Search Results for: Linee guida sul parto pre-termine

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.

Introduction
This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.

Methods and analysis
Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.

Ethics and dissemination
This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.

Introduction
Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.

Methods and analysis
40 individuals with acute LBP (onset

Maggior rischio di parto prematuro e complicanze dopo i 45 anni

Maggior rischio di parto prematuro e complicanze dopo i 45 anni

Nel 66% dei pazienti fremanezumab funziona anche a lungo termine

Introduction
Cardiovascular disease is one of the most common health issues facing the older population, and the number of older adults undergoing cardiac surgery is expected to increase. Postoperative neurocognitive impairment is a frequent and often unrecognised complication that can adversely affect a patient’s recovery, quality of life and daily activities, as well as impact the lives of their family members. Patients may express cognitive difficulties as a feeling of ‘not being the same since the operation’. This study aims to investigate the factors that influence neurocognitive function and patient-reported cognitive symptoms among patients aged 65 and older following cardiac surgery, and explore the impact on the overall postoperative recovery. Additionally, the study aims to describe the perspectives of close relatives on the recovery process.

Methods and analysis
A longitudinal observational study with a mixed-methods approach will be conducted in two thoracic surgical departments in Sweden. A total of 220 patients and 1 close relative for each patient will participate. Neurocognitive function will be assessed preoperatively and at 1, 3 and 6 months postoperatively using a digitalised neurocognitive test battery. We will also evaluate postoperative patient-reported cognitive symptoms and signs, delirium, frailty, health-related quality of life, depression, perceived self-efficacy, fatigue and functional capacity. Each patient’s close relative will assess the observed cognitive function and report on caregiver burden. At the 6-month mark, a purposive sample of patients and their close relatives will be interviewed to explore their experiences of postoperative cognitive recovery.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority (Reference number: 2024-03380-01) and will adhere to the Helsinki Declaration and its amendments. The results will be disseminated through peer-reviewed journals and scientific conferences, as well as presented in various popular science forums and patient organisations.

Trial registration number
NCT06469515; Pre-results.

Introduction
Postoperative nausea and vomiting (PONV) is a common complication following various surgical procedures, significantly contributing to patient discomfort and increasing healthcare costs. Despite the widespread use of multiple drug combinations, PONV remains a persistent challenge, particularly in high-risk populations. Existing evidence suggests a potential interaction between 5-HT3 receptors and μ-opioid receptors, indicating that they may function as co-receptors with a competitive relationship. Based on this hypothesis, we designed experiments to investigate this correlation.

Methods and analysis
This randomised, parallel, positive-controlled, double-blind (both intervener and participant) trial will take place at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Based on relevant literature and our pre-test, the incidence of PONV in the intervention group is estimated to be approximately 30%. With an expected 10% loss-to-follow-up rate and a desired statistical power of 0.9 (1-β), the required sample size for each group is 65 participants, totalling 130 subjects to be enrolled from 30 March 2025 to 30 April 2025. Eligible patients will be randomly allocated to either the intervention or control group. Ondansetron will be administered 15 min before anaesthesia induction in the intervention group (n=65) and at the end of surgery in the control group (n=65). The primary outcome is the incidence of PONV within the 0–24-hour postoperative period. The sample size will be calculated using PASS 15, statistical analysis will be conducted using SPSS 25 and missing data will be addressed using the Last Observation Carried Forward method. Two-tailed tests will be employed, with significance set at α=0.05. Results will be considered significant if p

39 quelle firmate dagli oncologi Aiom. Il caso delle terapie neoadiuvanti

Dagli esperti del Bambino Gesù, niente sole fino ai 6 mesi

Introduction
Recurrent pregnancy loss (RPL) is defined as the occurrence of two or more spontaneous pregnancy losses from the time of conception until 24 weeks of gestation. Currently, an underlying cause can be identified in only a minority of the losses. Potentially, an impaired maternal immune response targeting the semiallograft pregnancy may lead to miscarriage. While prior studies have explored the use of immune-suppressing corticosteroids to modulate the maternal immune system and hopefully improve pregnancy outcome, the absence of sufficiently powered randomised controlled trials (RCT) underscores the need for further research. The primary aim of this study is to evaluate if prednisolone administration in early pregnancy (20 mg daily for 6 weeks, then tapering doses for 2 weeks) in women with unexplained RPL leads to a higher live birth rate (LBR) in comparison to placebo. Additionally, the study assesses the tolerability, safety and the cost-effectiveness of this intervention. Finally, we will explore the effect of prednisolone in various subgroups (based on maternal age, number of previous pregnancy losses, presence of specific antibodies and pre-pregnancy endometrial immune cell level).

Methods and analysis
This ongoing multicentre, double-blind RCT will randomise 490 women with unexplained RPL and pregnancy

Introduction
Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis
This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination
Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number
ISRCTN77855199.

Purpose
Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.

Participants
MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home

Introduction
Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.

Methods and analysis
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at 1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.

Ethics and dissemination
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number
ISRCTN17992452.

Protocol version
4, 4 July 2024.

Introduction
Urinary tract infections (UTIs) are highly prevalent and pose a significant burden among older adults. Accurate diagnosis in this population is challenging due to the high prevalence of pre-existing lower urinary tract symptoms, inability to express symptoms and asymptomatic bacteriuria. Current diagnostic tests are unreliable, often resulting in over- and underdiagnosis. A previous pilot study proposed a higher cut-off for pyuria and identified five promising biomarkers for the diagnosis of UTIs in older adults. The UTI-GOLD study aims to validate these five new biomarkers and the higher leucocyte cut-off as a diagnostic tool for UTIs in older people in a real-world setting.

Methods and analysis
Between August 2024 and December 2027, an observational multicentre diagnostic accuracy study is being conducted across primary, secondary and tertiary healthcare facilities in the Netherlands and the UK. Adults ≥65 years with a suspected UTI will be considered eligible. Patients with pre-existing decision-making incapacity or an indwelling catheter will be excluded. UTI will be defined according to an international consensus-based reference standard. Biomarkers will be measured by liquid chromatography-mass spectrometry (neutrophil gelatinase-associated lipocalin, tissue inhibitor of metalloproteinase 2 and CXC motif chemokine ligand 9) and enzyme-linked immunosorbent assay (interleukin 6 and azurocidin). Pyuria will be quantified by automated microscopy and/or flow cytometry. Diagnostic accuracy measures will be calculated using the receiver operating characteristic curves, and sensitivity, specificity, likelihood ratios and predictive values will be reported for optimal cut-offs.

Ethics and dissemination
The protocol was reviewed by the local Leiden University Medical Center research committee, who declared on 15 April 2024 that the medical research involving human subject act (Dutch abbreviation: WMO) does not apply to the current study (reference number nWMODIV2_2024025). The study also received approval from the NHS Research Ethics Committee in the UK (reference number 24/LO/0649).
The study findings will be published in a peer-reviewed journal, presented at academic congresses and shared with healthcare providers.

Trial registration number
The study was registered at clinicaltrial.gov on the 24 September 2024 with registration number: NCT06610721.