Multicenter Cohort Study Research Articles

7428 Clinical and Radiological Characterization and Outcomes of Lipid-Poor Adrenal Masses- A Multi-Center Retrospective Study

Abstract Disclosure: V. Balderrama-Brondani: None. R. Al-ward: None. K. Kiseljak-Vassiliades: None. L.M. Fishbein: None. D.A. Kirelik: None. O. Hamidi: None. R. Pishdad: None. H.K. Ghayee: None. M. Sukkari: None. S.S. Bedrose: None. A.H. Hamrahian: None. M.A. Habra: None. Background: Lipid-poor adrenal masses (LPAMs) with pre-contrast radiodensity >10 Hounsfield Units (HU) on computed tomography (CT) represent ∼25% of adrenal tumors. There is limited data about the natural history of LPAMs; therefore, we evaluated a large series of patients with LPAMs to describe the radiological and clinical features and outcomes of these cases. Methods: We conducted a multi-center retrospective cohort study of patients with LPAMs with a baseline diameter of 10-39 mm and derived from 6 institution members of the American-Australian-Asian Adrenal Alliance (A5). We excluded suspected or proven adrenal metastasis, pheochromocytoma, sarcoma, lymphoma, myelolipoma, infiltrative lesions, and adrenal hemorrhage, as well as patients with personal/familial history of genetic predisposition to adrenal neoplasms. The data is presented in percentage and median (range). Results: A total of 242 adrenal masses from 218 patients were evaluated, but only 225 (93%) masses met the inclusion criteria and were analyzed. The age was 58 (23-92), and 61% were women. LPAMs were incidentally discovered in 155 (71.1%) cases, 32 (14.7%) cases were diagnosed due to hormonal overproduction, and 17 (7.8%) due to pain/mass effect. Forty-six (21.1%) patients were on surveillance for a history of extra adrenal malignancy. Masses were unilateral in 89.9% (left side, 57.1%), with size 21 (10-38) mm, with a pre-contrast density of 24 (11-136) HU. Absolute washout was reported in 107 LPAMs and was >60% in 73 (68.2%) cases. The follow-up time was 44.4 (0.9-241) months. Hormonal overproduction developed during the follow-up in 23 (10.5%) cases as follows: cortisol in 15 (6.9%), aldosterone in 4 (1.8%), and sex hormones in 3 (1.4%) cases. LPAM growth rate was 0.03 (-2.18-11.59) cm/year. Seventy-one masses (31.5%) underwent diagnostic procedures (surgery/biopsy) with adrenocortical adenoma (n=37; 52.1%) and adrenocortical carcinoma (ACC) (n=25; 35.2%) being the two most common diagnoses. The tumor growth rate of pathologically confirmed adenomas was 0.03 (-0.30-10.50) cm/year, and of ACC was 1.31 (0.03-11.59) cm/year. A total of 154 (68.4%) LPAMs remained under surveillance at the end of the study, with a follow-up time of 51.8 (6-241) months and a tumor growth rate of 0.02 (-2.18-1.36) cm/year. Forty-five (20.6%) LPAMs decreased by 2 mm (1-13) during the study period. Cases that proved to be ACC had the most significant tumor growth rate over the study (p<0.001). The median time between the initial discovery of LPAM and the surgical resection of ACC cases was 34 (6-128) months. Conclusion: Our study showed that LPAMs carry significant malignant potential, and close long-term follow-up is warranted when surgical resection is not pursued. Prospective studies are critically needed to validate our findings and to establish high-risk molecular, imaging, and biochemical features associated with malignancy. Presentation: 6/2/2024

Open laryngotracheal reconstruction for iatrogenic posterior glottic stenosis in adults: international multicenter experience.

Posterior glottic stenosis (PGS) has a significant impact on breathing and quality of life, and remains a challenging condition to manage. Literature does not provide a single optimal approach. In this study we aim to assess post-operative outcomes of adult patients with acquired PGS treated with open laryngotracheal reconstruction (LTR) with autologous or cadaveric rib grafting. This multicenter retrospective cohort study included adults who underwent open LTR for iatrogenic PGS (2015-2023) and were followed for 26 months on average. Data on comorbidities, surgical complications, and interventions following surgery were collected. Forty-three adult patients were included. Decannulation was successful in 76.7%, and 53.5% of patients required an endoscopic or open revision procedure for recurrent stenosis during the mean post-operative follow-up of 26 months. Patients with severe obesity (BMI ≥ 35), moderate to severe co-morbidity (ASA ≥ 3) or Chronic Kidney Disease were significantly more likely to fail decannulation after LTR. Diabetes Mellitus and ASA ≥ 3 were significant negative predictors for intervention-free survival. There were no significant differences in decannulation rate or intervention free survival between patients that had LTR with autologous (n = 26) versus cadaveric (n = 17) cartilaginous grafting. This study describes the largest consecutive multicenter cohort of adult PGS patients treated with open LTR. This technique significantly improves breathing outcomes in PGS, with minimal complications in selected patients with a healthy weight and few comorbidities. Patients with a BMI ≥ 35, ASA ≥ 3, Diabetes Mellitus or renal failure have less favorable outcomes, with respect to decannulation rates and intervention-free survival.

9294 Clinical and Radiological Characterization And Outcomes of Lipid-Poor Adrenal Masses- A Multi-Center Retrospective Study

Abstract Disclosure: V. Balderrama-Brondani: None. R. Al-ward: None. K. Kiseljak-Vassiliades: None. L.M. Fishbein: None. D.A. Kirelik: None. O. Hamidi: None. R. Pishdad: None. H.K. Ghayee: None. M. Sukkari: None. S.S. Bedrose: None. A.H. Hamrahian: None. M.A. Habra: None. Background: Lipid-poor adrenal masses (LPAMs) with pre-contrast radiodensity >10 Hounsfield Units (HU) on computed tomography (CT) represent ∼25% of adrenal tumors. There is limited data about the natural history of LPAMs; therefore, we evaluated a large series of patients with LPAMs to describe the radiological and clinical features and outcomes of these cases. Methods: We conducted a multi-center retrospective cohort study of patients with LPAMs with a baseline diameter of 10-39 mm and derived from 6 institution members of the American-Australian-Asian Adrenal Alliance (A5). We excluded suspected or proven adrenal metastasis, pheochromocytoma, sarcoma, lymphoma, myelolipoma, infiltrative lesions, and adrenal hemorrhage, as well as patients with personal/familial history of genetic predisposition to adrenal neoplasms. The data is presented in percentage and median (range). Results: A total of 242 adrenal masses from 218 patients were evaluated, but only 225 (93%) masses met the inclusion criteria and were analyzed. The age was 58 (23-92), and 61% were women. LPAMs were incidentally discovered in 155 (71.1%) cases, 32 (14.7%) cases were diagnosed due to hormonal overproduction, and 17 (7.8%) due to pain/mass effect. Forty-six (21.1%) patients were on surveillance for a history of extra adrenal malignancy. Masses were unilateral in 89.9% (left side, 57.1%), with size 21 (10-38) mm, with a pre-contrast density of 24 (11-136) HU. Absolute washout was reported in 107 LPAMs and was >60% in 73 (68.2%) cases. The follow-up time was 44.4 (0.9-241) months. Hormonal overproduction developed during the follow-up in 23 (10.5%) cases as follows: cortisol in 15 (6.9%), aldosterone in 4 (1.8%), and sex hormones in 3 (1.4%) cases. LPAM growth rate was 0.03 (-2.18-11.59) cm/year. Seventy-one masses (31.5%) underwent diagnostic procedures (surgery/biopsy) with adrenocortical adenoma (n=37; 52.1%) and adrenocortical carcinoma (ACC) (n=25; 35.2%) being the two most common diagnoses. The tumor growth rate of pathologically confirmed adenomas was 0.03 (-0.30-10.50) cm/year, and of ACC was 1.31 (0.03-11.59) cm/year. A total of 154 (68.4%) LPAMs remained under surveillance at the end of the study, with a follow-up time of 51.8 (6-241) months and a tumor growth rate of 0.02 (-2.18-1.36) cm/year. Forty-five (20.6%) LPAMs decreased by 2 mm (1-13) during the study period. Cases that proved to be ACC had the most significant tumor growth rate over the study (p<0.001). The median time between the initial discovery of LPAM and the surgical resection of ACC cases was 34 (6-128) months. Conclusion: Our study showed that LPAMs carry significant malignant potential, and close long-term follow-up is warranted when surgical resection is not pursued. Prospective studies are critically needed to validate our findings and to establish high-risk molecular, imaging, and biochemical features associated with malignancy. Presentation: 6/2/2024

12217 Exploring Thyroid-stimulating Hormone As A Potential Cardiovascular Disease Risk Marker In Euthyroid Individuals

Abstract Disclosure: A.P. Neto: None. H. Lucchesi: None. C.C. Silva Janovsky: None. I. Bensenor: None. L.S. Ward: None. L.L. Cunha: None. Previous studies have suggested that TSH levels may predict longevity primarily in elderly individuals. Aging is associated with a high prevalence of cardiovascular and metabolic diseases that reduce survival. However, the relationship between serum TSH levels and these conditions, especially traditional cardiovascular risk markers, remains poorly explored. We employed data from the longitudinal multicenter cohort study ELSA-Brasil, which includes workers from five Brazilian Universities, to evaluate thyroid function in 8,452 participants aged between 34 and 75 years, classified as euthyroid and followed for 8.9 ± 0.6 years. The participants were evaluated for the presence of diabetes, hypertension, angina, peripheral arterial disease, and cardiovascular mortality. Additionally, we measured cardiovascular markers, including global cardiovascular risk score, HbA1c, microalbuminuria (mg/dl), LDL levels, and triglyceride levels. Statistical analysis was used to compare TSH levels with clinically relevant outcomes and classical cardiovascular risk markers. We observed that higher TSH levels correlated negatively with global cardiovascular risk (Spearman rank -0.023, p-value=0.038), microalbuminuria (Spearman rank -0.055, p<0.000), and HbA1c (Spearman rank -0.041, p<0.000). However, TSH levels were positively correlated with hypertriglyceridemia (Spearman rank +0.125, p<0.000) but had no relationship with LDL (p >0.05). The appraisal of cardio-metabolic diseases showed that individuals without diabetes had higher TSH levels (1.79 mIU/L, IQR 1.07) than individuals with diabetes (1.71 mIU/L, IQR 1.07). Patients with arteriosclerosis diseases, such as coronary and peripheral arterial disease, had lower TSH levels (1.66, IQR 0.98 and 1.67, IQR 0.94, respectively) than those who did not have these comorbidities (1.79, IQR 1.07, and 1.79, IQR 1.07). Furthermore, TSH levels did not correlate with the incidence of hypertension (p >0.05). Finally, we divided the population into two groups: higher and lower TSH levels based on the median TSH levels (1.78 mIU/L, IQR 1.06). The Kaplan-Meier curve did not show a difference between these groups (p=0.758) in survival after cardiovascular events (08 events in total) during follow-up. In conclusion, our results suggest that higher serum TSH levels in euthyroid individuals are associated with a lower prevalence of metabolic and cardiovascular disease. However, the relatively short observation duration and low frequency of cardiovascular events in our cohort made it difficult to statistically analyze several endpoints, such as survival. Further investigation is necessary to completely understand whether TSH is a cardiovascular risk indicator. Presentation: 6/2/2024

Outcomes associated with Healthcare-associated Respiratory Syncytial Virus in Children's Hospitals.

To determine if healthcare-associated (HA)-RSV is associated with worse outcomes, this multicenter cohort study studied 26 children with HA-RSV and 78 matched non-HA-RSV patients of whom 58% and 55%, respectively, had >2 comorbidities. Overall, 39% of HA-RSV versus 18% of non-HA-RSV patients required respiratory support escalation (aOR 5.1, CI95 1.4,19.1).

Postoperative outcomes after receipt of ertapenem antimicrobial prophylaxis for colon surgery: a multicenter retrospective cohort study.

To evaluate postoperative outcomes among patients undergoing colon surgery who receive perioperative prophylaxis with ertapenem compared to other antibiotic regimens. Multicenter retrospective cohort study among adults undergoing colon surgery in seven hospitals across three health systems from 1/1/2010 to 9/1/2015. Generalized linear mixed logistic regression models were applied to assess differential odds of select outcomes among patients who received perioperative prophylaxis with ertapenem compared to other regimens. Postoperative outcomes of interest included surgical site infection (SSI), Clostridioides difficile infection (CDI) and clinical culture positivity for carbapenem-resistant Enterobacteraciae (CRE). Inverse probability weights were applied to account for differing covariate distributions across ertapenem and non-ertapenem groups. A total of 2,109 patients were included for analysis. The odds of postoperative SSI was 1.56 times higher among individuals who received ertapenem than among those receiving other perioperative antimicrobial prophylaxis regimens in our cohort (46 [3.5%] vs 20 [2.5%]; IPW-weighted OR 1.56, [95% CI, 1.08-2.26], P = .02). No statistically significant differences in odds of postoperative CDI (24 [1.8%] vs 16 [2.0%]; IPW-weighted OR 1.07 [95% CI, .68-1.68], P = .78) were observed between patients who received ertapenem prophylaxis compared to other regimens. Clinical CRE culture positivity was rare in both groups (.2%-.5%) and did not differ statistically. Ertapenem use for perioperative prophylaxis was associated with increased odds of SSI among patients undergoing colon surgery in our study population, though no differences in CDI or clinical CRE culture positivity were identified. Further study and replication of these findings are needed.

Characterisation of older patients that require, but do not undergo, emergency laparotomy: a multicentre cohort study

BackgroundOlder adults (≥65 yr) account for the majority of emergency laparotomies in the UK and are well characterised with reported outcomes. In contrast, there is limited knowledge on those patients that require emergency laparotomy but do not undergo surgery (NoLaps). MethodsA multicentre cohort study (n=64 UK surgical centres) recruited 750 consecutive NoLap patients (February 15th - November 15th 2021, inclusive of a 90-day follow up period). Each patient was admitted to hospital with a surgical condition treatable by an emergency laparotomy (defined by The National Emergency Laparotomy Audit (NELA) criteria), but a decision was made not to undergo surgery (NoLap). ResultsNoLap patients were predominately female (452 patients, 60%), of advanced age (median age 83.0 yr, interquartile range 77.0–88.8), frail (523 patients, 70%), and had severe comorbidity (750 patients, 100%); 99% underwent CT scanning. The commonest diagnoses were perforation (26%), small bowel obstruction (17%), and ischaemic bowel (13%). The 90-day mortality was 79% and influencing factors were >80 yr, underweight BMI, elevated serum lactate or creatinine concentration. The majority of patients died in hospital (77%), with those with ischaemic bowel dying early. For the 21% of NoLap patients that survived to 90 days, 77% returned home with increased care requirements. ConclusionsThis study reports that the NoLap patient population present significant medical challenges because of their extreme levels of comorbidity, frailty, and physiology. Despite these complexities a fifth remained alive at 90 days. Further work is underway to explore this high-risk decision-making process. Clinical trial registrationISRCTN14556210.

Opposing impact of hypertension/diabetes following hormone therapy initiation and preexisting statins on castration resistant progression of nonmetastatic prostate cancer: a multicenter study

Hormone therapy, especially androgen deprivation therapy (ADT), is effective against prostate cancer (PC), whereas long-term ADT is a risk for metabolic/cardiovascular disorders including diabetes (DM), hypertension (HT) and dyslipidemia (DL), and might result in progression to castration-resistant prostate cancer (CRPC). We thus conducted a multicenter retrospective cohort study to ask whether CRPC progression would be associated positively with HT, DM or DL and negatively with statins prescribed for treatment of DL. In this study, 1,112 nonmetastatic PC patients undergoing ADT were enrolled. Univariate statistical analyses clearly showed significant association of HT or DM developing after ADT onset, though not preexisting HT or DM, with early CRPC progression. On the other hand, preexisting DL or statin use, but not newly developed DL or started statin prescriptions following ADT, was negatively associated with CRPC progression. Multivariate analysis revealed significant independent association of the newly developed DM or HT, or preexisting statin use with CRPC progression [adjusted hazard ratios (95% confidence intervals): 3.85 (1.65–8.98), p = 0.002; 2.75 (1.36–5.59), p = 0.005; 0.25 (0.09–0.72), p = 0.010, respectively]. Together, ADT-related development of HT or DM and preexisting statin use are considered to have positive and negative impact on CRPC progression, respectively.

The association between serum S100β levels and prognosis in acute stroke patients after intravenous thrombolysis: a multicenter prospective cohort study

BackgroundS100β is a biomarker of astroglial damage, the level of which is significantly increased following brain injury. However, the characteristics of S100β and its association with prognosis in patients with acute ischemic stroke following intravenous thrombolysis (IVT) remain unclear.MethodsPatients in this multicenter prospective cohort study were prospectively and consecutively recruited from 16 centers. Serum S100β levels were measured 24 h after IVT. National Institutes of Health Stroke Scale (NIHSS) and hemorrhagic transformation (HT) were measured simultaneously. NIHSS at 7 days after stroke, final infarct volume, and modified Rankin Scale (mRS) scores at 90 days were also collected. An mRS score ≥ 2 at 90 days was defined as an unfavorable outcome.ResultsA total of 1072 patients were included in the analysis. The highest S100β levels (> 0.20 ng/mL) correlated independently with HT and higher NIHSS at 24 h, higher NIHSS at 7 days, larger final infarct volume, and unfavorable outcome at 3 months. The patients were divided into two groups based on dominant and non-dominant stroke hemispheres. The highest S100β level was similarly associated with the infarct volume in patients with stroke in either hemisphere (dominant: β 36.853, 95% confidence interval (CI) 22.659–51.048, P < 0.001; non-dominant: β 23.645, 95% CI 10.774–36.516, P = 0.007). However, serum S100β levels at 24 h were more strongly associated with NIHSS scores at 24 h and 3-month unfavorable outcome in patients with dominant hemisphere stroke (NIHSS: β 3.470, 95% CI 2.392–4.548, P < 0.001; 3-month outcome: odds ratio (OR) 5.436, 95% CI 2.936–10.064, P < 0.001) than in those with non-dominant hemisphere stroke (NIHSS: β 0.326, 95% CI − 0.735–1.387, P = 0.547; 3-month outcome: OR 0.882, 95% CI 0.538–1.445, P = 0.619). The association of S100β levels and HT was not significant in either stroke lateralization group.ConclusionsSerum S100β levels 24 h after IVT were independently associated with HT, infarct volume, and prognosis in patients with IVT, which suggests the application value of serum S100β in judging the degree of disease and predicting prognosis.

Contribution of Genomic Imbalance in Prenatal Congenital Anomalies of the Kidney and Urinary Tract: A Multi-Center Cohort Study.

To investigate the diagnostic utility of copy-number variant (CNV) detection by chromosomal microarray analysis (CMA) and genotype-phenotype associations in prenatal congenital anomalies of the kidney and urinary tract (CAKUT). This is a retrospective multi-center study of CNV analysis in 457 fetuses with ultrasound-detected CAKUT and normal karyotypes. Cohorts from published studies were included for further pooled analyses (N=2746). A literature review of single-nucleotide variant (SNV) and small insertions and deletions (Indel) analysis by whole-exome sequencing was performed to investigate monogenic causes. In our multi-center cohort, 5.3% (24/457) of fetuses had pathogenic CNVs (pCNV); 3.9% (14/359) and 10.2% (10/98) in isolated and non-isolated CAKUT, respectively. Fetuses with isolated hyperechogenic kidneys (HEK) had the highest incidence of having pCNVs. In the literature review, 6.6% (180/2746) of fetuses carried pCNVs; 6.1% and 7.5% in isolated and non-isolated CAKUT, respectively. SNV/Indel analysis provided at least 16.5% (63/381) additional diagnostic yield beyond CNV analysis; 12.8% and 23.8% in isolated and non-isolated CAKUT, respectively. pCNVs comprise a significant proportion of genetic diagnostic findings in prenatal CAKUT, most commonly detected in fetuses with isolated HEK, MCDK, renal agenesis, and non-isolated CAKUT. Monogenic causes should be considered when karyotyping and CMA are nondiagnostic.

Takotsubo cardiomyopathy following liver transplantation: A multicenter cohort study.

Takotsubo cardiomyopathy (TCM) is an acute, stress-mediated, reversible cardiomyopathy that occurs in the absence of hemodynamically significant coronary artery disease. We aimed to investigate the characteristics and outcomes of patients who developed TCM following liver transplantation (LT) in a multicenter study. Adult patients from 6 centers across the United States who developed TCM according to Mayo Clinic criteria following LT between 2008 and 2023 were included. Demographics, perioperative and long-term outcomes, and treatment modalities were assessed. Fifty-five patients were included. The center incidence of TCM ranged from 0.1% to 0.5%. The majority were female (54.5%) and Caucasian (87.2%), and the median age at transplant was 59 years. The primary etiologies for LT were alcohol-associated cirrhosis (49.1%) and metabolic dysfunction-associated steatotic liver disease cirrhosis (21.8%). The median time from LT to TCM diagnosis was 4 days. TCM was associated with a 60.9% reduction in left ventricular ejection fraction (LVEF) from a pretransplant median LVEF of 64.0%-25.0%. The most common treatment for TCM was diuretics (67.3%) and afterload reduction (54.5%), with only 27.3% of patients requiring vasopressor support. At a median follow-up of 31.5 months, 1-year and 3-year overall survivals (OSs) were 86.3% and 69.4%, respectively. A repeat echocardiogram performed at a median of 84 days demonstrated that 45/55 patients (81.8%) had recovered LVEF ≥50%. Patients with LVEF recovery to ≥50% had significantly improved OS compared to those without LVEF recovery >50% (106.4 vs. 12.2mo, p = 0.001). TCM following LT is associated with a significant reduction in LVEF; however, the majority of patients recover LVEF to >50% with minimal perioperative mortality. Importantly, follow-up assessment of LVEF has significant implications as lack of recovery is associated with worse OS.

Endovascular intervention for carotid blowout syndrome and predictors of recurrence: A retrospective and multicenter cohort study

IntroductionCarotid blowout syndrome (CBS) is a potentially life-threatening complication of head and neck cancer and associated treatment. In this study, we assess the safety and efficacy of deconstructive and reconstructive procedures with a focus on CBS recurrence. MethodsWe conducted a multicenter retrospective analysis of a prospectively maintained database and identified 80 consecutive neurointerventions for CBS from 2016 to 2020. Patients were divided into 2 groups: deconstructive embolization (68 patients) and reconstructive stenting (12 patients). A comparative analysis was performed between the two groups. ResultsThe CBS recurrence rate was 23.8 % with 84.2 % of recurrences occurring within 90 days of the primary event. The median time to rebleeding was 8.0 days (IQR: 2.0 – 28.5) with a mortality rate of 26.3 %. There was no significant difference in rates of peri-operative ischemic stroke (1.5 % vs. 0 %, p=0.672) or peri-operative mortality (1.5 % vs. 0 %, p=0.670). CBS recurrence was significantly higher in the reconstructive group (58.3 % vs. 17.6 %, p=0.002). On multivariate analysis, reconstructive stenting independently predicted rebleeding (adjusted hazard ratio 8.31, 95 % CI: 2.34–29.59, p=0.001). There was no significant association between CBS recurrence and pre-operative (p=0.600) or post-operative (p=0.275) anticoagulant/antiplatelet use. ConclusionCBS remains a challenging and potentially catastrophic complication of head and neck cancers. Reconstructive procedures, including stenting, predicted CBS recurrence independent of bleeding site or tumor invasion. Postoperative surveillance based on time intervals to CBS recurrence and engineering advancements including improved vessel reconstruction devices have the potential to reduce rehemorrhage rates and improve patient outcomes. Further clinical investigations amongst larger cohorts are needed.

Prenatal Diagnosis and Clinical Outcomes of Isolated Mega Cisterna Magna.

Objective: The study aimed to investigate the clinical outcomes of fetuses diagnosed with isolated mega cisterna magna in utero. Methods: A multicenter retrospective cohort study was conducted across 18 university hospitals from 2010 to 2019. Cases diagnosed with isolated mega cisterna magna, defined as a cisterna magna >10 mm with a normal cerebellar vermis and no cystic dilation of the fourth ventricle, were included. Cases with other central nervous system (CNS) anomalies, extra-central nervous system anomalies, chromosomal abnormalities, or congenital infections were excluded. Maternal demographics, prenatal findings, delivery outcomes, and postnatal outcomes were analyzed. Results: The mean gestational age at initial diagnosis was 28.6 ± 3.9 weeks, and the mean anteroposterior diameter of the cisterna magna was 12.5 ± 3.2 mm. Of the 71 cases initially assessed, 48 (67.6%) showed self-regression in utero. Postnatally, 13 cases (18.3%) had persistent isolated mega cisterna magna, whereas 10 cases (14.1%) were diagnosed with other central nervous system anomalies. Among the persistent isolated mega cisterna magna cases, one child exhibited delayed neurodevelopment. There was a higher incidence of isolated mega cisterna magna in male fetuses, which exhibited a significantly larger mean cisterna magna diameter compared with female fetuses (P = .045). Conclusion: Male fetuses exhibited a higher incidence of isolated mega cisterna magna compared with female fetuses and had larger anteroposterior diameters of the cisterna magna. The study demonstrated favorable neurodevelopmental outcomes associated with isolated mega cisterna magna, with self-regression observed in two-thirds of the cases. However, consecutive prenatal and postnatal evaluations for additional central nervous system or extra-central nervous system malformations need to be performed, considering the differences between prenatal and postnatal diagnoses.

A multi-centre prospective cohort study investigating the roles of psychological flexibility and self-compassion in appearance concerns after burn injuries.

Appearance concerns following burn injuries are common. Psychological factors are important in maintaining such concerns. However, there is a lack of longitudinal or prospective research investigating their development. This study investigated whether psychological flexibility and self-compassion at hospital admission predicted subsequent appearance concerns. A multi-centre prospective cohort study across six burn services. Adults (n = 175; 67% male) in hospital following burn injuries were recruited. Questionnaires measuring appearance concerns, psychological flexibility, self-compassion, post-traumatic stress disorder symptoms and perceived noticeability were completed during hospital admission and two- and six-months later. Demographic and burn injury information was collected. Correlational analyses showed that increased psychological flexibility and self-compassion at admission were associated with decreased appearance concerns cross-sectionally and prospectively at two- and six-month follow-up. These associations remained significant when controlling for key covariates (i.e. gender, age, ethnicity, percentage total body surface area burnt, perceived noticeability, PTSD symptoms). Multiple linear regression analyses revealed that psychological flexibility and self-compassion predicted appearance concerns during hospital admission. Although psychological flexibility significantly predicted appearance concerns over time, it became non-significant when controlling for baseline appearance concerns. Psychological flexibility has a protective role against appearance concerns soon after burn injuries, although this protective role is reduced when accounting for baseline appearance concerns. Early interventions targeting psychological flexibility (i.e. acceptance and commitment therapy) may be beneficial after burns if adapted to address appearance-related concerns.

Rate and risk factors of tip displacement of umbilical venous catheterization at different indwelling time points in preterm infants

Objectives: To investigate the rate and risk factors of tip displacement of umbilical venous catheterization (UVC) in preterm infants. Methods: This was a multicenter cohort study. Study population were preterm infants admitted to 44 tertiary hospitals in China between October 2019 and August 2021. Demographic information, general clinical data, UVC indwelling conditions and related complications were collected. The primary outcome was the rate of UVC tip displacement. The observation time points were 2 d and 7 d after UVC. They were grouped according to UVC displacement, gestational age, and birth weight. Binary Logistic regression was used to analyze the risk factors of UVC tip displacement. Results: The 2 086 preterm infants had a gestational age of (29.9±2.3) weeks and a birth weight of (1 248±298) g. There were 1 106 male preterm infants (53.0%). The rate of UVC displacement at 2 d and 7 d were 34.6% (721/2 086) and 33.6% (494/1 470), respectively, with no statistically significant difference (χ2=0.35, P=0.533). Univariate analysis indicated that male infants, small gestational age, low birth weight and small catheter diameter were all risk factors for UVC tip displacement at the 2 d time point (all P<0.05). Multivariate analysis showed that small catheter diameter was an independent risk factor for tip displacement at both 2 d (OR=0.47, 95%CI 0.34-0.66) and 7 d (OR=0.39, 95%CI 0.25-0.59) time points (both P<0.001). Conclusions: The rate of UVC tip displacement is high in preterm infants. It should be avoided to deliberately select a small diameter catheter for UVC, and pay attention to the imaging monitoring of the tip position after UVC.

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...

Impact of gluten intake on clinical outcomes in patients with chronic inflammatory diseases initiating biologics: Secondary analysis of the prospective multicentre BELIEVE cohort study.

Chronic inflammatory diseases (CIDs) pose a growing healthcare challenge, with a substantial proportion of patients showing inadequate response to biological treatment. There is renewed interest in dietary changes to optimize treatment regimens, with a growing body of evidence suggesting beneficial effects with adherence to a gluten-free diet. This study compared the likelihood of achieving clinical response to biological treatment after 14-16 weeks in patients with CID with high versus low-to-medium gluten intake. Secondary outcomes of interest included changes in disease activity, health-related quality of life and C-reactive protein. The study was a multicentre prospective cohort of 193 participants with a CID diagnosis (i.e. Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis or Psoriasis) who initiated biological treatment between 2017 and 2020. Participants were stratified based on their habitual gluten intake: the upper 33.3% (high gluten intake) and the remaining 66.6% (low-to-medium gluten intake). The proportion of patients achieving clinical response to biological treatment after 14-16 weeks was compared using logistic regression models. The median gluten intake differed significantly between groups (12.5 g/day vs. 5.9 g/day, standardized mean difference = 1.399). In total, 108 (56%) achieved clinical response to treatment, with no difference between 35 (55%) in the high gluten group and 73 (57%) in the medium-to-low gluten group (OR = 0.96 [0.51-1.79], p = 0.897). No differences were found with secondary outcomes. In conclusion, this study found no association between gluten intake and response to biological treatment in patients with CID.

Long-term efficacy of mepolizumab in patients with eosinophilic granulomatosis with polyangiitis: a propensity score matching analysis in the multicenter REVEAL cohort study.

Mepolizumab (MPZ) has demonstrated efficacy in clinical trials for eosinophilic granulomatosis with polyangiitis (EGPA); however, few studies compare the disease course between patients treated with MPZ (MPZ group) and those who were not treated with MPZ (non-MPZ group) in real-world settings. This study aimed to compare the disease course and outcomes between the two groups and assess the long-term efficacy of MPZ in a multicenter cohort in Japan. Methods: We enrolled 113 EGPA patients registered in the cohort until June 2023. Data on clinical characteristics, disease activity, organ damage, treatments, and outcomes were retrospectively collected. To minimize potential confounding factors, we conducted propensity score matching (PSM). After PSM, 37 pairs of matched patients were identified. Clinical characteristics, including age at disease onset, sex, disease duration at last observation, antineutrophil cytoplasmic antibody positivity at disease onset, Birmingham Vasculitis Activity Score (BVAS) at disease onset, and Five-factor score at disease onset, were comparable between the groups. The median BVAS at the last observation was 0 in both groups; however, more cases in the non-MPZ group exhibited elevated BVAS, resulting in a significantly higher BVAS in the non-MPZ group at the last observation (median; MPZ group: 0, non-MPZ group: 0, p=0.028). The MPZ group had significantly lower glucocorticoid (GC) doses at the last observation (median; MPZ group: 4 mg/day, non-MPZ group: 5 mg/day, p=0.011), with a higher proportion achieving a GC dose ≤ 4 mg/day at the last observation (MPZ group: 51.4%, non-MPZ group: 24.2%, p=0.027). Three models of multivariable logistic regression analyses were performed to identify factors associated with GC doses ≤ 4 mg/day at the last observation. In all models, achieving a GC dose ≤ 4 mg/day was positively associated with MPZ administration and inversely associated with asthma at disease onset. Finally, we evaluated the survival rates between the groups, and the 5-year survival rates were significantly higher in the MPZ group compared to the non-MPZ group (MPZ group: 100%, non-MPZ group: 81.3%, p=0.012). Mepolizumab not only contributes to disease activity control but also reduces the GC dose, which may lead to improved survival in EGPA patients.

EP.11A.23 REAL-IMPACT: Real-World Effectiveness of Immunotherapy in PD-L1 Negative Advanced NSCLC - A Multicenter Cohort Study in Argentina

EP.11A.23 REAL-IMPACT: Real-World Effectiveness of Immunotherapy in PD-L1 Negative Advanced NSCLC - A Multicenter Cohort Study in Argentina

Early clinical predictors of infected pancreatic necrosis: a multicentre cohort study

BackgroundInfected pancreatic necrosis (IPN) exacerbates complications in patients with acute pancreatitis (AP), increasing mortality rates if not treated promptly. We aimed to evaluate the predictive value of clinical characteristics within...