Observational Cohort Study Research Articles

Incidence and risk factors of venous thromboembolism in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis.

This systematic review and meta-analysis aimed to determine the annual incidence rate of venous thromboembolism (VTE) and identify risk factors of VTE in amyotrophic lateral sclerosis (ALS) patients. A comprehensive search of three databases was conducted up to April 8, 2024, to identify longitudinal studies reporting VTE incidence in ALS patients. The included studies were either prospective or retrospective, following up with ALS patients. Quality assessment was performed using the NIH tool for observational cohort studies. Meta-analysis was conducted using Open Meta Analyst, employing a random-effect model. Subgroup, Meta-regression, and sensitivity analyses were also carried out. Our analysis included eight studies comprising a total of 26,758 ALS patients that met the inclusion criteria. The pooled annual incidence of VTE across all studies was found to be 22 cases per 1,000 person-year (95% CI = 18 to 27). Subgroup analysis revealed that the annual incidence of VTE in males was 19 cases per 1,000 person-year (95% CI = 15 to 22), while in females, it was 20 cases per 1,000 person-year (95% CI = 16 to 25). Leave-one-out analysis demonstrated that the incidence ranged from 21 to 28 cases per 1,000 person-year when excluding each study individually. Meta-regression analysis did not find a significant association between age and the risk of VTE (P = 0.079). Based on the included studies, risk factors of VTE in ALS patients included a history of VTE, non-invasive ventilation, immobility, and decreased functional status. Patients with ALS face a higher risk of developing VTE compared to individuals of the same age. These findings underscore the importance of implementing preventive measures and closely monitoring VTE in ALS patients.

7978 Metabolic Outcomes in Transgender Youth Receiving Affirming Hormonal Therapy

Abstract Disclosure: M. Salama: None. R. Basmaci: None. T. Rajjo: None. O. Chuzhyk: None. A.N. Lteif: None. A. Al Nofal: None. Objective: Heightened societal acceptance of transgender youth and increased awareness of their unmet medical needs have led to a rise in referrals for hormonal therapy. There is limited literature available on the metabolic outcomes of hormone therapy on transgender youth. We investigated how the different metabolic markers of cardiovascular disease change after the initiation of gender-affirming hormonal therapy in transgender adolescents. Methods: A Retrospective, observational cohort study based on chart review of all children with gender dysphoria (under 18 years of age) who were evaluated in the Pediatric Endocrinology Clinic in a tertiary care center between January 2015 and December 2022. Children's demographic information, baseline weight, height, BMI, hematocrit, lipid profile, ALT, prolactin, and HbA1C levels were obtained before and after the initiation of gender-affirming hormonal therapy. The Wilcoxon signed-rank test was employed for paired analysis, while the chi-square test was used as appropriate. Results: We identified 106 transgender youth who were included in the analysis, with a median age at the start of hormonal therapy of 16 years (IQR: 15-17); comprising 68 trans-males (64%) and 38 trans-females (36%). The median treatment duration was 34 months (IQR: 18-54). Among trans-males, ALT levels increased post-treatment (mean difference 6.851 U/L, p < 0.001), as did BMI Z scores (mean difference 0.257, p < 0.001) and LDL-C (mean difference 12.734 mg/dl, p = 0.002), triglycerides (mean difference 10.18 mg/dl, p = 0.009), non-HDL-C (mean difference 12.8 mg/dl, p = 0.002), and total cholesterol (mean difference 10.18 mg/dl, p = 0.02). No significant differences were observed in HbA1C and HDL-C post-treatment. Among transfemales, BMI Z-scores were higher post-treatment (mean difference 0.27, p = 0.007), with increased total cholesterol (mean difference 19.88 mg/dl, p = 0.008), LDL-C (mean difference 12.6 mg/dl, p = 0.02), and HDL-C (mean difference 11.38 mg/dl, p < 0.001). Other variables did not significantly differ pre-and post-treatment. Ten transfemales with measured prolactin levels pre- and post-treatment showed no statistically significant differences. Conclusion: This pilot study revealed increased BMI Z scores following the commencement of hormone therapy in both trans-male and trans-female youths. Moreover, masculinizing treatment led to increased ALT levels. Furthermore, the cardiometabolic profile exhibited diverse alterations, particularly higher LDL-C levels in both cohorts. These findings underscore the necessity for close monitoring of these parameters during the treatment of transgender youth. Larger prospective randomized controlled trials are essential to comprehensively assess the impact of gender-affirming therapy on transgender youth. Presentation: 6/2/2024

6954 Effect Of The SARS-CoV-2 Pandemic on Metabolic Control In Patients With Type 2 Diabetes: A 5-year Cohort Follow-Up

Abstract Disclosure: D.P. Morales Rodríguez: None. M. Romero Ibarguengoitia: None. A. Garza-Silva: None. A. Rivera-Cavazos: None. I. Fernandez-Chau: None. A. Cepeda Medina: None. A. Gonzalez-Cantú: None. The SARS-CoV-2 pandemic brought a radical shift in the healthcare system and a suboptimal care for vulnerable patients, such as those with Type 2 Diabetes Mellitus (T2DM). Thus, we compared the metabolic control of patients with T2DM before and throughout 3 years of the SARS-CoV-2 pandemic, described the type of consultations and trends in attendance in various specialties, and compared the number of medications prescribed to patients before and during the pandemic. We conducted a retrospective observational cohort study on steelworkers with T2DM from a hospital in northeastern Mexico, who were treated by a multidisciplinary team from 2018 to 2022. We analyzed HbA1C levels, fasting serum glucose (FGS), low-density lipoprotein cholesterol (LDLc), blood pressure (BP) values, microalbuminuria, attendance at consultations across different specialties, and the trend in medication usage. We analyzed 999 subjects, 516 (51.7%) males, with a mean age (SD) of 60.1 (12.7) years. A significant difference was found in the proportion of controlled patients based on HbA1C with 55.5% in 2018 and 70.7% in 2022 (p<0.001). There was an increase of FGS control from 13.8% in 2018 to 56.1% in 2022 (p<0.001). LDL cholesterol control exhibited a decrease from 62.1% in 2018 to 57% in 2022 (p<0.001). Proportion of patients with systolic BP control decreased from 82.7% in 2018 to 80.1% in 2022 (p<0.001). Diastolic BP control was 89.6% in 2018 with an increase to 91.4% in 2022 (p=0.01). Microalbuminuria based control, increased from 80.5% in 2018 to 89% in 2022 (p=0.002). Telephone consultations were introduced in 2020, with 899 (90%) patients using this modality at least once, leading to a 35.8% decrease of in-person consultations (n=541,54.2%) and reaching its lowest point in 2021 (n=2, 0.2%). Throughout the follow-up period, all patients had at least one annual consultation with an internist or geriatrician based on their age group. There was an increase of endocrinology consultations from 8.5% in 2018 to 12.1% in 2022 and in cardiology from 6.9% in 2018 to 10.3% in 2022 (<0.05). There was a rise in the prescription of oral hypoglycemic agents raging from 4.9% to 14.2% between 2018 and 2020, with SGLT2 inhibitors being the highest prescribed and a 2.5% decrease in the prescription of sulfonylureas between 2018 and 2020. Similarly, there was an increase in the prescription of long-acting insulin by 5.9% between 2018 and 2020. There was a higher proportion of patients with controlled glycemic and diastolic blood pressure targets during the SARS-CoV-2 pandemic, this can be attributed to patient’s access to telemedicine and a multidisciplinary team capable of providing an appropriate medication prescription for an optimized management and improvement in patient’s quality of life. Presentation: 6/1/2024

6959 Variation of FIB-4 Classification In A 5-Year Follow-Up Cohort of Patients With Type 2 Diabetes Mellitus Managed By A Multi-Disciplinary Team In A Hospital In Northeastern Mexico

Abstract Disclosure: M. Romero Ibarguengoitia: None. D.P. Morales-Rodríguez: None. A. González-Cantú: None. A. Garza-Silva: None. A. Rivera-Cavazos: None. I. Fernández-Chau: None. A. Cepeda-Medina: None. Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common pathology associated to type 2 diabetes mellitus (T2DM), however the change in its classification over time is unknown in patients with T2DM managed by a multidisciplinary team in a population of Northern Mexico. Therefore, we analyzed the change in the FIB-4 classification for MASLD before and during 3 years of SARS-CoV-2 pandemic. We conducted a retrospective observational cohort study on a population of steelworkers with T2DM from a hospital in Northeastern Mexico from 2018 to 2022 treated by a multidisciplinary team. This team was comprised by an internist or geriatrician based on patient’s age, an endocrinologist, a nutritionist, and other specialties related to T2DM. We analyzed levels of HbA1C, fasting serum glucose (FSG), attendance to various specialties consultations, trends in medication usage and changes in the classification of FIB-4 scale. A total of 999 subjects were studied, with 516 (51.7%) being male, average age (SD) of 60.1 (12.7) years. There was a significant difference in the proportion of patients with controlled HbA1C levels, being 55.5% in 2018 and rising to 64.3% in 2020 and to 70.7% in 2022 (p<0.001). An increase in the proportion of patients in control based on FSG was observed, from 13.8% in 2018 to 54.8% in 2020 and 56.1% in 2022 (p<0.001). Throughout the follow-up period, all patients had at least one annual consultation with an internist or geriatrician according to their age group. Additionally, there was an increase in assistance to endocrinology consultations from 8.5% in 2018 to 9.9% in 2020 and 12.1% in 2022 (p<0.001). There was a rise in the prescription of oral hypoglycemic agents in general from 4.9% in 2018 to 14.2% in 2020, with an increase of GLP-1 analogs from 3.3% in 2018 to 9.3% in 2020 (p<0.001). Regarding the categorization by FIB-4, in 2018, a proportion of 64.8% of patients were observed in the F0-F1 category, 30.2% in the F2 category, and 4.8% in the F3-F4 category (p<0.001). These levels remained similar for 2020, with 62.6% in the F0-F1 category, 32.4% in the F2 category, and 4.9% in the F3-F4 category (p<0.001). In 2022, there is an increase in the proportion of patients in the F0-F1 category, reaching 71.8% of our population, along with a decrease in those classified as F2 to 20.9%, and a slight increase in the proportion of patients in the F3-F4 category to 7.2% (p<0.001). MASLD is a condition that occurs frequently in our population; however, it is possible to stabilize and even decrease its classification through a multidisciplinary and specialized team capable of treating T2DM effectively by optimizing its management with GLP-1 prescription and a prompt referral to endocrinology consultation with the aim of providing a good quality of life for the patients. Presentation: 6/2/2024

The impact of preoperative stroke on 1-year mortality and days at home alive after major surgery: an observational cohort study

ObjectiveThe lifetime risk of stroke is one in four people. As the population aged over 60 constantly expands, the impact of stroke on perioperative care is of increasing concern. This study investigates the effect of preoperative stroke on short- and long-term outcomes, hypothesizing that it decreases both 1-year mortality and days alive and at home up to 30 days after surgery (DAH30).MethodsThis cohort study investigated 290,306 adult patients with (7214) and without (283,092) preoperative stroke undergoing major non-cardiovascular, non-ambulatory surgery at 23 hospitals in Sweden between 2007 and 2014. Data were pre- and postoperatively matched with quality registers. Using logistic regression, significant independent risk factors influencing the risk of 1-year mortality and impeded DAH30 were identified with adjusted odds ratios calculated.ResultsPreoperative stroke was associated with higher 1-year mortality and lower DAH30, even after full adjustment for other co-morbid and surgical factors.ConclusionsThis large cohort showed preoperative stroke to impact both the patient-centered short-term outcome DAH30 and 1-year mortality. These findings should be considered in perioperative planning.

Assessment of Outcomes by Intention-to-Treat Comparison for Locally Advanced Pancreatic Cancer: A Population-Derived Cohort Study.

The overall treatment response among patients with locally advanced pancreatic cancer (LAPC) is poorly understood as most studies report solely on resected patients. We aimed to investigate the outcomes in patients with LAPC as an intention-to-treat-analysis from the time of diagnosis from a complete source population. An observational cohort study in a population-defined region within a universal healthcare system. All consecutive patients discussed at multi-disciplinary tumour board (MDT), aged ≥ 18 years and diagnosed with LAPC were included. Exposure was set as recommended treatment by MDT (i.e. upfront surgery, neoadjuvant therapy, palliative treatment or best supportive care). Outcome measures were overall survival analysed by Kaplan-Meier survival estimates and multivariable analyses using logistic regression for odds ratios (OR) and Cox proportional hazard analysis for hazard ratios (HR). In total, 8803 MDT events (6055 unique patients) with pancreatic disease were held during the study period. Some 1436 (24%) had pancreatic cancer, of which 162 (11%) had LAPC and 134 met the population-defined criteria. In overall survival analyses, the patients who were recommended neoadjuvant therapy (± surgery) demonstrated no significant difference to palliative chemotherapy (median 11.0 months vs. 11.8 months; p = 0.226). In multivariable analysis, adjusted OR for overall survival comparing the treatment groups was 0.27 (95% CI 0.02-3.29, p = 0.306) and Cox proportional HR 0.96 (95% CI 0.58-1.59, p = 0.865). In patients with LAPC, survival was not statistically different between those recommended for attempt at neoadjuvant (± surgery) compared with those recommended palliative chemotherapy. The findings suggest that conversion/downstaging chemotherapy is successful in only a select few.

Process-Specific Blood Biomarkers and Outcomes in COVID-19 Versus Non-COVID-19 ARDS (APEL-COVID Study): A Prospective, Observational Cohort Study.

Background: Severe acute respiratory syndrome (SARS) and acute respiratory distress syndrome (ARDS) are often considered separate clinico-radiological entities. Whether these conditions also present a single process-specific systemic biomolecular phenotype and how this relates to patient outcomes remains unknown. A prospective cohort study was conducted, including adult patients admitted to the ICU and general floors for COVID-19-related (COVID+) or non-COVID-19-related (COVID-) acute respiratory failure during the main phase of the pandemic. The primary objective was to study blood biomarkers and outcomes among different groups and severity subsets. Results: A total of 132 patients were included, as follows: 67 COVID+, 54 COVID- (with 11 matched control subjects for biomarker reference), and 58 of these patients allowed for further pre- and post-analysis. The baseline apelin (APL) levels were higher in COVID+ patients (p < 0.0001 vs. COVID- patients) and in SARS COVID+ patients (p ≤ 0.02 vs. ARDS), while the IL-6 levels were higher in ARDS COVID- patients (p ≤ 0.0001 vs. SARS). Multivariable logistic regression analyses with cohort biomarkers and outcome parameters revealed the following: (i) log-transformed neprilysin (NEP) activity was significantly higher in COVID+ patients (1.11 [95% CI: 0.4-1.9] vs. 0.37 [95% CI: 0.1-0.8], fold change (FC): 1.43 [95% CI: 1.04-1.97], p = 0.029) and in SARS patients (FC: 1.65 [95% CI: 1.05-2.6], p = 0.032 vs. non-SARS COVID+ patients, and 1.73 [95% CI: 1.19-2.5], p = 0.005 vs. ARDS COVID- patients) and (ii) higher lysyl oxidase (LOX) activity and APL levels were respectively associated with death and a shorter length of hospital stay in SARS COVID+ patients (Odds Ratios (OR): 1.01 [1.00-1.02], p = 0.05, and OR: -0.007 [-0.013-0.0001], p = 0.048). Conclusion: Process-specific blood biomarkers exhibited distinct profiles between COVID+ and COVID- patients, and across stages of severity. NEP and LOX activities, as well as APL levels, are particularly linked to COVID+ patients and their outcomes (ClinicalTrials.gov Identifier: NCT04632732).

Association of genetic ancestry with pre-eclampsia in multi-ethnic cohorts of pregnant women

ObjectivesMaternal self-reported ethnicity is recognised as a risk factor for pre-eclampsia in clinical screening tools and models. This study investigated whether ethnicity is acting as a proxy for genetic variants in this context. Study designA total of 436 women from multi-ethnic backgrounds recruited to two UK observational pregnancy hypertension cohort studies were genotyped. Genetically-computed individual ancestry estimates were calculated for each individual through comparison to the multi-ethnic 1000 Genomes reference panel genotypes. Regression models for pre-eclampsia using clinical risk factors including self-reported ethnicity with and without ancestry estimates were built and compared using Likelihood Ratio Tests (LRT). Main outcome measuresPre-eclampsia (early- and late-onset). ResultsIn these multi-ethnic cohorts (mean age 34.9 years; 41.3 % White, 34.2 % Black, 13.1 % Asian ethnic backgrounds; 82.6 % chronic hypertension), discrepancies between self-reported ethnicity and genetically-computed individual ancestry estimates were present in all ethnic groups, particularly minority groups. Genetically-computed pan-African ancestry percentage was associated with early-onset (< 34 weeks) pre-eclampsia in adjusted models (aOR 100 % vs 0 % African ancestry: 3.81, 95 % CI 1.04–14.14, p-value 0.044) independently of self-reported ethnicity and established clinical risk factors. Addition of genetically-computed African ancestry to a clinical risk factor model including self-reported ethnicity, improved model fit (Likelihood ratio test p-value 0.023). ConclusionsSelf-reported maternal ethnicity is an imperfect proxy for genetically-computed individual ancestry estimates, particularly in ethnic minority groups. Genetically-computed African ancestry percentage was associated with early-onset pre-eclampsia independently of self-reported maternal ethnicity. Well-powered studies in multi-ethnic cohorts are required to delineate the genetic contribution to pre-eclampsia.

Safety and efficacy of high thoracic epidural analgesia for chest wall surgery in young adolescents: A retrospective cohort analysis and a new standardised definition for success rate.

Chest wall surgery for the correction of pectus excavatum or pectus carinatum has gained increased interest in recent years. Adequate pain treatment, respiratory physiotherapy and early ambulation are key to improving the outcomes. Although thoracic epidural analgesia is highly effective, its safety is controversial, leading to extensive scrutiny and questioning of its role. We hypothesise that thoracic epidural analgesia is effective and well tolerated to use in adolescents, with a high success rate and low pain scores. Observational retrospective cohort study. All adolescent cases in a high-volume academic tertiary chest wall surgery centre between March 1993 and December 2017 were included. A total of 1117 patients aged from 12 to 19 years of age and receiving either Ravvitch, Nuss or Abramson chest wall reconstruction for pectus excavatum were identified in our institutional chest wall surgery database. After applying selection and exclusion criteria, 532 patients were included in the current analysis. The primary endpoint of this study was the safety of epidural analgesia, assessed by the incidence of acute adverse events. Secondary endpoints were block success rates using a specific novel definition, and analgesic efficacy using recorded postoperative pain scores. More than 60% of patients experienced one or more adverse events. However, all events were minor and without consequences. No serious or long-term adverse events were detected. The success rate of thoracic epidural placement was 81%. Low postoperative pain scores were observed. Thoracic epidural analgesia is an extremely effective pain control technique, with a surprisingly high number of minor adverse events but safe with regard to serious adverse events. The local research ethics committee approved and registered this study on 16 May 2022 (registration number: S66594).

Effects of intubation and hypoxemia on intraventricular hemorrhage in preterm infants during the first week: An observational study

BackgroundPreterm infants with intraventricular hemorrhage (IVH) are at a risk of developing neurodevelopmental disabilities. Few studies have examined the effects of oxygen saturation (SpO2) changes and intubation procedures on the risk of IVH. ObjectivesWe examined the effects of intubation and the rates of three thresholds of hypoxemia on the occurrence of IVH in preterm infants during their first week in the neonatal intensive care unit (NICU). MethodsIn this prospective observational cohort study, preterm infants with a gestational age (GA) of <37 weeks were included from two Level III NICUs in Taiwan. Continuous electrocardiography was used to monitor SpO2 changes, and cranial ultrasonography was used to monitor IVH. Thresholds of hypoxemia (SpO2 levels of <80 %, <85 %, and <90 %) were screened by digitally sampling data at 10-s intervals. Generalized estimating equations were used with logistic regression to analyze the effects of intubation and the rates of the three thresholds of hypoxemia on the risk of IVH during the first week after birth. ResultsIn all preterm infants (N = 73), the mean GA was 31.55 weeks, and the mean birth weight was 1508.86 g. Intubation within 3 days of birth, duration of mechanical ventilation and oxygen use, hypoxemia rate, and maternal use of magnesium sulfate before and during delivery were significantly associated with IVH. A multivariate analysis revealed that intubation was a key factor associated with the occurrence of IVH across different thresholds of hypoxemia (p = 0.004). ConclusionsAlthough the rate of hypoxemia, duration of mechanical ventilation and oxygen use, and maternal use of magnesium sulfate were significantly associated with IVH, intubation within 3 days of birth was the key factor responsible for increased IVH risk.

Hypoalbuminemia is a predictor of mortality in patients with cardiogenic shock requiring veno-arterial extracorporeal membrane oxygenation.

Hypoalbuminemia is predictive of mortality in critically ill patients, especially those with cardiac etiologies of illness. The objective of this study was to determine the association of albumin level pre-cannulation for veno-arterial (V-A) extracorporeal membrane oxygenation (ECMO) and important clinical hospital outcomes. This was a retrospective, observational cohort study of albumin levels in patients with cardiogenic shock requiring V-A ECMO between December 2015 and August 2021 in a single, high-volume ECMO center. The primary outcome was in-hospital mortality. Of 434 patients assessed, 318 were included. The overall mean pre-ECMO albumin was 3 ± 0.8g/dL and mean albumin at 72 hours post-cannulation was 2.7 ± 0.5g/dL. For patients with pre-ECMO albumin ≤3g/dL vs. >3g/dL, in-hospital mortality was 44.9% vs. 27.5%, respectively (p = .002). In multivariable logistic regression analysis, higher albumin (per 1g/dL increase) at time of V-A ECMO initiation was associated with decreased odds of in-hospital mortality (OR, 0.68; 95% CI, 0.48-0.96; p = .03). Patients with a pre-ECMO albumin ≤3g/dL required significantly more platelet transfusions and had higher incidence of gastrointestinal bleeding during V-A ECMO support (both p < .05). Hypoalbuminemia at time of cannulation is significantly associated with in-hospital mortality and ECMO-related complications including platelet transfusion and gastrointestinal bleeding. Albumin levels at the time of consideration of V-A ECMO may serve as a key prognostic indicator and may assist in effective decision-making regarding this invasive and costly resource.

Real-world evaluation of CYP2C19 guided antiplatelet therapy in patients undergoing intracranial aneurysm repair.

Aim: To evaluate the feasibility and impact of using CYP2C19 genotype to guide selection of antiplatelet therapy in patients undergoing intracranial aneurysm treatment with a flow diversion stent in a real-world clinical setting.Patients & methods: A single-center, retrospective, observational cohort study was conducted in 112 patients undergoing intracranial aneurysm repair with flow-diversion stenting from 2014 to2021. Data were abstracted from health records. The frequency of clopidogrel or alternative therapy (ticagrelor or prasugrel) use was compared across CYP2C19 status (intermediate or poor metabolizer [IM/PM] vs. normal, rapid, or ultrarapid metabolizer [NM/RM/UM]).Results: In the study population, CYP2C19 genotype testing was performed on 110 (98.2%) patients; of these, 106 (97.2%) had results available prior to the stent procedure and 28 (25.5%) were IM/PMs. Alternative therapy was used more frequently in IM/PMs compared with NM/RM/UMs (57.1 vs. 8.5%, respectively, p<0.0001). The frequency of thromboembolic events over 12months did not significantly differ across clopidogrel-treated IM/PMs, clopidogrel-treated NM/RM/UMs and patients on alternative therapy (p=0.352); although, event numbers were low.Conclusion: A pre-emptive CYP2C19 genotyping strategy to guide antiplatelet therapy selection in intracranial aneurysm repair patients is feasible in a real-world clinical setting. Larger studies are needed to assess the impact on clinical outcomes.

First postnatal lactate blood levels on day 1 and outcome of preterm infants with gestational age

Serum lactate levels are used as biomarkers for perinatal asphyxia, while their value for outcome prediction in preterm infants is uncertain. It was the aim of this observational study to determine the association of the first postnatal serum-lactate levels on day 1 of life and short-term outcome in preterm infants less than 29 gestational weeks. We analysed data in a population-based cohort of German Neonatal Network (GNN) preterm infants with available first postnatal lactate levels enrolled at 22-28 weeks of gestational age (GA) between 1st of April 2009 and 31st December 2020. We hypothesized that high lactate levels as measured in mmol/L increase the risk of intraventricular haemorrhage (IVH) and bronchopulmonary dysplasia (BPD) in infants with VLBW regardless of small-for-gestational-age (SGA) status. Hypotheses were evaluated in univariate analyses and multiple logistic regression models. First postnatal lactate levels were available in 2499 infants. The study population had a median GA of 26.7 [IQR 25.2-27.9] weeks and birth weight of 840 g [IQR 665-995]. Infants with short-term complications such as IVH and BPD had higher initial lactate levels than non-affected infants. The positive predictive value of a lactate cut-off of 4 mmol/L was 0.28 for IVH and 0.30 for BPD. After adjustment for known confounding variables, each 1 mmol/L increase of day 1 lactate levels was associated with a modestly increased risk of IVH (OR 1.18; 95% CI 1.03-1.37; p = 0.002) and BPD (OR 1.23; 95% CI 1.06-1.43; p = 0.005) but not with sepsis or mortality. Notably, SGA was associated with lower risk of any grade and severe IVH (OR 0.70; 95% CI 0.54-0.85; p = 0.001). In our observational cohort study higher initial lactate levels were associated with adverse outcome regardless of SGA status. However, the predictive value of lactate cut-off levels such as 4 mmol/L is low.

Disparities in pain management among transgender patients presenting to the emergency department for abdominal pain.

Transgender and gender-diverse (TGD) individuals have a gender identity or expression that differs from the sex assigned to them at birth. They are an underserved population who experience health care inequities. Our primary objective was to identify if there are treatment differences between TGD and cisgender lesbian/gay/bisexual/queer (LGBQ) or heterosexual individuals presenting with abdominal pain to the emergency department (ED). Retrospective observational cohort study of patients ≥12 years of age presenting to 21 EDs within a health care system with a chief complaint of abdominal pain between 2018 and 2022. TGD patients were matched 1:1:1:1 to cisgender LGBQ women and men and cisgender heterosexual women and men, respectively. Propensity score matching covariates included age, ED site, mental health history, and gastrointestinal history. The primary outcome was pain assessment within 60 min of arrival. The secondary outcome was analgesics administered in the ED. We identified 300 TGD patients, of whom 300 TGD patients were successfully matched for a total cohort of 1300 patients. The median (IQR) age was 25 (20-32) years and most patients were treated in a community ED (58.2%). There was no difference between groups in pain assessment within 60 min of arrival (59.0% TGD vs. 63.2% non TGD, p = 0.19). There were no differences in the number of times pain was assessed (median [IQR] 2 [1-3] vs. 2 [1-4], p = 0.31) or the severity of pain between groups (5.5 [4-7] vs. 6 [4-7], p = 0.11). TGD patients were more likely to receive nonsteroidal anti-inflammatory drugs (32.0% vs. 24.9%, p = 0.015) and less likely to receive opioids than non-TGD patients (24.7% vs. 36.9%, p = <0.001). TGD and nonbinary patients, along with LGBQ cisgender women (24.7%) and heterosexual cisgender women (34%), were less likely to receive opioids than LGBQ cisgender men (54%) and heterosexual cisgender men (42.3%, p < 0.01). There was no difference in frequency of pain assessment, regardless of gender identity or sexual orientation. More cisgender men, compared to TGD and cisgender women, received opioids for their pain.

Sotos Syndrome: Deep Neuroimaging Phenotyping Reveals a High Prevalence of Malformations of Cortical Development.

Sotos syndrome is a rare autosomal dominant condition caused by pathogenic mutations in the NSD1 gene that presents with craniofacial dysmorphism, overgrowth, seizures, and neurodevelopmental delay. Macrocephaly, ventriculomegaly, and corpus callosal dysmorphism are typical neuroimaging features that have been described in the medical literature. The purpose of this study was to expand on the neuroimaging phenotype by detailed analysis of a large cohort of patients with genetically proved Sotos syndrome. This multicenter, multinational, retrospective observational cohort study systematically analyzed the clinical characteristics and neuroimaging features of 77 individuals with genetically diagnosed Sotos syndrome, via central consensus review with 3 pediatric neuroradiologists. In addition to previously described features, malformations of cortical development were identified in most patients (95.0%), typically dysgyria (92.2%) and polymicrogyria (22.1%), varying in location and distribution. Incomplete rotation of the hippocampus was observed in 50.6% of patients and was associated with other imaging findings, in particular with dysgyria (100% versus 84.2%, P = .012). Our findings show a link between the genetic-biochemical basis and the neuroimaging features and aid in better understanding the underlying clinical manifestations and possible treatment options. These findings have yet to be described to this extent and correspond with recent studies that show that NSD1 participates in brain development and has interactions with other known relevant genetic pathways.

Quality of Life in People with HIV at the End of Life: Preliminary Results from the Last Gift Observational Cohort Study.

As people living with HIV (PWH) age, they face new challenges that can have a negative impact on their quality of life (QOL) and mental health. This study enrolled PWH at the end of life (EOL) who were actively engaged in cure-related research in Southern California, United States. EOL was defined as having a prognosis of six months or less to live. We examined the relationship between QOL, mental health, and research participation. Structured assessments were used to collect comprehensive data on QOL and mental health. From 2017 to 2023, 35 PWH in their final stages of life who were actively engaged in cure-related research were enrolled. Their median age was 62.7 years, and most were White or otherwise non-Hispanic/non-Latino (90.6%), and male (86.7%). Changes in QOL and the presence of neurologic and psychiatric conditions, with a focus on depression and anxiety, were the primary outcomes assessed in this study. Participants had stable QOL scores throughout the study. There was an inverse relationship between QOL and BDI scores, with higher mean QOL scores being associated with lower mean BDI scores (p < 0.001). QOL remained stable among PWH who participate in cure-related research at EOL. The inverse relationship between QOL and depressive symptoms suggests that participation in cure-related research may improve QOL or reduce depressive symptoms in this population. Future interventions should look into ways to improve the well-being of PWH at EOL through research and customized mental health interventions.

Respiratory viral testing for young febrile infants presenting to emergency care: a planned secondary analysis of the Febrile Infants Diagnostic assessment and Outcome (FIDO) prospective observational cohort study

ObjectiveTo describe the association of respiratory viral test results and the risk of invasive bacterial infection (IBI) for febrile young infants presenting to emergency care.DesignA planned secondary analysis within the...

Neurofilament heavy chain and chitinase 3-like 1 as markers for monitoring therapeutic response in multiple sclerosis

AimsThe aim of this study was to evaluate the association of serum neurofilament heavy chain (sNfH) and chitinase 3-like 1 (sCHI3L1) with treatment response and disease activity in multiple sclerosis (MS). MethodsThis single-center, prospective, observational cohort study was conducted at the MS Centre, University Hospital Ostrava, Czech Republic, from May 2020 to August 2023. sNfH and sCHI3L1 were determined using ELISA. A mixed-effects linear model with a log-transformed outcome variable was applied. ResultsWe analyzed 459 samples from 57 people with MS. Patients were sampled an average of 8.05 times during 21.9 months of follow-up. Those experiencing a relapse at sampling had a sNfH concentration 50 % higher than those in remission (exp(β) 1.5, 95 % CI 1.15–1.96). A longer duration of treatment was associated with lower sNfH (exp(β) 0.95, 95 % CI 0.94–0.96). Patients switched from low- to high-efficacy disease-modifying therapies (DMTs) had higher sNfH than patients treated with low-efficacy DMTs only (exp(β) 1.95, 95 % CI 1.35–2.81). Higher sCHI3L1 was associated with older age (exp(β) 1.01, 95 % CI 1.00–1.02) and longer DMT use (exp(β) 1.01, 95 % CI 1.00–1.02). sCHI3L1 values were not associated with relapse at the time of sampling, renal function, sex, or type of DMT. ConclusionIn contrast to sCHI3L1, sNfH may be a potential biomarker for monitoring treatment response and confirming clinical relapse in MS. Further research is needed to determine the long-term dynamics of sNfH and develop related treatment strategies.

A-011 Single High-Sensitivity Cardiac Troponin I Compared to High-Sensitivity Cardiac Troponin T Measurement to Rule Out Acute Myocardial Infarction at Low Risk for 30-Day Adverse Events: CONTRAST Study

Abstract Background Cardiac troponin (cTn) is the preferred biomarker for diagnosing myocardial injury and acute myocardial infarction (MI). There are few comparative studies addressing the clinical performance of high-sensitivity (hs)-cTnI and hs-cTnT assays using fresh plasma for early rule out of myocardial infarction (MI) on presentation in patients presenting to emergency departments (ED). This study examined the performance strategies of a derived optimal concentration for a single high-sensitivity cardiac troponin I (hs-cTnI) measurement compared to a derived optimal concentration for a single high-sensitivity cardiac troponin T (hs-cTnT) measurement to rule out acute MI. Methods The COmparisoN of high-sensitivity cardiac TRoponin I and T ASsays Trial (CONTRAST) (NCT03214029) is a prospective, observational cohort study of consecutive adult ED patients (n = 2208) undergoing serial cTn measurements as clinically indicated. hs-cTnI (Abbott ARCHITECT) and hs-cTnT (Gen 5, Roche e601) measurements using fresh EDTA plasma were obtained. We determine optimal hs-cTn cutoffs for negative predictive value (NPV) and sensitivity for the diagnosis of acute MI (type 1 and type 2) to allow for a maximum number for early discharges with minimal risk of adverse events (acute MI or cardiac death) at 30 days. Results Acute MI occurred in 161 patients (7.3%), including 68 (42.2%) type 1 MI and 93 (57.7%) type 2 MI. For hs-cTnI (&amp;lt;2 ng/L) optimal NPV and sensitivity for adverse events were 99.1% (95% confidence interval 97.7%-99.8%) and 98.2% (CI. 95.4-99.5%). 450 Patients (21%) qualified for early rule out, at a 1.8% miss rate at 30 days. For hs-cTnT (&amp;lt;6 ng/L) optimal NPV and sensitivity for adverse events were 99.2% (CI 98.0%-99.8%) and 98.1% (CI. 95.3-99.5%). 513 Patients (24%) qualified for early rule out, at a 1.9% miss rate at 30 days. Conclusions In CONTRAST, a strategy using a single sample hs-cTnI or hs-cTnT alone allows for the early identification of patients unlikely to have acute MI and who are at very low risk for adverse events at 30 days. Minor differences existed between the Abbott ARCHITECT hs-cTnI assay and the Roche e601 hs-cTnT (Gen 5) assay in fresh plasma were found.

A-165 Value Of Monocyte Distribution Width In Bacteremia Assessment In Emergency Department Patients

Abstract Background Monocyte distribution width (MDW) is an immune response biomarker and part of a CBC differential. MDW is derived from the distribution of monocyte volumes and elevated MDW values correlate with severe infections and sepsis in Emergency Department (ED) adult patients. Neutrophil to lymphocyte ratio (NLR) is predictive of infections and inflammatory stress. Evaluating these biomarkers could be valuable in bacteremia risk assessment. Bacteremia is the presence of viable bacteria in the bloodstream and is present in up to 20% of septic patients. Blood cultures establish pathogen identity but require culture time, potentially delaying appropriate treatment. Our goal was to characterize MDW and NLR clinical performance in ED patients with suspected bacteremia. Methods This was an observational cohort study of ED patients 18 years and older with CBC differential and blood cultures obtained. MDW values ≥20 is the published cut-off for increased infection risk. Clinical literature suggests that NLR ≥3 is abnormal. We assessed the diagnostic performance of MDW and NLR for positive blood cultures using SPSS Version 25. Results From 07/2021-09/2023, 9,400 blood cultures were ordered and 5174 patients had differential CBCs. The overall blood culture positivity rate was 14.4%. MDW and NLR performance for positive blood cultures is shown in Table 1. Conclusions Our analysis provides evidence that MDW and NLR may be useful for early recognition of bacteremia in ED patients. CBC differential results are reported sooner than culture results. MDW is directly reported, NLR can be readily calculated from the differential. Therefore both could contribute to earlier risk stratification and our findings suggest potentially distinct information from MDW and NLR. Combining MDW with other CBC parameters may provide additional diagnostic advantage. Further analysis will incorporate added clinical data for enhanced decision support in interpreting MDW values in the context of pending blood culture results.