Daily Archives: August 24, 2024
Cluster-Randomized Trial: Twice-Yearly Azithromycin Reduces Mortality in Children Aged 1 to 59 Months in Niger – New England Journal of Medicine
24 Aug, 2024 | 19:44h | UTCStudy Design and Population: This adaptive cluster-randomized trial evaluated the impact of twice-yearly azithromycin distribution on childhood mortality in rural communities in Niger. A total of 1273 communities were assigned to three groups: children aged 1 to 59 months receiving azithromycin, infants aged 1 to 11 months receiving azithromycin and placebo for older children, and a placebo group. The study included 382,586 children and followed mortality over 419,440 person-years.
Main Findings: The study found a significant 14% reduction in mortality among children aged 1 to 59 months in the azithromycin group compared to placebo (11.9 vs. 13.9 deaths per 1000 person-years; P<0.001). However, azithromycin did not significantly reduce mortality in infants aged 1 to 11 months when compared to placebo (22.3 vs. 23.9 deaths per 1000 person-years).
Implications for Practice: Azithromycin distribution to children aged 1 to 59 months effectively reduces mortality in rural sub-Saharan Africa. However, targeting only infants may not yield significant benefits. Continuous monitoring for antimicrobial resistance is essential.
RCT: : Belzutifan Improves Progression-Free Survival and Objective Response Compared to Everolimus in Advanced Renal-Cell Carcinoma – N Engl J Med
24 Aug, 2024 | 16:48h | UTCStudy Design and Population: This phase 3, multicenter, open-label trial included 746 participants with advanced clear-cell renal-cell carcinoma who had previously undergone immune checkpoint and antiangiogenic therapies. Participants were randomly assigned to receive either belzutifan (120 mg daily) or everolimus (10 mg daily) until disease progression or intolerable toxicity occurred.
Main Findings: The median progression-free survival was identical at 5.6 months for both groups. However, at 18 months, a significantly higher percentage of participants in the belzutifan group (24.0%) remained progression-free compared to the everolimus group (8.3%, P=0.002). Belzutifan also led to a significantly higher objective response rate (21.9% vs. 3.5%, P<0.001). Median overall survival was similar between the groups, with no significant difference (21.4 months vs. 18.1 months, P=0.20).
Implications for Practice: Belzutifan offers a substantial benefit in progression-free survival and objective response rate over everolimus in patients with advanced renal-cell carcinoma post previous therapies. It was well-tolerated, with safety comparable to everolimus, suggesting its potential as a preferred treatment option in this patient population.
Meta-Analysis: High-Dose Psilocybin Shows Small Advantage Over Escitalopram for Depression – The BMJ
24 Aug, 2024 | 16:41h | UTCStudy Design and Population: This systematic review and Bayesian network meta-analysis evaluated the effectiveness of oral monotherapy with psychedelics (psilocybin, LSD, MDMA, ayahuasca) compared to escitalopram in adults with depressive symptoms. The analysis included 15 trials with psychedelics and 5 trials with escitalopram, covering a total of 811 participants in psychedelic trials and 1968 in escitalopram trials.
Main Findings: The analysis revealed that only high-dose psilocybin demonstrated a significant improvement in depressive symptoms compared to placebo when considered in the context of antidepressant trials, but the effect size was small (standardized mean difference of 0.31). High-dose psilocybin also outperformed escitalopram (10 mg and 20 mg), with a mean difference exceeding the minimal important difference. However, the placebo response was generally lower in psychedelic trials compared to antidepressant trials, suggesting potential overestimation of effect sizes in psychedelic studies.
Implications for Practice: The findings suggest that while high-dose psilocybin may offer a small advantage over escitalopram for treating depression, the overall effect size is comparable to traditional antidepressants. The results highlight the importance of considering the impact of blinding and placebo response in psychedelic trials, and suggest that improved blinding and standardized psychotherapies could help better assess the true efficacy of these treatments.
Retrospective Study: AI Tool Accurately Excludes Pathology in Up to 52.7% of Unremarkable Chest Radiographs with Low Critical Misses – Radiology
24 Aug, 2024 | 16:14h | UTCStudy Design and Population: This retrospective study assessed the effectiveness of a commercial AI tool in correctly identifying unremarkable chest radiographs, thus potentially reducing the workload in radiology departments. The study analyzed 1,961 chest radiographs from adult patients (median age: 72 years) across four Danish hospitals. The radiographs were labeled as remarkable or unremarkable by thoracic radiologists, and the AI tool’s performance was evaluated at varying sensitivity thresholds.
Main Findings: The AI tool demonstrated a specificity of 24.5% to 52.7% at sensitivity thresholds of 99.9% to 98.0%, respectively, effectively excluding pathology in unremarkable chest radiographs. At sensitivities of 95.4% or higher, the AI had equal or lower rates of critical misses compared to radiology reports, with the AI missing only 2.2% of critical findings compared to 1.1% by radiologists at similar sensitivity levels.
Implications for Practice: The results suggest that AI tools could autonomously report up to 52.7% of unremarkable chest radiographs, potentially reducing radiologist workload without compromising patient safety. However, prospective studies are necessary to confirm these findings and optimize AI deployment in clinical practice.