Importance Clesrovimab is a long-acting monoclonal antibody approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season; data concerning clesrovimab from a second RSV season among children who remain at risk for severe disease are needed. Objective To evaluate the safety and tolerability of clesrovimab (105 mg) vs palivizumab in RSV season 1 in infants at increased risk for severe RSV disease. Key secondary objectives include describing the safety of 210 mg of clesrovimab in RSV season 2 in children who remain at increased risk for severe RSV disease, clesrovimab pharmacokinetics, and the incidence of RSV-associated disease. Design, Setting, and Participants SMART (MK-1654-007) was a randomized, partially masked, palivizumab-controlled, phase 3 clinical trial, conducted at 110 sites in 27 countries and territories between November 30, 2021, and November 20, 2025. The population constituted palivizumab-eligible infants, including those with prematurity, chronic lung disease of prematurity, or hemodynamically significant congenital heart disease. Interventions Participants, randomized 1:1 and stratified by region and condition, received clesrovimab (105 mg) on day 1 followed by placebo on day 28 or monthly palivizumab (15 mg/kg) up to 5 doses (1 dose per month). Eligible infants received open-label clesrovimab (210 mg) before their second RSV season. Main Outcomes and Measures The primary outcome was the observed proportions of participants experiencing adverse events (AEs) after clesrovimab or palivizumab in season 1. Results Overall, 997 infants (500 [50.2%] male; median age, 2.6 [range, 0.0-12.0] months) received clesrovimab, 105 mg (n = 498) or palivizumab (n = 499) in season 1; 276 received clesrovimab, 210 mg open-label in season 2. In season 1, the proportions of participants experiencing AEs were comparable between treatment groups. In season 2, clesrovimab, 210 mg was well tolerated. Incidence rates of RSV-associated medically attended lower respiratory infection (MALRI) were comparable between clesrovimab and palivizumab (3.2% [95% CI, 1.8%-5.2%] and 3.4% [95% CI, 2.0%-5.6%], respectively) through day 150 in season 1; total RSV-associated MALRI incidence through day 180 after a 210-mg dose in season 2 was 7.3% (95% CI, 4.4%-11.4%). Conclusions and Relevance In this randomized clinical trial, clesrovimab was well tolerated in infants at increased risk for severe RSV disease through 2 RSV seasons. These findings support the use of clesrovimab in children who remain at risk for severe RSV disease in their second RSV season. Trial Registration ClinicalTrials.gov Identifier: NCT04938830
Moral distress can occur in situations where one wants to follow a desired course of action but experiences restraints from internal and external barriers. Unaddressed moral distress is associated with negative outcomes (e.g., burnout). Due to the nature of their work with medically and neurodevelopmentally complex children and their families, pediatrics complex care coordinators are at risk of experiencing moral distress. However, there is limited understanding of moral distress in this professional population. Study objectives were to: (1) understand how pediatric complex care coordinators at a tertiary pediatric hospital defined moral distress; (2) explore factors that influence and modulate moral distress in these care coordinators; and (3) explore the impacts of moral distress on care coordinators. Semi-structured virtual interviews were conducted with twelve pediatric complex care coordinators from a pediatric tertiary care centre to explore experiences with moral distress. Interviews ranged from 25 to 60 min. Interview transcripts were examined by two researchers using inductive reflexive thematic analysis for each objective. The data were analyzed and coded and a 15-point checklist was utilized throughout each phase of the analysis process for consistency amongst coders. All participants reported experiencing moral distress using the seminal definition of moral distress. Care coordinators added additional context and depth to this definition. Factors influencing and modulating moral distress in care coordinators were identified: (1) restrictiveness of their scope and capacity; (2) individual experiences; (3) availability of coping mechanisms; (4) the nature of their interactions; and (5) resolution. Four themes on the impact of moral distress were also identified: (1) changes in perspective; (2) impacts on well-being; (3) need for internal and external change; and (4) influence on interpersonal relationships. An expanded definition of moral distress was co-created with care coordinators and identified factors that influenced moral distress and impacts of moral distress. This work is an important first step to developing a better understanding of moral distress in care coordinators and could inform future interventions to address moral distress in this population.
BackgroundThe COVID-19 pandemic introduced new challenges to provide care and educate junior doctors (resident physicians). We sought to understand the positive and negative experiences of first-year resident physicians and describe potential ethical issues from their stories.MethodWe used narrative inquiry (NI) methodology and applied a semistructured interview guide with questions pertaining to ethical principles and both positive and negative aspects of the pandemic. Sampling was purposive. Interviews were audio recorded and transcribed. Three members of the research team coded transcripts in duplicate to elicit themes. Discrepancies were resolved through discussion to attain consensus. A composite story with threads was constructed.Results11 residents participated across several programmes. Three main themes emerged from the participants’ stories: (1) complexities in navigating intersecting healthcare and medical education systems, (2) balancing public health and the public good versus the individual and (3) fair health systems planning/healthcare delivery. Within these themes, participants’ journeys through the first wave were elicited through the threads of (1) engage us, (2) because we see the need for the duty to treat and (3) we are all in this together.DiscussionCases of the ethical issues that took place during the COVID-19 pandemic may serve as a foundation on which ethics teaching and future pandemic planning can take place. Principles of clinical ethics and their limitations, when applied to public health issues, could help in contrasting clinical ethics with public health ethics.ConclusionEfforts to understand how resident physicians can navigate public health emergencies along with the ethical issues that arise could benefit both residency education and healthcare systems.
ABSTRACT Introduction Child Death Review (CDR) processes are public efforts to review a child’s death to understand how and why children die, to improve child health and to prevent future deaths. In 2013, the Canadian Paediatric Society made specific recommendations to establish structured and comprehensive CDR systems in each province and territory. In Alberta, there is no comprehensive CDR process but there are some components. The most public and probably the most expensive component is the public fatality inquiry. A new notification policy adopted after in June 2017 appears to be of limited value for child death prevention. Methods We examined all Alberta fatality inquiry reports from January 1, 1995 to April 15, 2023 concerning children aged 0-17 years (n=133) to determine whether the fatality inquiry system might be effective in preventing future similar deaths. Results Recommendations made by judges in a fatality inquiry were not always followed by action, and hence inquiry recommendations have been largely ineffective. Fatality inquiry recommendations were sometimes untimely, and therefore had little chance of being effective. There is an increasing trend from 1995 (case 1) to 2023 (case 133) in the time taken to initiate a child fatality inquiry review. Discussion and Conclusion Information and recommendations from fatality inquiries into Alberta childhood deaths tend to be delayed and not followed by action. A comprehensive CDR process is required in Alberta. With system changes, public fatality inquiries could be an effective part of the child death prevention process.
Esophageal Atresia/Tracheoesophageal Atresia (EA/TEF) is a multisystem congenital anomaly. Historically, children with EA/TEF lack coordinated care. A multidisciplinary clinic was established in 2005 to provide coordinated care and improve access to outpatient care. This single-center retrospective cohort study was conducted to describe our cohort of patients with EA/TEF born between March 2005 and March 2011, assess coordination of care, and to compare outcomes of children in the multidisciplinary clinic to the previous cohort without a multi-disciplinary clinic. A chart review identified demographics, hospitalizations, emergency visits, clinic visits, and coordination of outpatient care. Twenty-seven patients were included; 75.9% had a C-type EA/TEF. Clinics provided multidisciplinary care and compliance with the visit schedule was high with a median of 100% (IQR 50). Compared to the earlier cohort, the new cohort ( N = 27) had fewer hospital admissions and LOS was reduced significantly in the first 2 years of life. Multidisciplinary care clinics for medically complex children can improve coordination of visits with multiple health care providers and may contribute to reduced use of acute care services.
Purpose of Review The scientific consensus on which global health organizations base public health policies is that high sodium intake increases blood pressure (BP) in a linear fashion contributing to cardiovascular disease (CVD). A moderate reduction in sodium intake to 2000 mg per day helps ensure that BP remains at a healthy level to reduce the burden of CVD. Recent Findings Yet, since as long ago as 1988, and more recently in eight articles published in the European Heart Journal in 2020 and 2021, some researchers have propagated a myth that reducing sodium does not consistently reduce CVD but rather that lower sodium might increase the risk of CVD. These claims are not well-founded and support some food and beverage industry's vested interests in the use of excessive amounts of salt to preserve food, enhance taste, and increase thirst. Nevertheless, some researchers, often with funding from the food industry, continue to publish such claims without addressing the numerous objections. This article analyzes the eight articles as a case study, summarizes misleading claims, their objections, and it offers possible reasons for such claims. Summary Our study calls upon journal editors to ensure that unfounded claims about sodium intake be rigorously challenged by independent reviewers before publication; to avoid editorial writers who have been co-authors with the subject paper's authors; to require statements of conflict of interest; and to ensure that their pages are used only by those who seek to advance knowledge by engaging in the scientific method and its collegial pursuit. The public interest in the prevention and treatment of disease requires no less.
Introduction:The high burden of respiratory syncytial virus (RSV) infection in young children disproportionately occurs in low- and middle-income countries (LMICs). The PROUD (Preventing RespiratOry syncytial virUs in unDerdeveloped countries) Taskforce of 24 RSV worldwide experts assessed key needs for RSV prevention in LMICs, including vaccine and newer preventive measures.Methods:A global, survey-based study was undertaken in 2021. An online questionnaire was developed following three meetings of the Taskforce panellists wherein factors related to RSV infection, its prevention and management were identified using iterative questioning. Each factor was scored, by non-panellists interested in RSV, on a scale of zero (very-low-relevance) to 100 (very-high-relevance) within two scenarios: (1) Current and (2) Future expectations for RSV management.Results:Ninety questionnaires were completed: 70 by respondents (71.4% physicians; 27.1% researchers/scientists) from 16 LMICs and 20 from nine high-income (HI) countries (90.0% physicians; 5.0% researchers/scientists), as a reference group. Within LMICs, RSV awareness was perceived to be low, and management was not prioritised. Of the 100 factors scored, those related to improved diagnosis particularly access to affordable point-of-care diagnostics, disease burden data generation, clinical and general education, prompt access to new interventions, and engagement with policymakers/payers were identified of paramount importance. There was a strong need for clinical education and local data generation in the lowest economies, whereas upper-middle income countries were more closely aligned with HI countries in terms of current RSV service provision.Conclusion:Seven key actions for improving RSV prevention and management in LMICs are proposed.
Background: Since 2015, electronic-cigarette (e-cigarette) use increased among adolescents, necessitating research on effective cessation strategies. This qualitative research examined adolescents’ vaping behaviour and the perceived effectiveness of existing and proposed cessation resources, particularly Health Canada’s 2019 “Consider the Consequences of Vaping” video. Methods: In 2019, we conducted semi-structured interviews with 14 youth (ages 14-18) with e-cigarette use experience in Calgary, Alberta, Canada. The interviews were analyzed using qualitative description in NVivo. Results: Participants were introduced to vaping through members of their social groups. Parental guardians and friend groups were highly influential in encouraging and discouraging vaping. Almost all participants held the belief that vaping is healthier than smoking and said that Health Canada’s 2019 “Consider the Consequences of Vaping” campaign video required improvement. Many participants desired to cease vaping but lacked the resources to do so. Conclusions: This research suggests that a presentation from an ex-vaper, in addition to counselling might be the most useful resources to aid young people to cease vaping.
Objective This study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH). Study Design It involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection. Results A total of 25,003 infants (56.3% male) were enrolled at 32 sites; 109,579 PVZ injections were administered. Indications included: prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%). The "miscellaneous" group increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017) and included: trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group. Adherence measured by expected versus actual doses plus correct interdose interval was 64.7%. A total of 2,054 RIH occurred (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH 1.6%). Risk factors for RSVH included having siblings, attending daycare, family history of atopy, smoking exposure, and crowded household. Infants with 5 risk factors were 9.0 times (95% CI or confidence interval 4.4-18.2; p < 0.0005) more likely to have RSVH than infants without risk factors. Three adverse events occurred; none were fatal. Conclusion Results are relevant to both clinicians and decision-makers. We confirmed the safety of PVZ. Use of PVZ increased steadily for children with miscellaneous conditions and medical complexity. Medical and social factors pose a risk for severe RIH and RSVH with accompanying burden of illness. A vaccine that protects against RSV is urgently required.