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Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placebo-controlled trial

Por: Stotts · C. · Corrales-Medina · V. F. · deKemp · R. A. · Wells · G. A. · Beanlands · R. · Raggi · P. · Ferrara · G. · Sligl · W. · A Connelly · K. · Paul · N. · Brouwers · M. · Contreras-Dominguez · V. · Yadav · K. · Torres · C. · Tavoosi · A. · Wiefels · C. · Kirpalani · A. · Romsa · J.
Introduction

Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.

Methods and analysis

TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including 18F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).

Ethics and dissemination

The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT06710080.

Whom to include? A cross-sectional survey study investigating how culture impacts diagnostic decision making for paediatric cancer in Pakistan

Por: Graetz · D. · Wardell · J. · Hameed · A. · Tul Quanita · A. · Najmi · A. · Ahmad · S. · Shafiq · M. · Naheed · A. · Munir · S. · Ferrara · G. · Staples · C. · Chen · Y. · Devidas · M. · Rodriguez-Galindo · C. · Jeha · S. · Mack · J. · Hamid · S. A. · Rafie Raza · M. · Ahmad · A.
Objectives

This study sought to explore decision making among caregivers of children with cancer in Pakistan, one of the largest lower middle-income countries in the world.

Design

Cross-sectional survey study

Setting

This study was conducted in Pakistan at Indus Hospital and Health Network in Karachi and Children’s Hospital of Lahore. Children’s Hospital of Lahore is a public sector hospital, and Indus Hospital has a foundation-based funding structure. Both are larger tertiary care centers. Over 2,500 new patients are seen at these centers annually, this accounts for almost 50% of all children with cancer in Pakistan

Participants

Eligible participants included bedside caregivers, defined as a parent or family member involved in communication with the medical team, of children with cancer (

Primary and secondary outcome measures

Primary outcome measures included caregiver priorities and experiences related to communication including decision-making role, involvement of the paediatric patient and decisional regret.

Results

Participants included 200 caregivers of children

Conclusions

Findings from this study highlight the importance of exploring preferences for decision making and empowering bedside caregivers while respecting cultural norms. In the Pakistani context, it may be specifically important to consider gender roles and the inclusion of extended family members. Future work should investigate paediatric patient involvement in diverse settings.

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