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NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

Methods and analysis

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethics and dissemination

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Rethinking the way we measure access to language-concordant health services for minority language populations: a secondary analysis of publicly available physician and population data in Ontario, Canada

Por: Timony · P. E. · Belanger · C. · Belizaire · A. · Desilets · A. · Gauthier · A. · Karunananthan · S. · Muray · M.-N. · Peixoto · C. · Fitzsimon · J. P. · Godfrey · L. · Bjerre · L. M.
Objective

Providing care in a patient’s preferred language improves health outcomes and patient satisfaction. In Ontario, access to French-speaking physicians (FSPs) is estimated using FSP-to-Francophone population ratios and compared with total physician-to-total population ratios. This approach fails to consider the fact that FSPs also serve non-Francophone patients and that Francophones must compete with the entire population to access FSPs. As a result, this approach inaccurately suggests that Francophones have better access to language-concordant care than Anglophones/Allophones. We propose a novel approach to address this issue, enabling unbiased comparisons of access to language-concordant care across linguistic groups.

Design

This secondary analysis of publicly available data containing linguistic variables for the Ontario population (Statistics Canada, 2021 Census) and for family physicians (FPs) (College of Physicians and Surgeons of Ontario, January 2024) calculated competition-adjusted ratios and probabilities of accessing language-concordant care.

Setting

Ontario, Canada.

Participants

Census and publicly available data on FPs (ie, those providing comprehensive family medicine care to the community) and the Ontario population were obtained.

Results

Province-wide, the crude ratio of FSPs per 1000 Francophones was 3.46. After adjusting for competition, the ratio of FSP per 1000 population was 0.12, compared with a general physicians-per-1000 population ratio of 1.05. Anglophones/Allophones attached to a FP have a 100% probability of receiving care in English compared with an 11.4% probability for Francophones to receive care from a FSP. Expressed otherwise, Anglophones/Allophones are 8.8 times more likely to receive language-concordant care (ie, care in English) than Francophones.

Conclusions

Although crude physician-to-population ratios overestimate Francophones’ access to FSPs, competition-adjusted ratios and probabilities demonstrate that they are much less likely to access language-concordant care than Anglophones/Allophones. This novel approach has equity implications for health human resources planning and can be applied to other linguistic minority groups and healthcare providers.

Scoping review of interventions aimed at promoting healthy screen use among adolescents

Por: Tock · W. L. · Gauvin · L. · Hudon · F. · Tremblay · F. · Belanger · R. E. · Turcotte-Tremblay · A.-M.
Objectives

The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.

Design

We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

Data sources

We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.

Eligibility criteria

We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.

Data extraction and synthesis

One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.

Results

From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.

Conclusion

This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.

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