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Background: The uptake of minimally invasive surgery (MIS) for patients with colorectal cancer has progressed at differing rates, both across countries, and within countries. This study aimed to investigate uptake for a regional colorectal cancer improvement programme in England., Method: We calculated the proportion of patients receiving elective laparoscopic and robot-assisted surgery amongst those diagnosed with colorectal cancer over 3 time periods (2007-2011, 2012-2016 and 2017-2021) in hospitals participating in the Yorkshire Cancer Research Bowel Cancer Improvement Programme (YCR BCIP). These were benchmarked against national rates. Regression analysis and funnel plots were used to develop a data driven approach for analysing trends in the use of MIS at hospitals in the programme., Results: In England, resections performed by MIS increased from 34.9% to 72.9% for colon cancer and from 28.8% to 72.5% for rectal cancer. Robot-assisted surgery increased from 0.1% to 2.7% for colon cancer and from 0.2% to 7.9% for rectal cancer. Wide variation in the uptake of MIS was observed at a hospital level. Detailed analysis of the YCR BCIP region identified a decreasing number of surgical departments, since the start of the programme, as potential outliers for MIS when compared to the English national average., Conclusion: Wide variation in use of MIS for colorectal cancer exists within the English National Health Service and a data-driven approach can help identify outlying hospitals. Addressing some of the challenges behind the uptake of MIS, such as ensuring adequate provision of surgical training and equipment, could help increase its use., Competing Interests: Disclosure The authors declare there are no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Numerous studies have revealed age-related inequalities in colorectal cancer care. Increasing levels of frailty in an ageing population may be contributing to this, but quantifying frailty in population-based studies is challenging., Objective: To assess the feasibility, validity and reliability of the Hospital Frailty Risk Score (HFRS), the Secondary Care Administrative Records Frailty (SCARF) index and the frailty syndromes (FS) measures in a national colorectal cancer cohort., Design: Retrospective population-based study using 136,008 patients with colorectal cancer treated within the English National Health Service., Methods: Each measure was generated in the dataset to assess their feasibility. The diagnostic codes used in each measure were compared with those in the Charlson Comorbidity Index (CCI). Validity was assessed using the prevalence of frailty and relationship with 1-year survival. The Brier score and the c-statistic were used to assess performance and discriminative ability of models with included each measure., Results: All measures demonstrated feasibility, validity and reliability. Diagnostic codes used in SCARF and CCI have considerable overlap. Prevalence of frailty determined by each differed; SCARF allocating 55.4% of the population to the lowest risk group compared with 85.1% (HFRS) and 81.2% (FS). HFRS and FS demonstrated the greatest difference in 1-year overall survival between those with the lowest and highest measured levels of frailty. Differences in model performance were marginal., Conclusions: HFRS, SCARF and FS all have value in quantifying frailty in routine administrative health care datasets. The most suitable measure will depend on the context and requirements of each individual epidemiological study., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Geriatrics Society.)

This study aimed to use national data to examine the relationship between staff and inpatient survey results (National Health Service (NHS) Friends and Family Test (FFT)) and assess how these align with more traditional measurements of hospital quality as captured by the summary hospital mortality indicator (SHMI). Provider level FFT responses were obtained for 128 English non-specialist acute providers for staff and inpatients between April 2016 and March 2019. Multilevel linear regression models assessed the relationship between staff and patient FFT recommendations, and separately how SHMI related to each of staff and patient FFT recommendations. A total of 1,536 observations were recorded across all providers and financial quarters. Patients were more likely to recommend their provider (95.5%) than staff (76.8%). In multivariable regression, a statistically significant association was observed between staff and patient FFT recommendations. A statistically significant negative relationship was also observed between staff FFT recommendations and SHMI. The association between SHMI and staff FFT recommendations suggests that staff feedback tools may provide a useful analogue for providers in potential need of intervention and improvement in care. For patients meanwhile, qualitative approaches and hospital organisations working in partnership with patients may provide better opportunities for patients to drive improvement., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: While the integration of patient and public involvement (PPI) in clinical research is now widespread and recommended as standard practice, meaningful PPI in pre-clinical, discovery science research is more difficult to achieve. One potential way to address this is by integrating PPI into the training programmes of discovery science postgraduate doctoral students. This paper describes the development and formative evaluation of the Student Patient Alliance (SPA), a programme developed at the University of Birmingham that connects PPI partners with doctoral students., Methods: Following a successful pilot of the SPA by the Rheumatology Research Group at the University of Birmingham, the scheme was implemented across several collaborating Versus Arthritis / Medical Research Council (MRC) centres of excellence. Doctoral students were partnered with PPI partners, provided with initial information and guidance, and then encouraged to work together on research and public engagement activities. After six months, students, their PPI partners and the PPI coordinators at each centre completed brief surveys about their participation in the SPA., Results: Both doctoral students and their PPI partners felt that taking part in SPA had a positive impact on understanding, motivation and communication skills. Students reported an increased understanding of PPI and patient priorities and reported improved public engagement skills. Their PPI partners reported a positive impact of the collaboration with the students. They enjoyed learning about the student's research and contributing to the student's personal development. PPI coordinators also highlighted the benefits of the SPA, but noted some challenges they had experienced, such as difficulties matching students with PPI partners., Conclusions: The SPA was valued by students and PPI partners, and it is likely that initiatives of this kind would enhance students' PPI and public engagement skills and awareness of patients' experiences on a wider scale. However, appropriate resources are needed at an institutional level to support the implementation of effective programmes of this kind on a larger scale., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Use of data-driven methodologies in enhancing blood transfusion practices is rising, leveraging big data, machine learning, and optimization techniques to improve demand forecasting and supply chain management. This review used a narrative approach to identify, evaluate, and synthesize key studies that considered novel computational techniques for blood demand forecasting and inventory management through a search of PubMed and Web of Sciences databases for studies published from January 01, 2016, to March 30, 2023. The studies were analyzed for their utilization of various techniques, and their strengths, limitations, and areas for improvement. Seven key studies were identified. The studies focused on different blood components using various computational methods, such as regression, machine learning, hybrid models, and time series models, across different locations and time periods. Key variables used for demand forecasting were largely derived from electronic health record data, including clinical related predictors such as laboratory test results and hospital census by location. Each study offered unique strengths and valuable insights into the use of data-driven methods in blood bank management. Common limitations were unknown generalizability to other healthcare settings or blood components, need for field-specific performance measures, lack of ABO compatibility consideration, and ethical challenges in resource allocation. While data-driven research in blood demand forecasting and management has progressed, limitations persist and further exploration is needed. Understanding these innovative, interdisciplinary methods and their complexities can help refine inventory strategies and address healthcare challenges more effectively, leading to more robust, accurate models to enhance blood management across diverse healthcare scenarios., Competing Interests: Declaration of Competing Interest The authors report no relevant conflicts of interest., (Copyright © 2023. Published by Elsevier Inc.)

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., (© 2023 AABB.)

Background: Studies have demonstrated a higher risk of developing colorectal cancer (CRC) in individuals with Cystic Fibrosis (CF), and also a potentially increased risk in carriers of cystic fibrosis transmembrane conductance regulator (CFTR) mutations. Life expectancy for those with CF is rising, increasing the number at risk of developing CRC., Methods: The incidence of CRC amongst individuals with CF was calculated using data from CORECT-R and linked UK CF Registry and Secondary User Services (SUS) data. Crude, age-specific and age-standardised rates were compared to those without CF. The presence of CFTR mutations in individuals with CRC was assessed using 100,000 Genomes Project data., Findings: The crude incidence rate of CRC in the CF population was 0.29 per 1,000 person-years (28 cases). The CF population were significantly younger than those without (median age at CRC diagnosis 52 years versus 73 years; p<0·01). When age-adjusted, there was a 5-fold increased CRC incidence amongst individuals with CF compared to those without (SIR 5.0 95%CI 3.2-6.9). When compared to other population studies the overall prevalence of CFTR mutations in the CRC population was significantly higher than expected (p<0·01)., Interpretation: CF is linked to an increased risk of CRC. The incidence of CFTR mutations in the CRC population is higher than would be expected, suggesting an association between CFTR function and CRC risk. Further research is needed to develop effective screening strategies for these populations., Funding: Cancer Research UK (grants C23434/A23706 & C10674/A27140)., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

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., (© 2023 AABB.)

Background: People with type 2 diabetes mellitus (T2DM) have a higher risk of developing breast and bowel cancers but are less likely to participate in cancer screening., Purpose: Two interlinked studies examined public awareness of the fact that T2DM increases breast and bowel cancer risk, and provision of this information on diabetes websites., Methods: Study-1: phase-1 surveyed awareness of T2DM-increased cancer risk in a nationally-representative British sample aged 50-74 (N = 1,458) and compared respondents with and without T2DM (n = 125 vs. n = 1,305); phase-2 surveyed an additional exclusively T2DM sample (N = 319). Study-2: High-ranking diabetes websites (N = 25) were reviewed to determine the rate of inclusion of cancer risk and cancer screening information in evident sections about diabetes-related health conditions., Results: A low proportion of respondents were aware that T2DM increases risk of breast (13.7%) and bowel (27.6%) cancers, compared to much higher awareness of other diabetes-related conditions such as sight loss (82.2%) and foot problems (81.8%). Respondents with T2DM were significantly more likely than those without T2DM to be aware of all the surveyed diabetes-related health conditions (e.g., sight loss, OR: 3.14, 95%CI: 1.61-6.15; foot problems, OR: 2.58, 95%CI: 1.38-4.81), except breast (OR: 0.82, 95%CI: 0.46-1.45) and bowel (OR: 0.95, 95%CI: 0.63-1.45) cancer, for which awareness was equally low among people with and without T2DM. Few diabetes websites with a section on diabetes-related health conditions included cancer in this section (n = 4/19), and fewer still included cancer screening among any noted cancer-protective behaviors (n = 2/4)., Conclusions: There is low public awareness that T2DM increases the risk of developing breast and bowel cancers, even among people with T2DM, which may be partly due to limited information provision regarding T2DM-increased cancer risk from diabetes care providers and organizations., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Behavioral Medicine.)

Background: Data are limited on influenza testing among adults with acute respiratory illness (ARI)-associated hospitalizations. We identified factors associated with influenza testing in adult ARI-associated hospitalizations across the 2016-2017 through 2019-2020 influenza seasons., Methods: Using data from 4 health systems in the United States, we identified hospitalizations that had an ARI discharge diagnosis or respiratory virus test. A hospitalization with influenza testing was based on testing performed within 14 days before through 72 hours after admission. We used random forest analysis to identify patient characteristics and influenza activity indicators that were most important in terms of their relationship to influenza testing., Results: Across 4 seasons, testing rates ranged from 14.8%-19.4% at 3 pooled sites and 60.1%-78.5% at a fourth site with different testing practices. Discharge diagnoses of pneumonia or infectious disease of noninfluenza etiology, presence of ARI signs/symptoms, hospital admission month, and influenza-like illness activity level were consistently among the variables with the greatest relative importance., Conclusions: Select ARI diagnoses and indicators of influenza activity were the most important factors associated with influenza testing among ARI-associated hospitalizations. Improved understanding of which patients are tested may enhance influenza burden estimates and allow for more timely clinical management of influenza-associated hospitalizations., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)

Physical inactivity is common in people with chronic airways disease (pwCAD) and associated with worse clinical outcomes and impaired quality of life. We conducted a systematic review and meta-analysis to characterise and evaluate the effectiveness of interventions promoting step-based physical activity (PA) in pwCAD. We searched for studies that included a form of PA promotion and step-count outcome measure. A random-effects model was used to determine the overall effect size using post-intervention values. 38 studies (n=32 COPD; n=5 asthma; n=1 bronchiectasis; study population: n=3777) were included. Overall, implementing a form of PA promotion resulted in a significant increase in step-count: median (IQR) 705 (183-1210) when compared with usual standard care: -64 (-597-229), standardised mean difference (SMD) 0.24 (95% CI: 0.12-0.36), p<0.01. To explore the impact of specific interventions, studies were stratified into subgroups: PA promotion+wearable activity monitor-based interventions (n=17) (SMD 0.37, p<0.01); PA promotion+step-count as an outcome measure (n=9) (SMD 0.18, p=0.09); technology-based interventions (n=12) (SMD 0.16, p=0.01). Interventions promoting PA, particularly those that incorporate wearable activity monitors, result in a significant and clinically meaningful improvement in daily step-count in pwCAD., Competing Interests: Conflict of interest: I.J. Clifton reports personal fees from GlaxoSmithKline, outside the submitted work. The remaining authors have no conflicts to declare., (Copyright ©The authors 2023.)

Epidemiological and retrospective clinical studies on cancer outcomes frequently adjust for patients' comorbid conditions. Despite the existence of multiple comorbidity indices, the Charlson comorbidity index (CCI) is the most frequently applied. Indices are developed in specific settings and the extent of alignment between the development setting and subsequent study is unclear. The present study provides a contemporaneous snapshot of comorbidity indices used in retrospective observational cancer studies and the extent to which cancer type(s), data source(s) and outcome(s) matched the studies in which the indices were developed. A systematic literature search in PubMed identified retrospective, observational studies on outcomes in patients with cancer published between March 2015 and March 2020. Information including the cancer type, data source and outcome were extracted and compared to those used in the validation study of the comorbidity index used. Of 158 papers reviewed, 79 used the CCI, either alone or in combination with other indices. The cancer type matched to that used in the validation study of the comorbidity index in 16 of the 115 studies using an established index, whilst the data source matched in 27 studies and outcome in only two. Justification was rarely provided for index choice (15 of the 115 studies). It may be concluded that, while the CCI remains the dominant comorbidity index, it may not always align to key elements of the study design in terms of cancer type, data source and outcome. A range of indices exists and identification of the most appropriate measure has the potential to improve adjustment for comorbidity. The present study provided information about the indices used in included studies and encourages future studies to consider which comorbidity index offers the best alignment with the study population, data source and question addressed.

Introduction: Patients with inflammatory bowel diseases (IBDs) of the colon are at an increased risk of colorectal cancer (CRC). This study investigates the epidemiology of IBD-CRC and its outcomes., Methods: Using population data from the English National Health Service held in the CRC data repository, all CRCs with and without prior diagnosis of IBD (Crohn's, ulcerative colitis, IBD unclassified, and IBD with cholangitis) between 2005 and 2018 were identified. Descriptive analyses and logistic regression models were used to compare the characteristics of the 2 groups and their outcomes up to 2 years., Results: Three hundred ninety thousand six hundred fourteen patients diagnosed with CRC were included, of whom 5,141 (1.3%) also had a previous diagnosis of IBD. IBD-CRC cases were younger (median age at CRC diagnosis [interquartile range] 66 [54-76] vs 72 [63-79] years [ P < 0.01]), more likely to be diagnosed with CRC as an emergency (25.1% vs 16.7% [ P < 0.01]), and more likely to have a right-sided colonic tumor (37.4% vs 31.5% [ P < 0.01]). Total colectomy was performed in 36.3% of those with IBD (15.4% of Crohn's, 44.1% of ulcerative colitis, 44.5% of IBD unclassified, and 67.7% of IBD with cholangitis). Synchronous (3.2% vs 1.6% P < 0.01) and metachronous tumors (1.7% vs 0.9% P < 0.01) occurred twice as frequently in patients with IBD compared with those without IBD. Stage-specific survival up to 2 years was worse for IBD-associated cancers., Discussion: IBD-associated CRCs occur in younger patients and have worse outcomes than sporadic CRCs. There is an urgent need to find reasons for these differences to inform screening, surveillance, and treatment strategies for CRC and its precursors in this high-risk group., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Objective: To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, and by age and immunocompromised status., Design: Test negative case-control study., Setting: Hospitals, emergency departments, and urgent care clinics in 10 US states, 17 January 2021 to 12 July 2022., Participants: 893 461 adults (≥18 years) admitted to one of 261 hospitals or to one of 272 emergency department or 119 urgent care centers for covid-like illness tested for SARS-CoV-2., Main Outcome Measures: The main outcome was waning of vaccine effectiveness with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine during the omicron and delta periods, and the period before delta was dominant using logistic regression conditioned on calendar week and geographic area while adjusting for age, race, ethnicity, local virus circulation, immunocompromised status, and likelihood of being vaccinated., Results: 45 903 people admitted to hospital with covid-19 (cases) were compared with 213 103 people with covid-like illness who tested negative for SARS-CoV-2 (controls), and 103 287 people admitted to emergency department or urgent care with covid-19 (cases) were compared with 531 168 people with covid-like illness who tested negative for SARS-CoV-2. In the omicron period, vaccine effectiveness against covid-19 requiring admission to hospital was 89% (95% confidence interval 88% to 90%) within two months after dose 3 but waned to 66% (63% to 68%) by four to five months. Vaccine effectiveness of three doses against emergency department or urgent care visits was 83% (82% to 84%) initially but waned to 46% (44% to 49%) by four to five months. Waning was evident in all subgroups, including young adults and individuals who were not immunocompromised; although waning was morein people who were immunocompromised. Vaccine effectiveness increased among most groups after a fourth dose in whom this booster was recommended., Conclusions: Effectiveness of mRNA vaccines against moderate and severe covid-19 waned with time after vaccination. The findings support recommendations for a booster dose after a primary series and consideration of additional booster doses., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: NPK reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies and institutional support from Pfizer for a covid-19 vaccine trial. CM received institutional support from AstraZeneca for a covid-19 vaccine trial. ALN received institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy. SR received grant funding from GlaxoSmithKline and Biofire Diagnostics. Authors declare no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: RCTs have found that type 2 diabetes can be prevented among high-risk individuals by metformin medication and evidence-based lifestyle change programs. The purpose of this study is to estimate the use of interventions to prevent type 2 diabetes in real-world clinical practice settings and determine the impact on diabetes-related clinical outcomes., Methods: The analysis performed in 2020 used 2010‒2018 electronic health record data from 69,434 patients aged ≥18 years at high risk for type 2 diabetes in 2 health systems. The use and impact of prescribed metformin, lifestyle change program, bariatric surgery, and combinations of the 3 were examined. A subanalysis was performed to examine uptake and retention among patients referred to the National Diabetes Prevention Program., Results: Mean HbA1c values declined from before to after intervention for patients who were prescribed metformin (-0.067%; p&lt;0.001) or had bariatric surgery (-0.318%; p&lt;0.001). Among patients referred to the National Diabetes Prevention Program lifestyle change program, the type 2 diabetes postintervention incidence proportion was 14.0% for nonattendees, 12.8% for some attendance, and 7.5% for those who attended ≥4 sessions (p&lt;0.001). Among referred patients to the National Diabetes Prevention Program lifestyle change program, uptake was low (13% for 1‒3 sessions, 15% for ≥4 sessions), especially among males and Hispanic patients., Conclusions: Findings suggest that metformin and bariatric surgery may improve HbA1c levels and that participation in the National Diabetes Prevention Program may reduce type 2 diabetes incidence. Efforts to increase the use of these interventions may have positive impacts on diabetes-related health outcomes., (Copyright © 2022 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Diabetes mellitus (DM) is frequently encountered in the perioperative period. DM may increase the risk of adverse perioperative outcomes owing to the potential vascular complications of DM. We conducted a scoping review to examine the association between DM and adverse perioperative outcomes., Methods: A systematic search strategy of the published literature was built and applied in multiple databases. Observational studies examining the association between DM and adverse perioperative outcomes were included. Abstract screening determined full texts suitable for inclusion. Core information was extracted from each of the included studies including study design, definition of DM, type of DM, surgical specialties, and outcomes. Only primary outcomes are reported in this review., Results: The search strategy identified 2363 records. Of those, 61 were included and 28 were excluded with justification. DM was mostly defined by either haemoglobin A1c (HbA1c) or blood glucose values (19 studies each). Other definitions included 'prior diagnosis' or use of medication. In 17 studies the definition was unclear. Type 2 DM was the most frequently studied subtype. Five of seven studies found DM was associated with mortality, 5/13 reported an association with 'complications' (as a composite measure), and 12/17 studies found DM was associated with 'infection'. Overall, 33/61 studies reported that DM was associated with the primary outcome measure., Conclusion: Diabetes mellitus is inconsistently defined in the published literature, which limits the potential for pooled analysis. Further research is necessary to determine which cohort of patients with DM are most at risk of adverse postoperative outcomes, and how control influences this association., (Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

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., (© 2022 AABB.)

CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after 2 doses of mRNA vaccine has been observed during the period of the SARS-CoV-2 B.1.617.2 (Delta) variant predominance † (1-5), but little is known about durability of protection after 3 doses during periods of Delta or SARS-CoV-2 B.1.1.529 (Omicron) variant predominance. A test-negative case-control study design using data from eight VISION Network sites § examined vaccine effectiveness (VE) against COVID-19 emergency department/urgent care (ED/UC) visits and hospitalizations among U.S. adults aged ≥18 years at various time points after receipt of a second or third vaccine dose during two periods: Delta variant predominance and Omicron variant predominance (i.e., periods when each variant accounted for ≥50% of sequenced isolates). ¶ Persons categorized as having received 3 doses included those who received a third dose in a primary series or a booster dose after a 2 dose primary series (including the reduced-dosage Moderna booster). The VISION Network analyzed 241,204 ED/UC encounters** and 93,408 hospitalizations across 10 states during August 26, 2021-January 22, 2022. VE after receipt of both 2 and 3 doses was lower during the Omicron-predominant than during the Delta-predominant period at all time points evaluated. During both periods, VE after receipt of a third dose was higher than that after a second dose; however, VE waned with increasing time since vaccination. During the Omicron period, VE against ED/UC visits was 87% during the first 2 months after a third dose and decreased to 66% among those vaccinated 4-5 months earlier; VE against hospitalizations was 91% during the first 2 months following a third dose and decreased to 78% ≥4 months after a third dose. For both Delta- and Omicron-predominant periods, VE was generally higher for protection against hospitalizations than against ED/UC visits. All eligible persons should remain up to date with recommended COVID-19 vaccinations to best protect against COVID-19-associated hospitalizations and ED/UC visits., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies and institutional support from Pfizer for a COVID-19 vaccine trial. Charlene McEvoy reports institutional support from AstraZeneca for a COVID-19 vaccine trial. Allison L. Naleway reports institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy. Suchitra Rao reports grant funding from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.

There is limited evidence on the associations between patient safety culture and measures of health care quality in nursing homes. This study examines the relationship between scores on the Agency for Healthcare Research and Quality (AHRQ) Surveys on Patient Safety Culture™ (SOPS®) Nursing Home Survey (NH SOPS) and Centers for Medicare and Medicaid Services Nursing Home Five-Star Quality Ratings. Using data from 186 nursing homes, we conducted multiple regression analyses predicting the Five-Star Quality Ratings from the NH SOPS survey measures. Five NH SOPS measures were related to the Overall, Health Inspections, and Quality Five-Star Ratings. Four NH SOPS measures were related to at least two of the four Five-Star Quality Ratings and three SOPS measures were related to one Five-Star Rating. None of the NH SOPS measures were significantly associated with the Staffing Five-Star Rating. Findings generally indicated that stronger patient safety culture is associated with higher quality ratings.

Background: Severe hypoglycaemia may pose significant risk to individuals with type 2 diabetes (T2D), and evidence surrounding strategies to mitigate this risk is lacking., Methods: Data was re-analysed from a previous randomised controlled trial studying the impact of nurse-led intervention on mortality following severe hypoglycaemia in the community. A Cox-regression model was used to identify baseline characteristics associated with mortality and to adjust for differences between groups. Kaplan-Meier curves were created to demonstrate differences in outcome between groups across different variables., Results: A total of 124 participants (mean age = 75, 56.5% male) were analysed. In univariate analysis, Diabetes Severity Score (DSS), age and insulin use were baseline factors found to correlate to mortality, while HbA1C and established cardiovascular disease showed no significant correlations. Hazard ratio favoured the intervention (0.68, 95% CI: 0.38-1.19) and in multivariate analysis, only DSS demonstrated a relationship with mortality. Comparison of Kaplan-Meier curves across study groups suggested the intervention is beneficial irrespective of HbA1c, diabetes severity score or age., Conclusion: While DSS predicts mortality following severe community hypoglycaemia in individuals with T2D, a structured nurse-led intervention appears to reduce the risk of death across a range of baseline parameters.

Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared the odds of receiving a positive SARS-CoV-2 test result, and thus having laboratory-confirmed COVID-19, between unvaccinated patients with a previous SARS-CoV-2 infection occurring 90-179 days before COVID-19-like illness hospitalization, and patients who were fully vaccinated with an mRNA COVID-19 vaccine 90-179 days before hospitalization with no previous documented SARS-CoV-2 infection. Hospitalized adults aged ≥18 years with COVID-19-like illness were included if they had received testing at least twice: once associated with a COVID-19-like illness hospitalization during January-September 2021 and at least once earlier (since February 1, 2020, and ≥14 days before that hospitalization). Among COVID-19-like illness hospitalizations in persons whose previous infection or vaccination occurred 90-179 days earlier, the odds of laboratory-confirmed COVID-19 (adjusted for sociodemographic and health characteristics) among unvaccinated, previously infected adults were higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine with no previous documented infection (adjusted odds ratio [aOR] = 5.49; 95% confidence interval [CI] = 2.75-10.99). These findings suggest that among hospitalized adults with COVID-19-like illness whose previous infection or vaccination occurred 90-179 days earlier, vaccine-induced immunity was more protective than infection-induced immunity against laboratory-confirmed COVID-19. All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stephanie A. Irving reports support from Westat to Kaiser Permanente Northwest Center for Health Research. Nicola P. Klein reports support from Pfizer to Kaiser Permanente, Northern California for COVID-19 vaccine clinical trials, and institutional support from Merck, GlaxoSmithKline, and Sanofi Pasteur outside the current study. Charlene McEvoy reports support from AstraZeneca to HealthPartners Institute for COVID-19 vaccine trials. Allison L. Naleway reports Pfizer Research funding to Kaiser Permanente Northwest for unrelated study of meningococcal B vaccine safety during pregnancy. Suchitra Rao reports grants from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.

Objectives: To describe blood component usage in transfused children with congenital heart disease undergoing cardiopulmonary bypass surgery across perioperative settings and diagnostic categories., Design: Datasets from U.S. hospitals participating in the National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III were analyzed., Setting: Inpatient admissions from three U.S. hospitals from 2013 to 2016., Patients: Transfused children with congenital heart disease undergoing single ventricular, biventricular surgery, extracorporeal membrane oxygenation., Interventions: None., Measurements and Main Results: Eight hundred eighty-two transfused patients were included. Most of the 185 children with single ventricular surgery received multiple blood products: 81% RBCs, 79% platelets, 86% plasma, and 56% cryoprecipitate. In the 678 patients undergoing biventricular surgery, 85% were transfused plasma, 75% platelets, 74% RBCs, and 48% cryoprecipitate. All 19 patients on extracorporeal membrane oxygenation were transfused RBCs, plasma, and cryoprecipitate, and 18 were transfused platelets. Intraoperatively, patients commonly received all three components, while postoperative transfusions were predominantly single blood components. Pretransfusion hemoglobin values were normal/low-normal for age for all phases of care for single ventricular surgery (median hemoglobin 13.2-13.5 g/dL). Pretransfusion hemoglobin values for biventricular surgeries were higher intraoperatively compared with other timing (12.2 g/dL vs 11.2 preoperative and postoperative; p < 0.0001). Plasma transfusions for all patients were associated with a near normal international normalized ratio: single ventricular surgeries median international normalized ratio was 1.3 postoperative versus 1.8 intraoperative and biventricular surgeries median international normalized ratio was 1.1 intraoperative versus 1.7 postoperative. Intraoperative platelet transfusions with biventricular surgeries had higher median platelet count compared with postoperative pretransfusion platelet count (244 × 109/L intraoperative vs 69 × 109/L postoperative)., Conclusions: Children with congenital heart disease undergoing cardiopulmonary bypass surgery are transfused many blood components both intraoperatively and postoperatively. Multiple blood components are transfused intraoperatively at seemingly normal/low-normal pretransfusion values. Pediatric evidence guiding blood component transfusion in this population at high risk of bleeding and with limited physiologic reserve is needed to advance safe and effective blood conservation practices., Competing Interests: Drs. Hanson’s, Birch’s, and Gottschall’s institutions received funding from the National Heart, Lung, and Blood Institute (NHLBI). Dr. Hanson received support for article research from the NHLBI and the National Institute of Child Health and Human Development. Dr. Birch’s institution received funding from the Centers for Disease Control and Prevention and the Environmental Protection Agency; she disclosed work for hire for Westat. Drs. Karam, Birch, Goel, Patel, Sola-Visner, Sachais, Hauser, Gottschall, Josephson, Hendrickson, Karafin, and Nellis received support for article research from the National Institutes of Health (NIH). Dr. Patel received funding from the NHLBI Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric Program and Mednax. Dr. SolaVisner’s institution received funding from Sysmex America. Dr. Gottschall disclosed government work. Dr. Hendrickson’s institution received funding from the NIH. Dr. Karafin received funding from the NIH from a R23 and R01. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Background: There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department or urgent care clinic., Methods: We conducted a study involving adults (≥50 years of age) with Covid-19-like illness who underwent molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed 41,552 admissions to 187 hospitals and 21,522 visits to 221 emergency departments or urgent care clinics during the period from January 1 through June 22, 2021, in multiple states. The patients' vaccination status was documented in electronic health records and immunization registries. We used a test-negative design to estimate vaccine effectiveness by comparing the odds of a positive test for SARS-CoV-2 infection among vaccinated patients with those among unvaccinated patients. Vaccine effectiveness was adjusted with weights based on propensity-for-vaccination scores and according to age, geographic region, calendar time (days from January 1, 2021, to the index date for each medical visit), and local virus circulation., Results: The effectiveness of full messenger RNA (mRNA) vaccination (≥14 days after the second dose) was 89% (95% confidence interval [CI], 87 to 91) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization, 90% (95% CI, 86 to 93) against infection leading to an ICU admission, and 91% (95% CI, 89 to 93) against infection leading to an emergency department or urgent care clinic visit. The effectiveness of full vaccination with respect to a Covid-19-associated hospitalization or emergency department or urgent care clinic visit was similar with the BNT162b2 and mRNA-1273 vaccines and ranged from 81% to 95% among adults 85 years of age or older, persons with chronic medical conditions, and Black or Hispanic adults. The effectiveness of the Ad26.COV2.S vaccine was 68% (95% CI, 50 to 79) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization and 73% (95% CI, 59 to 82) against infection leading to an emergency department or urgent care clinic visit., Conclusions: Covid-19 vaccines in the United States were highly effective against SARS-CoV-2 infection requiring hospitalization, ICU admission, or an emergency department or urgent care clinic visit. This vaccine effectiveness extended to populations that are disproportionately affected by SARS-CoV-2 infection. (Funded by the Centers for Disease Control and Prevention.)., (Copyright © 2021 Massachusetts Medical Society.)

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 × 10 9 /L (10-90th percentile: 8-51 × 10 9 /L), and 37.9% of transfusions were given at platelet count of >20-50 × 10 9 /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., (© 2021 AABB.)

Objective: To estimate the incidence of blood product transfusion, including red blood cells, platelets, and plasma, and characterize pretransfusion hematologic values for infants during their initial hospitalization after birth., Study Design: Retrospective cohort study using data from 7 geographically diverse US academic and community hospitals that participated in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) from 2013 to 2016. Pretransfusion hematologic values were evaluated closest to each transfusion and no more than 24 hours beforehand., Results: Data from 60 243 infants were evaluated. The incidence of any transfusion differed by gestational age (P < .0001), with 80% (95% CI 76%-84%) transfused at <27 weeks of gestation (n = 329) and 0.5% (95% CI 0.5%-0.6%) transfused at ≥37 weeks of gestation (n = 53 919). The median pretransfusion hemoglobin was 11.2 g/dL (10th-90th percentile 8.8-14.1) for the entire cohort, ranging from 10.5 g/dL (8.8-12.3) for infants born extremely preterm at <27 weeks of gestation to 13.0 g/dL (10.5-15.5) for infants born at term. The median pretransfusion platelet count (×10 9 /L) was 71 (10th-90th percentile 26-135) for the entire cohort, and was >45 for all gestational age groups examined. The median pretransfusion international normalized ratio for the entire cohort was 1.7 (10th-90th percentile 1.2-2.8)., Conclusions: There is wide variability in pretransfusion hemoglobin, platelet count, and international normalized ratio values for neonatal transfusions. Our findings suggest that a large proportion of neonatal transfusions in the US are administered at thresholds greater than supported by the best-available evidence and highlight an opportunity for improved patient blood management., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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 × 10 9 cells/L (14-54 × 10 9 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., (© 2021 AABB.)

Background: Diabetes is considered a risk factor for mortality following a diagnosis of cancer. We hypothesised that the risk will vary due to the heterogeneous nature of the population and accurate classification of vascular complications will improve prediction of clinical outcomes., Methods: The COloRECTal cancer data Repository (CORECT-R) was used to identify individuals with primary colorectal cancer, who underwent surgical resection in England (2005-2016). Diabetes was recorded using ICD10 codes (E10-E14) during inpatient hospital admission in the six years preceding cancer diagnosis, complication status was determined using the adapted Diabetes Complications Severity Index (aDCSI). Survival and post-operative outcomes were compared between groups., Results: Of 232,367 individuals, 28,642 (12.3%) were recorded as having diabetes, 49.2% of whom had complications according to the aDCSI. Patients with diabetes complications had increased incidence of adverse post-operative outcomes (90-day post-operative mortality (6.6% versus 3.2%) and death during the surgical episode (7.9% versus 3.6%)), compared to those without diabetes. Those without complications had rates comparable to the population without diabetes. The odds of death within a year of diagnosis were higher for those with complicated diabetes compared to those without diabetes [OR 1.58 (95%CI 1.51-1.66) p < 0.01], but no difference was observed between those with uncomplicated diabetes and those without diabetes [OR 1.05 (95%CI 0.99-1.11) p = 0.10]., Conclusions: Prediction of outcome following surgery in colorectal cancer patients with diabetes relies on the accurate assessment of complications. This study suggests that the poor post-operative outcomes in diabetes patients may be associated with diabetes complication rather than diabetes itself., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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 HbA 1c 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 HbA 1c levels., (© 2021 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

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., (© 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.)

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., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Plain English Summary: Patient and public involvement (PPI) improves the quality of health research and ensures that research is relevant to patients' needs. Though PPI is increasingly evident in clinical and health services research, there are few examples in the research literature of effective PPI in translational and laboratory-based research. In this paper, we describe the development and evaluation of PPI in a multi-centre European project (EuroTEAM - T owards E arly biomarkers in A rthritis M anagement) that included both translational and laboratory-based and psychosocial research. We found that although most PPI in EuroTEAM was centred around the psychosocial research, there were examples of PPI in the laboratory studies. As the project evolved, researchers became better at accommodating PPI and identifying PPI opportunities. It was generally agreed that PPI had a positive impact on the project overall, particularly on public engagement with the research. We concluded that the inclusion of both psychosocial and laboratory-based research in the same project facilitated PPI across all aspects of the research. In future projects, we would try to specify individual PPI activities in more detail at the project-planning stage, and better accommodate patient partners who are not native speakers of English., Abstract: Background Patient and public involvement (PPI) enhances research quality and relevance and is central to contemporary health policy. The value of PPI has been recognised in rheumatology research, though there are limited examples of PPI in basic and translational science. The EU FP7 funded 'EuroTEAM' ( T owards E arly biomarkers in A rthritis M anagement) project was established to develop biomarker-based approaches to predict the future development of rheumatoid arthritis and incorporated psychosocial research to investigate the perceptions of 'at risk' individuals about predictive testing, and to develop informational resources about rheumatoid arthritis (RA) risk. Patient involvement was central to EuroTEAM from the inception of the project. The objective of this paper is to describe the development of PPI in EuroTEAM, formatively assess the impact of PPI from the perspectives of researchers and patient research partners (PRPs), reflect on successes and lessons learned, and formulate recommendations to guide future projects. Methods Two mixed-methods surveys (for PRPs and researchers) and a teleconference were undertaken to assess the impact of PPI on individual work packages and on EuroTEAM overall. Results There was consensus about the positive impact of PPI on the research and on the experiences of those involved. In particular, the positive impact of PPI on the personal development of researchers, and on effective public engagement with EuroTEAM research were highlighted. Researchers described adapting their practice in future projects to facilitate PPI. Spin-off projects and ongoing collaborations between PRPs and researchers reflected the value of PPI to participants. PPI was more frequently integrated in psychosocial research, though examples of PPI in laboratory/translational science were also described. PRPs asked for more opportunities to contribute meaningfully to basic scientific research and for more extensive feedback on their contributions. Conclusions The findings were used to formulate recommendations to guide effective involvement of patients in future similar projects, including identifying specific training requirements for PRPs and researchers, the identification of PRP focused tasks/deliverables at the project planning stage, and supporting access to involvement for all PRPs. Importantly, the distinctive multidisciplinary approach of EuroTEAM, incorporating both basic science and psychosocial research, facilitated patient involvement in the project overall., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2020.)

Background: There is significant debate as to where to draw the line between undertreating older rectal cancer patients and minimising treatment risks. This study sought to examine the use of radical rectal cancer treatments and associated outcomes in relation to age across the English NHS., Methods: Patient, tumour and treatment characteristics for all patients diagnosed with a first primary rectal cancer in England between 1st April 2009 and 31st December 2014 were obtained from the CORECT-R data repository. Descriptive analyses and adjusted logistic regression models were undertaken to examine any association between age and the use of major resection and post-surgical outcomes. Funnel plots were used to show variation in adjusted rates of major resection., Results: The proportion of patients who underwent a major surgical resection fell from 66.5% to 31.7%, amongst those aged <70 and aged ≥80 respectively. After adjustment, 30-day post-operative mortality, failure to rescue and prolonged length of stay were significantly higher among the oldest group when compared to the youngest. Patient reported outcomes were not significantly worse amongst older patients. Significant variation was observed in adjusted surgical resection rates in the oldest patients between NHS Trusts. The probability of death due to cancer was comparable across all age groups., Conclusions: Older patients who are selected for surgery have good outcomes, often comparable to their younger counterparts. Significant variation in the treatment of older patients could not be explained by differences in measured characteristics and required further investigation., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., (© 2017 AABB.)

Iron deficiency anemia is a common clinical condition often treated with tablets containing 65 mg of elemental iron. Such doses can elicit gastrointestinal side effects lowering patient compliance. Oral iron supplements also increase hepcidin production causing decreased fractional absorption of subsequent doses. Frequent blood donors often become iron deficient. Therefore, they were enrolled in a two-year study involving continued blood donations and randomization to receive no pill, placebo, 19, or 38 mg ferrous gluconate for 60 days. Total body iron (TBI) did not change for the subset of donors in the no pill and placebo groups who completed both enrollment and final visits (P = .21 and P = .28, respectively). However, repeated measures regression analysis on the complete dataset estimated a significant decrease in TBI of 52 mg/year for the placebo and no pill groups (P = .001). The effects of 19 and 38 mg iron supplementation on TBI were indistinguishable (P = .54). TBI increased by 229 mg after the initial 60 days of iron supplementation (P < .0001) and was maintained at this higher level with continued iron supplementation following each subsequent donation. The TBI increase was apportioned 51 mg to red cell iron (P < .0001) and 174 mg to storage iron (P < .0001). Changes in storage iron were negatively impacted by 57 mg due to concurrent antacid use (P = .04). These findings in blood donors suggest that much lower doses of iron than are currently used will be effective for clinical treatment of iron deficiency anemia., (© 2017 Wiley Periodicals, Inc.)

Background: Specimen labeling errors have long plagued the laboratory industry putting patients at risk of transfusion-related death, medication errors, misdiagnosis, and patient mismanagement. Many interventions have been implemented and deemed to be effective in reducing sample error rates. The objective of this review was to identify and evaluate the effectiveness of laboratory practices/ interventions to develop evidence based recommendations for the best laboratory practices to reduce labeling errors., Content: The standardized LMBP™ A-6 methods were used to conduct this systematic review. Total evidence included 12 studies published during the time periods of 1980 to September 2015. Combined data from seven studies found that the interventions developed as a result of improved communication and collaboration between the laboratory and clinical staff resulted in substantial decrease in specimen labeling errors (Median relative percent change in labeling errors: -75.86; IQI: -84.77, -58.00). Further data from subset of four studies showed a significant decrease in specimen labeling errors after the institution of the standardized specimen labeling protocols (Median relative percent decrease in specimen labeling errors: -72.45; IQI: -83.25, -46.50)., Summary: Based on the evidence included in this review, the interventions that enhance the communication and collaboration between laboratory and healthcare professionals can decrease the specimen identification errors in healthcare settings. However, more research is needed to make the conclusion on the effectiveness of other evaluated practices in this review including training and education of the specimen collection staff, audit and feedback of labeling errors, and implementation of new technology (other than barcoding).

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., (© 2017 AABB.)

Purpose: Poorly characterized macromolecular (MM) and baseline artefacts are known to reduce metabolite quantitation accuracy in 1 H 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., (© 2016 The Authors Magnetic Resonance in Medicine published by Wiley Periodicals, Inc. on behalf of International Society for Magnetic Resonance in Medicine.)

This study explored potential gender and racial/ethnic disparities in overall health risk related to 24 health risk indicators selected across six domains: socioeconomic, health status and health care, lifestyle, nutritional, clinical, and environmental. Using the 2003-2006 National Health and Nutrition Examination Surveys (NHANES), it evaluated cross-sectional data for 5,024 adults in the United States. Logistic regression models were developed to estimate prevalence odds ratios (PORs) adjusted for smoking, health insurance status, and age. Analyses evaluated disparities associated with 24 indicator variables of health risk, comparing females to males and four racial/ethnic groups to non-Hispanic Whites. Non-Hispanic Blacks and Mexican Americans were at greater risk for at least 50% of the 24 health risk indicators, including measures of socioeconomic status, health risk behaviors, poor/fair self-reported health status, multiple nutritional and clinical indicators, and blood lead levels. This demonstrates that cumulative health risk is unevenly distributed across racial/ethnic groups. A similarly high percentage (46%) of the risk factors was observed in females. Females as compared to males were more likely to have lower income, lower blood calcium, poor/fair self-reported health, more poor mental health days/month, higher medication usage and hospitalizations, and higher serum levels of some clinical indicators and blood cadmium. This analysis of cumulative health risk is responsive to calls for broader-based, more integrated assessment of health disparities that can help inform community assessments and public health policy.

The sodium iodide-symporter (NIS) mediates uptake of iodide into thyroid follicular cells. This key step in thyroid hormone synthesis is inhibited by perchlorate, thiocyanate (SCN) and nitrate (NO3) anions. When these exposures occur during pregnancy the resulting decreases in thyroid hormones may adversely affect neurodevelopment of the human fetus. Our objectives were to describe and examine the relationship of these anions to the serum thyroid indicators, thyroid stimulating hormone (TSH) and free thyroxine (FT4), in third trimester women from the initial Vanguard Study of the National Children's Study (NCS); and to compare urine perchlorate results with those in pregnant women from the National Health and Nutritional Examination Survey (NHANES). Urinary perchlorate, SCN, NO3, and iodine, serum TSH, FT4, and cotinine were measured and a food frequency questionnaire (FFQ) was administered to pregnant women enrolled in the initial Vanguard Study. We used multiple regression models of FT4 and TSH that included perchlorate equivalent concentration (PEC, which estimates combined inhibitory effects of the anions perchlorate, SCN, and NO3 on the NIS). We used multiple regression to model predictors of each urinary anion, using FFQ results, drinking water source, season of year, smoking status, and demographic characteristics. Descriptive statistics were calculated for pregnant women in NHANES 2001-2012. The geometric mean (GM) for urinary perchlorate was 4.04µg/L, for TSH 1.46mIU/L, and the arithmetic mean for FT4 1.11ng/dL in 359 NCS women. In 330 women with completed FFQs, consumption of leafy greens, winter season, and Hispanic ethnicity were significant predictors of higher urinary perchlorate, which differed significantly by study site and primary drinking water source, and bottled water was associated with higher urinary perchlorate compared to filtered tap water. Leafy greens consumption was associated with higher urinary NO3 and higher urinary SCN. There was no association between urinary perchlorate or PEC and TSH or FT4, even for women with urinary iodine <100µg/L. GM urinary perchlorate concentrations in the full sample (n=494) of third trimester NCS women (4.03µg/L) were similar to pregnant women in NHANES (3.58µg/L)., (Published by Elsevier Inc.)

Background: Advocates for environmental justice, local, state, and national public health officials, exposure scientists, need broad-based health indices to identify vulnerable communities. Longitudinal studies show that perception of current health status predicts subsequent mortality, suggesting that self-reported health (SRH) may be useful in screening-level community assessments. This paper evaluates whether SRH is an appropriate surrogate indicator of health status by evaluating relationships between SRH and sociodemographic, lifestyle, and health care factors as well as serological indicators of nutrition, health risk, and environmental exposures., Methods: Data were combined from the 2003-2006 National Health and Nutrition Examination Surveys for 1372 nonsmoking 20-50 year olds. Ordinal and binary logistic regression was used to estimate odds ratios and 95 % confidence intervals of reporting poorer health based on measures of nutrition, health condition, environmental contaminants, and sociodemographic, health care, and lifestyle factors., Results: Poorer SRH was associated with several serological measures of nutrition, health condition, and biomarkers of toluene, cadmium, lead, and mercury exposure. Race/ethnicity, income, education, access to health care, food security, exercise, poor mental and physical health, prescription drug use, and multiple health outcome measures (e.g., diabetes, thyroid problems, asthma) were also associated with poorer SRH., Conclusion: Based on the many significant associations between SRH and serological assays of health risk, sociodemographic measures, health care access and utilization, and lifestyle factors, SRH appears to be a useful health indicator with potential relevance for screening level community-based health and environmental studies.

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., (© 2016 AABB.)

Purpose: Accurate and fast (1) H 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., (2014 The Authors. Magnetic Resonance in Medicine Published by Wiley Periodicals, Inc. on behalf of International Society of Medicine in Resonance.)

Background: Consumption of finfish and shellfish is the primary exposure pathway of methylmercury (MeHg) in the US. MeHg exposure in utero is associated with neurodevelopmental and motor function deficits. Regulations and fish advisories may contribute to decreased exposure to mercury over time., Objectives: Combine fish tissue mercury (FTHg) concentrations and 1999-2010 NHANES blood mercury concentrations and fish consumption data to investigate trends in blood mercury concentrations, fish consumption, and mercury intake in women of reproductive age., Methods: Blood MeHg was calculated from the blood total and inorganic concentrations. Dietary datasets were combined to estimate 30-day fish consumption, then combined with FTHg concentrations to estimate mercury intake and mercury concentration in the fish consumed. Non-linear and logistic regression analyses were used to evaluate trends over time., Results: Regression analysis found NHANES 1999-2000 to have higher blood MeHg concentrations than the mean of the later releases (p<0.0001) and a positive quadratic trend since 2000 (p=0.004). No trend was observed in fish consumption amount or mercury intake. A decreasing trend was found in the ratio of mercury intake to fish consumed (p=0.04)., Conclusions: The analyses found blood MeHg concentrations in NHANES 1999-2000 to be significantly higher than the mean of the later releases. There was no trend in fish consumption amount across the study period. The analysis found a decreasing trend in the ratio of mercury intake to fish consumed, consistent with women shifting their consumption to fish with lower mercury concentrations., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Renal transplant recipients (RTR) are highly susceptible to urinary tract infections (UTIs) with over 50% of patients having at least one UTI within the first year. Yet it is generally acknowledged that there is considerable insensitivity and inaccuracy in routine urinalysis when screening for UTIs. Thus a large number of transplant patients with genuine urine infections may go undiagnosed and develop chronic recalcitrant infections, which can be associated with graft loss and morbidity. Given a recent study demonstrating ATP is released by urothelial cells in response to bacteria exposure, possibly acting at metabotropic P2Y receptors mediating a proinflammatory response, we have investigated alternative, and possibly more appropriate, urinalysis techniques in a cohort of RTRs. Mid-stream urine (MSU) samples were collected from 53 outpatient RTRs. Conventional leukocyte esterase and nitrite dipstick tests, and microscopic pyuria counts (in 1 μl), ATP concentration measurements, and identification of intracellular bacteria in shed urothelial cells, were performed on fresh unspun samples and compared to 'gold-standard' bacterial culture results. Of the 53 RTRs, 22% were deemed to have a UTI by 'gold-standard' conventional bacteria culture, whereas 87%, 8% and 4% showed evidence of UTIs according to leukocyte esterase dipstick, nitrite dipstick, and a combination of both dipsticks, respectively. Intracellular bacteria were visualized in shed urothelial cells of 44% of RTRs, however only 1 of the 23 RTRs (44%) was deemed to have a UTI by conventional bacteria culture. A significant association of the 'gold-standard' test with urinary ATP concentration combined with visualization of intracellular bacteria in shed urothelial cells was determined using the Fisher's exact test. It is apparent that standard bedside tests for UTIs give variable results and that seemingly quiescent bacteria in urothelial cells are very common in RTRs and may represent a focus of subclinical infection. Furthermore, our results suggest urinary ATP concentration combined with detection of intracellular bacteria in shed urinary epithelial cells may be a sensitive means by which to detect 'occult' infection in RTRs.

Purpose: Little is known about the factors that influence the place of inpatient care for teenage and young adult (TYA) cancer patients. Recent guidelines have recommended centralization of care for this group to a small number of specialized centers. This study aimed to investigate the influence of geography and travel times on the likelihood of admission to an age-specialist center in England during cancer treatment for patients aged 15-24 at the time of diagnosis. Methods: Data for 6788 patients aged 15-24, diagnosed between 2001 and 2006 and treated as an inpatient in England between 2001 and 2009, were obtained from the National Cancer Data Repository. Eight TYA age-specialist centers were identified in England during this time period; road travel times to these centers were calculated using ArcGIS Network Analyst. Factors thought to affect the likelihood of admission, such as diagnostic group, gender, and age at diagnosis were modeled using logistic regression. Results: Overall, 66.9% of patients never received inpatient treatment at a TYA age-specialist center during the course of their treatment. Increasing travel time significantly reduced the likelihood of admission to a TYA age-specialist center after adjustment for case mix factors. Conclusion: Many TYA patients received little or no inpatient treatment at a TYA age-specialist center during their treatment. The variation between diagnostic groups suggests that factors other than distance to the closest center are affecting the likelihood of admission and demonstrates the potential need to consider improvements to the structured referral practice for this unique group of patients.

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., (© 2013 American Association of Blood Banks.)

Purinergic signaling within the kidney is becoming an important focus in the study of renal health and disease. The effectors of ATP signaling, the P2Y and P2X receptors, are expressed to varying extents in and along the nephron. There are many studies demonstrating the importance of the P2Y2 receptor on kidney function, and other P2 receptors are now emerging as participants in renal regulation. The P2X4 receptor has been linked to epithelial sodium transport in the nephron and expression levels of the P2X7 receptor are up-regulated in certain pathophysiological states. P2X7 antagonism has been shown to ameliorate rodent models of DOCA salt-induced hypertension and P2X4 null mice are hypertensive. Interestingly, polymorphisms in the genetic loci of P2X4 and P2X7 have been linked to blood pressure variation in human studies. In addition to the increasing evidence linking these two P2X receptors to renal function and health, a number of studies link the two receptors in terms of physical associations between their subunits, demonstrated both in vitro and in vivo. This review will analyze the current literature regarding interactions between P2X4 and P2X7 and assess the potential impact of these with respect to renal function.

Background: There are few surveillance studies analyzing genotypes or primary (transmitted) drug resistance in HIV-infected blood donors in Brazil. The aim of this study was to characterize patterns of HIV genotypes and primary resistance among HIV-seropositive donors identified at 4 geographically dispersed blood centers in Brazil., Methods: All HIV-infected donors who returned for counseling at the 4 REDS-II Hemocenters in Brazil from January 2007 to March 2011 were invited to participate in a case-control study involving a questionnaire on risk factors. Viral sequencing was also offered to positive cases to assign genotypes and to detect and characterize primary resistance to reverse transcriptase and protease inhibitors according to World Health Organization guidelines., Results: Of the 341 HIV-seropositive donors who consented to participate in the risk factor and genetics study, pol sequences were obtained for 331 (97%). Clade B was predominant (76%) followed by F (15%) and C (5%). Primary resistance was present in 36 [12.2%, 95% confidence interval (CI) 8.2 to 15.5] of the 303 individuals not exposed to antiretroviral therapy, varying from 8.2% (95% CI: 2.7 to 13.6) in Recife to 19.4% in São Paulo (95% CI: 9.5 to 29.2); there were no significant correlations with other demographics or risk factors., Conclusions: Although subtype B remains the most prevalent genotype in all 4 areas, increasing rates of subtype C in Sao Paulo and F in Recife were documented relative to earlier reports. Transmitted drug resistance was relatively frequent, particularly in the city of Sao Paulo which showed an increase compared with previous HIV-seropositive donor data from 10 years ago.