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European Review For Medical and... Jun 2024The use of scoring systems contributes to the faster identification of septic patients, especially those at a high risk of a fatal outcome. The best scoring system does... (Observational Study)
Observational Study
OBJECTIVE
The use of scoring systems contributes to the faster identification of septic patients, especially those at a high risk of a fatal outcome. The best scoring system does not exist, so the search for the optimal one is always current. The aim of this study is to estimate the prognostic value of the six scoring systems in predicting 24-hour mortality among septic patients presented at the emergency department.
PATIENTS AND METHODS
An observational retrospective study was conducted in the Emergency Triage Room (ETR) of the Emergency Center (EC) at the University Clinical Center of Serbia (UCCS) in Belgrade. Consecutive septic patients, according to the Sepsis-3 definition, with or without shock, presented to the ETR and then hospitalized in Intensive Care Units were included in the study. Mortality data within 24 h and on the 28th day were extracted from the Hospital information system or the National mortality database. Scoring systems including sequential organ failure assessment (SOFA), quick sequential organ failure assessment (qSOFA), systemic inflammatory response syndrome (SIRS), National early warning score (NEWS), sepsis patient evaluation in the emergency department (SPEED), and mortality in emergency department sepsis (MEDS) were analyzed for all patients utilizing the available data. The primary outcome of this study was death within 24 hours of triage. Receiver operating characteristic (ROC) analysis was used to determine the most effective scoring system. Lactate was then added to this system to enhance its predictive accuracy.
RESULTS
Nineteen out of 120 patients included in the study (15.8%) experienced death within 24 hours of triage. The twenty-eight-day mortality rate was 55%. SOFA score demonstrated the highest predictive value for 24-hour mortality but was only moderately predictive overall, with an area under the receiver operating curve (AUC) of 0.755 (95% CI 0.625-0.885). SPEED, MEDS, and NEVS exhibited modest discriminatory power [0.673 (95% CI 0.543-0.803), 0.665 (95% CI 0.536-0.794), 0.630 (95% CI 0.528-0.724)], while SIRS and qSOFA remained insignificant in predicting 24-hour mortality. The predictive value of the SOFA score was increased by the addition of lactate (AUC 0.865, 95% CI 0.736-0.995; p=0.0081). All scores demonstrated better and satisfactory predictive power for 28-day mortality.
CONCLUSIONS
SOFA, with the addition of lactate, is a complex but reliable tool for the early stratification of septic patients who are presenting at an emergency department.
Topics: Humans; Sepsis; Retrospective Studies; Prognosis; Male; Female; Middle Aged; Organ Dysfunction Scores; Emergency Service, Hospital; Aged; Hospital Mortality; Triage; Intensive Care Units; ROC Curve
PubMed: 38946383
DOI: 10.26355/eurrev_202406_36462 -
European Review For Medical and... Jun 2024A condition known as ligamentum flavum (LF) hypertrophy occurs when the ligamentum flavum (LF) swells as a result of pressures applied to the spine. Among the elderly... (Observational Study)
Observational Study
OBJECTIVE
A condition known as ligamentum flavum (LF) hypertrophy occurs when the ligamentum flavum (LF) swells as a result of pressures applied to the spine. Among the elderly population, lumbar spinal stenosis is a major cause of pain and disabilities. Numerous studies indicate that lumbar spinal stenosis etiology involves the ligamentum flavum in a major way. This study looks into the relationship between low back pain and ligamentum flavum thickening.
PATIENTS AND METHODS
The imaging tests and case histories of all patients with low back pain who had consecutive magnetic resonance imaging exams performed at the Prince Sattam University and King Khalid hospitals in Al Kharj City will serve as the basis for this retrospective observational study. A radiologist utilized the Pfirrmann grading system, which is based on spinal levels starting from the first lumbar to the first sacral vertebrae, to measure the thickness of the ligamentum flavum in all cases who underwent magnetic resonance imaging (MRI). A correlation between age, hypertrophy of LF, and low back pain was investigated.
RESULTS
There were 79 participants in the study, ages ranging from 21 to 82, 49 of which were men. The patients' average age was 54 years, and 62% of them were men. We found no appreciable variations in LF thickness according to gender. At the L4-L5 and L5-S1 levels, the left LF was noticeably thicker than the right. Moreover, there was a significant difference (p < 0.05) in the bilateral LF thicknesses at L5-S1 compared to the comparable sides at L4-L5.
CONCLUSIONS
By evaluating the thickness of LF on magnetic resonance images, we discovered that it may be closely associated with the etiology of pain processes in the spine.
Topics: Humans; Ligamentum Flavum; Low Back Pain; Hypertrophy; Male; Middle Aged; Female; Aged; Magnetic Resonance Imaging; Retrospective Studies; Adult; Aged, 80 and over; Young Adult; Lumbar Vertebrae; Spinal Stenosis
PubMed: 38946379
DOI: 10.26355/eurrev_202406_36458 -
The American Journal of Psychiatry Jul 2024Antidepressants are commonly used to treat bipolar depression but may increase the risk of mania. The evidence from randomized controlled trials, however, is limited by... (Observational Study)
Observational Study
OBJECTIVE
Antidepressants are commonly used to treat bipolar depression but may increase the risk of mania. The evidence from randomized controlled trials, however, is limited by short treatment durations, providing little evidence for the long-term risk of antidepressant-induced mania. The authors performed a target trial emulation to compare the risk of mania among individuals with bipolar depression treated or not treated with antidepressants over a 1-year period.
METHODS
The authors emulated a target trial using observational data from nationwide Danish health registers. The study included 979 individuals with bipolar depression recently discharged from a psychiatric ward. Of these, 358 individuals received antidepressant treatment, and 621 did not. The occurrence of mania and bipolar depression over the following year was ascertained, and the intention-to-treat effect of antidepressants was analyzed by using Cox proportional hazards regression with adjustment for baseline covariates to emulate randomized open-label treatment allocation.
RESULTS
The fully adjusted analyses revealed no statistically significant associations between treatment with an antidepressant and the risk of mania in the full sample (hazard rate ratio=1.08, 95% CI=0.72-1.61), in the subsample concomitantly treated with a mood-stabilizing agent (hazard rate ratio=1.16, 95% CI=0.63-2.13), and in the subsample not treated with a mood-stabilizing agent (hazard rate ratio=1.16, 95% CI=0.65-2.07). Secondary analyses revealed no statistically significant association between treatment with an antidepressant and bipolar depression recurrence.
CONCLUSIONS
These findings suggest that the risk of antidepressant-induced mania is negligible and call for further studies to optimize treatment strategies for individuals with bipolar depression.
Topics: Humans; Bipolar Disorder; Antidepressive Agents; Male; Female; Denmark; Adult; Mania; Middle Aged; Registries; Proportional Hazards Models
PubMed: 38946271
DOI: 10.1176/appi.ajp.20230477 -
Acta Dermatovenerologica Croatica : ADC Mar 2024Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking. (Observational Study)
Observational Study
The Safety Profiles of Adalimumab, Infliximab, Etanercept, Secukinumab and Ustekinumab in Psoriasis - A 30-month Observational Cohort Prospective Study of Adverse Events in Biologic Therapy.
BACKGROUND
Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking.
METHODS
A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed.
RESULTS
Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values.
CONCLUSION
A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.
Topics: Humans; Psoriasis; Female; Male; Ustekinumab; Prospective Studies; Adalimumab; Infliximab; Middle Aged; Adult; Etanercept; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Cohort Studies; Dermatologic Agents
PubMed: 38946182
DOI: No ID Found -
Transfusion Medicine (Oxford, England) Jun 2024The aim of this retrospective and observational study was to analyse the impact of the introduction of a goal directed transfusion (GDT) strategy based on a viscoelastic...
BACKGROUND
The aim of this retrospective and observational study was to analyse the impact of the introduction of a goal directed transfusion (GDT) strategy based on a viscoelastic test (ROTEM®) and specific procoagulant products in a patient blood management (PBM) Program on blood product use and perioperative bleeding in a single cardiac surgery centre.
STUDY DESIGN AND METHODS
Patient population underwent cardiac surgery from 2011 to 2021 was divided in two groups based on PBM protocol used (G#11-14, years 2011-2014, G#15-21, years 2015-2021) and compared for the following variables: intraoperative and postoperative transfusions of packed red blood cell and any procoagulant products, postoperative drain blood loss volume and rate of re-exploration surgery. The second program was defined after the introduction of a GDT protocol based on viscoelastic tests and specific procoagulant products.
RESULTS
After the introduction of a GDT protocol, about 80% less amongst patients were transfused with fresh frozen plasma and any procoagulant product (p < 0.001 for both phases). Moreover, similar results were obtained with PRBC transfusions (p < 0.001) and drain blood loss volume (p = 0.006) in the postoperative phase. The main factors affecting the use of any procoagulant and PBRC transfusion in the multivariate logistic regression analysis was Group (2 versus 1, OR 0.207, p < 0.001) and preoperative haemoglobin (OR 0.728, p < 0.001), respectively.
DISCUSSION
In our experience, a GDT strategy for the diagnosis and treatment of the coagulopathy in patients undergone cardiac surgery led to a significant reduction in bleeding and transfusion.
PubMed: 38945994
DOI: 10.1111/tme.13063 -
American Journal of Critical Care : An... Jul 2024Pain is a significant burden for children with neurodevelopmental disabilities but is difficult for clinicians to identify. No pain assessment tools for children with... (Observational Study)
Observational Study
BACKGROUND
Pain is a significant burden for children with neurodevelopmental disabilities but is difficult for clinicians to identify. No pain assessment tools for children with neurodevelopmental disabilities have been validated for use in pediatric intensive care units. The Individualized Numeric Rating Scale (INRS) is an adapted 0-to-10 rating that includes parents' input on their child's pain indicators.
OBJECTIVES
To evaluate the reliability, validity, and feasibility and acceptability of use of the INRS for assessing pain in critically ill children with neurodevelopmental disabilities.
METHODS
This observational study enrolled critically ill patients with neurodevelopmental disabilities aged 3 to 17 years in 2 pediatric intensive care units at a children's hospital using a prospective repeated-measures cohort design. Structured parent interviews were used to populate each patient's INRS. Bedside nurses assessed pain using the INRS throughout the study. The research team completed independent INRS ratings using video clips. Participating parents and nurses completed feasibility and acceptability surveys. Psychometric properties of the INRS and survey responses were evaluated with appropriate statistical methods.
RESULTS
For 481 paired INRS pain ratings in 34 patients, interrater reliability between nurse and research team ratings was moderate (weighted κ = 0.56). Parents said that creating the INRS was easy, made them feel more involved in care, and helped them communicate with nurses.
CONCLUSIONS
The INRS has adequate measurement properties for assessing pain in critically ill children with neurodevelopmental disabilities. It furthers goals of patient- and family-centered care but may have implementation barriers.
Topics: Humans; Child; Child, Preschool; Female; Adolescent; Male; Critical Illness; Pain Measurement; Reproducibility of Results; Prospective Studies; Psychometrics; Intensive Care Units, Pediatric; Neurodevelopmental Disorders; Parents; Feasibility Studies
PubMed: 38945815
DOI: 10.4037/ajcc2024343 -
The Bone & Joint Journal Jul 2024There is a lack of high-quality research investigating outcomes of Ponseti-treated idiopathic clubfeet and correlation with relapse. This study assessed clinical and... (Observational Study)
Observational Study
AIMS
There is a lack of high-quality research investigating outcomes of Ponseti-treated idiopathic clubfeet and correlation with relapse. This study assessed clinical and quality of life (QoL) outcomes using a standardized core outcome set (COS), comparing children with and without relapse.
METHODS
A total of 11 international centres participated in this institutional review board-approved observational study. Data including demographics, information regarding presentation, treatment, and details of subsequent relapse and management were collected between 1 June 2022 and 30 June 2023 from consecutive clinic patients who had a minimum five-year follow-up. The clubfoot COS incorporating 31 parameters was used. A regression model assessed relationships between baseline variables and outcomes (clinical/QoL).
RESULTS
Overall, 293 patients (432 feet) with a median age of 89 months (interquartile range 72 to 113) were included. The relapse rate was 37%, with repeated relapse in 14%. Treatment considered a standard part of the Ponseti journey (recasting, repeat tenotomy, and tibialis anterior tendon transfer) was performed in 35% of cases, with soft-tissue release and osteotomies in 5% and 2% of cases, respectively. Predictors of relapse included duration of follow-up, higher initial Pirani score, and poor Evertor muscle activity. Relapse was associated with poorer outcomes.
CONCLUSION
This is the first multicentre study using a standardized COS following clubfoot treatment. It distinguishes patients with and without relapse in terms of clinical outcomes and QoL, with poorer outcomes in the relapse group. This tool allows comparison of treatment methods and outcomes, facilitates information sharing, and sets family expectations. Predictors of relapse encourage us to create appropriate treatment pathways to reduce relapse and improve outcome.
Topics: Humans; Clubfoot; Quality of Life; Male; Female; Recurrence; Child; Child, Preschool; Treatment Outcome; Casts, Surgical; Infant; Tenotomy; Follow-Up Studies
PubMed: 38945546
DOI: 10.1302/0301-620X.106B7.BJJ-2023-1258.R1 -
The Journal of Pediatrics Jun 2024To describe reported adverse events (AEs) associated with elexacaftor/tezacaftor/ivacaftor (ETI) in a pediatric sample with cystic fibrosis (CF) aged 6-18 years, with at...
Reported Adverse Events in a Multicenter Cohort of Patients Ages 6-18 Years with Cystic Fibrosis and at Least one F508del Allele Receiving Elexacaftor/Tezacaftor/Ivacaftor.
OBJECTIVE
To describe reported adverse events (AEs) associated with elexacaftor/tezacaftor/ivacaftor (ETI) in a pediatric sample with cystic fibrosis (CF) aged 6-18 years, with at least one F508del variant, followed at multiple Italian CF centers.
STUDY DESIGN
This was a retrospective, multicenter, observational study. All children receiving ETI therapy from October 2019 to December 2023 were included. We assessed the prevalence and type of any reported potential drug-related AEs, regardless of discontinuation necessity. Persistent AEs were defined as those continuing at the end of the observation period.
RESULTS
Among 608 patients on ETI, 109 (17.9%) reported at least one AE. The majority (N=85, 77.9%) were temporary, with a median duration of 11 days (range 1-441 days). Only 7 (1.1%) patients permanently discontinued treatment, suggesting good overall safety of ETI. The most common AEs leading to discontinuation were transaminase elevations (temporary 14.1%, persistent 25.9%) and urticaria (temporary 41.2%, persistent 7.4%). Creatinine phosphokinase elevation was uncommon. No significant differences in AEs were observed based on sex, age groups (6-11 vs. 12-18 years), or genotype. Pre-existing CF-related liver disease was associated with an increased risk of transaminase elevations. We identified significant variability in the percentage of reported AEs (ANOVA p-value 0·026).
CONCLUSIONS
This real-world study highlights significant variability in reported AEs. Our findings suggest that ETI is a safe and well-tolerated therapy in children and adolescents with CF. However, further long-term safety and effectiveness investigations are warranted.
PubMed: 38945446
DOI: 10.1016/j.jpeds.2024.114176 -
Thrombosis Research Jun 2024Incidence of central venous catheter (CVC)-related thrombosis in critically ill patients remains ambiguous and its association with potential hazardous sequelae unknown....
BACKGROUND
Incidence of central venous catheter (CVC)-related thrombosis in critically ill patients remains ambiguous and its association with potential hazardous sequelae unknown. The primary aim of the study was to evaluate the epidemiology of CVC-related thrombosis; secondary aims were to assess the association of catheter-related thrombosis with catheter-related infection, pulmonary embolism and mortality.
METHODS
This was a single-center, prospective observational study conducted at a tertiary intensive care unit (ICU) in the Netherlands. The study population consisted of CVC placements in adult ICU patients with a minimal indwelling time of 48 h. CVC-related thrombosis was diagnosed with ultrasonography. Primary outcomes were prevalence and incidence, incidence was reported as the number of cases per 1000 indwelling days.
RESULTS
173 CVCs in 147 patients were included. Median age of patients was 64.0 [IQR: 52.0, 72.0] and 71.1 % were male. Prevalence of thrombosis was 0.56 (95 % CI: 0.49, 0.63) and incidence per 1000 indwelling days was 65.7 (95 % CI: 59.0, 72.3). No association with catheter-related infection was found (p = 0.566). There was a significant association with pulmonary embolism (p = 0.022). All 173 CVCs were included in the survival analysis. Catheter-related thrombosis was associated with a lower 28-day mortality risk (hazard ratio: 0.39, 95 % CI: 0.17, 0.87).
CONCLUSION
In critically ill patients, prevalence and incidence of catheter-related thrombosis were high. Catheter-related thrombosis was not associated with catheter-related infections, but was associated with pulmonary embolism and a decreased mortality risk.
PubMed: 38945091
DOI: 10.1016/j.thromres.2024.109068 -
Heart & Lung : the Journal of Critical... Jun 2024Factors associated with cardiovascular complications of COVID-19 remain understudied.
Cardiovascular complications in the course of COVID-19 - lessons learned and implications for the future care of patients with viral respiratory diseases: Data from a single center retrospective observational study.
BACKGROUND
Factors associated with cardiovascular complications of COVID-19 remain understudied.
OBJECTIVES
Here we investigate the occurrence and risk factors of arrythmias, myocardial infarction and/or stroke, and thromboembolism in the course of COVID-19.
METHODS
We have performed an observational study with prospectively designed data collection. Data of patients diagnosed with COVID-19 who were admitted from March 6th 2020 to November 30th 2021 in our Hospital were analyzed. Logistic regression was used to identify variables associated with the odds of early hospital death due to COVID-19.
RESULTS
Fourteen-point three percent of 1964 patients had cardiovascular complications, 6.36 % arrhythmias, 5.5 % thromboembolic events and 2.39 % myocardial infarction and/or stroke. Factors independently increasing the odds of arrhythmia were older age (OR=1.49 [95 % CI: 1.17-1.92], p = 0.02), longer time between admission and the first onset of symptoms (1.02 [0.99-1.05], p = 0.049), concomitant atrial fibrillation/flutter (2.84 [1.37-5.70], p = 0.004), nicotinism (2.49 [1.37-4.49], p = 0.002), and eGFR<60 ml/min/1.73m (2.44 [1.08-5.59], p = 0.033). Factors independently increasing the odds of myocardial infarction and/or stroke were dementia (4.55 [0.97-19.3], p = 0.044), hemiplegia (12.67 [3.12-46.1], p < 0.001), nicotinism (3.36 [1.30-10.4], p = 0.013) and higher C-reactive protein concentration (1.01 [1.00-1.01], p = 0.040). Factors independently increasing the odds of thromboembolic events were longer hospitalization (1.08 [1.05-1.10], p < 0.001) and higher d-dimers (1.04 [1.02-1.05], <0.001).
CONCLUSIONS
The risk of cardiovascular complications was especially pronounced in patients with older age, pre-existing cardiovascular disease and more sever pneumonia at presentation to care. This underlines the importance of close and careful clinical follow-up in the course of COVID-19 for specific patients' populations, including a pro-active approach in diagnosis.
PubMed: 38944910
DOI: 10.1016/j.hrtlng.2024.06.009