经制定了不同的营养概况(NPs)来评估包装食品的营养质量。最近,作为2020年实施的新警告标签法规的一部分,墨西哥制定了NP,考虑到5个警告八角形(卡路里、糖、钠、饱和脂肪和反式脂肪)和2个警告矩形(咖啡因和非营养性甜味剂)。本横断面研究的目的是对照泛美卫生组织(PAHO)模型评估墨西哥NP和其他在拉丁美洲提出或使用的NP。方法与发现收集2016年和2017年墨西哥市场上38872种包装食品的营养成分数据。对墨西哥国家食品标准的评估,包括其日益严格的三个实施阶段(2020年、2023年和2025年),是通过比较被归类为"健康"(没有警告)或"不健康"(有一个或多个警告)的产品的百分比,以及分配给食品的警告的数量和类型,与泛美卫生组织国家食品标准进行的。使用校准方法,我们将PAHO模型产生的分类与厄瓜多尔、智利(3个阶段)、秘鲁(2个阶段)、乌拉圭和巴西的NP模型产生的分类进行了比较。估计Kappa系数和Pearson相关性,并进行比例检验。我们发现,墨西哥NP的3个实施阶段在健康食品分类方面具有近乎完美的一致性(墨西哥NP模型:19.1% ~ 23.8%;PAHO模型:19.7%),与PAHO模型相关性强(>91.9%)。其他与泛美卫生组织模式高度一致的国家计划有厄瓜多尔(89.8%)、乌拉圭(82.5%)、智利(82.3%)和秘鲁(84.2%)。相比之下,秘鲁第一阶段、巴西和智利第一阶段NP模型的健康食品比例最高(分别为49.2%、47.1%和46.5%),与泛美卫生组织模型的一致性最低(分别为69.9%、69.3%和73%)。研究的局限性包括,墨西哥NP模型考虑的警告被评估为好像所有警告都是八角形的,而7个警告中有2个是矩形警告(咖啡因和非营养性甜味剂),我们的数据受到成分列表和产品营养成分表中报告的信息质量的限制。结论墨西哥NP的三个实施阶段对健康食品的鉴别有一定的指导意义。相比之下,秘鲁第一阶段、巴西和智利第一阶段NP模型对于根据所关注的成分含量对食品进行分类可能用处有限。这项研究的结果可以为寻求调整和评估现有NP模型以用于特定人口应用的国家提供信息。
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引用次数: 0
Patient-level interventions to reduce alcohol-related harms in low- and middle-income countries: A systematic review and meta-summary. 低收入和中等收入国家减少酒精相关危害的患者级干预措施:系统综述和元综述
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-12 eCollection Date: 2022-04-01 DOI: 10.1371/journal.pmed.1003961
Catherine A Staton, João Ricardo Nickenig Vissoci, Deena El-Gabri, Konyinsope Adewumi, Tessa Concepcion, Shannon A Elliott, Daniel R Evans, Sophie W Galson, Charles T Pate, Lindy M Reynolds, Nadine A Sanchez, Alexandra E Sutton, Charlotte Yuan, Alena Pauley, Luciano Andrade, Megan Von Isenberg, Jinny J Ye, Charles J Gerardo

Background: Disease and disability from alcohol use disproportionately impact people in low- and middle-income countries (LMICs). While varied interventions have been shown to reduce alcohol use in high-income countries, their efficacy in LMICs has not been assessed. This systematic review describes current published literature on patient-level alcohol interventions in LMICs and specifically describes clinical trials evaluating interventions to reduce alcohol use in LMICs.

Methods and findings: In accordance with PRISMA, we performed a systematic review using an electronic search strategy from January 1, 1995 to December 1, 2020. Title, abstract, as well as full-text screening and extraction were performed in duplicate. A meta-summary was performed on randomized controlled trials (RCTs) that evaluated alcohol-related outcomes. We searched the following electronic databases: PubMed, EMBASE, Scopus, Web of Science, Cochrane, WHO Global Health Library, and PsycINFO. Articles that evaluated patient-level interventions targeting alcohol use and alcohol-related harm in LMICs were eligible for inclusion. No studies were excluded based on language. After screening 5,036 articles, 117 articles fit our inclusion criteria, 75 of which were RCTs. Of these RCTs, 93% were performed in 13 middle-income countries, while 7% were from 2 low-income countries. These RCTs evaluated brief interventions (24, defined as any intervention ranging from advice to counseling, lasting less than 1 hour per session up to 4 sessions), psychotherapy or counseling (15, defined as an interaction with a counselor longer than a brief intervention or that included a psychotherapeutic component), health promotion and education (20, defined as an intervention encouraged individuals' agency of taking care of their health), or biologic treatments (19, defined as interventions where the biological function of alcohol use disorder (AUD) as the main nexus of intervention) with 3 mixing categories of intervention types. Due to high heterogeneity of intervention types, outcome measures, and follow-up times, we did not conduct meta-analysis to compare and contrast studies, but created a meta-summary of all 75 RCT studies. The most commonly evaluated intervention with the most consistent positive effect was a brief intervention; similarly, motivational interviewing (MI) techniques were most commonly utilized among the diverse array of interventions evaluated.

Conclusions: Our review demonstrated numerous patient-level interventions that have the potential to be effective in LMICs, but further research to standardize interventions, populations, and outcome measures is necessary to accurately assess their effectiveness. Brief interventions and MI techniques were the most commonly evaluated and had the most consistent positive effect on alcohol-related outcomes.

Trial registration: Protocol Registry: PROSPERO C

背景:酒精使用导致的疾病和残疾对低收入和中等收入国家的人群的影响尤为严重。虽然各种干预措施已被证明可减少高收入国家的酒精使用,但其在中低收入国家的功效尚未得到评估。本系统综述描述了目前发表的关于中低收入国家患者水平酒精干预的文献,并特别描述了评估干预措施以减少中低收入国家酒精使用的临床试验。方法和发现根据PRISMA,我们从1995年1月1日至2020年12月1日使用电子检索策略进行了系统综述。标题、摘要、全文筛选和提取一式两份。对评估酒精相关结果的随机对照试验(rct)进行了荟萃总结。我们检索了以下电子数据库:PubMed、EMBASE、Scopus、Web of Science、Cochrane、WHO Global Health Library和PsycINFO。评估针对中低收入国家酒精使用和酒精相关危害的患者水平干预措施的文章符合纳入条件。没有基于语言的研究被排除在外。在筛选5036篇文章后,117篇文章符合我们的纳入标准,其中75篇为随机对照试验。在这些随机对照试验中,93%在13个中等收入国家进行,7%在2个低收入国家进行。这些随机对照试验评估了简短的干预措施(24项,定义为从建议到咨询的任何干预措施,每次持续时间少于1小时,最多4次),心理治疗或咨询(15项,定义为与咨询师的互动时间长于简短干预或包括心理治疗成分),健康促进和教育(20项,定义为鼓励个人照顾自己健康的干预措施),或生物治疗(19项,定义为以酒精使用障碍(AUD)的生物学功能作为干预的主要纽带的干预措施,包括3个混合类别的干预类型。由于干预类型、结果测量和随访时间的高度异质性,我们没有进行荟萃分析来比较和对照研究,而是对所有75项RCT研究进行了荟萃总结。最常评估的积极效果最一致的干预措施是短暂干预;同样,动机访谈(MI)技术在评估的各种干预措施中最常用。结论:我们的综述表明,许多患者层面的干预措施在中低收入国家有可能有效,但需要进一步的研究来规范干预措施、人群和结果测量,以准确评估其有效性。简短干预和心肌梗死技术是最常见的评估方法,对酒精相关的结果具有最一致的积极影响。试验注册协议注册中心:PROSPERO CRD42017055549
{"title":"Patient-level interventions to reduce alcohol-related harms in low- and middle-income countries: A systematic review and meta-summary.","authors":"Catherine A Staton, João Ricardo Nickenig Vissoci, Deena El-Gabri, Konyinsope Adewumi, Tessa Concepcion, Shannon A Elliott, Daniel R Evans, Sophie W Galson, Charles T Pate, Lindy M Reynolds, Nadine A Sanchez, Alexandra E Sutton, Charlotte Yuan, Alena Pauley, Luciano Andrade, Megan Von Isenberg, Jinny J Ye, Charles J Gerardo","doi":"10.1371/journal.pmed.1003961","DOIUrl":"10.1371/journal.pmed.1003961","url":null,"abstract":"<p><strong>Background: </strong>Disease and disability from alcohol use disproportionately impact people in low- and middle-income countries (LMICs). While varied interventions have been shown to reduce alcohol use in high-income countries, their efficacy in LMICs has not been assessed. This systematic review describes current published literature on patient-level alcohol interventions in LMICs and specifically describes clinical trials evaluating interventions to reduce alcohol use in LMICs.</p><p><strong>Methods and findings: </strong>In accordance with PRISMA, we performed a systematic review using an electronic search strategy from January 1, 1995 to December 1, 2020. Title, abstract, as well as full-text screening and extraction were performed in duplicate. A meta-summary was performed on randomized controlled trials (RCTs) that evaluated alcohol-related outcomes. We searched the following electronic databases: PubMed, EMBASE, Scopus, Web of Science, Cochrane, WHO Global Health Library, and PsycINFO. Articles that evaluated patient-level interventions targeting alcohol use and alcohol-related harm in LMICs were eligible for inclusion. No studies were excluded based on language. After screening 5,036 articles, 117 articles fit our inclusion criteria, 75 of which were RCTs. Of these RCTs, 93% were performed in 13 middle-income countries, while 7% were from 2 low-income countries. These RCTs evaluated brief interventions (24, defined as any intervention ranging from advice to counseling, lasting less than 1 hour per session up to 4 sessions), psychotherapy or counseling (15, defined as an interaction with a counselor longer than a brief intervention or that included a psychotherapeutic component), health promotion and education (20, defined as an intervention encouraged individuals' agency of taking care of their health), or biologic treatments (19, defined as interventions where the biological function of alcohol use disorder (AUD) as the main nexus of intervention) with 3 mixing categories of intervention types. Due to high heterogeneity of intervention types, outcome measures, and follow-up times, we did not conduct meta-analysis to compare and contrast studies, but created a meta-summary of all 75 RCT studies. The most commonly evaluated intervention with the most consistent positive effect was a brief intervention; similarly, motivational interviewing (MI) techniques were most commonly utilized among the diverse array of interventions evaluated.</p><p><strong>Conclusions: </strong>Our review demonstrated numerous patient-level interventions that have the potential to be effective in LMICs, but further research to standardize interventions, populations, and outcome measures is necessary to accurately assess their effectiveness. Brief interventions and MI techniques were the most commonly evaluated and had the most consistent positive effect on alcohol-related outcomes.</p><p><strong>Trial registration: </strong>Protocol Registry: PROSPERO C","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":null,"pages":null},"PeriodicalIF":15.8,"publicationDate":"2022-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9004752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47533888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of trends in child undernutrition and implementation of the National Rural Health Mission in India: A nationally representative serial cross-sectional study on data from 1992 to 2015. 儿童营养不良趋势与印度全国农村保健任务的执行之间的联系:1992年至2015年数据的全国代表性系列横断面研究
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2022-04-08 eCollection Date: 2022-04-01 DOI: 10.1371/journal.pmed.1003957
Apurv Soni, Nisha Fahey, Zulfiqar Bhutta, Wenjun Li, Tiffany Moore Simas, Somashekhar Nimbalkar, Jeroan Allison

Background: India launched the National Rural Health Mission (NRHM) in 2005 to strengthen its primary healthcare system in high-focus and northeast-focus states. One of the NRHM objectives was to reduce child undernutrition in India.

Methods and findings: We used data from 1992, 1998, 2005, and 2015 National Family Health Survey (NFHS) of India to evaluate trends in child undernutrition prevalence before and after NRHM and across different categories of focus states. Stunting, Wasting, and Comprehensive Index of Anthropometric Failure (CIAF) were assessed using the World Health Organization (WHO) growth curves to assess chronic, acute, and overall undernutrition. The study included 187,452 children aged 3 years or under. Survey-weighted and confounder-adjusted average annualized reduction rates (AARRs) and predicted probability ratios were used to assess trends and socioeconomic disparities for child undernutrition, respectively. Nationwide, the prevalence of all types of undernutrition decreased from 1992 to 2015. However, the trends varied before and after NRHM implementation and differentially by focus states. After NRHM, acute undernutrition declined more rapidly among high-focus states (AARR 1.0%) but increased in normal-focus states (AARR -1.9% per year; p-value for the difference <0.001). In contrast, the prevalence of chronic undernutrition declined more rapidly (AARR 1.6%) in the normal-focus states in comparison to high-focus states (0.3%; p-value for the difference = 0.01). Income and caste-based disparities in acute undernutrition decreased but did not disappear after the implementation of the NRHM. However, similar disparities in prevalence of chronic undernutrition appear to be exacerbated after the implementation of the NRHM. Major limitations of this study include the observational and cross-sectional design, which preclude our ability to draw causal inferences.

Conclusions: Our results suggests that NRHM implementation might be associated with improvement in wasting (acute) rather than stunting (chronic) forms of undernutrition. Strategies to combat undernutrition equitably, especially in high-focus states, are needed.

背景:印度于2005年启动了国家农村卫生任务(NRHM),以加强其重点州和东北重点州的初级卫生保健系统。该计划的目标之一是减少印度儿童营养不良的情况。方法和研究结果:我们使用了1992年、1998年、2005年和2015年印度全国家庭健康调查的数据,以评估儿童营养不良患病率在全国人口健康调整前后以及不同类别的重点邦之间的趋势。使用WHO生长曲线评估慢性、急性和全面营养不良,评估发育迟缓、消瘦和人体测量衰竭综合指数(CIAF)。该研究包括187,452名3岁或以下的儿童。调查加权和混杂因素调整平均年化减少率(AARR)和预测概率比分别用于评估儿童营养不良的趋势和社会经济差异。1992年至2015年,全国各类营养不良发生率均有所下降。然而,在实施新农改方案前后,趋势有所不同,且因重点州而异。NRHM后,急性营养不良在高度关注状态下下降更快(AARR为1.0%),但在正常关注状态下增加(AARR为-1.9% /年);p < 0.001)。相比之下,与高度关注状态相比,正常关注状态的慢性营养不良患病率下降更快(AARR 1.6%) (0.3%;p = 0.01)。急性营养不良的收入和种姓差异有所减少,但在实施国家营养管理方案后并未消失。然而,慢性营养不良患病率方面的类似差异在实施国家营养管理方案后似乎加剧了。本研究的主要局限性包括观察性和横断面设计,这排除了我们得出因果推论的能力。结论:我们的研究结果表明,NRHM的实施可能与改善营养不良(急性)形式的消瘦有关,而不是与营养不良(慢性)形式的发育不良有关。需要制定战略,公平地应对营养不良,特别是在重点高度集中的国家。
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引用次数: 0
Temporal trends in associations between severe mental illness and risk of cardiovascular disease: A systematic review and meta-analysis 严重精神疾病与心血管疾病风险相关性的时间趋势:一项系统回顾和荟萃分析
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003960
A. Lambert, H. Parretti, Emma Pearce, M. Price, Mark Riley, R. Ryan, N. Tyldesley-Marshall, T. Avşar, Gemma Matthewman, Alexandra Lee, Khaled Ahmed, M. Odland, C. Correll, M. Solmi, T. Marshall
Background Severe mental illness (SMI; schizophrenia, bipolar disorders (BDs), and other nonorganic psychoses) is associated with increased risk of cardiovascular disease (CVD) and CVD-related mortality. To date, no systematic review has investigated changes in population level CVD-related mortality over calendar time. It is unclear if this relationship has changed over time in higher-income countries with changing treatments. Methods and findings To address this gap, a systematic review was conducted, to assess the association between SMI and CVD including temporal change. Seven databases were searched (last: November 30, 2021) for cohort or case–control studies lasting ≥1 year, comparing frequency of CVD mortality or incidence in high-income countries between people with versus without SMI. No language restrictions were applied. Random effects meta-analyses were conducted to compute pooled hazard ratios (HRs) and rate ratios, pooled standardised mortality ratios (SMRs), pooled odds ratios (ORs), and pooled risk ratios (RRs) of CVD in those with versus without SMI. Temporal trends were explored by decade. Subgroup analyses by age, sex, setting, world region, and study quality (Newcastle–Ottawa scale (NOS) score) were conducted. The narrative synthesis included 108 studies, and the quantitative synthesis 59 mortality studies (with (≥1,841,356 cases and 29,321,409 controls) and 28 incidence studies (≥401,909 cases and 14,372,146 controls). The risk of CVD-related mortality for people with SMI was higher than controls across most comparisons, except for total CVD-related mortality for BD and cerebrovascular accident (CVA) for mixed SMI. Estimated risks were larger for schizophrenia than BD. Pooled results ranged from SMR = 1.55 (95% confidence interval (CI): 1.33 to 1.81, p < 0.001), for CVA in people with BD to HR/rate ratio = 2.40 (95% CI: 2.25 to 2.55, p < 0.001) for CVA in schizophrenia. For schizophrenia and BD, SMRs and pooled HRs/rate ratios for CHD and CVD mortality were larger in studies with outcomes occurring during the 1990s and 2000s than earlier decades (1980s: SMR = 1.14, 95% CI: 0.57 to 2.30, p = 0.71; 2000s: SMR = 2.59, 95% CI: 1.93 to 3.47, p < 0.001 for schizophrenia and CHD) and in studies including people with younger age. The incidence of CVA, CVD events, and heart failure in SMI was higher than controls. Estimated risks for schizophrenia ranged from HR/rate ratio 1.25 (95% CI: 1.04 to 1.51, p = 0.016) for total CVD events to rate ratio 3.82 (95% CI: 3.1 to 4.71, p < 0.001) for heart failure. Incidence of CHD was higher in BD versus controls. However, for schizophrenia, CHD was elevated in higher-quality studies only. The HR/rate ratios for CVA and CHD were larger in studies with outcomes occurring after the 1990s. Study limitations include the high risk of bias of some studies as they drew a comparison cohort from general population rates and the fact that it was difficult to exclude studies that had overlapping populations,
背景严重精神疾病(SMI;精神分裂症、双相情感障碍(BD)和其他非器质性精神病)与心血管疾病(CVD)和CVD相关死亡率的增加有关。到目前为止,还没有系统的综述调查人口水平CVD相关死亡率随日历时间的变化。目前尚不清楚这种关系是否随着治疗方法的改变而在高收入国家发生了变化。方法和发现为了解决这一差距,进行了一项系统综述,以评估SMI和CVD之间的关系,包括时间变化。检索了7个数据库(最后一次:2021年11月30日),以进行持续时间≥1年的队列或病例对照研究,比较了高收入国家患有SMI和未患有SMI人群的CVD死亡率或发病率。没有语言限制。随机效应荟萃分析用于计算患有和不患有SMI的CVD患者的合并危险比(HR)和比率比、合并标准化死亡率比(SMR)、合并优势比(OR)和合并风险比(RR)。按十年探讨了时间趋势。按年龄、性别、环境、世界地区和学习质量(纽卡斯尔-渥太华量表(NOS)评分)进行亚组分析。叙述性综合包括108项研究,定量综合包括59项死亡率研究(≥1841356例和29321409例对照)和28项发病率研究(≥401909例和14372146例对照)。在大多数比较中,除了BD的CVD相关总死亡率和混合SMI的脑血管意外(CVA)外,SMI患者的CVD相关死亡率高于对照组。精神分裂症的估计风险大于BD。合并结果范围为:BD患者CVA的SMR=1.55(95%置信区间(CI):1.33至1.81,p<0.001),精神分裂症患者CVA与HR/比率之比=2.40(95%可信区间:2.25至2.55,p<001)。对于精神分裂症和BD,在20世纪90年代和21世纪初进行的结果研究中,CHD和CVD死亡率的SMRs和合并HRs/rate比率比前几十年更大(20世纪80年代:SMR=1.14,95%CI:0.57至2.30,p=0.71;21世纪初:SMR=2.59,95%CI:1.93至3.47,精神分裂症与CHD的p<0.001),以及在包括年轻人在内的研究中。SMI的CVA、CVD事件和心力衰竭的发生率高于对照组。精神分裂症的估计风险范围从总CVD事件的HR/比率1.25(95%CI:1.04-1.51,p=0.016)到心力衰竭的比率3.82(95%CI:3.1-4.71,p<0.001)。BD患者的CHD发病率高于对照组。然而,对于精神分裂症,CHD仅在高质量研究中升高。结果发生在20世纪90年代之后的研究中,CVA和CHD的HR/比率更大。研究的局限性包括一些研究从一般人群比率中提取比较队列时存在较高的偏倚风险,以及很难排除具有重叠人群的研究,尽管已尝试将其降至最低。结论在这项研究中,我们发现SMI与CVD相关死亡率的比率大约翻了一番有关,特别是自20世纪90年代以来,以及在年轻群体中。自20世纪90年代以来,相对于对照组参与者,SMI也与CVA和CHD的发病率增加有关。需要更多的研究来阐明SMI和CHD之间的联系以及减轻这种风险的方法。
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引用次数: 33
Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial 坦桑尼亚艾滋病毒感染者孕期和哺乳期补充维生素D3:一项随机对照试验
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003973
C. Sudfeld, K. Manji, A. Muhihi, Christopher P. Duggan, S. Aboud, F. A. Alwy Al-Beity, Molin Wang, Ning Zhang, Nzovu K Ulenga, W. Fawzi
Background Observational studies suggest that vitamin D deficiency among people living with HIV is associated with a greater risk of disease progression and death. Low levels of vitamin D in pregnancy are also associated with poor fetal and infant growth. Therefore, vitamin D supplementation may improve clinical outcomes for pregnant women living with HIV and improve fetal and postnatal growth for their infants. Methods and findings We conducted a randomized, triple-blind, placebo-controlled trial of vitamin D3 supplementation among pregnant and lactating women living with HIV in Dar es Salaam, Tanzania (ClinicalTrials.gov NCT02305927). Participants were randomized with 1:1 allocation stratified by study clinic to receive either daily 3,000 IU vitamin D3 supplements or matching placebo supplements from the second trimester of pregnancy (12–27 weeks) until 1 year postpartum. The primary outcomes were (i) maternal HIV progression or death, (ii) small-for-gestational-age (SGA) live births (<10th percentile), and (iii) infant stunting at 1 year of age (length-for-age z-score < −2). We also examined the effect of vitamin D3 supplementation on secondary maternal and infant health outcomes, maternal and infant serum 25-hydroxyvitamin D (25[OH]D) concentrations, and maternal hypercalcemia. An intent-to-treat analysis was used as the primary analytic approach. We enrolled 2,300 pregnant women between June 15, 2015, and April 17, 2018, and follow-up of mothers and infants was completed on October 20, 2019. There were 1,148 pregnant women randomly assigned to the vitamin D3 group, and 1,152 to the placebo group. The proportion of mothers lost to follow-up at 1 year postpartum was 6.6% in the vitamin D3 group (83 of 1,148) and 6.6% in the placebo group (76 of 1,152). The proportion of children lost to follow-up at 1 year of age was 5.5% in the vitamin D3 group (59 of 1,074 live births) and 5.2% in the placebo group (57 of 1,093 live births). There was no difference in the risk of maternal HIV progression or death, with 166 events during 1,461 person-years of follow-up in the vitamin D3 group and 141 events during 1,469 person-years of follow-up in the placebo group (hazard ratio 1.21, 95% CI 0.97 to 1.52, p = 0.09). There was no difference in the risk of SGA birth between the vitamin D3 (229 SGA births among 1,070 live births) and placebo groups (236 SGA births among 1,091 live births) (relative risk 1.03, 95% CI 0.87 to 1.22, p = 0.70). There was also no difference in the risk of infant stunting at 1 year of age between the vitamin D3 (407 events among 867 infants) and placebo groups (413 events among 873 infants) (relative risk 1.00, 95% CI 0.92 to 1.10, p = 0.95). In terms of adverse events, no cases of maternal hypercalcemia were identified. One hypersensitivity reaction to the trial supplements occurred for a pregnant woman in the placebo group. A limitation of our study is that our findings may not be generalizable to HIV-negative pregnant women or con
观察性研究表明,艾滋病毒感染者缺乏维生素D与疾病进展和死亡的风险增加有关。怀孕期间维生素D水平低也与胎儿和婴儿发育不良有关。因此,补充维生素D可以改善感染艾滋病毒的孕妇的临床结果,并改善其婴儿的胎儿和产后生长。我们在坦桑尼亚达累斯萨拉姆对感染艾滋病毒的孕妇和哺乳期妇女进行了一项补充维生素D3的随机、三盲、安慰剂对照试验(ClinicalTrials.gov NCT02305927)。参与者按1:1的比例随机分配,根据研究诊所分层,从妊娠中期(12-27周)到产后1年,每天服用3,000 IU维生素D3补充剂或匹配的安慰剂补充剂。主要结局是(i)产妇艾滋病毒进展或死亡,(ii)小于胎龄(SGA)活产(<10百分位数),以及(iii) 1岁时婴儿发育迟缓(年龄长度z-score < - 2)。我们还研究了补充维生素D3对次级母婴健康结局、母婴血清25-羟基维生素D (25[OH]D)浓度和孕产妇高钙血症的影响。意向治疗分析被用作主要的分析方法。我们在2015年6月15日至2018年4月17日期间招募了2300名孕妇,并于2019年10月20日完成了对母婴的随访。1148名孕妇被随机分配到维生素D3组,1152名孕妇被分配到安慰剂组。维生素D3组(1148人中有83人)和安慰剂组(1152人中有76人)在产后1年失去随访的母亲比例分别为6.6%和6.6%。1岁时失去随访的儿童比例在维生素D3组为5.5%(1074名活产婴儿中有59名),安慰剂组为5.2%(1093名活产婴儿中有57名)。母体HIV进展或死亡的风险没有差异,维生素D3组在1461人-年的随访中有166个事件,安慰剂组在1469人-年的随访中有141个事件(风险比1.21,95% CI 0.97 ~ 1.52, p = 0.09)。维生素D3组(1070例活产中229例SGA出生)和安慰剂组(1091例活产中236例SGA出生)的SGA出生风险无差异(相对风险1.03,95% CI 0.87 ~ 1.22, p = 0.70)。在维生素D3组(867名婴儿中有407起事件)和安慰剂组(873名婴儿中有413起事件)之间,1岁婴儿发育迟缓的风险也没有差异(相对风险1.00,95% CI 0.92至1.10,p = 0.95)。在不良事件方面,没有发现产妇高钙血症的病例。一名服用安慰剂组的孕妇出现了对试验补充剂的过敏反应。我们研究的一个局限性是,我们的发现可能不适用于艾滋病毒阴性的孕妇或严重缺乏维生素D的情况。结论:试验结果不支持坦桑尼亚感染艾滋病毒的孕妇和哺乳期妇女常规补充维生素D。临床试验注册:ClinicalTrials.gov标识符:NCT02305927。
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引用次数: 6
Social justice now for an equitable tomorrow: Reflections from the Consortium of Universities for Global Health Conference 2022 为了公平的明天,现在的社会正义:2022年全球卫生会议大学联盟的思考
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003995
Beryne Odeny, C. Davidson
PLOS Medicine editors Beryne Odeny and Callam Davidson report from the Consortium of Universities for Global Health conference.
公共科学图书馆医学编辑Beryne Odeny和Callam Davidson在全球卫生大学联盟会议上报道。
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引用次数: 0
Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis 随机试验未注册、终止和未发表:一项重复元研究分析
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003980
B. Speich, D. Gryaznov, J. Busse, V. Gloy, S. Lohner, K. Klatte, Ala Taji Heravi, Nilabh Ghosh, Hopin Lee, A. Mansouri, I. Marian, R. Saccilotto, E. Nury, B. Kasenda, Elena Ojeda-Ruiz, S. Schandelmaier, Y. Tomonaga, A. Amstutz, C. Pauli-Magnus, K. Bischoff, K. Wollmann, Laura Rehner, J. Meerpohl, A. Nordmann, Jacqueline Wong, Ngai Chow, P. Hong, Kimberly Mc Cord-De Iaco, S. Sricharoenchai, A. Agarwal, M. Schwenkglenks, L. Hemkens, E. von Elm, Bethan Copsey, Alexandra N Griessbach, C. Schönenberger, D. Mertz, Anette Blümle, Belinda von Niederhäusern, S. Hopewell, A. Odutayo, M. Briel
Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rat
我们之前发现,2000年至2003年间批准的1017项随机临床试验(rct)中有25%过早终止,44%在中位随访12年后仍未发表。我们的目的是评估十年后(1)论文的完成率和发表率是否有所提高;(2)在试验注册库中识别未发表的随机对照试验的程度;(3)方案报告质量与rct过早终止或未发表之间的关系。方法和发现我们纳入了瑞士、英国、德国和加拿大研究伦理委员会于2012年批准的326项RCT方案。排除了试点、可行性和一期研究。我们从每个研究方案中提取试验特征,并系统地检索相应的试验注册(如果没有在方案中报道)和全文出版物,直到2022年2月。对于试验注册,我们检索了:(i)世界卫生组织:国际临床试验注册平台(ICTRP);(ii)美国国家医学图书馆(ClinicalTrials.gov);欧洲联盟药物管制当局临床试验数据库(EUCTR);ISRCTN登记处;(v)谷歌。对于全文出版物,我们搜索了PubMed、b谷歌Scholar和Scopus。我们记录RCTs是否注册、停止(包括停止的原因)和发表。采用33项SPIRIT检查表评估RCT方案的报告质量。我们使用多变量logistic回归来检验自变量(方案报告质量、计划样本量、对照类型(安慰剂与其他)、任何招募计划的报告、单中心与多中心试验、行业与研究者赞助)与2个因变量之间的关联:(1)RCT结果的发表;(2)因招募不良而中止试验。在纳入的326项试验中,19项(6%)未注册。98项试验(30%)过早终止,最常见的原因是招募不良(37%;36/98)。五分之一的试验(21%;70/326)在10年随访时仍未发表,21%未发表的试验(15/70)未注册。147项研究者赞助的试验中有23项(16%)在试验注册中报告了结果,而179项行业赞助的试验中有150项(84%)报告了结果。在纳入的RCT方案中,报告的SPIRIT项目的中位数比例为69%(四分位数范围为61%至77%)。我们没有发现与试验中止相关的变量;然而,较低的试验方案报告质量与未发表相关(每增加10%的SPIRIT项目比例,优势比为0.71;95%置信区间为0.55 ~ 0.92;P = 0.009)。研究的局限性包括适度的样本量可能限制了我们的回归模型识别显著关联的能力。结论:我们观察到,在过去十年中,过早终止试验的比率没有变化。不发表随机对照试验的情况有所下降,但仍很常见;21%未发表的试验无法在注册库中找到。只有16%的研究者赞助的试验在试验登记中报告了结果。较高的RCT方案报告质量与结果的发表相关。需要所有利益攸关方进一步努力提高临床研究的效率和透明度。
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引用次数: 13
School performance in Danish children exposed to maternal type 1 diabetes in utero: A nationwide retrospective cohort study 在子宫内暴露于母亲1型糖尿病的丹麦儿童的学校表现:一项全国性的回顾性队列研究
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003977
A. L. Spangmose, Niels Skipper, S. Knorr, Tina Wullum Gundersen, R. Beck Jensen, P. Damm, E. Lykke Mortensen, A. Pinborg, J. Svensson, Tine D. Clausen
Background Conflicting results have been reported concerning possible adverse effects on the cognitive function of offspring of mothers with type 1 diabetes (O-mT1D). Previous studies have included offspring of parents from the background population (O-BP), but not offspring of fathers with type 1 diabetes (O-fT1D) as the unexposed reference group. Methods and findings This is a population-based retrospective cohort study from 2010 to 2016. Nationally standardized school test scores (range, 1 to 100) were obtained for public school grades 2, 3, 4, 6, and 8 in O-mT1D and compared with those in O-fT1D and O-BP. Of the 622,073 included children, 2,144 were O-mT1D, and 3,474 were O-fT1D. Multiple linear regression models were used to compare outcomes, including the covariates offspring with type 1 diabetes, parity, number of siblings, offspring sex, smoking during pregnancy, parental age, and socioeconomic factors. Mean test scores were 54.2 (standard deviation, SD 24.8) in O-mT1D, 54.4 (SD 24.8) in O-fT1D, and 56.4 (SD 24.7) in O-BP. In adjusted analyses, the mean differences in test scores were −1.59 (95% CI −2.48 to −0.71, p < 0.001) between O-mT1D and O-BP and −0.78 (95% CI −1.48 to −0.08, p = 0.03) between O-fT1D and O-BP. No significant difference in the adjusted mean test scores was found between O-mT1D and O-fT1D (p = 0.16). The study’s limitation was no access to measures of glycemic control during pregnancy. Conclusions O-mT1D achieved lower test scores than O-BP but similar test scores compared with O-fT1D. Glycemic control during pregnancy is essential to prevent various adverse pregnancy outcomes in women with type 1 diabetes. However, the present study reduces previous concerns regarding adverse effects of in utero hyperglycemia on offspring cognitive function.
背景关于1型糖尿病(O-mT1D)母亲的后代可能对认知功能产生的不良影响,已经报道了相互矛盾的结果。先前的研究包括来自背景人群(O-BP)的父母的后代,但没有将患有1型糖尿病(O-fT1D)的父亲的后代作为未暴露的参考组。方法和发现这是一项2010年至2016年基于人群的回顾性队列研究。公立学校2、3、4、6和8年级在O-mT1D中获得了全国标准化的学校考试成绩(1至100分),并与O-fT1D和O-BP进行了比较。在纳入的622073名儿童中,2144名为O-mT1D,3474名为O-fT1D。多元线性回归模型用于比较结果,包括患有1型糖尿病的后代的协变量、产次、兄弟姐妹数量、后代性别、怀孕期间吸烟、父母年龄和社会经济因素。O-mT1D的平均测试得分为54.2(标准差,SD 24.8),O-fT1D为54.4(SD 24.8。在调整后的分析中,O-mT1D和O-BP之间的测试得分平均差异为−1.59(95%CI−2.48至−0.71,p<0.001),O-fT1D和O-BP之间的平均差异为–0.78(95%CI−1.48至−0.08,p=0.03)。O-mT1D和O-fT1D之间的调整后平均测试分数没有显著差异(p=0.16)。该研究的局限性是无法获得妊娠期间血糖控制的措施。结论O-mT1D的测试成绩低于O-BP,但与O-fT1D相似。妊娠期间的血糖控制对于预防1型糖尿病妇女的各种不良妊娠结局至关重要。然而,本研究减少了先前对子宫内高血糖对后代认知功能不良影响的担忧。
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引用次数: 4
Prenatal influenza vaccination and allergic and autoimmune diseases in childhood: A longitudinal, population-based linked cohort study 产前流感疫苗接种与儿童过敏和自身免疫性疾病:一项纵向、基于人群的相关队列研究
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2022-04-01 DOI: 10.1371/journal.pmed.1003963
Damien Foo, M. Sarna, G. Pereira, H. Moore, A. Regan
Background Few studies have evaluated the effect of maternal influenza vaccination on the development of allergic and autoimmune diseases in children beyond 6 months of age. We aimed to investigate the association between in utero exposure to seasonal inactivated influenza vaccine (IIV) and subsequent diagnosis of allergic and autoimmune diseases. Methods and findings This longitudinal, population-based linked cohort study included 124,760 singleton, live-born children from 106,206 mothers in Western Australia (WA) born between April 2012 and July 2016, with up to 5 years of follow-up from birth. In our study cohort, 64,169 (51.4%) were male, 6,566 (5.3%) were Aboriginal and/or Torres Strait Islander children, and the mean age at the end of follow-up was 3.0 (standard deviation, 1.3) years. The exposure was receipt of seasonal IIV during pregnancy. The outcomes were diagnosis of an allergic or autoimmune disease, including asthma and anaphylaxis, identified from hospital and/or emergency department (ED) records. Inverse probability of treatment weights (IPTWs) accounted for baseline probability of vaccination by maternal age, Aboriginal and/or Torres Strait Islander status, socioeconomic status, body mass index, parity, medical conditions, pregnancy complications, prenatal smoking, and prenatal care. The models additionally adjusted for the Aboriginal and/or Torres Strait Islander status of the child. There were 14,396 (11.5%) maternally vaccinated children; 913 (6.3%) maternally vaccinated and 7,655 (6.9%) maternally unvaccinated children had a diagnosis of allergic or autoimmune disease, respectively. Overall, maternal influenza vaccination was not associated with diagnosis of an allergic or autoimmune disease (adjusted hazard ratio [aHR], 1.02; 95% confidence interval [CI], 0.95 to 1.09). In trimester-specific analyses, we identified a negative association between third trimester influenza vaccination and the diagnosis of asthma (n = 40; aHR, 0.70; 95% CI, 0.50 to 0.97) and anaphylaxis (n = 36; aHR, 0.67; 95% CI, 0.47 to 0.95).We did not capture outcomes diagnosed in a primary care setting; therefore, our findings are only generalizable to more severe events requiring hospitalization or presentation to the ED. Due to small cell sizes (i.e., <5), estimates could not be determined for all outcomes after stratification. Conclusions In this study, we observed no association between in utero exposure to influenza vaccine and diagnosis of allergic or autoimmune diseases. Although we identified a negative association of asthma and anaphylaxis diagnosis when seasonal IIV was administered later in pregnancy, additional studies are needed to confirm this. Overall, our findings support the safety of seasonal inactivated influenza vaccine during pregnancy in relation to allergic and autoimmune diseases in early childhood and support the continuation of current global maternal vaccine programs and policies.
背景很少有研究评估母亲接种流感疫苗对6个月以上儿童过敏性和自身免疫性疾病发展的影响。我们旨在研究子宫内接触季节性灭活流感疫苗(IIV)与随后诊断过敏性和自身免疫性疾病之间的关系。方法和发现这项基于人群的纵向关联队列研究包括来自西澳大利亚州106206名母亲的124760名单胎活产儿童,这些儿童于2012年4月至2016年7月出生,从出生起随访长达5年。在我们的研究队列中,64169名(51.4%)为男性,6566名(5.3%)为原住民和/或托雷斯海峡岛民儿童,随访结束时的平均年龄为3.0岁(标准差,1.3)。暴露是在妊娠期间接受季节性IIV。结果是从医院和/或急诊科(ED)记录中确定的过敏性或自身免疫性疾病的诊断,包括哮喘和过敏反应。根据母亲年龄、原住民和/或托雷斯海峡岛民身份、社会经济地位、体重指数、产次、医疗条件、妊娠并发症、产前吸烟和产前护理,治疗权重的反向概率(IPTW)说明了接种疫苗的基线概率。模型还根据儿童的土著和/或托雷斯海峡岛民身份进行了调整。有14396名(11.5%)母亲接种疫苗的儿童;913名(6.3%)母亲接种过疫苗的儿童和7655名(6.9%)母亲未接种疫苗的儿童分别被诊断为过敏性或自身免疫性疾病。总体而言,母体流感疫苗接种与过敏性或自身免疫性疾病的诊断无关(调整后的危险比[aHR],1.02;95%置信区间[CI],0.95至1.09),我们确定了妊娠晚期流感疫苗接种与哮喘(n=40;aHR,0.70;95%CI,0.50至0.97)和过敏反应(n=36;aHR为0.67;95%CI为0.47至0.95)的诊断之间的负相关;因此,我们的研究结果只能推广到需要住院治疗或急诊科就诊的更严重事件。由于细胞大小较小(即<5),无法确定分层后所有结果的估计值。结论在本研究中,我们观察到子宫内接触流感疫苗与过敏性或自身免疫性疾病的诊断之间没有关联。尽管我们在妊娠后期使用季节性IIV时发现哮喘和过敏反应诊断呈负相关,但还需要更多的研究来证实这一点。总的来说,我们的研究结果支持季节性流感灭活疫苗在妊娠期间与儿童早期过敏性和自身免疫性疾病相关的安全性,并支持当前全球孕产妇疫苗计划和政策的延续。
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引用次数: 0
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