Delphi Method Consensus on Statistical Analysis and Reporting Recommendations for Single-Arm Pregnancy Medication Safety Studies Investigating Pregnancy, Birth and Neonatal Health Outcomes: A Contribution from IMI-ConcePTION.

Background And Objective: Standardised procedures for performing and reporting safety monitoring studies investigating medications use in pregnancy may help improve data quality and the speed of data generation. The objective of this study was to provide recommendations on the statistical analysis and reporting of single-arm pregnancy medication safety studies using primary source datasets.

Methods: A Delphi consensus-setting protocol was used to acquire agreement on recommendations from experts with extensive knowledge and experience in conducting studies investigating medication safety in pregnancy.

Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project.

Introduction And Objective: The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the possibility of developing a distributed data processing and analysis infrastructure using a common data model that could form a foundational platform for future surveillance and research. A prerequisite would be that data from various data access providers (DAPs) can be harmonised according to an agreed set of standard rules concerning the structure and content of the data.

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.

Introduction And Objective: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities.

Is It Time to Call 'Code Blue' on Nursing Infrastructure? A Nurse's Perspective from the COVID-19 Front-line.

The COVID-19 pandemic has highlighted the significance of every role within the interdisciplinary team and has exacerbated the challenges posed to every member. From the nursing perspective, many of these challenges were present before the pandemic but have become significantly larger problems that continue to demand global attention. This has provided an opportunity to critically evaluate and learn from the challenges the pandemic has both highlighted and created.

Comprehensive Medical Support in Complex Emergencies (CMSCE): pilot course review.

Global threats to health and health security are growing. Fragile and failed states, armed groups, ungoverned spaces, outbreaks and potential unknown "Disease X" threats, antimicrobial resistance (AMR), hybrid and gray zone conflict all exacerbate complex medical emergencies. These growing threats increase preventable morbidity and mortality of the most vulnerable populations.

Cryptococcal Meningitis Reported With Fingolimod Treatment: Case Series.

Background And Objectives: To describe the characteristics of patients with MS reporting cryptococcal meningitis (CM) while treated with fingolimod.

Methods: The Novartis safety database was searched for cases with CM between January 26, 2006, and February 28, 2020. The reporting rate of CM was estimated based on the case reports received and exposure to fingolimod in the postmarketing setting during the relevant period.

Capturing what matters: updating NICE methods guidance on measuring and valuing health.

In July 2019, the National Institute for Health and Care Excellence (NICE) initiated a major review of its health technology evaluation methods to update its methods guide. This update has recently concluded with the publication of its health technology evaluation manual in January 2022. This paper reports the methods and findings of the review in relation to the recommended approach to use for the measurement and valuation of health-related quality of life (HRQoL) in submissions to NICE.

Induction of tier-2 neutralizing antibodies in mice with a DNA-encoded HIV envelope native like trimer.

HIV Envelope (Env) is the main vaccine target for induction of neutralizing antibodies. Stabilizing Env into native-like trimer (NLT) conformations is required for recombinant protein immunogens to induce autologous neutralizing antibodies(nAbs) against difficult to neutralize HIV strains (tier-2) in rabbits and non-human primates. Immunizations of mice with NLTs have generally failed to induce tier-2 nAbs.

Nucleic acid delivery of immune-focused SARS-CoV-2 nanoparticles drives rapid and potent immunogenicity capable of single-dose protection.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines may target epitopes that reduce durability or increase the potential for escape from vaccine-induced immunity. Using synthetic vaccinology, we have developed rationally immune-focused SARS-CoV-2 Spike-based vaccines. Glycans can be employed to alter antibody responses to infection and vaccines.

Defining distribution and habitat use of west-central Florida's coastal sharks through a research and education program.

Identifying critical habitat for highly mobile species such as sharks is difficult, but essential for effective management and conservation. In regions where baseline data are lacking, non-traditional data sources have the potential to increase observational capacity for species distribution and habitat studies. In this study, a research and education organization conducted a 5-year (2013-2018) survey of shark populations in the coastal waters of west-central Florida, an area where a diverse shark assemblage has been observed but no formal population analyses have been conducted.

ARTP statement on pulmonary function testing 2020.

The Association for Respiratory Technology & Physiology (ARTP) last produced a statement on the performance of lung function testing in 1994. At that time the focus was on a practical statement for people working in lung function laboratories. Since that time there have been many technological advances and alterations to best practice in the measurement and interpretation of lung function assessments.

An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring.

Patient safety during pregnancy is an important concern. This article presents a method of using an industry safety database to access prospective pregnancy cases. This method, termed here 'PRegnancy outcomes Intensive Monitoring' (PRIM) was developed for fingolimod (Gilenya ™), a treatment option for multiple sclerosis (MS), due to slow enrollment in the company pregnancy registry.

Comorbid disease burden among MS patients 1968-2012: A Swedish register-based cohort study.

Background: People with multiple sclerosis (pwMS) have increased comorbid disease (CMD) risk. Most previous studies have not considered overall CMD burden.

Objective: To describe lifetime CMD burden among pwMS.

Health Utilities and Costs for Motor Neurone Disease.

Background: Motor neurone disease (MND) places a significant burden on patients, their carers, and healthcare systems.

Objectives: To estimate health utilities and costs of MND within the UK setting.

Methods: Patients with MND, recruited via 22 regional clinics, completed a postal questionnaire of a cost and quality-of-life survey.

Mapping ALSFRS-R and ALSUI to EQ-5D in Patients with Motor Neuron Disease.

Background: The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) is the preferred measure of health outcome in clinical trials in motor neuron disease (MND). It, however, does not provide a preference-based health utility score required for estimating quality-adjusted life-years in economic evaluations for health technology assessments.

Objectives: To develop algorithms for mapping from measures used in MND clinical studies to allow for future prediction of the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility in populations of patients with MND when utility data have not been collected.

Reply to Hurlburt.

Hurlburt (2018) states that Brouwers et al. (2018) find a much lower frequency of reported inner speech while reading than we find in Moore and Schwitzgebel (2018), and he attributes the difference to methodological shortcomings in Moore and Schwitzgebel's method. However, the method in Brouwers et al.

The experience of reading.

What do people consciously experience when they read? There has been almost no rigorous research on this question, and opinions diverge radically among both philosophers and psychologists. We describe three studies of the phenomenology of reading and its relationship to memory of textual detail and general cognitive abilities. We find three main results.

Increased core body temperature in astronauts during long-duration space missions.

Humans' core body temperature (CBT) is strictly controlled within a narrow range. Various studies dealt with the impact of physical activity, clothing, and environmental factors on CBT regulation under terrestrial conditions. However, the effects of weightlessness on human thermoregulation are not well understood.

Length of encapsidated cargo impacts stability and structure of in vitro assembled alphavirus core-like particles.

In vitro assembly of alphavirus nucleocapsid cores, called core-like particles (CLPs), requires a polyanionic cargo. There are no sequence or structure requirements to encapsidate single-stranded nucleic acid cargo. In this work, we wanted to determine how the length of the cargo impacts the stability and structure of the assembled CLPs.

Using confirmatory factor analysis to validate the Chamberlin affective instrument for mathematical problem solving with academically advanced students.

Background: Student affect plays a considerable role in mathematical problem solving performance, yet is rarely formally assessed. In this manuscript, an instrument and its properties are discussed to enable educational psychologists the opportunity to assess student affect.

Aims: The study was conducted to norm the CAIMPS (instrument) with gifted students.

Economic Studies in Motor Neurone Disease: A Systematic Methodological Review.

Background: Motor neurone disease (MND) is a devastating condition which greatly diminishes patients' quality of life and limits life expectancy. Health technology appraisals of future interventions in MND need robust data on costs and utilities. Existing economic evaluations have been noted to be limited and fraught with challenges.

The First 10 Years of Aerobic Exercise Responses to Long-Duration ISS Flights.

Introduction: Aerobic deconditioning may occur during International Space Station (ISS) flights. This paper documents findings from exercise testing conducted before, during, and after ISS expeditions.

Methods: There were 30 male and 7 female astronauts on ISS missions (48 to 219 d, mean 163 d) who performed cycle exercise protocols consisting of 5-min stages eliciting 25%, 50%, and 75% peak oxygen uptake (Vo(2peak)).

Mortality and comorbidities in patients with multiple sclerosis compared with a population without multiple sclerosis: An observational study using the US Department of Defense administrative claims database.

Background: Data are limited for mortality and comorbidities in patients with multiple sclerosis (MS).

Objectives: Compare mortality rates and event rates for comorbidities in MS (n=15,684) and non-MS (n=78,420) cohorts from the US Department of Defense (DoD) database.

Methods: Comorbidities and all-cause mortality were assessed using the database.

Keep an eye out for myasthenia gravis patients with an eye out.

Eye trauma and blindness are common in the United States, with an incidence of over 2 million cases/year and 25 million blind adults, respectively. However, literature is surprisingly scarce on the potential confounding effect of eye trauma or blindness on the diagnosis of myasthenia gravis (MG), an autoimmune neuromuscular disease in which fluctuating ocular symptoms are the most distinguishing feature. We present the case of a 75-year-old man with eye enucleation referred for electrodiagnostic evaluation of the right upper limb after an accidental fall.

Peak exercise oxygen uptake during and following long-duration spaceflight.

This investigation was designed to measure aerobic capacity (V̇o2peak) during and after long-duration International Space Station (ISS) missions. Astronauts (9 males, 5 females: 49 ± 5 yr, 77.2 ± 15.