Multicenter Prospective Observational Study Research Articles

Beyond secondary prevention drugs: added benefit in survival and events of a healthy lifestyle in patients after an acute coronary syndrome

Abstract Background Despite advances in drug treatment and secondary prevention programs, cardiovascular disease remains the leading cause of death. The full extent and independent benefit of a healthy lifestyle, particularly after optimal medical therapy in secondary prevention, has not been widely reported. Purpose To quantify the added benefit on survival and events of a healthy lifestyle following an acute coronary syndrome (ACS). Our study seeks to answer the question: Is adherence to medical therapy sufficient or a healthy lifestyle provides additional improvement?. Methods This a prospective observational multi-center study of 685 patients included during admission for ACS. At 6 months patients were asked about their post-ACS lifestyle and were given a score (range: 0-7) with the following items: Intake of ≥3 fruits and vegetables/day, ≥2 fish servings/week, ≤7 alcohol beverages/week, feeling stress RESULTS: After adjusting for demographic variables, cardiovascular risk factors, characteristics of the index event, high-sensitivity C-reactive protein (hs-CRP), and drug therapy, multivariate Cox regression showed that the lifestyle SCORE was independently and inversely associated with both the incidence of the primary outcome (ischemic events [any ACS, stroke, or Transient Ischemic Attack] or death) (HR 0.65 (CI95% 0.44-0.96); p=0.029) and death (HR 0.41 [95%CI 0.18-0.91]; p=0.029). Statin therapy was also independently and inversely associated with both the incidence of the primary outcome. Kaplan-Meier curves showed a higher event-free survival for both outcomes in patients with SCORE≥4 than in those with SCORE<4 (p=0.03 and p<0.001, respectively). Additionally, patients with a SCORE≥4 had a significantly greater decrease of total cholesterol (-52 [-16.5, -79] vs -38 [-7.5, -68] mg/dl; p=0.040) and hs-CRP (-1.1 [-0.1, 2.5] vs -0.5 [0.7, -1.9] mg/L; p=0.001) at six months. Conclusions Among patients with ACS and similar medical therapy, a healthy lifestyle is an independent and added marker of a lower incidence of ischemic events and death. It is also associated with a better lipid profile and lower inflammation.

Acute myocarditis presentation and intra-hospital prognosis: results of the multicenter prospective MYOCARDITIRM study

Abstract Background Acute myocarditis (AM) usually presents as chest pain with rising troponin and normal coronary arteries. Despite frequent favorable evolution at the acute phase, it is associated with heart failure and ventricular rhythm disorders and is considered the leading cause of sudden cardiac death in young apparently healthy adults. There is no recommendation for AM, only expert consensus, given the lack of important databases for a strong level of confidence. Methods We performed a multicenter prospective observational study of patients admitted for AM acknowledged by cardiac MRI to describe baseline characteristics, management, in-hospital and long-term outcomes of AM patients in France. Secondary objectives were to investigate determinants of prognosis, modalities of treatment and follow-up, and to identify gaps between expert consensus and real-life management. Results We enrolled 805 consecutive patients hospitalized for AM in 49 participating centers between May 2016 and February 2019. Median age was 31 (IQR 23-41) with 19% of female. Chest pain was the most frequent symptom (93%) and 112 (14%) had severity criteria upon admission (LVEF<50% or severe ventricular arrythmia or high-grade AV block or cardiogenic shock). ST elevation was observed in 49% of patients. One 26-years old patient died during initial hospital stay. Overall, 62 patients (8%) experienced intra-hospital complication of their AM, defined as a combined endpoint of death, LVEF<40% (MRI), sustained ventricular or supraventricular arrythmia, acute renal failure, cardiogenic shock, need for ventricular assistance device, need for inotropic drugs, temporary cardiac pacing, pace-maker or cardiac defibrillator implantation. Patients with initial severity criteria were 10 times more likely to present intra-hospital complication (33% vs 3.6%, p<0.001). Conclusion This prospective cohort represents the largest database on AM worldwide. Here we report baseline characteristics and in hospital events. Most patients had typical presentation with favorable outcomes but as much as 8% of patients did exhibit intra-hospital complication. The prospective follow up will provide valuable data to better identify subset of patients with poor prognosis that may be of interest to develop new therapeutic strategies.Acute myocarditis on cardiac MRI

Machine learning model for predicting the cold-heat pattern in Kampo medicine: a multicenter prospective observational study.

The purpose of this study was to predict the four cold-heat patterns in patients who have the subjective symptoms of the cold-heat pattern described in the International Classification of Diseases Traditional Medicine Conditions - Module 1 by applying a machine learning algorithm. Subjects were first-visit Kampo outpatients at six institutions who agreed to participate in this multicenter prospective observational study. The cold pattern model and the heat pattern model were created separately with 148 symptoms, body mass index, blood pressure (systolic and diastolic), age, and sex. Along with a single cold or heat pattern, the tangled heat/cold pattern is defined as being predicted by both cold and heat patterns, while the moderate (heat/cold) pattern is defined as being predicted by neither the cold pattern nor the heat pattern. We included 622 participants (mean age ±standard deviation, 54.4 ± 16.9; with female 501). The accuracy, macro-recall, precision, and F1-score of a combination of the two prediction models were 96.7%, 93.2%, 85.6%, and 88.5% respectively. The important items were compatible with the definitions of the cold-heat pattern. We developed a prediction model on cold-heat patterns with data from patients whose subjective cold/heat-related symptoms matched the cold-heat pattern diagnosis by the physician.

Inflammatory Neuropathy Consortium base (INCbase): a protocol of a global prospective observational cohort study for the development of a prediction model for treatment response in chronic inflammatory demyelinating polyneuropathy

BackgroundINCbase is an international, multicenter prospective observational study using a customizable web-based modular registry to study the clinical, biological and electrophysiological variation and boundaries of chronic inflammatory demyelinating polyneuropathy (CIDP). The primary objective of INCbase is to develop and validate a clinical prediction model for treatment response.MethodsAll patients meeting clinical criteria for CIDP can be included in INCbase. Collected data include demographics, clinical history, diagnostics and various domains of clinical outcomes. Data is collected at a minimum of every 6 months for two years, and more frequently at the discretion of the investigational site to allow for assessment of unexpected changes in treatment response or clinical status. Participants can be enrolled in various sub-studies designed to capture data relevant to specific groups of interest. Data is entered directly into the web-based data entry system by local investigators and/or participants. Collection and local storage of biomaterial is optional. To develop a clinical prediction model for treatment response, newly diagnosed patients with active disease warranting start of first-line treatment will be included. The study population will be split into a development and validation cohort. Univariate and multivariate logistic regression analysis will be used to identify and combine predictors at start of treatment for treatment response at six months. Model performance will be assessed through discrimination and calibration in an external validation cohort. The externally validated prediction model will be made available to researchers and clinicians on the INCbase website.DiscussionWith this study, we aim to create a clinically relevant and implementable prediction model for treatment response to first line treatments in CIDP. INCbase enrollment started in April 2021, with 29 centers across 8 countries and 303 patients participating to date. This collaborative effort between academia, patient advocacy organizations and pharmaceutical industry will deepen our understanding of how to diagnose and treat CIDP.

Respiratory rate-oxygenation index on the 3rd day is the best predictor of treatment failure in COVID-19 patients.

Predictors of outcomes are essential to identifying severe COVID-19 cases and optimizing treatment and care settings. The respiratory rate-oxygenation (ROX) index, originally introduced for predicting the failure of non-invasive support in acute hypoxemic respiratory failure (AHRF), has not been extensively studied over time during hospitalization. This multicenter prospective observational study analyzed COVID-19-related AHRF patients admitted to eight Italian hospitals during the second pandemic wave. The study assessed the ROX index using receiver operator characteristic curves and areas under the curve with 95% confidence intervals to predict treatment failure, defined as endotracheal intubation (ETI) or death. A total of 227 patients (69.2% males) were enrolled, with a median arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio at admission of 248 (interquartile range: 170-295). Nearly one-third (29.5%) required ETI or died during hospitalization. Those who experienced treatment failure were older (median age 70 versus 61 years, p<0.001), more likely to be current or former smokers (8.5% versus 6.4% and 42.4% versus 25.5%, p=0.039), had a higher prevalence of cardiovascular diseases (74.6% versus 46.3%, p<0.001), and had a lower PaO2/FiO2 ratio at presentation (median 229 versus 254, p=0.014). Gender, body mass index, and other comorbidities showed no significant differences. In patients who failed treatment, the ROX index was higher at presentation and worsened sharply by days 3 and 4. Conversely, in patients who survived without requiring ETI, the ROX index remained stable and reduced after 5-6 days. The ROX index's predictive ability improved notably by the third day of hospitalization, with the best cut-off value identified at 8.53 (sensitivity 75%, specificity 68%). Kaplan-Meier curves indicated that a ROX index of 8.53 or lower on days 1, 2, or 3 was associated with a higher risk of treatment failure. Thus, a single ROX index assessment on day 3 is more informative than its variability over time, with values of 8.53 or lower predicting non-invasive respiratory support failure in hospitalized COVID-19 patients.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

VISIT STROKE: non-inferiority of telemedicine-based neurological consultation for post-acute stroke patients – protocol of a prospective observational controlled multi-center study

BackgroundTelemedicine provides specialized medical expertise in underserved areas where neurological expertise is frequently not available on a daily basis for hospitalized stroke patients. While tele-consultations are well established in acute stroke assessment, the value of telemedicine-based ward-rounds in the subsequent in-patient stroke management is unknown.MethodsFour telemedicine stroke networks in Germany, implemented in eight out of 16 federal states, participate in this prospective observational multi-center study. We plan to enroll 523 patients hospitalized due to acute (suspected or confirmed) stroke or transient ischemic attack. Each recruited patient will receive both a tele-consultation and an on-site consultation at the same day within the first three days after hospital admission. We will test non-inferiority of telemedicine-based assessments in ward-rounds in terms of quality of medical assessment and recommendations for hospitalized stroke patients. The correctness of the medical assessment and recommendation is defined as positive evaluation (binary, correct vs. in-correct) of six out of six predefined quality indicators by at least two out of three blinded independent raters. The non-inferiority margin for the difference in proportions of correct assessments is set to 5%-points.DiscussionIf non-inferiority of telemedicine-based ward-rounds compared to on-site ward-rounds by a neurologist were demonstrated, telemedicine-based neurological consultation for post-acute stroke patients may contribute to deliver evidence-based high-quality stroke care more easily in underserved regions.Trial registrationDRKS - DRKS00028671 (https://drks.de/search/de/trial/DRKS00028671; registration date 09-27-2022).

Lung Ultrasound Score, Severity of Acute Lung Disease and Prolonged Mechanical Ventilation in Children.

Lung ultrasound may be useful for prognostication of acute lung disease. To assess whether the lung ultrasound score is associated with the severity of lung disease and may predict prolonged invasive mechanical ventilation in critically ill children. Prospective observational multicenter study in children aged 1 month to 18 years who required respiratory support in the intensive care unit. Children with chronic parenchymal lung disease were excluded. The lung ultrasound score was obtained at 12 hours and 48-72 hours from admission. Prolonged invasive mechanical ventilation was defined as >7 consecutive days. Correlation of the lung ultrasound score with oxygenation as well as its prognostic accuracy for prolonged invasive mechanical ventilation were investigated. 538 children were included and 62 (11.5%) required prolonged mechanical ventilation. In these subjects, the lung ultrasound score was higher at 12 [24 (19-26) vs. 8 (3-14); p<0.001] and 48-72 hours [16 (10.5-22.5) vs. 6 (3-11) vs; p<0.001]. At 12 hours the lung ultrasound score correlated with oxygenation index [R2= 0.435 (95% CI: 0.293-0.566), rho coefficient -0.705, p<0.001] and oxygen saturation index [R2 0.499 (95% CI: 0.370-0.613), rho coefficient 0.651, p<0.001p<0.001]. To predict prolonged invasive mechanical ventilation, the lung ultrasound score at 12 hours had a good accuracy [AUROC=0.87 (95% CI: 0.81-0.93)] while its use in a multivariable model had an excellent accuracy both in derivation [AUROC=0.92 (95% CI: 0.89-0.95)] and internal validation [AUROC=0.91 (95% CI: 0.90-0.92)]. In critically ill children, the lung ultrasound score early after admission may predict prolonged invasive mechanical ventilation.

Prediction of poor prognosis using the peak systolic velocity and early diastolic velocity of the central retinal artery in patients with post‐cardiac arrest syndrome

AbstractIntroductionMonitoring intracranial pressure (ICP) in patients with post‐cardiac arrest syndrome (PCAS) is crucial for effective management and prognosis assessment. However, continuous ICP monitoring is rarely practiced. Increased ICP is often associated with the impairment of brain autoregulation. This study investigated whether central retinal artery (CRA) flow velocity, autoregulation status according to mean arterial pressure (MAP), and the optic nerve sheath diameter (ONSD)/eyeball transverse diameter (ETD) ratio could predict poor prognosis related to increased ICP in PCAS patients.MethodsIn this multicenter prospective observational study, transocular ultrasonography of the optic nerve sheath was performed on 38 PCAS patients treated with targeted temperature management from December 2021 to November 2022. CRA peak systolic velocity (PSV), early diastolic velocity (eDV), MAP, CRA‐PSV changes following MAP changes (autoregulation), and ONSD/ETD ratio were measured repeatedly from days 0 to 4 post‐admission.ResultsUnivariable analysis indicated that CRA‐PSV, nonpositive or flat CRA‐eDV, and disrupted autoregulation correlated with a poor prognosis (Cerebral Performance Category 4 or 5). In multivariable analysis, nonpositive CRA‐eDV or disrupted autoregulation was the most significant predictor of poor prognosis (odds ratio, 40.576; p = 0.002), with an area under the curve of 0.774. The ONSD/ETD ratio did not show a significant correlation.ConclusionsNonpositive CRA‐eDV, CRA‐PSV and disrupted autoregulation can predict poor prognosis in PCAS patients. Transocular Doppler ultrasonography of the CRA and autoregulation assessment may aid in ICP monitoring and management in PCAS patients.

Concept, study design, and baseline nighttime blood pressure control status of the WISDOM-Night Study using a wrist-type oscillometric home blood pressure monitoring device.

There is growing evidence that nocturnal hypertension is an independent risk factor for cardiovascular diseases, including heart failure. However, brachial blood pressure (BP) measurements during sleep might themselves disturb sleep quality. We initiated a nationwide, multicenter observational prospective study using a wrist-type oscillometric nighttime BP monitoring device with new algorithms to measure supine BP accurately without sleep disturbance. This study, named the Wrist ICT-based Sleep and Circadian Blood Pressure Monitoring Program-Night BP Study (WISDOM-Night Study), was designed to clarify the impact of wrist-measured daily nighttime BPs on cardiovascular prognosis (stroke, coronary artery disease, heart failure, etc.) using 7 days of BP measurements at 2:00 a.m., 3:00 a.m., 4:00 a.m., and 4 h after bedtime. A total of 2751 patients with one or more cardiovascular risk factors were recruited between March 2021 and March 2024 and are currently being followed up for 7 years. Additionally, 1416 of the WISDOM-Night Study-enrolled patients who also agreed to participate in the WISDOM-Hypertension-Mediated Organ Damage (HMOD) Study underwent echocardiography to evaluate the association between wrist-measured BP and left ventricular structure. Data from this WISDOM-Night Study should provide the prospective association between nighttime BP and cardiovascular disease and reveal the indexes of nighttime BP with clinical pathological relevance. This first report of the WISDOM-Night Study describes the study design, baseline characteristics, and BP control status.

Update to: Study Pre-protocol for "BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study".

In 2021 we launched the BronchStart study, which collected information on 17,899 presentations in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation's decision to recommend the introduction maternal respiratory syncytial virus (RSV) vaccination, which was introduced in the United Kingdom in August/September 2024. We modified our original protocol to conduct a United Kingdom-wide assessment of maternal vaccination against RSV. We will conduct a multi-centre study, utilising the PERUKI network used in the original BronchStart study, to assess the effectiveness of maternal vaccination using a test-negative study design. We will gather detailed clinical information on children admitted with bronchiolitis in the post-RSV vaccination era, and understand possible reasons for incomplete vaccine uptake.

Analysis of nailfold capillaroscopy images with artificial intelligence: Data from literature and performance of machine learning and deep learning from images acquired in the SCLEROCAP study

ObjectiveTo evaluate the performance of machine learning and then deep learning to detect a systemic scleroderma (SSc) landscape from the same set of nailfold capillaroscopy (NC) images from the French prospective multicenter observational study SCLEROCAP. MethodsNC images from the first 100 SCLEROCAP patients were analyzed to assess the performance of machine learning and then deep learning in identifying the SSc landscape, the NC images having previously been independently and consensually labeled by expert clinicians. Images were divided into a training set (70 %) and a validation set (30 %). After features extraction from the NC images, we tested six classifiers (random forests (RF), support vector machine (SVM), logistic regression (LR), light gradient boosting (LGB), extreme gradient boosting (XGB), K-nearest neighbors (KNN)) on the training set with five different combinations of the images. The performance of each classifier was evaluated by the F1 score. In the deep learning section, we tested three pre-trained models from the TIMM library (ResNet-18, DenseNet-121 and VGG-16) on raw NC images after applying image augmentation methods. ResultsWith machine learning, performance ranged from 0.60 to 0.73 for each variable, with Hu and Haralick moments being the most discriminating. Performance was highest with the RF, LGB and XGB models (F1 scores: 0.75–0.79). The highest score was obtained by combining all variables and using the LGB model (F1 score: 0.79 ± 0.05, p < 0.01). With deep learning, performance reached a minimum accuracy of 0.87. The best results were obtained with the DenseNet-121 model (accuracy 0.94 ± 0.02, F1 score 0.94 ± 0.02, AUC 0.95 ± 0.03) as compared to ResNet-18 (accuracy 0.87 ± 0.04, F1 score 0.85 ± 0.03, AUC 0.87 ± 0.04) and VGG-16 (accuracy 0.90 ± 0.03, F1 score 0.91 ± 0.02, AUC 0.91 ± 0.04). ConclusionBy using machine learning and then deep learning on the same set of labeled NC images from the SCLEROCAP study, the highest performances to detect SSc landscape were obtained with deep learning and in particular DenseNet-121. This pre-trained model could therefore be used to automatically interpret NC images in case of suspected SSc. This result nevertheless needs to be confirmed on a larger number of NC images.

The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population.

The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.

Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).

Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140. PRR1-10.2196/57183.

The self-correction and influence factors of congenital auricular deformity: A prospective cohort study.

To prospectively observe the self-correction of congenital auricular deformity (CAD) and explore the potential factors affecting the self-correction. This study was a multi-center prospective observational study. Newborns aged 0-3 days from 12 Maternal and Child Health Hospitals or Maternity Hospitals were chosen as the participants and prospectively followed up until week 6 after birth. The primary and secondary outcome was the score of deformity, and the secondary outcome was the improvement rate, respectively. A total of 135 newborns diagnosed with CAD (237 ears) were recruited. Boys and girls accounted for 50.37% (117 ears) and 49.63% (120 ears). The top morphological type was the constricted ear (107 ears, 45.15%). The score of deformity at baseline, week 3, and week 6 after enrollment was 4.00, 3.00, and 2.00, decreasing over time (P < 0.05). The higher the severity of deformity, the worse the self-correcting effect (P < 0.05). The scores of deformity of Stahl's ear were lower than those of others after follow-up (P < 0.05). No significant differences among the scores of deformity in different genders (P >0.05). The total improvement rate at week 3 and week 6 was 29.96% (71/237 ears) and 37.13% (88/237), respectively. The improvement rate of the Stahl's ear at week 3 and week 6 after enrollment was higher than that of four other morphological types (P < 0.05). Some CAD tends to self-correction, but for most CADs, there is still a need for early correction. Morphological types and severity of deformity are the main influencing factors on self-correcting effect, whereas sex was not.

Modern CRRT systems are associated with lower risk of hypothermia.

One risk of continuous renal replacement therapy (CRRT) is inadvertent hypothermia (IH), which is defined as a non-therapeutic core temperature decrease below normal. In continuous renal replacement therapy, heat loss will always occur from blood pumped through the dialysis circuit to cooler environment, predisposing for hypothermia. Blood flow and effluent flows are the most important parameters causing heat loss. We investigated and compared the novel TherMax warmer to previous generation technologies during CRRT in a multicenter setting. This was a prospective observational multicenter study with historic single-center controls. The study group consisted of 100 patients in eight Swedish ICUs with clinical indication for CRRT, using the PrisMax platform and TherMax warmer. Both patient and set warmer temperatures were recorded hourly for the first 24h. The presence of treatment hours in hypothermia (< 36.0 Celsius) and the difference between set warmer temperature and measured patient temperature in the multi-center study cohort were compared to a matched single-center historic control cohort treated with the old Prismaflex platform and adjacent Barkey warmer. In the TherMax group 77/100 (77.0%) of patients, and for controls 26/86 (30.2%) of patients were free of hypothermia (Chi square, p < 0.001). The mean number of hours spent in hypothermia was (mean ± SD) 0.66 ± 1.60 and 6.92 ± 7.79h in the TherMax and control groups, respectively (Chi square p < 0.001).In the study group the patient temperature was higher than the set temperature on the warmer with a difference of Δ0.47 ± 0.80°C (minor difference), whereas in the control group the set temperature on the warmer was higher than the patient temperature with a difference of Δ4.55 ± 1.00°C (over-correction).The novel TherMax warmer technology protected against hypothermia and was significantly more accurate than the Barkey warmer.

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...

Effect of perioperative blood transfusion on preoperative haemoglobin levels as a risk factor for long-term outcomes in patients undergoing major noncardiac surgery: a prospective multicentre observational study

BackgroundPreoperative anaemia and red blood cell (RBC) transfusions are associated with poorer clinical outcomes. It is unknown whether perioperative RBC transfusions mediate the relationship between preoperative haemoglobin levels and postoperative outcomes. MethodsThis was a prospective observational study among patients aged ≥50 yr undergoing elective major noncardiac surgery from four Swedish hospitals. The co-primary outcomes were 1-yr major adverse cardiovascular and cerebrovascular events (MACCEs) and all-cause mortality. The secondary outcome was a composite of 30-day mortality, MACCEs, acute kidney injury (AKI), pulmonary embolism, anastomotic leak, and postoperative infection. Mediation analyses were conducted with preoperative haemoglobin as the exposure and RBC transfusion as a mediator. ResultsAmong 1060 patients (mean age 70 [SD 9] yr; 472 [45%] women), 171 patients (16.1%) developed 1-yr MACCEs, and 105 patients (9.9%) died within 1 yr. Preoperative haemoglobin levels were significantly associated with both 1-yr MACCEs (b=–0.015, P=0.041) and all-cause mortality (b=–0.028, P<0.001). Volume of RBC transfusion was not directly associated with the outcomes and did not mediate the relationship between preoperative haemoglobin levels and 1-yr MACCEs (b=–0.001, P=0.451) or all-cause mortality (b=–0.002, P=0.293). For the secondary outcome, RBC transfusions had a significant mediating effect between preoperative haemoglobin and the composite 30-day outcome; however, no direct association was observed (b=0.006, P=0.554). ConclusionsPreoperative haemoglobin levels were significantly associated with 1-yr MACCEs and all-cause mortality. This effect was not mediated by perioperative RBC transfusions. Further research is needed to confirm these findings.

Usefulness of the 4A's test for detecting delirium in critically ill patients: a multicenter prospective observation study.

The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a robust and reliable instrument for discerning delirium within the specific context of the intensive care unit (ICU). Nonetheless, the CAM-ICU is burdened by various limitations, including a protracted learning curve and the need for frequent daily administration. The 4 A's Test (4AT) was formulated to assess delirium in hospitalized patients and may have distinct advantages over the CAM-ICU, particularly regarding practical applicability within the ICU bundle. This study was performed to assess the utility of the 4AT in detecting delirium in critically ill patients. This multicenter prospective observational study involved critically ill patients at four academic tertiary care hospitals in South Korea from June 2021 to September 2022. In total, 274 patients (median age, 64years; 56.9% men) were included, and 75 (27.4%) developed delirium. The 4AT showed good performance in detecting ICU delirium (area under the curve, 0.879; P < 0.001). The 4AT showed a sensitivity of 74.0%, specificity of 95.4%, positive predictive value of 77.5%, negative predictive value of 94.6%, and accuracy of 91.7% for ICU detection of delirium. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the CAM-ICU for detecting ICU delirium were 71.3%, 97.1%, 83.8%, 94.1%, and 92.6%, respectively. The 4AT showed acceptable reliability and validity for detecting ICU delirium in critically ill patients. Because the 4AT is simpler and easier to learn, this scale could be a useful alternative to the CAM-ICU for detecting delirium in critically ill patients.

Incidence and clinical impact of inappropriate periprocedural and perioperative management of antiplatelet therapy

Background and aimsThere is little evidence on the impact of current recommendations on the use of antiplatelet therapy during the perioperative and periprocedural period in our setting. The aim of this study was to analyze the incidence and clinical impact of inappropriate use of antiplatelet therapy in a population of patients undergoing surgery or a diagnostic or therapeutic procedure in “real life” in Spain. MethodsA prospective multicenter observational study of patients treated with antiplatelet agents requiring intervention was conducted. The incidence of thrombotic and hemorrhagic events at 30 days was analyzed according to peri-intervention management of antiplatelet therapy. ResultsWe included 643 patients (31.9% women, 39.0% over 75 years of age), most of them (87.7%) receiving aspirin as antiplatelet therapy at a dose of 100mg/day. Indications for antiplatelet therapy were ischemic heart disease (44.9%), cerebrovascular disease (21.7%), and peripheral vascular disease (23.0%). Ischemic risk was low in 74.3%, while 51.6% had a low bleeding risk of the intervention. Periprocedural management was considered appropriate in 61.7% of cases. 30-day incidence of the combined primary endpoint of thrombotic events and major bleeding (12.1% versus 5.0%; p=0.002) and 30-day mortality (5.2% versus 1.5%; p=0.008) were significantly higher in patients with inappropriate periprocedural management of antiplatelet agents. ConclusionsDespite current recommendations for the use of antiplatelet drugs in the perioperative/periprocedural period, their implementation in the “real world” remains low. Inappropriate use is associated with an increased incidence of adverse events, both thrombotic and hemorrhagic.