Sharma A, Burnell M, Gentry-Maharaj A, Campbell S, Amso N N, Seif M W, Fletcher G, Brunell C, Turner G, Rangar R, Ryan A, Jacobs I, Menon U
Gynaecological Cancer Research Center, Department of Women's Cancer, Institute for Women's Health, University College London, London, UK.
Department of Gynaecological Oncology, University Hospital of Wales, Cardiff, UK.
Ultrasound Obstet Gynecol. 2016 Feb;47(2):228-35. doi: 10.1002/uog.14929.
To describe the quality assurance (QA) processes and their impact on visualization of postmenopausal ovaries in the ultrasound arm of a multicenter screening trial for ovarian cancer.
In the United Kingdom Collaborative Trial of Ovarian Cancer Screening, 50 639 women aged 50-74 years were randomized to the ultrasound arm and underwent annual transvaginal ultrasound (TVS) examinations. QA processes were developed during the course of the trial and included regular monitoring of the visualization rate (VR) of the right ovary. Non-subjective factors identified previously as impacting on VR of the right ovary were included in a generalized estimating equation model for binary outcomes to enable comparison of observed vs adjusted VR between individual sonographers who had undertaken > 1000 scans during the trial and comparison between centers. Observed and adjusted VRs of sonographers and centers were ranked according to the highest VR. Analysis of annual VRs of sonographers and those of the included centers was undertaken.
Between June 2001 and December 2010, 48 230 of 50 639 women attended one of 13 centers for a total of 270 035 annual TVS scans. One or both ovaries were seen in 228 145 (84.5%) TVS scans. The right ovary was seen on 196 426 (72.7%) of the scans. For the 78 sonographers included in the model, the median difference between observed and adjusted VR was -0.7% (range, -7.9 to 5.9%) and the median change in VR rank after adjustment was 3 (range, 0-18). For the 13 centers, the median difference between observed and adjusted VR was -0.5% (range, -2.2 to 1%), with no change in ranking after adjustment. The median adjusted VR was 73% (interquartile range (IQR), 65-82%) for sonographers and 74.7% (IQR, 67.1-79.0%) for centers. Despite the increasing age of the women being scanned, there was a steady decrease in the number of sonographers with VR < 60% (21.4% in 2002 vs 2.0% in 2010) and an increase in sonographers with VR > 80% (14.3% in 2002 vs 40.8% in 2010). The median VR of the centers increased from 65.5% (range, 55.7-81.0%) in 2001 to 80.3% (range, 74.5-90.9%) in 2010.
A robust QA program can improve visualization of postmenopausal ovaries and is an essential component of ultrasound-based ovarian cancer screening trials. While VR should be adjusted for non-subjective factors that impact on ovarian visualization, subjective factors are likely to be the largest contributors to differences in VR.
描述在一项卵巢癌多中心筛查试验的超声检查部分中，质量保证（QA）流程及其对绝经后卵巢可视化的影响。
在英国卵巢癌筛查协作试验中，50639名年龄在50 - 74岁的女性被随机分配至超声检查组，并接受年度经阴道超声（TVS）检查。在试验过程中制定了QA流程，包括定期监测右卵巢的可视化率（VR）。先前确定的影响右卵巢VR的非主观因素被纳入二元结局的广义估计方程模型，以便比较在试验期间进行了超过1000次扫描的个体超声检查医师之间观察到的VR与调整后的VR，并比较各中心之间的情况。根据最高VR对超声检查医师和中心的观察到的VR和调整后的VR进行排名。对超声检查医师和纳入中心的年度VR进行分析。
在2001年6月至2010年12月期间，50639名女性中的48230人到13个中心之一进行了总共270035次年度TVS扫描。在228145次（84.5%）TVS扫描中可见一个或两个卵巢。在196426次（72.7%）扫描中可见右卵巢。对于模型中纳入的78名超声检查医师，观察到的VR与调整后的VR之间的中位数差异为 - 0.7%（范围为 - 7.9%至5.9%），调整后VR排名的中位数变化为3（范围为0至18）。对于13个中心，观察到的VR与调整后的VR之间的中位数差异为 - 0.5%（范围为 - 2.2%至1%），调整后排名无变化。超声检查医师的调整后VR中位数为73%（四分位间距（IQR），65 - 82%），中心的为74.7%（IQR，67.1 - 79.0%）。尽管接受扫描的女性年龄不断增加，但VR < 60%的超声检查医师数量稳步下降（2002年为21.4%，2010年为2.0%），VR > 80%的超声检查医师数量增加（2002年为14.3%，2010年为40.8%）。各中心的VR中位数从2001年的65.5%（范围为55.7 - 81.0%）增加到2010年的80.3%（范围为74.5 - 90.9%）。
一个强大的QA计划可以改善绝经后卵巢的可视化，并且是基于超声的卵巢癌筛查试验的重要组成部分。虽然应针对影响卵巢可视化的非主观因素调整VR，但主观因素可能是VR差异的最大贡献者。
