Search

Introduction: Adalimumab is normally prescribed with methotrexate (MTX) in rheumatoid arthritis given the enhanced treatment effect and reduced antidrug antibody formation compared with adalimumab monotherapy (ADL). In psoriasis, the long-term treatment effects and pharmacokinetic profile have not been investigated extensively. Methods: We conducted a randomized controlled trial to assess the efficacy, safety, pharmacokinetics, and immunogenicity of adalimumab combined with MTX 10 mg per week (ADL-MTX group) compared with that of ADL (ADL group) in chronic plaque psoriasis. Results: A total of 31 patients in the ADL-MTX group and 30 in the ADL group were analyzed. After 1 year, a (nonsignificant) better drug survival was found in the ADL-MTX group (74.2 vs. 58.6%, P = 0.15). The PASI 75 response in week 49 was 58.1 versus 36.7% (P = 0.13), and the median (interquartile range) serum-trough concentrations were 6.8 (5.5‒9.2) versus 5.9 (3.5‒8.8) mg/l (P = 0.26) in the ADL-MTX group and ADL group, respectively. Fewer patients showed antidrug antibodies in the ADL-MTX group (22.6 vs. 60.0%, P < 0.01). No serious adverse events occurred. Conclusion: Combination therapy of adalimumab and MTX results in fewer patients showing antidrug antibodies, with a trend toward a better PASI 75 response, drug survival, and higher serum-trough concentrations than ADL. Patient-reported outcomes and adverse events were comparable between the groups.

BACKGROUND: Apheresis is increasingly being applied to collect cells or plasma, even allowing the collection of multiple blood components during one procedure. Although the quality of the cellular and plasma products that are obtained by apheresis have been extensively studied and shown to be of high quality, the impact of apheresis on the red blood cells (RBCs) that are returned to the donor has not been investigated. STUDY DESIGN AND METHODS: The effect of the plasma- or plateletpheresis procedures by four different devices—MCS+ (Haemonetics), PCS2 (Haemonetics), Trima Accel (Terumo BCT), and Autopheresis-C (Auto-C, Fresenius Kabi)—on the RBCs that are returned to the donor was tested in a blinded, prospective trial in a cohort of 25 donors. RESULTS: A rheologic analysis of donor RBCs before and after plasma- or plateletpheresis showed no differences in outcome. However, a strong increase in hemolysis was found in samples from the Trima Accel devices after plateletpheresis, compared to all other machines tested. Furthermore, an increase in complement deposition on RBCs was seen after all plasmapheresis procedures (MCS+, PCS2, and Auto-C). Finally, a significant decrease in the expression of the complement-regulating protein CD59 was seen in all postapheresis samples as well as a significant decrease of the adhesion molecule CD147. CONCLUSION: The increase in complement deposition and the decrease in the expression of CD59 suggests that RBC clearance might be enhanced after return to the donor. Possible side effects due to an increase in hemolysis after Trima Accel plateletpheresis should be further investigated.

Several countries have changed, or are reevaluating, their blood donor policies for men who have had sex with men (MSM). Changing policies has consequences for donor recruitment and the donor pool. In this study, we investigated whether MSM are eligible and willing to donate blood.Members of a research panel (n = 4422) in the Netherlands were invited to participate in an online survey. We asked questions about male-to-male sex and risk behavior that are also asked during the predonation screening of a blood donor. Furthermore, we asked questions about willingness to donate.The total response rate was 60% (n = 2654). Of MSM nondonors (n = 230), 32.2% would be eligible to donate under a 12-month deferral policy, according to their reported risk history and last male-to-male sex. In other scenarios, 42.6% (4-month deferral), 38.7% (6-month deferral), and 18.7% (5-year deferral) would be eligible to donate. When not taking their last male-to-male sex into account (n = 203), 47.8% of MSM reported a moderate or high willingness to donate.A 12-month deferral after last male-to-male sex is a commonly used criterion by blood services. Approximately one-third of the MSM in our study would be eligible to donate under this deferral policy. Higher proportions of MSM would be eligible to donate in shorter deferral scenarios. Almost half of MSM are willing to donate blood. Targeting MSM by donor recruitment campaigns could therefore prove fruitful.

Missing Minorities (MIMI) is a research project initiated by the European Blood Alliance that aims to develop new strategies to recruit blood donors from minority groups. This paper contributes to this larger project by analyzing data of the German Socio-Economic Panel study 2011 that questioned over 20,000 respondents about their blood donation behavior. Within this sample, the authors identify 1,726 potential blood donors from various migrant groups. Applying logistic regression analysis, the authors analyze differences between blood donors and non-donors with migration background. The results show that non-donors trust other people significantly less, use the internet less often, and have a significantly lower reading ability in German. Based on these findings, the authors discuss the current practices in minority blood donor recruitment as found in the MIMI project. Furthermore, promising recruitment tactics for blood donation managers and areas for further research are derived.

In this paper, we consider the analysis of unequally spaced longitudinal data using transition regression models with random effects. Diffusion as well as stabilization processes will be discussed, but our main focus will be on the latter. The initial conditions problem, which usually arises in transition models with random effects, is addressed. The usefulness of the proposed model is assessed on a large database of longitudinal haemoglobin values collected from blood donations by a Dutch private organization.

A too short recovery time after blood donation results in a gradual depletion of iron stores and a subsequent decline in hemoglobin (Hb) levels over time. This decline in Hb levels may depend on individual, unobserved characteristics of the donor.We used a data set of 5388 Dutch blood donors from the Donor InSight study. The statistical analysis is based on a Bayesian growth mixture model, which assumes that each donor belongs to one of several groups. Each group implies a different Hb trajectory, and donors with similar longitudinal trajectories belong to the same group. Analyses were performed for male and female donors separately.For both sexes the model identified four groups of donors. Stable Hb trajectories were found among 14% of male donors and 15% of female donors; declining Hb trajectories were observed in the remaining groups of donors. The percentage of donor deferrals differed strongly between groups.The model can be used to predict to which group a donor belongs, and this prediction can be updated after each donation. This is of high practical importance because early identification of donors with declining Hb levels could help to tailor donation intervals and to prevent iron deficiency and donor deferrals.

The cost-effectiveness of the donor health questionnaire (DHQ) as a tool to assess donor eligibility has not been quantified. This study focused on cost-effectiveness of the DHQ in preventing transfusion-transmitted infections (TTIs).Data on whole blood donor eligibility assessments in the Netherlands in 2008 to 2010 were analyzed. Based on test results and epidemiologic data on TTIs, the number of donor visits in their window phase was calculated. Subsequently, the incremental cost-effectiveness ratio (ICER) of the DHQ was calculated.The overall annual deferral rate in the study period was 9.6% (9.3%-10.0%). The annual deferral rate for TTI risk was 0.86% (0.82%-0.89%). Taking into account the number of self-deferrals, deferral rate for TTI risk in all donors was 1.90% (1.81%-2.02%). The calculated annual numbers of prevented cases of TTI were hepatitis B, 0.142; hepatitis C, 0.010; human immunodeficiency virus, 0.016; and syphilis, 0.135. The annual costs for TTI risk-related eligibility assessments, deferrals, and substitutions were €84,807 (€55,193-€123,811) for the blood establishment (BE) and €90,501 (€46,965-€159,571) for deferred donors. Annual savings were €991 (€276-€2325), while annual quality-adjusted life-years (QALYs) gained were 0.120 (0.059-0.226). Hence, the ICER for the DHQ on preventing TTIs was €696,744 (€315,422-€1,611,681) for BE costs only and €1,449,055 (€669,439-€3,145,961) including costs for deferred donors.The DHQ enhances self-selection and should not be abandoned. However, the DHQ is not a cost-effective tool for further reducing TTIs. The high costs per case prevented and the small number of QALYs gained argue against maintaining deferral policy through the DHQ at the current level.

Background To optimize the planning of blood donations but also to continue motivating the volunteers it is important to streamline the practical organization of the timing of donations. While donors are asked to return for donation after a suitable period, still a relevant proportion of blood donors is deferred from donation each year due to a too low hemoglobin level. Rejection of donation may demotivate the candidate donor and implies an inefficient planning of the donation process. Hence, it is important to predict the future hemoglobin level to improve the planning of donors’ visits to the blood bank. Methods The development of the hemoglobin prediction rule is based on longitudinal (panel) data from blood donations collected by Sanquin (the only blood product collecting and supplying organization in the Netherlands). We explored and contrasted two popular statistical models, i.e. the transition (autoregressive) model and the mixed effects model as plausible models to account for the dependence among subsequent hemoglobin levels within a donor. Results The predictors of the future hemoglobin level are age, season, hemoglobin levels at the previous visits, and a binary variable indicating whether a donation was made at the previous visit. Based on cross-validation, the areas under the receiver operating characteristic curve (AUCs) for male donors are 0.83 and 0.81 for the transition model and the mixed effects model, respectively; for female donors we obtained AUC values of 0.73 and 0.72 for the transition model and the mixed effects model, respectively. Conclusion We showed that the transition models and the mixed effects models provide a much better prediction compared to a multiple linear regression model. In general, the transition model provides a somewhat better prediction than the mixed effects model, especially at high visit numbers. In addition, the transition model offers a better trade-off between sensitivity and specificity when varying the cut-off values for eligibility in predicted values. Hence transition models make the prediction of hemoglobin level more precise and may lead to less deferral from donation in the future.

First-time donation is among recognised risk factors for vasovagal reactions to blood donation and reactions are known to reduce donor return. We assessed associations between potential risk factors and vasovagal reactions and needle-related complications in first-time whole blood donation in comparison to repeat donation and analysed the impact of complications on donor return.We performed a cohort study on whole blood donations in The Netherlands from 1/1/2010 to 31/12/2010 using data extracted from the blood service information system. Donation data up to 31/12/2011 were used to ascertain donor return.In 2010 28,786 donors made first whole blood donations and there were 522,958 repeat donations. Vasovagal reactions occurred in 3.9% of first donations by males and 3.5% of first donations by females compared to in 0.2% and 0.6%, respectively, of repeat donations. Associations of vasovagal reactions with other factors including age, body weight, systolic and diastolic blood pressure were similar in first-time and repeat donors. Needle-related complications occurred in 0.2% of male and 0.5% of female first-time donations and in 0.1% and 0.3%, respectively, of repeat donations. Among first-time donors, the return rate within 1 year was 82% following an uncomplicated first donation, but 55% and 61% following vasovagal reactions and needle-related complications, respectively; the corresponding percentages among repeat donors were 86%, 58% and 82%.Among first-time donors, females suffered less than males from vasovagal reactions. Other risk factors had similar associations among first-time and repeat donors. Vasovagal reactions and needle-related complications in both first-time and repeat donors are followed by reduced donor return.

This study investigates the effect of a vasovagal reaction (VVR) or needle reaction (NR) on the risk of stopping as a blood donor, taking into account variables from the Theory of Planned Behavior (TPB). Is stopping risk solely related to the adverse reaction itself, or do the TPB variables play a role as well? Emphasis is placed on possible sex differences.TPB variables were assessed within 12,051 whole blood donors. Also, donors reported the occurrence of adverse reactions during or after their last donation. Blood bank records were used to determine whether donors stopped donating within the next 2 years. Logistic regression analyses were performed to estimate the effect of self-reported adverse reactions on stopping risk, adjusting for the TPB variables. Analyses were performed separately for both sexes.Men have a lower odds of reporting a NR or a VVR than women (odds ratio [OR] 0.34, 95% confidence interval [CI], 0.28-0.43; and OR 0.26, 95% CI 0.19-0.36, for NR and VVR, respectively). For both sexes, only a VVR was associated with stopping risk, which is higher in men (men, OR 3.95, 95% CI 2.19-7.11; women, OR 1.78, 95% CI 1.35-2.35). After adjusting for the TPB variables both ORs declined (men, OR 3.38, 95% CI 1.86-6.15; women, OR 1.58, 95% CI 1.17-2.14). Also, self-efficacy and affective attitude are negatively associated with adverse reactions.Female donors report more VVRs than male donors, but male donors have a higher stopping risk after a VVR than female donors. Coping differences and possible reporting tendencies might play a role. For donor retention purposes, prevention and coping techniques should take sex differences into account.

Using constructs from the Theory of Planned Behavior and theories of altruism, this article explores how multiple motivations and beliefs for blood donation are clustered and change across the donor career. In so doing important distinctions, for blood donation, between impure altruism, pure altruism, and warm glow are explored.Measures of intentions, cognitive and affective attitudes, role merger, pure altruism, trust, self-efficacy, subjective and moral norms, and habit formation were assessed in a sample of 12,580 whole blood donors. Analyses showed that a distinction between first-time, novice (one to four donations), and experienced donors (five or more donations) is justified. Principal components analysis and confirmatory factor analytic Multiple-Indicator Multiple-Causal models were used to compare models across these groups.A cognition-behavior (CB) factor, including intentions, was common to all groups. First-time and novice donors were marked by a newly identified motivational factor: "reluctant altruism" (i.e., the motivation to donate because of a lack of trust in others). First-time donors exhibited an impure altruism factor whereas for experienced donors warm glow and pure altruism factors were observed. For first-time donors impure altruism and reluctant altruism were both associated with the CB factor in females and impure altruism only in males. For both sexes reluctant altruism was associated of the CB factor in novice donors and warm glow and pure altruism for experienced donors.New avenues for intervention are suggested by the emergence of reluctant altruism for novice donors and warm glow for experienced donors. The importance of distinguishing aspects of altruism is highlighted.

The shelf life of platelet concentrates (PCs) is a matter of days. Simultaneously, the demand is highly variable, shortages are not allowed, and producing too many results in outdating. Concurrently, younger PCs, implying an extended time till outdating (TTO), are preferred. Common PC inventory management relies on experience-based order-up-to rules. This study aimed at minimizing outdating and shortages, while extending the TTO through a theoretical approach. It focuses on PCs processed from whole blood donations.A combined approach of stochastic dynamic programming and simulation techniques (SDP/S), from the mathematical discipline operations research, has been implemented. This approach included the design of the dedicated software tool thrombocyte inventory management optimizer (TIMO). Based on the 2007 data, an optimal order-up-to rule was calculated. Outdating percentages and TTOs have been collected from August 2005 to July 2010. The resulting order-up-to rule has been applied and adjusted from summer 2007 onward.Over the study period, the results of the practical implementation showed significant improvements. The median weekly outdating percentage dropped to less than 1% and a gain in TTO of 0.48 day was reached. The results and the additional computer simulations brought confidence to the personnel to apply and adopt the "theoretical" approach and TIMO.Applying theory may help a blood bank to improve its PC inventory management and may help to identify to what extent practical limits can approach theoretical limits. The application of the theory has led to both a significant improvement and a more structured and less panic-driven PC inventory management.

This study investigates the influence of different variables from the theory of planned behavior (TPB) on intention within multiple donation categories, covering the entire range of lifetime number of donations (LND). Does the same set of variables predict intention equally strong throughout the donor career?Measures of intention, self-efficacy, cognitive and affective attitude, and subjective and moral norms were assessed within a sample of 11,480 whole blood donors. Donors were categorized into 65 donation classes using their LND; for example, all donors with one donation (n = 483) in the first donation class, all donors with two donations (n = 447) in the second donation class, and so on. For each donation class, separately for men and women, linear multiple regression models for intention were fitted using self-efficacy, cognitive attitude, affective attitude, subjective norm, and moral norm as predictor variables.During all stages of the donor career, self-efficacy is the main predictor of intention, with a relatively constant beta (β = 0.64, p0.001). Cognitive attitude (β = 0.1, p0.001) and moral norm (β = 0.10, p0.001) contributed marginally to the prediction. Several sex effects were observed; self-efficacy is a stronger predictor of intention in women, whereas subjective norm predicts intention in men only.Regardless of the number of lifetime donations, the same set of TPB variables, both in composition and in relative strength, predicts intention. A feeling of self-efficacy remains equally important for all donors. It is worthwhile to study whether directed intervention strategies are necessary to target self-efficacy within donor groups with different levels of donation experience.

Within blood establishments little comparative information is available about donors versus the general population. In this study, a description of the donor pool was made in terms of demographic factors and cardiovascular risk factors. The general Dutch population was used as a reference group.The Donor InSight study provided information on donors. Extensive information has been gathered by a self-administered questionnaire addressing various topics, like demographics, lifestyle, and health. Aggregated donor responses were compared with general population summary data.The study population consisted of 15,076 donors. The median age was 46.3 years and 47.3% were men. Donors were more likely to be highly educated (34.6%), married (71.7%), and of Dutch origin (97.4%), when compared to the general population. Donors were less often smokers (donors, 17.1%; general population, 31.8%), more often moderate drinkers (donors, 82.8%; general population, 74.7%), and physically more active (donors, 2.0 hr/week; general population, 1.0 hr/week). Male donors were more often moderately overweight (47.7%) than men from the general population (39.9%). In donors, 0.9% reported to have Type 2 diabetes versus 1.9% in the general population. In donors, 3.4% reported high cholesterol versus 4.6% in the general population.The study provided important knowledge about demographic distributions and cardiovascular risk factors within donors. A proper understanding of demographic characteristics of donors will help us to focus recruitment and retention strategies. The reported beneficial cardiovascular profile suggests a need for further research on the role of blood donation in cardiovascular risk reduction.

In eight greenhouses used for carnation culture, workers engaged in harvesting (n = 16), were monitored for dermal and respiratory exposure and urinary excretion of propoxur. Dermal exposure of hands and forearms was estimated from dislodgeable foliar residue, using a transfer factor (a measure of transfer of pesticides from leaves to the skin) and the total number of working hours. Total estimated dermal and respiratory exposure during harvesting ranged from 0.2 to 46 mg and from 3 to 278 μg, respectively. To study the relationship between external and internal exposure to propoxur, respiratory and dermal exposure levels were compared with the total amount of 2-isopropoxyphenol (IPP), the major metabolite of propoxur, excreted in urine in 24 hr. The Pearson correlation coefficient between dermal exposure and the total amount of excreted IPP was 0.95. A correlation coefficient of 0.84 was found between respiratory exposure and the amount of IPP excreted. The latter association was probably caused by the covariation of respiratory and dermal exposure levels (r = 0.85). Assuming negligible oral absorption, calculations indicated that dermal exposure could account for >80% of the amount of excreted IPP. On the basis of the amount of IPP excreted, there was no reason to suspect increased health risks for workers from exposure to propoxur during harvesting. © 1993 Wiley-Liss, Inc.