FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Convergent parallel mixed-methods study to understand the impact of decision-making for congenital cardiac surgery patients at a tertiary paediatric hospital: a study protocol

Por: Yin · L. · Pinkney · S. · Assadi · A. · Fan · M. · Zahiri · Y. · Mazwi · M. · Honjo · O. · Trbovich · P.
Introduction

Congenital heart disease (CHD) is the most common congenital condition, often necessitating complex heart surgeries that require careful planning by multidisciplinary teams. Multidisciplinary meetings (MDMs) in CHD care aim to integrate diverse expertise to optimise surgical planning. However, the lack of standardised protocols for conducting these meetings introduces undesirable variability in decision-making processes, potentially impacting patient outcomes. This study addresses the critical gap in understanding which aspects of MDMs should be standardised to ensure consistent, high-quality decision-making while also identifying areas where flexibility is essential to accommodate individual patient needs. The objective is to characterise current MDM practices in CHD care, identify factors contributing to variability and provide insights into how a balance between standardisation and flexibility can improve decision-making and patient outcomes.

Methods and analysis

A convergent parallel mixed-methods study design will be used to collect, analyse and interpret quantitative and qualitative data. Data collection will include a blend of naturalistic observations and chart reviews to track patient journeys from surgical planning through to postoperative outcomes. To complement these findings, interviews with healthcare providers will capture subjective perspectives on multidisciplinary decision-making. Additionally, departmental metrics will be collected to contextualise the broader clinical environment. Closed-ended observational and chart review data will be analysed using summary statistics and descriptive analysis (eg, percentages, means) to characterise MDM decision-making. Qualitative data (eg, reflections and learnings) from weekly post-surgical debriefs (called Performance Rounds) and clinician interviews on MDM decision-making will be analysed using a modified Framework Method.

Ethics and dissemination

Institutional research ethics approval has been acquired (REB #1000080464). To engage key stakeholders and foster collaborative improvement, study results will be shared in research rounds, where staff attending medical surgical conferences, team huddles, morbidity and mortality reviews, and Performance Rounds will be invited to participate. Targeted meetings with individual clinician groups will further allow for in-depth discussion and valuable feedback on the findings. Finally, the findings from this study are anticipated to make a meaningful contribution to the literature; a manuscript is planned for submission to a peer-reviewed journal.

Cardiac adverse events associated with remdesivir in COVID-19 patients: a systematic review and meta-analysis of randomised controlled trials

Por: Yang · C. · Lapp · L. · Amstutz · A. · Briel · M. · Shannon · C. P. · Zhao · H. · Espin · E. · Assadian · S. · Toma · M. · Tebbutt · S. J.
Objectives

To evaluate whether remdesivir is associated with cardiac adverse events (CAEs), addressing concerns raised by basic experiments, clinical case reports and observational studies.

Design

Systematic review and meta-analysis.

Data sources

MEDLINE and Embase, searched from January 2020 to December 2023.

Study selection

Randomised controlled trials (RCTs) comparing remdesivir with placebo or standard care in patients with COVID-19, with a primary focus on cardiac safety.

Eligibility criteria for selecting studies

We included RCTs that evaluated the safety of remdesivir in patients with COVID-19 . Eligible studies were those that compared remdesivir with placebo or standard care in adult patientsCOVID-19 . Inclusion criteria emphasised safety outcomes, particularly CAEs, as primary endpoints.

Data extraction and synthesis

Two reviewers independently extracted data. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-Harms guidelines. Risk of bias (RoB) was assessed using the Cochrane Collaboration tool. A random-effects model was used for data synthesis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was applied to assess the certainty of evidence. The primary outcome was the incidence of any CAEs, defined as a composite of all reported cardiac-related harms. Secondary outcomes included specific CAEs such as arrhythmias, heart failure and myocardial disorders.

Results

We identified 1698 studies, of which seven RCTs met the inclusion criteria, comprising a total of 4566 participants. The RoB was assessed across multiple domains, with four RCTs showing low risk and three showing moderate risk in specific areas. Pooled analysis revealed no significant association between remdesivir use and CAEs (RR=0.84, 95% CI: 0.68 to 1.04, p=0.118). Subgroup analyses showed consistent findings across different patient demographics and comorbidities. GRADE assessment indicated moderate certainty for overall CAEs, low certainty for arrhythmias and heart failure (due to imprecision and study-level bias), and very low certainty for myocardial disorders (due to small sample size and indirectness).

Conclusions

Contrary to preliminary concerns and case reports, our meta-analysis found no evidence of a statistically significant association between remdesivir and CAEs among patients with COVID-19 . These findings provide reassurance to clinicians regarding the safety profile of remdesivir in this patient population, supporting its use as an antiviral therapy in the treatment of COVID-19. Further research is warranted to validate these findings and to clarify whether remdesivir may have a neutral or potentially protective effect on cardiac outcomes.

PROSPERO registration number

CRD42022383647.

❌