9 research outputs found
The value of incorporating avoidable factors into perinatal audits
Objective. To assess whether incorporating a system of identifying, classifying and grading avoidable factors into a perinatal audit can be useful in identifying problem areas.Design. Descriptive study.Setting. Black urban population, Pretoria, South Africa.Subjects. All perinatal deaths of infants weighing more than 1 000 g from urban areas served by Kalafong Hospital between August 1991 and July 1992.Methods. All perinatal deaths were classified according to the primary obstetric cause of death and neonatal cause of death, and whether any avoidable factors were present which could have contributed to the death.Results. The perinatal mortality rate was 26/1 000 deliveries. Avoidable factors occurred in 58% of perinatal deaths. Our problem areas which were immediately remedial were identified as labour management-related problems, administrative problems in obtaining syphilis results, and estimation of fetal weight. Other problem areas which need to be solved are patient education, early attendance at clinics, improved documentation and continuing education of medical personnel.Conclusion. The use of this classification of avoidable factors has enabled the detection of problem areas that can be improved immediately at very little cost
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo
Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. © 2015 Elsevier Inc. All rights reserved