@article{30ba68194f35469f81e687368e2542d0,
title = "Quality control of ultrasound for fetal biometry: results from the INTERGROWTH-21st Project",
abstract = "Objective: To assess a comprehensive package of ultrasound quality control in the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project, a large multicenter study of fetal growth. Methods: Quality control (QC) measures were performed for 20 313 ultrasound scan images obtained prospectively from 4321 fetuses at 14–41 weeks' gestation in eight geographical locations. At the time of each ultrasound examination, three fetal biometric variables (head circumference (HC), abdominal circumference (AC) and femur length (FL)) were measured in triplicate on separately generated images. All measurements were taken in a blinded fashion. QC had two elements: (1) qualitative QC: visual assessment by sonographers at each study site of their images based on specific criteria, with 10% of images being re-assessed at the Oxford-based Ultrasound Quality Unit (compared using an adjusted kappa statistic); and (2) quantitative QC: assessment of measurement data by comparing the first, second and third measurements (intraobserver variability), remeasurement of caliper replacement in 10% (interobserver variability), both by Bland–Altman plots and plotting frequency histograms of the SD of triplicate measurements and assessing how many were above or below 2 SD of the expected distribution. The system allowed the sonographers' performances to be monitored regularly. Results: A high level of agreement between self- and external scoring was demonstrated for all measurements (κ = 0.99 (95% CI, 0.98–0.99) for HC, 0.98 (95% CI, 0.97–0.99) for AC and 0.96 (95% CI, 0.95–0.98) for FL). Intraobserver 95% limits of agreement (LoA) of ultrasound measures for HC, AC and FL were ± 3.3%, ± 5.6% and ± 6.2%, respectively; the corresponding values for interobserver LoA were ± 4.4%, ± 6.0% and ± 5.6%. The SD distribution of triplicate measurements for all biometric variables showed excessive variability for three of 31 sonographers, allowing prompt identification and retraining. Conclusions: Qualitative and quantitative QC monitoring was feasible and highly reproducible in a large multicenter research study, which facilitated the production of high-quality ultrasound images. We recommend that the QC system we developed is implemented in future research studies and clinical practice.",
keywords = "fetal growth, pregnancy, quality control, reproducibility, variability",
author = "A. Cavallaro and Ash, {S. T.} and R. Napolitano and S. Wanyonyi and Ohuma, {E. O.} and M. Molloholli and J. Sande and I. Sarris and C. Ioannou and T. Norris and V. Donadono and M. Carvalho and M. Purwar and Barros, {F. C.} and Jaffer, {Y. A.} and E. Bertino and R. Pang and Gravett, {M. G.} and Salomon, {L. J.} and Noble, {J. A.} and Altman, {D. G.} and Papageorghiou, {A. T.}",
note = "Funding Information: A.T.P. is the Chief Medical Officer of Intelligent Ultrasound and receives non-financial support from Philips Ultrasound. J.A.N. has received personal fees from Intelligent Ultrasound and grants and non-financial support from Philips Ultrasound. All other authors declare no competing interests. Funding Information: This project was supported by a generous grant from the Bill & Melinda Gates Foundation to the University of Oxford (Oxford, UK), for which we are very grateful. A.T.P. is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). We also thank the Health Authorities in Pelotas, Brazil; Beijing, China; Nagpur, India; Turin, Italy; Nairobi, Kenya; Muscat, Oman; Oxford, UK; and Seattle, WA, USA who facilitated the project by allowing participation of these study sites as collaborating centers. We are extremely grateful to Philips Medical Systems who provided the ultrasound equipment and technical assistance throughout the project. Funding Information: This project was supported by a generous grant from the Bill & Melinda Gates Foundation to the University of Oxford (Oxford, UK), for which we are very grateful. A.T.P. is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Centre (BRC). We also thank the Health Authorities in Pelotas, Brazil; Beijing, China; Nagpur, India; Turin, Italy; Nairobi, Kenya; Muscat, Oman; Oxford, UK; and Seattle, WA, USA who facilitated the project by allowing participation of these study sites as collaborating centers. We are extremely grateful to Philips Medical Systems who provided the ultrasound equipment and technical assistance throughout the project. A.T.P. is the Chief Medical Officer of Intelligent Ultrasound and receives non-financial support from Philips Ultrasound. J.A.N. has received personal fees from Intelligent Ultrasound and grants and non-financial support from Philips Ultrasound. All other authors declare no competing interests. Publisher Copyright: Copyright {\textcopyright} 2017 ISUOG. Published by John Wiley & Sons Ltd.",
year = "2018",
month = sep,
doi = "10.1002/uog.18811",
language = "English",
volume = "52",
pages = "332--339",
journal = "Ultrasound in Obstetrics and Gynecology",
issn = "0960-7692",
publisher = "John Wiley and Sons Ltd",
number = "3",
}