A core outcome set for pre‐eclampsia research: an international consensus development study

Abstract

Objective To develop a core outcome set for pre-eclampsia. Design Consensus development study. Setting International. Population Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods Modified Delphi method and Modified Nominal Group Technique. Results A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting.

Impact of new definitions of preeclampsia at term on identification of adverse maternal and perinatal outcomes

“…Major maternal morbidity was defined as 1 or more of eclampsia, blindness, stroke, myocardial ischemia, pulmonary edema, elevated liver enzymes, hepatic hematoma, low platelets, or acute kidney injury; morbidity was based on the core maternal outcome set in PE, with the exception of liver rupture, postpartum hemorrhage, intensive care unit admission, and intubation and ventilation (not for childbirth) that were not available, placental abruption that was defined clinically and underreported, and the addition of myocardial ischemia based on the Delphi-derived preeclampsia integrated estimate of risk score. 21,22 Neonatal death was considered up to 28 days after birth. Major neonatal morbidity was defined as 1 or more of the following, as indicated in the BadgerNet Neonatal discharge summary: ventilation (ie, need for continuous positive airway pressure or nasal continuous positive airway pressure or intubation), RDS (the need for surfactant and ventilation), brain injury (ie, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade !2, or periventricular leukomalacia), sepsis (based on positive blood cultures), anemia treated with blood transfusion, or necrotizing enterocolitis requiring surgical intervention.…”

The impact of pre‐eclampsia definitions on the identification of adverse outcome risk in hypertensive pregnancy – analyses from the CHIPS trial (Control of Hypertension in Pregnancy Study)

“…Our outcome definitions were rigorous and defined a priori , to enable measurement of pre‐eclampsia both restrictively and broadly in a number of ways, increasing the relevance of the results to settings where proteinuria and/or laboratory testing may not be available or consistently available. Also, our secondary maternal outcome (of serious maternal complications) derived from the Delphi consensus, 22 is very similar to the recently promulgated iHOPE core outcome set 2 . We used a rigorous measure of precision (i.e.…”

“…The composite secondary outcome in CHIPS was maternal: serious maternal complications before 6 weeks postpartum or until hospital discharge, whichever was later; serious maternal complications included death, stroke, eclampsia, blindness, uncontrolled hypertension, the use of inotropic agents, pulmonary oedema, respiratory failure, myocardial ischaemia or infarction, hepatic dysfunction, hepatic haematoma or rupture, renal failure and transfusion, similar to the recently published iHOPE core outcome set 2 . Additional outcomes for the woman were severe hypertension and admission to hospital before delivery.…”

“…The hypertensive disorders of pregnancy are chronic hypertension (i.e. that develops before pregnancy or 20 weeks' gestation), gestational hypertension (that develops at ≥20 weeks) and pre‐eclampsia, the hypertensive disorder associated with the highest maternal and perinatal risks 2 …”

Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: a feasibility study

“…Furthermore, there is currently inconsistent reporting of outcomes from randomised trials evaluating interventions for pre-eclampsia [ 28 ], leading to the potential omission of clinically important outcomes and difficulty in comparing and contrasting individual studies, thus limiting our ability to draw firm conclusions from the evidence available. Recent work has therefore focussed on the develop of a core outcome set for pre-eclampsia research [ 29 ]. The CRADLE-4 trial, informed by its feasibility phase, presents an opportunity to develop and validate these core outcomes, such that they may be shared and used in future pre-eclampsia trials taking place in similar settings.…”