non-US Populations Research Articles

Ultra-Processed Food Consumption and Risk of Incident Hypertension in US Middle-Aged Adults.

Consumption of ultra-processed food, which is manufactured food that is high in additives and sparse in intact foods, is adversely associated with cardiovascular health, primarily in non-US study populations. We aimed to estimate the association between ultra-processed food consumption and incident hypertension in middle-aged adults in the United States. We included 8923 ARIC (Atherosclerosis Risk in Communities) study participants who were hypertension free at baseline and had complete dietary, covariate, and hypertension data from visit 1 (1987-1989). Over a median (25th, 75th percentile) follow-up of 13 (6-21) years, 79% of participants developed hypertension. Participants in the highest quartile of ultra-processed food consumption had 15% higher risk of incident hypertension than those in the lowest quartile (hazard ratio [HR], 1.15 [95% CI, 1.08-1.23]). Participants in the highest quartile of consumption of sugar-sweetened beverages, red and processed meat, and margarine had 16% (HR, 1.16 [95% CI, 1.08-1.24]; p-trend <0.001), 10% (HR, 1.10 [95% CI, 1.03-1.19]; P trend = 0.005), and 6% (HR, 1.06 [95% CI, 0.99, 1.45]; P trend = 0.045) higher risk of incident hypertension, respectively, when compared with the lowest quartiles of consumption. Each additional serving of minimally or unprocessed food was associated with a 2% lower risk of incident hypertension (HR, 0.98 [95% CI, 0.98, 0.99], P<0.001). High consumption of ultra-processed foods, specifically of sugar-sweetened beverages, red and processed meat, and margarine, was associated with a higher incidence of hypertension, whereas minimally or unprocessed food consumption was associated with lower hypertension risk.

Initial non-adherence to lipid-lowering medication: a systematic literature review

BackgroundThe impact on cardiovascular health is lost when a patient does not obtain a newly prescribed lipid-lowering medication, a situation termed “initial medication nonadherence” (IMN). This research summarizes the published evidence on the prevalence, associated factors, consequences, and solutions for IMN to prescribed lipid-lowering medication in the United States.MethodsA systematic literature search using PubMed and Google Scholar, along with screening citations of systematic reviews, identified articles published from 2010 to 2021. Studies reporting results of IMN to lipid-lowering medications were included. Studies that evaluated non-adult or non-US populations, used weaker study designs (e.g., case series), or were not written in English were excluded.ResultsThere were 19 articles/18 studies that met inclusion and exclusion criteria. Estimates of the prevalence of IMN to newly prescribed lipid-lowering medications ranged from 10 to 18.2% of patients and 1.4–43.8% of prescriptions (n = 9 studies). Three studies reported prescriber and patient characteristics associated with IMN. Hispanic ethnicity, Black race, lower Charlson Comorbidity Index score and no ED visits or hospitalization were associated with IMN. Lipid lowering prescriptions from primary care providers were also associated with IMN. Four studies described patient-reported reasons for IMN, including preference for lifestyle modifications, lack of perceived need, and side effect concerns. Four intervention studies reported mixed results with automated calls, live calls, or letters. One study reported worse clinical outcomes in patients with IMN: higher levels of low-density lipoprotein and greater risk of emergency department visits.ConclusionsUp to one-fifth of patients fail to obtain a newly prescribed lipid-lowering medication but there is limited information about the clinical consequences. Future research should assess outcomes and determine cost-effective approaches to address IMN to lipid-lowering therapy.

Impact of Smokeless Tobacco on Cardiovascular Disease Risk in a Nigerian Metropolitan City.

The use of smokeless tobacco products (STP) as a substitute for tobacco smoking is driving increasing consumption of these products especially in developing countries. The study sought to make comparison of cardiovascular risk profile between chronic STP users and suitably matched tobacco-naïve controls. This is a preliminary report from the cross sectional part of a two-arm prospective study of Smokeless Tobacco Products Composition and Exposure Outcome in Enugu metropolis, Nigeria. Consecutively recruited current Smokeless tobacco users, who had no history of cigarette smoking, aged 18years and above, residing in selected communities in Enugu metropolis, Nigeria were recruited for the study from October 2022 to July 2023. Age and sex matched non-tobacco users from same localities as the study subjects served as controls. Written informed consent to participate in the study was obtained from all study participants. All participants were screened by the investigators, using the study case report forms, to obtain data on medical history, demographic, clinical, laboratory, and electrocardiographic evaluation. Data from 54 STP-users and 54 non-STP-users (mean age 56.58 ± 8.15years) were analyzed. Anthropometric parameters were similar in both groups. Smokeless tobacco users had higher erect and supine blood pressure indices as well asgreater postural drop in systolic blood pressure. The occurrence of diabetes mellitus (20.37% versus 5.56%) and hypertension (25.93%; 11.11%) was significantly higher in the STP-users than in the non-user population, (p = 0.02192 and 0.04751 respectively). Electrocardiographic evaluation showed significantly increased QTc and dispersions of P-wave, QRS and QT intervals as well as reduced PR interval in STP users. Electrocardiographic abnormalities observed in STP users include left ventricular hypertrophy, left atrial enlargement, ST-segment elevation, short PR interval and long QTc. Use of smokeless tobacco products is associated with increased risk burden of diabetes mellitus and hypertensive heart disease. Electrocardiographic findings linked to STP-use in this study are features consistent with arrhythmia, ventricular repolarization abnormality, myocardial hypertrophy and ischaemia, suggesting that smokeless tobacco products are not safe substitutes for tobacco smoking.

Health system utilization and perceived quality among adults in Lao PDR: evidence from a nationally representative phone survey

BackgroundThe World Health Organization (WHO) defines quality health services as being effective, safe, people-centered, timely, equitable, integrated and efficient. It is critical to understand people’s perspectives and care experiences to measure progress against these goals. However, many low- and middle-income governments do not routinely collect such information. In this study, we aim to measure health systems performance from the perspective of the adult population of users and non-users in Lao PDR.MethodsUsing the People’s Voice Survey (PVS), a novel phone-based survey designed to integrate people’s voices into primary care performance measurement, we conducted a cross-sectional survey of the general adult (18+) population in Lao PDR in 2022. We analyzed health care utilization patterns, user-reported quality of care, and coverage of key preventive health services. Data from the most recent MICS survey was used to create sampling weights generating nationally representative estimates.ResultsA total of 2007 adults completed interviews in approximately 3.5 months. About two thirds (65%) of respondents reported visiting a health facility in the past year and, of these, the majority (61%) visited a hospital as opposed to a health center or clinic. Among those that recently visited health facilities, 28% rated their experience as “poor” or “fair”. 16% had unmet need for care and 12% reported discrimination during treatment in the past year. 12% of women over 50 years old reported receiving a mammogram and 59% of adults reported receiving blood pressure screening in the previous year.ConclusionsThe study presents data from the first nationally representative survey in Lao PDR to measure health system performance. The results indicate that, despite progress towards universal coverage of health insurance in Lao PDR, significant gaps remain, particularly with respect to bypassing of primary care facilities, significant unmet need for care, experiences of discrimination, and overall low perceptions of quality of care.

External validation of predictive models of sexual, urinary, bowel and hormonal function after surgery in prostate cancer subjects

BackgroundIn 2020, a research group published five linear longitudinal models, predict Expanded Prostate Cancer Index Composite-26 (EPIC-26) scores post-treatment for radical prostatectomy, external beam radiotherapy and active surveillance collectively in US patients with localized prostate cancer.MethodsOur study externally validates the five prediction models for patient reported outcomes post-surgery for localised prostate cancer. The models’ calibration, fit, variance explained and discrimination (concordance-indices) were assessed. Two Australian validation cohorts 1 and 2 years post-prostatectomy were constructed, consisting of 669 and 439 subjects, respectively (750 in total). Patient reported function in five domains post-prostatectomy: sexual, bowel, hormonal, urinary incontinence and other urinary dysfunction (irritation/obstruction). Domain function was assessed using the EPIC-26 questionnaire.Results1 year post-surgery, R2 was highest for the sexual domain (35%, SD = 0.02), lower for the bowel (21%, SD = 0.03) and hormone (15%, SD = 0.03) domains, and close to zero for urinary incontinence (1%, SD = 0.01) and irritation/obstruction (− 5%, SD = 0.04). Calibration slopes for these five models were 1.04 (SD = 0.04), 0.84 (SD = 0.06), 0.85 (SD = 0.06), 1.16 (SD = 0.13) and 0.45 (SD = 0.04), respectively. Calibration-in-the-large values were − 2.2 (SD = 0.6), 2.1 (SD = 0.01), 5.1 (SD = 0.1), 9.6 (SD = 0.9) and 4.0 (SD = 0.2), respectively. Concordance-indices were 0.73, 0.70, 0.70, 0.58 and 0.62, respectively (all had SD = 0.01). Mean absolute error and root mean square error were similar across the validation and development cohorts. The validation measures were largely similar at 2 years post-surgery.ConclusionsThe sexual, bowel and hormone domain models validated well and show promise for accurately predicting patient reported outcomes in a non-US surgical population. The urinary domain models validated poorly and may require recalibration or revision.

Measuring trust in one's physician: A scoping review.

Trust in one's physician drives positive health practices. However, the conceptualization and subsequent operationalization of trust have become clouded due to the multitude of approaches that have resulted in several different measures with varied dimensions and indicators. The objectives of this scoping review were: 1) to discover any new developments in the measurement of trust, 2) to identify those measures of trust, whether newly created or refined in the last ten years, that have known reliability and validity, and 3) to compare those instruments' conceptualizations, dimensions, and indicators. This researcher conducted an electronic search of three databases (PubMed, SOCAB, and PsycINFO). Two reviewers screened those selected studies and identified the following six key measurement tools, of which three had shorter, more abbreviated derivatives: the Trust in Physician Scale and its modification, the Wake Forest Physician Trust Scale and its short form, the Health Care Relationship Trust Scale and its refinement, the Trust in Oncologist Scale and its shortened form, the Trust in Health Care Providers Scale, and the Trust in My Doctor Scale. Of these six distinct tools, only the Trust in Oncologist Scale was developed and validated in non-US populations. Also identified were ten dimensions of trust: fidelity, technical competence, communicative competence, interpersonal competence (i.e., caring), honesty, confidentiality, global, behavioral, fairness, and system trust/accountability. Interpersonal competence and fairness emerged as newer dimensions that deserve further study. A comparative analysis of the indicators of these trust dimensions revealed some discrepancies that deserve theoretical and psychometric attention. In addition, incorporating item-response theory to assess measurement invariance has enhanced the assessment of external validity. This review provides a resource for researchers that will lead to a more uniform understanding of trust, thereby setting the basis for future theoretical integration and measurement development.

Stability and optimal control of two products innovation diffusion system

The current study is aimed at analysing a four-compartmental system to examine the interaction and market dissemination of two product categories. In the first category, the product is low-priced and preferred by economically backward people. In the second category, the product is high-priced and liked by people in high-income groups. The non-user population is the potential buyer of products in the market, and frustrated people are fed up with both products. The nonnegativity and boundedness of the solution to the system help in ensuring the well-defined nature of the model. The viability of the model with UFE (user-free equilibrium), an equilibrium point in the absence of users of low-priced products, and interior equilibria is analysed. The analysis of the local and global stability of the model’s equilibria is conducted with reference to ℛ0. We examine the system’s transcritical bifurcation using the Centre Manifold Theory at ℛ0=1. The Hopf bifurcation’s occurrence condition has been identified. The frustration class population gets reduced using the optimal control theory. The extended optimum control model is used to build the Hamiltonian function, which is then solved using Pontryagin’s maximum principle to obtain the lowest cost. To realize which parameters impact the basic influence numbers most, we also run a sensitivity analysis on them. Finally, simulations are conducted to support the theoretical model.

Associations between the use of psychedelics and other recreational drugs with mental health and resilience during the COVID-19 pandemic.

The large-scale disruption to peoples' daily lives during the COVID-19 pandemic provides a context for examining whether use of substances such as psychedelics in a naturalistic (outside of a controlled environment) setting, is associated with better mental wellbeing and resilience relative to those who use other drugs, or who do not use drugs at all. We interrogate data from the Great British Intelligence Test and identify that 7.8% out of N = 30,598 unique respondents used recreational drugs inclusive of psychedelics, cannabis, cocaine, and MDMA during the COVID-19 pandemic. Recruitment materials did not mention drug use would be surveyed, thereby enabling us to model the relationship with mood and resilience in people who had not specifically self-selected themselves for a 'drug' study. We report that people form clusters, characterized by different real-world patterns of drug use, and the majority of psychedelics users also use cannabis. However, a subset of cannabis users do not use psychedelics, enabling a subtractive comparison. Those who primarily used psychedelics and cannabis during the COVID-19 pandemic had worse mood self-assessment and resilience scores compared to those who never used drugs or primarily used cannabis. This pattern was also evident for other recreational drug use clusters, except for those who primarily used MDMA and cannabis, who had better mood but were of too low incidence to have confidence in this estimate. These findings cast light on the significant differences in mental wellbeing between users of different drugs and the non-user population during a global-crisis and call for future research to explore the pharmacological, contextual and cultural variables associated with these differences, their generalisability and causal links with greater precision.

Abstract P419: Ultra-Processed Food Consumption and Risk of Hypertension in US Adults

Introduction: Ultra-processed food (UPF) consumption has an adverse impact on cardiovascular health. Current research is primarily based on non-US study populations. The purpose of our study was to estimate the association between UPF consumption and risk of incident hypertension in a population of middle-aged black and white men and women. Methods: Atherosclerosis Risk in Communities (ARIC) study participants who were hypertension free at baseline and had complete dietary, covariate, and hypertension data from visit 1 (1987 - 1989) were included (n = 8,866). Participants were followed through November 30, 2019 for the development of hypertension defined as systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or recent patient-reported use of blood pressure lowering medication. Processing level was determined using the NOVA classification system. Data were analyzed using three progressively adjusted Cox proportional hazards regression models. Results: 6,960 participants developed hypertension during a median follow-up of 13 years. Participants in the highest quartile of UPF consumption were 9% more likely to develop incident hypertension than those in the lowest quartile (model 2 HR: 1.09; CI: 1.02-1.16; P for trend = 0.01) ( Table ). Participants who were in the highest quartile of sugar-sweetened beverages and red and processed meat consumption had a 20% higher risk of hypertension (model 2 HR, 1.20; CI, 1.12 - 1.28; P for trend &lt;0.001) and 9% higher risk of hypertension (model 2 HR, 1.09; CI, 1.02 - 1.17; P for trend &lt;0.001), respectively, when compared to the lowest quartile. Participants in the highest quartile of minimally or unprocessed food consumption had 9% lower incidence of hypertension (model 2 HR, 0.91; 95% CI, 0.85 - 0.97; P for trend 0.01). Conclusions: High UPF consumption, specifically sugar-sweetened beverages and red and processed meat, was associated with higher risk of hypertension, whereas minimally or unprocessed food consumption was associated with lower hypertension risk.

Removing race from the CKD-EPI equation and its impact on prognosis in a predominantly White European population.

While American nephrology societies recommend using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate (eGFR) equation without a Black race coefficient, it is unknown how this would impact disease distribution, prognosis and kidney failure risk prediction in predominantly White non-US populations. We studied 1.6 million Stockholm adults with serum/plasma creatinine measurements between 2007 and 2019. We calculated changes in eGFR and reclassification across KDIGO GFR categories when changing from the 2009 to 2021 CKD-EPI equation; estimated associations between eGFR and the clinical outcomes kidney failure with replacement therapy (KFRT), (cardiovascular) mortality and major adverse cardiovascular events using Cox regression; and investigated prognostic accuracy (discrimination and calibration) of both equations within the Kidney Failure Risk Equation. Compared with the 2009 equation, the 2021 equation yielded a higher eGFR by a median [interquartile range (IQR)] of 3.9 (2.9-4.8) mL/min/1.73 m2, which was larger at older age and for men. Consequently, 9.9% of the total population and 36.2% of the population with CKD G3a-G5 was reclassified to a higher eGFR category. Reclassified individuals exhibited a lower risk of KFRT, but higher risks of all-cause/cardiovascular death and major adverse cardiovascular events, compared with non-reclassified participants of similar eGFR. eGFR by both equations strongly predicted study outcomes, with equal discrimination and calibration for the Kidney Failure Risk Equation. Implementing the 2021 CKD-EPI equation in predominantly White European populations would raise eGFR by a modest amount (larger at older age and in men) and shift a major proportion of CKD patients to a higher eGFR category. eGFR by both equations strongly predicted outcomes.

Cannabis use, attitudes, regulation and health: Survey data from an urban population of users and non-users.

Background: Although illegal in most countries, cannabis remains the most common illicit drug in Switzerland and worldwide. While there is growing evidence on adverse effects of cannabis use, most users do not report any problems or negative consequences. In the face of a sustained high prevalence of cannabis use and the recent legalization waves in different parts of the world, it is important to know how cannabis is perceived in the general population and how current users regulate their own use. The present study aims to investigate users’ and non-users’ attitudes towards cannabis regulations and towards current users. Additionally, self-rated health measures as well as protective behavioral strategies and other cannabis related variables were assessed.Design and methods: We collected data from 380 current users and 659 non-users who were recruited by invitation letter or online media platforms. The data was analyzed using basic descriptive statistical procedures.Results: Results revealed that both groups favor moderate cannabis regulation measures over prohibition and no regulation at all. On average, they report the same subjective health. Protective strategies are often used and are associated with better health and lower severity of dependence in cannabis users.Conclusions: Taken together, results indicate that safe use of cannabis is possible for most users, while there is a group of users at risk of 15-20%, which may benefit from control by regulatory measures. Significance for public health In the face of recent legalization waves in different parts of the world and the current public discourse on a possible legalization in Switzerland, it is important to know how cannabis is perceived in the general population and how current users regulate their own use. The manuscript contributes to the literature by showing that in Switzerland, users and non-users prefer a moderate regulation of cannabis over prohibition. Further, support is shown for recent findings that highlight the protective effect of behavioral strategies (measured by the Protective Behavioral Strategies for Marijuana, Pedersen et al.1) on adverse effects of marijuana, such as perceived dependence.

Interventions to Mitigate Vaping Misinformation: A Meta-Analysis

The impact of misinformation about vapes’ relative harms compared with smoking may lead to increased tobacco-related burden of disease and youth vaping. Unfortunately, vaping misinformation has proliferated. Despite growing attempts to mitigate vaping misinformation, there is still considerable ambiguity regarding the ability to effectively curb the negative impact of misinformation. To address this gap, we use a meta-analysis to evaluate the relative impact of interventions designed to mitigate vaping-related misinformation. We searched (from January 2020 till August 2021) various databases and gray literature. Only English language, original studies that employed experimental designs where participants were randomly assigned either to receive mitigating information or to a no-mitigation condition (either misinformation-only or neutral control) were included. Meta-analysis was conducted for the four eligible studies. The mean effect size of attempts to mitigate vaping misinformation was positive but not statistically significant (d = 0.383, 95% CI [−0.029, 0.796], p = .061, k = 5) with lack of evidence for publication bias. Given limited studies included, we were unable to determine factors affecting the efficacy of interventions. The limited focus on non-US studies and youth populations is concerning given the popularity of vaping in low- to middle-income countries (LMICs) and among youth. The findings of this meta-analysis describe the current state of the literature and prescribe specific recommendations to better address the proliferation of vaping misinformation, providing insights helpful in limiting the tobacco mortality burden and curtailing youth vaping.

POSB122 Healthcare Resource Use of People Who Use Illicit Opioids in England: A Retrospective Cohort Study Using Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES)

Health outcomes for opioid users are poor, with high mortality and morbidity for both drug-related diseases, and conditions not typically considered drug-related. However, very little research has investigated how this population engages with the healthcare system, particularly planned and primary care. This study investigates the healthcare resource use (HCRU) of illicit opioid users relative to a matched population of non-users.

Physiologically based serum ferritin thresholds for iron deficiency in children and non-pregnant women: a US National Health and Nutrition Examination Surveys (NHANES) serial cross-sectional study

Serum ferritin concentrations are the most widely used indicator for iron deficiency. WHO determined that insufficient data are available to revise the serum ferritin thresholds of less than 12 μg/L for children and less than 15 μg/L for women, which were developed on the basis of expert opinion, to define iron deficiency. We aimed to derive new physiologically based serum ferritin concentration thresholds for iron deficiency in healthy young children and non-pregnant women using data from the US National Health and Nutrition Examination Survey (NHANES). In this serial cross-sectional study, we examined the relationship of serum ferritin with two independent indicators of iron-deficient erythropoiesis, haemoglobin and soluble transferrin receptor (sTfR), in children (12-59 months) and non-pregnant women (15-49 years) using cross-sectional NHANES data from 2003-06, 2007-10, and 2015-18. NHANES is a US national stratified multistage probability sample that includes a household interview followed by a standardised physical examination in a mobile examination centre. We excluded individuals with missing serum ferritin, sTfR, haemoglobin, or white blood cell counts measurements; non-pregnant women with missing C-reactive protein (CRP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) data were also excluded. In addition, individuals with infection (white blood cell counts >10·0×109/L) and non-pregnant women with possible liver disease (ALT >70 IU/L or AST >70 IU/L) and inflammation (CRP >5·0 mg/L) were excluded. We examined distributions of haemoglobin and sTfR with serum ferritin and used restricted cubic spline regression models to determine serum ferritin thresholds for iron-deficient erythropoiesis. 5964 children and 10 462 non-pregnant women had physical examinations and were screened for inclusion in the study, of whom 2569 (43·1%) children and 7498 (71·7%) non-pregnant women were included. At lower serum ferritin concentrations, median haemoglobin concentration decreased as sTfR concentration increased, with each varying in a curvilinear manner. Using restricted cubic spline plateau points to determine the onset of iron-deficient erythropoiesis, the serum ferritin thresholds identified by haemoglobin and sTfR concentrations were not different. For children, the haemoglobin identified serum ferritin threshold was 19·9 μg/L (95% CI 18·8-22·6) and the sTfR identified serum ferritin threshold was 20·0 μg/L (19·4-20·9; p=0·89). For women the haemoglobin identified serum ferritin threshold was 25·2 μg/L (24·2-26·2) and the sTfR identified serum ferritin threshold was 24·0 μg/L (23·3-24·6; p=0·05). The association between two independent indicators of iron-deficient erythropoiesis, haemoglobin and sTfR, identified serum ferritin concentration thresholds of about 20 μg/L for children and 25 μg/L for non-pregnant women, providing physiological evidence of potential new thresholds for consideration when determining the prevalence and distribution of iron deficiency in populations. In healthy children and non-pregnant women, physiologically based thresholds for iron deficiency might be more clinically and epidemiologically relevant than those based on expert opinion. Validation of this physiologically based approach in non-US populations might help the international harmonisation of serum ferritin thresholds for iron deficiency. None.

A Systematic Literature Review of Patient-Reported Outcome Instruments Used in Sickle Cell Disease

Introduction: Patients with sickle cell disease (SCD) often have recurrent episodes of acute severe pain (vaso-occlusive crises, VOCs), which result in repeated hospital admissions and use of pharmacological treatments, and can negatively impact patients' health-related quality of life (HRQL). Most SCD randomized clinical trials (RCTs) are designed to evaluate efficacy in relation to changes in the number of VOCs and their impact on HRQL. We conducted a systematic literature review (SLR) to identify patient-reported outcome (PRO) and healthcare resource utilization (HCRU) instruments used in RCTs and real-world studies and to evaluate their psychometric properties with a view to provide recommendations of appropriate PRO endpoints for use in clinical trials for SCD treatments in the United States (US).Methods: An SLR was conducted to search, identify and summarize validated PRO instruments that have been used by patients with SCD in the US and their caregivers. MEDLINE and EMBASE were searched using terms synonymous with “sickle cell disease” and “psychometric properties” of PRO instruments for articles published in English between 1997 and March 2017 focusing on pediatric patients (5-17 years) and their caregivers, and adults (≥18 years). Studies were included if results were based on assessing psychometric properties of PRO instruments and if the studies were interventional or observational in design. Exclusion criteria included studies conducted in non-US populations, reporting on non-validated generic questionnaires or without any psychometric data. Conference abstracts, narrative reviews, letters to the editor, laboratory studies and case reports/series were excluded. The quality of PRO instruments in the included studies was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist, a well-established checklist to measure the methodological quality and performance of PRO instruments across a number of domains as reported in psychometric evaluation studies.Results: The SLR identified 504 references for title/abstract screening. Of these, 46 full-text articles were further assessed for inclusion and 19 articles were included. Two additional articles were identified from manual reference checks of relevant SLRs. Thus, a total of 21 US-based studies assessing 10 child and 15 adult PRO instruments in SCD were included in the review. No validated PRO instruments were found that measured caregiver burden in SCD and no validated HCRU instruments for any SCD population were identified. The review of pediatric studies identified the most commonly reported instrument to be the Pediatric Quality of Life Inventory (PedsQL), while most of the adult instruments (9 of 15) focused on evaluating self-efficacy/-esteem and pain in relation to SCD. Only one instrument, the Adult Sickle Cell Quality of Life Measurement (ASCQ-Me), was identified as evaluating HRQL in adults. Out of the 25 PRO instruments reviewed for both children and adults, only 3 out of 10 and 5 out of 15 instruments, respectively, were specifically developed for these age groups with SCD. There were little or no data on validation conducted in SCD development cohorts for most instruments. Additionally, the included studies did not assess minimally important differences in any of the instruments reviewed. In terms of instruments' psychometric properties, most instruments (9 of 15) identified for adult populations had strong internal reliability; however, there was often insufficient information to assess the content validity, construct validity, responsiveness and test-retest reliability of the instruments identified for both child and adult populations.Conclusions: Limited evidence on the psychometric properties of PRO instruments used in patients with SCD was identified. Furthermore, among the instruments reviewed, none was found to sufficiently capture all the PRO aspects of SCD and its complications on patients' HRQL for use as key trial endpoints. Further research should validate, or develop if no instrument is in existence, PRO instruments to assess HRQL of patients with SCD, PRO instruments for caregivers and HCRU instruments. DisclosuresSarri:Evidera: Employment. Bhor:Novartis: Employment, Equity Ownership, Research Funding. Abogunrin:Evidera: Consultancy; Novartis: Research Funding. Farmer:Evidera: Employment; Novartis: Research Funding. Nandal:Novartis: Employment, Equity Ownership, Research Funding. Revicki:Novartis: Consultancy, Research Funding.

The Epidemiology and Genetics of Hyperuricemia and Gout across Major Racial Groups: A Literature Review and Population Genetics Secondary Database Analysis.

Gout is an inflammatory condition caused by elevated serum urate (SU), a condition known as hyperuricemia (HU). Genetic variations, including single nucleotide polymorphisms (SNPs), can alter the function of urate transporters, leading to differential HU and gout prevalence across different populations. In the United States (U.S.), gout prevalence differentially affects certain racial groups. The objective of this proposed analysis is to compare the frequency of urate-related genetic risk alleles between Europeans (EUR) and the following major racial groups: Africans in Southwest U.S. (ASW), Han-Chinese (CHS), Japanese (JPT), and Mexican (MXL) from the 1000 Genomes Project. The Ensembl genome browser of the 1000 Genomes Project was used to conduct cross-population allele frequency comparisons of 11 SNPs across 11 genes, physiologically involved and significantly associated with SU levels and gout risk. Gene/SNP pairs included: ABCG2 (rs2231142), SLC2A9 (rs734553), SLC17A1 (rs1183201), SLC16A9 (rs1171614), GCKR (rs1260326), SLC22A11 (rs2078267), SLC22A12 (rs505802), INHBC (rs3741414), RREB1 (rs675209), PDZK1 (rs12129861), and NRXN2 (rs478607). Allele frequencies were compared to EUR using Chi-Square or Fisher’s Exact test, when appropriate. Bonferroni correction for multiple comparisons was used, with p < 0.0045 for statistical significance. Risk alleles were defined as the allele that is associated with baseline or higher HU and gout risks. The cumulative HU or gout risk allele index of the 11 SNPs was estimated for each population. The prevalence of HU and gout in U.S. and non-US populations was evaluated using published epidemiological data and literature review. Compared with EUR, the SNP frequencies of 7/11 in ASW, 9/11 in MXL, 9/11 JPT, and 11/11 CHS were significantly different. HU or gout risk allele indices were 5, 6, 9, and 11 in ASW, MXL, CHS, and JPT, respectively. Out of the 11 SNPs, the percentage of risk alleles in CHS and JPT was 100%. Compared to non-US populations, the prevalence of HU and gout appear to be higher in western world countries. Compared with EUR, CHS and JPT populations had the highest HU or gout risk allele frequencies, followed by MXL and ASW. These results suggest that individuals of Asian descent are at higher HU and gout risk, which may partly explain the nearly three-fold higher gout prevalence among Asians versus Caucasians in ambulatory care settings. Furthermore, gout remains a disease of developed countries with a marked global rising.

Moral injury: the effect on mental health and implications for treatment

Moral injury: the effect on mental health and implications for treatment

Knowledge, Attitudes, and Practices Regarding Dietary Sodium in College Students

ObjectiveTest a dietary sodium survey in a US adult population of college students using a survey previously validated in a non-US adult population. MethodsCross-sectional study of a convenience sample of college students from a Midwest (n = 168) and Pacific Island (n = 152) university. Main outcome measures were knowledge, attitudes, and practices regarding dietary sodium (38 items). Sum scores and percentages for constructs were calculated. A score <75% was considered unfavorable; t test or ANOVA were used to examine group differences. ResultsMidwest students were primarily non-Hispanic White individuals (81%) and 65% female. Pacific Island students were predominantly Asian (51%) and 66% female. Mean ± SD construct scores (percentage) for knowledge, attitudes, and practices were 58.69 ± 10.62, 63.96 ± 16.18, 66.00 ± 12.34 (Midwest) and 57.54 ± 10.93, 64.84 ± 14.96, 64.94 ± 13.18 (Pacific Island), respectively; there were no significant differences between schools or race. Conclusions and ImplicationsCollege students scored low in knowledge, attitudes, and practices regarding sodium. Results from this formative study may inform assessment strategies in future dietary sodium interventions.

Validation of a survival benefit estimator tool in a cohort of European kidney transplant recipients

Pre-transplant prognostic scores help to optimize donor/recipient allocation and to minimize organ discard rates. Since most of these scores come from the US, direct application in non-US populations is not advisable. The Survival Benefit Estimator (SBE), built upon the Estimated Post-Transplant Survival (EPTS) and the Kidney Donor Profile Index (KDPI), has not been externally validated. We aimed to examine SBE in a cohort of Spanish kidney transplant recipients. We designed a retrospective cohort-based study of deceased-donor kidney transplants carried out in two different Spanish hospitals. Unadjusted and adjusted Cox models were applied for patient survival. Predictive models were compared using Harrell’s C statistics. SBE, EPTS and KDPI were independently associated with patient survival (p ≤ 0.01 in all models). Model discrimination measured with Harrell’s C statistics ranged from 0.57 (KDPI) to 0.69 (SBE) and 0.71 (EPTS). After adjustment, SBE presented similar calibration and discrimination power to that of EPTS. SBE tended to underestimate actual survival, mainly among high EPTS recipients/high KDPI donors. SBE performed acceptably well at discriminating post-transplant survival in a cohort of Spanish deceased-donor kidney transplant recipients, although its use as the main allocation guide, especially for high KDPI donors or high EPTS recipients requires further testing.

Association of Air Pollution and Heat Exposure With Preterm Birth, Low Birth Weight, and Stillbirth in the US

Knowledge of whether serious adverse pregnancy outcomes are associated with increasingly widespread effects of climate change in the US would be crucial for the obstetrical medical community and for women and families across the country. To investigate prenatal exposure to fine particulate matter (PM2.5), ozone, and heat, and the association of these factors with preterm birth, low birth weight, and stillbirth. This systematic review involved a comprehensive search for primary literature in Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, PubMed, ClinicalTrials.gov website, and MEDLINE. Qualifying primary research studies included human participants in US populations that were published in English between January 1, 2007, and April 30, 2019. Included articles analyzed the associations between air pollutants or heat and obstetrical outcomes. Comparative observational cohort studies and cross-sectional studies with comparators were included, without minimum sample size. Additional articles found through reference review were also considered. Articles analyzing other obstetrical outcomes, non-US populations, and reviews were excluded. Two reviewers independently determined study eligibility. The Arskey and O'Malley scoping review framework was used. Data extraction was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Of the 1851 articles identified, 68 met the inclusion criteria. Overall, 32 798 152 births were analyzed, with a mean (SD) of 565 485 (783 278) births per study. A total of 57 studies (48 of 58 [84%] on air pollutants; 9 of 10 [90%] on heat) showed a significant association of air pollutant and heat exposure with birth outcomes. Positive associations were found across all US geographic regions. Exposure to PM2.5 or ozone was associated with increased risk of preterm birth in 19 of 24 studies (79%) and low birth weight in 25 of 29 studies (86%). The subpopulations at highest risk were persons with asthma and minority groups, especially black mothers. Accurate comparisons of risk were limited by differences in study design, exposure measurement, population demographics, and seasonality. This review suggests that increasingly common environmental exposures exacerbated by climate change are significantly associated with serious adverse pregnancy outcomes across the US.