Transverse Growth of the Maxillo-Mandibular Complex in Untreated Children: A Longitudinal Cone Beam Computed Tomography Study

The aim of this study is to evaluate the longitudinal transverse growth of the maxillo-mandibular complex in untreated children using the Cone Beam Computed Tomography (CBCT)Two sets of scans on 12 males (mean 8.75 years at T1 and 11.52 years at T2) and 18 females (mean 9.09 years at T1 and 10.80 years at T2) were analyzed using Dolphin 3D imaging. The transverse widths of various maxillary and mandibular skeletal landmarks and the dentoalveolar and dental landmarks at the level of first molars were measured. Overall, there were greater increases in the transverse dimension in the posterior than anterior portions of the maxilla and mandible. The increase in intergonial width of the mandible seems to be primarily due to the lengthening of the mandibular body. The dentoalveolar process at the first molar level increases at an equal rate corono-apically and is independent to the changes in molar inclination. When comparing maxillary dentoalveolar changes with that of the mandible, greater increases were noticed in the maxilla, which might be explained by the presence of sutural growth in the maxilla. Moreover, the first molars maintain their coordination with each other despite the differential increase in the maxillary and mandibular dentoalveolar processes. © 2021 by the authors. Licensee MDPI, Basel, Switzerland

Sagittal and Vertical Growth of the Maxillo–Mandibular Complex in Untreated Children: A Longitudinal Study on Lateral Cephalograms Derived from Cone Beam Computed Tomography

The aim of this longitudinal study was to evaluate the sagittal and vertical growth of the maxillo–mandibular complex in untreated children using orthogonal lateral cephalograms com-pressed from cone beam computed tomography (CBCT). Two sets of scans, on 12 males (mean 8.75 years at T1, and 11.52 years at T2) and 18 females (mean 9.09 years at T1, and 10.80 years at T2), were analyzed using Dolphin 3D imaging. The displacements of the landmarks and rotations of both jaws relative to the cranial base were measured using the cranial base, and the maxillary and mandibular core lines. From T1 to T2, relative to the cranial base, the nasion, orbitale, A-point, and B-point moved anteriorly and inferiorly. The porion moved posteriorly and inferiorly. The ANB and mandibular plane angle decreased. All but one subject had forward rotation in reference to the cranial base. The maxillary and mandibular superimpositions showed no sagittal change on the A-point and B-point. The U6 and U1 erupted at 0.94 and 1.01 mm/year (males) and 0.82 and 0.95 mm/year (females), respectively. The L6 and L1 erupted at 0.66 and 0.88 mm/year (males), and at 0.41 mm/year for both the L6 and the L1 (females), respectively. © 2021 by the authors. Licensee MDPI, Basel, Switzerland

Antibiotic resistance in the patient with cancer: Escalating challenges and paths forward

Infection is the second leading cause of death in patients with cancer. Loss of efficacy in antibiotics due to antibiotic resistance in bacteria is an urgent threat against the continuing success of cancer therapy. In this review, the authors focus on recent updates on the impact of antibiotic resistance in the cancer setting, particularly on the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.). This review highlights the health and financial impact of antibiotic resistance in patients with cancer. Furthermore, the authors recommend measures to control the emergence of antibiotic resistance, highlighting the risk factors associated with cancer care. A lack of data in the etiology of infections, specifically in oncology patients in United States, is identified as a concern, and the authors advocate for a centralized and specialized surveillance system for patients with cancer to predict and prevent the emergence of antibiotic resistance. Finding better ways to predict, prevent, and treat antibiotic-resistant infections will have a major positive impact on the care of those with cancer

Weekly SARS-CoV-2 screening of asymptomatic kindergarten to grade 12 students and staff helps inform strategies for safer in-person learning

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in K-12 schools was rare during in 2020-2021; few studies included Centers for Disease Control and Prevention (CDC)-recommended screening of asymptomatic individuals. We conduct a prospective observational study of SARS-CoV-2 screening in a mid-sized suburban public school district to evaluate the incidence of asymptomatic coronavirus disease 2019 (COVID-19), document frequency of in-school transmission, and characterize barriers and facilitators to asymptomatic screening in schools. Staff and students undergo weekly pooled testing using home-collected saliva samples. Identification of \u3e 1 case in a school prompts investigation for in-school transmission and enhancement of safety strategies. With layered mitigation measures, in-school transmission even before student or staff vaccination is rare. Screening identifies a single cluster with in-school staff-to-staff transmission, informing decisions about in-person learning. The proportion of survey respondents self-reporting comfort with in-person learning before versus after implementation of screening increases. Costs exceed $260,000 for assays alone; staff and volunteers spend 135-145 h per week implementing screening

Exploration of a Potential Desirability of Outcome Ranking Endpoint for Complicated Intra-Abdominal Infections Using 9 Registrational Trials for Antibacterial Drugs

BACKGROUND: Desirability of outcome ranking (DOOR) is a novel approach to clinical trial design that incorporates safety and efficacy assessments into an ordinal ranking system to evaluate overall outcomes of clinical trial participants. Here, we derived and applied a disease-specific DOOR endpoint to registrational trials for complicated intra-abdominal infection (cIAI). METHODS: Initially, we applied an a priori DOOR prototype to electronic patient-level data from 9 phase 3 noninferiority trials for cIAI submitted to the US Food and Drug Administration between 2005 and 2019. We derived a cIAI-specific DOOR endpoint based on clinically meaningful events that trial participants experienced. Next, we applied the cIAI-specific DOOR endpoint to the same datasets and, for each trial, estimated the probability that a participant assigned to the study treatment would have a more desirable DOOR or component outcome than if assigned to the comparator. RESULTS: Three key findings informed the cIAI-specific DOOR endpoint: (1) a significant proportion of participants underwent additional surgical procedures related to their baseline infection; (2) infectious complications of cIAI were diverse; and (3) participants with worse outcomes experienced more infectious complications, more serious adverse events, and underwent more procedures. DOOR distributions between treatment arms were similar in all trials. DOOR probability estimates ranged from 47.4% to 50.3% and were not significantly different. Component analyses depicted risk-benefit assessments of study treatment versus comparator. CONCLUSIONS: We designed and evaluated a potential DOOR endpoint for cIAI trials to further characterize overall clinical experiences of participants. Similar data-driven approaches can be utilized to create other infectious disease-specific DOOR endpoints

Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs

BACKGROUND: Desirability of outcome ranking (DOOR) is an innovative approach to clinical trial design and analysis that uses an ordinal ranking system to incorporate the overall risks and benefits of a therapeutic intervention into a single measurement. Here we derived and evaluated a disease-specific DOOR endpoint for registrational trials for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). METHODS: Through comprehensive examination of data from nearly 4000 participants enrolled in six registrational trials for HABP/VABP submitted to the Food and Drug Administration (FDA) between 2005 and 2022, we derived and applied a HABP/VABP specific endpoint. We estimated the probability that a participant assigned to the study treatment arm would have a more favorable overall DOOR or component outcome than a participant assigned to comparator. RESULTS: DOOR distributions between treatment arms were similar in all trials. DOOR probability estimates ranged from 48.3% to 52.9% and were not statistically different. There were no significant differences between treatment arms in the component analyses. Although infectious complications and serious adverse events occurred more frequently in ventilated participants compared to non-ventilated participants, the types of events were similar. CONCLUSIONS: Through a data-driven approach, we constructed and applied a potential DOOR endpoint for HABP/VABP trials. The inclusion of syndrome-specific events may help to better delineate and evaluate participant experiences and outcomes in future HABP/VABP trials and could help inform data collection and trial design

Creating corroborated crisis reports from social media data through formal concept analysis

During a crisis citizens reach for their smart phones to report, comment and explore information surrounding the crisis. These actions often involve social media and this data forms a large repository of real-time, crisis related information. Law enforcement agencies and other first responders see this information as having untapped potential. That is, it has the capacity extend their situational awareness beyond the scope of a usual command and control centre. Despite this potential, the sheer volume, the speed at which it arrives, and unstructured nature of social media means that making sense of this data is not a trivial task and one that is not yet satisfactorily solved; both in crisis management and beyond. Therefore we propose a multi-stage process to extract meaning from this data that will provide relevant and near real-time information to command and control to assist in decision support. This process begins with the capture of real-time social media data, the development of specific LEA and crisis focused taxonomies for categorisation and entity extraction, the application of formal concept analysis for aggregation and corroboration and the presentation of this data via map-based and other visualisations. We demonstrate that this novel use of formal concept analysis in combination with context-based entity extraction has the potential to inform law enforcement and/or humanitarian responders about on-going crisis events using social media data in the context of the 2015 Nepal earthquake. Keywords : formal concept analysis, crisis management, disaster response, visualisation, entity extraction

Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia

Background Ceftobiprole is a cephalosporin that may be effective for treating complicated Staphylococcus aureus bacteremia, including methicillin-resistant S. aureus.Methods In this phase 3, double-blind, double-dummy, noninferiority trial, adults with complicated S. aureus bacteremia were randomly assigned in a 1:1 ratio to receive ceftobiprole at a dose of 500 mg intravenously every 6 hours for 8 days and every 8 hours thereafter, or daptomycin at a dose of 6 to 10 mg per kilogram of body weight intravenously every 24 hours plus optional aztreonam (at the discretion of the trial-site investigators). The primary outcome, overall treatment success 70 days after randomization (defined as survival, bacteremia clearance, symptom improvement, no new S. aureus bacteremia-related complications, and no receipt of other potentially effective antibiotics), with a noninferiority margin of 15%, was adjudicated by a data review committee whose members were unaware of the trial-group assignments. Safety was also assessed.Results Of 390 patients who underwent randomization, 387 (189 in the ceftobiprole group and 198 in the daptomycin group) had confirmed S. aureus bacteremia and received ceftobiprole or daptomycin (modified intention-to-treat population). A total of 132 of 189 patients (69.8%) in the ceftobiprole group and 136 of 198 patients (68.7%) in the daptomycin group had overall treatment success (adjusted difference, 2.0 percentage points; 95% confidence interval [CI], -7.1 to 11.1). Findings appeared to be consistent between the ceftobiprole and daptomycin groups in key subgroups and with respect to secondary outcomes, including mortality (9.0% and 9.1%, respectively; 95% CI, -6.2 to 5.2) and the percentage of patients with microbiologic eradication (82.0% and 77.3%; 95% CI, -2.9 to 13.0). Adverse events were reported in 121 of 191 patients (63.4%) who received ceftobiprole and 117 of 198 patients (59.1%) who received daptomycin; serious adverse events were reported in 36 patients (18.8%) and 45 patients (22.7%), respectively. Gastrointestinal adverse events (primarily mild nausea) were more frequent with ceftobiprole.Conclusions Ceftobiprole was noninferior to daptomycin with respect to overall treatment success in patients with complicated S. aureus bacteremia

Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus.

BACKGROUND: Alternative therapies for Staphylococcus aureus bacteremia and endocarditis are needed. METHODS: We randomly assigned 124 patients with S. aureus bacteremia with or without endocarditis to receive 6 mg of daptomycin intravenously per kilogram of body weight daily and 122 to receive initial low-dose gentamicin plus either an antistaphylococcal penicillin or vancomycin. The primary efficacy end point was treatment success 42 days after the end of therapy. RESULTS: Forty-two days after the end of therapy in the modified intention-to-treat analysis, a successful outcome was documented for 53 of 120 patients who received daptomycin as compared with 48 of 115 patients who received standard therapy (44.2 percent vs. 41.7 percent; absolute difference, 2.4 percent; 95 percent confidence interval, -10.2 to 15.1 percent). Our results met prespecified criteria for the noninferiority of daptomycin. The success rates were similar in subgroups of patients with complicated bacteremia, right-sided endocarditis, and methicillin-resistant S. aureus. Daptomycin therapy was associated with a higher rate of microbiologic failure than was standard therapy (19 vs. 11 patients, P=0.17). In 6 of the 19 patients with microbiologic failure in the daptomycin group, isolates with reduced susceptibility to daptomycin emerged; similarly, a reduced susceptibility to vancomycin was noted in isolates from patients treated with vancomycin. As compared with daptomycin therapy, standard therapy was associated with a nonsignificantly higher rate of adverse events that led to treatment failure due to the discontinuation of therapy (17 vs. 8, P=0.06). Clinically significant renal dysfunction occurred in 11.0 percent of patients who received daptomycin and in 26.3 percent of patients who received standard therapy (P=0.004). CONCLUSIONS: Daptomycin (6 mg per kilogram daily) is not inferior to standard therapy for S. aureus bacteremia and right-sided endocarditis. (ClinicalTrials.gov number, NCT00093067 [ClinicalTrials.gov].)