Daily Archives: May 2, 2024
Clinical Trial Follow-up: Antenatal corticosteroids not associated with adverse neurodevelopmental outcomes in late preterm births – JAMA
2 May, 2024 | 23:25h | UTCStudy Design and Population:
This research involved a prospective follow-up study of a multicenter randomized clinical trial, specifically focusing on children aged 6 years or older whose birthing parents were enrolled in the Antenatal Late Preterm Steroids (ALPS) trial. The trial initially examined the impact of administering 12 milligrams of intramuscular betamethasone, given twice 24 hours apart, on late preterm infants (34-36 completed weeks). The follow-up study involved 949 children from 13 centers in the Maternal-Fetal Medicine Units (MFMU) Network, assessed for neurodevelopmental outcomes.
Main Findings:
The primary outcome measured was the General Conceptual Ability score less than 85 on the Differential Ability Scales, 2nd Edition (DAS-II). Results showed no statistically significant differences between the betamethasone group (17.1%) and the placebo group (18.5%) in achieving this score. Secondary outcomes related to motor function and social responsiveness also showed no significant differences between the groups. Sensitivity analyses further confirmed these findings, suggesting that the administration of betamethasone did not adversely affect neurodevelopmental outcomes at age 6 or older.
Implications for Practice:
These findings support the continued use of antenatal corticosteroids for improving short-term neonatal respiratory outcomes in late preterm deliveries without concern for long-term neurodevelopmental harm. Clinicians can consider these results reassuring, as the study effectively dispels earlier concerns about potential negative long-term effects related to neurodevelopment from antenatal steroid use in late preterm infants.
Reference (link to abstract – $ for full-text):
RCT: Xanomeline-trospium reduces psychosis symptoms in patients with schizophrenia – JAMA Psychiatry
2 May, 2024 | 23:24h | UTCStudy Design and Population:
This study, titled EMERGENT-3 (NCT04738123), is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial conducted to evaluate the efficacy and safety of xanomeline-trospium chloride in adults with schizophrenia experiencing acute psychosis. It involved 256 participants across 30 inpatient sites in the US and Ukraine, with the study period running from April 1, 2021, to December 7, 2022. Data analysis occurred from February to June 2023.
Main Findings:
The primary outcome was the change from baseline to week 5 in the Positive and Negative Syndrome Scale (PANSS) total score. Xanomeline-trospium significantly reduced the PANSS total score compared to placebo, with a least squares mean difference of -8.4 and a Cohen’s d effect size of 0.60. The most common adverse events were gastrointestinal, mild to moderate in intensity, and generally transient. Safety and tolerability profiles were favorable, with similar discontinuation rates due to adverse events between the xanomeline-trospium and placebo groups.
Implications for Practice:
The results of EMERGENT-3, alongside the consistent findings from earlier phases of the trial, affirm xanomeline-trospium’s potential as a novel class of antipsychotic medication. Its mechanism of action, which does not involve D2 dopamine receptor blocking, offers a promising alternative to traditional antipsychotics, particularly for patients who may benefit from different therapeutic approaches due to issues with current treatments.
Commentary on X:
Xanomeline-trospium is efficacious & well tolerated in people with schizophrenia experiencing acute psychosis, finds EMERGENT-3 trial, and supports potential of xanomeline-trospium to be first in a putative new class of antipsychotic medications. https://t.co/ioBCKOgvQa pic.twitter.com/CDmYEgYN2O
— JAMA Psychiatry (@JAMAPsych) May 1, 2024
Reference (link to free full-text):
Guideline: Management of age-related hearing loss – Otolaryngol Head Neck Surg
2 May, 2024 | 23:22h | UTCThis guideline by the American Academy of Otolaryngology–Head and Neck Surgery Foundation offers a comprehensive approach for the detection and management of age-related hearing loss (ARHL) in adults aged 50 and older. It stresses the importance of early identification and appropriate intervention to mitigate the effects of ARHL, which is commonly underdiagnosed despite being the most prevalent sensory deficit in the elderly. The guideline includes eleven Key Action Statements that guide clinicians in screening, diagnosis, and management strategies, emphasizing the use of audiograms, otoscopy, and hearing aids, as well as the importance of addressing sociodemographic factors affecting healthcare access. It also highlights the necessity of patient and family education on the impacts of hearing loss and communication strategies. This structured approach aims to enhance healthcare delivery and improve the quality of life for those affected by hearing loss.
Reference (link to free-full-text):
RCT: Serratus anterior plane block reduces pain and opioid use in rib fracture patients – JAMA Surgery
2 May, 2024 | 23:20h | UTCStudy Design and Population:
This study was a multicenter, open-label, pragmatic randomized clinical trial conducted across eight emergency departments in New South Wales, Australia. The trial included 210 patients aged 16 years or older who had clinically suspected or radiologically confirmed rib fractures. Patients intubated, transferred for urgent surgical intervention, or with major concomitant nonthoracic injuries were excluded.
Main Findings:
In the trial, patients were randomized to receive either a serratus anterior plane block (SAPB) along with standard rib fracture management or standard care alone. The primary outcome was a composite pain score measured 4 hours post-enrollment. The SAPB group showed a significant increase in patients achieving the desired pain score reduction (41% in SAPB group vs. 19.6% in control; RR 0.73, 95% CI 0.60-0.89, P = 0.001). Additionally, SAPB recipients had significantly lower opioid consumption at 24 hours compared to the control group.
Implications for Practice:
The trial’s results support the addition of a serratus anterior plane block (SAPB) to standard rib fracture management for providing effective early pain relief and reducing opioid use. However, it’s important to note that this study did not include a sham group, and patients were aware of whether they received the intervention. This lack of blinding could influence patient-reported outcomes due to placebo effects. Despite this limitation, the reduction in pain and opioid consumption suggests that SAPB is a beneficial component of care for patients with rib fractures.
Reference (link to abstract – $ for full-text):