The authors conclude that ADEs are not infrequent, often preventable, and usually caused by physician decisions. In this study, solicited reporting by nurses and pharmacists was inferior to chart review for identifying ADEs, but was effective for identifying potential ADEs. Optimal prevention strategies should cover many types of drugs and target physicians' ordering practices.
Context:The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.Objective: To report effectiveness outcomes across 36 weeks of randomized treatment.Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.Interventions: All treatments were administered per protocol.
Main Outcome Measures:The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating ScaleRevised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved.Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time ϫ treatment interaction (P Ͻ .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).
Conclusions:In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.
To investigate the occurrence and outcome of bacteremia associated with otitis media, charts were reviewed from patients who were 3 to 36 months of age, had temperatures ≥39°C, and were diagnosed with isolated clinical otitis media. A total of 2982 patients were identified. Blood cultures were obtained from 1666 (56%). Of the 1666 patients, who had blood drawn for cultures, 50 (3.0%) had bacteremia. These included 39 with Streptococcus pneumoniae, 4 with Haemophilus influenzae, 2 with Neisseria meningitidis, 3 with Salmonella species, and 2 with Staphylococcus aureus. The incidence of bacteremia increased at higher temperatures, being 1.9% at temperatures ≤40°C and 5.0% at temperatures >40°C. Younger children were more likely to have bacteremia; 3.7% ≤12 months of age, 2.4% 13 to 24 months of age, and 1.9% 25 to 36 months of age had blood culture results that were positive (not significant). Reevaluation of the 50 bacteremic patients showed that 9 patients had continued fever, 3 patients had persistent bacteremia, pneumonia developed in 1 patient, and meningitis developed in 1 patient. It was concluded that (1) 3% of young febrile children with otitis media have bacteremia at the time of evaluation, a rate comparable to that previously reported in children with no focus of infection; (2) the incidence of bacteremia increases at higher temperatures; and (3) most febrile children with otitis media do well. The clinician must therefore weigh the potential benefit of drawing a blood culture to identify children at risk for complications against the inherent cost, inconvenience, and discomfort.
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