Current medical research and opinion
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To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs' activities after the approval of trial protocols for clinical studies. ⋯ Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.
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The extent of short-acting β2-agonist (SABA) overuse in Africa remains poorly documented. As part of the SABA use IN Asthma (SABINA) III study, we assessed SABA prescriptions/clinical outcomes in 3 African countries. ⋯ Findings from this African cohort of the SABINA III study indicate that SABA over-prescription and SABA over-the-counter purchase are common and associated with poor asthma-related outcomes. This highlights the need for healthcare providers/policymakers to align clinical practices with the latest treatment recommendations.
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Review Meta Analysis
Relative efficacy of varicella vaccines: Network meta-analysis of randomized controlled trials.
Although varicella vaccination is highly effective, no head-to-head randomized controlled trials (RCTs) have compared the efficacy of different vaccine formulations. This study assessed the relative efficacy of different varicella vaccines using network meta-analysis (NMA). ⋯ Our study reported higher VE for two-dose V-MSD and MMRV-GSK. Among one-dose formulations, one-dose V-MSD was more efficacious than one-dose V-GSK. Policymakers should take into consideration differences in VE when implementing one- versus two-dose strategies in universal vaccination programs.
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The purpose of this study was to compare the effectiveness of the only Food and Drug Administration-authorized prescription digital therapeutic (PDT) Somryst versus face-to-face cognitive behavioral therapy for insomnia (CBT-I), or FDA-approved prescription medications for insomnia. ⋯ This network meta-analysis demonstrated that a PDT delivering CBT-I had the highest probability of being most effective compared to face-to-face CBT-I, prescription sleep medications, or placebo, as measured by reductions in mean ISI score from baseline and ISI-determined remittance.
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As a residual risk factor for coronary heart disease, lipoprotein(a) [Lp(a)] is associated with the occurrence of cardiovascular events after percutaneous coronary intervention (PCI). The revascularization rate after PCI is high among diabetic patients. However, the relationship between Lp(a) and revascularization after PCI in type 2 diabetes mellitus (T2DM) patients with acute coronary syndrome (ACS) remains unclear. ⋯ Lp(a) was an independent predictor of revascularization in patients with ACS complicated with T2DM, regardless of LDL-C levels. This suggests that Lp(a) measurement may help identify high-risk diabetic patients with ACS.