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Objective This study aimed to assess the iron status prior to discharge in very low birth weight (VLBW) infants utilizing reticulocyte hemoglobin content (CHr) and evaluate the impact of delayed cord clamping (DCC) on iron status. Study Design This is a retrospective analysis of VLBW infants from two tertiary level of care Neonatal Intensive Care Units. The primary outcome was the proportion of VLBW infants with low CHr (<29 pg) prior to discharge. Hematologic parameters were also compared between infants who received or did not receive DCC. Infants with a positive newborn screen for hemoglobin Bart's were excluded. Results Among the 315 infants included, 99 infants (31.4%) had low CHr prior to discharge. The median (interquartile range) CHr prior to discharge was 30.8 pg (28.4–39 pg). DCC was performed in 46.7% of infants. Hemoglobin at birth, discharge, and CHr prior to discharge were higher and the need for blood transfusion and the number of infants with low CHr prior to discharge were lower in the DCC group. Conclusion Approximately 31.4% of VLBW infants had low CHr near the time of discharge suggesting they were iron deficient. DCC improved hematological parameters prior to discharge in VLBW infants. CHr content can be used to guide iron supplementation in VLBW infants to potentially improve their iron status and long-term neurocognitive outcomes. Key Points DCC was associated with an improved hemoglobin and iron status at discharge in VLBW infants. CHr is an early and reliable marker for iron deficiency. Approximately one in three VLBW infants can be iron deficient at the time of discharge. [ABSTRACT FROM AUTHOR]

Summary: This study investigated the relationship between obstructive sleep apnea and haemoglobin A1c (HbA1c) among Hispanics/Latinos in the United States and assessed whether this relationship was moderated by glycaemic status. This was a cross‐sectional analysis of the Hispanic Community Health Study/Study of Latinos cohort. The sample consisted of 13,394 participants with valid measures of obstructive sleep apnea, HbA1c, and study covariates. Obstructive sleep apnea was assessed with the apnea–hypopnea index and categorised as obstructive sleep apnea if the apnea–hypopnea index was ≥5 events/h. HbA1c measures were obtained through fasting blood samples. Fasting plasma glucose (FPG), 2‐h post‐load plasma glucose (2h‐PG) and use of antihyperglycaemic medications were used to define glycaemic status (i.e., normoglycaemia [FPG < 5.6 mmol/L (< 100 mg/dL) and 2h‐PG < 7.8 mmol/L (140 mg/dL)], prediabetes [FPG 5.6‐6.9 mmol/L (100‐125 mg/dL), and/or 2h‐PG 7.8‐11.0 mmol/L (140‐199 mg/dL)], diabetes without treatment [FPG > 7.0 mmol/L (≥ 126 mg/dL) and/or 2h‐PG ≥ 11.1 mmol/L (≥ 200 mg/dL)], and diabetes with treatment. Multivariable linear regression was used to calculate adjusted least square means. Overall, 25.9% of the sample had obstructive sleep apnea and 49.2% had normal glycaemic levels, 36.1% had prediabetes, 6.5% diabetes without receiving treatment, and 8.3% diabetes and undergoing treatment for it. Participants with obstructive sleep apnea had significantly higher adjusted mean HbA1c (adjusted mean [standard error] 5.85 [0.03)]) than those without (5.70 [0.02)]; p < 0.001). Models stratified by diabetes status showed that the association between obstructive sleep apnea (versus not) and higher HbA1c was only for participants with normal glycaemic status (adjusted mean [standard error] 5.27 [0.01] versus 5.30 [0.01]; p = 0.013) and prediabetes (5.59 [0.01] versus 5.66 [0.01]; p < 0.001). In conclusion, obstructive sleep apnea was associated with higher HbA1c in a diverse sample of Hispanic/Latino adults in the United States. This association was present only for participants with normal glycaemic status or with prediabetes. Studies are needed to further understand the clinical implications of the association between obstructive sleep apnea and HbA1c according to glycaemic status. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Guidelines for monitoring of medications frequently used in the gender-affirming care of transgender and gender-diverse (TGD) adolescents are based on studies in adults or other medical conditions. In this study, we aimed to investigate commonly screened laboratory measurements in TGD adolescents receiving gender-affirming hormone therapy (GAHT). METHODS: TGD adolescents were recruited from 4 study sites in the United States before beginning GAHT. Hemoglobin, hematocrit, hemoglobin A1c, alanine transaminase, aspartate aminotransferase, prolactin, and potassium were abstracted from the medical record at baseline and at 6, 12, and 24 months after starting GAHT. RESULTS: Two-hundred and ninety-three participants (68% designated female at birth) with no previous history of gonadotropin-releasing hormone analog use were included in the analysis. Hemoglobin and hematocrit decreased in adolescents prescribed estradiol (-1.4 mg/dL and -3.6%, respectively) and increased in adolescents prescribed testosterone (+1.0 mg/dL and 13.9%) by 6 months after GAHT initiation. Thirteen (6.5%) participants prescribed testosterone had hematocrit > 50% during GAHT. There were no differences in hemoglobin A1c, alanine transaminase, or aspartate aminotransferase. There was a small increase in prolactin after 6 months of estradiol therapy in transfeminine adolescents. Hyperkalemia in transfeminine adolescents taking spironolactone was infrequent and transient if present. CONCLUSIONS: Abnormal laboratory results are rare in TGD adolescents prescribed GAHT and, if present, occur within 6 months of GAHT initiation. Future guidelines may not require routine screening of these laboratory parameters beyond 6 months of GAHT in otherwise healthy TGD adolescents. [ABSTRACT FROM AUTHOR]

Objective This study aimed to compare the effectiveness of sustained uterine compression versus uterine massage in reducing blood loos after a vaginal delivery. Study Design This was a prospective randomized trial conducted at the American University of Beirut Medical Center (AUBMC) between October 2015 and October 2017. Inclusion criteria were women with a singleton pregnancy at ≥36 weeks of gestation, with less than three previous deliveries, who were candidates for vaginal delivery. Participants were randomized into two groups, a sustained uterine compression group (group 1) and a uterine massage group (group 2). Incidence of postpartum hemorrhage (blood loss of ≥500 mL) was the primary outcome. We assumed that the incidence of postpartum hemorrhage at our institution is similar to previously published studies. A total of 545 women were required in each arm to detect a reduction from 9.6 to 4.8% in the primary outcome (50% reduction) with a one-sided α of 0.05 and a power of 80%. Factoring in a 10% dropout rate. Secondary outcomes were admission to intensive care unit (ICU), postpartum complications, drop in hemoglobin, duration of hospital stay, maternal pain, use of uterotonics, or of surgical procedure for postpartum hemorrhage. Results A total of 550 pregnant women were recruited, 273 in group 1 and 277 in group 2. There was no statistically significant difference in baseline characteristics between the two groups. Type of anesthesia, rate of episiotomy, lacerations, and mean birth weight were also equal between the groups. Incidence of the primary outcome was not different between the two groups (group 1: 15.5%, group 2: 15.4%; p = 0.98). There was no statistically significant difference in any of the secondary outcomes between the two groups, including drop in hemoglobin (p = 0.79). Conclusion There was no difference in blood loss between sustained uterine compression and uterine massage after vaginal delivery. Key Points Transabdominal uterine compression and uterine massage are appropriate to prevent postpartum hemorrhage. No significant difference in blood loss or maternal discomfort observed between the two techniques. Both methods are equally effective and either one can be used based on provider preference. [ABSTRACT FROM AUTHOR]

Introduction: Coronavirus disease 2019 (COVID‐19) is associated with poor outcomes in sickle cell disease (SCD) patients. However, there is a paucity of data comparing hemoglobin (Hb) genotypes in SCD and infection outcomes. Methods: The National Inpatient Sample was used to identify the record of hospitalizations with COVID‐19 and SCD in 2020 using the International Classification of Disease, Tenth Revision codes. Study outcomes (invasive mechanical ventilation, extracorporeal membrane oxygenation, shock, vasopressor use, measures of resource utilization, and in‐hospital mortality) were compared between hemoglobin SS, SC, and S‐beta thalassemia (Sβ). Results: Of the 102 975 COVID‐19 hospitalizations with SCD, 87.26% had HbSS, 7.16% had HbSC, and 5.58% had HbSβ. Younger patients were more likely to have HbSS, while older patients were likely to have HbSC and HbSβ. HbSS was more frequent with Blacks, while HbSβ was more prevalent with Whites and Hispanics. Though measures of resource utilization were higher in HbSS, there was no significant difference in in‐hospital outcomes between the three genotypes. Conclusion: There is no difference in COVID‐19 outcomes among Hb genotypes in SCD. Further studies are needed to explore the reasons for this observation. [ABSTRACT FROM AUTHOR]

Sickle cell disease (SCD) is a life-threatening condition. Given the nature of the disease and associated complications with high mortality and morbidity rates, it is imperative that patients are diagnosed in early infancy, are established with specialists and general pediatric care immediately, and receive continuity in care. A percentage of patients diagnosed with SCD fall within a vulnerable, at-risk population. This population may face greater social barriers that lead to missed or late diagnosis and therefore delayed management, significantly increasing the risk of morbidity and mortality. Screening tools such as state newborn screens help to identify the diagnosis early. However, patients in vulnerable, at-risk populations who are not established in the health care system may not receive timely communication about their illness and necessary next steps for care. We present a case of a 12-month-old female who is an example of one of the many patients who despite having undergone newborn screening, fell through the cracks due to social barriers including housing instability, food insecurity, and lack of access to transportation. This paper emphasizes the need for and provides a real example of the benefit of access to longitudinal primary care for vulnerable patients. We also demonstrate the role of primary care in clearing the care gaps and coordinating services quickly to ultimately prevent life-threatening complications specifically for children with previously undiagnosed chronic illnesses. [ABSTRACT FROM AUTHOR]

Objective Umbilical cord blood (UCB) for admission laboratories is an approach to decrease anemia risk in very low birth weight (VLBW) neonates. We hypothesized that UCB use results in higher hemoglobin concentration [HgB] around 24 hours of life. Study Design A randomized control trial among VLBW infants whose admission laboratories were drawn from UCB (n = 39) or the infant (n = 41) in three U.S. military NICUs (clinicaltrials.gov#NCT02103296). Results No demographic differences were observed between groups. UCB infants had higher [HgB] at 12 to 24 hours of life (15.5 vs. 14.0 g/dL, p = 0.02). The median time to first transfusion was 17 days longer in the experimental group (p = 0.04), and at discharge, their number of donor exposures was lower (1.1 vs. 1.8, p = 0.04). Conclusion In the first 24 hours of life that is a period of higher risk for hemodynamic instability, UCB utilization for admission bloodwork in VLBW infants results in higher [HgB]. Key Points Umbilical cord blood laboratory work in preterm infants is feasible. Cord blood use for admission laboratories results in increased hemoglobin in the first 24 hours of life. Cord blood use for admission laboratories delays time to first transfusion in preterm infants. [ABSTRACT FROM AUTHOR]

The article focuses on comparing the use of direct oral anticoagulants (DOACs) to conventional anticoagulants for the treatment of pulmonary embolism (PE). It mentions the study found that DOACs have similar efficacy and safety profiles compared to conventional anticoagulants for the treatment of PE, suggesting that DOACs offer practical advantages such as ease of use and no need for monitoring.

Objectives The cytokine oncostatin M (OSM) is implicated in the pathology of SSc. Inhibiting OSM signalling using GSK2330811 (an anti-OSM monoclonal antibody) in patients with SSc has the potential to slow or stop the disease process. Methods This multicentre, randomized, double-blind, placebo-controlled study enrolled participants ≥18 years of age with active dcSSc. Participants were randomized 3:1 (GSK2330811:placebo) in one of two sequential cohorts to receive GSK2330811 (cohort 1: 100 mg; cohort 2: 300 mg) or placebo s.c. every other week for 12 weeks. The primary endpoint was safety; blood and skin biopsy samples were collected to explore mechanistic effects on inflammation and fibrosis. Clinical efficacy was an exploratory endpoint. Results Thirty-five participants were randomized to placebo (n  = 8), GSK2330811 100 mg (n  = 3) or GSK2330811 300 mg (n  = 24). Proof of mechanism, measured by coordinate effects on biomarkers of inflammation or fibrosis, was not demonstrated following GSK2330811 treatment. There were no meaningful differences between GSK2330811 and placebo for any efficacy endpoints. The safety and tolerability of GSK2330811 were not favourable in the 300 mg group, with on-target, dose-dependent adverse events related to decreases in haemoglobin and platelet count that were not observed in the 100 mg or placebo groups. Conclusion Despite a robust and novel experimental medicine approach and evidence of target engagement, anticipated SSc-related biologic effects of GSK2330811 were not different from placebo and safety was unfavourable, suggesting OSM inhibition may not be a useful therapeutic strategy in SSc. Trial registration number ClinicalTrials.gov, NCT03041025; EudraCT, 2016-003417-95. [ABSTRACT FROM AUTHOR]

Subcutaneous pegcetacoplan (EMPAVELI® in the USA and ASPAVELI® in the EU) is the first complement component 3 (C3) inhibitor approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the USA, and in adults with PNH who are anaemic after ≥ 3 months of treatment with a C5 inhibitor in the EU. In the phase III PRINCE trial in adults with PNH who were anaemic and naïve to a complement inhibitor therapy, pegcetacoplan was superior to the control group (supportive care, excluding complement inhibitors) in achieving haemoglobin stabilization and reducing lactate dehydrogenase levels. Similarly, in the phase III PEGASUS trial in adults with PNH who had a haemoglobin level < 10.5 g/dL despite eculizumab therapy, pegcetacoplan was superior to eculizumab in improving haemoglobin levels. In both trials, pegcetacoplan also improved other clinical and haematological parameters of haemolysis, as well as quality of life (QOL) outcomes. Clinical benefits of pegcetacoplan were sustained for up to 48 weeks of treatment. Pegcetacoplan was generally well tolerated in patients with PNH, with its tolerability profile being similar in patients previously treated with eculizumab and in complement inhibitor-naïve patients. Long-term data would be beneficial to further support the safety profile of pegcetacoplan. Current evidence indicates that pegcetacoplan is a valuable treatment option for adults with PNH. Plain Language Summary: Paroxysmal nocturnal haemoglobinuria (PNH) is a rare haematological disorder that is characterized by complement-mediated haemolysis, fatigue and thrombotic events. Complement component 5 (C5) inhibitors eculizumab and ravulizumab have demonstrated substantial efficacy in reducing intravascular haemolysis and improving quality of life (QOL) in patients with PNH; however, many patients continue to exhibit anaemia and require transfusions because of uncontrolled extravascular haemolysis. Subcutaneous pegcetacoplan (EMPAVELI® in the USA and ASPAVELI® in the EU) is the first C3 inhibitor approved in the USA and EU for the treatment of PNH. Pegcetacoplan targets C3 in the complement cascade, upstream of C5, thereby providing control over both intravascular and extravascular haemolysis. Pegcetacoplan was superior to supportive care in improving clinical and haematological outcomes in patients with PNH who were naïve to a complement inhibitor therapy. Similarly, pegcetacoplan was superior to eculizumab in improving clinical and haematological outcomes in patients with uncontrolled PNH despite eculizumab therapy. Pegcetacoplan also improved QOL and fatigue symptoms. Pegcetacoplan was generally well tolerated, with most adverse events being mild to moderate in severity. Current evidence indicates that pegcetacoplan is a valuable treatment option for adults with PNH. [ABSTRACT FROM AUTHOR]

Iron deficiency and the more severe sequela, iron deficiency anemia, are public health problems associated with morbidity and mortality, particularly among pregnant women and younger children. The 1998 Centers for Disease Control and Prevention recommendations for prevention and control of iron deficiency in the United States is old and does not reflect recent evidence but is a foundational reference for many federal, clinical, and program guidelines. Surveillance data for iron deficiency are sparse at all levels, with critical gaps for pregnant women and younger children. Anemia, iron deficiency, and iron deficiency anemia are often conflated but should not be. Clinical guidelines for anemia, iron deficiency, and iron deficiency anemia give inconsistent recommendations, causing nonsystematic assessment of iron deficiency. Screening for iron deficiency typically relies on identifying anemia, despite anemia's low sensitivity for iron deficiency. In the National Health and Nutrition Examination Survey, more than 70% of iron deficiency is missed among pregnant women and children by relying on hemoglobin for iron deficiency screening. To improve assessment and diagnosis and strengthen surveillance, better and more complete data and updated foundational guidance on iron deficiency and anemia are needed that consider new evidence for measuring and interpreting laboratory results. (Am J Public Health. 2022;112(S8):S826–S835. https://doi.org/10.2105/AJPH.2022.306998) [ABSTRACT FROM AUTHOR]

Type 2 diabetes mellitus (T2DM) affects 31.5 million adults in the United States and is commonly treated in primary care settings. One promising approach to comprehensive care is to focus on an all-or-none diabetes bundle measure, which ensures each patient meets a set of guideline-recommended measures. This requires a practice-level coordinated strategy. The purpose of this initiative was to help health care organizations (HCOs) improve the care and outcomes of patients with T2DM using an all-or-none bundle measure. This observational study was carried out in the context of a national best practices learning Collaborative that implemented targeted interventions in primary care settings and measured success using an all-or-none bundle measure. Ten AMGA member-HCOs, across 8 states, treating nearly 300,000 adult patients with T2DM in primary care participated. The primary measure, the Together 2 Goal® Core Bundle, included hemoglobin A1c (A1c) control (<8%), blood pressure (BP) control (<140/90 mmHg), lipid management (prescribed a statin), and medical attention for nephropathy. All 10 HCOs improved the Core Bundle measure during the 12-month Collaborative. The rate for the Core Bundle improved from 40.2% to 42.8%, an absolute increase of 2.6% (P < 0.001). In addition, 9 HCOs improved BP control, 8 improved lipid management, 6 improved attention to nephropathy, and 4 improved A1c control. Implementing interventions in primary care settings was successful in achieving comprehensive care for an estimated additional 7700 people living with T2DM who met all 4 components of the bundle measure during the 12-month intervention period. [ABSTRACT FROM AUTHOR]

Ageing is associated with reduced muscle mass, strength, flexibility and balance, resulting in a poor quality of life (QOL). Past studies have occurred in highly controlled laboratory settings which provide strong support to determine whether similar gains can be made in community programmes. Twenty participants were enrolled in an eight-week community-based resistance training programme (mean age = 61.3 (standard error (SE) = 0.9) years); Body Mass Index = 32.0 (SE = 1.3) kg/m2). All participants completed surveys to assess outcomes associated with QOL. Given the relationship between muscle function and nerve health, nerve conduction studies (NCS) were also conducted in a separate group of participants (mean age = 64.9 (SE = 2.0) years; Body Mass Index = 32.6 (SE = 1.9) kg/m2). This community-based training programme significantly improved QOL measures in older adults (p < 0.001). Although weight loss was not the primary outcome of the study, participants reduced their body weights (p < 0.001), by primarily reducing fat mass (p = 0.007) while maintaining muscle mass. Significant improvements were observed in muscle strength (2.2%), flexibility and balance (3.2–464.2%, p ⩽ 0.05 for all). Improvements were also observed in plasma glucose (p = 0.05), haemoglobin A1C (p = 0.06) and aldolase enzyme levels (p < 0.001). Scores for surveys on memory and sleep improved (p < 0.05). Improved QOL was associated with increased lean mass (r = −0.714, p = 0.002), decreased fat mass (r = −0.702, p = 0.003) and improved flexibility and balance (r = −0.627, p = 0.008). An eight-week, community-based resistance training programme significantly improved QOL in older adults. Influence on the lipid profile and NCS still needs further investigation. [ABSTRACT FROM AUTHOR]

Background: A blood gas analyzer is a point-of-care (POC) testing device used in the Emergency Department (ED) to manage critically ill patients. However, there were differences in results found from blood gas analyzers for hemoglobin (Hgb) and electrolytes parameters. We conducted a comparative validity study in ED in patients who had requirements of venous gas analysis, complete blood count, and electrolytes. The objective was to find the correlation of Hgb, sodium (Na+), and potassium (K+) values between the blood gas analyzer and laboratory autoanalyzer. Methods: A total of 206 paired samples were tested for Hgb, Na+, and K+. Total 4.6 ml of venous blood was collected from each participant, 0.6 ml was used for blood gas analysis as POC testing and 4 ml was sent to the central laboratory for electrolyte and Hgb estimation. Results: The mean difference between POC and laboratory method was 0.608 ± 1.41 (95% confidence interval [CI], 0.41–0.80; P < 0.001) for Hgb, 0.92 ± 3.5 (95% CI, 0.44–1.40) for Na+, and 0.238 ± 0.62 (95% CI, −0.32–0.15; P < 0.001) for K+. POC testing and laboratory method showed a strong positive correlation with Pearson correlation coefficient (r) of 0.873, 0.928, and 0.793 for Hgb, Na+, and K+, respectively (P < 0.001). Conclusion: Although there was a statistical difference found between the two methods, it was under the United States Clinical Laboratory Improvement Amendment range. Hence, starting the therapy according to the blood gas analyzer results may be beneficial to the patient and improve the outcome. [ABSTRACT FROM AUTHOR]

This supplement discusses the potential utility of CGM in diabetes management, the updated Medicare coverage criteria, the CGM systems cleared by the FDA, and key steps and challenges in prescribing CGM. This supplement was supported by an educational grant to the AAFP from Abbott Diabetes Care.
[ABSTRACT FROM AUTHOR]

Dyslipidaemia, a significant risk factor of CVD, is threatening human health worldwide. PUFA are crucial long-chain fatty acids for TAG synthesis and removal, potentially decreasing dyslipidaemia risk. We examined dyslipidaemia prevalence among 15 244 adults aged ≥ 20 years from National Health and Nutrition Examination Survey 2009–2016. Dyslipidaemia was defined as total cholesterol ≥ 240 mg/dl, or HDL-cholesterol < 40 mg/dl/50 mg/dl for males/females, respectively, or LDL-cholesterol ≥ 160 mg/dl, or TAG ≥ 200 mg/dl, or taking lipid-modifying medications. We measured the daily PUFA intake using a 24-h dietary recall. Demographics, social economics, and lifestyle factors were collected using questionnaires/interviews. Additionally, we measured Se and Hg levels in the whole blood. Logistic regression models were used to examine the association between PUFA and dyslipidaemia. The unweighted and weighted dyslipidaemia prevalences were 72·4% and 71·0 %, respectively. When grouped into tertiles, PUFA intake above 19·524 g/d was associated with an independent 19 % decrease in dyslipidaemia risk (OR = 0·81 (95 % CI 0·71, 0·94)) compared with the lowest tertile (PUFA intake ≤ 12·349 g/d). A threshold inverse association was further determined by the restricted cubic spline analysis. When PUFA intake was increased to its turning point, that is, 19 g/d, the lower nadir risk for dyslipidaemia was obtained (OR = 0·72 (95 % CI 0·56, 0·89)). When the exposure was the sum of α-linolenic acid and octadecatetraenoic acid, the inverse linear association remained. Dietary PUFA intake is a beneficial factor for dyslipidaemia among American adults, independent of many potential confounders, including Hg and Se. [ABSTRACT FROM AUTHOR]

Objectives: Given the long-term consequences of untreated diabetes, patients benefit from timely diagnoses. Payer policies often recognize glucose but not hemoglobin A1c (HbA1c) for diabetes screening. This study evaluates the different information that glucose and HbA1c provide for diabetes screening.Methods: We conducted a retrospective review of national clinical laboratory testing during 2020 when glucose and HbA1c were ordered for routine diabetes screening, excluding patients with known diabetes, out-of-range glucose, or metabolic syndrome.Results: Of 15.47 million glucose and HbA1c tests ordered simultaneously, 672,467 (4.35%) met screening inclusion criteria; 116,585 (17.3%) were excluded because of diabetes-related conditions or the specimen was nonfasting, leaving 555,882 result pairs. More than 1 in 4 patients 60 years of age or older with glucose within range had an elevated HbA1c level. HbA1c claims were denied more often for Medicare beneficiaries (38,918/65,273 [59.6%]) than for other health plans combined (23,234/291,764 [8.0%]).Conclusions: Although many health plans do not cover HbA1c testing for diabetes screening, more than 1 in 4 glucose screening patients 60 years of age or older with an in-range glucose result had a concurrent elevated HbA1c result. Guideline developers and health plans should explicitly recognize that glucose and HbA1c provide complementary information and together offer improved clinical utility for diabetes screening. [ABSTRACT FROM AUTHOR]

Objectives: To describe real-world use/effectiveness of pegcetacoplan (PEG) in paroxysmal nocturnal haemoglobinuria (PNH)., Methods: Data were drawn from the Adelphi PNH Disease Specific Programme™, a cross-sectional survey conducted in France, Italy, Germany, Spain and the United States from January to November 2022. Patients had a confirmed PNH diagnosis and received PEG for ≥1 month. Physicians reported patient characteristics, treatment use/satisfaction and their perception of patients' fatigue and health-related quality of life (HRQoL). Patients reported treatment satisfaction and completed questionnaires assessing fatigue, HRQoL and productivity. Descriptive statistics were reported., Results: Overall, 14 physicians provided data for 61 patients who had received 1080 mg/dose PEG for 1.3-14.8 months. At data collection compared to PEG initiation: haemoglobin was 2.5 g/dL higher on average; proportion of patients with lactate dehydrogenase (LDH) ≥1.5 × upper limit of normal was reduced by 27.4%; physician-perceived fatigue was lower and HRQoL better. Physician- and patient-reported treatment satisfaction was high for >90% of patients. Physicians and patients were more satisfied with PEG than previously prescribed C5 complement inhibitors. Mean work impairment and activity impairment in the 7 days prior to data collection were 32.9% and 22.4%, respectively., Conclusions: These real-world data support the effectiveness of PEG through positive effects on haemoglobin, LDH, fatigue and HRQoL., (© 2023 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.)

Objective: This study aimed to quantify the indirect costs of sickle cell disease in the United States.Methods: Adult patients from a sickle cell disease clinic at an urban academic healthcare system completed an adapted Institute for Medical Technology Assessment Productivity Cost Questionnaire related to the impact of their disorder on absenteeism, presenteeism, ability to contribute through unpaid work outside of employment, and other aspects of life. Additional data were collected from patient records about each participant's genotype, total hemoglobin level, and pain level.Results: Of the 192 individuals, 187 who completed the survey reported experiencing vaso-occlusive crisis pain events during the last year that negatively affected their productivity at work and in daily roles. Three-fourths of respondents reported impairment in their ability to complete everyday tasks, such as caring for children, running errands, doing housework, shopping for groceries, and volunteer (unpaid) work. Only 30% of respondents reported being employed or self-employed. Of those employed, estimated costs of absenteeism and presenteeism attributable to pain events averaged $15 103 per person annually. Estimated total annual losses in unpaid work productivity averaged $3 145 862 for the study respondents and another $2 870 652 for their caregivers.Conclusions: Sickle cell disease affected the work productivity, nonwork productivity, and the daily lives of adults seen with the disorder in an academic medical center. [ABSTRACT FROM AUTHOR]

Objective: Short- and long-term glycemic variability are risk factors for diabetes complications. However, there are no validated A1C target ranges or measures of A1C stability in older adults. We evaluated the association of a patient-specific A1C variability measure, A1C time in range (A1C TIR), on major adverse outcomes.Research Design and Methods: We conducted a retrospective observational study using administrative data from the Department of Veterans Affairs and Medicare from 2004 to 2016. Patients were ≥65 years old, had diabetes, and had at least four A1C tests during a 3-year baseline period. A1C TIR was the percentage of days during the baseline in which A1C was in an individualized target range (6.0-7.0% up to 8.0-9.0%) on the basis of clinical characteristics and predicted life expectancy. Increasing A1C TIR was divided into categories of 20% increments and linked to mortality and cardiovascular disease (CVD) (i.e., myocardial infarction, stroke).Results: The study included 402,043 veterans (mean [SD] age 76.9 [5.7] years, 98.8% male). During an average of 5.5 years of follow-up, A1C TIR had a graded relationship with mortality and CVD. Cox proportional hazards models showed that lower A1C TIR was associated with increased mortality (A1C TIR 0 to <20%: hazard ratio [HR] 1.22 [95% CI 1.20-1.25]) and CVD (A1C TIR 0 to <20%: HR 1.14 [95% CI 1.11-1.19]) compared with A1C TIR 80-100%. Competing risk models and shorter follow-up (e.g., 24 months) showed similar results.Conclusions: In older adults with diabetes, maintaining A1C levels within individualized target ranges is associated with lower risk of mortality and CVD. [ABSTRACT FROM AUTHOR]

The association between elevated hemoglobin A1c (HbA1c) levels and the risk of postoperative infection after penile prosthesis surgery remains controversial. To examine the association between HbA1c levels and penile implant infections in men undergoing inflatable penile prosthesis (IPP) surgery for erectile dysfunction using a large insurance claims database. This was a retrospective review using Optum's de-identified Clinformatics Data Mart Database. Male subjects 18 years and older with available laboratory data undergoing IPP insertion between 2003 and 2018 were included. Administrative diagnosis and procedural codes were used to assess subsequent penile implant revision surgery status for either infectious or noninfectious causes. Associated conditions were controlled for such as smoking status, hyperlipidemia, hypertension, obesity status, and Peyronie's disease. The main outcomes were risk of revision for infection and time to revision. A total of 2,363 individuals underwent initial IPP insertion and had available HbA1c data with a mean HbA1c of 6.9%. The overall IPP infection revision rate was 3.9% and the highest rate of 12.1% was seen in the highest HbA1c group (>10%). After adjusting for demographic and health factors, a higher HbA1c level was associated with a higher risk of revision for infection, with every 1 point increase in HbA1c conferring an increased risk of infection requiring revision by 29% (95% CI 17–42%). When infections did occur, they happened sooner in men with HbA1c > 10.0% with an average of 1.3 months vs 3.5 months in the HbA1c < 6.0% group. These findings provide insight into the potential relationship between HbA1c levels and postoperative risk of infection after penile prosthesis surgery and may aid in clinical decision-making. Strengths include the large sample size, length of data coverage, and real-world analysis of surgeries done across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact infection rates. While the overall risk of penile prosthesis infection remains modest, the current report notes an increased risk of infection for diabetic men with poor glycemic control. Chen T, Li S, Eisenberg ML. The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data. J Sex Med 2021;18:1104–1109. [ABSTRACT FROM AUTHOR]

Background Women living with HIV (WLHIV) have a higher prevalence of anemia than women without HIV, possibly related to the effects of HIV and antiretroviral medications. Objectives To estimate the prevalence of anemia in the third trimester of pregnancy and the effect of anemia on preterm births in WLHIV in the longitudinal, US-based Pediatric HIV/AIDS Cohort Study (PHACS). Methods During the third trimester, we obtained up to three 24-hour dietary recalls to estimate daily intakes of nutrients and measured serum concentrations of iron, vitamin B6, vitamin B12, zinc, folate, ferritin, total iron-binding capacity (TIBC), and high sensitivity C-reactive protein. Third trimester anemia was defined as hemoglobin < 11 g/d and iron-deficiency anemia (IDA) was defined as low ferritin, high TIBC, and low transferrin saturation. A preterm birth was defined as birth at < 37 completed weeks of gestation, regardless of etiology. We fit separate modified Poisson regression models for each outcome (anemia, preterm birth) and each main exposure, adjusted for confounders, and report adjusted prevalence ratios (aPR) and 95% CIs. Results Of the 267 WLHIV, 50% were anemic in the third trimester, of whom 43.5% (n  = 57/131) had IDA. On average, women with anemia were younger, were more likely to be black, started antiretroviral medications in the second trimester, had a low CD4 count (<200 cells/mm3) early in pregnancy, and were less likely to meet recommended intakes for iron, B6, and folate. The prevalence of anemia was greater in WLHIV with a low CD4 count (aPR = 1.65; 95% CI: 1.20–2.27) and high HIV viral load (>10,000 copies/mL; aPR = 1.38; 95% CI: 1.02–1.87). In total, 16% of women delivered preterm. Anemia was associated with a 2-fold (aPR = 2.04; 95% CI: 1.12–3.71) higher prevalence of preterm births. Conclusions Anemia is common in pregnant WLHIV, highlighting the need to address the underlying factors and clinical outcomes of anemia in this population. [ABSTRACT FROM AUTHOR]

Background: Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, a class of drugs that stabilize HIF and stimulate erythropoietin and red-cell production.Methods: In two phase 3, randomized, open-label, active-controlled, noninferiority trials, we compared vadadustat with the erythropoiesis-stimulating agent (ESA) darbepoetin alfa in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) not previously treated with an ESA who had a hemoglobin concentration of less than 10 g per deciliter and in patients with ESA-treated NDD-CKD and a hemoglobin concentration of 8 to 11 g per deciliter (in the United States) or 9 to 12 g per deciliter (in other countries). The primary safety end point, assessed in a time-to-event analysis, was the first major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), pooled across the two trials. Secondary safety end points included expanded MACE (MACE plus hospitalization for either heart failure or a thromboembolic event). The primary and key secondary efficacy end points in each trial were the mean change in hemoglobin concentration from baseline during two evaluation periods: weeks 24 through 36 and weeks 40 through 52.Results: A total of 1751 patients with ESA-untreated NDD-CKD and 1725 with ESA-treated NDD-CKD underwent randomization in the two trials. In the pooled analysis, in which 1739 patients received vadadustat and 1732 received darbepoetin alfa, the hazard ratio for MACE was 1.17 (95% confidence interval [CI], 1.01 to 1.36), which did not meet the prespecified noninferiority margin of 1.25. The mean between-group differences in the change in the hemoglobin concentration at weeks 24 through 36 were 0.05 g per deciliter (95% CI, -0.04 to 0.15) in the trial involving ESA-untreated patients and -0.01 g per deciliter (95% CI, -0.09 to 0.07) in the trial involving ESA-treated patients, which met the prespecified noninferiority margin of -0.75 g per deciliter.Conclusions: Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority criterion for hematologic efficacy but not the prespecified noninferiority criterion for cardiovascular safety in patients with NDD-CKD. (Funded by Akebia Therapeutics and Otsuka Pharmaceutical; PRO2TECT ClinicalTrials.gov numbers, NCT02648347 and NCT02680574.). [ABSTRACT FROM AUTHOR]

Few studies have assessed the association between clustering of cardio-metabolic risk factors (CMRFs) and pre-diabetes in children or adolescents. We aimed to examine the association between clustering of CMRFs and pre-diabetes among U.S. adolescents. Data were available for 5,633 U.S. adolescents aged 12–19 years from the National Health and Nutrition Examination Surveys 1999–2014. Pre-diabetes was defined as impaired fasting glucose (IFG) (fasting plasma glucose 100–125 mg/dL), impaired glucose tolerance (IGT) (2-h plasma glucose 140–199 mg/dL) or elevated hemoglobin A1c (HbA1c) (HbA1c 5.7–6.4%). The individual CMRFs considered in the present study were as follows: waist-to-height ratio, blood pressure, triglycerides, and high-density lipoprotein cholesterol. CMRFs were defined based on the modified National Cholesterol Education Program (NCEP) criteria or the modified International Diabetes Federation (IDF) criteria. Logistic regression analysis was used to examine the association between clustering of CMRFs and pre-diabetes with adjustment for potential covariates. Among 5633 adolescents, 11.4% had IFG, 4.7% had IGT, 4.5% had elevated HbA1c and 16.1% had pre-diabetes. Compared with adolescents with no CMRFs, the odds ratios (ORs) with 95% confidence intervals (CIs) for pre-diabetes across the clustering of CMRFs (i.e., 1, 2, 3, and 4) were 1.32 (1.03–1.68), 2.07 (1.55–2.76), 2.52 (1.69–3.76), and 5.41 (3.14–9.32), respectively, based on the modified NCEP criteria. The corresponding ORs with 95% CIs were 1.16 (0.89–1.51), 1.78 (1.35–2.36), 3.07 (1.89–4.98) and 12.20 (3.93–37.89), respectively, based on the modified IDF criteria. The present study suggests that the clustering of CMRFs is associated with increased pre-diabetes among U.S. adolescents. It might be necessary for effective strategies and measures targeting adolescents with clustering of CMRFs, including those with less than 3 risk factors. [ABSTRACT FROM AUTHOR]

Objective: In recent years, many studies have shown that hemoglobin to red cell distribution width ratio (HRR), which is the ratio of hemoglobin (Hb) to red cell distribution width (RDW), is associated with inflammation. Inflammation is linked to both the development of stroke and the severe effects that follow. Therefore, the relationship between the HRR and mortality in patients with stroke was investigated in our study., Patients and Methods: 127 stroke patients who visited the emergency department between March 1, 2023, and June 1, 2023, were retrospectively evaluated. The National Institutes of Health Stroke Scale (NIHSS) was used to measure stroke severity. All stroke patients were divided into four groups: patients with atrial fibrillation (AF), those without AF, and those with low and high HRR. HRR levels were compared between patients with and without AF. The relationship between HRR and mortality was also analyzed., Results: HRR levels were found to be significantly lower in patients with AF compared to those without AF (p<0.05 for all). NIHSS, requirement for mechanical ventilation, and mortality rate were significantly higher in the low HRR (HRR≤0.795) group compared to the high HRR group (HRR>0.795) (p<0.05 for all). HRR outperformed Hb and RDW alone in predicting mortality (AUC; 0.975, 0.952, 0.911, respectively). Additionally, a significant positive correlation was found between HRR levels and NIHSS (p<0.001)., Conclusions: Low HRR measured on admission is a useful marker for predicting mortality and determining the severity of stroke.

Amphibians are more susceptible to environmental stressors than other vertebrates due to their semipermeable skin and physiological adaptations to living in very specific microhabitats. Therefore, the aim of the present study was to investigate the effects of a metal mixture from settleable particulate matter (SePM) released from metallurgical industries on Lithobates catesbeianus tadpoles. Endpoints analyzed included metal bioconcentration, morphological (biometrical indices), hematological parameters (hemoglobin and blood cell count), and erythrocyte DNA damage (genotoxicity and mutagenicity). American bullfrog tadpoles (Gosner's stage 25) were kept under control condition (no contaminant addition) or exposed to a sub-lethal and environmentally relevant concentration (1 g.L -1 ) of SePM for 96 h. Tadpoles exposed to SePM exhibited elevated whole blood levels of Fe 56 , AL, Sn, Pb, Zn, Cr, Cu, Ti, Rb, V, Ce, La, Ag, As. SePM-exposed tadpoles showed a significant decrease in condition factor (12%) and increases in hepatosomatic index (25%), hemoglobin concentration (17%), and total leukocytes (82%), thrombocytes (90%), and monocytes (78%) abundance. In addition, exposed tadpoles showed higher MN and ENAs (340 and 140%, respectively) frequencies, and erythrocyte DNA damage with approximately 1.2- to 1.8-fold increases in comet parameters. Taken together, these results suggest that the multimetal mixture found in SePM is potentially genotoxic and mutagenic to L. catesbeianus tadpoles, induces stress associated with hematological changes, and negatively affects growth. Although such contamination occurs at sublethal levels, regulatory standards are needed to control the emission of SePM and protect amphibian populations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objective To determine the regional- and district-level newborn prevalence of sickle cell trait and disease, and the prevalence of haemoglobin variants and genetic modifiers of sickle cell disease, in the nine regions of north-western United Republic of Tanzania. Methods We repurposed dried blood spot samples from children (aged 0-24 months) born to mothers living with human immunodeficiency virus (HIV), collected as part of the HIV Early Infant Diagnosis programme, for sickle cell diagnosis. We performed isoelectric focusing to determine whether samples had normal haemoglobin, sickle cell trait, sickle cell disease or a rare haemoglobin variant. We shipped samples diagnosed as disease or variant to Cincinnati Children's Hospital in the United States of America for deoxyribonucleic-acid-based analyses to determine the prevalence of α-thalassaemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency or fetal haemoglobin genetic modifiers. Findings We analysed a total of 17 200 specimens during February 2017--May 2018. We observed a prevalence of sickle cell trait and disease of 20.3% (3492/17 200) and 1.2% (210/17 200), respectively. District-level trait varied from 8.6% (5/58) to 28.1% (77/274). Among confirmed sickle cell disease specimens, we noted 42.7% (61/143) had 1-gene deletion and 14.7% (21/143) had 2-gene deletion α-thalassaemia trait. We documented G6PD A--deficiency in 19.2% (14/73) of males. Conclusion Our calculated prevalence is twice as high as previously reported and reinforces the need for enhanced sickle cell diagnostic services. Our district-level data will inform public health policy, allowing screening and disease-modifying hydroxyurea therapy to be focused on high-prevalence areas, until universal newborn screening is available. [ABSTRACT FROM AUTHOR]

• Formaldehyde is found in every living cell in the body. • Numerous endogenous and exogenous sources of formaldehyde exist. • This is the first normative value of formaldehyde in citizens of the U.S. • Endogenous formaldehyde levels of all demographics are presented. Formaldehyde (FA) is currently classified as a known carcinogen. In addition to being a ubiquitous compound with many common exogenous exposure sources, it is also part of multiple metabolic pathways and present in every living cell. The objectives of this study were to determine normative levels of FA as measured by FA-Hemoglobin (Hb) adducts in the United States (US) and to determine if FA-Hb levels differ based on a variety of demographic factors. Data collected between 2013 and 2016 by the National Health and Nutrition Examination Survey were assessed from 4521 participants representing approximately 244 million individuals living in the US. General linear models were used to examine associations between FA-Hb adducts and sample characteristics. FA-Hb levels were summarized using geometric mean concentrations (GMC) and associated 95% confidence intervals (CI). The overall GMC was 131.10 nmol/g Hb (95% CI 129.39–132.83). Analyses revealed no evidence to support associations between FA-Hb levels and age, gender, income, or nicotine use. Among adults, non-Hispanic Black race was associated with lower FA-Hb levels compared to all other race/ethnicity groups, P < 0.01. The study provides the first normative values for FA in adults and children. These data could be a tool to assess the body's response to acute and chronic exposure. [ABSTRACT FROM AUTHOR]

Objectives: Voxelotor was recently approved for use in the United States as a treatment for sickle cell disease (SCD) and has been shown to interfere with the quantitation of hemoglobin (Hb) S percentage. This study aimed to determine the effect of voxelotor on the quantitation of hemoglobin variant levels in patients with multiple SCD genotypes.Methods: In vitro experiments were performed to assess the impact of voxelotor treatment on hemoglobin variant testing. Whole blood samples were incubated with voxelotor and then analyzed by routinely used quantitative and qualitative clinical laboratory methods (high-performance liquid chromatography [HPLC], capillary zone electrophoresis [CZE], and acid and alkaline electrophoresis).Results: Voxelotor modified the α-globin chain of multiple hemoglobins, including HbA, HbS, HbC, HbD-Punjab, HbE, HbA2, and HbF. These voxelotor-hemoglobin complexes prevented accurate quantitation of multiple hemoglobin species, including HbS, by HPLC and CZE.Conclusions: Technical limitations in quantifying HbS percentage may preclude the use of HPLC or CZE for monitoring patients treated with voxelotor. Furthermore, it is unclear whether HbS-voxelotor complexes are clinically equivalent to HbS. Consensus guidelines for reporting hemoglobin variant percentages for patients taking voxelotor are needed, as these values are necessary for determining the number of RBC units to exchange in acute situations. [ABSTRACT FROM AUTHOR]

Objective: In African-born Blacks living in America, we determined by BMI category 1) prevalence of abnormal glucose tolerance (Abnl-GT) and 2) diagnostic value and reproducibility of hemoglobin A1c (HbA1c), fructosamine, and glycated albumin (GA).Research Design and Methods: Participants (n = 416; male, 66%; BMI 27.7 ± 4.5 kg/m2 [mean ± SD]) had an oral glucose tolerance test with HbA1c, GA, and fructosamine assayed. These glycemic markers were repeated 11 ± 7 days later. Abnl-GT diagnosis required 0 h ≥5.6 mmol/L (≥100 mg/dL) and/or 2 h ≥7.8 mmol/L (≥140 mg/dL). Thresholds for HbA1c, GA, and fructosamine were the values at the 75th percentile for the population (39 mmol/mol [5.7%], 14.2%, and 234 μmol/L, respectively).Results: Abnl-GT prevalence in the nonobese was 34% versus 42% in the obese (P = 0.124). Reproducibility was excellent for HbA1c and GA (both κ ≥ 0.8), but moderate for fructosamine (κ = 0.6). Focusing on HbA1c and GA in the nonobese, we found as single tests the sensitivities of HbA1c and GA were 36% versus 37% (P = 0.529). Combining HbA1c and GA, sensitivity increased to 58% because GA identified 37% of Africans with Abnl-GT not detected by HbA1c (P value for both tests vs. HbA1c alone was <0.001). For the obese, sensitivities for HbA1c, GA, and the combined tests were 60%, 27%, and 67%, respectively. Combined test sensitivity did not differ from HbA1c alone (P = 0.25) because GA detected only 10% of obese Africans with Abnl-GT not detected by HbA1c.Conclusions: Adding GA to HbA1c improves detection of Abnl-GT in nonobese Africans. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the effect of preoperative serum sodium and hemoglobin on oncologic outcomes in upper tract urothelial carcinoma (UTUC) based on a multi-center cohort from China and the United States (U.S.). Methods: We retrospectively reviewed the records of 775 patients with UTUC treated surgically at tertiary care medical facilities in China or the US from 1998 to 2015. We analyzed associations of preoperative serum sodium and hemoglobin with clinicopathological characteristics, overall survival (OS), cancer-specific survival (CSS) and intravesical recurrence free survival (IVRFS). Results: The US patients had comparatively lower serum sodium and similar hemoglobin at baseline. Preoperative low serum sodium value was associated with tumor multifocality, lymph node metastasis (LNM) and lymphovascular invasion (LVI); preoperative anemia was associated with advanced age, tumor multifocality, high tumor grade and LVI. Preoperative low serum sodium was an independent predictor of worse OS in the entire cohort; preoperative anemia was an independent predictor of worse OS and CSS in the US cohort alone, Chinese cohort alone and the combined cohort. We developed a predictive nomogram for OS which exhibited better prognostic value when it included the values of sodium and anemia, and successfully validated it in different cohorts. Conclusion: Preoperative low serum sodium and anemia could be informative in predicting worse pathologic and survival outcomes in different UTUC patient ethnic groups. [ABSTRACT FROM AUTHOR]

Background Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis. Methods We conducted an analysis of screening and enrollment during 2003–2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling ("screen out") varied by various individual, trial, or site characteristics. Results Of 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P =.19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30–35%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing. Conclusions In the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials. [ABSTRACT FROM AUTHOR]

• Objective: Several pressure ulcer (PU) risk factors including paralysis and age greater than 70 have been identified, while others such as nutrition are debated. The object of this study is to identify perioperative risk factors that may predict improved outcomes and reduced complications in primary and recurrent PU reconstructions. • Method: A retrospective chart review of patients treated surgically for PUs from 2004 to 2013 at the University of Toledo Medical Center, Toledo, Ohio, US, was completed. Data collected included ulcer and medical history, as well as risk factors, complications and postoperative outcome. Data were statistically analysed for perioperative variances between primary and recurrent ulcers and closure status. • Results: A total of 49 patients with 102 reconstructions were reviewed. Spinal cord injured patients accounted for 90% receiving flap coverage of ulcers. Numerous differences between primary and recurrent ulcers were identified, including ulcer location, patient nutritional status, wound infection, postoperative course and recurrence. Multivariate analysis revealed a flap reconstruction prediction model using creatinine, haematocrit, haemoglobin, and prealbumin that is able to successfully predict closure outcome in 83.6% of cases. • Conclusion: Many factors play a role in the development, course and treatment of PUs. It is vital to understand the role of patient risk factors in the development of PUs, to direct subsequent management and reconstruction, and to prevent future recurrences. [ABSTRACT FROM AUTHOR]

Background Patients living with human immunodeficiency virus (PLWH) with low CD4 counts are at high risk for immune reconstitution inflammatory syndrome (IRIS) and death at antiretroviral therapy (ART) initiation. Methods We investigated the clinical impact of IRIS in PLWH and CD4 counts <100 cells/μL starting ART in an international, prospective study in the United States, Thailand, and Kenya. An independent review committee adjudicated IRIS events. We assessed associations between baseline biomarkers, IRIS, immune recovery at week 48, and death by week 48 with Cox models. Results We enrolled 506 participants (39.3% were women). Median age was 37 years, and CD4 count was 29 cells/μL. Within 6 months of ART, 97 (19.2%) participants developed IRIS and 31 (6.5%) died. Participants with lower hemoglobin at baseline were at higher IRIS risk (hazard ratio [HR], 1.2; P =.004). IRIS was independently associated with increased risk of death after adjustment for known risk factors (HR, 3.2; P =.031). Being female (P =.004) and having a lower body mass index (BMI; P =.003), higher white blood cell count (P =.005), and higher D-dimer levels (P =.044) were also significantly associated with increased risk of death. Decision-tree analysis identified hemoglobin <8.5 g/dL as predictive of IRIS and C-reactive protein (CRP) >106 μg/mL and BMI <15.6 kg/m2 as predictive of death. Conclusions For PLWH with severe immunosuppression initiating ART, baseline low BMI and hemoglobin and high CRP and D-dimer levels may be clinically useful predictors of IRIS and death risk. [ABSTRACT FROM AUTHOR]

Introduction: Commercial motor vehicle drivers, such as truck drivers, experience unique health, lifestyle, and occupational challenges directly associated with their profession. Methods: All participants in this multistate cross-sectional study completed questionnaire measurements. Participants were categorized with metabolic syndrome (MetS) if they had at least three of the five modified criteria used in the joint scientific statement on metabolic syndrome. Results: Overall MetS prevalence was 52.4% (n = 428) of the 817 participants. Prevalence of MetS criteria were waist circumference (n = 634, 77.0%), low HDL cholesterol (n = 580, 71.0%), elevated triglycerides (n = 552, 67.6%), elevated blood pressure (n= 175, 21.2%), and elevated hemoglobin Ale (n = 91, 11.9%). Truck drivers were 2.7 times more likely to have MetS compared to the general working population. Conclusion: Truck drivers in the United States have a high prevalence of MetS compared to the general working population. [ABSTRACT FROM AUTHOR]

Objective: To determine whether patients transfused red blood cell (RBC) products according to guideline-specified pretransfusion hemoglobin (Hb) concentrations or for other reasons were more likely to survive their intensive care unit (ICU) stay. Design: An observational study of 375 478 episodes of ICU care, over 5 years, was performed with ICU survival as the primary outcome. Outcomes were analyzed as a function of pretransfusion Hb concentration for groups with distinct transfusion indications while adjusting for potential confounders. Setting and Patients: This study included all adult patients discharged from 1 of 203 adult ICUs from 32 US health-care systems. The patients were from community hospitals, tertiary, and academic medical centers. Intervention: Transfusion of allogenic packed RBCs or whole blood was prescribed at the discretion of the treating clinicians. Measurements and Main Results: We found that 15% of adult ICU patients are transfused RBC products, and most transfusions for hemodynamically stable patients are administered above the guideline-specified pretransfusion Hb threshold of 7 g/dL. Hemodynamically stable patients transfused below this threshold were significantly more likely to survive their ICU stay than those not transfused (odds ratio [OR] 0.59, 95% confidence interval [CI], 0.43-0.81; P =.001), and patients transfused at thresholds above 9 g/dL were less likely to survive their ICU stay than those not transfused. Patients of the acute blood loss group who were transfused appeared to benefit or were not harmed by transfusion. Conclusion: Conservative RBC product transfusion practices for groups that are targeted by guidelines are justified by outcomes observed in clinical practice. This study provides evidence for the liberal administration of RBC products to critically ill adults with acute blood loss based on association with lower risk of mortality. [ABSTRACT FROM AUTHOR]

Objective: To compare the accuracy of cord blood lactate measurement using gas analyzer and portable devices in order to assess possibility of implementation of these devices in clinical practice. Methods: We performed a prospective observational study using 30 umbilical cord samples which were obtained immediately after birth. Portable electrochemical devices Lactate Scout (SensLab GmbH, Leipzig, Germany) and StatStrip Lactate (NOVA Biomedical, Waltham, MA, USA) were used to determine lactate level. A gas analyzer ABL800 FLEX (Radiometer Medical ApS, Brønshøj-Husum, Denmark) was used as a reference. Base excess (BE), pH, partial oxygen (pO2) and carbon dioxide (pCO2) pressure, hemoglobin (ctHb) and bilirubin (ctBl) levels were measured. Results: The mean umbilical cord blood lactate level determined by the gas analyzer was 5.85 ± 2.66 mmol/L (ranging from 1.4 mmol/L to 13.4 mmol/L). Lactate level estimated by Lactate Scout was 5.66 ± 2.65 mmol/L and did not significantly differ from the reference method level (P = 0.2547). The mean lactate level determined by StatStrip Lactate was significantly lower than by the gas analyzer – 4.81 ± 2.38 mmol/L (P < 0.0001). Umbilical cord blood pH, BE, pO2 and pCO2, ctHb and ctBl levels did not affect the accuracy of the lactate measurement in absolute units (mmol/L). Conclusion: Umbilical cord blood lactate level measured by StatStrip Lactate was lower than estimated by the ABL800 FLEX gas analyzer. This shows the necessity to develop decision-making reference points separately for each device. Umbilical cord blood pH, BE, pO2 and pCO2, ctHb and ctBl levels did not affect the accuracy of measurements by electrochemical portable devices. [ABSTRACT FROM AUTHOR]

Objective: To evaluate feasibility of percutaneous nephrolithotomy (PCNL) for complex nephrolithiasis in patients 80 years of age and older compared to younger individuals.Methods: From an institutional IRB-approved database, 1,647 patients were identified who underwent PCNL from 1999 to 2019. Patients were stratified by age: group 1 (20-59), group 2 (60-79), and group 3 (>80). Statistics were performed using chi-square and ANOVA to compare outcomes.Results: Of the 1,647 patients, median age was 46, 66, and 83, respectively (P <0.0001). Three patients within group 3 were 90 or older. Females made up 54%, 46%, 56% of patients (P = 0.02). Average stone size with SD was 2.6 ± 2.2, 2.5 ± 2.3, 2.2± 1.9 cm for each group (P = 0.06). Mean preoperative hemoglobin (Hgb) was significantly lower in the 80+ group (13.8, 13.4, 13.1 g/dL, P <.0001). Change in Hgb was not significantly different. There were more Clavien II-IV complications (10.4, 14.4, 28.8%; P = 0.02) and transfusions (2.3, 4.7, 10.2%; P <0.001) in the elderly. The most common complications in the 80+ group were bleeding related (10.1%). No difference in readmission rates or ICU admissions was noted.Conclusion: PCNL is feasible in the extremely elderly; however with a higher rate of complications and longer hospitalizations. No long-term sequelae or deaths in the 80 and older cohort were seen. This study allows us to appropriately counsel older patients on a realistic postoperative course and supports use of PCNL as the best means of long-term survival. [ABSTRACT FROM AUTHOR]

Study Objective: Iron deficiency anemia is the most common form of anemia, and parenteral iron therapy is necessary in select patients. The objective of this analysis was to assess the impact of initial complete parenteral iron repletion on serum hemoglobin (Hgb) level normalization and on health care resource utilization in real‐world practice. Design: Retrospective observational study. Data Source: Decision Resources Group Real‐World Data Repository (United States databases). Patients: A total of 2966 patients who had a baseline Hgb level below normal (< 12 g/dl for females and < 13.5 g/dl for males) and were treated with parenteral iron between March 2015 and February 2017. Measurements and Main Results: The effect of receiving the required parenteral iron dose to replete the deficit, calculated by a modified Ganzoni formula, within 3 weeks of the first parenteral iron therapy claim (index date) on the likelihood of Hgb level normalization, was estimated by using logistic regression. All analyses were adjusted for sex, age, comorbidities, and use of prescription oral iron therapy. The adjusted mean numbers of all‐cause inpatient admissions, outpatient visits, and emergency department (ED) visits within 6 months and 1 year after the index date were compared between patients with and without normalized Hgb levels by using negative binomial regression. Of the 2966 included patients, 33.9% received the required iron dose within 3 weeks of the index date, and 19.6%, 48.2%, and 53.9% had a normalized Hgb level within 8 weeks of the index date, within 1 year of the index date, and until the end of data availability, respectively. Patients who received the required iron dose within 3 weeks of the index date were significantly more likely to have a normalized Hgb level within 8 weeks of the index date and at any time during the study period than those who did not: adjusted odds ratio (OR) (95% confidence interval [CI]) 2.67 (2.20, 3.24) and 2.33 (1.96, 2.77), respectively. Hgb level normalization within 1 year of the index date was associated with fewer inpatient admissions and outpatient visits and a similar number of ED visits compared with no Hgb level normalization 1 year after the index date. Conclusion: The results of these analyses underscore the importance of initial complete parenteral iron repletion for rapidly improving clinical outcomes. Prompt achievement of a normalized Hgb level may also provide an opportunity to reduce health care resource utilization in patients with iron deficiency anemia receiving parenteral iron therapy. [ABSTRACT FROM AUTHOR]

Extracorporeal membrane oxygenation (ECMO) has become a key tool in the management of cardiac and/or respiratory failure refractory to conventional management. Although ECMO has multiple indications, it has been widely studied for the management of acute respiratory distress syndrome in adults. ECMO provides rest and support while the damaged lungs heal. It is an invasive modality with risks of serious complications; therefore, clinicians should be vigilant during patient selection. Furthermore, users should be familiar with different components of the ECMO machinery and the management of different organ systems while patients are on the circuit. ECMO is a relatively new modality that has shown good results when used in certain circumstance, and its use is becoming more popular across the United States. [ABSTRACT FROM AUTHOR]

Background: Findings of the association between iron status and depressive symptoms in nonpregnant women of reproductive age (WRA) are equivocal, limited by a small sample size, or did not consistently control for confounders., Objective: We tested the association between iron status and depressive symptoms in WRA with the NHANES data (2005-2010)., Methods: Nonpregnant WRA (20-44 y) with complete data on iron (ferritin and transferrin receptor (TfR)) and anemia (hemoglobin) biomarkers, depressive symptoms (Patient Health Questionnaire-9), and sociodemographic variables were included. Logistic and negative binomial regressions were used to estimate presence (odds ratios) and magnitude (prevalence ratios), respectively, for depressive symptoms by iron deficiency (ID)/anemia/ID anemia in the total sample and stratified by poverty:income ratio (≤ 1.85 or >1.85)., Results: Among 2516 females, the prevalence of ID was 8 to 16% (depending on the iron biomarker used), of anemia 8%, of which 52 to 65% were also ID. The prevalence of depressive symptoms was 10%. Crude logistic models showed that females with ID (TfR ≥ 8.3 mg/L or body iron <0 mg/kg) from the total sample had 1.82 (95% confidence interval [CI]: 1.24, 2.68) and 1.62 (95% CI: 1.05, 2.48), respectively, higher odds of depressive symptoms than females with iron sufficiency; these associations were attenuated after adjustments for confounders. Adjusted negative binomial models showed that females with ID (TfR ≥ 8.3 mg/L) from the total and low-income samples showed 1.19 (95% CI: 1:00, 1.40) and 1.27 (95% CI: 1.03, 1.58), respectively, higher prevalence ratios of depressive symptoms scores than females with iron sufficiency., Conclusions: These nationally representative data indicate that nonpregnant WRA with ID (based on high TfR) in the United States have higher prevalence of somatic depressive symptoms scores than those with iron sufficiency, especially if they are of low income., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Massive hemorrhaging remains the most common cause of preventable battlefield deaths. Blood used for trauma care requires a robust donation network, capacity for long-term storage, and extensive and accurate testing. Bioengineering technologies could offer a remedy to these constraints in the form of blood substitutes-fluids that could be transfused into patients to provide oxygen, carry away waste, and aid in coagulation-that would be used in prolonged casualty care and in far-forward settings, overcoming the obstacles of distance and time. The different molecular properties of red blood cells (RBCs), blood substitutes, and platelet replacements contribute to their respective utilities, and each type is currently represented in ongoing clinical trials. Hemoglobin oxygen carriers (HBOCs) are the most advanced RBC replacements, many of which are currently being evaluated in clinical trials in the United States and other countries. Despite recent advancements, challenges remaining in the development of blood alternatives include stability, oxygen capacity, and compatibility. The continued research and investment in new technologies has the potential to significantly benefit the treatment of life-threatening emergency injuries, both on the battlefield and in the civilian sector. In this review, we discuss military blood-management practices and military-specific uses of individual blood components, as well as describe and analyze several artificial blood products that could be options for future battlefield use., (2023.)

Background: The number of red blood cell units transfused per capita in China is lower than in western countries and the reason(s) for the difference is unknown.Study Design and Methods: We randomly chose 5050 transfused patients from five Chinese hospitals. We compared transfused cases to nontransfused controls matched for the same underlying diagnosis. We assessed the pretransfusion hemoglobin (Hb) trigger and other clinical characteristics associated with transfusion. After stratifying by underlying disease, we compared pretransfusion Hb level in Chinese hospitals to 12 US hospitals.Results: In 5050 patients who received transfusion, the pretransfusion Hb levels were lower in medical (6.3 g/dL) compared to surgical patients receiving transfusion postoperatively (8.1 g/dL). In patients with nonsurgical diagnoses, the pretransfusion Hb was much lower than that in the United States; the difference in mean Hb level varied by underlying diagnosis from 0.4 to 1.8 g/dL. In case-control analysis of cases (n = 1356) compared to controls (n = 1201), the pretransfusion Hb showed the strongest association with transfusion. Compared to 10 g/dL, the odds ratio (95% confidence interval) for pretransfusion Hb of 7 to 7.9 g/dL was 37.7 (24.8-57.4).Conclusion: Transfusion triggers in five Chinese hospitals appear comparable to those in the United States for surgical patients; however, medical patients have lower pretransfusion Hb levels (approx. 6 g/dL). Of the factors assessed, the pretransfusion Hb was most strongly associated with transfusion. The clinical impact of lower transfusion thresholds used in China is unknown. [ABSTRACT FROM AUTHOR]

Despite advances in diabetes technology and treatment, a majority of children and adolescents with type 1 diabetes (T1D) fail to meet hemoglobin A1c (HbA1c) targets. Among high-income nations, the United States has one of the highest mean HbA1c values. We tracked the HbA1c values of 261 patients diagnosed with T1D in our practice over a 2.5-year period to identify inflection points in the HbA1c trajectory. The HbA1c declined until 5 months postdiagnosis. There was a rise in the HbA1c between the fifth and sixth month postdiagnosis. The HbA1c continued to steadily rise and by 18 months postdiagnosis, the mean HbA1c was 8.2%, which is also our clinic mean. Understanding the HbA1c trajectory early in the course of diabetes has helped to identify opportunities for intensification of diabetes management to flatten the trajectory of HbA1c and improve clinical outcomes. [ABSTRACT FROM AUTHOR]

The article discusses the report "Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline" which provides evidence-based recommendations for the treatment of newly diagnosed and relapsed multiple myeloma. Topics discussed include symptoms in majority of patients with myeloma, disease satage presented by the International Staging System (ISS) and the Revised-ISS and standard of care in cancer patients.

Background: The time between the creation of an arteriovenous fistula (AVF) and its successful use is significantly longer in hemodialysis (HD) patients in the United States compared to those in other countries, and there is an urgent need to reduce the residence time of central-venous catheters (CVC). Methods: Successful AVF creation and maturation results in typical hemodynamic changes, such as an increase in cardiac output and upper body blood flow (UBBF). In patients with CVC as vascular access, we measured once per minute intradialytic central-venous oxygen saturation (ScvO2) and hemoglobin levels simultaneously using the Crit-Line Monitor. Under conditions of stable upper body oxygen consumption and arterial oxygen saturation, ScvO2 and hemoglobin concentration allows the calculation of estimated UBBF (eUBBF). In a quality improvement project, we used ScvO2 and eUBBF to track the hemodynamic changes accompanying AVF maturation. Results: Out of 11 patients (9 incident to HD, 1 female, age 61 ± 13 years), AVF maturation was successful in 9. In 1 patient, the AVF did not mature. One patient died from sudden cardiac death with a maturing AVF. In the 9 patients with successful AVF maturation, ScvO2 increased from 60.9 ± 2.7% prior to AVF creation to 73.4 ± 3.6% a week after AVF creation (19.6 ± 6.3% increase). eUBBF increased from 1.3 ± 0.3 to 2.2 ± 0.6 L/min (62.7 ± 37.5% increase); no material ScvO2 or eUBBF changes occurred in the other 2 patients. Conclusion: Our results indicate the potential utility of ScvO2 and eUBBF to track the hemodynamic response to AVF maturation. To what extent these insights translate into shortening of the time between AVF creation and successful cannulation warrants further investigations. [ABSTRACT FROM AUTHOR]

Background: Glycated hemoglobin A1c (HbA1c) is routinely used to diagnose and monitor type 2 diabetes mellitus (T2DM) in cirrhotic patients. Remarkably, HbA1c may be falsely low in such patients.Aims: We assessed the diagnostic and monitoring yield of HbA1c in cirrhotic patients with T2DM (DM-Cirr) and without T2DM (NoDM-Cirr).Methods: We conducted a composite study allocating 21 NoDM-Cirr into a cross-sectional module and 16 DM-Cirr plus 13 controls with T2DM only (DM-NoCirr) into a prospective cohort. Oral glucose tolerance test (OGTT) was performed in NoDM-Cirr. DM-Cirr and DM-NoCirr were matched by sex, age, BMI, and T2DM treatment and studied with continuous glucose monitoring (CGM). Percent deviations from target, low/high blood glucose indexes (LBGI/HBGI) were calculated from CGM, as well as the average daily risk range (ADRR) as a marker of glucose variability.Results: Overall, HbA1c and OGTT diagnostic yield agreed in 12 patients (57%, ρ = 0.45, p < 0.03). CGM captured 3463 glucose determinations in DM-Cirr and 4273 in DM-NoCirr (p = 0.42). Regression analysis showed an inferior association between HbA1c and CGM in DM-Cirr (R2 = 0.52), when compared to DM-NoCirr (R2 = 0.94), and fructosamine did not improve association for DM-Cirr (R2 = 0.31). Interestingly, cirrhosis and Child-Turcotte-Pugh class accounted for HbA1c variance (p < 0.05). Patients in DM-Cirr were less frequently within target glucose (70-180 mg/dL), but at higher risk for hyperglycemia (HBGI > 9) when compared to DM-NoCirr, and they also showed higher glucose variability (ADRR 13.9 ± 2.5 vs. 8.9 ± 1.8, respectively, p = 0.03).Conclusion: HbA1c inaccurately represents chronic glycemia in patients with cirrhosis, likely in relation to increased glucose variability. [ABSTRACT FROM AUTHOR]

Introduction: There are no population-level estimates in the United States for achievement of blood pressure goals in patients with diabetes and hypertension by obesity weight class.Aim: We sought to examine the relationship between the extent of obesity and the achievement of guideline-recommended blood pressure goals and other quality of care metrics among patients with diabetes.Methods: We conducted an observational population-based cohort study of electronic health data of three large health systems from 2010-2012 in rural, urban and suburban settings of 51,229 adults with diabetes. Outcomes were achievement of diabetes quality of care metrics: blood pressure, A1c, and LDL control, and A1c and LDL testing. Two blood pressure goals were examined given the recommendation for adults with diabetes of 130/80 mmHg from JNC7 and the recommendation of 140/90 mmHg from JNC8 in 2014.Results: Patients in obesity classes I, II, and III with diagnosed hypertension were less likely to achieve blood pressure control at both the 140/90 mmHg and 130/80 mmHg control levels. The patients from obesity class III had the lowest likelihood of achieving control at the 130/80 mmHg goal, and control was markedly worse for the 130/80 mmHg threshold in all weight classes. There were minimal to no differences by weight class in LDL and A1c control and LDL and A1c testing.Conclusions: Although the cardiovascular risk for patients with obesity and diabetes is greater than for non-obese patients with diabetes, we found that patients with obesity are even further behind in achieving blood pressure control. [ABSTRACT FROM AUTHOR]

Background: The severe forms of thalassemia are the most common inherited anemias managed with regular blood transfusion therapy. Transfusion policies and complications are critical to quality of life and survival, but there is a lack of standardized care.Study Design and Methods: A survey of 58 items was completed in 2016 by 11 centers in California, Washington, Oregon, Nevada, and Arizona providing long-term care for thalassemia. The questionnaire addressed demographic information, transfusion practices and complications, and educational needs.Results: The centers followed 717 patients with β-thalassemia (314, 43.8%) or α-thalassemia (394, 55%). One-third (34.7%) of patients were transfusion-dependent. Indications and goals of transfusion therapy differed between centers. Prestorage leukoreduction was universal, while routine irradiation of units was limited to one site. Red blood cell antigen phenotype was determined before the first transfusion and patients received Rh/Kell-matched units. However, more than half of the transfused patients had received blood at multiple hospitals within or outside the United States. Alloantibodies were seen in 16.9% of transfused group, but management of such patients was variable. Unusual or emerging transfusion-transmitted pathogens were not observed. Multiple educational needs were recognized, with iron overload as the biggest challenge; the approach to iron chelation varied within the group.Conclusion: This study identified many patients not included in earlier surveys limited to major national centers, suggesting that the thalassemia population in the United States is vastly underestimated. Lack of evidence-based guidelines is a barrier to optimal care, which should be addressed through regional consortia of thalassemia centers. [ABSTRACT FROM AUTHOR]