In Reply We thank the authors for their thoughtful comments on the ORATOR2 trial. The comments can be divided into 4 main themes: surgical credentialing, margin requirements, treatment-related deaths as extremely rare “black swan” events, and questioning the requirements for adjuvant therapy after transoral surgery (TOS). We address each of these in turn.
Risultati per: Probiotici: in vivo vs in vitro
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Comorbidities in Korean Patients With Palmoplantar Pustulosis vs Psoriasis Vulgaris or Pompholyx
To the Editor We have read with great interest the article by Kim et al comparing the risks for several comorbidities between Korean patients with palmoplantar pustulosis (PPP) and psoriasis vulgaris (PSV) or pompholyx. They conducted a large cohort study that suggested that patients with PPP have an overlapping comorbidity profile with patients with PSV; however, the risk for comorbidities may substantially differ. Although whether PPP is a distinct entity or a subtype of psoriasis remains an ongoing debate, their findings deepen this discussion. We speculate that adding subgroup analyses based on PPP subtypes could potentially lead to more significant findings.
Aspirin vs. Enoxaparin for Prophylaxis After Hip or Knee Replacement
Fewer venous thromboembolic events occurred with enoxaparin, but distal deep venous thrombosis accounted for most of the difference.
Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Type 2 Diabetes
This randomized clinical trial assesses the effect of a comprehensive telehealth intervention vs a simpler telehealth approach for patients with persistently poorly controlled type 2 diabetes.
Preoperative mFOLFIRINOX With vs Without Hypofractionated Radiotherapy for Borderline Resectable PDAC
This randomized clinical trial compares treatment with neoadjuvant modified FOLFIRINOX with or without hypofractionated radiation therapy with historical data and establishes standards for therapy in borderline resectable pancreatic ductal adenocarcinoma.
Outcomes and Cost With Intravascular LVAD vs Intra-aortic Balloon Pump in AMI With Cardiogenic Shock
This cohort study examines the association of intravascular left ventricular assist device or intra-aortic balloon pump use with clinical outcomes and cost in patients with acute myocardial infarction complicated by cardiogenic shock.
Log-Rank Test vs MaxCombo and dRMST Tests for Comparing Survival Under Nonproportional Hazards
This systematic review and meta-analysis compares the performance of the log-rank test vs the MaxCombo and difference in restricted mean survival time tests in immuno-oncology trials.
Cost-Utility Analysis of Rituximab vs Mycophenolate Mofetil for the Treatment of Pemphigus Vulgaris
This cost-utility analysis evaluates the cost-effectiveness of rituximab biosimilars vs mycophenolate mofetil as a first-line steroid-sparing agent for moderate to severe pemphigus vulgaris.
Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With ADHD
This randomized clinical trial evaluates the safety and efficacy of at-home transcranial direct current stimulation in treating inattention in adults with attention-deficit/hyperactivity disorder.
Exploring changes in maternal and congenital syphilis epidemiology to identify factors contributing to increases in congenital syphilis in Florida: a two time-period observational study (2013-2014 vs 2018-2019)
Objectives
As, cases of congenital syphilis (CS) and infectious syphilis among women more than doubled in Florida and across the nation during 2013–2019, we sought to understand what may be contributing to these increases in Florida.
Design
A two time-period observational study.
Setting
Pregnant women with reported syphilis infections and their pregnancy outcomes (2013–2014 and 2018–2019) in Florida.
Participants
1213 pregnant women with reported syphilis infections living in Florida and 341 infants meeting the CS case definition.
Outcome measures
We assessed what proportion of the increase in CS was from increases in maternal syphilis infections. We examined maternal demographics, infection characteristics and timing of diagnoses that could explain the increase in CS. Finally, we reviewed if changes in presentation or severity of CS cases occurred.
Results
During 2013–2014, 83 (21%) of 404 pregnant women with syphilis delivered babies with CS. During 2018–2019, 258 (32%) of 809 pregnant women with syphilis delivered babies with CS. Comparing CS prevention rates, it was determined that 65% of the increase in CS was due to the increases in maternal syphilis infections. The proportion of maternal cases staged as primary or secondary increased over time (7%–13%) (p
Combination Antidepressant Therapy vs Monotherapy—Further Considerations
To the Editor Henssler et al conducted a systematic review and meta-analysis to investigate the treatment efficacy and tolerability of combining antidepressants vs monotherapy in adult patients with acute depression. Their meta-analysis found that combination therapy was superior to monotherapy in treatment efficacy (primary outcome standardized mean difference [SMD], 0.31; 95% CI, 0.19-0.44), and among the combinations, combining a reuptake inhibitor with an antagonist of presynaptic α2-autoreceptors (RI+α2) was associated with better outcomes than other combinations (SMD, 0.37; 95% CI, 0.19-0.55). Based on the findings, the authors concluded that combining antidepressants seemed to be more effective than monotherapy and that RI+α2 appeared to be the most effective combination therapy. However, when considering the limitations of SMDs and certainty of evidence as to the effect, this conclusion might be inappropriate.
Balovaptan vs Placebo for Social Communication in Childhood Autism Spectrum Disorder
This randomized clinical trial investigates if the oral selective vasopressin 1a receptor antagonist, balovaptan, improves socialization and communication difficulties in children and adolescents with autism spectrum disorder.
Enzalutamide Monotherapy vs Active Surveillance in Patients With Low-risk or Intermediate-risk Localized Prostate Cancer
This randomized clinical trial examines the efficacy and safety of enzalutamide monotherapy vs active surveillance in patients with low-risk or intermediate-risk prostate cancer.
Combination Antidepressant Therapy vs Monotherapy—Further Considerations—Reply
In Reply We appreciate the pharmacological and design-related input voiced in the 3 letters. It is an opportunity to clarify and emphasize key aspects of our systematic review and meta-analysis.
Effect of Apatinib Plus PLD vs PLD Alone on Platinum-Resistant Recurrent Ovarian Cancer
This randomized clinical trial examines the efficacy and safety of treatment with apatinib plus pegylated liposomal doxorubicin in Chinese patients with platinum-resistant recurrent ovarian cancer.
Combination Antidepressant Therapy vs Monotherapy—Further Considerations
To the Editor Henssler and colleagues address the important question of whether treatment of depression with a combination of antidepressant medications has greater efficacy than antidepressant monotherapy. They conclude that combination therapy is more effective, particularly when monoamine reuptake inhibitors, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), are combined with medications that antagonize presynaptic α2-adrenoceptors. Included in the latter category are mianserin, mirtazapine, and trazodone. However, I wonder whether trazodone at therapeutic doses does antagonize α2-adrenoceptors. Ligand binding studies of trazodone to human brain α2-adrenoceptors show varying affinities that are nevertheless consistently greater than 100 nm. In addition, Price et al found that treatment of patients with depression with trazodone (mean dose, 346 mg daily) produced little effect on presynaptic α2-adrenoceptor function as judged by neurochemical responses to the α2-adrenoceptor agonist clonidine.