Residual risk Research Papers - Academia.edu (original) (raw)
2025, Proceeding of the 33rd European Safety and Reliability Conference
The certification phase of military aeronautical design in Brazil necessitates the demonstration of compliance with mission-related requirements. Within the realm of engineering activities associated with initial airworthiness, the System... more
The certification phase of military aeronautical design in Brazil necessitates the demonstration of compliance with mission-related requirements. Within the realm of engineering activities associated with initial airworthiness, the System Safety Analysis (SSA) assumes a critical role in the design process. This analysis entails determining the adequacy of system safety measures and striking a balance between safety, cost, and military capability. In some instances, the emphasis placed on military capacity equals or surpasses that placed on operational safety. Competent authorities ensure the safety of systems and products employed in fulfilling missions, necessitating a methodical assessment of associated risks. To address this need, the development of a comprehensive guide to support risk assessment decisions in specific operations becomes imperative. In this article, the authors draw upon their extensive experience in certifying military aeronautical products to accomplish the following objectives: (1) provide a concise overview of the concept of risk acceptance as applied to aeronautical design; (2) introduce the risk analysis methodology employed in military aeronautical projects in Brazil; (3) present a robust methodology that substantiates the acceptance of residual risk in Brazilian military aeronautical projects; and (4) demonstrate the practical application of this methodology in substantiating the acceptance of residual risk in the operation of remotely piloted aircraft systems.
2025, Vnitřní lékařství
Úvod LDL-cholesterol (LDL-C) je známym a modifikovateľným rizikovým faktorom kardiovaskulárneho (KV) ochorenia. Monoklonálne protilátky, inhibujúce proprotein konvertázu subtilizín -kexin typ 9 (PCSK9), sú novou triedou liekov, ktoré... more
Úvod LDL-cholesterol (LDL-C) je známym a modifikovateľným rizikovým faktorom kardiovaskulárneho (KV) ochorenia. Monoklonálne protilátky, inhibujúce proprotein konvertázu subtilizín -kexin typ 9 (PCSK9), sú novou triedou liekov, ktoré vynikajúco redukujú sérové hladiny LDL-C [1]. Evolokumab, jeden zo zástupcov tejto novej triedy liekov, je plnou humánnou monoklonálnou protilátkou a redukuje sérový LDL-C asi o 60 % [2,3]. Genetické práce preukázali, že nositelia mutovaného génu PCSK9 "so stratou funkcie jeho alel" mávajú nižšie sérové hladiny LDL-C a spolu s tým mávajú redukované aj riziko vzniku infarktu myokardu. Údaje z klinických štúdií vo fázach 2 a 3 s PCSK9 inhibítormi preukázali, že ak sa predĺžilo sledovanie chorých, tak u týchto pacientov zaznamenali významnú redukciu vý-skytu KV príhod [6,7], avšak príhod bolo málo (celkovo < 100 príhod). Preto naplánovali a zahájili dlhodobú "prípadovú štúdiu" FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition subjects with Elevated Risk), ktorá analyzovala klinickú účinnosť a bezpečnosť evolokumabu pri jeho pridaní k statínovej liečbe (statín s vysokou alebo stredne silnou intenzitou pôsobenia) u chorých, ktorí trpeli zrejmým aterosklerotickým . FOURIER štúdia je randomizovaná, dvojito zaslepená, placebom kontrolovaná a počtom zaradených pacientov aj veľká (1 242 centier, 49 krajín) štúdia. Sponzor (Amgen) zodpovedal za zber údajov, tie sa posunuli
2025, Pharmaceuticals
Innovative lipid-modifying agents are valuable resources to improve the control of atherogenic dyslipidemias and reduce the lipid-related residual cardiovascular risk of patients with intolerance or who are not fully responsive to a... more
Innovative lipid-modifying agents are valuable resources to improve the control of atherogenic dyslipidemias and reduce the lipid-related residual cardiovascular risk of patients with intolerance or who are not fully responsive to a consolidated standard of care (statins plus ezetimibe). Moreover, some of the upcoming compounds potently affect lipid targets that are thus far considered “unmodifiable”. The present paper is a viewpoint aimed at presenting the incremental metabolic and cardiovascular benefits of the emerging lipid-modulating agents and real-life barriers, hindering their prescription by physicians and their assumption by patients, which need to be worked out for a more diffuse and appropriate drug utilization.
2025, Transfusion
BACKGROUND : Estimates of the risk of transfusion‐transmitted viral infections are essential for monitoring the safety of the blood supply. The aim of the present study was to estimate the residual risk of blood‐borne viral infections in... more
BACKGROUND : Estimates of the risk of transfusion‐transmitted viral infections are essential for monitoring the safety of the blood supply. The aim of the present study was to estimate the residual risk of blood‐borne viral infections in Spain. STUDY DESIGN AND METHODS : Incidence rates of seroconversion for HIV, HBV, and HCV were calculated among 673,018 persons who donated blood more than once (repeat donors), from 1997 through 1999 at 22 blood donation centers (for a total of 2,464,964 allogeneic blood donations and 1,052,752 person‐years). RESULTS : Incidence rates per 100,000 person‐years and their 95‐percent CIs were as follows: for HBV, 8.36 (5.24‐12.62); for HIV, 3.23 (2.24‐4.52); and for HCV, 3.70 (2.63‐5.07). After adjusting incidence rates for the estimated duration of the infectious window period for each virus, the residual risk per unit transfused was estimated at 1 in 513,000 for HIV, 1 in 74,000 for HBV, and 1 in 149,000 for HCV. The introduction of new screening tes...
2025, Diabetes Care
To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol (LDL-c)... more
To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol (LDL-c) treatment goals or when LDL-c is treated with intensive lipid-lowering therapy. We performed a prospective cohort study of 1,829 patients with type 2 diabetes included in the Second Manifestations of ARTerial disease (SMART) cohort. Cox proportional hazard models were used to evaluate the risk of HDL-c on cardiovascular events and all-cause mortality. Analyses were performed in strata of LDL-c levels (<2.0, 2.0-2.5, and >2.5 mmol/L) and lipid-lowering therapy intensity and were adjusted for age, sex, BMI, smoking, alcohol, LDL-c, triglycerides, systolic blood pressure, estimated glomerular filtration rate, glucose, and HbA 1c . A total of 335 new cardiovascular events and 385 deaths occurred during a median follow-up of 7.0 years (interquartile range 3.9-10.4). No relation was found between plasma HDL-c and cardiovascular events (hazard ratio [HR] 0.97, 95% CI 0.93-1.01) or all-cause mortality (HR 0.99, 95% CI 0.96-1.03). Subgroup analysis supported effect modification by plasma LDL-c levels. In patients with LDL-c levels <2.0 mmol/L, higher HDL-c was related to higher risk for all-cause mortality (HR 1.14, 95% CI 1.07-1.21). Higher HDL-c was also related to higher risk for cardiovascular events in patients with LDL-c levels <2.0 mmol/L (HR 1.10, 95% CI 1.07-1.21) in contrast to patients with LDL-c levels between 2.0 and 2.5 mmol/L (HR 0.85, 95% CI 0.75-0.95) and >2.5 mmol/L (HR 0.96, 95% CI 0.91-1.00). In high-risk patients with type 2 diabetes with LDL-c levels <2.0 mmol/L, higher HDL-c at baseline is unexpectedly related to a higher risk for cardiovascular events and all-cause mortality in contrast to high-risk patients with type 2 diabetes with LDL-c levels between 2.0 and 2.5 mmol/L. As a result of aging, urbanization, and associated lifestyle changes, the prevalence of type 2 diabetes is globally increasing (1). In an attempt to lower the high risk for cardiovascular disease in patients with type 2 diabetes, emphasis has been placed on improving glycemic control, lowering blood pressure, and improving the dyslipidemia
2025, Diabetes Care
To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol (LDL-c)... more
To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol (LDL-c) treatment goals or when LDL-c is treated with intensive lipid-lowering therapy. We performed a prospective cohort study of 1,829 patients with type 2 diabetes included in the Second Manifestations of ARTerial disease (SMART) cohort. Cox proportional hazard models were used to evaluate the risk of HDL-c on cardiovascular events and all-cause mortality. Analyses were performed in strata of LDL-c levels (<2.0, 2.0-2.5, and >2.5 mmol/L) and lipid-lowering therapy intensity and were adjusted for age, sex, BMI, smoking, alcohol, LDL-c, triglycerides, systolic blood pressure, estimated glomerular filtration rate, glucose, and HbA 1c . A total of 335 new cardiovascular events and 385 deaths occurred during a median follow-up of 7.0 years (interquartile range 3.9-10.4). No relation was found between plasma HDL-c and cardiovascular events (hazard ratio [HR] 0.97, 95% CI 0.93-1.01) or all-cause mortality (HR 0.99, 95% CI 0.96-1.03). Subgroup analysis supported effect modification by plasma LDL-c levels. In patients with LDL-c levels <2.0 mmol/L, higher HDL-c was related to higher risk for all-cause mortality (HR 1.14, 95% CI 1.07-1.21). Higher HDL-c was also related to higher risk for cardiovascular events in patients with LDL-c levels <2.0 mmol/L (HR 1.10, 95% CI 1.07-1.21) in contrast to patients with LDL-c levels between 2.0 and 2.5 mmol/L (HR 0.85, 95% CI 0.75-0.95) and >2.5 mmol/L (HR 0.96, 95% CI 0.91-1.00). In high-risk patients with type 2 diabetes with LDL-c levels <2.0 mmol/L, higher HDL-c at baseline is unexpectedly related to a higher risk for cardiovascular events and all-cause mortality in contrast to high-risk patients with type 2 diabetes with LDL-c levels between 2.0 and 2.5 mmol/L. As a result of aging, urbanization, and associated lifestyle changes, the prevalence of type 2 diabetes is globally increasing (1). In an attempt to lower the high risk for cardiovascular disease in patients with type 2 diabetes, emphasis has been placed on improving glycemic control, lowering blood pressure, and improving the dyslipidemia
2025, Diabetes Care
OBJECTIVE To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol... more
OBJECTIVE To evaluate whether low HDL cholesterol (HDL-c) levels are a risk factor for cardiovascular disease and mortality in patients with type 2 diabetes and whether it remains a residual risk factor when attaining low LDL cholesterol (LDL-c) treatment goals or when LDL-c is treated with intensive lipid-lowering therapy. RESEARCH DESIGN AND METHODS We performed a prospective cohort study of 1,829 patients with type 2 diabetes included in the Second Manifestations of ARTerial disease (SMART) cohort. Cox proportional hazard models were used to evaluate the risk of HDL-c on cardiovascular events and all-cause mortality. Analyses were performed in strata of LDL-c levels (<2.0, 2.0–2.5, and >2.5 mmol/L) and lipid-lowering therapy intensity and were adjusted for age, sex, BMI, smoking, alcohol, LDL-c, triglycerides, systolic blood pressure, estimated glomerular filtration rate, glucose, and HbA1c. RESULTS A total of 335 new cardiovascular events and 385 deaths occurred during a m...
2025, European journal of preventive cardiology
2025, Journal of Transfusion Medicine
Test cobas ® DPX typu multiplex jest przeznaczony do badań dawców krwi w analizatorze cobas ® 6800 fi rmy Roche. Wykorzystuje metodę real-time PCR i służy do ilościowego badania kwasu deoksyrybonukleinowego (DNA) parwowirusa B19 (B19V)... more
Test cobas ® DPX typu multiplex jest przeznaczony do badań dawców krwi w analizatorze cobas ® 6800 fi rmy Roche. Wykorzystuje metodę real-time PCR i służy do ilościowego badania kwasu deoksyrybonukleinowego (DNA) parwowirusa B19 (B19V) oraz wykrywania kwasu rybonukleinowego RNA wirusa zapalenia wątroby typu A (HAV) w ludzkim osoczu. Opcjonalnym elementem systemu jest cobas p 680 -w pełni zautomatyzowane urządzenie pipetujące przeznaczone do pulowania pojedynczych próbek osocza. Cel. Celem badań była ocena przydatności testów cobas ® DPX do prowadzenia badań w krwiodawstwie. Przeanalizowano między innymi czułość wykrywania markerów, poprawność identyfi kacji donacji zakażonych oraz ryzyko wystąpienia wyników fałszywych.
2025, Journal of Transfusion Medicine
Background. The cobas ® MPX test for use with the cobas ® 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously... more
Background. The cobas ® MPX test for use with the cobas ® 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously identifies HIV, HCV and HBV (multiplex). Optional component to the cobas ® 6800 System is the cobas p 680 instrument that creates pools from individual samples. Aim. To evaluate the cobas ® MPX test in individual donations and in plasma pools using the cobas p 680 instrument.
2025, Journal of Transfusion Medicine
Uzyskane wyniki pokazują, że poprawa swoistości (pozytywnej wartości predykcyjnej) badania przeglądowego przez dobór testu pod kątem tego parametru przynosi wymierne ograniczenie kosztów (m.in. przez zmniejszenie liczby badań powtarzanych... more
Uzyskane wyniki pokazują, że poprawa swoistości (pozytywnej wartości predykcyjnej) badania przeglądowego przez dobór testu pod kątem tego parametru przynosi wymierne ograniczenie kosztów (m.in. przez zmniejszenie liczby badań powtarzanych i weryfikacyjnych, kontrolnych oraz zniszczeń składników krwi) oraz prowadzi do ograniczenia liczby dyskwalifikowanych czasowo dawców.
2025, Journal of Transfusion Medicine
Background. The cobas ® MPX test for use with the cobas ® 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously... more
Background. The cobas ® MPX test for use with the cobas ® 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously identifies HIV, HCV and HBV (multiplex). Optional component to the cobas ® 6800 System is the cobas p 680 instrument that creates pools from individual samples. Aim. To evaluate the cobas ® MPX test in individual donations and in plasma pools using the cobas p 680 instrument.
2025, Journal of Transfusion Medicine
2025, Journal of Transfusion Medicine
Introduction The cobas DPX test for use on the cobas 6800 system, is real-time PCR test for the identification and quantitation of human parvovirus B19 (B19V) DNA and the detection of hepatitis A virus (HAV) RNA in human plasma.... more
Introduction The cobas DPX test for use on the cobas 6800 system, is real-time PCR test for the identification and quantitation of human parvovirus B19 (B19V) DNA and the detection of hepatitis A virus (HAV) RNA in human plasma. Optional component to the cobas 6800 system is the cobas p 680 instrument that creates pools from individual samples. Aim To evaluate the performance of cobas® DPX test and to demonstrate its ability to detect HAV and polymorphic forms of B19V during plasma testing. Sensitivity, correct identification of reactive donations and risk of false positive results was estimated. Material and method The analytical sensitivity of cobas® DPX test was assessed by testing dilutions of the WHO B19V Genotype 1-3 Reference Panels (09/110) and IS WHO RNA HAV (00/562) dilution panel. Six dilutions of each B19 panel were tested ranging from 31.6 IU/mL to 0.1 IU /mL of genotype 1, 2, 3 and six dilutions of RNA HAV panel ranging from 10-0,03 IU/ml (24 replicates/dilution). D...
2025, Journal of Transfusion Medicine
Background: Syphilis Total Ab BIO-RAD (France) is designed for detection of antibodies to Treponemapallidum antigens in human serum and plasma. Tests are performed in automatic analyzers Evolis (BIORAD). The aim was to evaluate the... more
Background: Syphilis Total Ab BIO-RAD (France) is designed for detection of antibodies to Treponemapallidum antigens in human serum and plasma. Tests are performed in automatic analyzers Evolis (BIORAD). The aim was to evaluate the advantages of the Syphilis Total Ab BIO-RADtest for blood donor screening in Poland. Specificity, sensitivity, repeatability and reproducibility of S/Co values were evaluated. After 18 months of using the test at the Military Blood Center (WCKiK), the results were analyzed and compared to those obtained with other EIA tests which had been in use for 36 months before the implementation of Syphilis Total Ab BIO-RAD. Material and methods: Specificity evaluation was performed at the Institute Hematology and Transfusion Medicine (IHiT) on samples collected from 2058 currently screened donors. Assessment of clinical sensitivity was based on study outcome of: 1) seropositive sample panels (confirmed), raw and prepared by dilution of positive archive serum, 2) se...
2025, Acta Haematologica Polonica
Zapewnieniu bezpieczeństwa przetoczeń składników krwi w zakresie czynników zakaźnych służy przede wszystkim pięć podstawowych działań: badanie lekarskie z wywiadem epidemiologicznym, badanie swoistych markerów zakażenia patogenami... more
Zapewnieniu bezpieczeństwa przetoczeń składników krwi w zakresie czynników zakaźnych służy przede wszystkim pięć podstawowych działań: badanie lekarskie z wywiadem epidemiologicznym, badanie swoistych markerów zakażenia patogenami przenoszonymi drogą krwi, leukoredukcja, karencja oraz procedury inaktywacji i redukcji patogenów. Dwie pierwsze procedury dotyczą wszystkich donacji, a c t a h a e m a t o l o g i c a p o l o n i c a 4 8 ( 2 0 1 7 ) 1 7 4 -1 8 2 i n f o r m a c j e o a r t y k u l e Historia artykułu:
2025, Journal of Transfusion Medicine
2025, Journal of Pharmacy Technology
Background: Despite significant impact of statins, there are a number of patients with residual risk of cardio vascular disease who have optimally controlled low-density lipoprotein cholesterol (LDL-C). Niaspan (extended-release nicotinic... more
Background: Despite significant impact of statins, there are a number of patients with residual risk of cardio vascular disease who have optimally controlled low-density lipoprotein cholesterol (LDL-C). Niaspan (extended-release nicotinic acid or niacin-ER) is indicated for its use as monotherapy for the treatment of very high triglyceride (TG) levels and for the raising of high-density lipoprotein cholesterol (HDL-C) representing those residual risk populations. The patient characteristics and lipid profile, prior to initiation of therapy, in the real-world clinical setting has not been well documented. Objectives: This study evaluated lipid levels among patients initiating Niaspan in real-world clinical practice. Methods: Patients with a first prescription of Niaspan were identified using electronic medical record data from GE. Lipid values were categorized into optimal and nonoptimal TG or HDL-C levels. Results: There were 89 091 new users. Most patients had nonoptimal TG, HDL-C,...
2025, La Houille Blanche
Le zonage des risques en montagne reste pensé comme une procédure normative issue de la transposition du « modèle inondation ». Au cœur de ce schéma figure le phénomène centennal, référence probabiliste d'une définition problématique,... more
Le zonage des risques en montagne reste pensé comme une procédure normative issue de la transposition du « modèle inondation ». Au cœur de ce schéma figure le phénomène centennal, référence probabiliste d'une définition problématique, inadaptée à des phénomènes destructeurs, et peu interprétable en termes d'exposition. Ces insuffisances sont sources d'incompréhensions, et elle rend nécessaire des raccourcis et des pratiques de terrain sécuritaires. Cet article propose un changement de paradigme. Le zonage y est envisagé comme la un compromis entre les pertes dues au phénomène dommageable et les restrictions que la société s'impose. L'état des connaissances scientifiques ne permet pour l'instant pas de définir une procédure directive complète qu'il ne revient de toute façon pas à la sphère technique d'énoncer. En revanche, cartographier le risque individuel en combinant modèle d'aléa et susceptibilité au dommages pour différents types d'enjeux ...
2025, Archivos de Cardiología de México
Background: Hypertension, hyperglycemia, dyslipidemia, overweight, obesity, and tobacco (smoking, chewing, and vaping), together with a pro-inflammatory and procoagulant state, are the main risk factors related to atherosclerotic... more
Background: Hypertension, hyperglycemia, dyslipidemia, overweight, obesity, and tobacco (smoking, chewing, and vaping), together with a pro-inflammatory and procoagulant state, are the main risk factors related to atherosclerotic cardiovascular
2025, Frontiers in Cardiovascular Medicine
= 498) were prescribed not in agreement with the current guidelines. More specifically, 392 patients (40.9%) were treated with metformin only, while the remaining 106 (11.1%) were treated with metformin together with hypoglycemic agents... more
= 498) were prescribed not in agreement with the current guidelines. More specifically, 392 patients (40.9%) were treated with metformin only, while the remaining 106 (11.1%) were treated with metformin together with hypoglycemic agents other than glucagon-like peptide-1 receptor agonists (GLP1-RA) or sodium-glucose-transporter 2 (SGLT2) Rottura et al. Diabetic Patients and Cardiovascular Risk inhibitors. Our results suggest the urgent need to improve the management of patients with diabetes at high and very high CVr in the real life, to reduce the burden of diabetes on the health system.
2025, Proceedings of International Structural Engineering and Construction
Safety is a major challenge in the Construction industry. Researchers have shown that many construction fatalities could have been avoided with proper design considerations. Design for safety (DfS) knowledge helps designers to identify... more
Safety is a major challenge in the Construction industry. Researchers have shown that many construction fatalities could have been avoided with proper design considerations. Design for safety (DfS) knowledge helps designers to identify how their design may pose a risk during the life cycle of a building facility. Hence, designers can use DfS knowledge to address these safety issues in the design phase. Nevertheless, identified risk and required mitigation of the risk must be noted in a risk register. Moreover, all the risks cannot be addressed or eliminated during design. Hence, residual risks must be addressed during actual construction, operation and maintenance. This study proposes a DfS knowledge-based risk register system that registers design deficient risk with mitigation action and the residual risks that must be addressed during actual construction. The risk register is integrated with the BIM so that the residual risks can be easily visualized in BIM compliant 3D model for...
2025, Automation in Construction
Safety is a major concern in the construction industry. Recent studies have shown that many construction fatalities are related to design and could have been avoided with proper design considerations. Nevertheless, designers have limited... more
Safety is a major concern in the construction industry. Recent studies have shown that many construction fatalities are related to design and could have been avoided with proper design considerations. Nevertheless, designers have limited knowledge about construction safety and often are unable to identify how their designs may pose a risk during the life cycle of a building facility such as construction, operation and maintenance. Limited effort has been made to help designer to address these safety issues in the design phase. This study presents a structured DfS rule-based knowledge library to provide safety knowledge to designer. Using the DfS knowledge library, an Intelligent BIM-integrated risk review system is proposed to help designers identify risk related to their design element along with required design features. A risk register system is also developed in the BIM platform to follow up for any residual risk. The proposed risk review system has been examined with an illustrative case project. It is found that many of the risks could have been avoided/eliminated with the DfS knowledge library and intelligent risk review system early in the design phase. Thus, it would help to avoid any unexpected delay or costly design change late in the project to mitigate the risk.
2025, Cureus
Ensuring blood safety is the primary goal of transfusion medicine. Despite extensive serological tests and strict safety measures, the risk of transfusion-transmitted infections (TTIs) still exists. As applied to blood screening, Nucleic... more
Ensuring blood safety is the primary goal of transfusion medicine. Despite extensive serological tests and strict safety measures, the risk of transfusion-transmitted infections (TTIs) still exists. As applied to blood screening, Nucleic Acid Amplification Test (NAT) offers much higher sensitivity for detecting viral infections. It is, however, currently available to a handful of centers due to the high cost. This study aims to establish the Effectiveness of NAT by assessing the NAT yield and residual risk of transmission of Hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV with and without NAT testing. This prospective cross-sectional study recruited blood donors from January 2020 to November 2022. All donors underwent routine serologic screening. Only serologically negative donors were tested for HBV, HCV, and HIV by NAT. The NAT yield and residual risk (RR) per million donors were computed for viral infections in seronegative blood donors and calculated using the incidence/window period model. A total of 59708 donors were included during the study period. The overall prevalence of TTI's were: For HCV 1.7% (n = 1018), HBV 1.5% (n = 918), HIV 0.07% (n = 47), Syphilis 1.2% (n = 758) and malaria 0.3% (n = 218). Out of 57759 seronegative donors, thirty-four NAT-reactive samples were identified, with 3 cases of HCV, 31 cases of HBV, and Nil HIV cases. NAT yield of HBV was 1 in 1863 with an RR of 8.6 per million, followed by HCV with a NAT yield of 1 in 19253 and RR of 0.8 per million donations. NAT testing reduced RR for HBV by 48.9% and HCV by 94.5%. Our study showed that NAT detected 34 out of 57759 cases initially missed by serological tests. The study suggests that the parallel use of serology and NAT screening of donated blood would be beneficial.
2025, Pharmaceuticals
Innovative lipid-modifying agents are valuable resources to improve the control of atherogenic dyslipidemias and reduce the lipid-related residual cardiovascular risk of patients with intolerance or who are not fully responsive to a... more
Innovative lipid-modifying agents are valuable resources to improve the control of atherogenic dyslipidemias and reduce the lipid-related residual cardiovascular risk of patients with intolerance or who are not fully responsive to a consolidated standard of care (statins plus ezetimibe). Moreover, some of the upcoming compounds potently affect lipid targets that are thus far considered "unmodifiable". The present paper is a viewpoint aimed at presenting the incremental metabolic and cardiovascular benefits of the emerging lipid-modulating agents and real-life barriers, hindering their prescription by physicians and their assumption by patients, which need to be worked out for a more diffuse and appropriate drug utilization.
2025, Interfaces
Organizations may view outsourcing as a way to manage risk. We developed a decision-analytic approach to determine which risks the buyer can share or shift to vendors and which ones it should bear. We found that allocating risks... more
Organizations may view outsourcing as a way to manage risk. We developed a decision-analytic approach to determine which risks the buyer can share or shift to vendors and which ones it should bear. We found that allocating risks incorrectly could increase costs dramatically. Between 1995 and 1998, we used this approach to develop the request for proposals (RFP) for the US Department of Energy's (DOE's) privatization initiative for the Hanford tank waste remediation system (TWRS). In the model, we used an assessment protocol to predict how vendors would react to proposed risk allocations in terms of their actions and their pricing. We considered the impact of allocating each major risk to potential vendors, to the DOE, or to both and identified the risk allocation that would minimize the DOE's total cost—its direct payments to vendors plus the costs of any residual risks it accepted. Allocating inappropriate risks to the vendor would have increased costs because the vendo...
2025, Safety Science
Structural engineers design buildings according to the earthquake action (demand) specified in code of practice, whilst the rationale behind such requirement is commonly untold. In fact, even if a structure is designed strictly in... more
Structural engineers design buildings according to the earthquake action (demand) specified in code of practice, whilst the rationale behind such requirement is commonly untold. In fact, even if a structure is designed strictly in accordance to the best standard and practice in the world, there is still a (small) chance of failure or collapse in an extreme earthquake event, due to the uncertainties in material properties and actual ground motions characteristics. This is the residual risk, which is unavoidable, and should be taken as a governing parameter for determining the performance goals of seismic design. This study attempts to establish the required (target) collapse risk limits for designing different types of ordinary buildings based on a well-accepted tolerable level of mortality risk and estimates of fatality rates in buildings. The proposed limits are compared with the target risk of collapse stipulated in the 2012 edition of the International Building Code (IBC). The risk-based approach presented in this paper should also be applicable for setting performance objectives for structural design of buildings and infrastructure against other natural, human-caused and technological hazards.
2024, Environmental Health Perspectives
2024, Atherosclerosis
showed moderate correlations with PWV: 0.375 (p<0.05) and 0.412 (p<0.0001) in males and 0.468 (p<0.0001) and 0.389 (p<0.001) in females. Only few biochemical markers demonstrated a significant correlation (p<0.05): TC and TG in males... more
showed moderate correlations with PWV: 0.375 (p<0.05) and 0.412 (p<0.0001) in males and 0.468 (p<0.0001) and 0.389 (p<0.001) in females. Only few biochemical markers demonstrated a significant correlation (p<0.05): TC and TG in males (0.326 and 0.290) and Lp(a) in females (-0.261). The stepwise least squares multiple regression analysis showed an association of PWV only with DBP (p<0.001) in males and with SBP (p<0.001) in females (R¼0.649 and 0.443, R2-adjusted ¼ 0.408 and 0.181). Conclusions: In young Tallinn adults, BP showed an important impact on PWV variability, whereas biochemical markers failed to demonstrate significant association.
2024, Transfusion
Human immunodeficiency virus (HIV)-positive blood donors pose a risk to blood safety. The Southeastern United States has the highest reported HIV infection rates. Here we calculate HIV prevalence, incidence, and residual risk in... more
Human immunodeficiency virus (HIV)-positive blood donors pose a risk to blood safety. The Southeastern United States has the highest reported HIV infection rates. Here we calculate HIV prevalence, incidence, and residual risk in Southeastern US blood donors and report risk factors disclosed by incident donors in counseling sessions. American Red Cross donation and testing data from 2009 to 2014 for three Southeastern collection regions were used to calculate HIV prevalence, incidence, and residual risk. Incident donors had a previous HIV-negative donation within 730 days of their positive donation. Residual risk was defined as the window period multiplied by incidence. From 2009 to 2014, a total of 236 HIV-positive donors occurred in these regions for an overall prevalence of 8.3 per 100,000 donations. There were 56 incident donors over the 6-year period with incidence decreasing from 7.1 per 100,000 person-years (PYs) in the first two years (2009-2010) to 3.5 in the last two years ...
2024
Background Despite advancements in secondary cardiovascular prevention, individuals with chronic coronary syndrome (CCS) still experience a lingering risk of adverse ischemic events. To minimize this residual risk by stabilizing and... more
Background Despite advancements in secondary cardiovascular prevention, individuals with chronic coronary syndrome (CCS) still experience a lingering risk of adverse ischemic events. To minimize this residual risk by stabilizing and regressing the chronic disease process, there is consensus that antithrombotic therapy is crucial role for secondary cardiovascular prevention. The combination of lowdose rivaroxaban (2.5mg BID) with aspirin, known as dual-pathway inhibition, has emerged as a strategy to mitigate this residual risk and lower major adverse cardiovascular events (MACE). European guidelines, based on ndings of the COMPASS trial, recommend incorporating low-dose rivaroxaban and aspirin into standard secondary prevention in CCS patients. However, real-world data on the impact of this approach are still lacking. Aim The primary objective of the DUTCH-CCS registry is to gather real-world data on the e cacy and safety of low-dose rivaroxaban in combination with aspirin among patients with CCS in the Netherlands. By conducting this registry, the aim is to bridge the gap in knowledge and provide insights into the practical outcomes and potential bene ts or risks associated with the use of dual-pathway inhibition in a real-world clinical setting, beyond the con nes of controlled clinical trials. Methods The DUTCH-CCS registry is a national, multicenter, prospective observational study, and aims to enroll 1000 adult CCS patients who are treated with rivaroxaban 2.5mg BID plus aspirin. The study focuses on high ischemic risk individuals with coronary artery disease (CAD) and/or peripheral artery disease, using a single-arm design. The primary effectiveness endpoint includes major adverse cardiac events (MACE), clinically driven coronary-, peripheral-or carotid revascularization, and stent thrombosis at 1-year follow-up, while the primary safety endpoint is major bleeding at 1-year. The study will collect outcome data at 3-month and 1-year follow-up. Conclusion The DUTCH-CCS registry holds the potential to enhance understanding of the real-world impact of low-dose rivaroxaban plus aspirin as a secondary prevention strategy in CCS patients. The ndings may offer valuable insights into the e cacy and safety of dual-pathway inhibition, providing clinicians and researchers with data for informed treatment decisions and may re ne guidelines for the management of CCS patients in everyday clinical practice.
2024, Current Opinion in Food Science
As risk-based approaches are increasingly recognized and used to manage food safety hazards, their implementation requires a recognition and appreciation of residual risk. We define residual risk as the one that remains even after a fully... more
As risk-based approaches are increasingly recognized and used to manage food safety hazards, their implementation requires a recognition and appreciation of residual risk. We define residual risk as the one that remains even after a fully compliant food safety system has been implemented. As true 'zero risk' is essentially unattainable, understanding and assessing the residual risks for different products is essential for the different actors involved in the food production system. Understanding residual risk is particularly critical as improved surveillance systems (e.g. facilitated by whole genome sequencing) can detect small outbreaks and potentially link cases to a product, even when they are consequences of residual risk rather than a non-compliant food safety system. Future work on assessing residual risk for different pathogenfood combinations are essential at both the company and governmental level to further fine tune food safety systems with the definition of an acceptable residual risk.
2024
A transparent, pragmatic geotechnical design system is outlined that presents a selection of risk options with associated risk/reward for decision makers. Risk options termed ‘robust’, ‘balanced’ and ‘aggressive’ have been defined... more
A transparent, pragmatic geotechnical design system is outlined that presents a selection of risk options with associated risk/reward for decision makers. Risk options termed ‘robust’, ‘balanced’ and ‘aggressive’ have been defined appropriate to ‘critical infrastructure’, ‘typical industry’ and ‘low risk’ mining environments (where the safety risk and the consequences of failure on the budgeted mine plan are acceptably low), respectively. The geotechnical model includes ‘most realistic’ and ‘reasonable lower case’ conditions. A ‘realistic’ design principle requires reporting a Factor of Safety on the realistic case, rather than to reduce design inputs due to uncertainty. Uncertainty is transparently covered by the ‘lower case’ in sensitivity analyses. Indicative probabilities of failure are estimated and a simple empirical tool estimates the consequence of failure in terms of the area of mining floor impacted. These together with indicative value or tonnage estimates are presented t...
2024, Circulation-cardiovascular Imaging
2024, The Journal of Medical Research
Background: Cameroon remains a country with high HIV prevalence among blood donors so there is a need for surveillance of HIV transmission through blood transfusion in order to evaluate blood safety and justify the change of screening... more
Background: Cameroon remains a country with high HIV prevalence among blood donors so there is a need for surveillance of HIV transmission through blood transfusion in order to evaluate blood safety and justify the change of screening strategy. The last evaluation of the HIV screening strategy in Cameroon in 2011 revealed that 55 HIV transmissions per 10,000 of blood donations could have prevented using a four generation assay than using a combination of third generation Rapid diagnostic test and Enzyme immuno-Assay. Aims and objectives: This study aimed to estimated and compare the HIV transmission risk among blood banks using different testing strategies. Study design and setting: A one year multi-center data records review study was conducted in five Blood Banks located in five regions of Cameroon in 2018. These Blood Banks were made of Yaounde Central Hospital (YCH), Douala Laquintinie Hospital (DLH), Bertoua Regional Hospital (BRH), Ebolowa Regional Hospital (ERH) and Maroua Regional Hospital (MRH). Material and methods: Records were reviewed using data from the 1 st January to the 31 st December 2017. Five blood banks out of 18 were selected based on the use of national standardized registries and properly completed data. The World Health Organisation incidence/window period model was used to estimate the residual risk. Statistics: The incidence (percentage and 95% confidence interval) of HIV was calculated per 100,000 blood donations in 2017. The chi-square test was used to measure the association between groups and P-values <0.05 were considered significant. The study was approved by the National Institutional Ethics Committee. Results: Overall, 22,980 blood donor candidates were received and 20,430 (88.90%) [95% CI, 88.49-89.30] were tested for HIV. Among the 20,430 tested for HIV, 1827 (8.94%) [95% CI, 8.55-9.34] donated at least twice. HIV prevalence was estimated at 471/20,430 (2.31%) [95% CI, 2.11-2.52] among blood donors with an inconclusive rate of 701/20,430 (3.43%) [95% CI, 3.19-3.69]. Comparing HIV prevalence per Region between blood donors and the general population, the prevalence was mostly lower among blood donors than in the general population except in YCH and MRH. The rate of reactivity of the first-line test differ with the one of the second-line test with a kappa agreement of 0.556 (0.526-0.585: CI 95%) giving a moderate level of agreement between first and second-line test. Considering the HIV testing algorithm, incidence rates ranged from 411.52 to 1946.47 per 100,000 person-year corresponding to a residual risk to transmit HIV associated with the window period varied from 1 in 669.7 donations to 1 in 5543.54 donations. At the blood banks level, the incidence rates ranged from 382.41 to 2834.01 per 100,000 person-year and the residual risk to transmit HIV associated with the window period varied from 1 in 460 donations to 1 in 5965 donations. Conclusion: The residual risk of HIV transmission remains high in Cameroon and varies according to the screening strategies. Thus, there is a need to revise the HIV testing strategy and implement an existing plan to recruit and retain voluntary and regular blood donors.
2024, New England Journal of Medicine
BACKGROUND Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its... more
BACKGROUND Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. RESULTS A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P = 0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P = 0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P = 0.06). CONCLUSIONS Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361.
2024, Mediterranean Journal of Hematology and Infectious Diseases
Background and ObjectiveThe improved performance of serological tests has significantly reduced the risk of human immunodeficiency and hepatitis B and C viruses transmission by blood transfusion, but there is a persistence of residual... more
Background and ObjectiveThe improved performance of serological tests has significantly reduced the risk of human immunodeficiency and hepatitis B and C viruses transmission by blood transfusion, but there is a persistence of residual risk. The objective of this study was to evaluate the impact of multiplex PCR in reducing the risk of residual transmission of these viruses in seronegative blood donors in Burkina Faso.MethodsThis cross-sectional study was conducted from March to September 2017. The serological tests were performed on sera using ARCHITECTSR i1000 (Abbot diagnosis, USA). Detection of viral nucleic acids was performed by multiplex PCR on mini-pools of seronegative plasma for HBV, HCV and HIV using SaCycler-96 Real Time PCR v.7.3 (Sacace Biotechnologies). Multiplex PCR-positive samples from these mini-pools were then individually tested by the same method.Results A total of 989 donors aged 17 to 65 were included in the present study. "Repeat donors" accounted f...
2024, Cardiovascular Risk Factors [Working Title]
Cardiovascular disease poses a major challenge for the 21st century. Although good control of blood pressure and type 2 diabetes and reducing low-density lipoprotein-cholesterol levels can improve cardiovascular outcomes, a substantial... more
Cardiovascular disease poses a major challenge for the 21st century. Although good control of blood pressure and type 2 diabetes and reducing low-density lipoprotein-cholesterol levels can improve cardiovascular outcomes, a substantial residual risk remains existed after treatment in most patient populations. Recently, many efforts have been directed at finding the important role of low high-density-lipoprotein cholesterol, high triglycerides, especially triglyceride-rich lipoproteins and lipoprotein (a) in the metabolism of atherosclerotic plaque formation Therefore, based on the recent evidence, identification and treatment of these risk factors may play a role in optimizing therapeutic strategy, particularly in high risk subjects along with conventional treatment. In clinical practice, adequate attention should be paid when screening and managing residual cardiovascular risk factors in dyslipidemia in term of individualized approach. The ongoing trials will give more answers to e...
2024, Journal of Clinical Medicine
It is well-known that elevated lipoprotein(a)—Lp(a)—levels are associated with a higher risk of cardiovascular (CV) mortality and all-cause mortality, although a standard pharmacotherapeutic approach is still undefined for patients with... more
It is well-known that elevated lipoprotein(a)—Lp(a)—levels are associated with a higher risk of cardiovascular (CV) mortality and all-cause mortality, although a standard pharmacotherapeutic approach is still undefined for patients with high CV risk dependent on hyperlipoproteinemia(a). Combined with high Lp(a) levels, familial hypercholesterolemia (FH) leads to a greater CVD risk. In suspected FH patients, the proportion of cases explained by a rise of Lp(a) levels ranges between 5% and 20%. In the absence of a specific pharmacological approach able to lower Lp(a) to the extent required to achieve CV benefits, the most effective strategy today is lipoprotein apheresis (LA). Although limited, a clear effect on Lp(a) is exerted by PCSK9 antagonists, with apparently different mechanisms when given with statins (raised catabolism) or as monotherapy (reduced production). In the era of RNA-based therapies, a new dawn is represented by the use of antisense oligonucleotides APO(a)Lrx, able...
2024, Galenika Medical Journal
Patients who have survived an acute myocardial infarction, as well as those with atherosclerotic cardiovascular disease, established or unequivocally confirmed by imaging techniques, represent a very high-risk group. This group of... more
Patients who have survived an acute myocardial infarction, as well as those with atherosclerotic cardiovascular disease, established or unequivocally confirmed by imaging techniques, represent a very high-risk group. This group of patients requires more aggressive treatment of risk factors, regular controls, and monitoring of the effect of therapy. The article aimed to point out the historical importance of risk factors and modern models for assessing residual risk by reviewing the literature. Recognizing the residual risk provides orientation and motivation for more aggressive implementation of secondary preventive therapy on an individual level in daily work with patients and the possibility of reaching the target values recommended by European guidelines.
2024, medRxiv (Cold Spring Harbor Laboratory)
Background: Cardiovascular disease is a rising global concern accounting for one-third of mortalities. Notably, cardiovascular disease risk factors; including dyslipidemia, smoking, obesity, poor diet, and hypertension are modifiable. It... more
Background: Cardiovascular disease is a rising global concern accounting for one-third of mortalities. Notably, cardiovascular disease risk factors; including dyslipidemia, smoking, obesity, poor diet, and hypertension are modifiable. It has been established through various studies that dyslipidemia is at the core of atherosclerosis observed in cardiovascular diseases making it important in risk assessment and as a therapeutic target as informed by various guidelines. Plasma lipid profile has been key in the diagnosis of dyslipidemia particularly low-density lipoprotein cholesterol that is used in initial risk assessment and treatment monitoring. However, due to clinical and analytical challenges, LDLC is understated or overstated in some patients due to biological variability. Objective: To compare low-density lipoprotein cholesterol, atherogenic index in plasma, and Apolipoprotein A1 / Apolipoprotein B ratio for cardiovascular risk assessment in patients sent for routine lipid profile testing at biochemistry laboratory-Kenyatta National Hospital Methodology: This was laboratory-based cross-sectional study, 307 residual samples from patients sent for lipid profile testing were tested for, Apo A1, and Apo B concentrations using Mindray BS 2000M chemistry analyzer using Mindray reagents (Shenzhen Mindray Bio-Medical Electronics Co., Ltd) at biochemistry laboratory KNH. The obtained data was used to calculate the atherogenic index of plasma (AIP) and Apo B/ Apo A ratio. Results: The median age of the participants was 49 years, 56% were female. The median(range) values were Total cholesterol 4.17 (3.11, 5.20),High-density lipoprotein cholesterol 1.21 (0.88, .
2024, MABIS: Jurnal Manajemen Bisnis Syariah
The purpose of this study was to determine the application of risk at PT Mayora Tbk. The research method uses a qualitative approach. Data collection techniques using documentation through literature review and interviews. The results... more
The purpose of this study was to determine the application of risk at PT Mayora Tbk. The research method uses a qualitative approach. Data collection techniques using documentation through literature review and interviews. The results showed that the risk management system in the company has been implemented using the principle of caution by considering short-term and long-term risks, this is used for the sake of continuity and development of the company's performance, so this is the right type of risk, namely speculative risk, to minimize a risk event that occurs in the company, it is applied with the ISOO 31000 2018 method. The existence of various risks faced then has an impact on PT Mayora Indah Tbk. The occurrence of speculative risk that is being experienced by the company, therefore residual risk is needed so that the risks that occur can reduce the risks that occur in the company
2024, Best Practice & Research Clinical Endocrinology & Metabolism
Glucose-control has a modest beneficial effect on cardiovascular outcomes in patients with type 2 diabetes mellitus. Thus, managing other atherogenic risk factors including hypertriglyceridemia, low HDL-cholesterol and moderately elevated... more
Glucose-control has a modest beneficial effect on cardiovascular outcomes in patients with type 2 diabetes mellitus. Thus, managing other atherogenic risk factors including hypertriglyceridemia, low HDL-cholesterol and moderately elevated LDL-cholesterol levels with increased small dense LDL-cholesterol fraction, is crucial. Insulin resistance is a key pathophysiologic factor in this population. Treatment starts with lifestyle modifications, but current best programmes have not translated into positive cardiovascular outcomes. Lowering LDL-cholesterol with statins is currently the main
2024, Journal of Space Safety Engineering
This paper will examine the typical decision process that National Aeronautics and Space Administration (NASA) project management team members utilize to rank and then accept residual risks before the launch of a spacecraft. Interviews of... more
This paper will examine the typical decision process that National Aeronautics and Space Administration (NASA) project management team members utilize to rank and then accept residual risks before the launch of a spacecraft. Interviews of two flight project management teams at NASA's Goddard Space Flight Center (GSFC) were conducted to understand the structuring of these decisions. Decision attribute preferences were elicited using a lottery technique and a multi-attribute preference model (MAPM) was constructed. MAPM model ranking was consistent with the actual project management team residual risk ranking as well as the ranking determined by the project's risk scoring scheme. While we found differing risk acceptance behaviors among project team members, the MAPM model generally agreed with the team's actual ranking decisions. However, the MAPM model showed incongruences between the risk scoring scheme ranking and model outputs in the moderate risk region as compared to the GSFC risk scorecard, which may point to a potential area of disagreement between project management team members when moderate risks must be accepted before flight.
2024, Transfusion and Apheresis Science
Background: Residual risk is estimated as the product of the incidence and the infectious window period, the time during which a blood donation could be infectious but the assay may not detect it. In 2011 nucleic acid multiplex testing... more
Background: Residual risk is estimated as the product of the incidence and the infectious window period, the time during which a blood donation could be infectious but the assay may not detect it. In 2011 nucleic acid multiplex testing (MPX) was implemented in 6 unit minipools (previously 24 unit minipools). MPX also included hepatitis B (HBV) NAT for the first time (complementing HBsAg screening) in addition to HIV-1 and hepatitis C (HCV) as before. We aimed to estimate window period risk-day equivalents for MPX, and the residual risk of viral infections in blood donations updated to reflect current incidence and testing. Methods: Transmissible disease conversions of repeat donations to Canadian Blood Services within the three-year period 2012-2014 divided by person-years estimated incidence for HIV, HCV and HBV (adjusted for transient viremia). Window period risk-day equivalents for MPX were estimated using a published method. Residual risk was the product of incidence and window period risk-day equivalents. 95% confidence intervals were estimated using Monte Carlo simulation of the window period risk-day equivalents and the incidence density 95% confidence intervals. Results: The incidence rate per 100,000 person years for HIV was 0.28, HCV 1.0 and HBV 0.26. The residual risk of HIV was 1 per 21.4 million donations, HCV 1 per 12.6 million donations and HBV 1 per 7.5 million donations. The residual risk of infection is very low, similar to 2006-2009. The safety benefit of further shortening of the infectious window period is below the threshold to quantify.
2024, Vox Sanguinis
Estimates of the viral residual risk should be updated to reflect current incidence of infection in blood donors. Incidence rates were estimated for allogeneic whole‐blood donations made to Canadian Blood Services from 2006 to 2009 based... more
Estimates of the viral residual risk should be updated to reflect current incidence of infection in blood donors. Incidence rates were estimated for allogeneic whole‐blood donations made to Canadian Blood Services from 2006 to 2009 based on transmissible disease conversions of repeat donations within a 3‐year period. Residual risk was estimated as the incidence multiplied by the window period. The residual risk of HIV was 1 per 8 million donations, HCV 1 per 6·7 million donations and HBV 1 per 1·7 million donations. The residual risk remains low and has decreased for HCV since our previous estimates due to reduced incidence.