Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Introduction
Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis
We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Leggi
Aprile 2024

Implementation of an intervention aimed at deprescribing benzodiazepines in a large US healthcare system using patient education materials: a pre/post-observational study with a control group

Objectives
Long-term benzodiazepine use is common despite known risks. In the original Eliminating Medications Through Patient Ownership of End Results (EMPOWER) Study set in Canada, patient education led to increased rates of benzodiazepine cessation. We aimed to determine the effectiveness of implementing an adapted EMPOWER quality improvement (QI) initiative in a US-based healthcare system.

Design
We used a pre–post design with a non-randomised control group.

Setting
A network of primary care clinics.

Participants
Patients with ≥60 days’ supply of benzodiazepines in 6 months and ≥1 risk factor (≥65 years of age, a concurrent high-risk medication prescribed or a diazepam equivalent daily dose ≥10) were eligible.

Intervention
In March 2022, we engaged 22 primary care physicians (PCPs), and 308 of their patients were mailed an educational brochure, physician letter and flyer detailing benzodiazepine risks; the control group included 4 PCPs and 291 of their patients.

Primary and secondary measures
The primary measure was benzodiazepine cessation by 9 months. We used logistic regression and a generalised estimating equations approach to control for clustering by PCP, adjusting for demographics, frailty, number of risk factors, and diagnoses of arthritis, depression, diabetes, falls, and pain.

Results
Patients in the intervention and control groups were comparable across most covariates; however, a greater proportion of intervention patients had pain-related diagnoses and depression. By 9 months, 26% of intervention patients (81 of 308) had discontinued benzodiazepines, compared with 17% (49 of 291) of control patients. Intervention patients had 1.73 greater odds of benzodiazepine discontinuation compared with controls (95% CI: 1.09, 2.75, p=0.02). The unadjusted number needed to treat was 10.5 (95% CI: 6.30, 34.92) and the absolute risk reduction was 0.095 (95% CI: 0.03 to 0.16).

Conclusions
Results from this non-randomised QI initiative indicate that patient education programmes using the EMPOWER brochures have the potential to promote cessation of benzodiazepines in primary care.

Leggi
Aprile 2024

Maternal outcomes of pre-eclampsia with severe features and its determinants at Abebech Gobena Mothers and Childrens Health and Saint Peters Specialized Hospital, Addis Ababa, Ethiopia: a cross-sectional study

Objective
The main objective of this study was to determine the prevalence and factors associated with unfavourable maternal outcomes among pregnant women with pre-eclampsia with severity features (PEWSF) at Abebech Gobena Maternal and Children’s Health and St. Peter’s Hospital, Addis Ababa, Ethiopia, 2023.

Design
A hospital-based cross-sectional study was conducted from 1 January 2023 to July 2023. The data was collected using a structured and pre-tested questionnaire through face-to-face interviews and a review clinical chart. Data was entered using EpiData V.4.6 and analysed using SPSS V.26.0 statistical software. Binary logistic regression analysis was run to identify predictors of maternal outcome.

Setting
Two hospitals in Addis Ababa, Ethiopia.

Participants
348 pregnant women with PEWSF were included.

Outcome measures
Unfavourable maternal outcome was defined as mothers with PEWSF that develop at least one complication, that is, eclampsia, abruption placenta, Haemolysis, Elevated Liver Enzymes and Low Platelet Count (HELLP) syndrome, acute renal failure, disseminated intravascular coagulation, cardiac failure, stroke, postpartum haemorrhage, pulmonary oedema and death.

Results
The overall prevalence of unfavourable maternal outcomes was 33.9% (N=118) (95% CI=28.7 to 38.8). Abruptio placenta (17.2%), HELLP syndrome (15.5%) and postpartum haemorrhage (13.8%) were common complications that occurred among mothers with PEWSF. Age above 35 years (adjusted OR (AOR) (95% CI)=2.70 (1.31 to 5.59)), rural residence (AOR (95% CI)=1.94 (1.07 to 3.53)), unemployment (AOR (95% CI)=0.35 (0.20 to 0.62)), severe blood pressure on admission (AOR (95% CI)=2.32 (1.03 to 5.19)) and complain of severe headache (AOR (95% CI)=1.91 (1.16 to 3.16)) were significant associates of unfavourable maternal outcomes.

Conclusions
The prevalence of unfavourable maternal outcomes was high compared with other studies in Ethiopia. Maternal age, residence, occupation, blood pressure on admission and severe headache have shown a statistically significant association with unfavourable maternal outcomes. Socioeconomic development and early identification of severe signs and symptoms of pre-eclampsia are needed to reduce unfavourable outcomes.

Leggi
Marzo 2024

Pre-COVID-19 hospital quality and hospital response to COVID-19: examining associations between risk-adjusted mortality for patients hospitalised with COVID-19 and pre-COVID-19 hospital quality

Objectives
The extent to which care quality influenced outcomes for patients hospitalised with COVID-19 is unknown. Our objective was to determine if prepandemic hospital quality is associated with mortality among Medicare patients hospitalised with COVID-19.

Design
This is a retrospective observational study. We calculated hospital-level risk-standardised in-hospital and 30-day mortality rates (risk-standardised mortality rates, RSMRs) for patients hospitalised with COVID-19, and correlation coefficients between RSMRs and pre-COVID-19 hospital quality, overall and stratified by hospital characteristics.

Setting
Short-term acute care hospitals and critical access hospitals in the USA.

Participants
Hospitalised Medicare beneficiaries (Fee-For-Service and Medicare Advantage) age 65 and older hospitalised with COVID-19, discharged between 1 April 2020 and 30 September 2021.

Intervention/exposure
Pre-COVID-19 hospital quality.

Outcomes
Risk-standardised COVID-19 in-hospital and 30-day mortality rates (RSMRs).

Results
In-hospital (n=4256) RSMRs for Medicare patients hospitalised with COVID-19 (April 2020–September 2021) ranged from 4.5% to 59.9% (median 18.2%; IQR 14.7%–23.7%); 30-day RSMRs ranged from 12.9% to 56.2% (IQR 24.6%–30.6%). COVID-19 RSMRs were negatively correlated with star rating summary scores (in-hospital correlation coefficient –0.41, p

Leggi
Marzo 2024