Performance of a semi-automated approach for risk estimation using a common data model for longitudinal healthcare databases.

Different structures and coding schemes may limit rapid evaluation of a large pool of potential drug safety signals using multiple longitudinal healthcare databases. To overcome this restriction, a semi-automated approach utilising common data model (CDM) and robust pharmacoepidemiologic methods was developed; however, its performance needed to be evaluated. Twenty-three established drug-safety associations from publications were reproduced in a healthcare claims database and four of these were also repeated in electronic health records.

Development and evaluation of a common data model enabling active drug safety surveillance using disparate healthcare databases.

Objective: Active drug safety surveillance may be enhanced by analysis of multiple observational healthcare databases, including administrative claims and electronic health records. The objective of this study was to develop and evaluate a common data model (CDM) enabling rapid, comparable, systematic analyses across disparate observational data sources to identify and evaluate the effects of medicines.

Design: The CDM uses a person-centric design, with attributes for demographics, drug exposures, and condition occurrence.

Semi-automated risk estimation using large databases: quinolones and Clostridium difficile associated diarrhea.

Purpose: The availability of large databases with person time information and appropriate statistical methods allow for relatively rapid pharmacovigilance analyses. A semi-automated method was used to investigate the effect of fluoroquinolones on the incidence of C. difficile associated diarrhea (CDAD).

Novel statistical tools for monitoring the safety of marketed drugs.

Robust tools for monitoring the safety of marketed therapeutic products are of paramount importance to public health. In recent years, innovative statistical approaches have been developed to screen large post-marketing safety databases for adverse events (AEs) that occur with disproportionate frequency. These methods, known variously as quantitative signal detection, disproportionality analysis, or safety data mining, facilitate the identification of new safety issues or possible harmful effects of a product.

Surfactant replacement for ventilator-associated pneumonia: a preliminary report.

Background: Surfactant abnormalities have been described in bacterial pneumonia.

Objective: To determine the safety and effect of exogenous surfactant replacement in patients with ventilator-associated pneumonia (VAP).

Methods: Patients with VAP were randomized in a double-blind study to receive either an artificial surfactant (Exosurf) consisting mostly of disaturated phospholipids (DSPL) or saline via a continuous nebulizer system for 5 days.

Organized sports for children and preadolescents.

Participation in organized sports provides an opportunity for young people to increase their physical activity and develop physical and social skills. However, when the demands and expectations of organized sports exceed the maturation and readiness of the participant, the positive aspects of participation can be negated. The nature of parental or adult involvement can also influence the degree to which participation in organized sports is a positive experience for preadolescents.

Effects of aerosolized synthetic surfactant, atovaquone, and the combination of these on murine Pneumocystis carinii pneumonia.

An immunosuppressed rat model was used to determine the pharmacokinetics of aerosolized atovaquone (administered with and without a synthetic surfactant) and to evaluate the efficacy of inhaled atovaquone in the prevention and treatment of Pneumocystis carinii pneumonia (PCP). After a single dose by aerosol, mean peak concentrations of atovaquone averaged 52 microg/mL in plasma and 31 microg/g in lungs of rats infected with P. carinii.

The relation of pneumothorax and other air leaks to mortality in the acute respiratory distress syndrome.

Background: In patients with the acute respiratory distress syndrome, pneumothorax and other air leaks - any extrusion of air outside the tracheobronchial tree - have been attributed to high ventilatory pressures or volumes and linked to increased mortality.

Methods: We analyzed data from a prospective trial of aerosolized synthetic surfactant in 725 patients with the acute respiratory distress syndrome induced by sepsis. We compared the ventilatory pressures and volumes in the patients without any air leaks (the highest values during the five-day study) with the pressures and volumes in those with pneumothorax or with any air leaks (the highest values during the 16- and 24-hour periods before the complication developed).

Effects of aerosolized surfactant in patients with stable chronic bronchitis: a prospective randomized controlled trial.

Context: Chronic bronchitis, estimated to affect more than 13 million adults in the United States, is characterized in part by retention of airway secretions, but no approved or effective therapy for airway mucus retention in patients with chronic bronchitis has been established. Surfactant reduces sputum adhesiveness, which contributes to difficulty in clearing secretions, but surfactant has not been tested in patients with chronic bronchitis.

Objective: To examine the effects of exogenous surfactant on sputum clearance and pulmonary function in patients with stable chronic bronchitis.

Changes in the inflammatory response of the lung during acute respiratory distress syndrome: prognostic indicators.

We studied paired bronchoalveolar lavage (BAL) in patients with sepsis-associated acute respiratory distress syndrome (ARDS). Patients were evaluated at one institution and underwent bronchoscopy with BAL within 48 h of the onset of ARDS. Patients were restudied with bronchoscopy and BAL after 4 d of treatment.

Aerosolized surfactant in adults with sepsis-induced acute respiratory distress syndrome. Exosurf Acute Respiratory Distress Syndrome Sepsis Study Group.

Background: Patients with acute respiratory distress syndrome (ARDS) have a deficiency of surfactant. Surfactant replacement improves physiologic function in such patients, and preliminary data suggest that it may improve survival.

Methods: We conducted a prospective, multicenter, double-blind, randomized, placebo-controlled trial involving 725 patients with sepsis-induced ARDS.

Clinical diagnostic criteria of the adult respiratory distress syndrome in the intensive care unit.

Objectives: To determine the use of commonly used diagnostic criteria for adult/acute respiratory distress syndrome (ARDS), evaluate physiologic variables of most value in diagnosing ARDS, and assess the frequency of newly diagnosed ARDS.

Design: Self-administered questionnaire by mail.

Setting: Hospital intensive care units (ICUs).

Safety and potential efficacy of an aerosolized surfactant in human sepsis-induced adult respiratory distress syndrome.

Objective: To evaluate the safety and potential efficacy of aerosolized surfactant in intubated patients with adult respiratory distress syndrome (ARDS).

Design: A prospective, double-blind, placebo-controlled, randomized, parallel, multicenter pilot clinical trial.

Patients: A total of 51 patients with sepsis-induced ARDS were entered into the study within 18 hours of developing sepsis or sepsis syndrome.

Aerosol characteristics of 99mTc-pentetic acid (DTPA) and synthetic surfactant (Exosurf).

This study evaluated the feasibility of using 99mTc-pentetic acid (DTPA) as a radioactive tracer for aerosolized synthetic surfactant (DPPC, cetyl alcohol, tyloxapol). The 99mTc-DTPA was admixed with surfactant and aerosolized using a nebulizer system interfaced to a ventilator with a cascade impactor attached to the endotracheal tube. Particle size distribution for DPPC, cetyl alcohol, and 99mTc-DTPA were almost identical during the 0- to 15-, 15- to 30-, and 0- to 30-min collection periods.

Other uses of surfactant.

Surfactant is found not only in the alveoli but in bronchioles and small airways. Along with its important role in surface-tension reduction in alveoli, surfactant has several other properties. Any condition characterized by mucus abnormality, mucociliary transport deficiency, airway obstruction, or bronchoalveolar collapse could potentially benefit from exogenous surfactant therapy.

Passive smoking and middle ear effusion among children in day care.

One hundred thirty-two children who attended a research day-care center were studied to determine whether passive tobacco smoke exposure was associated with an increased rate of otitis media with effusion or with an increased number of days with otitis media with effusion during the first 3 years of life. Based on preliminary studies, a serum cotinine concentration of greater than or equal to 2.5 ng/mL was considered indicative of exposure to tobacco smoke.

How are pediatric training programs preparing residents for practice?

The majority of pediatric residents continue to choose a career in practice on completion of their training. Despite knowing residents' career preferences, many training programs have focused on inpatient tertiary care at the expense of primary care. Perhaps this reflects service needs and the significant technology and extensive information resulting in the growth of pediatric subspecialties.

Quality of well-being before and after antibiotic treatment of pulmonary exacerbation in patients with cystic fibrosis.

General quality of life has only recently been measured with an objective tool in patients with cystic fibrosis (CF), and there have been no reported attempts to document changes in patients' overall well-being over time, as patients deteriorate or respond to intervention. We applied the Quality of Well-Being scale (QWB) in 28 patients with CF before and after a two-week course of oral ciprofloxacin used to treat pulmonary exacerbations. There were significant correlations between changes in QWB and various pulmonary function test results; QWB vs FEV1: r = 0.

Pulmonary function testing reference values and interpretations in pediatric training programs.

A questionnaire was sent to all pediatric training programs to evaluate the use of pulmonary function reference standards and the interpretation of pulmonary function test results. Responses were obtained from 107 of 130 institutions, and 94 of these had pulmonary function laboratories available. Of the 94, 60 used one of three reference standards.

Negative clinical trials in cystic fibrosis research.

The statistical power of 61 negative clinical trials of therapeutic regimens in patients with cystic fibrosis published from 1977 through 1988 was reviewed and the ability of the investigations to detect small, medium, and large standardized differences was calculated. Small, medium, and large standardized differences were defined as ratios of 0.2, 0.

Longitudinal response of pulmonary function to bronchodilators in cystic fibrosis.

Previous studies have found that between 0 and 95% of patients with cystic fibrosis (CF) have a significant response to bronchodilators. These studies have been limited by small numbers and the measurement of response at one point in time. We analyzed the response to bronchodilators of patients with CF in a longitudinal and cross-sectional manner using pulmonary function data from 1980 to 1988.

Thyroid storm. Presenting with coma and seizures. In a 3-year-old girl.

Thyroid storm is a rare occurrence in the adult population and is even more unusual in children. The current report is of a 3.5-year-old girl who had thyroid storm with unique neurologic manifestations, namely seizure and coma.