Large Population Studies Research Articles

Automated radiographic hip morphology measurements: An open-access method

ObjectiveThe aim of this study is to present a newly developed automated method to determine radiographic measurements of hip morphology on dual-energy x-ray absorptiometry (DXA) images. The secondary aim was to compare the performance of the automated and manual measurements. Design30 DXA scans from 13-year-olds of the prospective population-based cohort study Generation R were randomly selected. The hip shape was outlined automatically using radiographic landmarks from which the acetabular depth-width ratio (ADR), acetabular index (AI), alpha angle (AA), Wiberg and lateral center edge angle (WCEA) (LCEA), extrusion index (EI), neck-shaft angle (NSA), and the triangular index (TI) were determined. Manual assessments were performed twice by two orthopedic surgeons. The agreement within and between observers and methods was visualized using Bland-Altman plots, and the reliability was studied using the intraclass correlation coefficient (ICC) with 95 % confidence intervals (CI). ResultsThe automated method was able to perform all radiographic hip morphology measurements. The intermethod reliability between the automated and manual measurements ranged from 0.57 to 0.96 and was comparable to or better than the manual interobserver reliability, except for the AI. ConclusionThis open-access, automated method allows fast and reproducible calculation of radiographic measurements of hip morphology on right hip DXA images. It is a promising tool for performing automated radiographic measurements of hip morphology in large population studies and clinical practice.

A large population study to assess the magnitude of prenatal programming in dairy cattle

The performance of an adult dairy cow may be influenced by events that occur before her birth. The present study investigated potential effects of 2 prenatal groups of factors, Assisted Reproductive Techniques (ART) and maternal characteristics (e.g., dam parity), on offspring performance during their first lactation, in populations of 2 dairy cow breeds: French Holstein and Montbéliarde. The different ART studied included the type of semen (conventional or X-sorted) used for Artificial Insemination (AI) and the technology of conception used (AI, embryo transfer, or in vitro fertilization). Three maternal characteristics were considered: (1) the dam age at first calving, (2) dam parity number, and (3) indicators of dam udder health during gestation (somatic cell score and events of clinical mastitis). First, we investigated whether heifer survival from 3d to 18 mo old was associated with any of the prenatal factors considered. We then estimated the associations of these prenatal factors with 8 traits of commercial interest: (1) stature, (2-4) milk, fat, and protein yields, (5) somatic cell score, (6) clinical mastitis, and (7-8) heifer and cow conception rate, all measured on genotyped cows. Linear models were used for this study with the prenatal factors as covariates in the model, and for the 8 traits, phenotypes were adjusted for their corresponding genomic estimated breeding value. The results indicated that the survival rate of heifers born from embryo transfer was significantly higher than that of heifers born from AI (probably due to preferential management practices), while the other prenatal factors did not explain differences in heifer survival. Among the Montbéliarde cows born from AI, those born from X-sorted semen showed a lightly but significantly lower milk yield than those born without X-sorting of the semen (-52 kg of milk in the first lactation). Among the Holstein cows, those born from embryo transfer presented significantly lower milk performance than cows born from AI. Regarding the maternal characteristics, none or very weak associations were found between the dam age at first calving and the offspring performance in both breeds. Dam parity, on the other hand, was associated with offspring performance for milk, fat, and protein yield in both breeds, however not in the same direction. In the Holstein breed, an increase in dam parity was favorable for offspring performance for milk, fat, and protein yield, whereas in the Montbéliarde breed, an increase in dam parity was associated with lower milk and protein yield and no association was found for fat yield. The udder health of the dam during gestation was not or only weakly associated with the traits studied in the offspring. Although some significant associations were identified due to the large sample size, the effects were modest, typically less than 1% of the phenotypic mean, and were not consistently observed across the 2 breeds.

Self-Reported Findings of the Korean Intermittent Exotropia Multicenter Study Questionnaire.

To determine subjective symptoms and medical history of patients with intermittent exotropia in a large study population. The Korean Intermittent Exotropia Multicenter Study (KIEMS) is a nationwide, observational, cross-sectional, multicenter study conducted by the Korean Association for Pediatric Ophthalmology and Strabismus including 5,385 patients with intermittent exotropia. Subjective symptoms and medical history of patients with intermittent exotropia were extracted by a comprehensive survey based on a self-administered questionnaire according to the study protocol of the KIEMS. The mean age of symptom onset was 5.5 years. The most common symptom reported in patients with intermittent exotropia was photophobia (52.1%), followed by diplopia at near fixation (7.3%) and distance fixation (6.2%). Preterm birth was found in 8.8%, and 4.1% had perinatal complications. A family history of strabismus was present in 14.9%, and 5.5% of patients had a family member who underwent strabismus surgery. The KIEMS is one of the largest clinical studies on intermittent exotropia. Intermittent exotropia frequently caused photophobia and diplopia, and patients with a family history was not uncommon.

Hope, coping strategies, and their predictors in older patients with prostate and breast cancer undergoing radiotherapy: A cross-sectional study.

The aim of this paper was to evaluate the level of hope, coping methods, and the factors affecting them in patients aged 60 years and over who were diagnosed with breast and prostate cancer and who were receiving radiotherapy (RT) as part of their treatment. A total of 66 patients (37 breast cancer and 29 prostate cancer patients) were included in this cross-sectional study. The RT and treatment information of the patients were collected by using the records in the hospital database. The scale responses, baseline characteristics, and demographic information of the participants were collected through the questionnaire form and scales [HHI (Heart Hope Index), COPE (Coping Attitudes Assessment Scale), and VAS (Visual Analogue Scale)]. Two surveys were administered to the participants before and after radiotherapy treatment. A first survey was administered to the participants 10-15 days before radiotherapy treatment, and the second survey was administered within 2-3 weeks after radiotherapy treatment. The weight and waist circumference of the patients were also measured before and after radiotherapy. The median age of the participants was 65 (interquartile range (IQR): 62.0-70.2) years. There was a decrease in the weight (mean change (MC): -1.5, 95% CI: -2.9 to -0.2, P = 0.029) and waist circumference (MC: -1.8, 95% CI: -3.2 to -0.4, P = 0.014) of the participants after RT. There was no significant change in the HHI (MC: 0.4, 95% CI: -0.7 to 1.5) and COPE (MC: -0.6, 95% CI: -3.2 to 2.0) total scores of the patients before and after RT (P = 0.459 and P = 0.650, respectively). When only patients with prostate cancer were studied, the self-help sub-dimension of COPE (MC: -1.5, 95% CI: -2.7 to -0.3, P = 0.013) was found to be lower. Multidimensional evaluations and interventions may be required in terms of hope levels and coping attitudes of cancer patients receiving radiotherapy. There is an increasing need for further studies in larger populations and cohorts related to this topic in the literature.

Abstract LB373: Pilot whole-exome sequencing data of formalin-fixed paraffin embedded endometrial tumors in the Epidemiology of Endometrial Cancer Consortium (E2C2)

Abstract Background: Endometrial cancer (EC) is the most common gynecologic cancer in the U.S.: incidence and mortality are rising. Black women face 2-fold higher mortality compared with other racial groups. To understand the role of tumor biology underlying these health inequities, we are sequencing the tumor exomes of 1,000 Black and 2,000 non-Black women in the Epidemiology of Endometrial Cancer Consortium. To inform this effort, we have completed whole-exome tumor sequencing in 35 EC patients. We present early sample performance and mutational insights of this pilot. Methods: We extracted DNA from formalin-fixed paraffin-embedded (FFPE) tumor tissues (cores, scroll) and matched normal specimens (blood, tissue) from 35 women diagnosed with EC in the Louisiana Tumor Registry, Nurses’ Health Study, and Polish Endometrial Cancer Study. Whole-exome sequencing was conducted by the Center for Inherited Disease Research at Johns Hopkins University, which called somatic alterations using matched normal samples as the germline profile (NovaSeq6000). We excluded two contaminated core samples and one paired scroll with extremely low coverage, leaving 33 women in our analytic sample. We examined the mutational landscape of EC overall and separately in 7 Black and 26 non-Black patients. For 23 women, we obtained both an FFPE scroll of the full block and FFPE tumor cores enabling a direct comparative analysis of DNA extraction yield and sequencing performance by sample source. We ran a published allele-specific copy number and clonal heterogeneity analysis tool (FACETS) in these 23 women to calculate tumor purity by tissue type. Results: Results from our pilot study revealed the most frequently mutated genes in our pilot population were PTEN (61%), ARID1A (48%), and PIK3CA (39%). We observed similar mutation frequencies for PIK3CA in both non-Black and Black women (38% vs 43%). TP53 was more frequently mutated in Black women (57% vs 16%), while ARID1A mutation was more common in non-Black women (58% vs 14%). 10 (30%) patient samples had chromosome 10 copy-neutral loss of heterozygosity. Of these, 8 (80%) had PTEN bi-allelic alterations. Of participants with both core and scroll tissue available, both sample types were successfully sequenced, although cores showed modestly better performance: 74% of core samples (vs 26% for scrolls) had a higher percentage of bases read at a target depth of 100x, and the median tumor purity for cores estimated using FACETS was higher than scrolls (53% vs 42%). Tumor purity could not be calculated for seven tissue samples due to either tumor diploidy or purity being too low: of these samples the majority were scrolls (86%). We observed greater concordance between core and scroll variant allele frequency when tumor purity was ≥30%: the benefits of cores vs scrolls matter at lower tumor purity. ConclusionsIn line with TCGA data, these pilot findings suggest potential differences in tumor mutational landscape by race and we will be interrogating these in our larger study population. FFPE core tissue generally performed better than FFPE scroll tissue in whole-exome sequencing, but our data suggest scrolls remain a viable option for sequencing when cores are unavailable. This has the potential to offer valuable insight for conducting population-based next-generation studies, which mostly rely on FFPE-derived tissues. Citation Format: Noah C. Peeri, Megan A. Clarke, Immaculata De Vivo, Mengmeng Du, Lucio Miele, Jeffin Naduparambil, Kathryn L. Penney, Venkat Seshan, Ronglai Shen, Veronica W. Setiawan, Nicolas Wentzensen, Xiao-Cheng Wu, Arnold Zea, Wenyu Zhang. Pilot whole-exome sequencing data of formalin-fixed paraffin embedded endometrial tumors in the Epidemiology of Endometrial Cancer Consortium (E2C2) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB373.

Assessment of Cobalt Binding Activity of Albumin in COVID-19 Patients and its Correlation with CRP

Background: Covid 19 pandemic has thrown a big challenge in terms of available manpower, space and financial recourses at all levels of healthcare facilities. The disease manifestation ranges from asymptomatic to severe but a pro-inflammatory milieu is the underlying ongoing event. Detection of pro- inflammatory markers in early stages of the disease is instrumental to avert future complications.Method: For the present study 35 RT-PCR positive Covid patients were chosen from indoor admissions along with 35 age and sex matched controls. C Reactive Protein (CRP) and cobalt binding activity of albumin measured in both groups and compared statistically.The values of CRP is elevated in cases (153.92± 87.56) as compared to controls (3.71± 3.07) which is statistically significant (p value= 0.001).Elevation of Cobalt binding activity of albumin is statistically significant (p value=0.0001) in cases (151.04± 37.38) when compared to controls (81.96± 29.49). Moreover elevation of cobalt binding activity of albumin bears moderate positive correlation (r=0.609) with the elevation of CRP levels.Conclusion: As laboratory assay of cobalt binding albumin has manifold advantages, when compared to assay of CRP, the former may emerge as a promising marker if similar result are obtained with a larger study population.

Fluoride exposure among children with different blood groups at Kolar district, Karnataka,India

Fluoride is present naturally in water at < 1.5 ppm and it is considered to be essential for dental and bone enamel mineralization forming fluorapatite. Chronic exposure (> 2ppm) is considered to be toxic and it leads to fluorosis. Fluoride in minor quantities is excreted through sweat, saliva and feaces. Kidneys are the major route of excretion of fluoride and are thus it is the primary organ to be affected. Therefore, it is of interest to assess urinary fluoride among school children with different blood groups at Kolar district, Karnataka, India. Study was conducted in 155 subjects, aged 16-17 years. Data shows that blood group B has high risk of effecting by fluorosis (mean value of urine fluoride = 1.11). However, subjects with negative blood groups are least affected by fluorosis (mean value of urine fluoride =0.30). However, a larger population study is required for validation.

Rotational Thromboelastometry as a Diagnostic Tool for Persistent Infection in Two-Stage Exchange Arthroplasty.

Background/Objectives: There is a lack of reliable biomarkers for diagnosis of infection eradication prior to second-stage reimplantation in two-stage exchange arthroplasty for periprosthetic joint infections (PJIs). The aim of this study was to assess the diagnostic accuracy of rotational thromboelastometry (ROTEM) for persistent infection in two-stage exchange arthroplasties. Methods: A pilot, retrospective analysis was performed including 70 patients who underwent a two-stage exchange arthroplasty for PJI. They were categorized as patients without (n = 64) or patients with persistent infection (n = 6) prior to reimplantation. Definition of persistent infection prior to reimplantation was based on the 2018 ICM criteria. Conventional coagulation biomarkers and ROTEM parameters were compared between groups. Results: Higher FIBTEM MCF values were associated with persistent infection (odds ratio [OR], 1.30, 95% confidence interval [CI], 1.04-1.63; p = 0.020), and FIBTEM MCF had the highest diagnostic accuracy for persistent infection prior to second-stage reimplantation (AUC, 0.907; 95% CI, 0.812-1.000). A cut-off value ≥ 18 mm for FIBTEM MCF was found to have 100.0% sensitivity and 73.4% specificity for diagnosing persistent infection prior to second-stage reimplantation. Moreover, the diagnostic accuracy of FIBTEM MCF was higher than that of fibrinogen levels (p = 0.036) and D-dimer (p = 0.006). Conclusions: Our findings indicate that ROTEM parameters have the potential to identify persistent infections before reimplantation in two-stage exchange arthroplasties for PJI. Such coagulation biomarkers could provide guidance regarding the optimal timing for reimplantation. Further studies in larger populations are warranted to validate the diagnostic accuracy of ROTEM parameters for persistent PJI.

Neurobiological developmental disorders in preschool girls are associated with obesity

Background: The prevalence of abnormal weight in young children with neurobiological developmental disorders is not known. Children with abnormal weight are at risk for both mental health problems now and in their future. Moreover, abnormal weight can have a detrimental effect on their treatment., This prospective study examines the length and weight in preschool children with neurobiological developmental disorders requiring special day care. Methods: Trained medical employees measured height and weight of children aged 3 till 5 years old with developmental disorders, who started special youth day care between 2019 and 2021 in the province of Drenthe in the Netherlands. Results: A total 73% of the children had normal weight, 16% had overweight, 12% were underweight. Girls had more often overweight (28%) and underweight (14%), compared to boys. Conclusions: Our results suggest that pre-school children and especially girls with psychological problems, have already a significant increased risk of an abnormal body mass index (BMI). Although studies with a larger study population are needed to ascertain this conclusion, screening for an abnormal BMI should be conducted as a standard procedure in this group of children, since it can affect their therapy and future health.

Abstract 6479: Metastases in uveal melanoma patients: Trends and risk factors

Abstract Purpose: Uveal melanoma has a high tendency to metastasize. Due to its rarity, there has not been large population studies that have demonstrated the effect of demographic variables on a patient’s risk to have metastases. Methods: The Nationwide Emergency Department Sample was queried from the last quarter of 2015 to 2019 to identify patients with a diagnosis of uveal melanoma. Multivariable logistic regression, with patient- and hospital-level characteristics as covariates, was used to identify factors associated with a higher chance of developing a metastasis and specific metastasis locations. Results: From the last quarter of 2015 to 2019, there were 7,561 ED encounters with a diagnosis of uveal melanoma. Of these patients, 5.8% had at least one metastasis. Most patients with a metastasis were at least 65 years of age (47.1%), male (54.4%), a Medicare beneficiary (45.2%), and belonged to a family in the highest income quartile (29.7%). The median age of these patients was 61 years (IQR: 32-74). Most patients presented to hospitals in the South (40.7%), with a Trauma Level I designation (56.1%), and to a metropolitan teaching hospital (72.9%). The most common sites of metastasis were liver (17.0%), brain (5.3%), and bone (2.0%). Multivariable logistic regression identified the following factors to be associated with increased risk of developing a metastasis: private insurance (odds ratio [OR]=1.62; p=0.012), highest income quartile (OR=2.30; p<0.001), and 2nd highest income quartile (OR=1.78; p=0.002). The following factors were associated with higher odds of developing a liver metastasis specifically: no-charge/charity work (OR=15.8; p=0.012), highest income quartile (OR=1.99; p=0.003), and second highest income quartile (OR=1.66; p=0.035). Presenting to a Trauma Level I hospital was associated with decreased risk of developing a liver metastasis (OR=0.57; p=0.016). Belonging to the highest income quartile was associated with a higher chance of developing a brain metastasis (OR=2.13; p=0.023) or a bone metastasis (OR=2.74; p=0.045). Among patients with a metastasis, the in-hospital mortality rate was 8.3%. Conclusion: Metastasis is an important complication to monitor in uveal melanoma patients. In this study, we have demonstrated that income and insurance status are factors that are associated with higher rates of metastases. Physicians should place special attention to these groups to ensure that metastases are minimized. Citation Format: Alice A. Beneke, Kamil Taneja, Lauren Ladehoff, Kevin Root, Eric Toloza. Metastases in uveal melanoma patients: Trends and risk factors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6479.

Clinical, Epidemiologic, and Pathologic Significance of ERBB2-Low Expression in Breast Cancer

It is unclear whether breast cancer (BC) with low ERBB2 expression (ERBB2-low) is a distinct clinical, pathological, and epidemiological entity from BC classified as no ERBB2 expression (ERBB2-negative). To evaluate the clinical, pathological, and epidemiologic features of BC with ERBB2-low expression compared with ERBB2-negative BC in a large population study. This cohort study was conducted as part of the Pathways Study, a prospective, racially and ethnically diverse cohort study of women with BC enrolled between 2006 and 2013 in Kaiser Permanente Northern California (KPNC). The hematoxylin and eosin slides underwent centralized pathology review, including the percentage of tumor infiltrating lymphocytes (TILs). Breast biomarker results were extracted from pathology reports, and women were included if they had a documented ERBB2 value that was not classified ERBB2-positive. Data were analyzed from February 2023 through January 2024. Clinical and tumor characteristics associated with BC and ERBB2-low or ERBB2-negative status. ERBB2-low was defined as immunohistochemistry score of 1+ or 2+ (negative by in situ hybridization); ERBB2-negative was defined as immunohistochemistry score of 0+. Other data were collected by self-report or extraction from electronic health records, including BC risk factors, tumor characteristics, treatment modality, and survival outcomes, with recurrence-free survival (RFS) as the primary outcome and overall survival (OS) and BC-specific mortality (BCSM) as secondary outcomes. The clinical, pathological, and epidemiological variables were compared between ERBB2-low and ERBB2-negative BC. Of 2200 eligible patients (all female; with mean [SD] age, 60.4 [11.9] years), 1295 (57.2%) had tumors that were ERBB2-low. Hormone receptors were positive in 1956 patients (88.9%). The sample included 291 Asian patients (13.2%), 166 Black patients (7.5%), 253 Hispanic patients (11.5%), 1439 White patients (65.4%), and 51 patients (2.3%) who identified as other race or ethnicity (eg, American Indian or Alaska Native and Pacific Islander). Within the hormone receptor-negative group, patients whose tumors had ERBB2-low staining, compared with those with ERBB2-negative tumors, had better OS (hazard ratio [HR], 0.54; 95% CI, 0.33-0.91; P = .02), RFS (HR, 0.53; 95% CI, 0.30-0.95; P = .03), and BCSM (HR, 0.43; 95% CI, 0.22-0.84; P = .01). In multivariable survival analysis stratified by hormone receptor status and adjusted for key covariates, patients with ERBB2-low and hormone receptor-negative tumors had lower overall mortality (HR, 0.48; 95% CI, 0.27-0.83; P = .009), RFS (HR, 0.45; 95% CI, 0.24-0.86; P = .02), and BCSM (subdistribution HR, 0.21; 95% CI, 0.10-0.46; P < .001) compared with patients with ERBB2-negative and hormone receptor-negative tumors. Within the hormone receptor-negative subtype, patients with ERBB2-low and high TILs tumors had better survival across all 3 outcomes compared with patients with ERBB2-negative and low TILs tumors. Additionally, patients with ERBB2-low and low TILs tumors had better BCSM (subdistribution HR, 0.36; 95% CI, 0.14-0.92; P = .03). These findings suggest that there were clinical, pathological, and epidemiological differences between ERBB2-low and ERBB2-negative BC, raising the possibility that ERBB2-low might be a unique biologic entity.

A Workflow for Meaningful Interpretation of Classification Results from Handheld Ambient Mass Spectrometry Analysis Probes.

While untargeted analysis of biological tissues with ambient mass spectrometry analysis probes has been widely reported in the literature, there are currently no guidelines to standardize the workflows for the experimental design, creation, and validation of molecular models that are utilized in these methods to perform class predictions. By drawing parallels with hurdles that are faced in the field of food fraud detection with untargeted mass spectrometry, we provide a stepwise workflow for the creation, refinement, evaluation, and assessment of the robustness of molecular models, aimed at meaningful interpretation of mass spectrometry-based tissue classification results. We propose strategies to obtain a sufficient number of samples for the creation of molecular models and discuss the potential overfitting of data, emphasizing both the need for model validation using an independent cohort of test samples, as well as the use of a fully characterized feature-based approach that verifies the biological relevance of the features that are used to avoid false discoveries. We additionally highlight the need to treat molecular models as "dynamic" and "living" entities and to further refine them as new knowledge concerning disease pathways and classifier feature noise becomes apparent in large(r) population studies. Where appropriate, we have provided a discussion of the challenges that we faced in our development of a 10 s cancer classification method using picosecond infrared laser mass spectrometry (PIRL-MS) to facilitate clinical decision-making at the bedside.

Abstract P101: The Association Between Residing in a Food Desert and Hypertension in Victims of Sudden Death

Introduction: Sudden deaths, defined as unexpected deaths not attributable to suicide, trauma or cancer account for over 10% of deaths in adults aged 18-64 years. More evidence is needed to understand how socioeconomic factors interplay with physiological processes such as hypertension to contribute to sudden death. We hypothesized that residing in a food desert would be associated with hypertension and poor blood pressure (BP) control in people who died of sudden death. Methods: We screened Emergency Medical Services (EMS) records from 2013 to 2015 in Wake County, NC, which includes the capital city of Raleigh and &gt;1 million residents, and adjudicated 399 sudden death victims using a standardized protocol. We collected medical history and BP measures from health records and linked geocoded patient addresses to census-tract data from the USDA’s Food Access Research Atlas. Of these, 350 victims had address data available, and of these 196 had blood pressures available. Residing in a food desert was defined as living in a low income and low access area, which is defined as no access to grocery stores within 1 mile in urban areas and 10 miles in rural areas. The ten most recent systolic BP measures prior to death were used to calculate average BP. We calculated unadjusted differences in mean BP by residence in a food desert. We also calculated unadjusted odds ratios (ORs) comparing the probability of having a hypertension diagnosis and of having controlled BP (systolic BP &lt;130 mmHg) by residence in a food desert. Results: We examined 350 sudden decedents who were 33% Black (116 of 350), 64% White (224 of 350), 31% women (109 of 350), and a median age of 55. Of these, seventy-nine (23%) resided in a food desert, and these were more likely to have diabetes mellitus (38.0% vs. 26.6%), (30 of 79 and 72 of 271 respectively). Sudden decedents who resided in a food desert had higher systolic BP with a mean of 140 mmHg compared with 134 mmHg for those who did not reside in a food desert (mean difference 6.15, CI 6.012-6.298). Of those residing in a food desert, 60.8% (48 of 79) had a medical diagnosis of hypertension, and 33.3% (14 of 48) had controlled BP. There was no association between residing in a food desert and a diagnosis of hypertension (OR 1.04, 95% CI 0.62-1.74) or controlled BP (OR 1.73, 95% CI 0.85-3.54). Conclusion: Almost a quarter of sudden decedents resided in a food desert at the time of death. In this case group, residing in a food desert was associated with a small BP increase but not with diagnosed hypertension or controlled BP. Large population studies are necessary to investigate the risk of sudden death and poor blood pressure control associated with residing in a food desert.

Centralization as the key survival benefit in acute neonatal surgery.

Centralization of neonatal surgical care for congenital malformations is already under discussion. Acute care of neonatal emergencies in perinatal centers with affiliated hospitals is not uniformly regulated in Germany. Analyses are based on acute pediatric surgical care at four affiliated hospitals of a perinatal center. Epidemiologic data and outcome parameters "survival", "intracerebral hemorrhage", and "revision of surgical indication" are assessed. Comparison is made between patients receiving surgical treatment at affiliated hospitals (group A) and patients with transfer to the university center for therapy in case of surgical indication for gastrointestinal diseases (group B). 17 group A-patients are compared to 40 group B-patients. Comparison of epidemiological data reveals no significant differences. There is a survival advantage with transfer to the university center (mortality of 29% in group A vs. 2% in group B, p = 0.007). Intracerebral hemorrhage occurred more frequently in externally treated patients (group A 24% vs. group B 2%, p = 0.024). Surgical indication was revised in 30% of group B at the university center (p = 0.011) with consecutive successful conservative treatment. Transfer of patients at the beginning of the acute phase of gastrointestinal diseases is key to optimize the quality of neonatal surgical care. However, larger population studies should confirm the presented results, discuss restricting factors of real care structures and should rule out bias in triage of patients.

Automated extraction of standardized antibiotic resistance and prescription data from laboratory information systems and electronic health records: a narrative review

Antimicrobial resistance in bacteria has been associated with significant morbidity and mortality in hospitalized patients. In the era of big data and of the consequent frequent need for large study populations, manual collection of data for research studies on antimicrobial resistance and antibiotic use has become extremely time-consuming and sometimes impossible to be accomplished by overwhelmed healthcare personnel. In this review, we discuss relevant concepts pertaining to the automated extraction of antibiotic resistance and antibiotic prescription data from laboratory information systems and electronic health records to be used in clinical studies, starting from the currently available literature on the topic. Leveraging automatic extraction and standardization of antimicrobial resistance and antibiotic prescription data is an tremendous opportunity to improve the care of future patients with severe infections caused by multidrug-resistant organisms, and should not be missed.

Intra-Articular Hyaluronic Acid for Osteoarthritis of the Hip, Shoulder, and Ankle

What Is the Issue?&#x0D; &#x0D; Osteoarthritis (OA) is a chronic disease of the joints, such as the hip, shoulder, and ankle. OA causes the joints to be painful, unstable, and less functional. In adults 55 years and younger, joint trauma is a common cause of OA.&#x0D; Hyaluronic acid (HA) is a naturally occurring molecule found in human cells that provides lubrication when injected into the joint. HA injections are a less invasive option than surgery, with potentially fewer complications.&#x0D; To support decision-making about treating hip, shoulder, or ankle OA in adults 55 years and younger, it is important to understand the potential benefits and harms of using HA in this population.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; We reviewed the clinical effectiveness of high molecular weight (MW) injection of HA in adults between the ages of 18 and 55 years with OA of the hip, shoulder, or ankle joints to guide decisions on the use of high MW HA injection.&#x0D; An information specialist searched for peer-reviewed and grey literature sources published on January 1, 2013 to December 12, 2023. One reviewer screened citations and selected and critically appraised the included studies.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; The evidence for this report was based on observational before-and-after studies. We found no relevant comparative studies examining the effect of high MW HA versus placebo or no treatment.&#x0D; While most studies reported post-treatment outcome improvements, it is uncertain whether high MW injection of HA improves pain, function, and disability in adults 55 years and under with hip, shoulder, or ankle OA. This is due to the low-quality evidence, small sample sizes, and methodological problems. Serious side effects of high MW HA were not reported.&#x0D; &#x0D; What Does This Mean?&#x0D; &#x0D; Due to the uncertainty of the clinical effectiveness evidence, health care providers and decision-makers may consider other factors when considering high MW IA-HA for patients with hip, shoulder, or ankle OA; these factors could include acceptability, feasibility, costs, health equity, and patient values and preferences.&#x0D; Future research from randomized studies in large populations is needed to understand the effectiveness and safety of high MW HA injections for hip, shoulder, and ankle OA.&#x0D;

Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial

ObjectiveEvaluate efficacy and safety of two doses of vilaprisan versus placebo in participants with symptomatic endometriosis. DesignMulticenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial (NCT03573336). The initially planned sample size was 315 patients. Recruitment was paused to assess long-term toxicity findings in rodents; although findings were assessed as likely to be of limited clinical relevance in humans, the study was closed by the sponsor. During the pause, enrolled patients completed 3 or 6 months of treatment per their assigned regimen. ParticipantsPre-menopausal adults with confirmed endometriosis and moderate-to-severe pelvic pain (≥4/10 on a numerical rating scale) were enrolled. Inclusion required protocol adherence, including ≥24 diary entries, and an average pain score of ≥3.5. InterventionParticipants were randomly assigned 1:1:1 to receive vilaprisan 2 mg, vilaprisan 4 mg, or placebo. Main Outcome MeasuresPrimary outcome was change in 7-day mean “worst pain” (per the Endometriosis Symptom Diary item 1) from baseline to Month 3. All analyses were descriptive only. ResultsEight participants were randomly assigned to treatment before the study pause: six received vilaprisan (4 mg, n=4; 2 mg, n=2) and two received placebo. The six vilaprisan recipients experienced an improvement in endometriosis-associated pelvic pain, whereas the two placebo recipients experienced no change or increased pain; all eight participants had decreased use of pain medication. Bleeding intensity decreased from baseline in the vilaprisan group. ConclusionThe study findings suggest that vilaprisan may improve outcomes in patients with endometriosis. Further studies in larger populations would be needed to accurately assess treatment effects.

Mismatch repair status and surgical approach in apparent early-stage endometrial cancer

ObjectiveTo test the hypothesis that mismatch repair (MMR) status (as an accurate surrogate marker for microsatellite stability) modifies the effect of surgical approach on oncological outcome for apparent early-stage endometrial...

Accuracy of commercial ELISA and ICT for screening schistosomiasis infections at a low endemicity area in Brazil.

Control interventions recommended by the World Health Organization have successfully resulted in low-intensity schistosomiasis transmission areas. To achieve elimination of transmission, new diagnostic screening tools are needed to overcome less than adequate sensitivity of the currently used Kato-Katz faecal thick smear method. Ideally, in-house serological tests should be avoided due to not having a continuous supply of kits as would be necessary for large population studies. Quality assurance provided by manufacturers and proper performance evaluations are also needed. We evaluated the accuracy of two commercially available serology tests as screening methods for detecting light schistosomiasis infections. Serum samples were collected in 2015 from individuals living in a low-endemicity locality in northeastern Brazil and deposited in a biorepository. We evaluated immunoglobulin G (IgG) and IgM enzyme-linked immunosorbent assays (ELISAs) and an immunochromatographic test (ICT). The Helmintex method was used to define true-positive samples. Overall sensitivity was close to 90% for both the IgG ELISA and ICT, yet specificity was 28% and 18%, respectively. For the IgM ELISA, the values were estimated to be 55% and 43%, respectively. Poor specificity and positive predictive values prevent these tests from being recommended for screening populations in low-intensity schistosomiasis-endemic areas.

A longitudinal mixed-methods study of pathology explanation clinics in patients with newly diagnosed localized prostate cancer.

To characterize the role of pathology explanation clinics (PECs) in prostate cancer care and determine their impact on patients, urologic oncologists, and quality of care. Semistructured interviews with 10 patients with newly diagnosed prostate cancer were conducted before and after a PEC pilot and at the 1- and 6-month follow-up visits. Information about participants' cancer knowledge and anxiety were collected quantitatively. Documented pathologist communications and proper review of outside biopsy slides were collected. Semistructured interviews were also completed with participating urologic oncologists following the pilot. Pathology explanation clinics improved participants' understanding of their diagnosis, cognitively and emotionally supporting them first in their urologic oncology visit and later in making an informed treatment decision. Mean knowledge scores were high, and a minority of participants had prostate cancer anxiety. Urologic oncologists noted improved understanding and reduced anxiety among participants, enabling nuanced conversations about prognosis and management during the visit. By ensuring review of outside biopsy slides and communication of clinically significant or unexpected diagnoses, PECs supported high-quality care and patient safety. In this small pilot, PECs positively affected patients with prostate cancer, their clinicians, and the overall care system. Additional studies in larger populations and diverse settings will be useful.