Preparation of acidic and alkaline macrocapsules for pH control.

A series of experiments was performed to prepare acidic macroencapsulated buffers composed of 20% Ca(H2PO4)(2) and 80% Eudragit S 100 polymer and alkaline macrocapsules composed of 65% K2HPO4 and 35% Eudragit E PO polymer (the powdered form of Eudragit E 100). Eudragit S 100 was shown to be soluble at a pH greater than 7.0, while Eudragit E 100 was soluble at a pH less than 7.

Clinical efficacy of three assays for cardiac troponin I for risk stratification in acute coronary syndromes: a Thrombolysis In Myocardial Infarction (TIMI) 11B Substudy.

Background: Significant analytic variability exists between the multiple assays for cardiac troponin I (cTnI) approved for clinical use. Until adequate cTnI standardization is possible, an evidence-based approach evaluating each assay at specific thresholds appears warranted.

Methods: We examined the efficacy of three cTnI assays for predicting death, myocardial infarction (MI), or the composite of death, MI, or urgent revascularization at 43 days among patients with non-ST-elevation acute coronary syndromes enrolled in the Thrombolysis In Myocardial Infarction (TIMI) 11B study.

Myoglobin, creatine-kinase-MB and cardiac troponin-I 60-minute ratios predict infarct-related artery patency after thrombolysis for acute myocardial infarction: results from the Thrombolysis in Myocardial Infarction study (TIMI) 10B.

Objectives: We examined the diagnostic performance of serum myoglobin, creatine-kinase-MB (CK-MB) and cardiac troponin-I (cTnI) for predicting the infarct-related artery (IRA) patency in patients receiving TNK-tissue plasminogen activator (TNK-tPA) therapy for acute myocardial infarction (AMI) in the Thrombolysis in Myocardial Infarction (TIMI) 10B trial.

Background: A reliable noninvasive serum marker of IRA patency is desired to permit early identification of patients with a patent IRA after thrombolysis.

Methods: We measured myoglobin, CK-MB and cTnI concentrations in sera obtained just before thrombolysis (T0) and 60 min later (T60) in 442 patients given TNK-tPA and who underwent coronary angiography at 60 min.

A randomized trial of a computer-based intervention to reduce utilization of redundant laboratory tests.

Purpose: To determine the impact of giving physicians computerized reminders about apparently redundant clinical laboratory tests.

Subjects And Methods: We performed a prospective randomized controlled trial that included all inpatients at a large teaching hospital during a 15-week period. The intervention consisted of computerized reminders at the time a test was ordered that appeared to be redundant.

Value of additional two-hour myoglobin for the diagnosis of myocardial infarction in the emergency department.

Myoglobin has been described as an early marker of myocardial injury. It increases within 1 to 3 hours of myocardial injury, and falls back to normal early after the event. Few data suggest that myoglobin can be used to triage patients with chest pain.

Cardiac troponin I as a predictor of major cardiac events in emergency department patients with acute chest pain.

Objectives: We sought to evaluate the diagnostic and prognostic value of cardiac troponin I (cTnI) in emergency department (ED) patients with chest pain.

Background: Although cTnI has been shown to correlate with an increased risk for complications in patients with unstable angina, the prognostic significance of this assay in the heterogeneous population of patients who present to the ED with chest pain is unclear.

Methods: cTnI and creatine kinase-MB fraction (CK-MB) mass concentration were collected serially during the first 48 h from onset of symptoms in 1,047 patients > or =30 years old admitted for acute chest pain.

Does the computerized display of charges affect inpatient ancillary test utilization?

Background: The computerized display of charges for ancillary tests in outpatients has been found to affect physician-ordering behavior, but this issue has not been studied in inpatients.

Objective: To assess whether the computerized display of charges for clinical laboratory or radiological tests affected physician-ordering behavior.

Patients And Methods: Two prospective controlled trials, randomized by patient, were performed.

Myoglobin, creatine kinase MB, and cardiac troponin-I to assess reperfusion after thrombolysis for acute myocardial infarction: results from TIMI 10A.

Background: The availability of a reliable, noninvasive serum marker of reperfusion may permit early identification of patients with occlusion after thrombolysis who might benefit from further interventions.

Methods: We measured myoglobin, creatine kinase MB (CK-MB), and cardiac troponin-I (cTnI) concentrations in sera obtained just before thrombolysis (T0) and 60 minutes later (T60) in 30 patients given TNK-tPA for acute myocardial infarction as part of the Thrombolysis in Myocardial Infarction (TIMI) 10A trial.

Results: Angiography at T60 showed reperfusion (TIMI flow grade 2 to 3; n = 19) or occlusion (TIMI flow grade 0 to 1; n = 8).

How fast is fast enough for clinical laboratory turnaround time? Measurement of the interval between result entry and inquiries for reports.

We measured the time interval from result entry by the clinical laboratory to inquiry for reports by clinicians as a proxy for the actual turnaround time required to meet current patient care needs and to determine whether different patterns of report inquiry occur among clinical departments. The study included 4,004 complete blood cell (CBC) count reports that were sought by the clinical services using the hospital information system. The median time to report inquiry was 90 minutes for routine inpatient tests, 35 minutes for stat inpatient tests, and 30 minutes for the stat outpatient CBC counts.

Cardiac-specific troponin I levels to predict the risk of mortality in patients with acute coronary syndromes.

Background: In patients with acute coronary syndromes, it is desirable to identify a sensitive serum marker that is closely related to the degree of myocardial damage, provides prognostic information, and can be measured rapidly. We studied the prognostic value of cardiac troponin I levels in patients with unstable angina or non-Q-wave myocardial infarction.

Methods: In a multicenter study, blood specimens from 1404 symptomatic patients were analyzed for cardiac troponin I, a serum marker not detected in the blood of healthy persons.

Prediction of fetal lung maturity in infants of diabetic mothers using the FLM S/A and disaturated phosphatidylcholine tests.

The authors evaluated the performance of the amniotic fluid surfactant to albumin ratio (FLM S/A), and disaturated phosphatidylcholine (DSPC) tests in assessing fetal lung maturity in infants of mothers with insulin-dependent diabetes mellitus antedating pregnancy. The distribution of the study population (n = 180) by class of diabetes was class B (27%); class C (28%); class D (29%); class F, FR and T (8%); and class R patients (8%). The diagnosis of respiratory distress syndrome (RDS) was the standard for evaluating the performance of FLM S/A and DSPC.

Clinical laboratory test findings in patients with chronic fatigue syndrome.

Background: Results of readily available clinical laboratory tests in patients with chronic fatigue syndrome were compared with results in healthy control subjects.

Methods: Cases consisted of all 579 patients who met either the Centers for Disease Control and Prevention, Atlanta, Ga, British, or Australian case definition for chronic fatigue syndrome. They were from chronic fatigue clinics in Boston, Mass, and Seattle, Wash.

Total serum calcium reference intervals in postmenopausal outpatients.

The distribution of values of serum calcium has been studied in the following four outpatient populations: premenopausal (n = 411) and postmenopausal women (n = 399), men less than 50 years old (n = 365) and men over 55 years old (n = 361). Their respective average total serum calcium values (mg/dl) were 9.42, 9.

A predictive model for fetal lung maturity employing gestational age and test results.

Most laboratory tests for fetal lung maturity (FLM) are optimized to exclude false-negative predictions of absence of respiratory distress syndrome (RDS), with a reciprocal low predictive value for maturity. The authors employed FLM Surfactant/Albumin Ratio (FLM S/A) test results to construct a predictive model for FLM that included the obstetric estimates of gestational age. The charts of 388 newborns were abstracted and reviewed.

The fiscal consequences of central vs distributed testing of glucose.

We have compared the operational, medical, and fiscal consequences of performing urgent glucose testing at the bedside vs in the central laboratory. The turnaround time (TAT) with bedside testing was only 1-2 min shorter than that from the central laboratory, to which specimens are sent by pneumatic tube and from which results are automatically broadcast by computer to the originating site. No significant adverse medical outcomes were associated with this difference in TAT.

Quantification of medical and operational factors determining central versus satellite laboratory testing of blood gases.

Blood gas measurements performed at the central laboratory and at a satellite laboratory of Brigham and Women's Hospital were studied to determine the differences in quality, turnaround time (TAT), and cost. The quality in both laboratories, as determined by results on proficiency and quality control samples, satisfactorily met current standards for patient care. The central laboratory receives specimens for blood gas measurements through a pneumatic tube system and broadcasts results to computer terminals at the originating site, with a mean TAT of 6 minutes.

Cost savings in a hospital clinical laboratory with a pay-for-performance incentive program for supervisors.

A pay-for-performance incentive program for clinical laboratory supervisors was developed and implemented at Brigham and Women's Hospital (Boston, Mass). It provides monetary rewards to personnel who directly produce cost savings in their area of responsibility. This reward system is new to the hospital laboratory but is commonly used in industry.

Determination of ionized calcium in serum that has been exposed to air.

We examined changes in ionized calcium concentration in serum after its exposure to air. Samples with total protein concentrations ranging from 50 to 90 g/liter were equilibrated with CO2 in nitrogen (5/95, by vol) or CO2 alone, to produce pH values of 7.0 to 8.