Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard.

Introduction: In 2018, we published the MONARCSi algorithmic decision support tool showing high inter-rater agreement, moderate sensitivity, and high specificity compared with drug-event pairs (DEPs) previously reviewed using current, industry-established approaches. Following publication, MONARCSi was implemented as a prototype system to facilitate medical review of individual case safety reports (ICSRs). This paper presents subsequent evaluation of MONARCSi-supported causality assessments against an independent, best achievable reference standard.

Exploring nutrition education for migrants to Canada in Alberta's health and community sectors: Promising practices and gaps as informed by community workers and healthcare providers.

This qualitative study explored how migrant-serving agencies and healthcare providers in Alberta can support migrants to maintain healthy eating patterns. Through semi-structured interviews, respondents provided insight on their experiences working with migrant populations in the community. Observations about dietary acculturation (including food access, unfamiliar food environments, and perceptions of common foods in Canada) point to nutrition information that may be relevant for migrants.

Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy.

Background: The proposed use of bevacizumab with radiotherapy/temozolomide for newly diagnosed glioblastoma raised potential safety concerns. Bevacizumab has been linked with stroke, bleeding events, and wound-healing complications in other tumor types; these events are of particular concern for glioblastoma (highly vascular tumors that are usually resected). Published data on the interaction of bevacizumab with radiotherapy/temozolomide are also limited.

A phase 2, double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the efficacy, safety, and tolerability of naloxegol in patients with opioid-induced constipation.

Naloxegol (previously known as NKTR-118) is a peripherally acting μ-opioid receptor antagonist engineered using polymer conjugate technology in development as an oral, once-daily agent for the treatment of opioid-induced constipation (OIC). Eligible patients with OIC (n=207), defined as <3 spontaneous bowel movements (SBMs) per week with accompanying symptoms, on a stable opioid regimen of 30-1000 mg/day morphine equivalents for ≥ 2 weeks were randomized to receive 4 weeks of double-blind placebo or naloxegol (5, 25, or 50mg) once daily in sequential cohorts after a 1-week placebo run-in. The primary end point, median change from baseline in SBMs per week after week 1 of drug administration, was statistically significant for the 25- and 50-mg naloxegol cohorts vs placebo (2.