METHODS: We performed an observational cohort study in tertiary care hospitals from 14 countries across Asia and Ibero-America. We included patients <5 years old who were admitted to participating pediatric intensive care units (PICUs) with moderate to severe traumatic brain injury (TBI). We performed descriptive analysis and multivariable logistic regression for risk factors of AHT.
RESULTS: 47 (12%) out of 392 patients were diagnosed with AHT. Compared to those with accidental injuries, children with AHT were more frequently < 2 years old (42, 89.4% vs 133, 38.6%, p
METHODOLOGY: Five electronic databases were searched for studies that compared implant outcomes in patients with differing HbA1c values. Research quality was evaluated using Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. Narrative synthesis and meta-analysis were performed for survival rate, plaque index (PI), bleeding on probing (BOP), probing pocket depth, and marginal bone loss (MBL). Categorical dose-response meta-analysis (DRMA) was conducted according to length of follow-up.
RESULTS: Twenty-two studies met the inclusion criteria. Prospective studies were mostly of moderate quality, but non-prospective papers had serious to critical risk of bias. Survival rate was high for the first 3 years (92.6%-100%) for patients with HbA1c less than 8%. Meta-analysis revealed worsening clinical parameters with increasing HbA1c. DRMA further established a significant dose-response relationship between glycemic control with BOP (10% more bleeding, 95% CI 0.05-0.16, P = .008) and MBL (0.05 mm more bone loss, 95% CI 0.01-0.09, P = .002) per HbA1c category, but no association with probing pocket depth. Osseointegration progressed at a slower rate, and inflammatory cytokines and bone biomarkers were adversely affected in patients with HbA1c above 8%.
CONCLUSION: Moderate evidence suggests a high short-term survival but possible dose-response trend of worsening BOP and MBL in association with glycemic control. Clinically, HbA1c values must be considered for risk assessment before placement and throughout the lifespan of the implant placed in a patient with diabetes.
Trial design: Double-blind, counter-balanced, crossover trials were conducted to examine whether tennis performance was affected during menstruation, with and without dehydroepiandrosterone sulfate (DHEA-S) supplementation.
Methods: Ten Division 1 collegiate tennis players (aged 18-22 years) were evenly assigned into placebo-supplemented and DHEA-supplemented (25 mg/day) trials. Treatments were exchanged among the participants after a 28-day washout. Tennis serve performance was assessed on the first day of menstrual bleeding (day 0/28) and on days 7, 14 and 21.
Results: Mood state was unaltered during the menstrual cycles in both trials. The lowest tennis serve performance score (speed times accuracy) occurred on day 14 (P=0.06 vs day 0; P=0.01 vs day 21) in both placebo and DHEA trials. Decreased performance on day 14 was explained by decreased accuracy (P=0.03 vs day 0/28; P=0.01 vs day 21), but not velocity itself. Isometric hip strength, but not quadriceps strength, was moderately lower on day 14 (P=0.08). Increasing plasma DHEA-S (by ~65%) during the DHEA-supplemented trial had no effects on mood state, sleep quality or tennis serve performance.
Conclusion: We have shown that menses does not affect serve performance of collegiate tennis players. However, the observed decrement in the accuracy of serve speed near ovulation warrants further investigation.
PATIENTS AND METHODS: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety.
RESULTS: A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade ≥3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP.
CONCLUSION: These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients with EGFR mutation-positive NSCLC (NCT01342965).