The prevalence and incidence of TTIs among Dutch blood donors are six- to 60-fold lower than in the general Dutch population, illustrating the effectiveness of donor selection procedures. However, at least a quarter of infected donors appeared noncompliant to the donor health questionnaire (DHQ), suggesting that DHQs, or the way donor questioning is implemented, can be improved.
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 <15 ng/mL (WHO threshold) are deferred for 12 months; those ≥15 and ≤30 ng/mL for 6 months. The first results were analyzed and are presented here.
RESULTS
The results show that 25% of women (N = 20151, 95% CI 24%‐25%) and 1.6% of men (N = 10391, 95% CI 1.4%‐1.8%) have ferritin levels ≤30 ng/mL at their first blood center visit. For repeat (non‐first‐time) donors, these proportions are higher: 53% of women (N = 28329, 95% CI 52%‐54%) and 42% of men (N = 31089, 95% CI 41%‐43%). After a 6‐month deferral, in 88% of returning women (N = 3059, 95% CI 87%‐89%) and 99% of returning men (N = 3736, 95% CI 98%‐99%) ferritin levels were ≥15 ng/mL. After a 12‐month deferral, in 74% of returning women (N = 486, 95% CI 70%‐78%) and 95% of returning men (N = 479, 95% CI 94%‐97%) ferritin levels increased to ≥15 ng/mL.
CONCLUSION
Deferral of donors whose pre‐donation ferritin levels were ≤30 ng/mL might prevent donors from returning with ferritin levels <15 ng/mL. This policy is promising to mitigate effects of repeated donations on iron stores.
The model can be used to quantify EID outbreak risks to blood transfusion recipients and the effect of targeted safety interventions and as such support public health decision-making.
Despite an aging population, RBC demand may not increase as much as predicted in other studies. This depends on the extent to which other effects, like that of optimal blood use, will neutralize the effects of aging of the transfusion recipient population. Still, the observed downward trend in donor recruitment in the Netherlands must be stopped to maintain a sufficient RBC supply.
Inhibitory antibodies to exogenous FVIII/FIX are a major complication of haemophilia treatment. Up to 30% of previously untreated patients (PUPs) with severe haemophilia A develop inhibitors, most likely during the initial 50 exposure days to concentrate. In addition to classical cohort studies, a European monitoring system (EUHASS) has been set up to evaluate inhibitor development in PUPs. The present study addresses the reliability of estimating the cumulative incidence of inhibitor development in this registry. Data from the retrospective CANAL cohort study, including 288 PUPs with severe haemophilia A and complete treatment records until the 50th exposure to FVIII, were used to simulate the consequences of several cross-sectional sampling techniques on the estimated incidence of inhibitors. Both mathematical calculus and computer modelling were applied to study the effects of sample size and the introduction of a new product. For existing concentrates, both longitudinal cohort study methods and the EUHASS method yielded similar estimates of the cumulative incidence of inhibitor cases over a 5-year time period: 27.9% (95% CI: 21-36) vs. 29.4% (22-38). For a newly introduced concentrate, a reliable estimate of inhibitor incidence with the EUHASS method could only be made after 3-4 years, even in large datasets. The results from EUHASS in inhibitor incidence in PUPs are expected to be valid. After introduction of a new concentrate, the inhibitor incidence on this concentrate can only be reliably determined after an observation period of several years.
The increasing attention to healthcare costs and treatment efficiency has led to an increasing demand for quantitative data concerning patient and treatment characteristics in haemophilia. However, most of these data are difficult to obtain. The aim of this study was to use expert judgement elicitation (EJE) to estimate currently unavailable key parameters for treatment models in severe haemophilia A. Using a formal expert elicitation procedure, 19 international experts provided information on (i) natural bleeding frequency according to age and onset of bleeding, (ii) treatment of bleeds, (iii) time needed to control bleeding after starting secondary prophylaxis, (iv) dose requirements for secondary prophylaxis according to onset of bleeding, and (v) life-expectancy. For each parameter experts provided their quantitative estimates (median, P10, P90), which were combined using a graphical method. In addition, information was obtained concerning key decision parameters of haemophilia treatment. There was most agreement between experts regarding bleeding frequencies for patients treated on demand with an average onset of joint bleeding (1.7 years): median 12 joint bleeds per year (95% confidence interval 0.9-36) for patients ≤ 18, and 11 (0.8-61) for adult patients. Less agreement was observed concerning estimated effective dose for secondary prophylaxis in adults: median 2000 IU every other day The majority (63%) of experts expected that a single minor joint bleed could cause irreversible damage, and would accept up to three minor joint bleeds or one trauma related joint bleed annually on prophylaxis. Expert judgement elicitation allowed structured capturing of quantitative expert estimates. It generated novel data to be used in computer modelling, clinical care, and trial design.
The resulting ICERs are very high, especially when compared to other health care interventions. Nevertheless, these screening tests are implemented in the Netherlands and elsewhere. Policy makers should reflect more explicit on the acceptability of costs and effects whenever additional blood screening tests are implemented.
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