Search

Background: The Recipient Epidemiology and Donor Evaluation Study‐IV‐Pediatric (REDS‐IV‐P) is the fourth iteration of the National Heart, Lung, and Blood Institute's REDS program and includes a focus on pediatric populations. The REDS‐IV‐P Vein‐to‐Vein (V2V) database encompasses linked information from blood donors, blood components, and patients to facilitate studies in transfusion medicine. Study Design and Methods: The V2V database is an Observational Medical Outcomes Partnership Common Data Model database. The study period is April 1, 2019 through December 31, 2023. Data from all donors and donations at participating blood centers, all blood components derived from the donations, and all inpatient visits and selected outpatient visits at participating hospitals are included. The database captures all information within patient data domains not restricting data to a preselected subset of medical records. Results: The V2V database contains data from 7 blood centers and 22 hospitals. We project the database will have over 2 billion pieces of information from 1.3 million patients with 20.6 million healthcare encounters. The database will include data on approximately 1 million transfused units and 2.3 million donors with approximately 6.8 million donation visits. Conclusion: The REDS‐IV‐P V2V database is a comprehensive database with data from millions of blood donors, blood components, and patients. A diverse set of data from the encounters are included in the database such that emerging questions can likely be addressed. The Observational Medical Outcomes Partnership Common Data Model is an efficient, flexible, and increasingly used common data model. The final de‐identified database will be publicly available. [ABSTRACT FROM AUTHOR]

Background: Due to platelet availability limitations, platelet units ABO mismatched to recipients are often transfused. However, since platelets express ABO antigens and are collected in plasma which may contain ABO isohemagglutinins, it remains controversial as to whether ABO non‐identical platelet transfusions could potentially pose harm and/or have reduced efficacy. Study Design and Methods: The large 4‐year publicly available Recipient Epidemiology and Donor Evaluation Study‐III (REDS‐III) database was used to investigate patient outcomes associated with ABO non‐identical platelet transfusions. Outcomes included mortality, sepsis, and subsequent platelet transfusion requirements. Results: Following adjustment for possible confounding factors, no statistically significant association between ABO non‐identical platelet transfusion and increased risk of mortality was observed in the overall cohort of 21,176 recipients. However, when analyzed by diagnostic category and recipient ABO group, associations with increased mortality for major mismatched transfusions were noted in two of eight subpopulations. Hematology/Oncology blood group A and B recipients (but not group O) showed a Hazard Ratio (HR) of 1.29 (95%CI: 1.03–1.62) and intracerebral hemorrhage group O recipients (but not groups A and B) showed a HR of 1.75 (95%CI: 1.10–2.80). Major mismatched transfusions were associated with increased odds of receiving additional platelet transfusion each post‐transfusion day (through day 5) regardless of the recipient blood group. Discussion: We suggest that prospective studies are needed to determine if specific patient populations would benefit from receiving ABO identical platelet units. Our findings indicate that ABO‐identical platelet products minimize patient exposure to additional platelet doses. [ABSTRACT FROM AUTHOR]

Background: The Recipient Epidemiology and Donor Evaluation Study‐IV‐Pediatric (REDS‐IV‐P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. Study Design and Methods: The US program includes blood centers and hospitals (22 including 6 free‐standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7‐year REDS‐IV‐P program. Results: The US is building a centralized, vein‐to‐vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non‐transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus‐2 (SARS‐CoV‐2). Conclusions: The REDS‐IV‐P program endeavors to improve donor‐recipient‐linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues. [ABSTRACT FROM AUTHOR]

Background: To evaluate transfusion practices in pediatric oncology and hematopoietic stem cell transplant (HSCT) patients. Study design and methods: This is a multicenter retrospective study of children with oncologic diagnoses treated from 2013 to 2016 at hospitals participating in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study‐III. Transfusion practices were evaluated by diagnosis codes and pre‐transfusion laboratory values. Results: A total of 4766 inpatient encounters of oncology and HSCT patients were evaluated, with 39.3% (95% confidence interval [CI]: 37.9%–40.7%) involving a transfusion. Red blood cells (RBCs) were the most commonly transfused component (32.4%; 95% CI: 31.1%–33.8%), followed by platelets (22.7%; 95% CI: 21.5%–23.9%). Patients in the 1 to <6 years of range were most likely to be transfused and HSCT, acute myeloid leukemia, and aplastic anemia were the diagnoses most often associated with transfusion. The median hemoglobin (Hb) prior to RBC transfusion was 7.5 g/dl (10–90th percentile: 6.4–8.8 g/dl), with 45.7% of transfusions being given at 7 to <8 g/dl. The median platelet count prior to platelet transfusion was 20 × 109/L (10–90th percentile: 8–51 × 109/L), and 37.9% of transfusions were given at platelet count of >20–50 × 109/L. The median international normalized ratio (INR) prior to plasma transfusion was 1.7 (10–90th percentile: 1.3–2.7), and 36.3% of plasma transfusions were given at an INR between 1.4 and 1.7. Discussion: Transfusion of blood components is common in hospitalized pediatric oncology/HSCT patients. Relatively high pre‐transfusion Hb and platelet values and relatively low INR values prior to transfusion across the studied diagnoses highlight the need for additional studies in this population. [ABSTRACT FROM AUTHOR]

Background: While previous studies have described the use of blood components in subsets of children, such as the critically ill, little is known about transfusion practices in hospitalized children across all departments and diagnostic categories. We sought to describe the utilization of red blood cell, platelet, plasma, and cryoprecipitate transfusions across hospital settings and diagnostic categories in a large cohort of hospitalized children. Study Design and Methods: The public datasets from 11 US academic and community hospitals that participated in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study‐III (REDS‐III) were accessed. All nonbirth inpatient encounters of children 0–18 years of age from 2013 to 2016 were included. Results: 61,770 inpatient encounters from 41,943 unique patients were analyzed. Nine percent of encounters involved the transfusion of at least one blood component. RBC transfusions were most common (7.5%), followed by platelets (3.9%), plasma (2.5%), and cryoprecipitate (0.9%). Children undergoing cardiopulmonary bypass were most likely to be transfused. For the entire cohort, the median (interquartile range) pretransfusion laboratory values were as follows: hemoglobin, 7.9 g/dl (7.1–10.4 g/dl); platelet count, 27 × 109 cells/L (14–54 × 109 cells/L); and international normalized ratio was 1.6 (1.4–2.0). Recipient age differences were observed in the frequency of RBC irradiation (95% in infants, 67% in children, p <.001) and storage duration of RBC transfusions (median storage duration of 12 [8–17] days in infants and 20 [12–29] days in children, p <.001). Conclusion: Based on a cohort of patients from 2013 to 2016, the transfusion of blood components is relatively common in the care of hospitalized children. The frequency of transfusion across all pediatric hospital settings, especially in children undergoing cardiopulmonary bypass, highlights the opportunities for the development of institutional transfusion guidelines and patient blood management initiatives. [ABSTRACT FROM AUTHOR]

Aims: To understand the relationship between insulin resistance (IR), assessed as estimated glucose disposal rate (eGDR), and microvascular/macrovascular complications in people with type 1 diabetes. Materials and methods: Individuals with a confirmed diagnosis of type 1 diabetes were included in this cross‐sectional study. BMI was categorised into normal weight (18.0–24.9 kg m−2), overweight (25.0–29.9 kg m−2) and obese groups (≥30.0 kg m−2). We categorised eGDR into four groups: eGDR >8, 6–7.9, 4–5.9 and <4 mg kg−1 min−1. Multiple logistic regression was used to identify associations with vascular complications, after adjusting for relevant confounders. Results: A total of 2151 individuals with type 1 diabetes were studied. Median [interquartile range (IQR)] age was 41.0 [29.0, 55.0] with diabetes duration of 20.0 [11, 31] years. Odds ratio (OR) for retinopathy and nephropathy in obese compared with normal weight individuals was 1.64 (95% CI: 1.24–2.19; p = 0.001) and 1.62 (95% CI: 1.10–2.39; p = 0.015), while the association with cardiovascular disease just failed to reach statistical significance (OR 1.66 [95% CI: 0.97–2.86; p = 0.066]). Comparing individuals with eGDR ≥8 mg kg−1 min−1 and <4 mg kg−1 min−1 showed OR for retinopathy, nephropathy and macrovascular disease of 4.84 (95% CI: 3.36–6.97; p < 0.001), 8.35 (95% CI: 4.86–14.34; p < 0.001) and 13.22 (95% CI: 3.10–56.38; p < 0.001), respectively. Individuals with the highest eGDR category (≥8 mg kg−1 min−1) had the lowest complication rates irrespective of HbA1c levels. Conclusions: Obesity is prevalent in type 1 diabetes and diabetes complications are not only related to glucose control. IR, assessed as eGDR, is strongly associated with both microvascular and macrovascular complications, regardless of HbA1c levels. [ABSTRACT FROM AUTHOR]

Analysis of routine population‐based data has previously shown that patterns of surgical treatment for colorectal cancer can vary widely, but there is limited evidence available to determine if such variation is also seen in the use of chemotherapy. This study quantified variation in adjuvant chemotherapy across both England using cancer registry data and in more detail across the representative Yorkshire and Humber regions. Individuals with Stages II and III colorectal cancer who underwent major resection from 2014 to 2015 were identified. Rates of chemotherapy were calculated from the Systemic Anticancer Treatment database using multilevel logistic regression. Additionally, questionnaires addressing different clinical scenarios were sent to regional oncologists to investigate the treatment preferences of clinicians. The national adjusted chemotherapy treatment rate ranged from 2% to 46% (Stage II cancers), 19% to 81% (Stage III cancers), 24% to 75% (patients aged <70 years) and 5% to 46% (patients aged ≥70 years). Regionally, the rates of treatment and the proportions of treated patients receiving combination chemotherapy varied by stage (Stage II 4%‐26% and 0%‐55%, Stage III 48%‐71% and 40%‐84%) and by age (<70 years 35%‐68% and 49%‐91%; ≥70 years 15%‐39% and 6%‐75%). Questionnaire responses showed significant variations in opinions for high‐risk Stage II patients with both deficient and proficient mismatch repair tumours and Stage IIIB patients aged ≥70 years. Following a review of the evidence, open discussion in our region has enabled a consensus agreement on an algorithm for colorectal cancer that is intended to reduce variation in practice. What's new? Population‐based data have shown that surgery practice for colorectal cancer varies widely among different regions. Here, the authors delved into the population data to quantify the variation in adjuvant chemotherapy across England. They found a surprisingly high variation in chemotherapy rates for high‐risk stage II patients, and they suggest this difference results in part from clinicians' differing opinions about the effectiveness of chemotherapy for these patients. By highlighting the amount of regional variation in treatment practice, they achieved a consensus agreement on an algorithm they developed to provide standardized guidance for the use of chemotherapy. [ABSTRACT FROM AUTHOR]

Aims: To ascertain the effects of improvements in diabetic foot services over 18 years on incidence of diabetic foot ulceration. We also compared survival time from first ulcer development with presence of neuropathy, peripheral vascular disease, age and healing. Methods: Persons with new ulceration and those at high risk of ulcer development were referred to community podiatry from 1998. Their details were recorded, with verbal consent, on a central database. The effects of neuropathy, peripheral vascular disease, healing and age on survival were analysed by Cox proportional hazards ratios. Results: The incidence of first ulcer presentation decreased from 11.1 to 6.1 per 1000 persons between 2003 to 2017 (P <0.0001). Recurrent ulceration incidence remained stable. Prevalence of chronic and new foot ulceration combined increased from 20.7 to 33.1 per 1000 persons (P <0.0001). Ten‐year survival was 85% for persons presenting with first ulcer and aged < 65 years, 50% for those aged 65–74 years and 25% for those aged 75–81 years (P < 0.0001). In those with peripheral vascular disease 5‐year survival was 35% (P <0.001). Conclusions: Integrated care for the diabetic foot in one National Health Service (NHS) health service area over 18 years was associated with a reduction in first presentations of diabetic foot ulceration, but failed to reduce recurrent ulceration. Cumulative prevalence of all ulcers continues to increase. Monitoring ulceration incidence can inform audit and planning of diabetic foot care services. Survival is better than reported previously in persons < 65 years and in the absence of peripheral vascular disease. What's new?: Prevention of diabetic foot ulceration has been difficult to acheiveSurvival after diabetic foot ulceration has historically been poorThis study has shown reduction in first diabetes related foot ulceration with improved foot care services Participant survival after development of first diabetic foot ulceation was longer than in recent reports especially for those under 65 years of age, where ulcers healed, and in those without peripheral vascular diseaseAdequate commissioning of diabetic foot care services is necessary to prevent first foot ulcerationCounselling for younger patients with diabetic foot ulceration can be more posisitve [ABSTRACT FROM AUTHOR]

Background: Donor behaviors in STRIDE (Strategies to Reduce Iron Deficiency), a trial to reduce iron deficiency, were examined.Study Design and Methods: Six hundred ninety-two frequent donors were randomized to receive either 19 or 38 mg iron for 60 days or an educational letter based on their predonation ferritin. Compliance with assigned pills, response to written recommendations, change in donation frequency, and future willingness to take iron supplements were examined.Results: Donors who were randomized to receive iron pills had increased red blood cell donations and decreased hemoglobin deferrals compared with controls or with pre-STRIDE donations. Donors who were randomized to receive educational letters had fewer hemoglobin deferrals compared with controls. Of those who received a letter advising of low ferritin levels with recommendations to take iron supplements or delay future donations, 57% reported that they initiated iron supplementation, which was five times as many as those who received letters lacking a specific recommendation. The proportion reporting delayed donation was not statistically different (32% vs. 20%). Of donors who were assigned pills, 58% reported taking them "frequently," and forgetting was the primary reason for non-compliance. Approximately 80% of participants indicated that they would take iron supplements if provided by the center.Conclusions: Donors who were assigned iron pills had acceptable compliance, producing increased red blood cell donations and decreased low hemoglobin deferrals compared with controls or with pre-STRIDE rates. The majority of donors assigned to an educational letter took action after receiving a low ferritin result, with more donors choosing to take iron than delay donation. Providing donors with information on iron status with personalized recommendations was an effective alternative to directly providing iron supplements. [ABSTRACT FROM AUTHOR]

Background: Repeated blood donation alters the iron balance of blood donors. We quantified these effects by analyzing changes in body iron as well as calculating iron absorbed per day for donors enrolled in a prospective study.Study Design and Methods: For 1308 donors who completed a final study visit, we calculated total body iron at the enrollment and final visits and the change in total body iron over the course of the study. Taking into account iron lost from blood donations during the study and obligate losses, we also calculated the average amount of iron absorbed per day.Results: First-time/reactivated donors at enrollment had iron stores comparable to previous general population estimates. Repeat donors had greater donation intensity and greater mean iron losses than first-time/reactivated donors, yet they had little change in total body iron over the study period, whereas first-time/reactivated donors had an average 35% drop. There was higher estimated iron absorption in the repeat donors (men: 4.49 mg/day [95% confidence interval [CI], 4.41-4.58 mg/day]; women: 3.75 mg/day [95% CI, 3.67-3.84 mg/day]) compared with estimated iron absorption in first-time/reactivated donors (men: 2.89 mg/day [95% CI, 2.75-3.04 mg/day]; women: 2.76 mg/day [95% CI, 2.64-2.87 mg/day]). The threshold for negative estimated iron stores (below "0" mg/kg stores) was correlated with the development of anemia at a plasma ferritin value of 10 ng/mL.Conclusions: These analyses provide quantitative data on changes in estimated total body iron for a broad spectrum of blood donors. In contrast to using ferritin alone, this model allows assessment of the iron content of red blood cells and the degree of both iron surplus and depletion over time. [ABSTRACT FROM AUTHOR]

Purpose Poorly characterized macromolecular (MM) and baseline artefacts are known to reduce metabolite quantitation accuracy in 1H MR spectroscopic imaging (MRSI). Increasing echo time (TE) and improvements in MM analysis schemes have both been proposed as strategies to improve metabolite measurement reliability. In this study, the influence of TE and two MM analysis schemes on MRSI reproducibility are investigated. Methods An experimentally acquired baseline was collected using an inversion recovery sequence (TI = 750 ms) and incorporated into the analysis method. Intrasubject reproducibility of MRSI scans, acquired at 3 Tesla, was assessed using metabolite coefficients of variance (COVs) for both experimentally acquired and simulated MM analysis schemes. In addition, the reproducibility of TE = 35 ms, 80 ms, and 144 ms was evaluated. Results TE = 80 ms was the most reproducible for singlet metabolites with COVs < 6% for total N-acetyl-aspartate, total creatine, and total choline; however, moderate multiplet dephasing was observed. Analysis incorporating the experimental baseline achieved higher Glu and Glx reproducibility at TE = 35 ms, and showed improvements over the simulated baseline, with higher efficacy for poorer data. Conclusion Overall, TE = 80 ms yielded the most reproducible singlet metabolite estimates. However, combined use of a short TE sequence and the experimental baseline may be preferred as a compromise between accuracy, multiplet dephasing, and T2 bias on metabolite estimates. Magn Reson Med 77:34-43, 2017. © 2016 The Authors Magnetic Resonance in Medicine published by Wiley Periodicals, Inc. on behalf of International Society for Magnetic Resonance in Medicine. [ABSTRACT FROM AUTHOR]

Background: The historical approach of offering dietary advice to donors with low hemoglobin (Hb) is ineffective for preventing iron deficiency in frequent donors. Alternative approaches to maintaining donor iron status were explored.Study Design and Methods: Frequent blood donors were randomly assigned into five arms for 2 years of follow-up. Three double-blinded arms provided 60 once-daily pills after each donation (38, 19, or 0 mg of iron). Two single-blinded arms provided iron status (ferritin) or no information letters after each donation. Ferritin, soluble transferrin receptor, and complete blood count were measured at each donation.Results: There were 692 subjects enrolled and 393 completed the study. Subjects in pill groups deenrolled more than those in letter groups (39% vs. 7%). Adverse events occurred equally in subjects receiving iron or placebo pills. Of those completing the study, the prevalence of ferritin of less than 12 or less than 26 ng/mL declined by more than 50% and was statistically indistinguishable in the three intervention groups (19 or 38 mg of iron; iron status letter). Longitudinal analyses of all subjects showed improved iron status in iron pill groups and worsening iron status in control groups (placebo; no information letter). The iron pill groups experienced a net increase of approximately 0.6 g/dL Hb compared to control groups. The iron status letter group had little change in Hb.Conclusion: Providing 19 or 38 mg of daily iron or iron status information were effective and mostly equivalent interventions for mitigating iron deficiency in regular donors when compared at the end of the 2-year longitudinal phase of the study. Donors without intervention had worsened iron deficiency with continued donation. [ABSTRACT FROM AUTHOR]

Purpose: Accurate and fast 1H MR spectroscopic imaging (MRSI) water reference scans are important for absolute quantification of metabolites. However, the additional acquisition time required often precludes the water reference quantitation method for MRSI studies. Sensitivity encoding (SENSE) is a successful MR technique developed to reduce scan time. This study quantitatively assesses the accuracy of SENSE for water reference MRSI data acquisition, compared with the more commonly used reduced resolution technique. Methods: 2D MRSI water reference data were collected from a phantom and three volunteers at 3 Tesla for full acquisition (306 s); 2× reduced resolution (64 s) and SENSE R = 3 (56 s) scans. Water amplitudes were extracted using MRS quantitation software (TARQUIN). Intensity maps and Bland-Altman statistics were generated to assess the accuracy of the fast-MRSI techniques. Results: The average mean and standard deviation of differences from the full acquisition were 2.1 ± 3.2% for SENSE and 10.3 ± 10.7% for the reduced resolution technique, demonstrating that SENSE acquisition is approximately three times more accurate than the reduced resolution technique. Conclusion: SENSE was shown to accurately reconstruct water reference data for the purposes of in vivo absolute metabolite quantification, offering significant improvement over the more commonly used reduced resolution technique. Magn Reson Med 73:2081-2086, 2015. © 2014 The Authors. Magnetic Resonance in Medicine Published by Wiley Periodicals, Inc. on behalf of International Society of Medicine in Resonance. [ABSTRACT FROM AUTHOR]

Background Human immunodeficiency virus ( HIV) risk factor screening among blood donors remains a cornerstone for the safety of blood supply and is dependent on prospective donor self-disclosure and an attentive predonation interview. Audio computer-assisted structured interview ( ACASI) has been shown to increase self-reporting of risk behaviors. Study Design and Methods This cross-sectional study was conducted between January 2009 and March 2011 at four Brazilian blood centers to identify the population of HIV-negative eligible blood donors that answered face-to-face interviews without disclosing risks, but subsequently disclosed deferrable risk factors by ACASI. Compared to the donor interview, the ACASI contained expanded content on demographics, sexual behavior, and other HIV risk factors questions. Results A total of 901 HIV-negative blood donors were interviewed. On the ACASI, 13% of donors (n = 120) declared a risk factor that would have resulted in deferral that was not disclosed during the face-to-face assessment. The main risk factors identified were recent unprotected sex with an unknown or irregular partner (49 donors), sex with a person with exposure to blood or fluids (26 donors), multiple sexual partners (19 donors), and male-male sexual behavior (10 donors). Independent factors associated with the disclosure of any risk factor for HIV were age (≥40 years vs. 18-25 years; adjusted odds ratio [AOR], 0.45; 95% confidence interval [CI], 0.23-0.88) and blood center ( Hemope vs. Hemominas; AOR, 2.51; 95% CI, 1.42-4.44). Conclusion ACASI elicited increased disclosure of HIV risk factors among blood donors. ACASI may be a valuable modality of interview to be introduced in Brazilian blood banks. [ABSTRACT FROM AUTHOR]