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Background and Objectives: Blood banks use a haemoglobin (Hb) threshold before blood donation to minimize donors' risk of anaemia. Hb prediction models may guide decisions on which donors to invite, and should ideally also be generally applicable, thus in different countries and settings. In this paper, we compare the outcome of various prediction models in different settings and highlight differences and similarities. Materials and Methods: Donation data of repeat donors from the past 5 years of Australia, Belgium, Finland, the Netherlands and South Africa were used to fit five identical prediction models: logistic regression, random forest, support vector machine, linear mixed model and dynamic linear mixed model. Only donors with five or more donation attempts were included to ensure having informative data from all donors. Analyses were performed for men and women separately and outcomes compared. Results: Within countries and overall, different models perform similarly well. However, there are substantial differences in model performance between countries, and there is a positive association between the deferral rate in a country and the ability to predict donor deferral. Nonetheless, the importance of predictor variables across countries is similar and is highest for the previous Hb level. Conclusion: The limited impact of model architecture and country indicates that all models show similar relationships between the predictor variables and donor deferral. Donor deferral is found to be better predictable in countries with high deferral rates. Therefore, such countries may benefit more from deferral prediction models than those with low deferral rates.

Blood donors are at risk of iron deficiency anaemia. While this risk is decreased through ferritin-based deferral, ideally ferritin monitoring should also aid in optimising donation frequencies. We extended an existing model of haemoglobin (Hb) synthesis with iron homeostasis and validated the model on a cohort of 300 new donors whose ferritin levels were measured from stored blood samples collected over a 2-year period. We then used the donor's gender, body weight, height, and baseline Hb and ferritin levels to predict subsequent Hb and ferritin levels. The prediction error was within measurement variability in 88% of Hb level predictions and 64% of ferritin level predictions. A sensitivity analysis of the model revealed that baseline ferritin level was the most important in predicting future ferritin levels. Finally, we used the model to calculate the annual donation frequency at which donors would keep their ferritin level >15 ng/ml when measured after donating for 2 years. The mean annual donation frequency would then be 1.9 for women and 4.1 for men. The computational model, requiring baseline values only, can predict future Hb and ferritin levels remarkably well. This enables determination of optimal donation frequencies for individual donors at the start of their donation career.

Background and Objectives: To protect transfusion recipients from transfusion-transmissible infections, blood donors are deferred from donating after recent tattooing or piercing. To explore to what extent and how this deferral impacts donor availability, we performed an international study to investigate how many donors were deferred for a recent tattoo or piercing and how many of these donors returned to donate. Materials and Methods: We surveyed blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative and the European Blood Alliance Donor Studies Working Group on their numbers of donations, tattoo and piercing deferrals, and return rates in the year 2017. Results: Eight blood centres participated. Overall, deferral rates were lower for repeat donors compared to new donors. Repeat donors were more likely to return than new donors. Women and young donors were more often deferred than male and older donors. Men were more demotivated by tattoo or piercing deferral, resulting in lower return rates compared to women. Return rates differed greatly between blood centres. Conclusion: Tattoo and piercing deferrals lead to missed donations and result in lower return rates. However, the numbers vary largely internationally, probably due to cultural and policy differences. Shortening deferral periods after tattooing or piercing may reduce the impact on donor availability, which should be investigated in single-centre studies.

It has been proposed that blood donation could be protective against cardiovascular disease. The aim of this study is to systematically summarize and evaluate existing observational and experimental studies on effects of blood donation on cardiovascular risk and disease in donor and general populations. The electronic databases PubMed and EMBASE were searched until March 2019 for experimental and observational studies on blood donation and cardiovascular risk or disease. Excluded were studies performed in patient populations or with controls compared to a patient population, and studies performed in individuals aged 70. All identified studies were independently screened for eligibility and quality using validated scoring systems by 2 reviewers. A total of 44 studies met all criteria. We included 41 observational studies and 3 experimental studies. 14 studies had a quality assessment score of 7 or higher. Of those, a majority of 9 studies reported a protective effect of blood donation, while 5 studies found no effects on cardiovascular risk factors. Results on other various outcomes were inconsistent and study quality was generally poor. Whether or not blood donation protects against cardiovascular disease remains unclear. Studies showing beneficial effects may have inadequately dealt with the healthy donor effect. High quality studies are lacking and therefore definite conclusions cannot be drawn. Large RCTs or cohort studies of high quality with sufficient follow-up should be conducted to provide evidence on the possible association between blood donation and cardiovascular disease.

Background and Objectives: Donor eligibility questions and criteria for medical conditions vary between blood centres, suggesting that they are based more on local regulations or experience, rather than on published data, which are limited. As the donor population ages, medical conditions become more common. We assessed donor health assessment criteria at blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Our aim was to compare eligibility criteria and determine their underlying basis. Materials and Methods: A REDCap survey was sent to blood centre participants, based on medical conditions of greatest interest suggested by the Donor Studies Team of the BEST Collaborative. Participants were asked about current donor health assessment questions, deferral criteria and the basis for their deferral policy (donor risk, recipient risk or both) for 20 medical conditions. Results: Complete responses were received from 26 blood donor centres (24 separate responses) representing a combination of hospital-based centres, large regional centres and community/national blood centres in 14 different countries. Most centres specifically ask about heart and lung conditions, whereas fewer than half inquire about kidney, gastrointestinal or neurological conditions. North American blood centres tended to be less restrictive, while regulatory restrictions are more prevalent in Europe. Most participants felt that the criteria were based on regulatory requirements or experience, rather than on published data. Conclusion: There is considerable variability in criteria by region. Ideally, criteria would be more evidence-based rather than based on regulatory requirements or experience. Deferral criteria must balance donor and recipient safety and maintain an adequate blood supply.

ImportanceBlood donors are at increased risk for iron deficiency. Current hemoglobin (Hb) monitoring policies are inadequate and new iron management strategies are warranted.ObjectiveTo determine the effects of ferritin-guided donation intervals for whole blood donors on Hb and ferritin levels, Hb deferral, iron deficiency (ferritin < 15 ng/mL) prevalence, donor return, and iron deficiency-related symptoms.DesignBetween November 2017 and November 2019 a ferritin-guided donation interval policy was gradually implemented nationwide and evaluated through a stepped-wedge cluster-randomized controlled trial.SettingAll blood collection centers in the Netherlands.Participants412,888 whole blood donors were included.InterventionsFerritin was measured in all new donors and at every 5thwhole blood donation. Subsequent donation intervals were extended to six months if ferritin is 15 ≤ 30 ng/mL and to twelve months if ferritin is Main outcomes and MeasuresThe primary outcomes are ferritin and Hb levels, iron deficiency, Hb deferral, and donor return. Secondary outcomes are self-reported iron deficiency-related symptoms.ResultsWe measured 36,099 donors, median age 43 years and 52% female, making 37,621 donations during the study period. Ferritin-guided donation intervals increased log-transformed ferritin levels at all time points in the trial, up to 0.56 log-transformed ng/mL as compared to baseline (95% CI0.49 – 0.63, p 95% CI0.32 – 0.45, p 95% CI8 – 22, p 95% CI6 – 47, p 95% CI48 – 66, p Conclusion and RelevanceFerritin-guided donation intervals significantly increased overall Hb and ferritin levels, thereby decreasing the prevalence of iron deficiency and Hb deferrals in whole blood donors. Ferritin-guided donation intervals seem beneficial for Hb levels and iron maintenance, but additional efforts are required to retain donors and to remedy self-reported iron deficiency-related symptoms.Trial RegistrationThis trial has been registered in the Dutch trial registry (NTR6738) on September 29th,, 2017 (https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6738).

Background: Blood donation is associated with a loss of hemoglobin (Hb)-bound iron. Hb levels recover relatively fast by using stored iron. However, it takes more time to replenish iron stores, potentially resulting in iron deficiency. Study design: Hb and ferritin levels were measured in 5056 new, first-time, and repeat whole blood donors. We investigated whether increasing numbers of donations are associated with lower ferritin levels. Furthermore, we tested whether low ferritin levels are associated with low-Hb deferral at the subsequent donation attempt by performing logistic regression adjusted for age and stratified by sex. Results: Whereas mean Hb levels are relatively stable, ferritin levels significantly decrease with increasing numbers of donations and were approximately 50% lower for donors with >50 donations compared with those with 2–10 donations. Despite the poor correlation of ferritin and Hb levels, cross-sectional, iron-deficient donors (ferritin

While donating blood during the COVID-19 pandemic offers individuals a possibility to contribute to their community, donation also exposes donors to additional risks, as physical distancing is impossible during a donation. This study explored what motivated blood and plasma donors in the Netherlands to donate during the COVID-19 pandemic, in order to identify potential focus points for donor recruitment in future crises. In total, 3175 of the invited 7286 donors who donated between 1 and 14 April 2020 participated in an online questionnaire including questions about motivations for blood donation. Motivations for blood donation were compared among donation types, sexes, age groups, and regions. Respondents consisted of 10.6% new, 18.9% whole blood, and 70.5% plasma donors. About 80% of all donors indicated wanting to help COVID-19 patients. Particularly whole blood donors were motivated by a call for donations (90.8%). Plasma donors more often hoped to get tested for SARS-CoV-2 antibodies than new and whole blood donors. Older donors (aged ≥40) more often reported hoping to get tested for SARS-CoV-2 antibodies, wanting to help COVID-19 patients, and thinking that getting infected during the donation process was impossible. Younger donors (aged ≤39) more often indicated that getting out of the house and not having to go to work motivated them to donate. Donors mainly had pro-social motivations to donate during the COVID-19 pandemic, as helping COVID-19 patients was the most important motivator. This shows the promise of explicitly expressing need in times of crisis, for blood banks in particular and philanthropic organizations in general.

Background: Severe blood donor adverse events are rare, but due to their rarity studying them can be difficult. To get an accurate estimate of their frequency and rate in the donor population it may be necessary to combine donation data across countries. Study Design and Methods: International blood collection organizations (BCOs) provided data on rare/severe donor reactions as well as denominator information for their donor populations from 2015 to 2017. Donor reactions were classified using standardized definitions. Results: BCOs from six countries provided reaction data for more than 22 million donations. A total of 480 rare reactions were reported of which 76.7% were imputed as definite and 11% probable. Rates of rare reactions were higher in females and first-time donors. Systemic rare reactions were the most common reaction type, accounting for over three quarters of reactions reported. Of systemic reactions, vasovagal reactions with loss of consciousness and injury or off-site (n = 350) made up the majority and occurred 1.53 per 100,000 donations. For the 22.3% that were localized reactions, the majority of these were cellulitis (n = 71, 0.31 per 100,000 donations) followed by deep venous thrombosis (n = 21, 0.09 per 100,000 donations). Conclusion: Pulling together data from multiple BCOs across countries allows for a better understanding of rare reactions, such as vasovagal reaction with injury or cellulitis, and for generating a reliable incidence rate for air embolism or compartment syndrome. However, gaps remain due to missing elements such as unknown donor status or location of reaction.

BACKGROUND: Traditionally, during crises the number of new blood donors increases. However, the current coronavirus disease 2019 (COVID-19) pandemic created additional barriers to donate due to governmental prevention measures and increased personal health risks. In this report, we examined how the pandemic affected new donor registrations in the Netherlands, especially among groups with higher risk profiles for severe COVID-19. Additionally, we explored the role of media for blood donation and new donor registrations.STUDY DESIGN AND METHODS: We analyzed new donor registrations and attention for blood donation in newspapers and on social media from January until May 2020, in comparison to the same period in 2017 to 2019.RESULTS: After the introduction of nationwide prevention measures, several peaks in new donor registrations occurred, which coincided with peaks in media attention. Interestingly, people with a higher risk profile for COVID-19 (e.g., due to age or region of residence) were overrepresented among new registrants.DISCUSSION: In sum, the first peak of the current pandemic has led to increased new blood donor registrations, despite the associated increased health risks. Time and future studies will have to tell whether these new donors are one-off 'pandemic' donors or if they will become regular, loyal donors.

BackgroundWhole blood donors lose approximately 200-250 mg of iron per donation. Depending on post-donation erythropoiesis, available iron stores, and iron absorption rates, optimal donation intervals may differ between donors. This project aims to define subpopulations of donors with different ferritin trajectories over repeated donations.MethodsFerritin levels of 300 new whole blood donors were measured from stored (lookback) samples from each donation over a two-year period in an observational cohort study. Latent classes of ferritin level trajectories were investigated using growth mixture models for male and female donors, separately. Associations of ferritin levels with subsequent iron deficiency and/or low haemoglobin were assessed with generalized linear mixed models.ResultsIn both genders two groups of donors were identified using group-based trajectory modelling. Ferritin levels showed rather linear reductions among 42.9% of male donors and 87.7% of female donors. For the remaining groups of donors, steeper declines in ferritin levels were observed. Ferritin levels at baseline and the end of follow-up varied greatly between groups.ConclusionRepeated ferritin measurements show depleting iron stores in all new whole blood donors, the level at which mainly depends on baseline ferritin levels. Tailored, less intensive donation strategies might help to prevent low iron in donors, and could be supported with ferritin monitoring and/or iron supplementation.

Background Whole blood donors may experience post-donation symptoms such as fatigue, dizziness, or headache after blood donation, which could influence donor retention. We aimed to examine post-donation symptoms during 1 week after whole blood donation, investigate donor characteristics associated with symptoms, and evaluate associations between symptoms and donor return. Methods During 1 week, whole blood donors who donated successfully at one of the collection centers in The Netherlands were invited to participate. Three thousand seventy six donors filled in a diary, assessing post-donation symptoms during days 1 to 6 after donation. We used linear mixed models analyses to determine the change in post-donation symptoms after donation for male and female donors separately. Furthermore, we investigated associations between post-donation symptoms and donors' physical characteristics using multivariable regression and determined associations between symptoms and donor return. Results Donors reported fatigue as the most common symptom, with approximately 3% of donors experiencing severe problems at the first day after donation. Multiple symptoms improved significantly up to day 3 after whole blood donation. Age, BMI, blood pressure (male donors), and blood volume (female donors) were significantly associated with post-donation symptoms. Donors with less fatigue after whole blood donation were more likely to return for their next donation within 31 days after receiving an invitation. Conclusion Post-symptoms improve up to 3 days after whole blood donation. Our results may help blood collection centers to identify donors more prone to post-donation symptoms and provide personalized information about the presence and course of post-donation symptoms, possibly increasing donor return rates.

Whole blood donors, especially frequently donating donors, have a risk of iron deficiency and low hemoglobin levels, which may affect their health and eligibility to donate. Lifestyle behaviors, such as dietary iron intake and physical activity, may influence iron stores and thereby hemoglobin levels. We aimed to investigate whether dietary iron intake and questionnaire-based moderate-to-vigorous physical activity were associated with hemoglobin levels, and whether ferritin levels mediated these associations. In Donor InSight-III, a Dutch cohort study of blood and plasma donors, data on heme and non-heme iron intake (mg/day), moderate-to-vigorous physical activity (10 minutes/day), hemoglobin levels (mmol/L) and ferritin levels (μg/L) were available in 2,323 donors (1,074 male). Donors with higher heme iron intakes (regression coefficients (β) in men and women: 0.160 and 0.065 mmol/L higher hemoglobin per 1 mg of heme iron, respectively) and lower non-heme iron intakes (β: -0.014 and -0.017, respectively) had higher hemoglobin levels, adjusted for relevant confounders. Ferritin levels mediated these associations (indirect effect (95% confidence interval) in men and women respectively: 0.074 (0.045; 0.111) and 0.061 (0.030; 0.096) for heme and -0.003 (-0.008;0.001) and -0.008 (-0.013;-0.003) for non-heme). Moderate-to-vigorous physical activity was negatively associated with hemoglobin levels in men only (β: -0.005), but not mediated by ferritin levels. In conclusion, higher heme and lower non-heme iron intake were associated with higher hemoglobin levels in donors, via higher ferritin levels. This indicates that donors with high heme iron intake may be more capable of maintaining iron stores to recover hemoglobin levels after blood donation.

BACKGROUND: This study examined the impact of age and sex of first-time donors who had not experienced an adverse event or deferral on their likelihood of and time to return. STUDY DESIGN AND METHODS: On behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative, international blood collection agencies (BCAs) were invited to provide data on first-time whole blood donors in 2014, including initial presentation date, collection site type, age, sex, blood type, return to donate within 24 months (yes/no), and subsequent presentation date. RESULTS: Eight BCAs contributed 706,789 records. The overall odds of returning to donate were slightly lower in female versus male donors, and the overall age trend was U-shaped with younger and older donors having higher odds for returning relative to middle-aged donors. However, variations by BCA were observed. Specifically, in three BCAs, women had higher odds of returning to donate than men. Further, while across seven BCAs the smallest cohort of older first-time donors returned at a higher rate and returned more quickly than middle-aged first-time donors, the behavior of younger donors varied substantially between BCAs. CONCLUSION: While older first-time donors are more likely to return and return more quickly than middle-aged donors they make up only a small proportion of first-time donors, whereas the larger group of younger donors exhibits less clear patterns of return compared to middle-aged donors. Further research is needed to determine whether targeting the recruitment of older donors or bolstering retention of middle-aged donors would be most effective in maintaining the blood supply.

Background and Objectives: Serum ferritin levels are increasingly being used to assess iron stores. Considerable variation in ferritin levels within and between individuals has been observed, but our current understanding of factors that explain this variation is far from complete. We aim to combine multiple potential determinants in an integrative model, and investigate their relative importance and potential interactions. Methods: We use ferritin measurements collected by Sanquin Blood Bank on both prospective (N = 59 596) and active blood donors (N = 78 318) to fit a structural equation model with three latent constructs (individual characteristics, donation history, and environmental factors). Parameters were estimated separately by sex and donor status. Results: The model explained 25% of ferritin variance in prospective donors, and 40% in active donors. Individual characteristics and donation history were the most important determinants of ferritin levels in active donors. The association between environmental factors and ferritin was smaller but still substantial; higher exposure to air pollution was associated with higher ferritin levels, and this association was considerably stronger for active blood donors than for prospective donors. Discussion: In active donors, individual characteristics explain 20% (17%) of ferritin variation, donation history explains 14% (25%) and environmental factors explain 5% (4%) for women (men). Our model presents known ferritin determinants in a broader perspective, allowing for comparison with other determinants as well as between new and active donors, or between men and women.

BackgroundFrequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation.MethodsTwelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire.Ethics and disseminationThis study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels.Trial registration numberNL8590; The Dutch trial registry.

Background and Objectives: Efficiency in mitigating HIV transmission risk by transfusion may vary internationally. We compared HIV prevalence and incidence in blood donors across different jurisdictions in relation to those rates in the general population and differences in deferral practices. Materials and Methods: Data from 2007 to 2016 were collected in Australia, Brazil (São Paulo), Canada, England, France, Italy, Ireland, Japan, the Netherlands, New Zealand, Norway, Spain (Basque Country), USA (Vitalant) and Wales. For each country/region, the number of HIV antibody-positive donations and nucleic acid testing (NAT)-only-positive donations was broken down according to first-time or repeat donor status, along with the relevant denominators. Results: There is a modest correlation between HIV prevalence among first-time donors and HIV prevalence in the general population. However, rates of HIV-positive donations in repeat donors, a proxy for incidence, do not correlate with incidence rates in the general population. Rates in donors from Italy and Basque Country, where deferral criteria for men having sex with men are less stringent, are higher compared with most other jurisdictions. Rates of NAT-only-positive donations are extremely low and do not differ significantly after adjustment for multiple comparisons. Conclusion: Donor HIV rates are only weakly associated with those observed in the general population. Countries with less stringent deferral criteria have higher HIV rates in their donor population, but the rates remain very low.

Background: Many blood collection agencies are generating important data on donor health outcomes using large-scale blood donor cohort studies. Such studies can be very effective when donors provide access to linkage of their data to external health databases, and storage and genomic testing of their blood sample. In this study, we aimed to assess the willingness of Australian blood donors to provide additional data and blood sample for donation-related and other health research. Study design and methods: We invited 2017 donors to complete a survey using four methods (postal letter, postal letter and email, email only, and in-center recruitment). The survey asked for information on demographics, lifestyle behaviors, health, experience and attitude to blood donation, and willingness to give blood sample and additional data for research. Results: Response rates ranged from 23.8% for email only to 77.2% for in-center recruitment. Of those who responded (n = 827), 95.5% indicated they would be willing to provide a blood sample for donation and transfusion-related research. Of these, >90.0% were willing for their sample to be used in research involving genetic testing and other health-related topics. Also, >90.0% were willing to consent for linkage of their information to external health databases. Conclusions: Donors surveyed reported a high willingness to participate in health research by completing surveys, allowing linkage to external datasets, and providing a blood sample. These findings provide strong support for future longitudinal research studies with Australian blood donors.

BACKGROUND AND OBJECTIVES: A donor health questionnaire (DHQ) aims to ensure the safety of donors and recipients of transfusions or transplantations with blood components, plasma-derived medicinal products, tissues, haematopoietic stem cells and medically assisted reproduction (in short substances of human origin; SoHO). Currently, many different DHQs exist across countries and SoHO. TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors) developed and validated a standardized DHQ to use across countries and SoHO. We tested whether participants understand the questions and provide honest answers.METHODS: For the validation of the standardized DHQ, two demographically representative online surveys were conducted in Germany (N = 3329) and Austria (N = 3432). We surveyed whether participants understood each DHQ question and would answer the questions truthfully. We used experimental settings to test whether there is a difference between mode of administration (print vs. online), the order of the questions (subject vs. chronological order), and the positioning of the general state of health question (beginning vs. end) in the DHQ. Using regression models, we tested the DHQ's impact on participant mood after completion and on socially desirable response behaviour.RESULTS: Participants understood the DHQ questions well and would answer them honestly. Nevertheless, the data show different levels of understanding and honesty when responding. Administration mode was the only characteristic that had a significant influence on mood, with the online version resulting in a more favourable mood in comparison to the printed version.CONCLUSION: The DHQ was well understood and had a low dishonest tendency. Our findings can serve as an impulse for further research on DHQ criteria across other SoHO and countries.

BACKGROUND: Whole blood donors are screened for iron depletion through hemoglobin measurement alone or in combination with ferritin. Ferritin measurement gives the advantage of earlier detection of iron depletion. In a previous study we identified a ferritin level of 30 mu g/L or less as a possible indicator of suboptimal erythropoiesis. In this study, erythropoietic parameters were measured to determine if a ferritin level of 30 mu g/L or less is indicative of iron-deficient erythropoiesis in repeat whole blood donors.STUDY DESIGN AND METHODS: Twenty-one healthy male repeat whole blood donors were divided into two groups according to their predonation ferritin values: 30 mu g/L or less (low-ferritin group) and greater than 30 mu g/L (normal-ferritin group). Ferritin and erythropoietic parameters were measured before whole blood donation and weekly in the 8 weeks after donation.RESULTS: A significantly lower value was found for hemoglobin, mean corpuscular volume (MCV), reticulocytes, and reticulocyte hemoglobin content on at least three of the nine time points in the low-ferritin group compared to the normal-ferritin group (p CONCLUSION: Based on the lower values of the erythropoietic parameters in the low-ferritin group, it can be concluded that repeat whole blood donors with a ferritin value of 30 mu g/L or less have iron-deficient erythropoiesis and therefore require a longer donation interval than the current 56 days.

Awareness of infection with SARS-CoV-2 is crucial for the effectiveness of COVID-19 control measures. Here, we investigate awareness of infection and symptoms in relation to antibodies against SARS-CoV-2 in healthy plasma donors. We ask individuals donating plasma across the Netherlands between May 11th and 18th 2020 to report COVID-19 related symptoms and we test for antibodies indicative of a past infection with SARS-CoV-2. Among 3,676 with antibody and questionnaire data 239 (6.5%) are positive for SARS-CoV-2 antibodies. Of those, 48% suspect no COVID-19 despite the majority reporting symptoms. 11% of seropositive individuals report no, and 27% very mild symptoms at any time during the first peak of the epidemic. Anosmia/ageusia and fever are most strongly associated with seropositivity. Almost half of seropositive individuals do not suspect SARS-CoV-2 infection. Improved recognition of COVID-19 symptoms, in particular anosmia/ageusia and fever, is needed to reduce widespread SARS-CoV-2 transmission., Graphical Abstract, Van den Hurk et al. investigate awareness of SARS-CoV-2 infection and symptoms in relation to antibody status in healthy plasma donors. Forty-eight percent of seropositive individuals do not suspect SARS-CoV-2 infection, 11% are asymptomatic. Improved recognition of COVID-19 symptoms, in particular anosmia/ageusia and fever, is needed to reduce SARS-CoV-2 transmission.

BACKGROUND AND OBJECTIVE: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle.MATERIALS AND METHODS: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence.RESULTS: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process.CONCLUSIONS: While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

Background: As Western blood transfusion practices are changing, there is interest and need in anticipating the future demand of blood products and how a blood establishment can actively prepare for various long-term developments. This article provides an overview of how a scenario approach was used to prioritize key categories of drivers for the future demand of red blood cells and the organizational implications thereof for Sanquin, the Dutch national blood establishment. Study Design and Methods: Based on previously identified drivers from interviews and a literature review (Step 1), we conducted scenario sessions and a survey to rank a list of drivers (“themes”) with its related opportunities and threats (Step 2), to identify mitigating measures per theme through focus groups (Step 3). Results: In Step 2, 10 themes were found that were classified in terms of importance and uncertainty. These were plotted on a two-dimensional graph with an ellipse to indicate the interquartile ranges per theme. Experts rated the top three most important themes to be the blood supply organization, precision medicine, and red blood cell replacements. In Step 3, focus groups identified specific mitigating measures per theme. These measures had parallel ideas, such as the need for an innovative mentality, internal and external communication and collaboration, and building Sanquin's reputation and trust with the public. Conclusion: Having identified the most important themes with suggestions for mitigating measures, Sanquin can take steps to become adaptive and proactive. Other blood establishments may also use a scenario approach to create contextualized long-term strategies.

Background and objectives: Blood donors might develop iron deficiency as approximately 250 mg of iron is lost with every donation. Susceptibility to iron deficiency and low haemoglobin levels differs between individuals, which might be due to genetic variation. Therefore, the aim of this study was to investigate associations between single nucleotide polymorphisms (SNPs) and haemoglobin trajectories, haemoglobin levels and ferritin levels in blood donors. Materials and methods: In 2655 donors participating in the observational cohort study Donor InSight-III (2015–2017), haemoglobin and ferritin levels were measured in venous EDTA whole blood and plasma samples, respectively. Haemoglobin trajectories (stable/declining) were determined by fitting growth-mixture models on repeated pre-donation capillary haemoglobin measurements. Genotyping was done using the UK Biobank – version 2 Axiom Array. Single SNP analyses adopting an additive genetic model on imputed genetic variants were performed for haemoglobin trajectories, haemoglobin levels and ferritin levels. Conditional analyses identified independent SNPs. Results: Twelve, twenty and twenty-four independent SNPs were associated with haemoglobin trajectories, haemoglobin levels and ferritin levels respectively (P

Funder: Scottish Government; doi: https://doi.org/10.13039/100012095, Funder: Cancer Research UK (CRUK); doi: https://doi.org/10.13039/501100000289, Restless legs syndrome (RLS) is a common neurological sensorimotor disorder often described as an unpleasant sensation associated with an urge to move the legs. Here we report findings from a meta-analysis of genome-wide association studies of RLS including 480,982 Caucasians (cases = 10,257) and a follow up sample of 24,977 (cases = 6,651). We confirm 19 of the 20 previously reported RLS sequence variants at 19 loci and report three novel RLS associations; rs112716420-G (OR = 1.25, P = 1.5 × 10−18), rs10068599-T (OR = 1.09, P = 6.9 × 10−10) and rs10769894-A (OR = 0.90, P = 9.4 × 10−14). At four of the 22 RLS loci, cis-eQTL analysis indicates a causal impact on gene expression. Through polygenic risk score for RLS we extended prior epidemiological findings implicating obesity, smoking and high alcohol intake as risk factors for RLS. To improve our understanding, with the purpose of seeking better treatments, more genetics studies yielding deeper insights into the disease biology are needed.

Background Blood donors are at risk for reduced iron stores, because of which donor iron monitoring received increased attention in the last decade. Despite the importance for donor health, international consensus on an appropriate policy for iron monitoring is lacking. Therefore, we conduct a trial to evaluate to what extent ferritin-guided donation intervals are effective in increasing haemoglobin and ferritin levels, decreasing low-haemoglobin deferral, increasing donor return and improving the health of whole blood donors in the Netherlands. Methods Sanquin Blood Bank is implementing ferritin-guided donation intervals to prevent donors from increasing iron loss at repeated donations. Using a stepped wedge cluster randomised trial approach, the design involves a random crossover of 29 clusters of blood collection centres from the existing policy without ferritin measurements to a ferritin-guided donation interval policy. This new policy includes ferritin measurements for all new donors and at every 5th whole blood donation, extending donation intervals to 6 months if ferritin is 15–≤ 30 ng/mL and to 12 months if ferritin is Discussion This stepped wedge cluster randomised trial will provide insight into the effectiveness of ferritin-guided donation intervals in lowering iron deficiency, decreasing donor deferrals due to low haemoglobin and improving donor health. We will evaluate a policy that is implemented nationwide in a real-life setting. Our study is therefore not limited to a small experimental setting and the results will guide policymakers seeking an appropriate policy for iron monitoring. Trial registration The Dutch trial registry NTR6738. Registered on 29 September 2017. Retrospectively registered.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic challenges governments worldwide to balance appropriate virus control measures and their societal and economic consequences. These control measures include the identification, isolation and testing of potentially infected individuals. As this relies on an individual’s awareness of infection, we investigated the extent to which healthy adults suspected having had COVID-19, and how COVID-19 suspicion and symptoms relate to antibodies indicative of a past infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).Methods and findingsFor this cross-sectional study, individuals donating plasma anywhere in the Netherlands between May 11th and 18th were screened for total SARS-CoV-2 antibodies using ELISA and invited to participate in an online questionnaire about COVID-19-related symptoms and awareness. Antibody and questionnaire data were complete for 3,676 individuals, including 239 (6.5%) that tested positive for SARS-CoV-2 antibodies. Here, we show that a 38% of the individuals that tested positive for SARS-CoV-2 antibodies reported having had no or only very mild symptoms at any time during the peak of the epidemic. The loss of taste and/or smell in particular was significantly associated with seropositivity, independent of age and sex. Forty-eight percent of antibody-positive persons did not suspect having had COVID-19, in spite of most of them reporting symptoms.ConclusionsAwareness of infection was low among individuals that tested positive for SARS-CoV-2 antibodies, even at the peak of the epidemic. Improved awareness and recognition of COVID-19 symptoms and tracing of asymptomatic contacts is crucial to halting SARS-CoV-2 transmission.

BACKGROUND: Whole blood donors are at risk of becoming iron deficient. To monitor iron stores, Sanquin implemented a new deferral policy based on ferritin levels, in addition to the traditional hemoglobin measurements. METHODS: Ferritin levels are determined in every fifth donation, as well as in all first-time donors. Donors with ferritin levels

It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity ? Dickens On March 12th, the Dutch government announced its first measures to combat COVID-19 in the Netherlands through implementation of strict social distancing (e g closing of public venues and employees working from home) as part of maximum control measures, lasting until April 6th 1 For Sanquin, the national blood establishment solely responsible for the blood supply in the Netherlands, it was vital the organization continue to operate The leadership knew that as outbreaks may adversely impact blood supply and its related activities, steps would be needed to assess, plan, and respond appropriately in a time like this 2 Thus, the employees directly involved in the supply chain, from collection to distribution, remained hard at work

BACKGROUND: Blood donors with a relatively low haemoglobin (Hb) level at their previous donation attempt have an increased risk of Hb deferral at the subsequent donation attempt. The aim of this study was to investigate whether the interventions prolongation of donation interval and/or a dietary advice decrease the Hb deferral rate.METHODS: 11 897 whole blood donors with Hb levels from below to 0·2 mmol/l above the cut-off level for donation received either no intervention, a prolongation of the donation interval to six or twelve months, a dietary advice, or both. Deferral rates for low Hb levels at the subsequent donation attempt were compared in the different intervention groups. Additionally, the effects of the interventions on Hb deferral risk and donor return for a subsequent donation attempt were analysed using generalized estimating equations.RESULTS: The Hb deferral rate was substantially lower in the group that received a prolongation of the donation interval to six months than in the Control Group (12·9% vs. 6·3% in men and 20·4% vs. 13·4% in women). However, the additional benefit of twelve over 6-month interval prolongation was small, and no benefit of a dietary advice showed up. On the other hand, receiving a dietary advice increased the likelihood of donor return for a subsequent donation attempt.CONCLUSION: Implementation of a protocol for the prolongation of donation intervals to six months for donors with Hb levels from below to slightly above the cut-off level for donation may reduce the deferral rate for low Hb levels while keeping donor lapse at a minimum.

BACKGROUND: Determination of blood donor hemoglobin (Hb) levels is a pre-requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low-Hb deferral rates. METHODS: An online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative-binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut-offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post-versus pre-donation Hb measurement and geographical location (Asian vs. rest), with low-Hb deferral rates. RESULTS: Data were included from 38 blood services. Low-Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33-0.84) and men (RR 0.53, 95%CI 0.31-0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23-0.94). Finally, being located in Asia was associated with higher low-Hb deferral rates; RR 9.10 (95%CI 3.89-21.27) for women and 6.76 (95%CI 2.45-18.68) for men. CONCLUSION: Differences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low-Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care.

Objective: To investigate the added value of questionnaire-based predictors to existing prediction models for low haemoglobin (Hb) deferral in whole blood donors. Background: Prediction models for Hb deferral risk can be applied in the invitation process of donors for a blood donation. Existing prediction models are based on routinely collected data. The model performance might be improved by the addition of predictive factors. Methods: The added value of food consumption, smoking, physical activity, ethnicity and menstruation in the prediction of Hb deferral was assessed by comparing the existing models with extended models using the following measures: model X2, concordance (c)-statistic and net reclassification improvement (NRI). Results: Addition of one candidate predictor to the models did not substantially improve the model performance. Addition of multiple new candidate predictors significantly increased the model X2 (from 137 to 159 for men, and from 157 to 199 for women) and resulted in a non-significant increase of the c-statistic (from 0.85 to 0.87 for men, and from 0.78 to 0.81 for women). The NRI for men was 11.4% and for women 1.5% after addition of multiple predictors. Conclusion: Addition of lifestyle behaviours, ethnicity or menstruation to prediction models for low Hb deferral in whole blood donors improved the model performance, but not substantially. For easy use in practice, we do not recommend addition of the investigated predictors to the prediction models.

Each year, blood transfusions save millions of lives. However, under current blood-matching practices, sensitization to non–self-antigens is an unavoidable adverse side effect of transfusion. We describe a universal donor typing platform that could be adopted by blood services worldwide to facilitate a universal extended blood-matching policy and reduce sensitization rates. This DNA-based test is capable of simultaneously typing most clinically relevant red blood cell (RBC), human platelet (HPA), and human leukocyte (HLA) antigens. Validation was performed, using samples from 7927 European, 27 South Asian, 21 East Asian, and 9 African blood donors enrolled in 2 national biobanks. We illustrated the usefulness of the platform by analyzing antibody data from patients sensitized with multiple RBC alloantibodies. Genotyping results demonstrated concordance of 99.91%, 99.97%, and 99.03% with RBC, HPA, and HLA clinically validated typing results in 89 371, 3016, and 9289 comparisons, respectively. Genotyping increased the total number of antigen typing results available from 110 980 to >1 200 000. Dense donor typing allowed identification of 2 to 6 times more compatible donors to serve 3146 patients with multiple RBC alloantibodies, providing at least 1 match for 176 individuals for whom previously no blood could be found among the same donors. This genotyping technology is already being used to type thousands of donors taking part in national genotyping studies. Extraction of dense antigen-typing data from these cohorts provides blood supply organizations with the opportunity to implement a policy of genomics-based precision matching of blood.

BACKGROUND: As blood transfusion has evolved, there is a need to understand its historical trends and underlying drivers. Furthermore, for blood bank management to make decisions about the future, they need to consider what transformational factors (defined as developments in science, society, and technology) could significantly impact blood demand and to what effect. This study has a two-fold aim: to explore transfusion experts' perspectives regarding 1) historical trends and drivers of red blood cells (RBCs) in the past 20 years and 2) transformational factors that would impact the future demand of RBCs and to what effect. STUDY DESIGN AND METHODS: Forty-two semi-structured interviews were held with transfusion experts from the Netherlands and abroad, supplemented with a literature review of Pubmed, Google Scholar, and gray literature. RESULTS: With regard to historical trends and drivers, experts shared two main trends: decreased or increased demands for RBCs. Various drivers were reported for each trend, coupled with evidence from literature. With regard to the future, experts anticipated that RBC demands will either increase (17%), decrease (45%), decrease but stabilize (12%), or stabilize as is (7%). Various transformational factors were found to support each trend (e.g., gene therapy will reduce RBC demand), although there were factors for which experts were unsure about its effects (e.g., cultured RBCs). Seven groups of transformation factors were identified in the literature review. CONCLUSION: While the future of blood transfusion is uncertain, there are actions that blood banks may take now to prepare for potential future developments.