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Prevention of preterm birth in twin pregnancy: international Delphi consensus.
Full text linkObjective
To use the Delphi method to gain insight into approaches to prenatal diagnosis and management of preterm birth (PTB) in twin pregnancies, including complications such as twin-to-twin transfusion syndrome (TTTS) and a short and/or dilated cervix.
Methods
A three-round Delphi process was conducted among an international panel of experts to assess their approach to prevention, monitoring and management strategies for PTB in twin pregnancies. Experts were selected based on their publication record or membership of related organizations. Response options were multiple-choice answers or a five-point Likert scale. A priori, a cut-off of ≥ 70% agreement was used to define consensus.
Results
A total of 117 experts participated in the first round, of whom 94/117 (80.3%) completed all subsequent rounds. Representatives came from at least 22 countries (across five continents), most commonly the USA (50.4%) and the UK (12.0%). Over 70% of experts performed routine screening of cervical length (CL) using transvaginal ultrasound at 18–23 weeks' gestation, using CL ≤ 25 mm to diagnose short cervix in twin pregnancies, regardless of a history of PTB. In twin pregnancies with a short non-dilated cervix, most experts offered vaginal progesterone rather than pessary or cervical cerclage, regardless of a history of PTB. In twin pregnancies with asymptomatic dilated cervix, consensus was reached (88.3% agreement) for placement of cervical cerclage, performed up to 24 weeks' gestation (67.5% agreement; no consensus). Similarly, 96.1% of experts agreed that performing serial transvaginal ultrasound measurements of CL at 16–24 weeks' gestation was warranted in women with a current singleton pregnancy who had a previous twin pregnancy that required physical examination-indicated cerclage; these patients should be considered high risk for PTB (83.1% agreement). In twin pregnancies with TTTS, laser surgery is offered by most experts, regardless of preoperative CL. In patients with TTTS and short CL, most experts would recommend cervical cerclage (71.9%) or vaginal progesterone (65.6%) rather than pessary or expectant management. However, no consensus was reached on measures to prevent PTB in cases of TTTS with cervical dilation.
Conclusions
This Delphi consensus study highlights practice variations among healthcare providers worldwide in the evaluation and management of PTB in twin pregnancies, which often differ from recommendations given by national and international societies
Statistical analysis plan for the ARtificially Intelligent image fusion system versus standard treatment to guide endovascular Aortic aneurysm repair (ARIA): a multi-centre randomised controlled trial
Full text linkBackground
Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evaluate the efficacy of using Cydar-EV with EVAR procedures to reduce operating time while enhancing procedural precision, patient outcomes, and cost-effectiveness. This paper describes the statistical analysis plan for the study.
Methods/design
The ARIA trial, a phase III, multi-centre, open-label, two-armed, parallel groups randomised controlled surgical trial, seeks to recruit 340 patients diagnosed with abdominal or thoraco-abdominal aortic aneurysms. Participants are randomly assigned to receive either standard endovascular repair or an endovascular repair assisted by Cydar-EV for planning and surgical guidance. Primary and secondary outcomes are assessed at baseline, 4–12 weeks, and 52 weeks. The primary outcome measure is procedure duration at baseline, while additional secondary outcomes are recorded at various time points and include indicators for technical effectiveness, patient outcomes, procedure efficiency, and cost-effectiveness. We plan to analyse the patient outcome data according to the treatment they received regardless of initial allocation. The statistical analysis plan outlines methods for handling missing data, covariates for adjusted analyses, and planned sensitivity analyses to ensure robust evaluation of treatment effects.
Trial registration
The trial was registered with the ISRCTN register on 03/12/2021, number ISRCTN13832085
Use of 4CMenB vaccine in the control of an outbreak of serogroup B invasive meningococcal disease in an elderly care home, England, November 2023
Full text linkIn November 2023, a cluster of two invasive meningococcal disease (IMD) cases caused by serogroup B Neisseria meningitidis (MenB) occurred in elderly residents (≥ 70 years) of a dementia care home in England. An epidemiological investigation was conducted and public health actions, including infection control measures and antibiotic chemoprophylaxis, were implemented to prevent further cases. Nasopharyngeal swabbing before chemoprophylaxis identified three meningococcal carriers, including two carrying the outbreak strain, highlighting the importance of immediate antibiotic prophylaxis in such settings. Microbiological investigations showed that the outbreak strain belonged to the sequence type (ST)-9316 complex, potentially covered by the 4CMenB vaccine. Although 4CMenB is licensed for children and adults, there are no safety or reactogenicity data on use in older adults (≥ 65 years). Given the severity of IMD, residents (64–95 years) and staff (18–72 years) were offered 4CMenB for longer-term protection, with daily diary cards to monitor side effects. In total, 30 residents and 35 of 47 staff received the first dose, with completed diary cards for 26 residents and 32 staff. Twenty-six residents and 28 staff received the second dose, and all completed diary cards. Elderly residents reported fewer and less severe side effects after each dose than younger staff
Household economic impact of HIV-associated cryptococcal meningitis in five countries in Southern and Eastern Africa
Full text linkIntroduction
HIV-associated cryptococcal meningitis is the second leading cause of AIDS-related mortality. Cryptococcal meningitis is a poverty-related disease and the majority of cases occur in settings where resources are limited and access to quality care is often linked to an individual's ability to pay for services. We have previously demonstrated the efficacy, safety and cost-effectiveness of a single, high-dose liposomal amphotericin-based treatment regimen within the AMBITION-cm trial. Here, we present a five-country, within-trial analysis exploring the household economic impact of cryptococcal meningitis.
Methods
Eight hundred and ten participants were recruited into this sub-study in Botswana, Malawi, South Africa, Uganda and Zimbabwe between January 2018 and February 2021. We collected data on annual household expenditure, direct costs and indirect costs incurred prior to enrolment and during the 10-week trial period. Costs were inflated and converted to 2022 USD. We calculated out-of-pocket expenditure, lost income and catastrophic healthcare expenditure, defined as costs exceeding 20% of annual household expenditure.
Results
The average total out-of-pocket expenditure plus lost income prior to enrolment was 516 and 29.1% of annual household expenditure across all countries, ranging from 592 (64.2%) in Zimbabwe. More than half (296/581, 51.0%, 95% CI 46.9–55.0) of households experienced catastrophic healthcare expenditure by the end of the trial, ranging from 16.0% (13/81, 95% CI 7.9–24.2) in South Africa to 68.1% (156/229, 95% CI 62.0–74.2) in Uganda.
Conclusions
This is the first study exploring the household economic impact experienced by those diagnosed with cryptococcal meningitis. The household economic impact of cryptococcal meningitis is high and more than half of households of individuals who survive experience catastrophic healthcare expenditure. It is likely these figures are higher outside of the research setting. This highlights the profound financial impact of this devastating infection and provides a rationale to offer financial and social protection to those affected
Reassessing the need for primary prevention implantable cardioverter-defibrillators in contemporary patients with heart failure.
No full textThe main function of the implantable cardioverter-defibrillator (ICD) is to protect against sudden cardiac death (SCD) due to ventricular tachyarrhythmia (VTA). Current guidelines provide a recommendation to implant a prophylactic ICD for the primary prevention of SCD in individuals having heart failure with reduced ejection fraction (HFrEF) who never experienced a previous sustained VTA. However, these recommendations are based on clinical trials conducted more than 20 years ago and may not be applicable to contemporary patients with HFrEF who have a lower arrhythmic risk as a result of advances in heart failure medical therapies. Thus, there is an unmet need for more appropriate selection of contemporary patients with HFrEF for a primary prevention ICD. In this article, we review data underlying the current clinical equipoise on the need for routine implantation of a primary prevention ICD in patients with HFrEF and the rationale for conducting clinical trials that aim to reassess the role of the ICD in this population
Effect of ethnicity and other sociodemographic factors on attendance at ophthalmology appointments following referral from a Diabetic Eye Screening Programme: a retrospective cohort study.
Full text linkBACKGROUND/AIMS: To examine the association between sociodemographic characteristics and attendance at Hospital Eye Service (HES) referrals from the Diabetic Eye Screening Programme (DESP), in a large, ethnically diverse urban population. METHODS: Retrospective cohort study (4 January 2016-12 August 2019) of people with diabetic retinopathy (DR) referred from an English DESP to a tertiary referral eye hospital. We conducted a multivariable logistic regression with attendance as the primary outcome, controlling for age, sex, ethnicity, Index of Multiple Deprivation, best eye visual acuity and baseline DR grade. RESULTS: Of 7793 people referred (mean age 64 years, 62.6% male, 13.9% white, 12.5% black, 25.3% South Asian, 6.5% any other Asian background, 19.3% no recorded ethnicity and 20.9% of 'Other' ethnic origin), 69% attended. Compared with white individuals, people of black ethnic origin were similarly likely to attend. South Asians and those of other Asian backgrounds were more likely, and people with 'Other' or missing ethnicity were less likely to attend. Those with higher levels of deprivation, younger (aged 18-45 years) and older (76-90 years) age groups and worse visual acuity were less likely to attend, whereas people identified as having proliferative DR in both eyes were more likely to attend. CONCLUSION: Sociodemographic patterns in attendance after referral from the DESP to the HES exist, and these do not appear to explain ethnic differences in more severe sight-threatening DR, suggesting other explanations. More work is needed to understand and reduce inequalities in HES attendance
Up-regulated matrix metalloproteinase activity in soil-transmitted helminth-tuberculosis co-infection is associated with increased lung pathology.
Full text linkIndividuals with soil-transmitted helminth (STH) infection are more likely to have active pulmonary TB. Both TB and STH infections are independently associated with elevated plasma MMPs, which correlate with worse lung pathology. https://bit.ly/3VgGWj
Top Ten epilepsy research priorities: A UK priority setting partnership.
Full text linkPURPOSE: Research into epilepsy has experienced decades of chronic underfunding compared to other neurological conditions despite its prevalence and seriousness. To evidence the need for greater investment, the Epilepsy Research Institute (formerly Epilepsy Research UK) funded, led and managed a James Lind Alliance (JLA) Priority Setting Partnership (PSP). This "industry standard" methodology brings together healthcare professionals, patients, carers and patient group representatives to identify and prioritise research uncertainties within a defined area of health or care. METHODS: The UK Epilepsy PSP is a once-in-a-generation, national consensus that collated and ranked the research priorities of the UK epilepsy and associated condition community. Following JLA methodology, this 18-month project engaged over 100 patient groups and 5000 people affected by and working in epilepsy, including medics and allied healthcare professionals, from across the UK. RESULTS: Over 5400 priorities were received, with anti-seizure medication, sudden unexpected death in epilepsy (SUDEP) and epilepsy in women among the most frequently reported themes. The responses received were categorised and translated into distinct, researchable questions. Questions were excluded if deemed to be "answered" following an evidence check, while research uncertainties (i.e. unanswered and partially answered questions) formed the basis of a second, shortlisting survey. The shortlisted questions were then discussed and debated at the final workshop by participants that broadly represented the UK epilepsy and associated condition community. The final ranking and Top Ten priorities for research into epilepsy were then agreed. CONCLUSION: The aim of the UK Epilepsy PSP is to encourage and inspire researchers to investigate the research areas prioritised by those most affected by the condition and provide the evidence of need to aid future policy making discussions and support research funding applications
Flexible and stable cycle-by-cycle phase-locked deep brain stimulation system targeting brain oscillations in the management of movement disorders
Full text linkBACKGROUND: Precisely timed brain stimulation, such as phase-locked deep brain stimulation (PLDBS), offers a promising approach to modulating dysfunctional neural networks by enhancing or suppressing specific oscillations. However, its clinical application has been hindered by the lack of user-friendly systems and the challenge of real-time phase estimation amid stimulation artifacts. MATERIAL AND METHOD: In this work, we developed a clinically translatable PLDBS framework that enables real-time, cycle-by-cycle stimulation using standard amplifiers and a computer-in-the-loop system. Our approach integrates Kalman filter-based artifact suppression and non-resonant oscillators for accurate phase tracking. We tested this system in a small clinical trial (n=4) targeting subthalamic nucleus (STN) stimulation at specific phases of cortical alpha and STN beta rhythms in patients with movement disorders during acute lead externalization following deep brain stimulation surgery. RESULT: The system delivered stimulation with over 90% accuracy, within ±π/2 for STN beta and ±π/4 for cortical alpha. Stimulations delivered at different STN beta phases led to a significant difference in evoked potentials in STN local field potentials in all participants. STN beta-triggered stimulation showed potential phase-dependent modulation of finger-tapping velocity and amplitude in Parkinson's disease. CONCLUSION: This study presents a flexible and stable pipeline for precise PLDBS with CE-marked devices and a computer-in-the-loop. Using this pipeline, we showed that PLDBS at different STN beta phases differentially modulates the evoked action potentials in the STN and motor behavior used to quantify bradykinesia, paving the way for further studies and clinical trials for PLDBS
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