Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria.

ABP 959 is a biosimilar to the eculizumab reference product (RP), which is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). This multicenter, randomized, double-blind, active-controlled, two-period crossover study randomized eculizumab RP-treated patients with PNH to one of two treatment sequences (ABP 959/eculizumab RP or eculizumab RP/ABP 959) to evaluate the clinical similarity of ABP 959 when compared with eculizumab RP. This study evaluated the efficacy of ABP 959 when compared with eculizumab RP based on control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) and by the time-adjusted area under the effect curve of LDH.

Undergraduate occupational medicine education in European Medical Schools: better training to meet today's challenges.

Background: Occupational medicine (OM) faces considerable challenges today, one of them related to the university training of future physicians considered suboptimal at a global level as it has been pointed out in many studies. The aim of this study is to update the state of OM medical education in European universities.

Methods: Between March and August 2022, an e-mail survey regarding OM training to undergraduate medical students was conducted among OM professors at European universities in 28 countries (n = 347).

Use of business model potential in Dutch academic medical centres-A case study.

Academic Medical Centres (AMCs) are large organisations with a complex structure due to various intertwined missions and (public) roles that can be conflicting. This complexity makes it difficult to adapt to changing circumstances. The literature points to the use of business models to address such challenges.

Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): final prespecified overall survival results of a randomised, double-blind, phase 3 trial.

Background: PROpel met its primary endpoint showing statistically significant improvement in radiographic progression-free survival with olaparib plus abiraterone versus placebo plus abiraterone in patients with first-line metastatic castration-resistant prostate cancer (mCRPC) unselected by homologous recombination repair mutation (HRRm) status, with benefit observed in all prespecified subgroups. Here we report the final prespecified overall survival analysis.

Methods: This was a randomised, double-blind, phase 3 trial done at 126 centres in 17 countries worldwide.

[Evaluation of an information booklet on end-of-life care in dementia: a mixed-methods study assessing the preferences of family caregivers and healthcare professionals].

A booklet was developed in Canada in 2005 to inform family caregivers of people with dementia about end-of-life care. A Dutch version was published in 2011 after evaluation and revision. Developments in research and society call for a second revision.

Societal burden and quality of life in patients with Lisfranc Injuries.

Background: The incidence of Lisfranc fractures is rising, along with the incidence of foot fractures in general. These injuries can lead to long-term healthcare use and societal costs. Current economic evaluation studies are scarce in Lisfranc fracture research, and only investigate the healthcare costs.

Inventory and analysis of literature on the organisation of eight European academic medical centres-A scoping review.

Academic Medical Centres (AMCs) are important organisations for shaping healthcare. The purpose of this scoping review is to understand the scope and type of evidence related to the organisation of European AMCs. We selected the study population intending to obtain a demographic cross-section of European countries: Czech Republic, Germany, Latvia, the Netherlands, Poland, Spain, Sweden and the UK.

Teamwork Training With a Multiplayer Game in Health Care: Content Analysis of the Teamwork Principles Applied.

Background: In health care, teamwork skills are critical for patient safety; therefore, great emphasis is placed on training these skills. Given that training is increasingly designed in a blended way, serious games may offer an efficient method of preparing face-to-face simulation training of these procedural skills.

Objective: This study aimed to investigate the teamwork principles that were used during gameplay by medical students and teamwork experts.

ImmUniverse Consortium: Multi-omics integrative approach in personalized medicine for immune-mediated inflammatory diseases.

Immune mediated inflammatory diseases (IMIDs) are a heterogeneous group of debilitating, multifactorial and unrelated conditions featured by a dysregulated immune response leading to destructive chronic inflammation. The immune dysregulation can affect various organ systems: gut (e.g.

[Do community-dwelling Dutch older adults receive the care that they need?].

Background Aged care homes have been substituted by homecare to reduce the increasing Dutch healthcare costs. Ageing in place has led to a growing demand on formal and informal caregivers. The aim of this study was to examine: 1) the trends in formal and informal care, 2) whether care needs of community-living older adults are met, and 3) the association between care needs and quality of life (QoL).

Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer.

BACKGROUND: Preclinical studies and results of a phase 2 trial of abiraterone and olaparib suggest a combined antitumor effect when the poly(adenosine diphosphate[ADP]-ribose) polymerase inhibitor olaparib is combined with next-generation hormonal agent abiraterone to treat metastatic castration-resistant prostate cancer (mCRPC). METHODS: We conducted a double-blind, phase 3 trial of abiraterone and olaparib versus abiraterone and placebo in patients with mCRPC in the first-line setting. Patients were enrolled regardless of homologous recombination repair gene mutation (HRRm) status.

Children's behavioral and emotional problems and peer relationships across elementary school: Associations with individual- and school-level parental education.

This study examined (a) whether growing up with lower-educated parents and attending lower parental education schools associated with children's problem development within the behavioral, emotional, and peer relationship domains; and (b) whether the association of lower individual-level parental education with children's development within these three domains depended upon school-level parental education. To this end, 698 children (M = 7.08 in first grade) from 31 mainstream elementary schools were annually followed from first grade to sixth grade.

The LIFE TRIAD of emergency general surgery.

Emergency General Surgery (EGS) was identified as multidisciplinary surgery performed for traumatic and non-traumatic acute conditions during the same admission in the hospital by general emergency surgeons and other specialists. It is the most diffused surgical discipline in the world. To live and grow strong EGS necessitates three fundamental parts: emergency and elective continuous surgical practice, evidence generation through clinical registries and data accrual, and indications and guidelines production: the LIFE TRIAD.

[Prediction model for gallstones can support the general practitioner].

The management of gallstones in primary care is challenging. After diagnosis, the GP has to decide which symptomatic patients will profit from referral for surgery. This is complicated, as many patients will continue to have symptoms also after surgery.

Governance of academic medical centres in changing healthcare systems: An international comparison.

We provide an explorative and international comparison of the governance models of academic medical centres (AMCs). These centres face significant challenges, including disruptive external pressures and enduring financial conflicts pertaining to patient treatment, research and education. Therefore, we covered 10 European countries (Cyprus, Czechia, Denmark, Germany, Italy, Latvia, the Netherlands, Norway, Poland and Spain) and one associated state (Israel) in our analysis.

[Metamizol: current status in Dutch practice].

Metamizole is a non-selective NSAID with a strong analgesic and spasmolytic effect. In the late 1970s, metamizole has been withdrawn from the market in many industrialized countries because of an allegedly unacceptable high risk of agranulocytosis. The absolute risk of metamizole-related agranulocytosis is estimated to be less than 1 per million daily doses.

[Severe malnutrition after gastric: the importance of lifelong follow-up].

Two cases are described of patients who present with severe malnutrition more than five years after undergoing a Roux-en-Y gastric bypass and who have deficiencies of both micronutrients (vitamins and minerals) and macronutrients (proteins). This problem appears to be caused by both iatrogenic malabsorption after gastric bypass as well as dysphagia due to a local anastomotic complication (stenosis and marginal ulcer). Although both the severity of the deficiencies and the timing are exceptional, we want to emphasize the importance of lifelong supplement use and follow-up after bariatric surgery.

IMI-Bigpicture: A Central Repository for Digital Pathology.

To address the challenges posed by large-scale development, validation, and adoption of artificial intelligence (AI) in pathology, we have constituted a consortium of academics, small enterprises, and pharmaceutical companies and proposed the BIGPICTURE project to the Innovative Medicines Initiative. Our vision is to become the catalyst in the digital transformation of pathology by creating the first European, ethically compliant, and quality-controlled whole slide imaging platform, in which both large-scale data and AI algorithms will exist. Our mission is to develop this platform in a sustainable and inclusive way, by connecting the community of pathologists, researchers, AI developers, patients, and industry parties based on creating value and reciprocity in use based on a community model as the mechanism for ensuring sustainability of the platform.

Guided by joy to live and work with hearing loss.

It was a Monday evening, about 8 years ago, when I entered my weekly yoga class tired and in a hurry. I let out a sigh of relief and wondered myself "why I don't do this every day" ..

Multicenter Next-Generation Sequencing Studies between Theory and Practice: Harmonization of Data Analysis Using Real-World Myelodysplastic Syndrome Data.

In the age of personalized medicine, genetic testing by means of targeted sequencing has taken a key role. However, when comparing different sets of targeted sequencing data, these are often characterized by a considerable lack of harmonization. Laboratories follow their own best practices, analyzing their own target regions.

Prediction of obstructive sleep apnea: comparative performance of three screening instruments on the apnea-hypopnea index and the oxygen desaturation index.

Purpose: To evaluate the performance of the NoSAS (neck, obesity, snoring, age, sex) score, the STOP-Bang (snoring, tiredness, observed apneas, blood pressure, body mass index, age, neck circumference, gender) questionnaire, and the Epworth sleepiness score (ESS) as a screening tool for obstructive sleep apnea (OSA) severity based on the apnea-hypopnea index (AHI) and the oxygen desaturation index (ODI).

Methods: Data from 235 patients who were monitored by ambulant polysomnography (PSG) were retrospectively analyzed. OSA severity was classified based on the AHI; similar classification categories were made based on the ODI.

Body composition and its association with fatigue in the first 2 years after colorectal cancer diagnosis.

Purpose: Persistent fatigue among colorectal cancer (CRC) patients might be associated with unfavorable body composition, but data are sparse and inconsistent. We studied how skeletal muscle index (SMI), skeletal muscle radiodensity (SMR), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) at diagnosis are associated with fatigue up to 24 months post-diagnosis in stage I-III CRC patients.

Methods: SMI, SMR, VAT, and SAT were assessed among 646 CRC patients using pre-treatment computed tomography images.