Selection for proton radiotherapy of grade 1-3 glioma patients.

Background: For adult patients with grade 1-3 gliomas, identifying patients with an indication for proton therapy (PT) can be challenging due to sparse evidence supporting its benefits. In this study, we aimed to ensure national consensus and develop a decision support tool to aid clinicians in identifying patients with grade 1-3 gliomas eligible for PT.

Methods: Sixty-one historic patients referred for postoperative radiotherapy for glioma grade 1-3 were included in this study and had new photon therapy and PT plans calculated.

Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data.

Background: Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. A single study generally does not have sufficient sample size to evaluate all important safety events with reasonable precision and may not cover the full target population for the investigational treatment. Integrated analyses (pooled or meta-analysis) over several studies may be helpful in that regard.

Directed causal effect with PCMCI in hyperscanning EEG time series.

Social activities are likely to cause effects or reactivity in the brains of the people involved in collaborative social situations. This study assesses a new method, Tigramite, for time domain analysis of directed causality between the prefrontal cortex (PFC) of persons in such situations. An experimental situation using hyperscanning EEG was applied while individuals led and followed each other in finger-tapping rhythms.

A safety estimand for late phase clinical trials where the analysis period varies over the subjects.

Background/aims: Evaluating safety is as important as evaluating efficacy in a clinical trial, yet the tradition for safety analysis is rudimentary. This article explores more complex methodologies for safety evaluation, with the aim of improving the interpretability, as well as generalizability, of the results.

Methods: For studies where the analysis periods vary over the subjects, using the International Council for Harmonisation estimand framework, we construct a formal estimand that could be used in the setting of safety surveillance that answers the clinical question of 'What is the magnitude of the increase in risk of experiencing an adverse event if the treatment is taken, as prescribed, for a specific period of time?'.

A Case Study and Literature Review of Local Anesthetic Systemic Toxicity During Placement of a Dual-chamber Pacemaker.

Local anesthetics are commonly deployed for a variety of medical procedures across many disciplines. Systemic toxicity is rarely seen in clinical practice, and quick recognition and how to manage this syndrome are crucial. The development of systemic toxicity is influenced by the site of administration, the type of anesthetic used, and the total dose administered.