Ultrasound-guided QLB effective adjuvant analgesic technique in pediatric patients undergoing pyeloplasty, claims study

Recently published article reports the findings of a randomized clinical trial that investigated the impact of ultrasound-guided quadratus lumborum block (QLB) on analgesia and neuroendocrine stress response in pediatric patients undergoing pyeloplasty. The study involved 60 children aged 1-7 years undergoing elective open pyeloplasty, who were randomly assigned to receive either QLB with 0.5 ml/kg of 0.25% ropivacaine after induction of general anesthesia (GA) or GA alone. The researchers found that the QLB group exhibited decreased serum cortisol and blood glucose levels at 30 minutes after surgical incision and 24 hours after surgery compared to the preoperative values and the GA group. Additionally, the quality of analgesia assessed using the FLACC scale was significantly better in the QLB group, and the fentanyl consumption was lower in the QLB group compared to the GA group, both intraoperatively and postoperatively.

Benefits and Outcomes of QLB in Pediatric Pyeloplasty Patients

The study also emphasized the importance of reducing neuroendocrine stress response in pediatric surgical patients and noted that QLB attenuated this response effectively in the pyeloplasty patients. The research showcased the potential of QLB as part of multimodal analgesia and its ability to provide effective pain relief in pediatric patients undergoing pyeloplasty. The data indicated stable hemodynamics and a reduced stress response in patients receiving QLB, without significant complications such as postoperative nausea and vomiting, urinary retention, motor weakness, respiratory distress, or block site hematoma formation. The study’s strength lies in its detailed assessment of the neuroendocrine and analgesic effects of QLB in pediatric patients undergoing pyeloplasty, thereby contributing to the understanding of effective pain management strategies in this population.

In conclusion, the study demonstrated that ultrasound-guided QLB holds potential as an effective adjuvant analgesic technique in pediatric patients undergoing pyeloplasty, with the ability to attenuate neuroendocrine stress response and improve postoperative analgesia. The findings contribute to the growing body of evidence supporting the use of regional analgesic techniques such as QLB in pediatric surgical patients, particularly in procedures associated with significant postoperative pain. However, the study also noted some limitations, including the need for further research to evaluate additional stress response indicators and consider alternative forms of analgesia in the control group.

Key Points

– The study emphasized the importance of reducing neuroendocrine stress response in pediatric surgical patients and noted that QLB effectively attenuated this response in the pyeloplasty patients. QLB was found to provide stable hemodynamics and reduce the stress response in patients without significant complications. The research highlighted the potential of QLB as part of multimodal analgesia, providing effective pain relief without significant side effects in pediatric patients undergoing pyeloplasty.

– The study demonstrated that ultrasound-guided QLB holds potential as an effective adjuvant analgesic technique in pediatric patients undergoing pyeloplasty, with the ability to attenuate neuroendocrine stress response and improve postoperative analgesia. The findings contribute to the evidence supporting the use of regional analgesic techniques such as QLB in pediatric surgical patients, particularly in procedures associated with significant postoperative pain. However, the study noted the need for further research to evaluate additional stress response indicators and consider alternative forms of analgesia in the control group.

Reference –

Rathod, Pyarelal Ramsing; Bhoi, Debesh; Kumar, Ajeet; Ray, Bikash Ranjan; Mohan, Virender Kumar; Kashyap, Lokesh. Effect of ultrasound-guided quadratus lumborum block on neuroendocrine stress response and postoperative analgesia in paediatric patients undergoing elective open pyeloplasty – A randomised clinical trial. Indian Journal of Anaesthesia 68(5):p 467-472, May 2024. | DOI: 10.4103/ija.ija_608_23

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Intranasal Medications Show Efficacy in Treating Allergic Rhinitis: Study

Researchers have found that most intranasal medications, including corticosteroids and antihistamines, are effective in improving nasal and ocular symptoms, as well as the quality of life for patients with perennial or seasonal allergic rhinitis (AR). However, there are notable differences in the certainty of evidence supporting their efficacy. This study was published in the The Journal of Allergy and Clinical Immunology. The study was conducted by Bernardo S. and colleagues.

Allergic rhinitis (AR) is a common condition that affects the nasal passages, causing symptoms such as sneezing, congestion, and itchy eyes. Intranasal medications, such as corticosteroids and antihistamines, are often used to manage AR symptoms. However, the effectiveness of these medications has not been systematically compared against placebo.

A systematic review was conducted to evaluate the efficacy of individual intranasal corticosteroids and antihistamines in adult patients with seasonal or perennial AR. The review included randomized controlled trials that compared the use of intranasal medications versus placebo.

The assessed outcomes included:

  1. Total Nasal Symptom Score (TNSS)

  2. Total Ocular Symptom Score (TOSS)

  3. Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ)

Random-effects meta-analyses were performed to compare mean differences in outcomes for each medication and placebo. Evidence certainty was assessed using the GRADE approach.

The key findings of the study were:

  • A total of 151 primary studies were included in the review, with most studies focusing on patients with seasonal AR.

  • Most assessed treatments were found to be more effective than placebo in improving symptoms and quality of life for both perennial and seasonal AR.

  • In seasonal AR, azelastine-fluticasone, fluticasone furoate, and fluticasone propionate showed the highest probability of moderate or large improvements in TNSS and RQLQ.

  • Azelastine-fluticasone also displayed the highest probability of moderate or large improvements in TOSS.

  • Evidence certainty was rated as “high” in 6 out of 46 analyses, “moderate” in 23 out of 46 analyses, and “low” or “very low” in 17 out of 46 analyses.

The study’s findings suggest that intranasal medications are generally effective in treating rhinitis symptoms and improving quality of life. However, the varying levels of evidence certainty indicate that additional research may be needed to further support the use of certain medications.

Intranasal medications, including corticosteroids and antihistamines, are effective in managing allergic rhinitis symptoms and improving quality of life. Nonetheless, the certainty of evidence supporting their efficacy varies, highlighting the need for further research in this area.

Reference:

Sousa-Pinto, B., Vieira, R. J., Brozek, J., Cardoso-Fernandes, A., Lourenço-Silva, N., Ferreira-da-Silva, R., Ferreira, A., Gil-Mata, S., Bedbrook, A., Klimek, L., Fonseca, J. A., Zuberbier, T., Schünemann, H. J., & Bousquet, J. (2024). Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis. The Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2024.04.016

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A Year-Long Clinical Study Compares Self-Adhesive and Conventional Bulk-Fill Composites in Class II Cavities

Egypt: In the realm of dental care, advancements in materials and techniques continually shape the landscape of treatment options available to patients. A recent randomized controlled clinical study conducted over a year has shed light on the comparative efficacy of self-adhesive and conventional bulk-fill composites in treating Class II cavities. The study, published in the Journal of Esthetic and Restorative Dentistry, offers valuable insights into the performance of these two commonly used dental materials.

In the study, the researchers compared the efficacy of self-adhesive and conventional bulk-fill composites in class II restorations over 12 months. They found that both materials met Federation Dentaire Internationale criteria, with the self-adhesive composite demonstrating comparable biological and functional performance to the conventional composite. However, the conventional composite exhibited superior esthetic qualities.

Class II cavities, which occur on the sides of molars and premolars, pose unique challenges for dental restorations due to their location and the forces they endure during chewing. In the study, Mohamed S. Ellithy, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt, and colleagues compared the clinical efficacy of self-adhesive bulk-fill Surefil One with a traditional bulk-fill composite in class II restorations.

For this purpose, the researchers included sixty-four direct class II composite restorations. They were categorized into two groups: Group I, control group (n = 32): cavities were restored by Filtek One bulk-fill composite with Scotchbond Universal (SBU) adhesive in self-etch mode, Group II, test group (n = 32): cavities were restored by Surefil One self-adhesive bulk-fill composite.

The follow-up period was one year, during which restoration assessment was done at baseline (BL), six months, and 12 months using Federation Dentaire Internationale (FDI) criteria. Data analysis was performed using nonparametric tests. A comparison of restoration characteristics was performed.

The study led to the following findings:

  • Filtek One and Surefil One bulk-fill composites revealed clinically acceptable FDI scores over 12-month recalls.
  • Thirty-two patients (64 restorations) were available for all follow-up visits; 100% of the restorations survived.
  • For esthetic properties, Filtek One was far better than Surefil One at all time points.
  • In terms of functional and biological properties, both restorations demonstrated comparable performances.

“Filtek One bulk-fill restorations were superior in terms of surface staining, surface luster, color match, and translucency, but Surefil One restorations performed well and were comparable to Filtek One restorations,” the researchers wrote. “However, there is a need for additional advancements and research to obtain better esthetics. Furthermore, there is a need for longitudinal studies with extended follow-up periods to assess the clinical potential of both materials.”

Reference:

Ellithy, M. S., Abdelrahman, M. H., & Afifi, R. R. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. Journal of Esthetic and Restorative Dentistry. https://doi.org/10.1111/jerd.13242

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Revolutionizing postoperative care: CT volumetric imaging enhances lung function assessment in lung cancer patients

China: In a groundbreaking development in thoracic oncology, the clinical application of computed tomographic (CT) volumetric imaging is poised to revolutionize postoperative lung function assessment in patients undergoing lung cancer surgery. This innovative approach offers unprecedented insights into lung function recovery following surgical intervention, heralding a new era of personalized postoperative care for lung cancer patients.

A recent study published in BMC Medical Imaging has shown the potential of CT volumetric imaging analysis to determine the pre-and post-operative lung function and to predict post-surgery complication occurrence in lung cancer patients with pulmonary lobectomy.

“We found that lung function detected from CT volumetric analysis is consistent with those from the lung function measurements in lung cancer patients, suggesting that CT volumetric imaging can be a future tool to predict postoperative lung function and to predict the postoperative complications of patients,” the researchers wrote.

Lung cancer surgery, while often essential for disease management, poses inherent risks to pulmonary function, potentially leading to postoperative complications such as respiratory insufficiency and impaired lung capacity. Traditionally, lung function assessment relied on spirometry and pulmonary function tests, which provided limited information on regional lung ventilation and perfusion dynamics.

The advent of computed tomographic volumetric imaging has transformed the landscape of postoperative lung function evaluation by enabling comprehensive three-dimensional characterization of lung anatomy and function. Leveraging advanced imaging techniques, including dynamic contrast-enhanced imaging and perfusion scans, clinicians can visualize and quantify regional lung ventilation and perfusion with unprecedented precision.

Against the above background, Yanni Zhang, ZhangJiaKou First Hospital, Zhangjiakou, Hebei, China, and colleagues aimed to evaluate the effectiveness of the CT volumetric analysis in postoperative lung function assessment and the predicting value for postoperative complications in patients who had segmentectomy for lung cancer.

For this purpose, the researchers performed CT scanning and pulmonary function examination for 100 patients with lung cancer. CT volumetric analyses were performed by specific software, for the mean lung density at the expiratory phase (MLDex), for the mean inspiratory lung density (MLDin), the volume of the inspiratory phase (Vin), and the volume of the expiratory phase (Vex).

Postoperative lung function was predicted using pulmonary function examination results and CT volumetric analysis results. The correlations and concordance of these values were evaluated by Pearson correlation analysis and Bland-Altman analysis, respectively. Multivariate binomial logistic regression analysis was executed to evaluate the associations of CT data with complication occurrence.

The study revealed the following findings:

· Correlations between CT scanning data and pulmonary function examination results were significant in both pre-and post-operation (0.8083 ≤ r ≤ 0.9390).

· Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the ratio of FVC and FEV1 estimated by CT volumetric analyses showed high concordance with those detected by pulmonary function examination.

· Preoperative (Vin-Vex) and (MLDex- MLDin) values were identified as predictors for post-surgery complications, with hazard ratios of 5.378 and 6.524, respectively.

The findings showed that lung function detected from CT volumetric analysis is consistent with those from the lung function measurements in patients with lung cancer. In addition, CT volumetric imaging can be a future tool to predict post-operative lung function and predict patients, postoperative complications.

“This study may propose important implications for improving the prediction of patients’ post-operative lung function and ultimately contributing to better patient outcomes,” the researchers concluded.

Reference:

Xu, Z., Wang, X., Shen, Z. et al. Clinical application of computed tomographic volumetric imaging in postoperative lung function assessment in patients with lung cancer. BMC Med Imaging 24, 99 (2024). https://doi.org/10.1186/s12880-024-01268-7

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Researchers identify biomarkers in blood to predict liver cancer

Early detection has the potential to transform treatment and outcomes in cancer care, especially for cancers like liver cancer, which is typically diagnosed at a late stage with limited options for cure. A new study led by investigators from Mass General Brigham and Beth Israel Deaconess Medical Center suggests that proteins detectable in the blood could improve predictions about risk of liver cancer years before typical diagnosis. Results are published in JNCI.

“Liver cancer rates are rapidly increasing, and liver cancer has a high mortality rate, but if we can diagnose it early, therapeutic interventions can be potentially curative,” said lead author Xinyuan (Cindy) Zhang, PhD, of the Channing Division of Network Medicine at Brigham and Women’s Hospital. “We need to have a way to detect this form of cancer early enough to intervene with surgery or liver transplantation to treat the disease before it becomes metastatic.”

Liver cancer, or hepatocellular carcinoma (HCC), ranks as the third leading cause of cancer worldwide and the second leading cause of cancer-related deaths globally, with its incidence rate nearly tripled since 1980s in the US. Detection of liver cancers often occurs at advanced stages, where life expectancy typically spans less than 12 months. Certain high-risk populations, such as individuals with cirrhosis and hepatitis, stand to significantly benefit from early detection tests. Currently, there is a notable deficiency in accurate, sensitive, and specific tools for the early detection of liver cancer. Many existing methods are relatively expensive, invasive, or limited in accessibility, primarily confined to major hospitals.

The research team included investigators from Mass General Brigham’s founding members, Brigham and Women’s Hospital and Massachusetts General Hospital, Harvard T.H. Chan School of Public Health, Beth Israel Deaconess Medical Center and Yale University. The team utilized proteomics (profiling of proteins) to develop a prediction model aimed at diagnosing or screening for liver cancer at an earlier stage. They used the SomaScan Assay Kit, a high-throughput proteomics platform that measures protein levels in biological samples, available through the Beth Israel Deaconess Medical Center Genomics, Proteomics, Bioinformatics and Systems Biology Center. The SomaScan platform allowed them to detect minute levels of circulating proteins that may be present at early stage of disease, measuring 1,305 proteins simultaneously in the blood.

“It’s always been challenging to identify highly specific disease biomarkers in the blood using traditional tools, but this new technology allows us to detect a broad and dynamic range of both high and low abundant proteins,” said co-senior author Towia A. Libermann, PhD, of the Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center. “New insights into the biological mechanisms underlying liver cancer development emerge from our data that may lead to identification of novel therapeutic targets. Most importantly, we were able to validate these early detection biomarkers using alternative protein analysis techniques and in an independent population cohort from the UK.”

The study team used SomaScan to analyze plasma samples from participants in both the Nurses’ Health Study and the Health Professional Follow-Up Study, two longitudinal, ongoing, prospective cohorts in the U.S. Notably, they examined blood samples obtained from individuals an average of 12 years before their liver cancer diagnosis to pinpoint protein biomarker signals. After examination, the researchers cross-referenced medical records to confirm whether these patients ultimately developed liver cancer.

From the blood samples, the researchers identified 56 plasma proteins that showed significantly elevated levels in individuals with liver cancer compared to matched control individuals without hepatocellular cancer. The team selected four of these proteins to create a predictive model, which they tested on the UK Biobank Pharma Proteomics dataset, comprised of 50,000 individuals, 45 of whom were diagnosed with liver cancer. Their model had greater accuracy in predicting liver cancer compared to traditional risk factors.

The authors caution that their study included a limited number of liver cancer cases and further validation in larger, more diverse patient populations and in high-risk populations is needed.

“Even though further investigation in additional populations is absolutely needed, our results reveal a robust circulating protein profile associated with liver cancer years before diagnosis, which is remarkable,” said co-senior author Xuehong Zhang, MBBS, ScD, who conducted work on this study while at the Channing Division of Network Medicine at the Brigham. Zhang is now at Yale.

The study team also aims to extend their methodology to uncover additional plasma protein biomarkers utilizing the more expanded SomaScan assay measuring 11,000 proteins, explore biomarkers linked with different cancer types, and gain deeper insights into the role of hepatocellular cancer risk factors across specific patient populations. With further progress, the protein biomarkers investigated in the study could potentially hold clinical significance as a non-invasive test for assessing liver cancer risk.

Reference:

Xinyuan Zhang, Longgang Zhao, Long H Ngo, Simon T Dillon, Xuesong Gu, Michelle Lai, Tracey G Simon, Andrew T Chan, Edward L Giovannucci, Towia A Libermann, Xuehong Zhang, Pre-diagnostic plasma proteomics profile for hepatocellular carcinoma, JNCI: Journal of the National Cancer Institute, 2024;, djae079, https://doi.org/10.1093/jnci/djae079

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Nonmotor seizures may be missed in children and teenagers, finds study

Children and teens may experience nonmotor seizures for months or years before being seen in an emergency department for a more obvious seizure that includes convulsions, according to a study published in online issue of Neurology®, the medical journal of the American Academy of Neurology. Even then, the history of nonmotor seizures may not be recognized.

“Early diagnosis of epilepsy is of the utmost importance because epileptic seizures can lead to injury and even death,” said study author Jacqueline French, MD, of NYU Grossman School of Medicine in New York City and a Fellow of the American Academy of Neurology. “Medications can reduce these risks, but our study found that a history of nonmotor seizures was being missed when children and teens were seen in emergency care.”

Subtle, nonmotor seizures have no noticeable movement. Symptoms affect the senses and may include nausea, visual distortions, feelings of déjà vu, or smelling odd odors. Motor seizures involve uncontrolled movements of the arms and legs and include more severe tonic-clonic seizures with full body convulsions.

The study involved 83 children and teens 12 to 18 years old. All were within four months of starting treatment for focal epilepsy, which accounts for more than half of all epilepsy cases and involves recurring seizures that begin in a localized area of the brain. Researchers reviewed participants’ medical records. There were 39 participants whose first seizure was a motor seizure, and 44 whose first seizure was a nonmotor seizure.

Before diagnosis, 58 went to emergency care for seizures. Looking back at medical records, researchers determined for 32, their first seizure was a motor seizure, and for 26, a nonmotor seizure. But when seeking this emergency care, 90% were seen for motor seizures, with 38% of that group having an unidentified history of nonmotor seizures.

There were 17 participants who were seen for their first motor seizure who had a history of nonmotor seizures, but none were recognized at the time as having had prior nonmotor seizures. As a result, they received similar treatment as those experiencing their first seizure, even though they were more advanced in the disease. French noted nonmotor seizures often worsen over time and progress to tonic-clonic seizures when left untreated.

Researchers found those with initial nonmotor seizures were less likely to seek emergency care with only 59% seeking care compared to 82% of those with initial motor seizures.

In emergency care, researchers also found just 33% of nonmotor seizures were correctly identified compared to 81% of motor seizures.

“Participants with nonmotor seizures described symptoms of hearing repeated phrases or jumbled noises, zoning out and episodes of dizziness, yet for many, this history was not collected until they had a tonic-clonic seizure and were referred to a neurologist,” said French. “This highlights a critical need for doctors to ask about these symptoms when someone seeks care for a motor seizure to ensure they get the best care.”

A limitation of the study was that nonmotor seizures may have been underreported, particularly in children who may have had difficulty identifying and communicating the symptoms of those seizures.

Reference:

Nora Jandhyala, Monica Ferrer, Jacob Pellinen, Hadley T. Greenwood, Dennis J. Dlugos, MSCE, Kristen L. Park,  Liu Lin Thio, and Jacqueline French, Unrecognized Focal Nonmotor Seizures in Adolescents Presenting to Emergency Departments, Neurology, https://doi.org/10.1212/WNL.0000000000209389.

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Repeated low-level red light exposure may improve myopia among children: Study

Repeated low-level red light exhibited a stronger impact on myopic children compared with premyopic individuals suggests a study published in the British Journal of Ophthalmology.

A study was done to compare the effects of repeated low-level red light (RLRL) treatment on axial length growth and refractive error changes in myopic and premyopic children. Subjects were assigned randomly to four subgroups: myopia-repeated low-level red light group (M-RL), myopia-control group (M-C), premyopia-repeated low-level red light group (PM-RL) and premyopia-control group (PM-C). Subjects in the RLRL group completed a 12-month treatment composed of a 3 min repeated low-level red light treatment session twice daily, with an interval of at least 4 hours, for 7 days per week. Visits were scheduled before and at 1-month, 3-month, 6-month, 9-month and 12-month follow-up after the treatment. Repeated-measures analysis of variance was used to compare the spherical equivalent refractive errors (SE) and axial length (AL) changes between the groups across the treatment period.Results: After 12 months of treatment, in the myopia group, SE and AL changes were −0.078±0.375 D and 0.033±0.123 mm for M-RL and −0.861±0.556 D and 0.415±0.171 mm for M-C; in the premyopia group, the progression of SE and AL was −0.181±0.417 D and 0.145±0.175 mm for PM-RL and −0.521±0.436 D and 0.292±0.128 mm for PM-C. PM-RL indicated a lower myopia incidence than PM-C (2.5% vs 19.4%). Additionally, the percentage of AL shortening in the M-RL was higher than that in the PM-RL before the 9-month follow-up. Repeated low-level red light effectively delayed myopia progression in children with myopia and reduced the incidence of myopia in premyopic children. Moreover, repeated low-level red light exhibited a stronger impact on myopic children compared with premyopic individuals.

Reference:

Liu G, Rong H, Liu Y, et alEffectiveness of repeated low-level red light in myopia prevention and myopia control. British Journal of Ophthalmology. Published Online First: 17 April 2024. doi: 10.1136/bjo-2023-324260

Keywords:

Liu G, Rong H, Liu Y, British Journal of Ophthalmology, Rpeated, low-level red light, stronger impact, myopic, children, premyopic

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Fracture in number of ribs independent risk factor for venous thromboembolism, finds study

Rib fracture in number of ribs independent risk factor for venous thromboembolism suggests a new study published in the Journal of Orthopaedic Surgery and Research.

Venous thromboembolism (VTE) refers to a condition characterized by abnormal coagulation of blood within the veins, leading to impaired venous flow. Venous thromboembolism represents a potentially life-threatening complication following trauma, including both types of pulmonary embolism (PE) and deep vein thrombosis (DVT). Investigating the incidence of VTE and associated risk factors in patients with traumatic rib fractures can effectively aid in the early clinical diagnosis and improve diagnostic efficiency for this condition. This study aimed to determine the incidence and influencing factors of venous thromboembolism (VTE) in patients with traumatic rib fractures. The retrospective study analyzed medical records of patients with traumatic rib fractures from 33 hospitals. Results: The overall incidence of Venous thromboembolism in hospitalized patients with traumatic rib fractures was 8.1%. Patients with isolated traumatic rib fractures had a significantly lower incidence of Venous thromboembolism (4.4%) compared to patients with rib fractures combined with other injuries (12.0%). Multivariate analysis identified the number of rib fractures as an independent risk factor for thrombosis. Surgical stabilization of isolated rib fractures involving three or more ribs was associated with a lower Venous thromboembolism incidence compared to conservative treatment. Patients with rib fractures have a higher incidence of Venous thromboembolism, positively correlated with the number of rib fractures. However, the occurrence of thrombosis is relatively low in isolated rib fractures. Targeted thromboprophylaxis strategies should be implemented for these patients, and surgical stabilization of rib fractures may be beneficial in reducing the risk of Venous thromboembolism.

Reference:

Zhang, D., Yang, Y., Yi, Y. et al. Incidence and influence factors of venous thromboembolism in traumatic rib fracture patient: a multicenter study. J Orthop Surg Res 19, 152 (2024). https://doi.org/10.1186/s13018-024-04622-1

Keywords:

Rib fracture, number of ribs, independent risk factor, venous thromboembolism,Journal of Orthopaedic Surgery and Research, Zhang, D., Yang, Y., Yi, Y, VTE, Influencing factors, Epidemiological study

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Novel Combination Therapy Xanomeline-Trospium Promising for Treatment of Schizophrenia: JAMA

Researchers have found that the investigational combination of xanomeline-trospium (KarXT) is effective and well-tolerated in individuals with schizophrenia who are experiencing acute psychosis. The randomized controlled phase III EMERGENT-3 trial demonstrated that the combination therapy significantly reduced Positive and Negative Syndrome Scale (PANSS) total scores over five weeks compared to placebo, indicating its potential as an alternative treatment option. This study was published in the journal JAMA Psychiatry by Kaul and colleagues.

Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. Traditional antipsychotic medications often target dopamine receptors, but the combination therapy of xanomeline-trospium represents a new approach that does not involve D2 dopamine receptor blocking activity.

The EMERGENT-3 trial was a randomized, double-blind, multicenter, placebo-controlled trial involving 256 participants aged 18 to 65 with a diagnosis of schizophrenia. Participants were assigned to either the xanomeline-trospium group (n=125) or the placebo group (n=131). The xanomeline-trospium group received varying doses of the combination therapy over the five-week treatment period, while the placebo group received a placebo.

The primary outcome was a change in PANSS total scores from baseline to week 5. Secondary endpoints included changes in PANSS positive and negative subscale scores.

The key findings of the study were:

  • Participants receiving xanomeline-trospium experienced a greater reduction in PANSS total scores compared to those on placebo (−20.6 vs −12.2).

  • The least squares mean difference was −8.4 (95% CI −12.4 to −4.3, P<0.001).

  • The Cohen d effect size was 0.60, indicating a moderate effect of the combination therapy.

  • The xanomeline-trospium group showed significant reduction in PANSS positive subscale score (−7.1 vs −3.6) at week 5 compared to placebo.

  • The combination therapy was well tolerated, with few serious treatment-emergent adverse events.

  • Discontinuation rates were similar between the therapy and placebo groups (6.4% vs 5.5%).

The findings suggest that the novel combination therapy xanomeline-trospium may offer a new treatment option for individuals with schizophrenia experiencing acute psychosis. The results are consistent with previous trials and support the potential for xanomeline-trospium to be the first non-dopamine medication with proven efficacy in treating acute episodes of schizophrenia.

Xanomeline-trospium demonstrates promise as a novel combination therapy for treating acute psychosis in individuals with schizophrenia. The therapy’s efficacy and tolerability make it a potential alternative to traditional antipsychotics. Further research is needed to evaluate the long-term durability of the therapy’s effect and safety.

Reference:

Kaul, I., Sawchak, S., Walling, D. P., Tamminga, C. A., Breier, A., Zhu, H., Miller, A. C., Paul, S. M., & Brannan, S. K. (2024). Efficacy and safety of xanomeline-trospium chloride in schizophrenia: A randomized clinical trial. JAMA Psychiatry (Chicago, Ill.). https://doi.org/10.1001/jamapsychiatry.2024.0785

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Wearable biosensor paired with AI may predict aggression among young psychiatric inpatients with autism: JAMA

Wearable biosensors paired with AI may predict aggression among young psychiatric inpatients with autism JAMA Network open

Aggressive behavior is a prevalent and challenging issue in individuals with autism. A study was done to investigate whether changes in peripheral physiology recorded by a wearable biosensor and machine learning can be used to predict imminent aggressive behavior before it occurs in inpatient youths with autism.

This noninterventional prognostic study used data collected from March 2019 to March 2020 from 4 primary care psychiatric inpatient hospitals. Enrolled participants were 86 psychiatric inpatients with confirmed diagnoses of autism exhibiting operationally defined self-injurious behavior, emotion dysregulation, or aggression toward others; 16 individuals were not included (18.6%) because they would not wear the biosensor (8 individuals) or were discharged before an observation could be made (8 individuals). Data were analyzed from March 2020 through October 2023.

Research staff performed live behavioral coding of aggressive behavior while inpatient study participants wore a commercially available biosensor that recorded peripheral physiological signals (cardiovascular activity, electrodermal activity, and motion). Logistic regression, support vector machines, neural networks, and domain adaptation were used to analyze time-series features extracted from biosensor data. Area under the receiver operating characteristic curve (AUROC) values were used to evaluate the performance of population- and person-dependent models.

Results

There were 70 study participants (mean [range; SD] age, 11.9 [5-19; 3.5] years; 62 males [88.6%]; 1 Asian [1.4%], 5 Black [7.1%], 1 Native Hawaiian or Other Pacific Islander [1.4%], and 63 White [90.0%]; 5 Hispanic [7.5%] and 62 non-Hispanic [92.5%] among 67 individuals with ethnicity data). Nearly half of the population (32 individuals [45.7%]) was minimally verbal, and 30 individuals (42.8%) had an intellectual disability. Participant length of inpatient hospital stay ranged from 8 to 201 days, and the mean (SD) length was 37.28 (33.95) days. A total of 429 naturalistic observational coding sessions were recorded, totaling 497 hours, wherein 6665 aggressive behaviors were documented, including self-injury (3983 behaviors [59.8%]), emotion dysregulation (2063 behaviors [31.0%]), and aggression toward others (619 behaviors [9.3%]). Logistic regression was the best-performing overall classifier across all experiments; for example, it predicted aggressive behavior 3 minutes before onset with a mean AUROC of 0.80 (95% CI, 0.79-0.81).

This study replicated and extended previous findings suggesting that machine learning analyses of preceding changes in peripheral physiology may be used to predict imminent aggressive behaviors before they occur in inpatient youths with autism. Further research will explore clinical implications and the potential for personalized interventions.

Reference:

Imbiriba T, Demirkaya A, Singh A, Erdogmus D, Goodwin MS. Wearable Biosensing to Predict Imminent Aggressive Behavior in Psychiatric Inpatient Youths With Autism. JAMA Netw Open. 2023;6(12):e2348898. doi:10.1001/jamanetworkopen.2023.48898

Keywords:

Wearable, biosensor, paired, AI, may, predict, aggression, among, young, psychiatric, inpatients, with, autism, JAMA Network open, Imbiriba T, Demirkaya A, Singh A, Erdogmus D, Goodwin MS.

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