A Cavallaro1, S T Ash1, R Napolitano1, S Wanyonyi2, E O Ohuma1,3, M Molloholli1, J Sande2, I Sarris1, C Ioannou1, T Norris1, V Donadono1, M Carvalho2, M Purwar4, F C Barros5,6, Y A Jaffer7, E Bertino8, R Pang9, M G Gravett10, L J Salomon11, J A Noble12, D G Altman3, A T Papageorghiou1. 1. Nuffield Department of Obstetrics & Gynaecology and Oxford Maternal & Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK. 2. Faculty of Health Sciences, Aga Khan University, Nairobi, Kenya. 3. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK. 4. Nagpur INTERGROWTH-21st Research Centre, Ketkar Hospital, Nagpur, India. 5. Programa de Pós-Graduação em Epidemiologia, Universidade Federal de Pelotas, Pelotas, RS, Brazil. 6. Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, RS, Brazil. 7. Department of Family & Community Health, Ministry of Health, Muscat, Sultanate of Oman. 8. Dipartimento di Scienze Pediatriche e dell'Adolescenza, Cattedra di Neonatologia, Università degli Studi di Torino, Torino, Italy. 9. School of Public Health, Peking University, Beijing, China. 10. Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), Seattle, WA, USA. 11. Maternité Necker-Enfants Malades, AP-HP, Université Paris Descartes, Paris, France. 12. Department of Engineering Science, University of Oxford, Oxford, UK.
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.
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.
Authors: Russell Fung; Jose Villar; Ali Dashti; Leila Cheikh Ismail; Eleonora Staines-Urias; Eric O Ohuma; Laurent J Salomon; Cesar G Victora; Fernando C Barros; Ann Lambert; Maria Carvalho; Yasmin A Jaffer; J Alison Noble; Michael G Gravett; Manorama Purwar; Ruyan Pang; Enrico Bertino; Shama Munim; Aung Myat Min; Rose McGready; Shane A Norris; Zulfiqar A Bhutta; Stephen H Kennedy; Aris T Papageorghiou; Abbas Ourmazd Journal: Lancet Digit Health Date: 2020-06-23
Authors: Jens Henrichs; Viki Verfaille; Petra Jellema; Laura Viester; Eva Pajkrt; Janneke Wilschut; Henriëtte E van der Horst; Arie Franx; Ank de Jonge Journal: BMJ Date: 2019-10-15
Authors: A Banerjee; Z Al-Dabbach; F E Bredaki; D Casagrandi; A Tetteh; N Greenwold; M Ivan; D Jurkovic; A L David; R Napolitano Journal: Ultrasound Obstet Gynecol Date: 2022-09 Impact factor: 8.678