Measurement of endometrial thickness at US in multicenter drug trials: Value of central quality assurance reading
Measurement of endometrial thickness at US in multicenter drug trials: Value of central quality assurance reading
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DOI：
10.1148/radiology.217.2.r00nv34516
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发表时间：
2000-11-01
期刊：
影响因子：
19.7
通讯作者：
Genant, HK
中科院分区：
文献类型：
--
作者：
Bredella, MA;Feldstein, VA;Genant, HK
目的：评估中央质量保证 (QA) 读取经阴道超声 (US) 图像的价值，以测量子宫内膜厚度和评估图像质量。 材料和方法：评估两项多中心药物试验之一期间对 1,000 名受试者进行的 2,000 次超声检查的结果。在研究地点测量子宫内膜厚度；然后将图像发送到 QA 中心，由经验丰富的超声医师评估子宫内膜厚度和图像质量。 结果：在 2,000 次检查中，有 360 次 (18%) 的图像质量不足以进行中心 QA 读取。要求重复检查，并提供技术改进建议。在 360 次检查中，有 349 次 (97%) 重复的 US 图像质量合格。在测量子宫内膜厚度的 1,989 次检查中，有 99 次（5%）的中心测量值与现场测量值相差超过 2 毫米。在随访 1 年的一组 (n = 300) 中，重复超声检查的请求从基线时的 24% 下降到 1 年时的 11%。 结论：中央 QA 读数对多中心药物试验中获得的超声图像提供了对子宫内膜厚度的一致评估，有助于确保获得高质量的经阴道超声图像。它还进一步显着提高了站点性能。
PURPOSE: To assess the value of central quality assurance (QA) reading of transvaginal ultrasonographic (US) images obtained to measure endometrial thickness and to assess image quality.MATERIALS AND METHODS: Results of 2,000 US examinations performed in 1,000 subjects during one of two multicenter drug trials were evaluated. Endometrial thickness was measured at the study site; images were then sent to the QA center, where an experienced sonologist evaluated endometrial thickness and image quality.RESULTS: In 360 (18%) of the 2,000 examinations, image quality was insufficient for central QA reading. Repeat examinations were requested, and suggestions for improvement in technique were provided. In 349 (97%) of the 360 examinations, repeat US images were of acceptable quality. In 99 (5%) of the 1,989 examinations in which endometrial thickness was measured, central measurement of thickness differed by more than 2 mm from that of the site. In a group (n = 300) that was followed up for 1 year, requests for repeat US examinations decreased from 24% at baseline to 11% at 1 year.CONCLUSION: Central QA reading provides a consistent evaluation of endometrial thickness on US images obtained in multicenter drug trials and helps to ensure the acquisition of high-quality transvaginal US images. It further leads to demonstrable improvement in site performance.