Analytical Methods for Comparing Uncontrolled Trials With External Controls From Real-World Data: A Systematic Literature Review and Comparison With European Regulatory and Health Technology Assessment Practice.

Objectives: This study aimed to provide an overview of analytical methods in scientific literature for comparing uncontrolled medicine trials with external controls from individual patient data real-world data (IPD-RWD) and to compare these methods with recommendations made in guidelines from European regulatory and health technology assessment (HTA) organizations and with their evaluations described in assessment reports.

Methods: A systematic literature review (until March 1, 2023) in PubMed and Connected Papers was performed to identify analytical methods for comparing uncontrolled trials with external controls from IPD-RWD. These methods were compared descriptively with methods recommended in method guidelines and encountered in assessment reports of the European Medicines Agency (2015-2020) and 4 European HTA organizations (2015-2023).

The effect of ATLS/PHTLS spinal motion restriction protocol on the incidence of spinal cord injury, a nationwide database study.

Purpose: To study trends in incidence and outcome of patients with traumatic spinal cord injury (TSCI) in the Netherlands before, during and after implementation of the Advanced Trauma Life Support (ATLS) and Pre-Hospital Trauma Life Support (PHTLS)- Spinal Motion Restriction(SMR) protocol.

Methods: In an observational database we studied national hospital admission and emergency department databases to analyse incidence rates and outcome of traumatic spinal cord injury and spinal fractures in the emergency department and in admittances in The Netherlands between 1986 and 2021.

Results: A significant increase of 39% in TSCI in admitted patients with spinal fractures over the past 35 years (p < 0.

Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned.

The tumour-agnostic authorisations of larotrectinib and entrectinib shifted the paradigm for indication setting. European healthcare decision-makers agreed on their therapeutic potential but diverged primarily in identified uncertainties concerning basket trial designs and endpoints, prognostic value of neurotrophic tropomyosin receptor kinase (NTRK) gene fusions, and resistance mechanisms. In addition, assessments of relevant comparators, unmet medical needs (UMNs), and implementation of NTRK-testing strategies diverged.

Electrodermal activity as an index of food neophobia outside the lab.

Introduction: Understanding how food neophobia affects food experience may help to shift toward sustainable diets. Previous research suggests that individuals with higher food neophobia are more aroused and attentive when observing food-related stimuli. The present study examined whether electrodermal activity (EDA), as index of arousal, relates to food neophobia outside the lab when exposed to a single piece of food.