Stern Judy E, Gopal Daksha, Liberman Rebecca F, Anderka Marlene, Kotelchuck Milton, Luke Barbara
Department of Obstetrics and Gynecology and Pathology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.
Department of Community Health Sciences, Boston University, Boston, Massachusetts.
Fertil Steril. 2016 Sep 1;106(3):717-722.e2. doi: 10.1016/j.fertnstert.2016.04.042. Epub 2016 May 18.
To assess the validity of outcome data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) compared with data from vital records and the birth defects registry in Massachusetts.
Longitudinal cohort.
Not applicable.
PARTICIPANT(S): A total of 342,035 live births and fetal deaths from Massachusetts mothers giving birth in the state from July 1, 2004, to December 31, 2008; 9,092 births and fetal deaths were from mothers who had conceived with the use of assisted reproductive technology (ART) and whose cycle data had been reported to the SART CORS.
INTERVENTION(S): Not applicable.
MAIN OUTCOME MEASURE(S): Percentage agreement between maternal race and ethnicity, delivery outcome (live birth or fetal death), plurality (singleton, twin, or triplet+), delivery date, and singleton birth weight reported in the SART CORS versus vital records; sensitivity and specificity for birth defects among singletons as reported in the SART CORS versus the Massachusetts Birth Defects Monitoring Program (BDMP).
RESULT(S): There was >95% agreement between the SART CORS and vital records for fields of maternal race/ethnicity, live birth/fetal death, and plurality; birth outcome date was within 1 day with 94.9% agreement and birth weight was within 100 g with 89.6% agreement. In contrast, sensitivity for report of any birth defect was 38.6%, with a range of 18.4%-50.0%, for specific birth defect categories.
CONCLUSION(S): Although most SART CORS outcome fields are accurately reported, birth defect variables showed poor sensitivity compared with the gold standard data from the BDMP. We suggest that reporting of birth defects be discontinued.
评估向辅助生殖技术协会诊所结局报告系统(SART CORS)报告的结局数据与马萨诸塞州生命记录及出生缺陷登记处数据相比的有效性。
纵向队列研究。
不适用。
2004年7月1日至2008年12月31日在马萨诸塞州分娩的马萨诸塞州母亲所生的342,035例活产和死胎;9,092例出生和死胎来自使用辅助生殖技术(ART)受孕且其周期数据已报告给SART CORS的母亲。
不适用。
SART CORS报告的母亲种族和民族、分娩结局(活产或死胎)、多胎情况(单胎、双胎或三胎及以上)、分娩日期和单胎出生体重与生命记录之间的百分比一致性;SART CORS报告的单胎出生缺陷与马萨诸塞州出生缺陷监测项目(BDMP)相比的敏感性和特异性。
SART CORS与生命记录在母亲种族/民族、活产/死胎和多胎情况等方面的一致性>95%;出生结局日期在1天内的一致性为94.9%,出生体重在100克内的一致性为89.6%。相比之下,任何出生缺陷报告的敏感性为38.6%,特定出生缺陷类别的敏感性范围为18.4%-50.0%。
尽管SART CORS的大多数结局字段报告准确,但与BDMP的金标准数据相比,出生缺陷变量的敏感性较差。我们建议停止出生缺陷报告。