Detection of Fetal Anomalies by Remotely Directed and Interpreted Ultrasound (Teleultrasound): A Randomized Noninferiority Trial

Abstract

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.

Keywords

telemedicine - teleultrasound - fetal anomalies - patient satisfaction

• References

• 1 Implementing telehealth in practice: ACOG Committee Opinion Summary, Number 798. Obstet Gynecol 2020; 135 (02) 493-494
• 2 Fisk NM, Sepulveda W, Drysdale K. et al. Fetal telemedicine: six month pilot of real-time ultrasound and video consultation between the Isle of Wight and London. Br J Obstet Gynaecol 1996; 103 (11) 1092-1095
• 3 Chan FY, Soong B, Lessing K. et al. Clinical value of real-time tertiary fetal ultrasound consultation by telemedicine: preliminary evaluation. Telemed J 2000; 6 (02) 237-242
• 4 Salomon LJ, Alfirevic Z, Berghella V. et al; ISUOG Clinical Standards Committee. Practice guidelines for performance of the routine mid-trimester fetal ultrasound scan. Ultrasound Obstet Gynecol 2011; 37 (01) 116-126
• 5 Levi S. Ultrasound in prenatal diagnosis: polemics around routine ultrasound screening for second trimester fetal malformations. Prenat Diagn 2002; 22 (04) 285-295
• 6 Committee on Practice Bulletins—Obstetrics and the American Institute of Ultrasound in Medicine. 175: ultrasound in pregnancy. Obstet Gynecol 2016; 128 (06) e241-e256
• 7 Lowery C, Bronstein J, McGhee J, Ott R, Reece EA, Mays GP. ANGELS and University of Arkansas for Medical Sciences paradigm for distant obstetrical care delivery. Am J Obstet Gynecol 2007; 196 (06) 534.e1-534.e9
• 8 Rabie NZ, Sandlin AT, Barber KA. et al. Teleultrasound: how accurate are we?. J Ultrasound Med 2017; 36 (11) 2329-2335
• 9 Anderson N, Boswell O, Duff G. Prenatal sonography for the detection of fetal anomalies: results of a prospective study and comparison with prior series. AJR Am J Roentgenol 1995; 165 (04) 943-950
• 10 Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT). 2016 . Accessed May 6, 2020 at: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
• 11 Tinker SC, Carmichael SL, Anderka M. et al; Birth Defects Study To Evaluate Pregnancy exposureS. Next steps for birth defects research and prevention: the birth defects study to evaluate pregnancy exposures (BD-STEPS). Birth Defects Res A Clin Mol Teratol 2015; 103 (08) 733-740
• 12 Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33 (01) 159-174
• 13 Vinayak S, Sande J, Nisenbaum H, Nolsøe CP. Training midwives to perform basic obstetric point-of-care ultrasound in rural areas using a tablet platform and mobile phone transmission technology-a WFUMB COE project. Ultrasound Med Biol 2017; 43 (10) 2125-2132
• 14 Ross AB, DeStigter KK, Rielly M. et al. A low-cost ultrasound program leads to increased antenatal clinic visits and attended deliveries at a health care clinic in rural Uganda. PLoS One 2013; 8 (10) e78450
• 15 Long MC, Angtuaco T, Lowery C. Ultrasound in telemedicine: its impact in high-risk obstetric health care delivery. Ultrasound Q 2014; 30 (03) 167-172
• 16 Wyatt SN, Rhoads SJ, Green AL, Ott RE, Sandlin AT, Magann EF. Maternal response to high-risk obstetric telemedicine consults when perinatal prognosis is poor. Aust N Z J Obstet Gynaecol 2013; 53 (05) 494-497