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Prior studies have suggested that obstetrical (OB) ultrasound in low- and middle-income countries has aided in detection of high-risk conditions, which in turn could improve OB management. We are participating in a cluster-randomized clinical trial of OB ultrasound, which is designed to assess the effect of basic OB ultrasound on maternal mortality, fetal mortality, neonatal mortality, and maternal near-miss in 5 low-income countries. We designed a 2-week course in basic OB ultrasound, followed by 12 weeks of oversight, to train health care professionals with no prior ultrasound experience to perform basic OB ultrasound to screen for high-risk pregnancies. All patients with high-risk pregnancies identified by the trainees were referred to higher-level health facilities where fully trained sonographers confirmed the diagnoses before any actions were taken. Although there have been several published studies on basic OB ultrasound training courses for health care workers in low- and middle-income countries, quality control reporting has been limited. The purpose of this study is to report on quality control results of these trainees. Health care workers trained in similar courses could have an adjunctive role in ultrasound screening for high-risk OB conditions where access to care is limited. After completion of the ultrasound course, 41 trainees in 5 countries performed 3801 ultrasound examinations during a 12-week pilot period. Each examination was reviewed by ultrasound trainers for errors in scanning parameters and errors in diagnosis, using predetermined criteria. Of the 32,480 images comprising the 3801 examinations, 94.8% were rated as satisfactory by the reviewers. There was 99.4% concordance between trainee and reviewer ultrasound diagnosis. The results suggest that trained health care workers could play a role in ultrasound screening for high-risk OB conditions.
The pretrial training period consisted of the following 2 parts: a 2-week intensive course in basic OB ultrasound and a 12-week pilot phase in which trainees performed basic ultrasound examinations on pregnant patients who presented to intervention health centers. The basic OB ultrasound course was administered to the 41 health care workers in the following 5 sites: Karawa, Democratic Republic of Congo; Chimaltenango, Guatemala; Eldoret, Kenya; Karachi, Pakistan; and Lusaka, Zambia. Table 1 displays individual site characteristics. Health care workers were chosen by the study sites to participate as trainees and had no prior ultrasound training. They varied in background, sex, and experience within and between sites (Table 2). Site characteristics Characteristics of ultrasound course trainees The course was designed to provide the trainees with the knowledge and skills to perform a basic OB ultrasound examination to screen for high-risk pregnancies. The pregnancies considered as high risk were multiple gestation, malpresentation, placenta previa or low-lying placenta, oligohydramnios, polyhydramnios, and cervical insufficiency. When a high-risk pregnancy was identified, trainees were instructed to perform a follow-up ultrasound or to refer the patient to a participating referral facility according to study protocol. The basic examination consisted of detection of cardiac activity, fetal number, fetal position, amniotic fluid assessment, biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), femur length (FL), placental position, cervical length at 16-24 weeks gestational age (GA), and detection of some anomalies (ventriculomegaly, anencephaly, hydronephrosis, and spina bifida). Many parameters of the standard second or third trimester ultrasound examination as detailed in the ACR-ACOG-AIUM-SRU Practice Parameter For The Performance of Obstetrical Ultrasound,14 such as abnormal heart rhythm and most components of the fetal anatomical survey, were not included in our basic examination. Approximately one-third of the course time was spent in didactic sessions and two-thirds in supervised hands-on training. The goal was for each trainee to complete 2 supervised ultrasound examinations on each day of the course. These examinations were rudimentary initially, but included all aspects of a basic examination by the fourth day. Trainees, therefore, had hands-on scanning experience with multiple patients by the end of the course. The course was conducted at the study sites by practitioners experienced in ultrasound training. The lead trainer at each site was assisted by local practitioners with substantial ultrasound experience. During the pilot phase, the trainees performed basic OB ultrasound examinations at intervention health centers. Pregnant women were offered basic OB ultrasound examinations twice during their pregnancies, targeted at 16-22 weeks GA and 32-36 weeks GA. For each ultrasound examination conducted, the trainees saved images on the ultrasound machines depicting fetal position, fetal number, placenta position, cervical length (if 16-24 weeks GA), BPD, HC, AC, FL, and amniotic fluid measurements. The biometry measurements, ultrasound-estimated date of delivery, and final interpretations based on ultrasound findings were summarized on an OB worksheet, and an image of this worksheet was saved for each examination. If fetal or placental abnormalities were discovered by the trainees but were not a part of the routine set of images, images of these abnormalities were also recorded and findings noted by the trainees in a comments section. At least once a week, the images from all the ultrasound machines at each site were downloaded to flash drives and then uploaded to the QC website. Every ultrasound examination was reviewed and rated on a QC website created for the study by either UW or by local reviewers at each site. Comments were added to individual examinations if indicated. The UW reviewer was a radiologist with 25 years of OB ultrasound experience. The local reviewers were 2 professors of OBs, both of whom conducted OB ultrasound courses at their institutions; a professor of radiology with 10 years of OB ultrasound experience; and 2 lead OB sonographers at their large regional referral hospitals. Multiple scanning parameters as well as the final interpretations were assessed and scored (Fig 1). All reviewers used the same criteria to rate each component. The reviewers were blinded to the clinical data. After reviews were completed, the examinations with ratings and comments were available for viewing on the website (Fig 2) by the local trainers and trainees. For data analysis, scanning parameter errors are defined as images that do not conform to the criteria established by the investigators for fetal position, fetal number, placental position, cervical length, BPD, HC, AC, FL, amniotic fluid assessment, and technical factors (scanning parameters). Diagnostic errors are defined as errors in interpretation which would have resulted in either inappropriate referral or no referral if referral was indicated. Evaluation web page from QC website. (Color version of figure is available online.) Comments web page from QC website. In addition to feedback from the QC website, the trainees met with the local trainers at least biweekly to discuss their performance. The local trainers observed each trainee scanning at an intervention health center at least biweekly during the pilot period. Conference calls between the UW and the local trainers took place periodically during the pilot phase at each site to discuss the progress of each trainee, using the results of the scanning skills tests, the scan reviews, and direct observation by local trainers. Targeted remedial training was given to some trainees during the pilot period based on the in-person observations, test results, QC results, and conference calls between the local training team and the UW. Progress during the pilot phase was assessed by QC results as well as by results on practical examinations administered to trainees monthly. In order to obtain certification to participate subsequently in the trial, trainees were required to pass a written examination and a practical examination at the conclusion of the ultrasound course and a practical examination at the conclusion of the pilot phase. As a part of the QC activities, we conducted replicate secondary reviews for 20 examinations for each of the 5 clinical sites in which both the central reader at the University of Washington and the in-country reviewer in each site replicated those readings, and generated Kappa statistics on the outcome of assessment of acceptability of the intervention. The overall Kappa statistic aggregated across the 5 sites was 0.33 with site-specific values in the 0.3-0.4 range, suggesting that the overall agreement between secondary reviewers could be classified as fair agreement.15 No patterns were noted in comparing the central and in-country reviewers, and the percentage of images classified as acceptable by one reviewer and unacceptable by the other being equivalent independent of whether the central reviewer or in-country reviewer found the assessment unacceptable.
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