How do we build a comprehensive Vein-to-Vein (V2V) database for conduct of observational studies in transfusion medicine? Demonstrated with the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric V2V database protocol.

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.

Does Timing of Levonorgestrel Insertion in Women with Abnormal Uterine Bleeding Affect its Expulsion and Bleeding Pattern? A Follow-Up Study.

Background: Levonorgestrel Intra Uterine System insertion for contraception is preferred in the follicular phase. However, the ideal time of insertion for Abnormal Uterine Bleeding is not stated clearly. The aim of our study is to find out the effect of timing of insertion on expulsion and irregular bleeding pattern post insertion. Methods: A follow-up study of patients with LNG-IUS for AUB was conducted. They were grouped into four based on the day of insertion from Last Menstrual Period (LMP). The pattern of irregular bleeding post insertion was compared with odds ratio and the expulsion rate was compared with log rank test. Results: The most common indication for the 76 patients was ovulatory dysfunction (39.4%) followed by Adenomyosis (36.84%). Those who had LNG-IUS insertion from day 22-30 had quicker expulsions of 25% of patients by 3 months. By 6 months and later expulsion rate was much higher in the luteal phase than the follicular phase (p < 0.03). The least risk of moderate or heavy bleeding was for the 8-15 day group when compared to the 22-30 day group, the odds ratio being 0.03 [95% CI: (0.01-0.2)]. Conclusion: Based on expulsion rate alone, insertion of LNG-IUS at any time in the follicular phase is ideal. Considering both expulsion rate and pattern of bleeding the ideal time would be late follicular phase, that is 8-15th day.

Aloe Vera Functionalized Magnetic Nanoparticles Entrapped Ca Alginate Beads as Novel Adsorbents for Cu(II) Removal from Aqueous Solutions.

CABs (Ca alginate beads), AVCABs (Aloe vera Ca alginate beads), and AVMNCABs (Aloe-vera functionalized magnetic nanoparticles entrapped Ca alginate beads) were developed as adsorbents for the removal of Cu(II) from aqueous solutions. The materials were characterized using Fourier-transform infrared (FTIR) spectroscopy, high-resolution scanning electron microscopic (HR-SEM) analysis, X-ray diffraction (XRD), energy-dispersive X-ray (EDX) spectroscopy, and a vibrating-sample magnetometer (VSM). The effect of several parameters, such as pH, time, temperature, adsorbent dose, etc., were investigated. The adsorption isotherm of Cu(II) was adjusted best to the Langmuir model. The maximum adsorption capacities were 111.11 mg/g, 41.66 mg/g, and 15.38 mg/g for AVMNCABs, AVCABs, and CABs, respectively. The study of the adsorption kinetics for Cu(II) ions on beads followed a pseudo-second-order kinetic model, with a very good correlation in all cases. The adsorption studies used a spectrophotometric method, dealing with the reaction of Cu(II) with KSCN and variamine blue.

How do we form and coordinate a national serosurvey of SARS-CoV-2 within the blood collection industry?

BACKGROUND: A national serosurvey of U.S. blood donors conducted in partnership with the Centers for Disease Control and Prevention (CDC) was initiated to estimate the prevalence of SARS-CoV-2 infections and vaccinations. METHODS: Beginning in July 2020, the Nationwide Blood Donor Seroprevalence Study collaborated with multiple blood collection organizations, testing labs, and leadership from government partners to capture, test, and analyze approximately 150,000 blood donation specimens per month in a repeated, cross-sectional seroprevalence survey. RESULTS: A CDC website (https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence) provided stratified, population-level results to public health professionals and the general public. DISCUSSION: The study adapted operations as the pandemic evolved, changing specimen flow and testing algorithms, and collecting additional data elements in response to changing policies on universal blood donation screening and administration of SARS-CoV-2 spike-based vaccines. The national serosurvey demonstrated the utility of serosurveillance testing of residual blood donations and highlighted the role of the blood collection industry in public-private partnerships during a public health emergency.

The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P): A research program striving to improve blood donor safety and optimize transfusion outcomes across the lifespan.

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.

Calcium Alginate Beads with Entrapped Iron Oxide Magnetic Nanoparticles Functionalized with Methionine-A Versatile Adsorbent for Arsenic Removal.

A novel beads adsorbent, consisting of calcium alginate entrapped on magnetic nanoparticles functionalized with methionine (MFMNABs), was developed for effective elimination of arsenic from water. The material was characterized by FT-IR (Fourier Transform Infrared Spectroscopy), SEM (Scanning Electron Microscopic), XRD (X-ray Diffraction) and TEM (Transmission Electron Microscopy). The arsenic removal capacity of the material was studied by altering variables such as pH of the solution, contact time, adsorbent dose and adsorbate concentration. The maximal removal of As(III) was 99.56% under optimal conditions with an equilibrium time of 110 min and pH 7.0-7.5. The adsorption followed a second order kinetics and data best fitted the Langmuir isotherm with a correlation coefficient of R2 = 0.9890 and adsorption capacity (qm) of 6.6533 mg/g. The thermodynamic study showed entropy change (∆S) and enthalpy change (∆H) to be 34.32 J mol-1 K and 5.25 kJ mol-1, respectively. This study proved that it was feasible to treat an As(III) solution with MFMNABs. The synthesized adsorbent was cost-effective, environmentally friendly and versatile, compared to other adsorbents. The adsorption study was carried by low cost spectrophotometric method using N- bromosuccinimide and rhodamine-B developed in our laboratory.

The Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR): Unique 1.4 M patient Electronic Health Record cohort.

BACKGROUND: The Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR) study uses a novel Electronic Health Record (EHR) data approach as a tool to assess the epidemiology of known and new risk factors for type 2 diabetes mellitus (T2DM) and study how prevention interventions affect progression to and onset of T2DM. We created an electronic cohort of 1.4 million patients having had at least 4 encounters with a healthcare organization for at least 24-months; were aged ≥18 years in 2010; and had no diabetes (i.e., T1DM or T2DM) at cohort entry or in the 12 months following entry. EHR data came from patients at nine healthcare organizations across the U.S. between January 1, 2010-December 31, 2016. RESULTS: Approximately 5.9% of the LEADR cohort (82,922 patients) developed T2DM, providing opportunities to explore longitudinal clinical care, medication use, risk factor trajectories, and diagnoses for these patients, compared with patients similarly matched prior to disease onset. CONCLUSIONS: LEADR represents one of the largest EHR databases to have repurposed EHR data to examine patients' T2DM risk. This paper is first in a series demonstrating this novel approach to studying T2DM. IMPLICATIONS: Chronic conditions that often take years to develop can be studied efficiently using EHR data in a retrospective design. LEVEL OF EVIDENCE: While much is already known about T2DM risk, this EHR's cohort's 160 M data points for 1.4 M people over six years, provides opportunities to investigate new unique risk factors and evaluate research hypotheses where results could modify public health practice for preventing T2DM.

A quality improvement programme to reduce hospital-acquired pressure injuries.

BACKGROUND: At Heart Hospital in Doha, Qatar (HH), 127 pressure injuries (PI) were identified in 2014, corresponding to an incidence of 6.1/1000 patient-days in first 4 months of 2014. Hospital-acquired pressure injury (HAPI) is one of the most common preventable complications of hospitalisation. HAPI significantly increases healthcare costs, including use of resources (dressings, support surfaces, nursing care time and medications). They also have a significant impact on patients in terms of pain, worsened quality of life, psychological trauma and increased length of stay. Working with the Institute for Healthcare Improvement (IHI), we implemented evidence-based practices in all In patient Units at HH with the aim of reducing the number of HAPIs by 60% within 2 years. METHODS: In collaboration with IHI, our multidisciplinary clinical and risk assessment teams tested several changes and implemented a successful programme. The Surface, Skin inspection, Keep moving, Incontinence and Nutrition bundle was implemented. Signs, turning clocks and PI incidence 'calendars' were used in the units as reminders. Attention was paid to endotracheal tube ties in order to address device-related pressure injuries. Counts of HAPI (incidence) and number of PIs per 100 patients surveyed (prevalence) were prominently displayed. Changes were tested using the Plan-Do-Study-Act methodology. Statistical analysis using the independent t-test was applied to detect the significance of any difference in the incidence of HAPI before and after implementation of the changes. RESULTS: The incidence of HAPI dropped from 6.1/1000 patient-days to 1.1/1000 patient-days, an 83.5% reduction. The prevalence, based on quarterly survey fell from 9.7/100 patients surveyed to 2.0/100 patients surveyed, a 73.4% decline. CONCLUSIONS: The interventions proved to be successful, reducing the incidence of PI by >80%. The outcomes were sustained over a 4-year period.

Leveraging social and digital media for participant recruitment: A review of methods from the Bayley Short Form Formative Study.

INTRODUCTION: Social media is increasingly being used in research, including recruitment. METHODS: For the Bayley Short Form Formative Study, which was conducted under the the National Children's Study, traditional methods of recruitment proved to be ineffective. Therefore, digital media were identified as potential channels for recruitment. RESULTS: Results included successful recruitment of over 1800 infant and toddler participants to the Study. CONCLUSIONS: This paper outlines the methods, results, and future research opportunities.

The Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial Pathology Tissue Resource.

BACKGROUND: Pathology tissue specimens with associated epidemiologic and clinical data are valuable for cancer research. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial undertook a large-scale effort to create a public resource of pathology tissues from PLCO participants who developed a cancer during the trial. METHODS: Formalin-fixed paraffin-embedded tissue blocks were obtained from pathology laboratories on a loan basis for central processing of tissue microarrays, with additional free-standing tissue cores collected for nucleic acid extraction. RESULTS: Pathology tissue specimens were obtained for prostate cancer (n = 1,052), lung cancer (n = 434), colorectal cancer (n = 675) and adenoma (n = 658), ovarian cancer and borderline tumors (n = 212), breast cancer (n = 870), and bladder cancer (n = 204). The process of creating this resource was complex, involving multidisciplinary teams with expertise in pathology, epidemiology, information technology, project management, and specialized laboratories. CONCLUSIONS: Creating the PLCO tissue resource required a multistep process, including obtaining medical records and contacting pathology departments where pathology materials were stored after obtaining necessary patient consent and authorization. The potential to link tissue biomarkers to prospectively collected epidemiologic information, screening and clinical data, and matched blood or buccal samples offers valuable opportunities to study etiologic heterogeneity, mechanisms of carcinogenesis, and biomarkers for early detection and prognosis. IMPACT: The methods and protocols developed for this effort, and the detailed description of this resource provided here, will be useful for those seeking to use PLCO pathology tissue specimens for their research and may also inform future tissue collection efforts in other settings. Cancer Epidemiol Biomarkers Prev; 25(12); 1635-42. ©2016 AACR.

PLCO: Evolution of an Epidemiologic Resource and Opportunities for Future Studies.

The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), a large-scale, multi-institutional, randomized controlled trial, was launched in 1992 to evaluate the effectiveness of screening modalities for prostate, lung, colorectal, and ovarian cancer. However, PLCO was additionally designed to serve as an epidemiologic resource and the National Cancer Institute has invested substantial resources over the years to accomplish this goal. In this report, we provide a summary of changes to PLCO's follow-up after conclusion of the screening phase of the trial and highlight recent data and biospecimen collections, including ancillary studies, geocoding, administration of a new medication use questionnaire, consent for linkage to Medicare, and additional tissue collection that enhance the richness of the PLCO resource and provide further opportunities for scientific investigation into the prevention, early detection, etiology and treatment of cancer.

Direct and selective spectrophotometric method for the determination of vanadium in steel, environmental and biological samples.

A simple, direct and selective spectrophotometric method for determination of vanadium is described. The present methodology is based on the strong oxidizing power of vanadium (V). Vanadium (V) selectively oxidizes leucocrystal violet (LCV) to crystal violet in the presence of phosphoric acid. The violet colored dye obtained shows maximum absorbance at 590 nm. Beer's law is obeyed in the concentration range 0.06-0.6 µg ml(-1). The molar absorptivity and Sandell's sensitivity are found to be 6.78×10(4) l mol(-1) cm(-1) and 0.0044 µg cm(-2), respectively. The proposed method is simple, direct, and sensitive. It has been successfully applied for the determination of vanadium in various environmental, biological and steel samples.

The Leukocyte Antibody Prevalence Study-II (LAPS-II): a retrospective cohort study of transfusion-related acute lung injury in recipients of high-plasma-volume human leukocyte antigen antibody-positive or -negative components.

BACKGROUND: We used a multicenter retrospective cohort study design to evaluate whether human leukocyte antigen (HLA) antibody donor screening would reduce the risk of transfusion-related acute lung injury (TRALI) or possible TRALI. STUDY DESIGN AND METHODS: In the Leukocyte Antibody Prevalence Study-II (LAPS-II), we evaluated pulmonary outcomes in recipients of 2596 plasma-rich blood components (transfusable plasma and plateletpheresis) sent to participating hospitals; half of the components were collected from anti-HLA-positive donors (study arm) and half from anti-HLA-negative donors (control arm) matched by sex, parity, and blood center. A staged medical record review process was used. Final recipient diagnosis was based on case review by a blinded expert panel of pulmonary or critical care physicians. RESULTS: TRALI incidence was 0.59% (seven cases) in study arm recipients versus 0.16% (two cases) in control arm recipients for an odds ratio (OR) of 3.6 (95% confidence interval [CI], 0.7-17.4; p = 0.10). For possible TRALI cases (nine study arm, eight control arm), the OR was 1.2 (95% CI, 0.4-3.0; p = 0.81), and for TRALI and possible TRALI aggregated together, it was 1.7 (95% CI, 0.7-3.7; p = 0.24). Transfusion-associated circulatory overload incidence was identical in the two arms (1.17 and 1.22%, respectively; OR, 1.0; p = 1.0). CONCLUSIONS: TRALI incidence in recipients of anti-HLA-positive components was relatively low for a lookback study (1 in 170) and was higher than in the control arm, but did not reach significance. Based on this trend, the data are consistent with the likelihood that TRALI risk is decreased by selecting high-volume plasma components for transfusion from donors at low risk of having HLA antibodies.

Biospecimen repositories: are blood donors willing to participate?

BACKGROUND: Sponsored by the National Heart, Lung, and Blood Institute, the Retrovirus Epidemiology Donor Studies (REDS-I/-II) have conducted epidemiologic, laboratory, and survey research on volunteer blood donors. Some studies request additional permission to store biospecimens for future studies. The representativeness and applicability of studies performed using repositories may be reduced by low participation rates. STUDY DESIGN AND METHODS: Demographics from subjects consenting to participate in the 2007 REDS-II Leukocyte Antibodies Prevalence Study (LAPS) repository were compared to "study-only" subjects. Data from the 1998 REDS-I survey of donor opinion regarding storage and use of biospecimens were also explored. RESULTS: Overall, 91% of LAPS subjects agreed to participate in the repository. Odds of repository participation were lower among African American and Hispanic donors, 35- to 44-year-olds, donors who had not completed high school, and donors from one geographic location, regardless of other variables. Survey data from 1998 revealed that 97% of respondents approved of long-term storage of biospecimens, although only 87% indicated that they would personally participate. Many respondents would require notification or their permission be obtained before participation. Minority respondents would require permission or notification more often and were less certain they would personally participate in a repository. CONCLUSION: Blood donors are quite willing to participate in biospecimen repositories. Regional differences and lower odds of participation in the minority blood donor population may result in a reduced number of biospecimens available for study and a decreased ability to definitely answer specific research questions in these populations.

Opinions about donating blood among those who never gave and those who stopped: a focus group assessment.

BACKGROUND: Understanding what prevents people from ever donating blood, or having donated, what influenced them to stop, are both equally important in devising recruitment strategies. Enlisting new donors and encouraging previous donors to return are vital to increasing collections. STUDY DESIGN AND METHODS: Six racially homogeneous focus groups of never donors and lapsed donors were conducted. Both sexes and a range of age groups were represented. The importance of blood donation as a volunteer activity, deterrents, motivations, awareness of need, and effective recruitment messages were topics discussed. RESULTS: Never donors do not see blood donation as an important volunteer activity on par with others like volunteering at hospitals, schools, and support groups. Fear and inconvenience were major barriers to donating. Better education campaigns to allay fears about donating and workplace drives were considered important motivators. Participants were unaware of the need for blood. Media messages that combine safety of the process along with who it benefits were considered most effective. Messages that target the specific needs of minority communities were considered good motivators for their recruitment. CONCLUSION: Blood collection agencies should increase awareness that blood donation is a worthwhile and important volunteer activity. Another strategy would be to capitalize on the existing perception that donating blood is like donating money or used clothing, by focusing on the concept of giving something tangible. Along with providing convenient opportunities to donate, blood centers need to effectively convey the need for blood and allay fears about the donation process to increase the current donor pool.

A rapid spectrophotometric assay of some organophosphorus pesticide residues in vegetable samples.

A rapid and sensitive spectrophotometric method for the determination of some organophosphorus insecticides, i.e. malathion, dimethoate and phorate is described. It is based on the oxidation of organophosphorus pesticide with slight excess of N-bromosuccinimide (NBS) and the unconsumed NBS is determined with rhodamine B (lambda max: 550 nm). Beer's law is obeyed in the concentration range 0.108-1.08, 0.056-0.56 and 0.028-0.28 microg mL(-1) for malathion, phorate and dimethoate, respectively. The method has been successfully applied for the determination of organophosphorus pesticide residues in various vegetable samples.

Factors influencing the decision to donate: racial and ethnic comparisons.

BACKGROUND: Understanding factors that encourage different racial and ethnic groups to donate is crucial for donor recruitment and retention. STUDY DESIGN AND METHODS: A 28-item self-administered questionnaire was completed in 2003 by 1862 Asian, 1479 black, 1641 Hispanic, and 2940 White US donors who had given whole blood within the past year. With a 1 to 5 scale, donors were asked to rate the importance of 17 factors in their last donation decision. Logistic regression was conducted to compare the odds of a factor being important or very important (score of 4 or 5) in one's decision to donate between race or ethnic groups, stratified by first-time and repeat status. RESULTS: More than 90 percent of each respondent group cited a desire, responsibility, or perceived duty to help others as an important or very important motivator. Being asked to donate at work was also an important motivator for all race and ethnic groups (56-70%). Getting the results of a health screen appealed to many (approx. 30% found it important or very important) and was most important to Black and Hispanic donors (odds ratios of 1.3-1.9 compared to White donors; p<0.003). CONCLUSION: Recruitment and retention programs should build on people's sense of social responsibility. Direct requests to donate are particularly effective motivators. Of a variety of incentives evaluated, offering more comprehensive health screens may motivate many donors, especially Black and Hispanic donors.