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SUMMARY: With the development of several 'vein‐to‐vein' databases, which capture data on the entire donor–recipient continuum and link this data to health outcomes, there has been an increasing number of studies investigating the health effects of all aspects of the practice of transfusion medicine. The Scandinavian Donations and Transfusions (SCANDAT) database is one of several such databases, which includes all electronically available data on blood donors, donations and transfusions since the late 1960s in Sweden and the early 1980s in Denmark. The SCANDAT database has been used to characterise disease occurrence among blood donors and transfused patients, as well as to investigate possible health effects of blood donations, aspects of transfusion care and possible transfusion transmission of disease. Recent publications include studies on recipient mortality associated with the storage lesion, studies on the effects of donor demographics on patient mortality and health effects of frequent blood donation. Although this research approach is clearly very powerful, the appropriate analysis of such real‐world data is complex and requires close methodological attention. The purpose of this review is to present some of the research conducted within the SCANDAT collaboration. We hope more international collaboration may help improve our understanding of the important remaining questions about donor and recipient health. [ABSTRACT FROM AUTHOR]

Background: Both hepatitis B and C viruses were transmitted through blood transfusion before implementation of donor screening. The existence of additional, yet unknown transfusion transmittable agents causing liver disease could have important public health implications.Methods: Analyses were based on the Scandinavian Donations and Transfusions (SCANDAT2) database. Cox regression models were used to estimate the hazard ratio (HR) of developing chronic liver disease in recipients of blood from donors who later developed any chronic liver disease compared to recipients who received blood transfusion from healthy donors. We also studied whether the risk of liver disease was increased in patients who received units from 'high-risk' donors, defined as donors who had a higher than expected occurrence of liver disease amongst their previous recipients. All analyses were stratified before and after 1992 to account for the effect of screening for hepatitis C virus.Results: A total of 1 482 922 transfused patients were included in the analyses. Analyses showed evidence of transfusion transmission of liver diseases before, but not after the implementation of hepatitis C virus screening in 1992, with HRs for any liver disease of 1.38 [95% confidence interval (CI), 1.30-1.46] and 0.99 (95% CI, 0.91-1.07), before and after 1992, respectively. Similarly, blood components from 'high-risk' donors conferred increased risks before, but not after 1992.Conclusions: Our data provide no evidence for transfusion transmission of agents causing liver disease after the implementation of screening for hepatitis B and C, and suggest that if such transmission does occur, it is rare. [ABSTRACT FROM AUTHOR]

Background and Objectives An increasing number of investigations into different aspects of transfusion therapy are being conducted using data extracted from a wide range of electronic data sources. Results of such observational studies, however, have in some instances been conflicting, possibly as an effect of variable attention to methodological and statistical detail. In this review, we will introduce and discuss some recent examples of important methodological problems. Materials and Methods We reviewed the recent literature of observational studies of possible deleterious effects of aspects of transfusion therapy, including donor factors, donation factors and component factors. From this literature, we identified a number of potential methodological problems and assessed these using data from the Scandinavian donations and transfusions ( SCANDAT2) database. Results The main finding of our review relates to the importance of maintaining sufficient attention to epidemiological and statistical methods. The most important factor to consider is perhaps the number of transfusions which is often found to be an important confounding factor in this field. We also review recently applied methods for studying disease transmission through blood transfusion. Conclusion While observational research in the transfusion medicine field has great potential for improving transfusion safety, pitfalls are plentiful and easy to overlook. In this review, we have gone over some methodological issues that we feel are especially important to consider for researchers who are involved in this type of research. [ABSTRACT FROM AUTHOR]

Background and Objectives The consequences of ABO-compatible non-identical plasma for patient outcome have not been studied in randomized clinical trials or large cohort studies and use varies widely in the absence of evidence-based policies. We investigated if transfusion with compatible instead of identical plasma confers any short-term survival disadvantage on the recipients. Materials and Methods The cohort of all 86 082 Swedish patients who received their first plasma transfusion between 1990 and 2002 was followed for 14 days and the risk of death in patients exposed to compatible non-identical plasma compared to recipients of only identical plasma. Results After adjustment for potential confounding factors, there was an increased mortality associated with exposure to ABO-compatible non-identical plasma, with the excess risk mostly confined to those receiving 5 or more units (relative risk, 1·15; 95% confidence interval, 1·02–1·29). Stratification by blood group indicated higher risks in group O recipients, especially when the compatible plasma was from a group AB donor. Conclusions This study suggests that ABO-compatible non-identical plasma is less safe than identical plasma. Subanalyses by blood group suggest a role for circulating immune complexes. Our findings may have policy implications for improving transfusion safety. [ABSTRACT FROM AUTHOR]

Background and Objectives Even with appropriate donor deferrals and advanced screening tests, the risk of disease transmission through blood transfusion cannot be completely disregarded. Efficient monitoring of possible disease transmission between blood donors and recipients should be an important component of a comprehensive haemovigilance system. Materials and Methods We assembled the Scandinavian Donations and Transfusions (SCANDAT) database, with data on virtually all blood donors and recipients who have been registered at least once in any of the computerized local blood bank databases in Sweden and Denmark since the start of computerized registration in 1966. The records of these individuals, with their entire computerized donation and/or transfusion histories and all donor-component-recipient connections, were linked to nationwide population and health registers to attain essentially complete follow-up for up to 36 years regarding reproduction, hospital morbidity, cancer, and death. Results After data cleaning, the database contained 1 134 290 blood donors who contributed 15 091 280 records of donations and 1 311 079 recipients who received 11 693 844 transfusions. The data quality in the existing data sources was satisfactory. From the data obtained from local blood banks, 4·6%, 1·6%, and 6·4% of the person, donation, and transfusion records, respectively, had to be discarded after review of the legitimacy of recorded values, and comparisons with independent, external databases. Conclusion It is possible to use existing computerized data, collected in routine health care, in haemovigilance systems for monitoring long-term outcome and disease concordance in blood donors and transfusion recipients. [ABSTRACT FROM AUTHOR]

Objective: To investigate the risk of recurrent maternal red-cell transfusion in delivery., Design: Nationwide long-standing retrospective cohort study., Setting: Swedish medical birth register., Population: All registered births from 2000 to 2017 in Sweden., Methods: We included all women with between one and three consecutive registered births from 22 weeks of gestation onwards and all maternal red-cell transfusions in the peripartum period within the defined period of study. Information on gestational and non-gestational comorbidity was collected and we identified any female siblings. In our analyses we compared the risk of red-cell transfusion in delivery in relation to transfusion history and gestational and non-gestational comorbidity., Main Outcome Measures: Maternal peripartum red-cell transfusion, defined as a recorded transfusion in the period from 1 day before and 7 days after delivery., Results: We included 825 451 women with a total 1 419 909 deliveries, including 786 097 (55.4%) first, 511 398 (36.0%) second and 122 414 (8.6%) third deliveries. Of women with previous obestric transfusion, 8.7% were transfused in a second delivery, compared with 1.7% of women without transfusion or diagnosis of haemorrhage. A previous diagnosis of haemorrhage did not affect the odds ratio of transfusion recurrence. Among women who were transfused in their first two deliveries, 15.5% were transfused in third delivery, corresponding to an 11-fold increase, compared with non-transfused women (adjusted odds ratio aOR 11.5, 95% CI 7.9-16.6). Women with a sister transfused in delivery were at increased risk of transfusion in a second delivery (aOR 1.8, 95% CI 1.6-2.1)., Conclusions: Women with previous red-cell transfusion are at an increased risk of red-cell transfusion in a subsequent delivery, compared with women without a history of red-cell transfusion., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background The prognostic implications of temporal change of previously stable high-sensitivity cardiac troponin concentrations are unknown. We investigated the prognosis associated with temporal changes of stable high-sensitivity cardiac troponin T (hs-cTnT) concentrations. Methods and Results All patients presenting with cardiac symptoms and ≥2 hs-cTnT measurements at the time of their first visit to 7 different emergency departments in Sweden between December 9, 2009, and December 31, 2016, were identified (n=66 159). We included all patients with stable hs-cTnT but no acute coronary syndrome diagnosis who had ≥1 hs-cTnT measured also at a second visit >30 days from the first visit. Hazard ratios (HRs) with 95% CIs were calculated for all-cause mortality and cardiovascular events according to temporal change of hs-cTnT between the visits, using patients without myocardial injury (<15 ng/L) at the first visit and persistently stable hs-cTnT at the second visit as the reference. Altogether, 12 869 patients were included, of whom 5191 (40%) had myocardial injury (hs-cTnT ≥15 ng/L). During a median follow-up of 2.3 (interquartile range, 1.4-3.7) years, 3271 (25%) patients died. In patients with myocardial injury and a temporal increase in hs-cTnT, the adjusted all-cause and cardiovascular mortality was 4- and 5-fold elevated (HR, 4.21; 95% CI, 3.55-5.00; and HR, 5.08; 95% CI, 3.73-6.92), and the adjusted risk of heart failure hospitalization almost 3-fold (HR, 2.77; 95% CI, 2.26-3.39). Conclusions Temporal change of previously stable hs-cTnT is associated with the risk of death and cardiovascular outcomes, with highest risks observed in patients with myocardial injury and increasing hs-cTnT.

Tyrosine kinase inhibitors (TKIs) have profoundly improved the clinical outcome for patients with chronic myeloid leukemia (CML), but their overall survival is still subnormal and the treatment is associated with adverse events. In a large cohort-study, we assessed the morbidity in 1328 Swedish CML chronic phase patients diagnosed 2002-2017 and treated with TKIs, as compared to that in carefully matched control individuals. Several Swedish patient registers with near-complete nationwide coverage were utilized for data acquisition. Median follow-up was 6 (IQR, 3-10) years with a total follow-up of 8510 person-years for the full cohort. Among 670 analyzed disease categories, the patient cohort showed a significantly increased risk in 142 while, strikingly, no category was more common in controls. Increased incidence rate ratios/IRR (95% CI) for more severe events among patients included acute myocardial infarction (AMI) 2.0 (1.5-2.6), heart failure 2.6 (2.2-3.2), pneumonia 2.8 (2.3-3.5), and unspecified sepsis 3.5 (2.6-4.7). When comparing patients on 2nd generation TKIs vs. imatinib in a within-cohort analysis, nilotinib generated elevated IRRs for AMI (2.9; 1.5-5.6) and chronic ischemic heart disease (2.2; 1.2-3.9), dasatinib for pleural effusion (11.6; 7.6-17.7) and infectious complications, for example, acute upper respiratory infections (3.0; 1.4-6.0). Our extensive real-world data reveal significant risk increases of severe morbidity in TKI-treated CML patients, as compared to matched controls, particularly for 2nd generation TKIs. Whether this increased morbidity may also translate into increased mortality, thus preventing CML patients to achieve a normalized overall survival, needs to be further explored., (© 2022 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.)

Previous observational studies suggest associations between red blood cell (RBC) transfusion and risk for arterial or venous thrombosis. We determined the association between thrombosis and RBC transfusion in hospitalized patients using the Recipient Database from the National Heart Lung and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III. A thrombotic event was a hospitalization with an arterial or venous thrombosis ICD-9 code and administration of a therapeutic anticoagulant or antiplatelet agent. Patients with history of thrombosis or a thrombosis within 24 hours of admission were excluded. A proportional hazards regression model with time-dependent covariates was calculated. Estimates were adjusted for age, sex, hospital, smoking, medical comorbidities, and surgical procedures. Of 657 412 inpatient admissions, 67 176 (10.2%) received at least one RBC transfusion. Two percent (12927) of patients experienced a thrombosis. Of these, 2587 developed thrombosis after RBC transfusion. In unadjusted analyses, RBC transfusion was associated with an increased thrombosis risk [HR = 1.3 (95% CI 1.23-1.36)]. After adjustment for surgical procedures, age, sex, hospital, and comorbidities, no association between RBC transfusion on risk of venous and arterial thrombosis was found [HR 1.0 (95% CI: 0.96-1.05)]. Thus, RBC transfusion does not appear to be an important risk factor for thrombosis in most hospitalized patients., (© 2020 Wiley Periodicals LLC.)

Background: The purpose of this study was to investigate the association between weekday of surgery and survival following cardiac surgery., Methods and Results: In a nationwide cohort study, we included all patients who underwent cardiac surgery in 1999-2013 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. All-cause mortality until March 2014 was obtained from national registers. The association between weekday of surgery and mortality was estimated using Cox regression, and reported as hazard ratios with 95% CI. We used the restricted mean survival time difference to estimate loss of life related to weekday of surgery. Among 106 473 patients, 25 221 (24%), 24 471 (23%), 22 977 (22%), 20 189 (19%), 9251 (8.7%), and 4364 (4.1%) underwent surgery during a Monday, Tuesday, Wednesday, Thursday, Friday, and a Saturday/Sunday, respectively. More patients were operated on urgently during Friday to Sunday, and unadjusted analyses showed higher early and late mortality in those patients. The adjusted hazard ratios (95% CI) were 1.00 (0.89-1.13), 1.00 (0.88-1.12), 1.02 (0.90-1.16), 1.17 (1.01-1.37), and 1.05 (0.86-1.29) in patients who underwent surgery during a Tuesday, Wednesday, Thursday, Friday, and Saturday/Sunday compared to a Monday, after 1 year of follow-up conditional on 30-day survival. In elective surgery (n=46 146), the 1-year restricted mean survival time difference (95% CI) was -0.5 (-1.8-0.8), -0.5 (-1.9-0.8), -1.0 (-2.6-0.5), 0.02 (-2.2-2.3), and -1.2 (-6.3-3.9) days in patients who underwent surgery during a Tuesday, Wednesday, Thursday, Friday, and a Saturday/Sunday, respectively, compared to a Monday., Conclusions: We found no evidence of a clinically relevant weekday effect in patents who underwent cardiac surgery in Sweden during a 15-year period. These data suggest that the early risk and long-term prognosis following cardiac surgery was not affected by the weekday of surgery., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02276950., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)