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Objective  To determine the accuracy and reliability of remotely directed and interpreted ultrasound (teleultrasound) as compared with standard in-person ultrasound for the detection of fetal anomalies, and to determine participants' satisfaction with teleultrasound. Study Design  This was a single-center, randomized (1:1) noninferiority study. Individuals referred to the maternal–fetal medicine (MFM) ultrasound clinic were randomized to standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling. The primary outcome was major fetal anomaly detection rate (sensitivity). All ultrasounds were performed by registered diagnostic medical sonographers and interpretations were done by a group of five MFM physicians. After teleultrasound was completed, the teleultrasound patients filled out a satisfaction survey using a Likert scale. Newborn data were obtained from the newborn record and statewide birth defect databases. Results  Of 300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group. The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%. The observed difference in sensitivity was 0.0286, much smaller than the proposed noninferiority limit of 0.05. Specificity, negative predictive value, positive predictive value, and accuracy were more than 94% for both groups. Patient satisfaction was more than 95% on all measures, and there were no significant differences in patient satisfaction based on maternal characteristics. Conclusion  Teleultrasound is not inferior to standard in-person ultrasound for the detection of fetal anomalies. Teleultrasound was uniformly well received by patients, regardless of demographics. These key findings support the continued expansion of telemedicine services. Key Points For detection of major anomalies, teleultrasound is comparable to standard ultrasound. Teleultrasound was well accepted by patients. Teleultrasound use should be expanded. [ABSTRACT FROM AUTHOR]

Introduction/Purpose: There are no large validation trials comparing teleultrasound to on‐site ultrasound. We aim to compare the sensitivity and accuracy of teleultrasound and demonstrate that teleultrasound is not inferior to on‐site ultrasound in the pre‐natal diagnosis of fetal anomalies. Methods: All targeted ultrasounds performed between November 2010 and December 2012 were considered. We excluded studies performed at less than 17 weeks' gestation, on multiple gestations and for reasons other than an anatomical survey. Post‐natal diagnoses were obtained from a state level mandatory birth defects surveillance programme. Descriptive statistics (sensitivity, specificity, positive and negative predictive values and accuracy) were calculated for both groups. A test of non‐inferiority was performed, with the non‐inferiority difference set at 0.15. Results: The teleultrasound and on‐site ultrasound groups consisted of 2368 and 3145 studies, respectively. The sensitivity of teleultrasound and on‐site ultrasound was 57.46% and 76.57%, and the accuracy was 95.9% and 90.97%, respectively. The observed sensitivity difference was −0.1911. The accuracy, specificity, positive and negative predictive values of teleultrasound are similar to on‐site ultrasound. Discussion: Teleultrasound is inferior to on‐site ultrasound in the detection of fetal anomalies; however, it has improved accuracy, as well as higher negative and positive predictive values. A negative teleultrasound is more likely to identify a non‐anomalous fetus, and a positive teleultrasound is more likely to correctly identify an anomalous fetus. Conclusion: Teleultrasound has an important role in pre‐natal diagnosis for those patients unable or unwilling to travel for an on‐site ultrasound. [ABSTRACT FROM AUTHOR]