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Background: Combining pathogen reduction technology (PRT) with blood screening may alleviate concerns over the risk of transfusion-transmitted infections (TTI) and support changes in blood donor selection to potentially increase blood availability. This study aimed to estimate the residual risk of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) transfusion-transmission in Canada after implementing PRT, while eliminating deferrals for sexual risk behaviors., Study Design and Methods: A probabilistic approach that combined Bayesian networks with Monte Carlo simulations was used to estimate the risk of transfusing HIV-, HBV-, or HCV-contaminated blood components. Different scenarios were considered to compare the current residual risk after PRT implementation, with and without donor deferral criteria for sexual risk behaviors. Donor profiles and blood component outcomes were simulated based on a literature review including the prevalence and incidence of HIV, HBV, and HCV in the Canadian blood donor population; the use of current blood screening assays; and HIV, HBV, and HCV blood donor viral loads., Results: In the universal PRT scenario (i.e., with PRT/without deferral criteria), the estimated risks of HIV, HBV, and HCV transmission were significantly lower than those in the currently observed scenario (i.e., without PRT/with deferral criteria)., Conclusions: This risk model suggests that PRT for platelets and plasma (and eventually for RBCs when available) significantly reduces the residual risks of HIV, HBV and HCV transfusion-transmission and could enable the removal of blood donor deferral criteria for sexual risk behaviors., (© 2024 AABB.)

Background: Data from multiple organizations are crucial for advancing learning health systems. However, ethical, legal, and social concerns may restrict the use of standard statistical methods that rely on pooling data. Although distributed algorithms offer alternatives, they may not always be suitable for health frameworks., Objective: This paper aims to support researchers and data custodians in three ways: (1) providing a concise overview of the literature on statistical inference methods for horizontally partitioned data; (2) describing the methods applicable to generalized linear models (GLM) and assessing their underlying distributional assumptions; (3) adapting existing methods to make them fully usable in health settings., Methods: A scoping review methodology was employed for the literature mapping, from which methods presenting a methodological framework for GLM analyses with horizontally partitioned data were identified and assessed from the perspective of applicability in health settings. Statistical theory was used to adapt methods and to derive the properties of the resulting estimators., Results: From the review, 41 articles were selected, and six approaches were extracted for conducting standard GLM-based statistical analysis. However, these approaches assumed evenly and identically distributed data across nodes. Consequently, statistical procedures were derived to accommodate uneven node sample sizes and heterogeneous data distributions across nodes. Workflows and detailed algorithms were developed to highlight information-sharing requirements and operational complexity., Conclusions: This paper contributes to the field of health analytics by providing an overview of the methods that can be used with horizontally partitioned data, by adapting these methods to the context of heterogeneous health data and by clarifying the workflows and quantities exchanged by the methods discussed. Further analysis of the confidentiality preserved by these methods is needed to fully understand the risk associated with the sharing of summary statistics.

Background: The response of Canada's research community to the COVID-19 pandemic provides a unique opportunity to examine the country's clinical health research ecosystem. We sought to describe patterns of enrolment across Canadian Institutes of Health Research (CIHR)-funded studies on COVID-19., Methods: We identified COVID-19 studies funded by the CIHR and that enrolled participants from Canadian acute care hospitals between January 2020 and April 2023. We collected information on study-and site-level variables from study leads, site investigators, and public domain sources. We described and evaluated factors associated with cumulative enrolment., Results: We obtained information for 23 out of 26 (88%) eligible CIHR-funded studies (16 randomized controlled trials [RCTs] and 7 cohort studies). The 23 studies were managed by 12 Canadian and 3 international coordinating centres. Of 419 Canadian hospitals, 97 (23%) enrolled a total of 28 973 participants - 3876 in RCTs across 78 hospitals (median cumulative enrolment per hospital 30, interquartile range [IQR] 10-61), and 25 097 in cohort studies across 62 hospitals (median cumulative enrolment per hospital 158, IQR 6-348). Of 78 hospitals recruiting participants in RCTs, 13 (17%) enrolled 50% of all RCT participants, whereas 6 of 62 hospitals (9.7%) recruited 54% of participants in cohort studies., Interpretation: A minority of Canadian hospitals enrolled the majority of participants in CIHR-funded studies on COVID-19. This analysis sheds light on the Canadian health research ecosystem and provides information for multiple key partners to consider ways to realize the full research potential of Canada's health systems., Competing Interests: Competing interests:: Christopher Yarnell reports receiving a Vanier Scholarship from the Canadian Institutes of Health Research (CIHR), outside the submitted work. Kathryn Rowan reports holding the role of programme director, Health & Social Care Delivery Research Programme, UK National Institute for Health and Care Research (NIHR), a part-time, paid secondment from the Intensive Care National Audit and Research Centre. Kusum Menon reports receiving salary support from a CHEO Foundation Research Chair in Pediatric Intensive Care Medicine. Dr. Menon has also received a CIHR grant for researching stress hydrocortisone in pediatric septic shock. Dr. Menon is the chair of the Canadian Critical Care Trials Group. Robert Fowler reports receiving a grant from CIHR in support of the COVID-19 Network of Clinical Trials Networks. Alison Fox-Robichaud is the nominated principal applicant and holder of the CIHR Sepsis Canada network grant. As scientific director of Sepsis Canada, Dr. Fox-Robichaud also reports receiving additional support from McMaster University and Hamilton Health Sciences. John Marshall reports receiving support from CIHR in support of the current manuscript. Dr. Marshall has also participated on a data safety monitoring or advisory board for the AM Pharma REVIVAL Trial and the SHIPSS Trial, and is the chair of the International Forum for Acute Care Trialists. Michelle Kho reports receiving support as the Canada Research Chair in Critical Care Rehabilitation and Knowledge Translation and from Sepsis Canada and the COVID-19 Network of Clinical Trials Networks, in support of the current manuscript. No other competing interests were declared., (© 2024 CMA Impact Inc. or its licensors.)

Background and Objectives: Until recently, gay, bisexual and other men who have sex with men (MSM) were deferred from donating blood for 3-12 months since the last male-to-male sexual contact. This MSM deferral has been discontinued by several high-income countries (HIC) that now perform gender-neutral donor selection., Materials and Methods: An international symposium (held on 20-04-2023) gathered experts from seven HICs to (1) discuss how this paradigm shift might affect the mitigation strategies for transfusion-transmitted infections and (2) address the challenges related to gender-neutral donor selection., Results: Most countries employed a similar approach for implementing a gender-neutral donor selection policy: key stakeholders were consulted; the transition was bridged by time-limited deferrals; donor compliance was monitored; and questions or remarks on anal sex and the number and/or type of sexual partners were often added. Many countries have now adopted a gender-neutral approach in which questions on pre- and post-exposure prophylaxis for human immunodeficiency virus (HIV) have been added (or retained, when already in place). Other countries used mitigation strategies, such as plasma quarantine or pathogen reduction technologies for plasma and/or platelets., Conclusion: The experience with gender-neutral donor selection has been largely positive among the countries covered herein and seems to be acceptable to stakeholders, donors and staff. The post-implementation surveillance data collected so far appear reassuring with regards to safety, although longer observation periods are necessary. The putative risks associated with HIV antiretrovirals should be further investigated., (© 2024 International Society of Blood Transfusion.)

Importance: Research diversity and representativeness are paramount in building trust, generating valid biomedical knowledge, and possibly in implementing clinical guidelines., Objectives: To compare variations over time and across World Health Organization (WHO) geographic regions of corticosteroid use for treatment of severe COVID-19; secondary objectives were to evaluate the association between the timing of publication of the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial (June 2020) and the WHO guidelines for corticosteroids (September 2020) and the temporal trends observed in corticosteroid use by region and to describe the geographic distribution of the recruitment in clinical trials that informed the WHO recommendation., Design, Setting, and Participants: This prospective cohort study of 434 851 patients was conducted between January 31, 2020, and September 2, 2022, in 63 countries worldwide. The data were collected under the auspices of the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC)-WHO Clinical Characterisation Protocol for Severe Emerging Infections. Analyses were restricted to patients hospitalized for severe COVID-19 (a subset of the ISARIC data set)., Exposure: Corticosteroid use as reported to the ISARIC-WHO Clinical Characterisation Protocol for Severe Emerging Infections., Main Outcomes and Measures: Number and percentage of patients hospitalized with severe COVID-19 who received corticosteroids by time period and by WHO geographic region., Results: Among 434 851 patients with confirmed severe or critical COVID-19 for whom receipt of corticosteroids could be ascertained (median [IQR] age, 61.0 [48.0-74.0] years; 53.0% male), 174 307 (40.1%) received corticosteroids during the study period. Of the participants in clinical trials that informed the guideline, 91.6% were recruited from the United Kingdom. In all regions, corticosteroid use for severe COVID-19 increased, but this increase corresponded to the timing of the RECOVERY trial (time-interruption coefficient 1.0 [95% CI, 0.9-1.2]) and WHO guideline (time-interruption coefficient 1.9 [95% CI, 1.7-2.0]) publications only in Europe. At the end of the study period, corticosteroid use for treatment of severe COVID-19 was highest in the Americas (5421 of 6095 [88.9%]; 95% CI, 87.7-90.2) and lowest in Africa (31 588 of 185 191 [17.1%]; 95% CI, 16.8-17.3)., Conclusions and Relevance: The results of this cohort study showed that implementation of the guidelines for use of corticosteroids in the treatment of severe COVID-19 varied geographically. Uptake of corticosteroid treatment was lower in regions with limited clinical trial involvement. Improving research diversity and representativeness may facilitate timely knowledge uptake and guideline implementation.

Background and Objectives: Blood operator must establish selection criteria according to the populations at risk of blood-related infections and complications. Therefore, this study aimed to assess the risks of transfusion-related acute lung injury (TRALI) and human immunodeficiency virus (HIV) associated with donations from trans persons., Materials and Methods: Donor screening data from Héma-Québec were used. The risks of TRALI and HIV were estimated based on internal data and assumptions derived from the literature. The risk was assessed under four scenarios: a most likely scenario, an optimistic scenario and two pessimistic scenarios. All scenarios assumed no prior screening for trans donors., Results: The trans population comprised 134 donors, including 94 (70.1%) trans men. Of the 134 donors, 58 (43.3%) were deferred from donating a blood-derived product because of an ongoing gender-affirming genital surgery, and the remaining 76 (56.7%) were eligible donors. The risk of having a TRALI-causing donation, given that it comes from a trans man, was estimated at one every 115-999 years for all scenarios. The risk of having an HIV-contaminated donation, given that it comes from a trans woman, was estimated at one every 1881-37,600 years for all scenarios., Conclusion: This study suggests that donations from trans persons are associated with a negligible risk of TRALI and HIV., (© 2022 International Society of Blood Transfusion.)