Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse Event Reporting System.

We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies.

Occurrence of Ascospores and White Mold Caused by Sclerotinia sclerotiorum in Dry Bean Fields in Alberta, Canada.

White mold caused by the fungal pathogen Sclerotinia sclerotiorum (Lib.) de Bary is one of the most important biological constraints to dry bean (Phaseolus vulgaris L.) production in Canada. Disease forecasting is one tool that could help growers manage the disease while reducing fungicide use. However, predicting white mold epidemics has remained difficult due to their sporadic occurrence. In this study, over the course of four growing seasons (2018 to 2021), we surveyed dry bean fields in Alberta and collected daily in-field weather data and daily in-field ascospore counts. White mold levels were variable and generally high in all years, confirming that the disease is ubiquitous and a constant threat to dry bean production. Ascospores were present throughout the growing season, and mean ascospore levels varied by field, month, and year. Models based on in-field weather and ascospore levels were not highly predictive of final disease incidence in a field, suggesting that environment and pathogen presence were not limiting factors to disease development. Rather, significant effects of market class on disease were found, with pinto beans, on average, having the highest disease incidence (33%) followed by great northern (15%), black (10%), red (6%), and yellow (5%). When incidence of these market classes was modeled separately, different environmental variables were important in each model; however, average wind speed was a significant variable in all models. Taken together, these findings suggest that white mold management in dry bean should focus on fungicide use, plant genetics, irrigation management, and other agronomic factors.

Routine hiatal hernia repair in laparoscopic gastric banding.

Laparoscopic gastric banding is now well established as an effective means of obtaining safe, healthy weight loss in the morbidly obese patient population. The procedure has evolved over the years to minimize complications and optimize results. Preoperative patient evaluation includes upper endoscopy to assess the baseline integrity of the stomach and rule out pathology. Upper endoscopy fails to demonstrate the majority of small hiatal hernias in these patients preoperatively. Hiatal hernias are grossly underappreciated in patients with morbid obesity due to the presence of a large distal esophageal fat pad. With post-operative internal weight loss, a small crural defect can become relatively large in a short amount of time. Performing gastric banding without dissecting and repairing the hiatal hernia can lead to incorrect positioning of the gastric band, which is associated with poor weight loss, chronic reflux, and increased complications. Concomitant hiatal hernia repair is felt by the authors to be a necessary component for the correct placement of the gastric band device, which, in turn, provides excellent long-term results to our patients.

Report of the Tennessee Task Force on Screening Newborn Infants for Critical Congenital Heart Disease.

A member of the Tennessee state legislature recently proposed a bill that would mandate all newborn infants to undergo pulse oximetry screening for the purpose of identifying those with critical structural heart disease before discharge home. The Tennessee Task Force on Screening Newborn Infants for Critical Congenital Heart Defects was convened on September 29, 2005. This group reviewed the current medical literature on this topic, as well as data obtained from the Tennessee Department of Health, and debated the merits and potential detriments of a statewide screening program. The estimated incidence of critical congenital heart disease is 170 in 100,000 live births, and of those, 60 in 100,000 infants have ductal-dependent left-sided obstructive lesions with the potential of presentation by shock or death if the diagnosis is missed. Of the latter group, the diagnosis is missed in approximately 9 in 100,000 by fetal ultrasound assessment and discharge examination and might be identified by a screening program. Identification of the missed diagnosis in these infants before discharge could spare many of them death or neurologic sequelae. Four major studies using pulse oximetry screening were analyzed, and when data were restricted to critical left-sided obstructive lesions, sensitivity values of 0% to 50% and false-positive rates of between 0.01% and 12% were found in asymptomatic populations. Because of this variability and other considerations, a meaningful cost/benefit analysis could not be performed. It was the consensus of the task force to provide a recommendation to the legislature that mandatory screening not be implemented at this time. In addition, we determined that a very large, prospective, perhaps multistate study is needed to define the sensitivity and false-positive rates of lower-limb pulse oximetry screening in the asymptomatic newborn population and that there needs to be continued partnering between the medical community, parents, and local, state, and national governments in decisions regarding mandated medical care.

The use of pulse oximetry to detect congenital heart disease.

OBJECTIVE: To evaluate whether pulse oximetry can be used as a screening test to detect congenital heart disease (CHD) in otherwise well newborns before nursery discharge. METHODS: Births at Lakeland Regional Medical Center (LRMC) who met inclusion criteria, had a single pulse oximeter reading before discharge. A normal reading was considered to be >94%. Abnormal readings were repeated on a different extremity and if still abnormal, an echocardiography was performed. The number of children with CHD and the number of echocardiograms were compared with the previous year at LRMC. RESULTS: There were 2114 infants enrolled, 88 echocardiograms (3.8%) were performed, and 43 were abnormal (yield = 48.9%), of which 12 required management (13.6%). The control group consisted of 2851 births, producing 108 echocardiograms (3.8%), 42 of which were abnormal (38.9%), and 13 required management (12.0%). No comparisons were significant. During both years, 3 children with cyanotic CHD were born. Routine pulse oximetry failed to detect a child with total anomalous pulmonary venous return. Not a single normal echocardiogram was generated by the study. CONCLUSION: Routine pulse oximetry was nearly 100% specific for detecting cyanotic CHD; as a result there was no increase in the number of echocardiograms. Routine pulse oximetry did detect a child who might not have been detected otherwise but failed to detect one that should have been detected.