Department of Obstetrics, University Hospital Leipzig, Leipzig, Germany.
Biostatistics, Data Science and Digital Solutions, Roche Diagnostics GmbH, Penzberg, Germany.
PLoS One. 2022 Feb 24;17(2):e0263443. doi: 10.1371/journal.pone.0263443. eCollection 2022.
We investigated the impact of the soluble fms-like tyrosine kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio to predict short-term risk of preeclampsia on clinical utility and healthcare resource utilisation using real-world data (RWD), and compared findings with health economic modelling from previous studies.
This retrospective analysis compared data from the German population of a multicentre clinical study (PROGNOSIS, n = 203; sFlt-1/PlGF ratio blinded and unavailable for decision-making) with RWD from University Hospital Leipzig, Germany (n = 281; sFlt-1/PlGF ratio used to guide clinical decision-making). A subgroup of the RWD cohort with the same inclusion criteria as the PROGNOSIS trial (RWD prediction only, n = 99) was also included. sFlt-1/PlGF ratio was measured using fully automated Elecsys® sFlt-1 and PlGF immunoassays (cobas e analyser; Roche Diagnostics). A similar proportion of women in the RWD and PROGNOSIS cohorts experienced preeclampsia (14.95% vs. 13.79%; p = 0.7938); a smaller proportion of women in the RWD prediction only cohort experienced preeclampsia versus PROGNOSIS (6.06%; p = 0.0526). In women with preeclampsia, median gestational age at delivery (weeks) was comparable in the RWD and PROGNOSIS cohorts (34.0 vs. 34.3, p = 0.5895), but significantly reduced in the RWD prediction only cohort versus PROGNOSIS (27.1, p = 0.0038). sFlt-1/PlGF ratio at baseline visit was not statistically significantly different for the RWD and PROGNOSIS cohorts, irrespective of preeclampsia outcome. Hospitalisations for confirmed preeclampsia were significantly shorter in the RWD cohort versus PROGNOSIS (median 1 vs. 4 days, p = 0.0093); there was no significant difference between RWD prediction only and PROGNOSIS (3 days, p = 0.9638). All-cause hospitalisations were significantly shorter in the RWD (median 1 day; p<0.0001) and RWD prediction only (1 day; p<0.0001) cohorts versus PROGNOSIS (3 days).
This study supports the findings of previous studies, showing that routine clinical use of the sFlt-1/PlGF ratio may result in shorter duration of hospitalisations, with potential economic benefits.
我们使用真实世界数据(RWD)研究了可溶性 fms 样酪氨酸激酶 1(sFlt-1)/胎盘生长因子(PlGF)比值预测子痫前期短期风险的临床应用,并与先前研究中的健康经济学模型进行了比较。
本回顾性分析比较了多中心临床研究(PROGNOSIS,n=203;sFlt-1/PlGF 比值设盲且不作为决策依据)的德国人群数据与德国莱比锡大学医院的 RWD(n=281;sFlt-1/PlGF 比值用于指导临床决策)。RWD 队列的一个亚组也包括了与 PROGNOSIS 试验相同的纳入标准(仅 RWD 预测,n=99)。sFlt-1/PlGF 比值使用全自动 Elecsys® sFlt-1 和 PlGF 免疫分析(cobas e 分析仪;罗氏诊断公司)进行测量。RWD 和 PROGNOSIS 队列中发生子痫前期的女性比例相似(14.95% vs. 13.79%;p=0.7938);仅 RWD 预测队列中发生子痫前期的女性比例显著低于 PROGNOSIS(6.06%;p=0.0526)。在发生子痫前期的女性中,RWD 和 PROGNOSIS 队列的中位分娩孕周(周)相似(34.0 对 34.3,p=0.5895),但仅 RWD 预测队列的中位分娩孕周显著缩短(27.1,p=0.0038)。无论子痫前期的结果如何,基线时 sFlt-1/PlGF 比值在 RWD 和 PROGNOSIS 队列之间均无统计学差异。与 PROGNOSIS 相比,RWD 队列中确诊子痫前期的住院时间明显缩短(中位数 1 天对 4 天,p=0.0093);RWD 仅预测与 PROGNOSIS 之间无显著差异(3 天,p=0.9638)。RWD(中位数 1 天;p<0.0001)和 RWD 仅预测(中位数 1 天;p<0.0001)队列的全因住院时间均明显短于 PROGNOSIS(中位数 3 天)。
本研究支持了先前研究的结果,表明常规临床使用 sFlt-1/PlGF 比值可能会缩短住院时间,并带来潜在的经济效益。