Ethics and informed consent in clinical trial integrity: An international, multi-stakeholder consensus statement by Cairo Consensus Group.

Recent studies have revealed issues with ethical practice and informed consent in randomized clinical trials (RCTs). We aimed to develop an international, multi-stakeholder consensus statement on human research ethics committee approval and informed participant consent for RCTs. The consensus process encompassed a systematic scoping review, modified two-round Delphi survey, and final consensus meeting of a multi-stakeholder group, including trialists, ethics committee members, methodologists, patient representatives, journal editors, and other experts on RCTs.

Time-lapse imaging systems for embryo incubation and assessment to improve reproductive outcomes in women undergoing in vitro fertilisation: study protocol for an individual participant data meta-analysis of randomised controlled trials.

Introduction: Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Effects of maternal education on maternal and perinatal outcomes: An individual participant data meta-analysis of 2 356 402 pregnancies.

Background: Maternal and perinatal mortality remain critical indicators of global health inequity. In 2020, an estimated 287 000 women died from preventable causes related to pregnancy, and in 2021, approximately 2.3 million neonatal deaths occurred within the first 28 days of life.

Recognition of the microbial metabolite -cresol in autism spectrum disorder: systematic review and meta-analysis.

Introduction: In recent years, research has focused on the gut-brain axis and its microbial metabolites as potential etiological or physiopathological agents of autism spectrum disorders (ASDs). Elevated levels of the organic compound -cresol (-cresol) have been reported in various populations of children with ASD, suggesting that it could be validated as a possible ASD biomarker related to microbiota. The aim of this study was to perform a systematic review of -cresol in ASD along with a meta-analysis to elucidate the scientific evidence of its potential as a biomarker.

Recommendations for the use of biomarkers for the management of adults with sepsis: a scoping review and critical appraisal.

Objective: A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.

Design: Scoping review.

Coronavirus-two infection among adults: A scoping review of literature published in 2023-24.

Objective: To identify and synthesize evidence on Coronavirus-two infection (SARS-CoV-2) among adults diagnosed by polymerase chain reaction.

Methods: The protocol was registered on Open Science Forum (doi: 10.17605/OSF.

Global maternal mortality associated with SARS-CoV-2 infection: a systematic review and meta-analysis.

Background: Pregnant and recently pregnant women infected with SARS-CoV-2 are at increased risk of death and serious complications than those without the infection. The extent of variation in mortality rates in pregnant women with SARS-CoV-2 infection across regions, and the causes of death are not known. We systematically reviewed all available evidence on the variation in mortality rates in pregnant women with SARS-CoV-2 infection across geographical and country income groups, and the reported cause of death.

Causes of and risk factors for postpartum haemorrhage: a systematic review and meta-analysis.

Background: An understanding of the causes of postpartum haemorrhage is needed to provide appropriate treatment and services. Knowledge of the risk factors for postpartum haemorrhage can help address modifiable risk factors. We did a systematic review and meta-analysis to identify and quantify the various causes and risk factors for postpartum haemorrhage.

Sex as a prognostic factor for mortality in adults with acute symptomatic pulmonary embolism.

Background: Pulmonary embolism (PE) is relatively common worldwide. It is a serious condition that can be life-threatening. Studies on the relationship between adverse outcomes of this condition and whether a patient is male or female have yielded inconsistent results.

Seizure prediction in pregnant women with epilepsy: An umbrella review of clinical practice guidelines and systematic reviews.

Objective: To identify risk factors for seizure in pregnant women, and in the general population with epilepsy.

Study Design: Umbrella review of clinical practice guidelines and systematic reviews on risk factors or prediction models for seizure occurrence in pregnant women with epilepsy, adults with epilepsy, or all individuals with epilepsy. Guidelines or systematic reviews exclusively for children were excluded.

Quality of causality assessment among observational studies in intensive care: A methodological review.

Intensive care units (ICUs) rely in many instances on observational research and often encounter difficulties in establishing cause-and-effect relationships. After conducting a thorough search focused on ICU observational studies, this review analysed the causal language and evaluated the quality of reporting of the methodologies employed. The causal was assessed by analysing the words linking exposure to outcomes in the title and main objective.

Variations in caesarean section outcome reporting in low- and middle-income countries: A systematic review.

Objective: To explore the variation and quality of the outcomes reported using descriptive analysis and interactive network visualisation of CS outcomes of comparative studies conducted in low-and middle-income settings.

Study Design: Systematic review of comparative studies to reduce caesarean section complications in low- and middle-income countries and outcome assessment using the modified Harman questionnaire, assessing for the presence of a clear primary outcome, an explanation of how the outcomes were analysed and a description of the methods used to enhance the quality of these measures.

Results: 102 comparative studies were included.

International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials by Cairo Consensus Group.

The number of retractions of randomized clinical trials (RCTs) following post-publication allegations of misconduct is increasing. To address this issue, we aimed to establish an international multistakeholder consensus on post-publication integrity concerns related to RCTs. After prospective registration (https://osf.

Measuring the impact of hospitalization for infectious diseases on the quality of life of older patients in four European countries: the AEQUI longitudinal matched cohort study (2020-2023).

Objectives: To evaluate the impact of hospitalization for infectious diseases on the Health-Related Quality of life (HRQOL), multidimensional frailty, and functioning of older patients, we conducted a longitudinal matched cohort study in four European countries.

Methods: HRQOL, frailty, and functioning were assessed using validated questionnaires at inclusion, at discharge, and up to 6 months later in patients aged over 65 years hospitalized for severe acute respiratory or bloodstream infections, and matched controls hospitalized for non-infectious conditions. Comparative analyses employed multilevel mixed-effect linear or logistic models to assess changes from inclusion.

Tuberculosis in adult migrants in Europe: a TBnet consensus statement.

Introduction: Global migration has increased in recent decades owing to war, conflict, persecution and natural disasters, but also secondary to increased opportunities related to work or study. Migrants' risk of tuberculosis (TB) differs depending on migration, socioeconomic status, mode of travel and TB risk in transit, TB incidence and healthcare provision in country of origin. Despite advances in TB care for migrants and new treatment strategies, decisions for managing migrants at risk of TB often rely on expert opinions, rather than clinical evidence.

Prioritisation of early pregnancy risk factors for stillbirth: An international multistakeholder modified e-Delphi consensus study.

Objective: To identify and prioritise early pregnancy risk factors for stillbirth to inform prognostic factor and model research.

Study Design: We used a modified e-Delphi method and consultation meeting to achieve consensus. Risk factors for early, late and stillbirth at any gestation identified from an umbrella review of risk factors for stillbirth were entered into a two-stage online Delphi survey with an international group of stakeholders made up of healthcare professionals and researchers.

Development and validation of prediction models for fetal growth restriction and birthweight: an individual participant data meta-analysis.

Background: Fetal growth restriction is associated with perinatal morbidity and mortality. Early identification of women having at-risk fetuses can reduce perinatal adverse outcomes.

Objectives: To assess the predictive performance of existing models predicting fetal growth restriction and birthweight, and if needed, to develop and validate new multivariable models using individual participant data.

Development and validation of a prognostic model to predict birth weight: individual participant data meta-analysis.

Objective: To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit.

Design: Individual participant data meta-analysis.

Data Sources: Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset.

Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis.

Objective: To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes.

Design: Systematic review and meta-analysis.

Data Sources: Major databases between December 2019 and January 2023.

Multidrug-resistant bacterial infections after liver transplantation: Prevalence, impact, and risk factors.

Background & Aims: Infections by multidrug-resistant bacteria (MDRB) are an increasing healthcare problem worldwide. This study analyzes the incidence, burden, and risk factors associated with MDRB infections after liver transplant(ation) (LT).

Methods: This retrospective, multicenter cohort study included adult patients who underwent LT between January 2017 and January 2020.