Objective To develop a set of core outcomes for studies on pregnant women with epilepsy.Design Delphi consensus study.Population Healthcare professionals, and patient representatives with lived experience of epilepsy in the UK.Methods We used a modified Delphi method and a consultation meeting to achieve consensus. Potential outcomes were identified by systematic review, and were scored using a Likert scale anchored between 1 (least important) and 5 (most important). We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants.Main outcome measures Outcomes in studies on epilepsy in pregnancy.Results Seventy-five healthcare professionals completed the first round, 48 (64%) completed the second round, and 37 (49%) completed the third round of the survey. Twenty-four patient representatives participated. The final core outcome set included 31 outcomes in three domains: neurological, offspring, and obstetric. Outcomes in the neurological domain were seizure control in pregnancy and postpartum, status epilepticus, maternal mortality, drowning, sudden unexpected death in epilepsy, postnatal depression, and quality of life. Offspring domain included congenital abnormalities (major and minor), fetal anticonvulsant syndrome, neurodevelopment, autism disorder, neonatal clinical complications, admission to a neonatal intensive care unit, and anthropometric measurements. The obstetric domain included live birth, stillbirth, miscarriage, ectopic, termination of pregnancy, admission to a high dependency or intensive care unit, breastfeeding, mode of delivery, preterm birth, pre-eclampsia, and eclampsia. Outcomes specific for studies on anti-epileptic drugs (AEDs) included maternal AED toxicity, AED compliance, neonatal withdrawal symptoms, and neonatal haemorrhagic disease.Conclusion Embedding this core set in future clinical trials will promote the standardisation of reporting to inform clinical practice.Keywords Core outcomes, CROWN, Delphi, epilepsy, pregnancy.Tweetable abstract A Delphi method identifying core outcomes for epilepsy in pregnancy. Final core set includes 31 outcomes.
Background Adnexal torsion (AT), a serious gynaecological emergency, often presents with non-specific symptoms leading to delayed diagnosis. Objective To compare the test accuracy of ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) to diagnose AT. Search strategy We searched EMBASE, MEDLINE and Cochrane CENTRAL until December 2019. Selection criteria Studies reporting on the accuracy of any imaging modality (Index Test) in female patients (paediatric and adult) suspected of AT compared with surgical diagnosis and/or standard clinical/radiological follow-up period until resolution of symptoms (Reference Standard). Data collection and analysis We assessed study quality using QUADAS-2. We conducted test accuracy meta-analysis using a univariate model or a hierarchical model. Main results We screened 3836 citations, included 18 studies (1654 women, 665 cases), and included 15 in the meta-analyses. Ultrasound pooled sensitivity (n = 12, 1187 women) was 0.79 (95% CI 0.63-0.92) and specificity was 0.76 (95% CI 0.54-0.93), with negative and positive likelihood ratios of 0.29 (95% CI 0.13-0.66) and 4.35 (95% CI 2.03-9.32), respectively. Using Doppler with ultrasound (n = 7, 845 women) yielded similar sensitivity (0.80, 95% CI 0.67-0.93) and specificity (0.88, 95% CI 0.72-1.00). For MRI (n = 3, 99 women), the pooled sensitivity was 0.81 (95% CI 0.63-0.91) and specificity was 0.91 (95% CI 0.80-0.96). A meta-analysis for CT was not possible with two case-control studies and one cohort study (n = 3, 232 women). Its sensitivity range was 0.74-0.95 and specificity was 0.80-0.90. Conclusions Ultrasound has good performance as a first-line diagnostic test for suspected AT. Magnetic resonance imaging could offer improved specificity to investigate complex ovarian morphology, but more evidence is needed.
Objective To compare rates of vaginal delivery and adverse outcomes of instrumental delivery trials in obstetric theatre compared to primary emergency full dilation caesarean section. Design Retrospective cohort study. Setting University teaching hospital. Population Women with singleton, non‐anomalous, pregnancy undergoing instrumental delivery trial in obstetric theatre. Methods Data were collected from consecutive cases during 2014 until 2018 using clinical records. Multivariate regression analysis was used comparing outcomes per first delivery method. Main Outcome Measures Primary outcome was completion of vaginal delivery between all methods of instrumental delivery. Secondary outcome was a composite of immediate perinatal adverse outcomes for instrumental delivery modes and primary full dilation caesarean section. Results From 971 deliveries analysed: ventouse delivery was significantly less likely to achieve vaginal delivery compared with Keilland’s forceps delivery (odds ratio [OR] 0.42, 95% CI 0.22–0.79). Once confounding factors were adjusted for, adverse outcome rates were less frequent in the Keilland’s forceps group than with primary full dilation caesarean section (OR 0.37, 95% CI 0.16–0.81); however, the receiver operating characteristic curve produced from this model demonstrated a low predictive value (AUC 0.64). Conclusions Attempting instrumental delivery in delivery suite theatre, as an alternative to primary emergency full dilation caesarean section, is both reasonable and safe. In this study, ventouse delivery performed poorly in comparison with other modes of instrumental delivery. Further research in the form of randomised controlled trials to identify the optimal mode of second stage delivery is paramount. Tweetable abstract Instrumental delivery trials in theatre are safe but use of ventouse was associated with a higher rate of failure.
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