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Proactive therapeutic drug monitoring of biologic drugs in patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis: systematic review and meta-analysis. 对炎症性肠病、炎症性关节炎和银屑病患者的生物药物进行主动治疗药物监测:系统综述和荟萃分析。
Pub Date : 2024-10-28 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000998
Dena Zeraatkar, Tyler Stacy Pitre, Sarah Kirsh, Tanvir Jassal, Michael Ling, Muizz Hussain, Rachel J Couban, Leticia Kawano-Dourado, Eirik K Kristianslund, Per Olav Vandvik
<p><strong>Objective: </strong>To address the efficacy and safety of proactive therapeutic drug monitoring of biologic drugs for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources: </strong>Medline, Embase, Central, and CINAHL, from database inception to 23 May 2024.</p><p><strong>Eligibility criteria for selecting studies: </strong>Trials including people with inflammatory bowel disease, inflammatory arthritis, and psoriasis were selected. Selected trials also randomly assigned people to either proactive therapeutic drug monitoring of tumour necrosis factor-alpha inhibitors or other biologic drugs in the intervention group, and to either no therapeutic drug monitoring or standard care in the control group. Reviewers worked independently and in duplicate to screen search records and collect data from eligible trials. For each outcome, a frequentist, pairwise, random effects meta-analysis was done and the certainty of evidence was assessed using GRADE (grading of recommendations, assessment, development, and evaluations).</p><p><strong>Results: </strong>Of 10 eligible trials identified, reporting on 2383 patients, two investigated induction with infliximab (533 patients), four assessed maintenance with infliximab (901 patients), and three assessed maintenance with adalimumab (710 patients). One trial was of maintenance with infliximab, adalimumab, and etanercept (239 patients). For patients who had induction with infliximab, the effects of proactive therapeutic drug monitoring on remission and adverse events were uncertain. Low certainty evidence suggested that proactive therapeutic drug monitoring may have little or no effect on disease activity, physical function, mental health, and quality of life. For patients who had maintenance with infliximab, low certainty evidence suggested that proactive therapeutic drug monitoring may increase the proportion of patients who had sustained disease control or remission (relative risk 1.26 (95% confidence interval (CI) 1.14 to 1.40), absolute risk difference of 146 more per 1000 patients treated for one year (95% CI 78 to 224). Additionally, this treatment and monitoring may reduce disease worsening, and may have little or no effect on disease activity, physical function, mental health, and quality of life. The effects of proactive therapeutic drug monitoring of infliximab on adverse events and formation of anti-drug antibodies were uncertain. For patients who had maintenance with adalimumab, the effects of proactive therapeutic drug monitoring were uncertain.</p><p><strong>Conclusion: </strong>Proactive therapeutic drug monitoring of infliximab during maintenance may help patients to have sustained disease control or remission. No compelling evidence supported the effectiveness of proactive therapeutic drug monitoring of infliximab during induction or proactive therapeutic drug monit
目的探讨对炎症性肠病、炎症性关节炎和银屑病患者的生物药物进行主动治疗药物监测的有效性和安全性:系统综述和荟萃分析:数据来源:Medline、Embase、Central 和 CINAHL,从数据库开始到 2024 年 5 月 23 日:选择了包括炎症性肠病、炎症性关节炎和银屑病患者在内的试验。所选试验还随机分配干预组患者接受肿瘤坏死因子-α抑制剂或其他生物药物的主动治疗药物监测,对照组患者接受无治疗药物监测或标准护理。审稿人独立工作,重复筛选检索记录,从符合条件的试验中收集数据。对于每项结果,都进行了频数、配对、随机效应荟萃分析,并使用 GRADE(建议、评估、发展和评价分级)对证据的确定性进行了评估:10项符合条件的试验共报告了2383名患者,其中两项研究了英夫利西单抗的诱导治疗(533名患者),四项评估了英夫利西单抗的维持治疗(901名患者),三项评估了阿达木单抗的维持治疗(710名患者)。一项试验评估了英夫利西单抗、阿达木单抗和依那西普的维持治疗效果(239 名患者)。对于使用英夫利西单抗进行诱导治疗的患者,主动治疗药物监测对缓解和不良事件的影响尚不确定。低确定性证据表明,主动治疗药物监测可能对疾病活动、身体功能、心理健康和生活质量影响很小或没有影响。对于接受英夫利西单抗维持治疗的患者,低确定性证据表明,主动治疗药物监测可能会增加疾病得到持续控制或缓解的患者比例(相对风险为 1.26(95% 置信区间(CI)为 1.14 至 1.40),每 1000 名接受一年治疗的患者的绝对风险差异为 146(95% 置信区间(CI)为 78 至 224)。此外,这种治疗和监测可减少疾病的恶化,对疾病活动、身体功能、心理健康和生活质量的影响很小或没有影响。英夫利西单抗主动治疗药物监测对不良事件和抗药抗体形成的影响尚不确定。对于使用阿达木单抗维持治疗的患者,主动治疗药物监测的效果尚不确定:结论:在维持治疗期间对英夫利西单抗进行前瞻性治疗药物监测可能有助于患者获得持续的疾病控制或缓解。没有令人信服的证据支持在诱导期对英夫利西单抗进行主动治疗药物监测或在维持期对阿达木单抗进行主动治疗药物监测的有效性。系统综述注册:https://osf.io/x4m28/。
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引用次数: 0
Human papillomavirus nonavalent (HPV9) vaccination and risk of immune mediated diseases, myocarditis, pericarditis, and thromboembolic outcomes in Denmark: self-controlled case series study. 丹麦人乳头瘤病毒无价 (HPV9) 疫苗接种与免疫介导疾病、心肌炎、心包炎和血栓栓塞结局的风险:自我对照病例系列研究。
Pub Date : 2024-10-22 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000854
Kristýna Faksová, Anna D Laksafoss, Anders Hviid
<p><strong>Objective: </strong>To assess the associations between vaccination with the nonavalent human papillomavirus (HPV9) vaccine and immune mediated diseases, myocarditis, pericarditis, arterial thromboembolism, and venous thromboembolism with or without thrombocytopenia, in adolescent girls and boys in Denmark.</p><p><strong>Design: </strong>Self-controlled case series study.</p><p><strong>Setting: </strong>Population based study of linked nationwide health registers in Denmark for HPV vaccination and hospital diagnosis data, 1 October 2017 (or age 10 years) to 31 December 2022 or censored. Personal data were obtained from the Central Person Register. Information on dates of HPV vaccination and type of vaccine were obtained from the Danish Vaccination Register. Primary or secondary diagnoses of inpatient or outpatient hospital contact were sourced from the Danish National Patient Register.</p><p><strong>Participants: </strong>Source cohort 854 586. 350 687 individuals aged 10-17 years living in Denmark received at least one dose of HPV9 vaccine. Self-controlled case series analysis of 3354 individuals (1913 girls and 1441 boys) who received at least one dose of HPV9 vaccine and had at least one outcome.</p><p><strong>Main outcome measures: </strong>Rate ratios of the study outcomes in a 28 day or 180 day risk period (depending on the type of outcome) after HPV9 vaccination compared with the reference period were calculated. 47 immune mediated diseases, myocarditis, pericarditis, and seven thromboembolic outcomes were assessed. A safety signal for a specific outcome was identified if at least three outcomes were seen in the risk period after vaccination, the rate ratio was significantly increased (lower bound of the 95% confidence interval (CI) for the self-controlled case series rate ratio >1.0), and the false discovery rate adjusted P value was significant (<0.05).</p><p><strong>Results: </strong>696 776 doses of any HPV vaccine were given during the study period, including 673 530 doses of HPV9 vaccine in 350 687 individuals who received at least one dose. In the self-controlled case series analysis, rate ratios of all immune mediated outcomes combined were 0.99 (95% CI 0.86 to 1.13) and 1.03 (0.89 to 1.20) in girls and boys, respectively, after HPV9 vaccination. Rate ratios for any of the 47 analysed immune mediated outcomes were not increased in the risk periods in girls after vaccination. The only increased rate ratio seen was for Raynaud's disease (rate ratio 2.62, 95% CI 1.07 to 6.40) after HPV9 vaccination in boys, which did not fulfil the criteria of a safety signal. These findings should be interpreted in the light of the study limitations. None of the other 55 outcomes examined showed an association with HPV9 vaccination.</p><p><strong>Conclusions: </strong>The results of this study did not suggest an association between HPV9 vaccination and the study outcomes in adolescent boys and girls aged 10-17 years. This study contributes
目的评估丹麦男女青少年接种无价人类乳头瘤病毒 (HPV9) 疫苗与免疫介导疾病、心肌炎、心包炎、动脉血栓栓塞症和伴有或不伴有血小板减少症的静脉血栓栓塞症之间的关联:自我对照病例系列研究:基于丹麦全国范围内HPV疫苗接种和医院诊断数据的关联健康登记的人群研究,时间跨度为2017年10月1日(或10岁)至2022年12月31日或删减。个人数据来自中央人员登记册。HPV疫苗接种日期和疫苗类型信息来自丹麦疫苗接种登记册。住院或门诊病人的主要或次要诊断信息来自丹麦全国病人登记册:源队列 854 586 人。350 687 名居住在丹麦的 10-17 岁儿童接种了至少一剂 HPV9 疫苗。对3354人(1913名女孩和1441名男孩)进行了自我对照病例系列分析,这些人至少接种了一剂HPV9疫苗,并至少出现了一种结果:主要结果测量:计算接种 HPV9 疫苗后 28 天或 180 天风险期(取决于结果类型)内研究结果与参照期的比率比。评估了 47 种免疫介导疾病、心肌炎、心包炎和 7 种血栓栓塞结果。如果在接种疫苗后的风险期内出现至少三种结果,且比率显著增加(自我对照病例系列比率的 95% 置信区间 (CI) 下限 >1.0),且经调整的误诊率 P 值显著,则确定为特定结果的安全信号(结果:在接种疫苗后的风险期内出现至少三种结果,且比率显著增加(自我对照病例系列比率的 95% 置信区间 (CI) 下限 >1.0),且经调整的误诊率 P 值显著,则确定为特定结果的安全信号:研究期间共接种了 696 776 剂任何 HPV 疫苗,其中包括 673 530 剂 HPV9 疫苗,350 687 人至少接种了一剂。在自控病例系列分析中,接种 HPV9 疫苗后,女孩和男孩所有免疫介导结果的比率分别为 0.99(95% CI 0.86 至 1.13)和 1.03(0.89 至 1.20)。在接种疫苗后的风险期内,女孩的 47 个分析免疫介导结果中的任何一个比率都没有增加。唯一出现比率增加的是接种 HPV9 疫苗后男孩雷诺氏病(比率为 2.62,95% CI 为 1.07 至 6.40),这不符合安全信号的标准。在解释这些结果时应考虑到研究的局限性。其他55项检查结果均未显示与接种HPV9疫苗有关:本研究的结果并未表明接种 HPV9 疫苗与 10-17 岁男女青少年的研究结果之间存在关联。这项研究为HPV9疫苗的安全性提供了证据。
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引用次数: 0
Sodium-glucose co-transporter-2 inhibitors in patients with chronic kidney disease with or without type 2 diabetes: systematic review and meta-analysis. 钠-葡萄糖共转运体-2 抑制剂在伴有或不伴有 2 型糖尿病的慢性肾病患者中的应用:系统综述和荟萃分析。
Pub Date : 2024-10-01 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001009
Xinyu Zou, Qingyang Shi, Per Olav Vandvik, Yunhe Mao, Arnav Agarwal, Belen Ponte, Xiaoxi Zeng, Gordon Guyatt, Qinbo Yang, Xianghang Luo, Chang Xu, Ping Fu, Haoming Tian, Thomas Agoritsas, Sheyu Li
<p><strong>Objective: </strong>To examine cardiovascular and kidney benefits and harms of sodium-glucose co-transporter-2 (SGLT-2) inhibitors stratified by risk in adults with chronic kidney disease regardless of diabetes status.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources: </strong>Ovid Medline, Embase, and Cochrane Central from database inception to 15 June 2024.</p><p><strong>Eligibility criteria for selecting studies: </strong>Randomised controlled trials that compared SGLT-2 inhibitors with placebo or standard care with no SGLT-2 inhibitors in adults with chronic kidney disease with a follow-up duration of ≥12 weeks were eligible. Secondary analyses based on subpopulations from randomised controlled trials and publications not in English language were excluded.</p><p><strong>Data synthesis: </strong>Random effects meta-analyses were conducted, with effect estimates presented as risk ratios with 95% confidence intervals (CIs). Absolute treatment effects were estimated over a five year duration for individuals with varied risks of cardiovascular and kidney complications based on the Kidney Disease Improving Global Outcomes (KDIGO) risk stratification system. Certainty of evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.</p><p><strong>Results: </strong>Evidence from 13 randomised controlled trials (29 614 patients) informed treatment effect estimates. In relative terms, SGLT-2 inhibitors reduced all cause death (risk ratio 0.85 (95% CI 0.74 to 0.98)), cardiovascular death (0.84 (0.74 to 0.96)), kidney failure (0.68 (0.60 to 0.77)), non-fatal stroke (0.73 (0.57 to 0.94)), non-fatal myocardial infarction (0.75 (0.60 to 0.93)), and admission to hospital for heart failure (0.68 (0.60 to 0.78)). No credible subgroup effects were found from diabetes status, heart failure status, estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and follow-up duration. Absolute effect estimates across these outcomes over a five year period varied across risk groups based on baseline risks of cardiovascular and kidney events. Effects of SGLT-2 inhibitors in the group at low risk included seven fewer all- cause deaths, four fewer admissions to hospital for heart failure per 1000 individuals, and no effects on kidney failure. Effects in the higher risk group included 48 fewer all cause deaths, 58 fewer kidney failures, and 25 fewer admissions to hospital for heart failure per 1000 individuals. Although SGLT-2 inhibitor use was associated with a relative increase in the risk of harms, including genital infection (2.66 (95% CI 2.07 to 3.42)), ketoacidosis (2.27 (1.30 to 3.95)), and symptomatic hypovolaemia (1.29 (1.15 to 1.44)), absolute differences for all harm outcomes were small.</p><p><strong>Conclusions: </strong>Among people who have chronic kidney disease either with type 2 diabetes or not, SGLT-2 inhibitors improved cardiov
目的研究钠-葡萄糖协同转运体-2(SGLT-2)抑制剂对心血管和肾脏的益处和危害,根据慢性肾脏病成人患者的风险分层,无论其是否患有糖尿病:设计:系统综述和荟萃分析:数据来源:Ovid Medline、Embase 和 Cochrane Central(从数据库开始到 2024 年 6 月 15 日):对慢性肾脏病成人患者进行SGLT-2抑制剂与安慰剂或标准治疗与无SGLT-2抑制剂比较的随机对照试验,随访时间≥12周。基于随机对照试验亚群的二次分析和非英语出版物除外:进行随机效应荟萃分析,效应估计值以风险比和 95% 置信区间 (CI) 表示。根据肾病改善全球结果(KDIGO)风险分层系统,对心血管和肾脏并发症风险不同的个体进行了为期五年的绝对治疗效果估算。采用 GRADE(建议、评估、发展和评价分级)方法对证据的确定性进行评估:结果:13 项随机对照试验(29 614 名患者)的证据为治疗效果估算提供了依据。相对而言,SGLT-2 抑制剂可降低全因死亡(风险比为 0.85 (95% CI 0.74 to 0.98))、心血管死亡(0.84 (0.74 to 0.96))、肾衰竭(0.68 (0. 60 to 0.77))、肾功能衰竭(0.60至0.77))、非致命中风(0.73(0.57至0.94))、非致命心肌梗死(0.75(0.60至0.93))和因心力衰竭入院(0.68(0.60至0.78))。糖尿病状态、心力衰竭状态、估计肾小球滤过率、尿白蛋白与肌酐比值以及随访时间均未发现可信的亚组效应。根据心血管和肾脏事件的基线风险,不同风险组在五年内对这些结果的绝对效应估计值各不相同。SGLT-2抑制剂对低风险组的影响包括每1000人中因各种原因死亡的人数减少7人,因心力衰竭住院的人数减少4人,对肾衰竭没有影响。对高风险组的影响包括每 1000 人中因各种原因死亡的人数减少 48 人,肾衰竭人数减少 58 人,因心力衰竭住院的人数减少 25 人。虽然使用SGLT-2抑制剂与生殖器感染(2.66(95% CI 2.07至3.42))、酮症酸中毒(2.27(1.30至3.95))和症状性低血钾(1.29(1.15至1.44))等危害风险的相对增加有关,但所有危害结果的绝对差异都很小:在患有慢性肾病的2型糖尿病患者或非2型糖尿病患者中,SGLT-2抑制剂可改善心血管和肾脏预后,其绝对获益程度因个人心血管和肾脏相关后遗症的基线风险而异。按风险分层并与 SGLT-2 抑制剂相关的绝对获益和危害应为患者层面的个人决策提供参考:系统综述注册:PREMCORD42022325483。
{"title":"Sodium-glucose co-transporter-2 inhibitors in patients with chronic kidney disease with or without type 2 diabetes: systematic review and meta-analysis.","authors":"Xinyu Zou, Qingyang Shi, Per Olav Vandvik, Yunhe Mao, Arnav Agarwal, Belen Ponte, Xiaoxi Zeng, Gordon Guyatt, Qinbo Yang, Xianghang Luo, Chang Xu, Ping Fu, Haoming Tian, Thomas Agoritsas, Sheyu Li","doi":"10.1136/bmjmed-2024-001009","DOIUrl":"10.1136/bmjmed-2024-001009","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To examine cardiovascular and kidney benefits and harms of sodium-glucose co-transporter-2 (SGLT-2) inhibitors stratified by risk in adults with chronic kidney disease regardless of diabetes status.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Systematic review and meta-analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data sources: &lt;/strong&gt;Ovid Medline, Embase, and Cochrane Central from database inception to 15 June 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Eligibility criteria for selecting studies: &lt;/strong&gt;Randomised controlled trials that compared SGLT-2 inhibitors with placebo or standard care with no SGLT-2 inhibitors in adults with chronic kidney disease with a follow-up duration of ≥12 weeks were eligible. Secondary analyses based on subpopulations from randomised controlled trials and publications not in English language were excluded.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data synthesis: &lt;/strong&gt;Random effects meta-analyses were conducted, with effect estimates presented as risk ratios with 95% confidence intervals (CIs). Absolute treatment effects were estimated over a five year duration for individuals with varied risks of cardiovascular and kidney complications based on the Kidney Disease Improving Global Outcomes (KDIGO) risk stratification system. Certainty of evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Evidence from 13 randomised controlled trials (29 614 patients) informed treatment effect estimates. In relative terms, SGLT-2 inhibitors reduced all cause death (risk ratio 0.85 (95% CI 0.74 to 0.98)), cardiovascular death (0.84 (0.74 to 0.96)), kidney failure (0.68 (0.60 to 0.77)), non-fatal stroke (0.73 (0.57 to 0.94)), non-fatal myocardial infarction (0.75 (0.60 to 0.93)), and admission to hospital for heart failure (0.68 (0.60 to 0.78)). No credible subgroup effects were found from diabetes status, heart failure status, estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and follow-up duration. Absolute effect estimates across these outcomes over a five year period varied across risk groups based on baseline risks of cardiovascular and kidney events. Effects of SGLT-2 inhibitors in the group at low risk included seven fewer all- cause deaths, four fewer admissions to hospital for heart failure per 1000 individuals, and no effects on kidney failure. Effects in the higher risk group included 48 fewer all cause deaths, 58 fewer kidney failures, and 25 fewer admissions to hospital for heart failure per 1000 individuals. Although SGLT-2 inhibitor use was associated with a relative increase in the risk of harms, including genital infection (2.66 (95% CI 2.07 to 3.42)), ketoacidosis (2.27 (1.30 to 3.95)), and symptomatic hypovolaemia (1.29 (1.15 to 1.44)), absolute differences for all harm outcomes were small.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Among people who have chronic kidney disease either with type 2 diabetes or not, SGLT-2 inhibitors improved cardiov","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001009"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","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 between maternal mRNA covid-19 vaccination in early pregnancy and major congenital anomalies in offspring: population based cohort study with sibling matched analysis. 孕早期接种母体 mRNA covid-19 疫苗与后代重大先天畸形之间的关系:基于同胞匹配分析的人群队列研究。
Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000743
Sarah C J Jorgensen, Samantha S M Drover, Deshayne B Fell, Peter C Austin, Rohan D'Souza, Astrid Guttmann, Sarah A Buchan, Sarah E Wilson, Sharifa Nasreen, Kevin A Brown, Kevin L Schwartz, Mina Tadrous, Kumanan Wilson, Jeffrey C Kwong

Objective: To examine the association between maternal mRNA covid-19 vaccination during the first trimester of pregnancy and the prevalence of major congenital anomalies in offspring.

Design: Population based cohort study with sibling matched analysis.

Setting: Multiple health administrative databases, linked and analysed at ICES, an independent, non-profit research institute that collects and analyses healthcare and demographic data, Ontario, Canada, from 16 October 2021 to 1 May 2023.

Population: 174 296 singleton live births >20 weeks' gestation with an expected birth date between 16 October 2021 and 1 May 2023: 34 181 (20%) born to mothers who received one or two doses of an mRNA covid-19 vaccine in the first trimester and 34 951 (20%) born to mothers who did not receive a vaccine before or during pregnancy. The sibling matched analysis included 13 312 infants exposed to a covid-19 vaccine in the first trimester and 15 089 matched older siblings with the same mother, with an expected birth date after 16 October 2016 and no reported in utero exposure to a covid-19 vaccine.

Main outcome measures: Major congenital anomalies, overall and grouped by specific organ systems, diagnosed within 28 days of birth.

Results: Major congenital anomalies were present in 832 (24.3 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester compared with 927 (26.5 per 1000 live births) infants not exposed to a vaccine, resulting in an adjusted prevalence ratio of 0.89 (95% confidence interval (CI) 0.79 to 1.01). Major congenital anomalies were present in 283 (21.3 per 1000 live births) and 343 (22.7 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester and their older siblings not exposed to a vaccine, respectively (adjusted prevalence ratio 0.91, 95% CI 0.77 to 1.07). First trimester vaccination was not associated with an increase in major congenital anomalies grouped by specific organ system in the primary or sibling matched analyses. Results were similar across a range of subgroup and sensitivity analyses.

Conclusions: In this large population based cohort study and sibling matched analysis, mRNA covid-19 vaccination during the first trimester of pregnancy was not associated with an increase in major congenital anomalies in offspring, overall or grouped by organ system.

目的研究母亲在怀孕头三个月接种mRNA covid-19疫苗与后代重大先天性畸形发生率之间的关系:设计:基于同胞匹配分析的人群队列研究:加拿大安大略省的ICES是一家独立的非营利性研究机构,负责收集和分析医疗保健和人口数据,研究时间为2021年10月16日至2023年5月1日:174 296 名孕周大于 20 周、预产期在 2021 年 10 月 16 日至 2023 年 5 月 1 日之间的单胎活产婴儿:34 181 名(20%)的母亲在怀孕前三个月接种过一或两剂 mRNA covid-19 疫苗,34 951 名(20%)的母亲在怀孕前或怀孕期间未接种过疫苗。同胞配对分析包括13 312名在妊娠头三个月接种过covid-19疫苗的婴儿和15 089名母亲相同、预计出生日期在2016年10月16日之后且未报告在子宫内接种过covid-19疫苗的配对同胞:出生 28 天内确诊的主要先天性畸形,包括总体畸形和按特定器官系统分组的畸形:前三个月接种过 mRNA covid-19 疫苗的婴儿有 832 例(每 1000 例活产婴儿中有 24.3 例)出现重大先天畸形,而未接种过 mRNA covid-19 疫苗的婴儿有 927 例(每 1000 例活产婴儿中有 26.5 例)出现重大先天畸形,调整后的患病率为 0.89(95% 置信区间 (CI) 0.79 至 1.01)。在前三个月接种过 mRNA covid-19 疫苗的婴儿中,有 283 例(每 1000 例活产中 21.3 例)出现重大先天畸形,而在未接种过 mRNA covid-19 疫苗的婴儿中,有 343 例(每 1000 例活产中 22.7 例)出现重大先天畸形(调整患病率比为 0.91,95% 置信区间为 0.77 至 1.07)。在初次或同胞匹配分析中,妊娠头三个月接种疫苗与按特定器官系统分组的主要先天性畸形的增加无关。各种亚组和敏感性分析的结果相似:在这项基于人群的大型队列研究和同胞匹配分析中,无论是总体还是按器官系统分组,怀孕头三个月接种 mRNA covid-19 疫苗与后代重大先天性畸形的增加无关。
{"title":"Association between maternal mRNA covid-19 vaccination in early pregnancy and major congenital anomalies in offspring: population based cohort study with sibling matched analysis.","authors":"Sarah C J Jorgensen, Samantha S M Drover, Deshayne B Fell, Peter C Austin, Rohan D'Souza, Astrid Guttmann, Sarah A Buchan, Sarah E Wilson, Sharifa Nasreen, Kevin A Brown, Kevin L Schwartz, Mina Tadrous, Kumanan Wilson, Jeffrey C Kwong","doi":"10.1136/bmjmed-2023-000743","DOIUrl":"10.1136/bmjmed-2023-000743","url":null,"abstract":"<p><strong>Objective: </strong>To examine the association between maternal mRNA covid-19 vaccination during the first trimester of pregnancy and the prevalence of major congenital anomalies in offspring.</p><p><strong>Design: </strong>Population based cohort study with sibling matched analysis.</p><p><strong>Setting: </strong>Multiple health administrative databases, linked and analysed at ICES, an independent, non-profit research institute that collects and analyses healthcare and demographic data, Ontario, Canada, from 16 October 2021 to 1 May 2023.</p><p><strong>Population: </strong>174 296 singleton live births >20 weeks' gestation with an expected birth date between 16 October 2021 and 1 May 2023: 34 181 (20%) born to mothers who received one or two doses of an mRNA covid-19 vaccine in the first trimester and 34 951 (20%) born to mothers who did not receive a vaccine before or during pregnancy. The sibling matched analysis included 13 312 infants exposed to a covid-19 vaccine in the first trimester and 15 089 matched older siblings with the same mother, with an expected birth date after 16 October 2016 and no reported in utero exposure to a covid-19 vaccine.</p><p><strong>Main outcome measures: </strong>Major congenital anomalies, overall and grouped by specific organ systems, diagnosed within 28 days of birth.</p><p><strong>Results: </strong>Major congenital anomalies were present in 832 (24.3 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester compared with 927 (26.5 per 1000 live births) infants not exposed to a vaccine, resulting in an adjusted prevalence ratio of 0.89 (95% confidence interval (CI) 0.79 to 1.01). Major congenital anomalies were present in 283 (21.3 per 1000 live births) and 343 (22.7 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester and their older siblings not exposed to a vaccine, respectively (adjusted prevalence ratio 0.91, 95% CI 0.77 to 1.07). First trimester vaccination was not associated with an increase in major congenital anomalies grouped by specific organ system in the primary or sibling matched analyses. Results were similar across a range of subgroup and sensitivity analyses.</p><p><strong>Conclusions: </strong>In this large population based cohort study and sibling matched analysis, mRNA covid-19 vaccination during the first trimester of pregnancy was not associated with an increase in major congenital anomalies in offspring, overall or grouped by organ system.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000743"},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multimorbidity in emergency departments: urgent need for integrated care. 急诊科的多病症:急需综合护理。
Pub Date : 2024-08-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000989
Youri Yordanov, Agathe Beauvais, Pierre-Clément Thiébaud
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引用次数: 0
Progressive pulmonary fibrosis: a need for real world data to solve real world clinical problems. 进行性肺纤维化:需要真实世界的数据来解决真实世界的临床问题。
Pub Date : 2024-08-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000911
Huajian Liu, Kerri-Marie Heenan, Liam Coyle, Nazia Chaudhuri
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引用次数: 0
Multimorbidity and adverse outcomes following emergency department attendance: population based cohort study. 急诊科就诊后的多病症和不良后果:基于人群的队列研究。
Pub Date : 2024-08-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000731
Michael C Blayney, Matthew J Reed, John A Masterson, Atul Anand, Matt M Bouamrane, Jacques Fleuriot, Saturnino Luz, Marcus J Lyall, Stewart Mercer, Nicholas L Mills, Susan D Shenkin, Timothy S Walsh, Sarah H Wild, Honghan Wu, Stela McLachlan, Bruce Guthrie, Nazir I Lone

Abstract:

Objectives: To describe the effect of multimorbidity on adverse patient centred outcomes in people attending emergency department.

Design: Population based cohort study.

Setting: Emergency departments in NHS Lothian in Scotland, from 1 January 2012 to 31 December 2019.

Participants: Adults (≥18 years) attending emergency departments.

Data sources: Linked data from emergency departments, hospital discharges, and cancer registries, and national mortality data.

Main outcome measures: Multimorbidity was defined as at least two conditions from the Elixhauser comorbidity index. Multivariable logistic or linear regression was used to assess associations of multimorbidity with 30 day mortality (primary outcome), hospital admission, reattendance at the emergency department within seven days, and time spent in emergency department (secondary outcomes). Primary analysis was stratified by age (<65 v ≥65 years).

Results: 451 291 people had 1 273 937 attendances to emergency departments during the study period. 43 504 (9.6%) had multimorbidity, and people with multimorbidity were older (median 73 v 43 years), more likely to arrive by emergency ambulance (57.8% v 23.7%), and more likely to be triaged as very urgent (23.5% v 9.2%) than people who do not have multimorbidity. After adjusting for other prognostic covariates, multimorbidity, compared with no multimorbidity, was associated with higher 30 day mortality (8.2% v 1.2%, adjusted odds ratio 1.81 (95% confidence interval (CI) 1.72 to 1.91)), higher rate of hospital admission (60.1% v 20.5%, 1.81 (1.76 to 1.86)), higher reattendance to an emergency department within seven days (7.8% v 3.5%, 1.41 (1.32 to 1.50)), and longer time spent in the department (adjusted coefficient 0.27 h (95% CI 0.26 to 0.27)). The size of associations between multimorbidity and all outcomes were larger in younger patients: for example, the adjusted odds ratio of 30 day mortality was 3.03 (95% CI 2.68 to 3.42) in people younger than 65 years versus 1.61 (95% CI 1.53 to 1.71) in those 65 years or older.

Conclusions: Almost one in ten patients presenting to emergency department had multimorbidity using Elixhauser index conditions. Multimorbidity was strongly associated with adverse outcomes and these associations were stronger in younger people. The increasing prevalence of multimorbidity in the population is likely to exacerbate strain on emergency departments unless practice and policy evolve to meet the growing demand.

摘要:目的:描述多重疾病对急诊科就诊者以患者为中心的不良后果的影响:描述多病对急诊科就诊者以患者为中心的不良后果的影响:设计:基于人群的队列研究:2012年1月1日至2019年12月31日期间苏格兰洛锡安国民医疗服务体系的急诊科:急诊科就诊的成年人(≥18 岁):数据来源:来自急诊科、出院和癌症登记处的关联数据以及全国死亡率数据:多病症的定义是至少患有 Elixhauser 合并症指数中的两种疾病。多变量逻辑或线性回归用于评估多病症与 30 天死亡率(主要结果)、入院率、七天内急诊科复诊率和急诊科就诊时间(次要结果)之间的关系。主要分析按年龄分层(v ≥65岁):研究期间,451 291 人在急诊科就诊 1 273 937 次。43 504人(9.6%)患有多种疾病,与不患有多种疾病的人相比,患有多种疾病的人年龄更大(中位数为73岁对43岁),更有可能乘坐急救车(57.8%对23.7%)到达,更有可能被分流为非常紧急(23.5%对9.2%)。在对其他预后协变量进行调整后,与无多重疾病者相比,多重疾病者的 30 天死亡率更高(8.2% 对 1.2%,调整后的几率比 1.81(95% 置信区间 (CI) 1.72 至 1.91)),入院率更高(60.1% 对 20.5%,调整后的几率比 1.81(95% 置信区间 (CI) 1.72 至 1.91))。1%对20.5%,1.81(1.76至1.86)),七天内再次到急诊科就诊的比例更高(7.8%对3.5%,1.41(1.32至1.50)),在急诊科花费的时间更长(调整系数为0.27小时(95% CI为0.26至0.27))。年轻患者的多病症与所有结果之间的相关性更大:例如,65岁以下患者的30天死亡率调整后的几率比为3.03(95% CI为2.68至3.42),而65岁或以上患者的几率比为1.61(95% CI为1.53至1.71):在急诊科就诊的患者中,几乎每十个人中就有一个人患有埃利克豪斯指数条件下的多病症。多病症与不良预后密切相关,而这些关联在年轻人中更为明显。除非实践和政策能不断发展以满足日益增长的需求,否则人口中多病发病率的增加很可能会加剧急诊科的压力。
{"title":"Multimorbidity and adverse outcomes following emergency department attendance: population based cohort study.","authors":"Michael C Blayney, Matthew J Reed, John A Masterson, Atul Anand, Matt M Bouamrane, Jacques Fleuriot, Saturnino Luz, Marcus J Lyall, Stewart Mercer, Nicholas L Mills, Susan D Shenkin, Timothy S Walsh, Sarah H Wild, Honghan Wu, Stela McLachlan, Bruce Guthrie, Nazir I Lone","doi":"10.1136/bmjmed-2023-000731","DOIUrl":"10.1136/bmjmed-2023-000731","url":null,"abstract":"<p><strong>Abstract: </strong></p><p><strong>Objectives: </strong>To describe the effect of multimorbidity on adverse patient centred outcomes in people attending emergency department.</p><p><strong>Design: </strong>Population based cohort study.</p><p><strong>Setting: </strong>Emergency departments in NHS Lothian in Scotland, from 1 January 2012 to 31 December 2019.</p><p><strong>Participants: </strong>Adults (≥18 years) attending emergency departments.</p><p><strong>Data sources: </strong>Linked data from emergency departments, hospital discharges, and cancer registries, and national mortality data.</p><p><strong>Main outcome measures: </strong>Multimorbidity was defined as at least two conditions from the Elixhauser comorbidity index. Multivariable logistic or linear regression was used to assess associations of multimorbidity with 30 day mortality (primary outcome), hospital admission, reattendance at the emergency department within seven days, and time spent in emergency department (secondary outcomes). Primary analysis was stratified by age (<65 <i>v</i> ≥65 years).</p><p><strong>Results: </strong>451 291 people had 1 273 937 attendances to emergency departments during the study period. 43 504 (9.6%) had multimorbidity, and people with multimorbidity were older (median 73 <i>v</i> 43 years), more likely to arrive by emergency ambulance (57.8% <i>v</i> 23.7%), and more likely to be triaged as very urgent (23.5% <i>v</i> 9.2%) than people who do not have multimorbidity. After adjusting for other prognostic covariates, multimorbidity, compared with no multimorbidity, was associated with higher 30 day mortality (8.2% <i>v</i> 1.2%, adjusted odds ratio 1.81 (95% confidence interval (CI) 1.72 to 1.91)), higher rate of hospital admission (60.1% <i>v</i> 20.5%, 1.81 (1.76 to 1.86)), higher reattendance to an emergency department within seven days (7.8% <i>v</i> 3.5%, 1.41 (1.32 to 1.50)), and longer time spent in the department (adjusted coefficient 0.27 h (95% CI 0.26 to 0.27)). The size of associations between multimorbidity and all outcomes were larger in younger patients: for example, the adjusted odds ratio of 30 day mortality was 3.03 (95% CI 2.68 to 3.42) in people younger than 65 years versus 1.61 (95% CI 1.53 to 1.71) in those 65 years or older.</p><p><strong>Conclusions: </strong>Almost one in ten patients presenting to emergency department had multimorbidity using Elixhauser index conditions. Multimorbidity was strongly associated with adverse outcomes and these associations were stronger in younger people. The increasing prevalence of multimorbidity in the population is likely to exacerbate strain on emergency departments unless practice and policy evolve to meet the growing demand.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000731"},"PeriodicalIF":0.0,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142057475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
All cause and cause specific mortality in 15-24-year-olds in Denmark 2010 to 2022: nationwide study of socioeconomic predictors. 2010 年至 2022 年丹麦 15-24 岁人口的全因和特定原因死亡率:全国范围内的社会经济预测因素研究。
Pub Date : 2024-08-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000685
Sofie Kruckow, Janne S Tolstrup

Objective: To assess inequalities in all cause and cause specific mortality in young people and if there are differences across gender and age groups.

Design: Nationwide cohort study of socioeconomic predictors.

Setting: Denmark, 1 January 2010 to 31 December 2022.

Participants: All Danes of ages 15 to 24 years during the study period summing to a total of 9 314 807 person years and 2297 deaths. Participant and parental information were linked to obtain information on socioeconomic background to investigate differences in parents' educational level, employment status, and family's disposable income, using annually updated nationwide registers.

Main outcome measures: All cause and cause specific mortality including natural deaths (ie, medical conditions and diseases) and unnatural deaths (accidents, suicides, and homicides). Poisson regression was used to calculate incidence rate ratios and 95% confidence intervals (CI).

Results: Overall mortality rate was 24.7 (95% CI 23.7 to 25.7) and higher for men (33.2 (31.5 to 34.8)) compared with women (15.8 (14.6 to 16.9)). All cause and cause specific mortality were higher in financially disadvantaged groups compared with more affluent groups, and consistently so for all three measures of socioeconomic position. Results generally reflected a dose dependent association showing a higher mortality with lower levels of socioeconomic position. For instance, incidence rate ratios of all cause mortality related to parents' education was 2.3 (95% CI 2.0 to 2.7) for elementary level, 1.5 (1.3 to 1.6) for low, and 1.3 (1.1 to 1.4) for medium level as compared with high level. For deaths, incidence rate ratios of elementary education level compared with the most well educated group were 2.2 (1.5 to 3.2) for natural causes, 3.3 (2.5 to 4.4) for accidents, 1.6 (1.2 to 2.2) for suicides, and 3.1 (0.8 to 12) for homicides. Associations were similar in strata of men and women and by age group (15-17 v 18-24 years). Mortality in young men was considerably higher than in young women for all of the causes.

Conclusion: Young people from disadvantaged backgrounds have a markedly higher mortality from all causes than those from more affluent families. The socioeconomic position of their parents was associated with premature mortality in a dose dependent manner meaning that this effect is not only a concern for marginalised groups. Public health attention should be directed to respond to these inequities by strengthening advocacy for adolescent health, ensuring focus on adolescents in health policies and strategies, using the response to adolescent health as an indicator of equity, and prioritising research into the underlying mechanisms linking socioeconomic position in adolescence and mortality.

目标评估年轻人因各种原因和特定原因死亡的不平等现象,以及不同性别和年龄组之间是否存在差异:环境:丹麦,2010 年 1 月 1 日至 2022 年 12 月 31 日:环境:丹麦,2010 年 1 月 1 日至 2022 年 12 月 31 日:在研究期间,所有 15 至 24 岁的丹麦人共计 9 314 807 人年,2297 人死亡。利用每年更新的全国登记册,将参与者和父母的信息联系起来,以获得社会经济背景信息,从而调查父母教育水平、就业状况和家庭可支配收入的差异:所有原因和特定原因的死亡率,包括自然死亡(即医疗状况和疾病)和非自然死亡(事故、自杀和他杀)。采用泊松回归法计算发病率比和 95% 的置信区间 (CI):总死亡率为 24.7(95% 置信区间为 23.7 至 25.7),男性(33.2(31.5 至 34.8))高于女性(15.8(14.6 至 16.9))。与较为富裕的群体相比,经济条件较差的群体的所有病因和特定病因死亡率均较高,而且在社会经济地位的所有三种衡量标准中,这一比例始终较高。结果普遍反映出一种剂量依赖关系,即社会经济地位越低,死亡率越高。例如,与父母受教育程度相关的所有原因死亡率的发病率比为:小学为 2.3(95% CI 2.0 至 2.7),初中为 1.5(1.3 至 1.6),高中为 1.3(1.1 至 1.4)。就死亡而言,与受教育程度最高的组别相比,小学教育程度组别的自然死亡发生率比为 2.2(1.5 至 3.2),事故死亡发生率比为 3.3(2.5 至 4.4),自杀死亡发生率比为 1.6(1.2 至 2.2),他杀死亡发生率比为 3.1(0.8 至 12)。不同年龄组(15-17 岁与 18-24 岁)的男女死亡率相似。在所有死因中,年轻男性的死亡率都远远高于年轻女性:结论:与来自富裕家庭的青少年相比,来自贫困家庭的青少年因各种原因导致的死亡率明显较高。他们父母的社会经济地位与过早死亡之间存在剂量依赖关系,这意味着这种影响不仅仅是边缘群体的问题。公共卫生应关注这些不平等现象,加强对青少年健康的宣传,确保在卫生政策和战略中关注青少年,将对青少年健康的反应作为公平的指标,并优先研究青少年时期社会经济地位与死亡率之间的内在联系。
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引用次数: 0
Development and validation of a prognostic model to predict birth weight: individual participant data meta-analysis. 开发和验证预测出生体重的预后模型:个体参与者数据荟萃分析。
Pub Date : 2024-08-14 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000784
John Allotey, Lucinda Archer, Kym I E Snell, Dyuti Coomar, Jacques Massé, Line Sletner, Hans Wolf, George Daskalakis, Shigeru Saito, Wessel Ganzevoort, Akihide Ohkuchi, Hema Mistry, Diane Farrar, Fionnuala Mone, Jun Zhang, Paul T Seed, Helena Teede, Fabricio Da Silva Costa, Athena P Souka, Melanie Smuk, Sergio Ferrazzani, Silvia Salvi, Federico Prefumo, Rinat Gabbay-Benziv, Chie Nagata, Satoru Takeda, Evan Sequeira, Olav Lapaire, Jose Guilherme Cecatti, Rachel Katherine Morris, Ahmet A Baschat, Kjell Salvesen, Luc Smits, Dewi Anggraini, Alice Rumbold, Marleen van Gelder, Arri Coomarasamy, John Kingdom, Seppo Heinonen, Asma Khalil, François Goffinet, Sadia Haqnawaz, Javier Zamora, Richard D Riley, Shakila Thangaratinam, Alex Kwong, Ary I Savitri, Sohinee Bhattacharya, Cuno Spm Uiterwaal, Annetine C Staff, Louise Bjoerkholt Andersen, Elisa Llurba Olive, Christopher Redman, Maureen Macleod, Baskaran Thilaganathan, Javier Arenas Ramírez, Francois Audibert, Per Minor Magnus, Anne Karen Jenum, Fionnuala M McAuliffe, Jane West, Lisa M Askie, Peter A Zimmerman, Catherine Riddell, Joris van de Post, Sebastián E Illanes, Claudia Holzman, Sander M J van Kuijk, Lionel Carbillon, Pia M Villa, Anne Eskild, Lucy Chappell, Luxmi Velauthar, Miriam van Oostwaard, Stefan Verlohren, Lucilla Poston, Enrico Ferrazzi, Christina A Vinter, Mark Brown, Karlijn C Vollebregt, Josje Langenveld, Mariana Widmer, Camilla Haavaldsen, Guillermo Carroli, Jørn Olsen, Nelly Zavaleta, Inge Eisensee, Patrizia Vergani, Pisake Lumbiganon, Maria Makrides, Fabio Facchinetti, Marleen Temmerman, Robert Gibson, Tiziana Frusca, Jane E Norman, Ernesto A Figueiró-Filho, Hannele Laivuori, Jacob A Lykke, Agustin Conde-Agudelo, Alberto Galindo, Alfred Mbah, Ana Pilar Betran, Ignacio Herraiz, Lill Trogstad, Gordon G S Smith, Eric A P Steegers, Read Salim, Tianhua Huang, Annemarijne Adank, Wendy S Meschino, Joyce L Browne, Rebecca E Allen, Kerstin Klipstein-Grobusch, Caroline A Crowther, Jan Stener Jørgensen, Jean-Claude Forest, Ben W Mol, Yves Giguère, Louise C Kenny, Anthony O Odibo, Jenny Myers, SeonAe Yeo, Lesley McCowan, Eva Pajkrt, Bassam G Haddad, Gustaaf Dekker, Emily C Kleinrouweler, Édouard LeCarpentier, Claire T Roberts, Henk Groen, Ragnhild Bergene Skråstad, Kajantie Eero, Athanasios Pilalis, Renato T Souza, Lee Ann Hawkins, Francesc Figueras, Francesca Crovetto

Objective: To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit.

Design: Individual participant data meta-analysis.

Data sources: Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset.

Eligibility criteria for selecting studies: Studies in the IPPIC network were identified by searching major databases for studies reporting risk factors for adverse pregnancy outcomes, such as pre-eclampsia, fetal growth restriction, and stillbirth, from database inception to August 2019. Data of four IPPIC cohorts (237 228 pregnancies) from the US (National Institute of Child Health and Human Development, 2018; 233 483 pregnancies), UK (Allen et al, 2017; 1045 pregnancies), Norway (STORK Groruddalen research programme, 2010; 823 pregnancies), and Australia (Rumbold et al, 2006; 1877 pregnancies) were included in the development of the model.

Results: The IPPIC birth weight model was developed with random intercept regression models with backward elimination for variable selection. Internal-external cross validation was performed to assess the study specific and pooled performance of the model, reported as calibration slope, calibration-in-the-large, and observed versus expected average birth weight ratio. Meta-analysis showed that the apparent performance of the model had good calibration (calibration slope 0.99, 95% confidence interval (CI) 0.88 to 1.10; calibration-in-the-large 44.5 g, -18.4 to 107.3) with an observed versus expected average birth weight ratio of 1.02 (95% CI 0.97 to 1.07). The proportion of variation in birth weight explained by the model (R2) was 46.9% (range 32.7-56.1% in each cohort). On internal-external cross validation, the model showed good calibration and predictive performance when validated in three cohorts with a calibration slope of 0.90 (Allen cohort), 1.04 (STORK Groruddalen cohort), and 1.07 (Rumbold cohort), calibration-in-the-large of -22.3 g (Allen cohort), -33.42 (Rumbold cohort), and 86.4 g (STORK Groruddalen cohort), and observed versus expected ratio of 0.99 (Rumbold cohort), 1.00 (Allen cohort), and 1.03 (STORK Groruddalen cohort); respective pooled estimates were 1.00 (95% CI 0.78 to 1.23; calibration slope), 9.7 g (-154.3 to 173.8; calibration-in-the-large), and 1.00 (0.94 to 1.07; observed v expected ratio). The model predictions were more accurate (smaller mean square error) in the lower end of predicted birth weight, which is important in informing clinical decision making.

Conclusions: The IPPIC birth weight model allowed birth weight predictions for a range of possible gestational ages. The model explained about 50% of individual variation in birth weights, was well calibrated (especiall

目的根据首次产前检查的常规数据,预测不同潜在孕龄的出生体重:个人参与者数据荟萃分析:国际妊娠并发症预测(IPPIC)网络数据集中的四个队列(237 228例妊娠)的个体参与者数据:通过检索主要数据库中报告不良妊娠结局(如子痫前期、胎儿生长受限和死胎)风险因素的研究来确定 IPPIC 网络中的研究,研究时间从数据库开始至 2019 年 8 月。在建立模型时,纳入了来自美国(美国国家儿童健康与人类发展研究所,2018年;233 483例妊娠)、英国(Allen等人,2017年;1045例妊娠)、挪威(STORK Groruddalen研究计划,2010年;823例妊娠)和澳大利亚(Rumbold等人,2006年;1877例妊娠)的4个IPPIC队列(237 228例妊娠)的数据:结果:IPPIC 出生体重模型是通过随机截距回归模型和后向排除法进行变量选择而建立的。进行了内部-外部交叉验证,以评估该模型的特定研究和汇总性能,报告为校准斜率、大校准以及观察到的与预期的平均出生体重比。元分析表明,该模型具有良好的校准性能(校准斜率为 0.99,95% 置信区间 (CI) 为 0.88 至 1.10;大校准为 44.5 克,-18.4 至 107.3),观察到的与预期的平均出生体重比为 1.02(95% CI 为 0.97 至 1.07)。该模型解释的出生体重变异比例(R2)为 46.9%(每个队列的范围为 32.7-56.1%)。在内部-外部交叉验证中,该模型在三个队列中的校准斜率分别为 0.90(艾伦队列)、1.04(STORK Groruddalen 队列)和 1.07(Rumbold 队列),大校准分别为-22.3 克(艾伦队列)、-33.42 克(Rumbold 队列)和 86.4 克(STORK Groruddalen 队列),显示出良好的校准和预测性能。4克(STORK Groruddalen队列),观测值与预期值的比值分别为0.99(Rumbold队列)、1.00(Allen队列)和1.03(STORK Groruddalen队列);各自的汇总估计值分别为1.00(95% CI 0.78至1.23;校准斜率)、9.7克(-154.3至173.8;大范围校准)和1.00(0.94至1.07;观测值与预期值的比值)。在预测出生体重的低端,模型预测更准确(均方误差更小),这对临床决策很重要:结论:IPPIC 出生体重模型可预测一系列可能孕龄的出生体重。该模型解释了出生体重个体差异的 50%,校准良好(尤其是在胎儿生长受限及其并发症的高风险婴儿中),并在个体参与者数据荟萃分析所包括的四个不同人群中表现出良好的性能。还需要进一步研究在其他国家、环境和亚群体中的通用性:试验注册:PREMCOCRD42019135045。
{"title":"Development and validation of a prognostic model to predict birth weight: individual participant data meta-analysis.","authors":"John Allotey, Lucinda Archer, Kym I E Snell, Dyuti Coomar, Jacques Massé, Line Sletner, Hans Wolf, George Daskalakis, Shigeru Saito, Wessel Ganzevoort, Akihide Ohkuchi, Hema Mistry, Diane Farrar, Fionnuala Mone, Jun Zhang, Paul T Seed, Helena Teede, Fabricio Da Silva Costa, Athena P Souka, Melanie Smuk, Sergio Ferrazzani, Silvia Salvi, Federico Prefumo, Rinat Gabbay-Benziv, Chie Nagata, Satoru Takeda, Evan Sequeira, Olav Lapaire, Jose Guilherme Cecatti, Rachel Katherine Morris, Ahmet A Baschat, Kjell Salvesen, Luc Smits, Dewi Anggraini, Alice Rumbold, Marleen van Gelder, Arri Coomarasamy, John Kingdom, Seppo Heinonen, Asma Khalil, François Goffinet, Sadia Haqnawaz, Javier Zamora, Richard D Riley, Shakila Thangaratinam, Alex Kwong, Ary I Savitri, Sohinee Bhattacharya, Cuno Spm Uiterwaal, Annetine C Staff, Louise Bjoerkholt Andersen, Elisa Llurba Olive, Christopher Redman, Maureen Macleod, Baskaran Thilaganathan, Javier Arenas Ramírez, Francois Audibert, Per Minor Magnus, Anne Karen Jenum, Fionnuala M McAuliffe, Jane West, Lisa M Askie, Peter A Zimmerman, Catherine Riddell, Joris van de Post, Sebastián E Illanes, Claudia Holzman, Sander M J van Kuijk, Lionel Carbillon, Pia M Villa, Anne Eskild, Lucy Chappell, Luxmi Velauthar, Miriam van Oostwaard, Stefan Verlohren, Lucilla Poston, Enrico Ferrazzi, Christina A Vinter, Mark Brown, Karlijn C Vollebregt, Josje Langenveld, Mariana Widmer, Camilla Haavaldsen, Guillermo Carroli, Jørn Olsen, Nelly Zavaleta, Inge Eisensee, Patrizia Vergani, Pisake Lumbiganon, Maria Makrides, Fabio Facchinetti, Marleen Temmerman, Robert Gibson, Tiziana Frusca, Jane E Norman, Ernesto A Figueiró-Filho, Hannele Laivuori, Jacob A Lykke, Agustin Conde-Agudelo, Alberto Galindo, Alfred Mbah, Ana Pilar Betran, Ignacio Herraiz, Lill Trogstad, Gordon G S Smith, Eric A P Steegers, Read Salim, Tianhua Huang, Annemarijne Adank, Wendy S Meschino, Joyce L Browne, Rebecca E Allen, Kerstin Klipstein-Grobusch, Caroline A Crowther, Jan Stener Jørgensen, Jean-Claude Forest, Ben W Mol, Yves Giguère, Louise C Kenny, Anthony O Odibo, Jenny Myers, SeonAe Yeo, Lesley McCowan, Eva Pajkrt, Bassam G Haddad, Gustaaf Dekker, Emily C Kleinrouweler, Édouard LeCarpentier, Claire T Roberts, Henk Groen, Ragnhild Bergene Skråstad, Kajantie Eero, Athanasios Pilalis, Renato T Souza, Lee Ann Hawkins, Francesc Figueras, Francesca Crovetto","doi":"10.1136/bmjmed-2023-000784","DOIUrl":"10.1136/bmjmed-2023-000784","url":null,"abstract":"<p><strong>Objective: </strong>To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit.</p><p><strong>Design: </strong>Individual participant data meta-analysis.</p><p><strong>Data sources: </strong>Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset.</p><p><strong>Eligibility criteria for selecting studies: </strong>Studies in the IPPIC network were identified by searching major databases for studies reporting risk factors for adverse pregnancy outcomes, such as pre-eclampsia, fetal growth restriction, and stillbirth, from database inception to August 2019. Data of four IPPIC cohorts (237 228 pregnancies) from the US (National Institute of Child Health and Human Development, 2018; 233 483 pregnancies), UK (Allen et al, 2017; 1045 pregnancies), Norway (STORK Groruddalen research programme, 2010; 823 pregnancies), and Australia (Rumbold et al, 2006; 1877 pregnancies) were included in the development of the model.</p><p><strong>Results: </strong>The IPPIC birth weight model was developed with random intercept regression models with backward elimination for variable selection. Internal-external cross validation was performed to assess the study specific and pooled performance of the model, reported as calibration slope, calibration-in-the-large, and observed versus expected average birth weight ratio. Meta-analysis showed that the apparent performance of the model had good calibration (calibration slope 0.99, 95% confidence interval (CI) 0.88 to 1.10; calibration-in-the-large 44.5 g, -18.4 to 107.3) with an observed versus expected average birth weight ratio of 1.02 (95% CI 0.97 to 1.07). The proportion of variation in birth weight explained by the model (R<sup>2</sup>) was 46.9% (range 32.7-56.1% in each cohort). On internal-external cross validation, the model showed good calibration and predictive performance when validated in three cohorts with a calibration slope of 0.90 (Allen cohort), 1.04 (STORK Groruddalen cohort), and 1.07 (Rumbold cohort), calibration-in-the-large of -22.3 g (Allen cohort), -33.42 (Rumbold cohort), and 86.4 g (STORK Groruddalen cohort), and observed versus expected ratio of 0.99 (Rumbold cohort), 1.00 (Allen cohort), and 1.03 (STORK Groruddalen cohort); respective pooled estimates were 1.00 (95% CI 0.78 to 1.23; calibration slope), 9.7 g (-154.3 to 173.8; calibration-in-the-large), and 1.00 (0.94 to 1.07; observed <i>v</i> expected ratio). The model predictions were more accurate (smaller mean square error) in the lower end of predicted birth weight, which is important in informing clinical decision making.</p><p><strong>Conclusions: </strong>The IPPIC birth weight model allowed birth weight predictions for a range of possible gestational ages. The model explained about 50% of individual variation in birth weights, was well calibrated (especiall","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000784"},"PeriodicalIF":0.0,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142057474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predicting birth weight at booking. 预测预约时的出生体重。
Pub Date : 2024-08-14 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001018
Emily Prior, Sabita Uthaya
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引用次数: 0
期刊
BMJ medicine
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