Diagnostic Accuracy of an Integrated AI Tool to Estimate Gestational Age From Blind Ultrasound Sweeps.

Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device. Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography. Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard). Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days. Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, -0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index. Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people. Trial Registration: ClinicalTrials.gov Identifier: NCT05433519.

Impact of first-trimester anomaly scan on health-related quality of life and healthcare costs: a scoping review.

IMPORTANCE: The first-trimester anomaly scan (FTAS) has the potential to detect major congenital anomalies in an early stage of pregnancy. Due to this potential early detection, there is a trend to introduce FTAS in regular care. Data regarding the impact of FTAS on the patient's perspective are limited. OBJECTIVE: To provide an overview of the literature assessing the impact of the FTAS on health-related quality of life (HRQoL) and healthcare costs. EVIDENCE ACQUISITION: Literature search was performed in Embase, PubMed, Medline Ovid, Cochrane Library database, Web-of-Science, and Google Scholar were searched. All studies that reported the performance of a nuchal translucency measurement with a basic fetal assessment HRQoL or healthcare costs of FTAS were included. Studies solely describing screening of chromosomal anomalies were excluded. Three authors independently screened the studies and extracted the data. Results were combined using descriptive analysis. PROSPERO registration number: CRD42016045190. RESULTS: The search yielded 3242 articles and 16 were included. Thirteen articles (7045 pregnancies) examined the relationship between FTAS and HRQoL. Anxiety scores were raised temporarily before FTAS and returned to early pregnancy baseline following the absence of anomalies. Depression scores did not change significantly as a result of FTAS. Three articles studied healthcare costs. These studies, published before 2005, found a combination of FTAS and second-trimester anomaly scan (STAS) resulted in an increased amount of detected anomalies when compared to a STAS-only regimen. However, the combination would also be more costly. CONCLUSIONS: Women experience anxiety in anticipation of the FTAS result and following a reassuring FTAS result, anxiety returns to the baseline level. FTAS seems to be a reassuring experience. The included studies on costs showed the addition of FTAS is likely to increase the number of detected anomalies against an increase in healthcare costs per pregnancy.Review registration: PROSPERO CRD42016045190.

Routine Third Trimester Sonogram: Friend or Foe.

Several risk factors for adverse pregnancy outcomes can be identified by a routine third trimester ultrasound scan. However, there is also potential for harm, anxiety, and additional health care costs through unnecessary intervention due to false positive results. The evidence base informing the balance of risks and benefits of universal screening is inadequate to fully inform decision making. However, data on the diagnostic effectiveness of universal ultrasound suggest that better methods are required to result in net benefit, with the exception of screening for presentation near term, where a clinical and economic case can be made for its implementation.

Implementation of a fetal ultrasound telemedicine service: women's views and family costs.

BACKGROUND: The complexity of fetal medicine (FM) referrals that can be managed within obstetric units is dependent on the availability of specialist ultrasound expertise. Telemedicine can effectively transfer real-time ultrasound images via video-conferencing. We report the successful introduction of a fetal ultrasound telemedicine service linking a specialist fetal medicine (FM) centre and a remote obstetric unit. METHODS: Over a four-year period from October 2015, all women referred for FM consultation from the obstetric unit were seen via telemedicine, excluding cases where invasive testing, intrauterine therapy or cardiac anomalies were anticipated. The outcomes measured included the indication for FM referral; scan duration and image and sound quality during the consultation. Women's perceptions of the telemedicine consultation and estimated costs to attend the FM centre were measured by a structured questionnaire completed following the first telemedicine appointment during the Phase 1 of the project. RESULTS: Overall, 297 women had a telemedicine consultation during Phase 1 (pilot and evaluation) and Phase 2 (embedding and adoption) of the project, which covered a 4 year period 34 women completed questionnaires during the Phase 1 of the study. Travel to the telemedicine consultation took a median (range) time of 20 min (4150), in comparison to an estimated journey of 230 min (120,450) to the FM centre. On average, women would have spent approximately £28 to travel to the FM centre per visit. The overall costs for the woman and her partner/ friend to attend the FM centre was estimated to be £439. Women were generally satisfied with the service and valued the opportunity to have a FM consultation locally. CONCLUSIONS: We have demonstrated that a fetal ultrasound telemedicine service can be successfully introduced to provide FM ultrasound of sufficient quality to allow fetal diagnosis and specialist consultation with parents. Furthermore, the service is acceptable to parents, has shown a reduction in family costs and journey times.

Cost-effectiveness of prenatal screening methods for congenital heart defects in pregnancies conceived by in-vitro fertilization.

OBJECTIVES: To determine if a policy of universal fetal echocardiography (echo) in pregnancies conceived by in-vitro fertilization (IVF) is cost-effective as a screening strategy for congenital heart defects (CHDs) and to examine the cost-effectiveness of various other CHD screening strategies in IVF pregnancies. METHODS: A decision-analysis model was designed from a societal perspective with respect to the obstetric patient, to compare the cost-effectiveness of three screening strategies: (1) anatomic ultrasound (US): selective fetal echo following abnormal cardiac findings on detailed anatomic survey; (2) intracytoplasmic sperm injection (ICSI) only: fetal echo for all pregnancies following IVF with ICSI; (3) all IVF: fetal echo for all IVF pregnancies. The model initiated at conception and had a time horizon of 1 year post-delivery. The sensitivities and specificities for each strategy, the probabilities of major and minor CHDs and all other clinical estimates were derived from the literature. Costs, including imaging, consults, surgeries and caregiver productivity losses, were derived from the literature and Medicare databases, and are expressed in USA dollars ($). Effectiveness was quantified as quality-adjusted life years (QALYs), based on how the strategies would affect the quality of life of the obstetric patient. Secondary effectiveness was quantified as number of cases of CHD and, specifically, cases of major CHD, detected. RESULTS: The average base-case cost of each strategy was as follows: anatomic US, $8119; ICSI only, $8408; and all IVF, $8560. The effectiveness of each strategy was as follows: anatomic US, 1.74487 QALYs; ICSI only, 1.74497 QALYs; and all IVF, 1.74499 QALYs. The ICSI-only strategy had an incremental cost-effectiveness ratio (ICER) of $2 840 494 per additional QALY gained when compared to the anatomic-US strategy, and the all-IVF strategy had an ICER of $5 692 457 per additional QALY when compared with the ICSI-only strategy. Both ICERs exceeded considerably the standard willingness-to-pay threshold of $50 000-$100 000 per QALY. In a secondary analysis, the ICSI-only strategy had an ICER of $527 562 per additional case of major CHD detected when compared to the anatomic-US strategy. All IVF had an ICER of $790 510 per case of major CHD detected when compared with ICSI only. It was determined that it would cost society five times more to detect one additional major CHD through intensive screening of all IVF pregnancies than it would cost to pay for the neonate's first year of care. CONCLUSION: The most cost-effective method of screening for CHDs in pregnancies following IVF, either with or without ICSI, is to perform a fetal echo only when abnormal cardiac findings are noted on the detailed anatomy scan. Performing routine fetal echo for all IVF pregnancies is not cost-effective. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Analysis of the cost effectiveness of different strategies for the antenatal diagnosis of chromosomal aberrations in cases of ultrasound-identified fetal abnormalities.

OBJECTIVE: Principal objective of this work was to analyse the cost effectiveness of different sequences of cytogenetic techniques from the hospital's point of view, after prenatal ultrasound has identified fetal malformations. METHODS: Cytogenetic tests were performed for each case in 3 strategies, and their results are reported and compared to one reference strategy. Two new simulated strategies were considered: chromosomal microarrays alone and a direct test + CMA. MAIN OUTCOMES MEASURES: cost-effectiveness ratio. RESULTS: A single test result was positive in 234 of the 835 pregnancies studied (28%). CMA alone would have identified 239 abnormalities. In the simulated direct test + CMA sequence, the direct test alone would have been positive for 66.1% of the abnormalities identified. When testing was indicated for NT, reference strategy (Direct + karyotyping) costs 1 084.8 euros by positive test results. Strategies Direct + CMA and CMA alone cost respectively 992.7 and 550.0 euros by positive test results. For OUM indications, reference strategy costs 2 937.8 euros by positive test results. Strategies Direct + CMA and CMA alone cost respectively, 2 118.4 and 1 304.7 euros by positive test results. CONCLUSIONS: CMA appears to be the most effective test for prenatal cytogenetic diagnosis of fetal abnormalities identified by ultrasound.

Exome Sequencing for Prenatal Detection of Genetic Abnormalities in Fetal Ultrasound Anomalies: An Economic Evaluation.

INTRODUCTION: In light of the prospective Prenatal Assessment of Genomes and Exomes (PAGE) study, this paper aimed to determine the additional costs of using exome sequencing (ES) alongside or in place of chromosomal microarray (CMA) in a fetus with an identified congenital anomaly. METHODS: A decision tree was populated using data from a prospective cohort of women undergoing invasive diagnostic testing. Four testing strategies were evaluated: CMA, ES, CMA followed by ES ("stepwise"); CMA and ES combined. RESULTS: When ES is priced at GBP 2,100 (EUR 2,407/USD 2,694), performing ES alone prenatally would cost a further GBP 31,410 (EUR 36,001/USD 40,289) per additional genetic diagnosis, whereas the stepwise would cost a further GBP 24,657 (EUR 28,261/USD 31,627) per additional genetic diagnosis. When ES is priced at GBP 966 (EUR 1,107/USD 1,239), performing ES alone prenatally would cost a further GBP 11,532 (EUR 13,217/USD 14,792) per additional genetic diagnosis, whereas the stepwise would cost a further additional GBP 11,639 (EUR 13,340/USD 14,929) per additional genetic diagnosis. The sub-group analysis suggests that performing stepwise on cases indicative of multiple anomalies at ultrasound scan (USS) compared to cases indicative of a single anomaly, is more cost-effective compared to using ES alone. DISCUSSION/CONCLUSION: Performing ES alongside CMA is more cost-effective than ES alone, which can potentially lead to improvements in pregnancy management. The direct effects of test results on pregnancy outcomes were not examined; therefore, further research is recommended to examine changes on the projected incremental cost-effectiveness ratios.

Detection of fetal cardiac anomalies: cost-effectiveness of increased number of cardiac views.

OBJECTIVE: To compare the recommended three-view fetal heart screening method to detect major congenital heart disease (CHD) with more elaborate screening strategies to determine the cost-effective strategy in unselected (low-risk) pregnancies. METHODS: A decision-analytic model was designed to compare four screening strategies to identify fetuses with major CHD in a theoretical cohort of 4 000 000 births in the USA. The four strategies were: (1) three views: four-chamber view (4CV) and views of the left (LVOT) and right (RVOT) ventricular outflow tracts; (2) five views: 4CV, LVOT, RVOT and longitudinal views of the ductal arch and aortic arch; (3) five axial views: 4CV, LVOT, RVOT, three-vessel (3V) view and three-vessels-and-trachea view; and (4) six views: 4CV, LVOT, RVOT and 3V views and longitudinal views of the ductal arch and aortic arch. Outcomes related to neonatal mortality and neurodevelopmental disability were evaluated. The analysis was performed from a healthcare-system perspective, with a cost-effectiveness willingness-to-pay threshold set at $100 000 per quality-adjusted life year (QALY). Baseline analysis, one-way sensitivity analysis and Monte-Carlo simulation were performed. RESULTS: In our baseline model, screening with five axial views was the optimal strategy, detecting 3520 more CHDs, and resulting in 259 fewer children with neurodevelopmental disability, 40 fewer neonatal deaths and only slightly higher costs, compared with screening with the currently recommended three views. Screening with six views was more effective, but also cost considerably more, compared with screening with five axial views, and had an incremental cost of $490 023/QALY, which was over the willingness-to-pay threshold. The five-view strategy was dominated by the other three strategies, i.e. it was more costly and less effective in comparison. The data were robust when tested with Monte-Carlo and one-way sensitivity analysis. CONCLUSION: Although current guidelines recommend a minimum of three views for detecting CHD during the mid-trimester anatomy scan, screening with five axial views is a cost-effective strategy that may lead to improved outcome compared with three-view screening. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Impact of maternal obesity on fetal cardiac screening: which follow-up strategy is cost-effective?

OBJECTIVE: To perform a cost-effectiveness analysis of different follow-up strategies for non-obese and obese women who had incomplete fetal cardiac screening for major congenital heart disease (CHD). METHODS: Three decision-analytic models, one each for non-obese, obese and Class-III-obese women, were developed to compare five follow-up strategies for initial suboptimal fetal cardiac screening. The five strategies were: (1) no follow-up ultrasound (US) examination but direct referral to fetal echocardiography (FE); (2) one follow-up US, then FE if fetal cardiac views were still suboptimal; (3) up to two follow-up US, then FE if fetal cardiac views were still suboptimal; (4) one follow-up US and no FE; and (5) up to two follow-up US and no FE. The models were designed to identify fetuses with major CHD in a theoretical cohort of 4 000 000 births in the USA. Outcomes related to neonatal mortality and neurodevelopmental disability were evaluated. A cost-effectiveness willingness-to-pay threshold was set at US$100 000 per quality-adjusted life year (QALY). Base-case and sensitivity analysis and Monte-Carlo simulation were performed. RESULTS: In our base-case models for all body mass index (BMI) groups, no follow-up US, but direct referral to FE led to the best outcomes, detecting 7%, 25% and 82% more fetuses with CHD in non-obese, obese and Class-III-obese women, respectively, compared with the baseline strategy of one follow-up US and no FE. However, no follow-up US, but direct referral to FE was above the US$100 000/QALY threshold and therefore not cost-effective. The cost-effective strategy for all BMI groups was one follow-up US and no FE. Both up to two follow-up US with no FE and up to two follow-up US with FE were dominated (being more costly and less effective), while one follow-up US with FE was over the cost-effectiveness threshold. One follow-up US and no FE was the optimal strategy in 97%, 93% and 86% of trials in Monte-Carlo simulation for non-obese, obese and Class-III-obese models, respectively. CONCLUSION: For both non-obese and obese women with incomplete fetal cardiac screening, the optimal CHD follow-up screening strategy is no further US and immediate referral to FE; however, this strategy is not cost-effective. Considering costs, one follow-up US and no FE is the preferred strategy. For both obese and non-obese women, Monte-Carlo simulations showed clearly that one follow-up US and no FE was the optimal strategy. Both non-obese and obese women with initial incomplete cardiac screening examination should therefore be offered one follow-up US. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.