| Summary, etc. |
<h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;">OBJECTIVE:</h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">To test the hypothesis that the performance of first-trimester screening for pre-eclampsia (PE) by a method that uses Bayes' theorem to combine maternal factors with biomarkers is superior to that defined by current National Institute for Health and Care Excellence (NICE) guidelines.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">METHODS:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">This was a prospective multicenter study (screening program for pre-eclampsia (SPREE)) in seven National Health Service maternity hospitals in England, of women recruited between April and December 2016. Singleton pregnancies at 11-13 weeks' gestation had recording of maternal characteristics and medical history and measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and serum pregnancy-associated plasma protein-A (PAPP-A). The performance of screening for PE by the Bayes' theorem-based method was compared with that of the NICE method. Primary comparison was detection rate (DR) using NICE method vs mini-combined test (maternal factors, MAP and PAPP-A) in the prediction of PE at any gestational age (all-PE) for the same screen-positive rate determined by the NICE method. Key secondary comparisons were DR of screening recommended by the NICE guidelines vs three Bayes' theorem-based methods (maternal factors, MAP and PAPP-A; maternal factors, MAP and PlGF; and maternal factors, MAP, UtA-PI and PlGF) in the prediction of preterm PE, defined as that requiring delivery &lt; 37 weeks.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">RESULTS:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">All-PE developed in 473 (2.8%) of the 16 747 pregnancies and preterm PE developed in 142 (0.8%). The screen-positive rate by the NICE method was 10.3% and the DR for all-PE was 30.4% and for preterm PE it was 40.8%. Compliance with the NICE recommendation that women at high risk for PE should be treated with aspirin from the first trimester to the end of pregnancy was only 23%. The DR of the mini-combined test for all-PE was 42.5%, which was superior to that of the NICE method by 12.1% (95% CI, 7.9-16.2%). In screening for preterm PE by a combination of maternal factors, MAP and PlGF, the DR was 69.0%, which was superior to that of the NICE method by 28.2% (95% CI, 19.4-37.0%) and with the addition of UtA-PI the DR was 82.4%, which was higher than that of the NICE method by 41.6% (95% CI, 33.2-49.9%).</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">CONCLUSIONS:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">The performance of screening for PE as currently recommended by NICE guidelines is poor and compliance with these guidelines is low. The performance of screening is substantially improved by a method combining maternal factors with biomarkers.</span></p> |