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Biomedical subjects

Paul A Gluck

Publications and source records attributed to Paul A Gluck.

8 recordsLinked to original sources
PubMed2007

Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery. METHODS: A cluster-randomized controlled trial was conducted at seven intervention and eight control hospitals. The intervention was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at 20 weeks or more of gestation in which one or more adverse maternal or neonatal outcomes or both occurred (Adverse Outcome Index). Additional outcomes included 11 clinical process measures. RESULTS: A total of 1,307 personnel were trained and 28,536 deliveries analyzed. At baseline, there were no differences in demographic or delivery characteristics between the groups. The mean Adverse Outcome Index prevalence was similar in the control and intervention groups, both at baseline and after implementation of teamwork training (9.4% versus 9.0% and 7.2% versus 8.3%, respectively). The intracluster correlation coefficient was 0.015, with a resultant wide confidence interval for the difference in mean Adverse Outcome Index between groups (-5.6% to 3.2%). One process measure, the time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes versus 21.2 minutes, P=.03). CONCLUSION: Training, as was conducted and implemented, did not transfer to a detectable impact in this study. The Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00381056 LEVEL OF EVIDENCE: I.

Delivery, Obstetric↗
PubMed2006

The effect of pregnancy on the course of asthma.

The course of asthma is changed by pregnancy in variable ways for unknown reasons. Although the prospective studies used different criteria to stratify the severity of the patients' asthma, their conclusions were remarkably similar. Over-all, an equal number of women have asthma symptoms that improve, worsen, or are unchanged through pregnancy. Asthma symptoms can worsen during pregnancy because of identifiable factors, such as infection, gastroesophageal re-flux disease, reduction of appropriate medications by physician or patient, and smoking. Undertreatment, which remains a problem during pregnancy, can lead to continued difficulty with asthma. Severe asthmatics tend to have increased symptoms compared with mild asthmatics. If symptoms worsen, it usually occurs in the second and third trimesters, with the peak in the sixth month. Generally, there is improvement in asthma in the last 4 weeks of pregnancy. During labor and delivery, only 10% to 20% of asthmatics have symptoms;severe asthmatics are more likely to have exacerbations. Asthma tends to return to the prepregnancy state within 3 months post partum. Successive pregnancies tend to have a similar course in each individual. Every asthmatic woman should be maintained on appropriate medications and followed carefully throughout pregnancy, especially in the second and third trimesters. Asthma specialists should be available for collaborative care when asthma is uncontrolled, or if there is an exacerbation. A timely adjustment in treatment for any changes in asthma course that might occur ensures the best control of the disease in the face of complex multiple influences.

Asthma↗
PubMed2005

Asthma controller therapy during pregnancy.

OBJECTIVE: This study was undertaken to educate physicians on the safety of asthma controller use during pregnancy. STUDY DESIGN: A comprehensive literature search using MEDLINE, the Cochrane Controlled Trials Register and Database of Systematic Reviews, EMBASE, and selected bibliographies identified human gestational studies of asthma controller medications from which maternal and fetal outcomes were obtained. The US Food and Drug Administration (FDA) pregnancy category ratings were identified from product package inserts. RESULTS: Human gestational studies were identified for the inhaled corticosteroids (ICSs) beclomethasone, budesonide, and triamcinolone and for cromolyn sodium, theophylline, and salmeterol. Human pregnancy data support an FDA Pregnancy Category B rating for budesonide. Pregnancy Category B ratings for cromolyn, nedocromil, montelukast, and zafirlukast are based primarily on safety in animal reproduction studies. ICSs other than budesonide, theophylline, zileuton, and long-acting beta 2 -adrenergic agonists are Pregnancy Category C. CONCLUSION: Human pregnancy data for many asthma controllers are lacking; nonetheless, data support a range of choices among medications rated Pregnancy Category B.

Abnormalities, Drug-Induced↗
PubMed2005

A review of pregnancy outcomes after exposure to orally inhaled or intranasal budesonide.

BACKGROUND: Inadequately controlled rhinitis is associated with worsening asthma, one of the most common potentially serious causes of pregnancy complications. Recent evidence-based guidelines now stress the importance of inhaled corticosteroids as first-line therapy in controlling asthma during pregnancy, with preference given to budesonide. Both inhaled and intranasal budesonide formulations are rated Pregnancy Category B; all other inhaled and intranasal corticosteroids are rated Pregnancy Category C. OBJECTIVE: To review data from clinical and epidemiological studies investigating the effects of orally inhaled or intranasal budesonide on pregnancy outcomes. METHODS: Clinical and epidemiological studies on the effects of maternal exposure to orally inhaled or intranasal budesonide were identified through searches of the literature indexed on Medline or the Developmental and Reproductive Toxicology (DART) database through January 2005. The search terms used were: 'budesonide' and 'pregnancy'; 'pregnancy complications'; 'teratogens'; 'fetus'; 'embryo'; or 'toxicology'. The search was limited to English-language articles and those evaluating humans. Pertinent abstracts were identified from recent US asthma and allergy meetings. RESULTS: A total of five articles and three abstracts meeting the search criteria were identified. Retrospective epidemiological studies and a randomized, placebo-controlled, multicenter trial found no clinically or statistically significant effects on fetal outcomes among more than 6600 infants whose mothers were exposed to orally inhaled budesonide during pregnancy. Women who reported use of orally inhaled budesonide either during early pregnancy only or throughout pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths, multiple births, or congenital malformations. In a retrospective case-control analysis, no association was found between inhaled budesonide or intranasal budesonide and the overall rate of infant cardiovascular defects. However, a marginally increased risk of less severe cardiovascular defects (odds ratio = 1.58, 95% confidence interval 1.02 to 2.46) was observed with intranasal budesonide in one analysis, possibly the result of a random association due to multiple testing or an unidentified confounder. CONCLUSION: Maternal exposure to orally inhaled budesonide during pregnancy is not associated with an increased risk of congenital malformations or other adverse fetal outcomes in studies of more than 6600 infants. Data on pregnancy outcomes after maternal exposure to intranasal budesonide are limited, but the totality of evidence, including pharmacological studies showing a much lower systemic exposure after intranasal administration, indicates its safety profile is at least comparable with that of orally inhaled budesonide.

Abnormalities, Drug-Induced↗
PubMed2003

Peer review in obstetrics and gynecology by a national medical specialty society.

BACKGROUND: Since 1986 the American College of Obstetricians and Gynecologists (ACOG) has offered a voluntary consultation service (Voluntary Review of Quality of Care [VRQC] program) to assist departments of obstetrics and gynecology in assessing their quality of care. HOW THE VQRC PROGRAM WORKS: The VRQC program review team selects three to five topics for on-site medical record review to further investigate the care processes that may contribute to the perceived problems. Each chart is evaluated by a single reviewer with the use of worksheets with explicit, objective criteria that represent practice guidelines. In addition, key departmental and hospital personnel are interviewed on site to provide insight into the issues that prompted the request. EVALUATION OF THE VRQC PROGRAM: The first 100 site visits took place in 29 states and represented a diverse geographic cohort of hospital departments of obstetrics and gynecology. Overall departmental and systemic deficiencies were significantly more common than clinical concerns. Obstetric issues were more prevalent than gynecologic issues. Induction and augmentation of labor was the most common deficiency, and the availability and quality of obstetric anesthesia was the second. CONCLUSION: The VRQC program, as a voluntary consultative peer review program, addresses hospital-specific quality problems and also identifies common deficiencies across a diverse group of hospitals, which may warrant continuing education.

Consultants↗