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In this section, we will highlight the key high-impact studies, updates, and analyses published in medicine during the past week.
Incidence of Childhood Obesity in the United States
In this retrospective analysis of data from the Early Childhood Longitudinal Study, data was collected from a cohort of 7738 kindergarteners in 1998 and followed for 9 years. Upon enrollment, 12.4% of participants were obese and 14.9% were overweight. At the end of the study, 20.8% of participants were obese and 17.0% were overweight, with an annual incidence of 5.4% in kindergarten and 1.7% after fifth grade. Of the participants who became obese, nearly half were overweight at baseline and 75% were at 70th percentile or higher of BMI .This suggests that obese children most likely became overweight at an early age and were previously overweight.
Rapid point-of-care tests for tuberculosis have been used in a variety of settings, however there is limited knowledge on how this affects clinical decision making and tuberculosis-related mortality. In this multicenter, randomized, parallel-group trial, 1502 participants from five primary care centers in Africa were randomized to either smear microscopy or Xpert MTB/RIF, a rapid point-of-care test. 182 out of 758 patients randomized to smear microscopy were culture positive compared to 185 out of 744 patients randomized to MTB/RIF. MTB/RIF had higher sensitivity than microscopy (154 [83%] of 185 vs 91 [50%] of 182; p=0·0001), leading to higher rates of same day diagnosis (24% vs. 13%, p<0.0001) and same day treatment (23% vs. 15%, p=0.0002). The MTB/RIF group had less drop-out, resulting in more culture-positive patients started on treatment (92% vs. 85%, p = 0.0302). The Xpert MTB/RIF system appears to be effective in an outpatient clinic setting with improved sensitivity, specific, rates of same day diagnosis, and same day treatment.
Proteome-wide Analysis and CXCL4 as a Biomarker in Systemic Sclerosis
Platelet factor 4 (PF4), also known as chemokine (CXC) motif 4 (CXCL4), is a soluble small chemokine regulating platelet aggregation. In this case-control study, plasmacytoid dendritic cells from patients with systemic sclerosis (SS) were compared with similar cells from healthy controls. Proteomic analysis showed that plasmacytoid dendritic cells from patients with SS secreted significantly more CXCL4 than similar cells from healthy controls. These cells also secreted significantly more CXCL4 when compared to patients with systemic lupus erythematosus, ankylosing spondylitis, or liver fibrosis. CXCL4 levels were correlated with incidence of pulmonary arterial hypertension as well as skin and liver fibrosis.
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
The US Food and Drug Administration (FDA) approved 188 novel therapeutic agents between 2005 and 2012. In this retrospective, cross-sectional analysis of publicly available documents, investigators examined the quality of efficacy trials leading to therapeutic agent approval by randomization, blinding, comparator, trial end point, and the use of surrogate outcomes. Approvals were attributed to a median of 2 pivotal trials, although 36.8% of approvals relied on only one significant trial. Almost all trials were randomized (89.3%), double-blinded (79.5%), and used a comparison agent (87.1%). The quality of trials varied widely by indication.
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