In our current health care climate, it is becoming more common to compare patient outcome benchmarks across institutions and across providers within an institution. The JCAHO is mandating hospitals to…
Contributing Factors To Serious Adverse Outcomes
JCAHO is an accrediting body for hospitals in the United States. As part of the accreditation process, the JCAHO is initiating a new program called ORYX. The goal of the program is to integrate routinely…
An automated drug concentration screening and quality assurance program for clinical trials
The collection and analysis of drug concentration data collected during clinical trials is growing in popularity as a mechanism for explaining variability in patient outcomes.
Efficacy Of Bupropion Sr On Reducing Craving In Smoking Cessation
Bupropion HCl sustained release (Bup SR, ZybanTM) is the first non-nicotine treatment proven to be safe and effective for smoking cessation. Clinical studies have demonstrated that when used in…
Relationship between didanosine exposure and surrogate marker response in human immunodeficiency virus-infected outpatients
We used information available from routine clinic visits to characterize the pharmacokinetics of didanosine in 82 human immunodeficiency virus-infected patients.
Zalcitabine population pharmacokinetics: application of radioimmunoassay
Zalcitabine population pharmacokinetics were evaluated in 44 human immunodeficiency virus-infected patients (39 males and 5 females) in our immunodeficiency clinic.
Dose proportionality of cisatracurium
The dose proportionality of cisatracurium pharmacokinetics was assessed using a population approach by incorporating the collection of sparse...
Implementation of concentration dependent “first-pass” models using NONMEM
The development of drugs extensively metabolized by the P450 enzyme system may require the need to model concentration dependent 'first-pass' effects. This simulation study, performed using NONMEM…
Pharmacoepidemiology: a scientific basis for outcomes research
The discovery of fossils estimated to be about 550 million years old' and later, the interpretation of these fossils, forced a rethinking
Pretreatment regimens for adverse events related to infusion of amphotericin B
Infusion-related adverse events (IRAEs) such as nausea, vomiting, fever, chills, and thrombophlebitis that are associated with amphotericin B therapy often lead clinicians to prescribe a number of adjunctive pretreatment medications...
Adverse drug reaction reporting in a multicenter surveillance study
To evaluate the performance of a multicenter, prospective surveillance program in identifying adverse events, and to seek explanations for misclassification bias.
Sepsis syndrome and associated sequelae in patients at high risk for gram negative sepsis
We conducted a prospective surveillance study of 80 hospitals across the United States to determine the incidence of sepsis syndrome and its associated sequelae in hospitalized patients over age 18 years who...
Analysis of potential risk factors associated with the development of pancreatitis in phase I patients with AIDS or AIDS related complex receiving didanosine
Phase I dose-escalating trials of didanosine revealed dose-limiting toxicities, including pancreatitis, and established a total daily dose of 12.5 mg/kg/day as the maximum tolerated dose.
Risk factors for acute renal insufficiency in patients with suspected or documented bacterial pneumonia
To describe the incidence of acute renal insufficiency and identify potential risk factors associated with this adverse medical event.
Use of antifungal therapy in hospitalized patients. II. Results after the marketing of fluconazole
To evaluate the prescribing patterns of antifungal agents in the hospital setting after the introduction of fluconazole, a new broad-spectrum bis-triazole antifungal agent.
Effects on recovery when isoflurane is used to supplement propofol-nitrous oxide anesthesia
During propofol-nitrous oxide (N2O) anesthesia, volatile anesthetics are frequently administered to treat signs of inadequate anesthesia and to decrease the possibility of intraoperative awareness.
The role of pharmacoepidemiology research in postmarketing surveillance and anesthesia practice critical care medicine
Despite tremendous efforts to ensure the safety and effectiveness of newly marketed medications, a number of these have had significant problems after introduction of the drug to the market.
The initial clinical experience of 1819 physicians in maintaining anesthesia with propofol characteristics associated with prolonged time to awakening
In October 1989, propofol underwent Phase IV Food and Drug Administration testing that involved 25,981 patients, 1722 institutions, and 1819 anesthesiologists. Participants were 18-80 yr of age and ASA physical status I-III...
Hemodynamic effects of propofol: data from over 25,000 patients
To investigate clinically important hypotension and bradycardia after induction of anesthesia with propofol, we analyzed data from a Phase IV stepwise study involving 25,981 patients, 1722 institutions, and 1819 anesthesiologists. In Step 1, propofol was used for...