Self Assessment Vs. Expert for Fetal Ultra Sound Biometry Images
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Increase in the percentage of IMAC at 3-6 months after inclusion comparing the group with self-assessment and the group with assessment by expert.
研究概览
简要总结
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective.
To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups.
One group assess their own images (self assessment). The other group has their images assessed by an expert. Images are audited via the internet in a standardized procedure that generates feedback with recommendation for change.
Three to 6 months later, participants are audited again. If the improvement in image quality turns to be the same in both groups, it will be likely that self assessment is indeed as effective as assessment by an expert reviewer - at least for professionals experienced in fetal ultrasound.
详细描述
Background: Audit and feedback based on image scoring by an expert improve ultrasound image quality, but is time consuming. Self assessment of ultrasound still images might be an alternative to assessment by an expert.
Objective. To compare image quality improvement following self assessment of fetal biometry images versus audit and feedback by an expert.
Methods. Study design: prospective blinded randomised controlled trial. Inclusions Doctors or midwifes experienced in the field of fetal ultrasound, are solicited by email to enrol. Volunteers upload a first set of 30 biometry images (10 cephalic, 10 abdominal and 10 femoral) obtained from 10 consecutive screening scans performed in the second or third trimester of pregnancy. Abnormal scans are excluded.
Randomization:
After uploading the first set of images, ultrasonographers are randomised with a 1:1 ratio * Arm 1: Ultrasonographers assess their own images online according to a standardized procedure. They receive an automatically generated report with detailed recommendations for change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer ultrasonographers
- •Single pregnancy
- •gestational age at ultrasound: 18-36
排除标准
- •any fetal structural abnormality identified during ultrasound
- •multiple pregnancy
研究组 & 干预措施
1
self assessment of ultrasound fetal biometry images followed by automatically generated feedback
干预措施: Self assessment of ultrasound fetal biometry images (Behavioral)
2
assessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback
干预措施: assessment of ultrasound fetal biometry images by expert (Behavioral)
结局指标
主要结局
Increase in the percentage of IMAC at 3-6 months after inclusion comparing the group with self-assessment and the group with assessment by expert.
时间窗: 3-6 months
次要结局
- Increase in mean images quality score at 3-6 months comparing the group with self-assessment and the group with assessment by expert(3-6 months)