Storr Ashleigh, Venetis Christos A, Cooke Simon, Kilani Suha, Ledger William
IVFAustralia, Sydney, NSW, Australia
School of Women's and Children's Health, UNSW Medicine, UNSW, NSW, Australia.
Hum Reprod. 2017 Feb;32(2):307-314. doi: 10.1093/humrep/dew330. Epub 2016 Dec 28.
What is the inter-observer and intra-observer agreement between embryologists when selecting a single Day 5 embryo for transfer?
The inter-observer and intra-observer agreement between embryologists when selecting a single Day 5 embryo for transfer was generally good, although not optimal, even among experienced embryologists.
Previous research on the morphological assessment of early stage (two pronuclei to Day 3) embryos has shown varying levels of inter-observer and intra-observer agreement. However, single blastocyst transfer is now becoming increasingly popular and there are no published data that assess inter-observer and intra-observer agreement when selecting a single embryo for Day 5 transfer.
STUDY DESIGN, SIZE, DURATION: This was a prospective study involving 10 embryologists working at five different IVF clinics within a single organization between July 2013 and November 2015.
PARTICIPANTS/MATERIALS, SETTING, METHODS: The top 10 embryologists were selected based on their yearly Quality Assurance Program scores for blastocyst grading and were asked to morphologically grade all Day 5 embryos and choose a single embryo for transfer in a survey of 100 cases using 2D images. A total of 1000 decisions were therefore assessed. For each case, Day 5 images were shown, followed by a Day 3 and Day 5 image of the same embryo. Subgroup analyses were also performed based on the following characteristics of embryologists: the level of clinical embryology experience in the laboratory; amount of research experience; number of days per week spent grading embryos. The agreement between these embryologists and the one that scored the embryos on the actual day of transfer was also evaluated. Inter-observer and intra-observer variability was assessed using the kappa coefficient to evaluate the extent of agreement.
This study showed that all 10 embryologists agreed on the embryo chosen for transfer in 50 out of 100 cases. In 93 out of 100 cases, at least 6 out of the 10 embryologists agreed. The inter-observer and intra-observer agreement among embryologists when selecting a single Day 5 embryo for transfer was generally good as assessed by the kappa scores (kappa = 0.734, 95% CI: 0.665-0.791 and 0.759, 95% CI: 0.622-0.833, respectively). The subgroup analyses did not substantially alter the inter-observer and intra-observer agreement among embryologists. The agreement when Day 3 images were included alongside Day 5 images of the same embryos resulted in a change of mind at least three times by each embryologist (on average for <10% of cases) and resulted in a small decrease in inter-observer and intra-observer agreement between embryologists (kappa = 0.676, 95% CI: 0.617-0.724 and 0.752, 95% CI: 0.656-808, respectively).The assessment of the inter-observer agreement with regard to morphological grading of Day 5 embryos showed only a fair-to-moderate agreement, which was observed across all subgroup analyses. The highest overall kappa coefficient was seen for the grading of the developmental stage of an embryo (0.513; 95% CI: 0.492-0.538). The findings were similar when the individual embryologists were compared with the embryologist who made the morphological assessments of the available embryos on the actual day of transfer.
LIMITATIONS, REASONS FOR CAUTION: All embryologists had already completed their training and were working under one organization with similar policies between the five clinics. Therefore, the inter-observer agreement might not be as high between embryologists working in clinics with different policies or with different levels of training.
The generally good, although not optimal uniformity between participating embryologists when selecting a Day 5 embryo for transfer, as well as, the surprisingly low agreement when morphologically grading Day 5 embryos could be improved, potentially resulting in increased pregnancy rates. Future studies need to be directed toward technologies that can help achieve this.
STUDY FUNDING/COMPETING INTERESTS: None declared.
Not applicable.
胚胎学家在选择单个第5天胚胎进行移植时，观察者间和观察者内的一致性如何？
胚胎学家在选择单个第5天胚胎进行移植时，观察者间和观察者内的一致性总体良好，但即便在经验丰富的胚胎学家中也并非最佳。
先前关于早期（原核期至第3天）胚胎形态学评估的研究显示，观察者间和观察者内的一致性水平各异。然而，单囊胚移植如今越来越普遍，尚无已发表的数据评估在选择单个胚胎进行第5天移植时观察者间和观察者内的一致性。
研究设计、规模、持续时间：这是一项前瞻性研究，涉及2013年7月至2015年11月期间在一个机构内五家不同体外受精诊所工作的10名胚胎学家。
参与者/材料、环境、方法：根据胚胎学家每年囊胚分级的质量保证计划得分选出排名前十的胚胎学家，要求他们对100例病例的所有第5天胚胎进行形态学分级，并使用二维图像选择单个胚胎进行移植。因此，总共评估了1000次决策。对于每个病例，展示第5天的图像，随后展示同一胚胎的第3天和第5天图像。还根据胚胎学家的以下特征进行了亚组分析：在实验室的临床胚胎学经验水平；研究经验数量；每周用于胚胎分级的天数。还评估了这些胚胎学家与在实际移植当天对胚胎进行评分的胚胎学家之间的一致性。使用kappa系数评估观察者间和观察者内的变异性，以评估一致程度。
本研究表明，在100例病例中，所有10名胚胎学家在50例中对选择移植的胚胎达成了一致。在100例病例中的93例中，10名胚胎学家中至少有6名达成了一致。根据kappa评分评估，胚胎学家在选择单个第5天胚胎进行移植时，观察者间和观察者内的一致性总体良好（kappa分别为0.734，95%置信区间：[0.665, 0.791]和0.759，95%置信区间：[0.622, 0.833]）。亚组分析并未实质性改变胚胎学家之间的观察者间和观察者内的一致性。当同一胚胎的第3天图像与第5天图像一起展示时，每位胚胎学家至少改变了三次主意（平均在不到10%的病例中），并且导致胚胎学家之间的观察者间和观察者内的一致性略有下降（kappa分别为0.676，95%置信区间：[0.617,0.724]和0.752，95%置信区间：[0.656, 0.808]）。对第5天胚胎形态学分级的观察者间一致性评估仅显示出中等至尚可的一致性，在所有亚组分析中均观察到这一点。胚胎发育阶段分级的总体kappa系数最高（0.513；95%置信区间：[0.492, 0.538]）。将个体胚胎学家与在实际移植当天对可用胚胎进行形态学评估的胚胎学家进行比较时，结果相似。
局限性、谨慎理由：所有胚胎学家均已完成培训，且在一个机构内工作，五家诊所的政策相似。因此，在政策不同或培训水平不同的诊所工作的胚胎学家之间，观察者间的一致性可能没有这么高。
参与研究的胚胎学家在选择第5天胚胎进行移植时，总体一致性良好但并非最佳，以及在对第5天胚胎进行形态学分级时令人惊讶的低一致性可能会得到改善，这有可能提高妊娠率。未来的研究需要针对有助于实现这一目标的技术。
研究资金/利益冲突：未声明。
不适用。
