Measurement of Endometrial Thickness at US in Multicenter Drug Trials: Value of Central Quality Assurance Reading

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Abstract
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. 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. 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. 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.