Search

Introduction: Migraine is a prevalent neurological headache disorder. Due to challenges associated with finding effective treatment, many individuals with migraine feel compelled to explore alternative treatment strategies, such as blood donation, hypothesized to provide migraine relief. Methods: Through logistic, Poisson, and Cox regression methods, we examined the links between migraine and blood donation activities in two population cohorts: Danish blood donors in the Scandinavian Donations and Transfusions Database (SCANDAT‐DK, N >1 million) and the Danish Blood Donor Study (N ~ 100,000). Results: SCANDAT‐DK analyses showed no link between migraine and the propensity to become a blood donor among males (odds ratio [OR]Males = 0.95 [95% Confidence Interval: 0.86–1.04], and a reduced propensity among females ORFemales = 0.88 [0.83–0.93]). The incidence of migraine was not reduced upon blood donation (standardized incidence ratio [SIR]Males = 0.94 [0.83–1.06]; SIRFemales = 1.04 [0.99–1.10]). Donors with migraine demonstrated longer intervals between donations (hazard ratio [HR]Males = 0.87 [0.85–0.91], HRFemales = 0.80 [0.78–0.82]), and an increased risk of donor lapse (ORMales = 1.23 [1.14–1.32]; ORFemales = 1.28 [1.22–1.33]). Results were corroborated in DBDS using self‐reported migraine. Genetic predisposition to migraine associated with longer intervals in females (HRFemales = 0.98 [0.97–0.99]), but not in males. Discussion: Our findings do not support the hypothesis that blood donation serves as a viable treatment strategy among migraine patients. Future prospective investigations may help to elucidate the underlying biological mechanisms by which blood donation may influence migraine pathology. [ABSTRACT FROM AUTHOR]

Background and Objectives: Two years after implementing a new national donor vigilance system, the Danish Haemovigilance Committee conducted a nationwide survey to evaluate the implementation among different staff groups. We present the results here. Materials and Methods: The study was designed as an anonymous online survey to evaluate the satisfaction with the new registration, understanding of the parameters used and the user‐friendliness. The REDCap platform was used. The questionnaire consisted of 22 questions. Ordinal variables were answered using five‐point Likert scale (1 = strongly disagree to 5 = strongly agree). The data were analysed using descriptive statistics. Successful implementation was defined as mean overall satisfaction ≥4 and mean understanding of the individual components (adverse reaction category, severity and imputability) in the registration ≥4. Results: In all, 104 staff members (77.9% donation staff) participated. The mean (SD) overall satisfaction among all participants was 3.96 (0.94), highest among medical doctors (4.43 (0.78)) and lowest for administrative or other personnel (2.78 (1.09)). The mean scores for understanding the adverse reaction categories, severity and imputability were 3.92 (0.94), 3.92 (0.94) and 3.88 (1.00), respectively. Experience with a previous donor vigilance system was associated with lower scores. The most successful implementation programme included a medical doctor for introduction and a contact person. Conclusion: The goal for successful implementation was not met. However, the overall attitude towards the new registration was positive and indicates that the system is suitable for different staff groups. Our results suggest that implementation could benefit from special attention to administrative staff and those accustomed to another donor vigilance system. [ABSTRACT FROM AUTHOR]

Background and Objectives: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. Materials and Methods: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. Results: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. Conclusion: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background and objective: The European consortium project TRANSPOSE (TRANSfusion and transplantation: PrOtection and SElection of donors) aimed to assess and evaluate the risks to donors of Substances of Human Origin (SoHO), and to identify gaps between current donor vigilance systems and perceived risks. Materials and methods: National and local data from participating organizations on serious and non‐serious adverse reactions in donors were collected from 2014 to 2017. Following this, a survey was performed among participants to identify risks not included in the data sets. Finally, participants rated the risks according to severity, level of evidence and prevalence. Results: Significant discrepancies between anticipated donor risks and the collected data were found. Furthermore, many participants reported that national data on adverse reactions in donors of stem cells, gametes, embryos and tissues were not routinely collected and/or available. Conclusions: These findings indicate that there is a need to further develop and standardize donor vigilance in Europe and to include long‐term risks to donors, which are currently underreported, ensuring donor health and securing the future supply of SoHO. [ABSTRACT FROM AUTHOR]