Cost-effectiveness of pathogen reduction technology for plasma and platelets in Québec: A focus on potential emerging pathogens.

BACKGROUND: The last economic evaluation of pathogen reduction technology (PRT) in Canada was conducted in 2007. We reassessed the cost-effectiveness of PRT in the province of Québec (which has its own blood supplier) and included an evaluation of the potential impact of emerging pathogens on cost-effectiveness. STUDY DESIGN AND METHODS: Decision analytic Markov models were developed to simulate the costs and quality-adjusted life-years (QALY) associated with PRT as an addition to existing safety measures for plasma and platelet products (except for bacterial culture). Models accounted for several infectious and noninfectious transfusion reactions, recipients' productivity losses ensuing from these reactions, and the impact of PRT on platelet function. Scenario analyses were conducted to evaluate the impact of a new highly contagious human immunodeficiency virus (HIV)-like or West Nile virus (WNV)-like pathogen, assuming various epidemiological scenarios. RESULTS: In the base case, the incremental cost-effectiveness ratio (ICER) of PRT was estimated at $8,088,974/QALY gained. Assuming the presence of an HIV-like pathogen, the ICER was $265,209/QALY gained in the "average transmission" scenario, $1,274,445/QALY gained in the "rapid testing scenario," and $123,063/QALY gained in the "highly contagious" scenario. Assuming the presence of a WNV-like pathogen, the ICER was $7,469,167/QALY gained in the "average transmission" scenario and $6,652,769/QALY gained in the "highly contagious" scenario. CONCLUSION: The cost-effectiveness of PRT may substantially improve in the event of a new, blood-borne pathogen. Given their significant impact on cost-effectiveness, the emergence of new pathogens should be considered when deciding whether to adopt PRT.

Balancing non-discriminatory donor selection and blood safety in the Netherlands: Evaluation of an individual risk assessment of sexual behavior.

BACKGROUND: To better balance the safety of the blood supply and the inclusion of men who have sex with men (MSM), further improvements are needed to the risk management strategy employed in the Netherlands to reduce transfusion-transmissible infections (TTIs). A gender-neutral individual risk assessment could provide a solution by determining donor eligibility based on sexual behaviors known to increase the risk of TTIs. Our objective is to estimate the proportion of blood donors that would be deferred by such an assessment, as well as their discomfort answering such questions. STUDY DESIGN AND METHODS: Two surveys were distributed in May 2020 to assess sexual behavior in blood donors in the last 4, 6, and 12 months, as well as their discomfort reporting such information. A combination of both surveys measured the extent to which discomfort was associated with reporting sexual behavior. A high-risk sexual behavior pattern was defined as having had multiple sexual partners and having engaged in anal sex, without consistent condom use. RESULTS: Of all 2177 participating whole blood donors, 0.8% report engaging in high-risk sexual behaviors over the last 4 months and would therefore be ineligible to donate. When accounting for the additional proportion of donors that reported such questions would stop them from donating, 2.0% and 3.2% of female and male donors, respectively, would be lost. DISCUSSION: Gender-neutral eligibility criteria based on high-risk sexual behaviors may reduce the overall number of eligible donors in the Netherlands, but could make blood donation more accessible to a broader group of donors.

Effects of the COVID-19 pandemic on supply and use of blood for transfusion.

The COVID-19 pandemic has major implications for blood transfusion. There are uncertain patterns of demand, and transfusion institutions need to plan for reductions in donations and loss of crucial staff because of sickness and public health restrictions. We systematically searched for relevant studies addressing the transfusion chain-from donor, through collection and processing, to patients-to provide a synthesis of the published literature and guidance during times of potential or actual shortage. A reduction in donor numbers has largely been matched by reductions in demand for transfusion. Contingency planning includes prioritisation policies for patients in the event of predicted shortage. A range of strategies maintain ongoing equitable access to blood for transfusion during the pandemic, in addition to providing new therapies such as convalescent plasma. Sharing experience and developing expert consensus on the basis of evolving publications will help transfusion services and hospitals in countries at different stages in the pandemic.

Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study.

BACKGROUND: Banked human milk (BHM) offers potential health benefits to premature babies. BHM is pasteurized to mitigate infectious risks, but pasteurization is ineffective against sporulating bacteria such as Bacillus cereus. Sepsis related to Bacillus cereus in premature infants is severe and can often be fatal. Even if a causal link has never been established, BHM has been suggested as a potential source of infection in premature infants. OBJECTIVE: Our aim was to estimate the potential risk of Bacillus cereus infection in preterm infants caused by the ingestion of contaminated pasteurized BHM using different post-pasteurization release criteria (i.e., 9 sampling of 100 microliters versus the HMBANA guideline of 1 sampling of 100 microliters per pool). METHODS: In the absence of scientific evidence regarding the risk of Bacillus cereus infection by the ingestion of BHM in premature infants, risk assessment using Monte Carlo simulation with the exponential dose-response model was performed. Three scenarios of infectious risk (annual incidence rate of 0.01%, 0.13%, and 0.2%) with 18 variations of the B. cereus virulent dose (from 0.5 CFU/ml to 200 CFU/ml) were simulated. RESULTS: The mean risk differential between the two methods of post-pasteurization bacteriological control for realistic infectious doses of 30 to 200 CFU/ml ranges from 0.036 to 0.0054, 0.47 to 0.070, and 0.72 to 0.11 per million servings, for each of the three scenarios. CONCLUSION: Simulation highlights the very small risk of Bacillus cereus infection following the ingestion of pasteurized BHM, even in the worst case scenarios, and suggests that a 100-microliter sample for post-pasteurization culture is sufficient.

Determining the rate of underrecognition of West Nile virus neurologic disease in the province of Quebec in 2012.

BACKGROUND: During a major outbreak of West Nile virus (WNV) infection in the province of Quebec in 2012, public health authorities (PHAs) suspected underrecognition of West Nile neurologic disease (WNND). With data on acute infections detected in blood donors, an estimate of the degree of underrecognition was produced. STUDY DESIGN AND METHODS: All 2012 donors were tested for WNV infection with the use of reverse transcription-polymerase chain reaction (RT-PCR). With the number of cases detected, the number of donors tested, our estimate of the duration of viremia, an estimate of the population at risk, and the ratio of WNND to total cases, an expected number of WNND cases was calculated. A Monte Carlo simulation was used to estimate the range of several of these variables. RESULTS: Seventeen RT-PCR-positive donors were found among 52,309 donations tested. In the base case, the total number of cases was 16,095 and the expected number of WNND cases was 115. In the Monte Carlo simulation, the mean number of expected WNND cases was 136, and the median was 129. Since only 85 cases were reported to PHAs, it is estimated that between 26 and 37.5% of cases occurring in the province went undetected. CONCLUSION: The observation that close to one-third of cases of WNND went undetected because of the omission of appropriate laboratory testing indicates the need for improvement in the investigation of acute neurologic syndrome of suspected infectious etiology in Québec.

Preoperative Autologous Blood Donation: Waning Indications in an Era of Improved Blood Safety.

A downward trend in preoperative autologous donation (PAD) continues in Europe and the Americas, with many jurisdictions only funding medically necessary collections at present. This is the result of decreasing real and perceived residual risks of allogeneic transfusion-transmitted disease and the declining need for transfusion due to patient blood management, which have also led to escalating logistical and cost constraints for PAD programs. We outline collection trends in North America, Europe, and Latin America and review the benefits, risks, effectiveness, and safety of PAD. Important elements of informed consent follow from these points. Evidence-based medical criteria for PAD and autologous transfusion are discussed as are methods to optimize autologous collection timing to regenerate donated red cells. Recommendations for identification of patients whose risk-to-benefit ratio suggests substantial benefit compared with other autologous blood salvage and anemia management alternatives conclude the review.

Determinants of return behavior: a comparison of current and lapsed donors.

BACKGROUND: There is a need to identify factors explaining why some people stop donating blood. STUDY DESIGN AND METHODS: A random mail survey of first-time (FT) and repeat (RPT) current (donating within 6 months before survey) and lapsed (donating >2 years prior) donors was conducted. The self-administered questionnaire included questions on personal, social, and behavioral characteristics. RESULTS: Among 1280 current and 1672 lapsed donors with valid addresses, the participation rate was 66.8 and 39.2 percent, respectively. In FT donors, the odds of lapsing increased with education (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.34-3.55 for college or higher vs. Grade 12 or less education). Lapsed FT donors were more often asked to donate (OR, 1.89; 95% CI, 1.32-2.70) and had less interest in incentives (p < 0.001) than current FT donors. In RPT donors, lapsed status was associated with being younger (p < 0.001) and female (OR, 1.19; 95% CI, 1.00-1.42). Lapsed status was inversely associated with satisfaction with the last donation experience in both FT (p = 0.043) and RPT (p < 0.001) donors. Lapsed and current donors did not differ in perceived need for blood, personal transfusion experience, or mean reported altruistic behavior score. CONCLUSION: A positive donation experience appears to be a major determinant of donor return behavior. Lapsed donors do not appear, on average, to engage in fewer altruistic behaviors than currently active donors. Retention marketing strategies that appeal solely to altruistic values need to be further evaluated for their effectiveness.