{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T08:44:30Z","timestamp":1790671470999,"version":"4.1.0"},"reference-count":308,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["17\/19\/10"],"award-info":[{"award-number":["17\/19\/10"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>\nIn the United Kingdom, pregnant women are offered two scans: at 11\u201314 and 18\u201320 weeks\u2019 gestation. Current guidance supports fetal anatomical screening at the second scan, but evidence suggests earlier detection is possible.<\/jats:p>\n<\/jats:sec>\nObjectives<\/jats:title>\nTo determine clinical and cost-effectiveness of a detailed two-dimensional ultrasound scan in the first trimester for detection of fetal anomalies, in addition to usual practice.<\/jats:p>\n<\/jats:sec>\nDesign<\/jats:title>\n\nSystematic review and meta-analysis.<\/jats:p><\/jats:list-item>\nNationwide survey.<\/jats:p><\/jats:list-item>\nAnalysis of National Congenital Anomaly Disease Registry data.<\/jats:p><\/jats:list-item>\nConsensus procedure.<\/jats:p><\/jats:list-item>\nProspective survey of parental opinions.<\/jats:p><\/jats:list-item>\nProbabilistic decision-analytic model for cost-effectiveness.<\/jats:p><\/jats:list-item>\nValue-of-information analysis.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:sec>\nSetting<\/jats:title>\nUnited Kingdom National Health Service.<\/jats:p>\n<\/jats:sec>\nParticipants<\/jats:title>\nPregnant women and partners.<\/jats:p>\n<\/jats:sec>\nInterventions<\/jats:title>\nDetailed anomaly ultrasound at 11\u201314 weeks\u2019 gestation, in addition to usual practice.<\/jats:p>\n<\/jats:sec>\nMain outcome measures<\/jats:title>\nDiagnostic accuracy, protocol development, health economic modelling and value-of-information analysis.<\/jats:p>\n<\/jats:sec>\nData sources<\/jats:title>\nMEDLINE (OvidSP), EMBASE (OvidSP), Science Citation Index and Conference Proceedings Citation Index-Science (Web of Science Core Collection); National Congenital Anomaly Disease Registry; European Congenital Anomalies Registry; Surveys of National Health Service Trusts; screening sonographers, midwives and doctors; and parents; National Schedule of National Health Service Costs (2019\u201320).<\/jats:p>\n<\/jats:sec>\nReview methods<\/jats:title>\nSystematic review and meta-analysis for diagnostic accuracy.<\/jats:p>\n<\/jats:sec>\nResults<\/jats:title>\nFirst-trimester ultrasound detects 93.3% (95% confidence interval 90.4% to 95.7%) of a pre-selected group of eight major anomalies with specificity of 99.99% (95% confidence interval 99.98% to 99.99%) and positive predictive value of 96.5% (95% confidence interval 93.3 to 98.8, 416,877 fetuses, 40 studies). For major cardiac anomalies, the respective data are 55.8% (95% confidence interval 45.9% to 65.5%), 99.98% (95% confidence interval 99.97% to 99.99%) and 94.85% (95% confidence interval 91.63% to 97.32%, 306,872 fetuses, 45 studies). Of NHS trusts surveyed, 77% currently perform first-trimester anatomy assessment, with evidence of inequity of care; earlier screening resulted in more diagnoses before 16 weeks\u2019 gestation. A consensus procedure (n<\/jats:italic>\u2005=\u2005172) developed an anatomical protocol and minimum targets for diagnosis. Parental survey (n<\/jats:italic>\u2005=\u20051374) indicated that over 90% would opt for such screening. Modelling of singleton pregnancies undergoing earlier anomaly screening using two-dimensional ultrasound was associated with increased mean healthcare costs per woman (\u00a311, 95% confidence interval \u00a31 to \u00a329) and maternal quality-adjusted life-years (0.002065, 95% confidence interval 0.000565 to 0.00358), an incremental cost per quality-adjusted life-year of \u00a35270, with likelihood of being cost-effective at \u00a320,000 per quality-adjusted life-year of over 95%. Additional modelling predicted reductions in infant healthcare costs and quality-adjusted life-years. Decision uncertainty was low. Value-of-information analysis of cost-effectiveness results showed no groups of parameters for which further research to reduce uncertainty would likely prove cost-effective.<\/jats:p>\n<\/jats:sec>\nLimitations<\/jats:title>\nStudy heterogeneity; the lack of a universal reference standard; simplifying assumptions relating to economic model structure; and estimation of some parameters are documented and justified. The rarity of the conditions made estimation of longer-term maternal and infant costs and quality-adjusted life-years challenging, resulting in likely under-estimation of healthcare costs.<\/jats:p>\n<\/jats:sec>\nConclusions<\/jats:title>\nWith standardisation and training, first-trimester ultrasound screening for fetal anomalies is clinically effective with over 90% detection for eight major conditions and low false-positive rates. Decision uncertainty around implementation is low and a prospective study would not be an efficient investment. Adding first-trimester anomaly screening to the current screening likely represents a cost-effective use of resources and is acceptable to parents.<\/jats:p>\n<\/jats:sec>\nFuture work<\/jats:title>\nFocus on developing an implementation framework to modify the current United Kingdom Fetal Anomaly Screening Programme.<\/jats:p>\n<\/jats:sec>\nStudy registration<\/jats:title>\nThis study is registered as PROSPERO CRD42018111781 and CRD42018112434.<\/jats:p>\n<\/jats:sec>\nFunding<\/jats:title>\nThis award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17\/19\/10) and is published in full in Health Technology Assessment<\/jats:italic>; Vol. 29, No. 22. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/nltp7102","type":"journal-article","created":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T15:44:13Z","timestamp":1748879053000},"page":"1-250","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Clinical and cost-effectiveness of detailed anomaly ultrasound screening in the first trimester: a mixed-methods study"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1199-6283","authenticated-orcid":true,"given":"Jehan N","family":"Karim","sequence":"first","affiliation":[{"name":"University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2070-7794","authenticated-orcid":true,"given":"Helen","family":"Campbell","sequence":"additional","affiliation":[{"name":"University of Oxford, Oxford, 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