Proceedings of the 2022 NHLBI and OASH state of the science in transfusion medicine symposium.

BACKGROUND: State of the Science (SoS) meetings are used to define and highlight important unanswered scientific questions. The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services held a virtual SoS in transfusion medicine (TM) symposium. STUDY DESIGN AND METHODS: In advance of the symposium, six multidisciplinary working groups (WG) convened to define research priorities in the areas of: blood donors and the supply, optimizing transfusion outcomes for recipients, emerging infections, mechanistic aspects of components and transfusion, new computational methods in transfusion science, and impact of health disparities on donors and recipients. The overall objective was to identify key basic, translational, and clinical research questions that will help to increase and diversify the volunteer donor pool, ensure safe and effective transfusion strategies for recipients, and identify which blood products from which donors best meet the clinical needs of specific recipient populations. RESULTS: On August 29-30, 2022, over 400 researchers, clinicians, industry experts, government officials, community members, and patient advocates discussed the research priorities presented by each WG. Dialogue focused on the five highest priority research areas identified by each WG and included the rationale, proposed methodological approaches, feasibility, and barriers for success. DISCUSSION: This report summarizes the key ideas and research priorities identified during the NHLBI/OASH SoS in TM symposium. The report highlights major gaps in our current knowledge and provides a road map for TM research.

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.

Economic implications of FDA platelet bacterial guidance compliance options: Comparison of single-step strategies.

BACKGROUND: Bloodborne pathogens pose a major safety risk in transfusion medicine. To mitigate the risk of bacterial contamination in platelet units, FDA issues updated guidance materials on various bacterial risk control strategies (BRCS). This analysis presents results of a budget impact model updated to include 5- and 7-day pathogen reduced (PR) and large volumed delayed sampling (LVDS) BRCS. STUDY DESIGN AND METHODS: Model base-case parameter inputs were based on scientific literature, a survey distributed to 27 US hospitals, and transfusion experts' opinion. The outputs include hospital budget and shelf-life impacts for 5- and 7-day LVDS, and 5- and 7-day PR units under three different scenarios: (1) 100% LVDS, (2) 100% PR, and (3) mix of 50% LVDS - and 50% PR. RESULTS: Total annual costs from the hospital perspective were highest for 100% LVDS platelets (US$2.325M) and lowest for 100% PR-7 units (US$2.170M). Net budget impact after offsetting annual costs by outpatient reimbursements was 5.5% lower for 5-day PR platelets as compared to 5-day LVDS (US$1.663 vs. US$1.760M). A mix of 7-day LVDS and 5-day PR platelets had net annual costs that were 1.3% lower than for 100% 7-day LVDS, but 1.3% higher than for 100% 5-day PR. 7-day PR platelets had the longest shelf life (4.63 days), while 5-day LVDS had the shortest (2.00 days). DISCUSSION: The model identifies opportunities to minimize transfusion center costs for 5- and 7-day platelets. Budget impact models such as this are important for understanding the financial implications of evolving FDA guidance and new platelet technologies.

Cost-effectiveness and budget impact of whole blood pathogen reduction in Ghana.

BACKGROUND: Despite the promise of pathogen reduction for reducing transfusion-associated adverse events in sub-Saharan Africa, no health-economic assessment is publicly available. STUDY DESIGN AND METHODS: We developed a mathematical risk reduction model to estimate the impact of nationwide whole blood pathogen reduction in Ghana on the incidence of six infectious and one non-infectious transfusion-associated adverse events. We estimated the lifetime direct healthcare costs and disability-adjusted life years lost for each adverse event. For HIV, HCV, and HBV, we simulated disease progression using Markov models, accounting for the likelihood and timing of clinical detection and treatment. We performed probabilistic and univariate sensitivity analysis. RESULTS: Adding whole blood pathogen reduction to Ghana's blood safety portfolio would avert an estimated 19,898 (11,948-27,353) adverse events and 38,491 (16,444-67,118) disability-adjusted life years annually, primarily by averting sepsis (49%) and malaria (31%) infections. One year of pathogen reduction would cost an estimated $8,037,191 ($6,381,946-$9,880,760) and eliminate $8,656,389 ($4,462,614-$13,469,448) in direct healthcare spending on transfusion-associated adverse events. We estimate a 58% probability that the addition of pathogen reduction would reduce overall direct healthcare spending. Findings were most sensitive to uncertainty in the probability that a bacterially contaminated blood donation causes sepsis. CONCLUSION: Whole blood pathogen reduction would substantially reduce the burden of known transfusion-associated adverse events in Ghana and may reduce overall healthcare spending. Additional benefits not captured by this analysis may include averting secondary transmission of infectious diseases, reducing non-medical costs, and averting new or re-emerging transfusion-transmitted infections.

Research initiatives of blood services worldwide in response to the covid-19 pandemic.

BACKGROUND AND OBJECTIVES: While coronavirus (COVID-19) is not transfusion-transmitted, the impact of the global pandemic on blood services worldwide is complex. Convalescent plasma may offer treatment, but efficacy and safety are not established. Measuring seroprevalence in donors would inform public health policy. Here, we survey blood services around the world to assess the different research programmes related to COVID-19 planned or in progress. MATERIALS AND METHODS: Blood collection services were surveyed in June 2020 to determine whether they were participating in serosurveys or convalescent plasma collection and clinical trials. RESULTS: A total of 48 countries (77% of those contacted) responded. Seroprevalence studies are planned or in progress in 73% of countries surveyed and in all continents, including low- and middle-income countries. Most aimed to inform public health policy. Convalescent plasma programmes have been initiated around the globe (79% of surveyed), about three quarters as clinical trials in high-, middle- and low-income countries. CONCLUSION: Blood services around the world have drawn upon their operational capacity to provide much-needed seroprevalence data to inform public health. They have rapidly implemented preparation of potential treatment when few treatments are available and mostly as clinical trials. At the same time, they must continue to provide blood products for recipients despite challenges of working in a state of emergency. It is important to track and coordinate research efforts across jurisdictions to gain a composite evidence-based view that will influence future practice and preparative strategies.

Factors that contribute to blood donation behavior among primary healthcare users: A structural approach.

This study aimed to evaluate the relative contribution of psychosocial variables to donation behavior in a sample of primary healthcare users in a Brazilian municipality. Donor recruitment and retention continue to pose significant challenges to blood collection services worldwide and is especially important among low and middle income countries (LMICs), challenged with higher rates of stigma and low public awareness about donation. A cross-sectional study with randomized stratified sampling of 1055 primary healthcare users was conducted across 12 healthcare facilities in Ribeirão Preto, state of São Paulo. Participants completed measures assessing psychosocial variables, including religiosity, knowledge regarding blood donation process, overall quality of life, blood donation of peers, sociodemographic variables, and the fear of blood, injections, and fainting. The associations between psychosocial variables and donation behaviour was examined using structural equation modelling. Blood donation was more frequent in males and among individuals with higher socioeconomic and educational levels. The structural model indicated associations between blood donation behaviour and fear, knowledge, age, sex, socioeconomic status, and educational level. Fear of blood, injections and vasovagal reactions, and a lack of knowledge of the donation process were revealed as important barriers to the decision to donate blood. In addition, there is evidence that considering the population of primary healthcare users, the women, the youngers, and those with lower socioeconomic status and lower educational level are less likely to donate blood.

Hepatitis E Virus Infection in Blood Donors and Risk to Patients in the United States and Canada.

Hepatitis E virus (HEV) is the most common cause of acute hepatitis worldwide including large water-borne outbreaks, zoonotic infections and transfusion transmissions. Several countries have initiated or are considering blood donor screening in response to high HEV-RNA donation prevalence leading to transfusion-transmission risk. Because HEV transmission is more common through food sources, the efficacy of blood donor screening alone may be limited. HEV-nucleic acids in 101 489 blood donations in the United States and Canada were studied. A risk-based decision-making framework was used to evaluate the quantitative risks and cost-benefit of HEV-blood donation screening in Canada comparing three scenarios: no screening, screening blood for all transfused patients or screening blood for only those at greatest risk. HEV-RNA prevalence in the United States was one per 16 908 (95% confidence interval [CI], 1:5786-1:81987), whereas Canadian HEV-RNA prevalence was one per 4615 (95% CI, 1:2579-1:9244). Although 4-fold greater, Canadian HEV-RNA prevalence was not significantly higher than in the United States. Viral loads ranged from 20 to 3080 international units per mL; all successfully typed infections were genotype 3. No HEV-RNA false-positive donations were identified for 100 percent specificity. Without donation screening, heart and lung transplant recipients had the greatest HEV-infection risk (1:366962) versus kidney transplant recipients with the lowest (1:2.8 million) at costs of $225 546 to $561 810 per quality-adjusted life-year (QALY) gained for partial or universal screening, respectively. Higher cost per QALY would be expected in the United States. Thus, HEV prevalence in North America is lower than in countries performing blood donation screening, and if implemented, is projected to be costly under any scenario.

Health economic implications of testing blood donors in South Africa for HTLV 1 & 2 infection.

BACKGROUND AND OBJECTIVES: Currently, HTLV screening is not performed in South Africa (SA). This report describes an economic assessment (budget impact and cost-effectiveness) of implementing different HTLV screening strategies. METHODS: A modified version of the Alliance of Blood Operators risk-based decision-making framework was used to assess the risk and consequences of HTLV in the blood supply in SA. We developed a deterministic model of the cost and consequences of four screening strategies: none, universal, all donors once and first time donors only assuming a transfusion-transmission (TT) efficiency of 10% and a manifestation of clinical disease of 6%. RESULTS: Unscreened blood results in 3·55 symptomatic TT-HTLV cases and a total healthcare cost of Rand (R)3 446 950 (US Dollars (USD)229 800) annually. Universal screening would cost R24 000 000 (USD1 600 000) per annum and prevent 3·54 (99·8%) symptomatic TT-HTLV cases in the first year and 0·55 (98·4%) symptomatic TT-HTLV cases in the second year at a cost per TT-HTLV prevented of R6 780 000 (USD450 000) in year one and R43 254 000 (USD2 890 000) in year two. Screening all donors once would cost R16,200,000 (USD1 080 000) or R4 600 000 (USD306 000) per symptomatic TT-HTLV infection prevented in year one. Total costs decrease to R5 100 000 (USD340 000) in year 2 but the cost per TT-HTLV prevented increases to R10 700 000 (USD713 333). CONCLUSION: This analysis contributed to the decision not to implement HTLV screening as the healthcare budget and particularly the budget for blood transfusion in SA is insufficient to provide appropriate treatment. Arguably, available resources can be more efficiently utilized in other healthcare programs.

Screening the Blood Supply for Zika Virus in the 50 U.S. States and Puerto Rico: A Cost-Effectiveness Analysis.

Background: In 2016, universal individual donation nucleic acid testing (ID-NAT) of donated blood for Zika virus began in U.S. states and territories. Objective: To assess the cost-effectiveness of universal ID-NAT in the first year of screening compared with alternatives for the 50 states and separately for Puerto Rico. Design: Microsimulation that captured Zika-related harms to transfusion recipients, sexual partners, and their infants. Data Sources: National testing results compiled by AABB and costs, utilities, and outcome probabilities estimated from the literature. Target Population: Transfusion recipients. Time Horizon: Lifetime. Perspective: Societal. Intervention: Universal ID-NAT, universal mini-pool NAT (MP-NAT), and ID-NAT exclusively for components transfused to women of childbearing age. Seasonally targeted strategies in Puerto Rico and geographically targeted strategies in the 50 states were also considered. Outcome Measures: Costs, quality-adjusted life-years (QALYs), and outcomes. Results of Base-Case Analysis: In Puerto Rico, MP-NAT exclusively during high mosquito season was cost-effective at $81 123 per QALY (95% CI, -$49 138 to $978 242 per QALY). No screening policy was cost-effective in the 50 states. Universal ID-NAT cost $341 million per QALY (CI, $125 million to $2.90 billion per QALY) compared with no screening in the 50 states. Results of Sensitivity Analysis: In Puerto Rico, MP-NAT only during the season of high mosquito activity was most cost-effective in 64% of probabilistic sensitivity analysis iterations. In the 50 states, no intervention was cost-effective in 99.99% of iterations. Cost-effectiveness was highly dependent on the rate of assumed infectious donations. Limitation: Data were limited on the component-specific transmissibility of Zika and long-term sequelae of infection. Conclusion: Screening was cost-effective only in the high mosquito season in Puerto Rico, and no evaluated screening policy was cost-effective in the 50 states. During periods with lower rates of Zika-infectious donations, the cost-effectiveness of screening will be even less favorable. Primary Funding Source: None.

Comparison of the demographic and social profile of blood donors and nondonors in Brazil.

Population-based studies on blood donation prevalence and its association with sociodemographic and behavioural factors are scarce, but remain the best approach to assess correlates of donation, including those which could be the target for donor recruitment campaigns. This study describes the population of primary healthcare users from the public system in a medium-sized Brazilian municipality to investigate the association of blood donation practice with other sociodemographic factors. A stratified, representative sample of primary healthcare users at 12 healthcare facilities in Ribeirão Preto, São Paulo, Brazil, were invited to participate. Analysis focused on demographic and psychosocial factors including, sex, age, marital status, socioeconomic status, educational level, health insurance, self-perception of health, religious beliefs, and blood donation history. Blood donors, self-defined ineligible donors, and never donors were compared. Multiple correspondence analysis (MCA) was used to assess positively and negatively associated variables in the dataset. MCA was conducted on respondents' age and monthly household income to assess dimensionality of other questionnaire responses. Of a total of 1,055 study participants, 79.7% were females and the mean age was 40.6 years. Blood donation practice was reported by 246 participants (23.3%), 669 (63.4%) had never donated, and 140 (13.3%) reported being unable to donate blood. Graphical presentation of the MCA showed that male, older age groups, those who have health insurance, and with higher socioeconomic and educational level are more likely to donate blood. Poor or average self-perception of health, lower socioeconomic status, and divorced or widowed marital status were associated with self-defined inability to donate blood. Thus, our results are useful to understand the multifactorial nature of blood donation behaviour. Our findings provide guidance for targeted recruitment campaigns focused on relevant contextual factors. The focus on reducing barriers to blood donation according to sociodemographic groups can be a relevant strategy to expand the donor base.

Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop.

In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of the workshop was to identify research opportunities for implementation science (IS) to improve the availability of safe blood and blood components and transfusion practices in LMICs. IS describes the late stages of the translational research spectrum and studies optimal and sustainable strategies to deliver proven-effective interventions. Regional working groups were formed to focus on opportunities and challenges in East Africa, Central/West Africa, Middle East and North Africa, Latin America and the Caribbean, Southeast Asia, Western Pacific Asia, Eastern Europe, and Central Asia. The need for an "adequate supply of safe blood" emerged as the major overriding theme. Among the regional working groups, common cross-cutting themes were evident. The majority of research questions, priorities, and strategies fell into the categories of blood availability, blood transfusion safety, appropriate use of blood, quality systems, health economics and budgeting, and training and education in IS. The workshop also brought into focus inadequate country-level data that can be used as the basis for IS initiatives. A mixed approach of needs assessment and targeted interventions with sufficient evidence base to move toward sustainment is an appropriate next step for blood availability and transfusion safety research in LMICs.

Blood donation history and eligibility assessment in a community-based sample of men who have sex with men.

BACKGROUND: In 2016, the US Food and Drug Administration changed the regulation from a permanent deferral from donation for men who have sex with men (MSM) to a 1-year deferral since last sexual contact. It is unknown what proportions of MSM try to donate and if they would be willing to answer individual risk-based questions to assess their current eligibility. STUDY DESIGN AND METHODS: The National HIV Behavioral Surveillance surveys periodically measure human immunodeficiency virus (HIV) prevalence and risk behaviors among MSM using a venue-based, time-location sampling method. In the 2014 cycle, that is, before the policy change, investigators in San Francisco and New Orleans added questions about blood donation. Questions inquired into three domains: donation history, policy awareness, and knowledge about HIV testing of donations. RESULTS: There were 404 and 557 respondents in San Francisco and New Orleans, respectively. Nearly one in three MSM in San Francisco (27.4%) and New Orleans (31.4%) tried to donate after their first MSM contact. A majority (63.1% in San Francisco, 58.8% in New Orleans) somewhat or strongly agreed that they would be willing to be asked detailed questions for donation eligibility assessment. CONCLUSIONS: The proportion of MSM who reported trying to donate was similar in the two cities. However, a substantial proportion did not agree to be asked more detailed risk behavior questions to assess eligibility. In these two geographic locations, prominent regional differences were not evident.

Cost-utility and budget impact of methylene blue-treated plasma compared to quarantine plasma.

BACKGROUND: Methylene blue and visible light treatment and quarantine are two methods used to reduce adverse events, mostly infections, associated with the transfusion of fresh-frozen plasma. The objective of this study was to estimate and compare the budget impact and cost-utility of these two methods from a payer's perspective. MATERIALS AND METHODS: A budget impact and cost-utility model simulating the risks of hepatitis B virus, hepatitis C virus, cytomegalovirus, a West Nile virus-like infection, allergic reactions and febrile non-haemolytic transfusion reactions achieved using plasma treated with methylene blue and visible light (MBP) and quarantine plasma (QP) was constructed for Spain. QP costs were estimated using data from one blood centre in Spain and published literature. The costs of producing fresh-frozen plasma from whole blood, apheresis plasma, and multicomponent apheresis, and separately for passive and active methods of donor recall for QP were included. Costs and outcomes over a 5-year and lifetime time horizon were estimated. RESULTS: Compared to passive QP, MBP led to a net increase of € 850,352, and compared to active QP, MBP led to a net saving of € 5,890,425 over a 5-year period. Compared to passive QP, MBP increased the cost of fresh-frozen plasma per patient by € 7.21 and had an incremental cost-utility ratio of € 705,126 per quality-adjusted life-year. Compared to active QP, MBP reduced cost by € 50.46 per patient and was more effective. DISCUSSION: Plasma collection method and quarantine approach had the strongest influence on the budget impact and cost-utility of MBP. If QP relies on plasma from whole blood collection and passive quarantine, it is less costly than MBP. However, MPB was estimated to be more effective than QP in all analyses.

Introducing Pathogen Reduction Technology in Poland: A Cost-Utility Analysis.

BACKGROUND: Mirasol® pathogen reduction technology (PRT) uses UV light and riboflavin to chemically inactivate pathogens and white blood cells in blood components. In the EU, Mirasol PRT is CE-marked for both plasma and platelet treatment. In Poland, the decision to introduce PRT treatment of the national supply of fresh frozen plasma has spurred interest in evaluating the cost-effectiveness of this strategy. METHODS: A decision-analytic model evaluated the incremental costs and benefits of introducing PRT to the existing blood safety protocols in Poland. RESULTS: Addition of PRT treatment of plasma to current screening in Poland is estimated to cost 2.595 million PLN per quality-adjusted life year (QALY) (610,000 EUR/QALY); treating both plasma and platelet components in addition to current safety interventions had a lower cost of 1.480 million PLN/QALY (348,000 EUR/QALY). CONCLUSIONS: The results suggest that in Poland the cost per QALY of PRT is high albeit lower than found in previous economic analyses of PRT and nucleic acid testing in North America. Treating both platelets and plasma components is more cost-effective than treating plasma alone. Wide confidence intervals indicate high uncertainty; to improve the precision of the health economic evaluation of PRT, additional hemovigilance data are needed.

Health economics and outcomes methods in risk-based decision-making for blood safety.

Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making.

Costs, consequences, and cost-effectiveness of strategies for Babesia microti donor screening of the US blood supply.

BACKGROUND: Babesia microti is regarded as the foremost infectious risk to the US blood supply for which a regulatory-approved screening test is unavailable. More than 160 cases of transfusion-transmitted Babesia microti (TTB) have been reported to date, yet there is little consensus regarding a mitigation strategy. STUDY DESIGN AND METHODS: This study sought to assess the cost-utility of donation screening by mode of testing (immunofluorescence assay, enzyme-linked immunosorbent assay [ELISA], polymerase chain reaction [PCR], and combinations thereof) as well as extent of geographic inclusion (4-state, 7-state, 20-state, or national screening). A discrete-time Markov cohort model to simulate the outcomes of B. microti infection and survival of the transfused population was developed. Seroprevalence was estimated by extrapolating babesiosis claims from the Centers for Medicaid and Medicare Services and reports to the Centers for Disease Control and Prevention. Test performance was estimated from clinical diagnostics and limited donor screening studies, while transmissibility was estimated as a weighted average of three studies. Results are reported as the cost per quality-adjusted life-year (QALY) for each strategy compared to no screening. RESULTS: Given model inputs, 4-state and 7-state ELISA in combination with PCR would cost $5.2 million and $6.6 million/QALY, respectively. Cost-effectiveness for 20-state and national screening strategies were less favorable. CONCLUSION: Targeted screening in states with the highest seroprevalence of infection is likely to exceed an implicit threshold of $1 million/QALY often used in blood safety. However, the proportion of donor-seronegative parasitemia, transmissibility, and clinical outcomes resulting from TTB are uncertain.

Risk perception and its role in attitudes toward blood transfusion: a qualitative systematic review.

Despite improvements in blood safety making transfusion a much safer clinical procedure, the general public still perceives it as risky. We systematically reviewed available literature to examine evidence regarding the reasons and causes behind this perception. Electronic databases including PubMed, Cochrane Library, and EMBASE for literature dating back to the 1980s were searched. Eligible studies collected information on blood recipients' demographics, measures of risk domains (sets of values that risks encompass), and general knowledge of blood transfusion in terms of risks and benefits. Each study was assessed for quality of data, research method, and relevant findings. A scoring system was used to subjectively rate the overall quality of each study. Each study was reviewed for its method of data collection and information abstracted on hazards and conceptual dimensions used to measure risk. Risk perception between blood transfusion and other hazards including alternatives to transfusion were compared. Fifteen studies met the inclusion criteria, all of which were conducted outside the United States, with most of the studies published more than 10 years ago and conducted by only 3 research groups. Five studies were rated as being very good, four good, five fair, and one of poor quality. The finding of the studies consistently show that objective or raw knowledge is not correlated with risk perception, but subjective or calibrated knowledge is. Thus, it is what people think they know rather than what they actually do know that influences risk perception of transfusion. Of the 3 common conceptual domains-dread, unknown risk, and benefits-blood transfusion was found to be of intermediate dread, intermediate unknown risk, and most beneficial compared with other hazards. Donated blood was found to have lower perceived risk than all other alternatives to transfusion, except for use of autologous blood. There is a lack of recent studies on allogeneic transfusion. However, the more recent studies show that perceived high risk is still prevalent in the general public. The available risk perception studies suggest that although blood transfusion is safe, elevated risk perception of infections persists. Studies of the US population are needed to better understand the influence of both psychological and scientific factors.

Outpatient red blood cell transfusion payments among patients on chronic dialysis.

BACKGROUND: Payments for red blood cell (RBC) transfusions are separate from US Medicare bundled payments for dialysis-related services and medications. Our objective was to examine the economic burden for payers when chronic dialysis patients receive outpatient RBC transfusions. METHODS: Using Truven Health MarketScan® data (1/1/02-10/31/10) in this retrospective micro-costing economic analysis, we analyzed data from chronic dialysis patients who underwent at least 1 outpatient RBC transfusion who had at least 6 months of continuous enrollment prior to initial dialysis claim and at least 30 days post-transfusion follow-up. A conceptual model of transfusion-associated resource use based on current literature was employed to estimate outpatient RBC transfusion payments. Total payments per RBC transfusion episode included screening/monitoring (within 3 days), blood acquisition/administration (within 2 days), and associated complications (within 3 days for acute events; up to 45 days for chronic events). RESULTS: A total of 3283 patient transfusion episodes were included; 56.4% were men and 40.9% had Medicare supplemental insurance. Mean (standard deviation [SD]) age was 60.9 (15.0) years, and mean Charlson comorbidity index was 4.3 (2.5). During a mean (SD) follow-up of 495 (474) days, patients had a mean of 2.2 (3.8) outpatient RBC transfusion episodes. Mean/median (SD) total payment per RBC transfusion episode was $854/$427 ($2,060) with 72.1% attributable to blood acquisition and administration payments. Complication payments ranged from mean (SD) $213 ($168) for delayed hemolytic transfusion reaction to $19,466 ($15,424) for congestive heart failure. CONCLUSIONS: Payments for outpatient RBC transfusion episodes were driven by blood acquisition and administration payments. While infrequent, transfusion complications increased payments substantially when they occurred.