COVID-19 in pregnancy-what study designs can we use to assess the risk of congenital anomalies in relation to COVID-19 disease, treatment and vaccination?
COVID-19 in pregnancy-what study designs can we use to assess the risk of congenital anomalies in relation to COVID-19 disease, treatment and vaccination?
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妊娠期COVID-19-我们可以使用哪些研究设计来评估与COVID-19疾病、治疗和疫苗接种相关的先天性异常风险？
DOI：
10.1111/ppe.12840
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发表时间：
2022-07
影响因子：
2.8
通讯作者：
Loane, Maria
中科院分区：
文献类型：
--
作者：
Dolk, Helen;Damase-Michel, Christine;Morris, Joan K.;Loane, Maria
COVID-19大流行加速了妊娠结局研究，但很少有人专门关注先天性异常（CA）和妊娠早期暴露的风险。我们回顾了国际上（特别是欧洲）用于CA研究的主要数据来源和研究设计，以及它们在研究COVID-19疾病、药物和疫苗方面的优势和局限性。我们根据四个数据来源对研究设计进行分类：a）自发不良事件报告，其中研究受试者的暴露和结局均为阳性; B）妊娠暴露登记，其中研究受试者的暴露为阳性; c）先天性异常登记，其中研究受试者的结局为阳性; d）人群医疗保健数据，其中包括整个出生人群，无论暴露和结局如何。每个数据源允许不同的研究设计，包括病例系列、暴露妊娠队列（使用外部对照药物）、生态学研究、病例对照研究和人群队列研究（使用内部对照药物）。对CA研究的数据源质量进行了审查，包括CA数据的诊断准确性、研究人群规模、纳入因胎儿异常终止妊娠、纳入妊娠早期COVID-19相关暴露和使用内部对照组等标准。跨国合作模式进行了审查。妊娠暴露登记一直是COVID-19妊娠研究的主要设计，但缺乏与CA相关的妊娠早期暴露或合适的对照组的详细信息。CA注册为提高COVID-19研究的诊断准确性提供了机会，特别是当与其他数据源相关联时。人群医疗保健数据中住院患者用药的可用性有限。更多地使用正在进行的母婴联动系统将提高研究效率。多国合作提供统计力量。挑战和机遇并存，以改善与COVID-19大流行和未来大流行相关的CA研究。
The COVID‐19 pandemic has accelerated pregnancy outcome research, but little attention has been given specifically to the risk of congenital anomalies (CA) and first trimester exposures. We reviewed the main data sources and study designs used internationally, particularly in Europe, for CA research, and their strengths and limitations for investigating COVID‐19 disease, medications and vaccines. We classify research designs based on four data sources: a) spontaneous adverse event reporting, where study subjects are positive for both exposure and outcome, b) pregnancy exposure registries, where study subjects are positive for exposure, c) congenital anomaly registries, where study subjects are positive for outcome and d) population healthcare data where the entire population of births is included, irrespective of exposure and outcome. Each data source allows different study designs, including case series, exposed pregnancy cohorts (with external comparator), ecological studies, case‐control studies and population cohort studies (with internal comparator). The quality of data sources for CA studies is reviewed in relation to criteria including diagnostic accuracy of CA data, size of study population, inclusion of terminations of pregnancy for foetal anomaly, inclusion of first trimester COVID‐19‐related exposures and use of an internal comparator group. Multinational collaboration models are reviewed. Pregnancy exposure registries have been the main design for COVID‐19 pregnancy studies, but lack detail regarding first trimester exposures relevant to CA, or a suitable comparator group. CA registries present opportunities for improving diagnostic accuracy in COVID‐19 research, especially when linked to other data sources. Availability of inpatient hospital medication use in population healthcare data is limited. More use of ongoing mother‐baby linkage systems would improve research efficiency. Multinational collaboration delivers statistical power. Challenges and opportunities exist to improve research on CA in relation to the COVID‐19 pandemic and future pandemics.
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影响因子：
4.3
作者：
Collin, Julius;Bystrom, Emma;Ahrne, Malin
通讯作者：
Ahrne, Malin
影响因子：
4.2
作者：
Cavadino, Alana;Sandberg, Lovisa;Morris, Joan K.
通讯作者：
Morris, Joan K.
DOI：
10.1016/j.ajogmf.2020.100111
发表时间：
2020-05-01
影响因子：
6.3
作者：
Breslin, Noelle;Baptiste, Caitlin;D'Alton, Mary
通讯作者：
D'Alton, Mary
DOI：
10.1002/ajmg.c.30313
发表时间：
2011-08-15
影响因子：
3.1
作者：
Adam, Margaret P.;Polifka, Janine E.;Friedman, J. M.
通讯作者：
Friedman, J. M.
DOI：
10.15585/mmwr.mm6938e1
发表时间：
2020-09-25
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
Delahoy MJ;Whitaker M;O'Halloran A;Chai SJ;Kirley PD;Alden N;Kawasaki B;Meek J;Yousey-Hindes K;Anderson EJ;Openo KP;Monroe ML;Ryan PA;Fox K;Kim S;Lynfield R;Siebman S;Davis SS;Sosin DM;Barney G;Muse A;Bennett NM;Felsen CB;Billing LM;Shiltz J;Sutton M;West N;Schaffner W;Talbot HK;George A;Spencer M;Ellington S;Galang RR;Gilboa SM;Tong VT;Piasecki A;Brammer L;Fry AM;Hall AJ;Wortham JM;Kim L;Garg S;COVID-NET Surveillance Team
通讯作者：
COVID-NET Surveillance Team