Abstract

During recent months, the Centers for Disease Control and Prevention (CDC) announced the occurrence of three major biosafety incidents, raising serious concern about biosafety and biosecurity guideline implementation in the most prestigious agencies in the United States: the CDC, the National Institutes of Health (NIH) and the Federal Drug Administration (FDA). These lapses included: a) the mishandling of Bacillus anthracis spores potentially exposing dozens of employees to anthrax; b) the shipment of low pathogenic influenza virus unknowingly cross-contaminated with a highly pathogenic strain; and c) an inventory lapse of hundreds of samples of biological agents, including six vials of variola virus kept in a cold storage room for decades, unnoticed. In this review we present the published data on these events, report the CDC inquiry’s main findings, and discuss the key lessons to be learnt to ensure safer scientific practice in biomedical and microbiological service and research laboratories.

Abstract

Background: A single self-rated health (SRH) assessment is associated with clinical outcome and mortality, but the biological process linking SRH with immune status remains incompletely understood.

Objectives: To examine the association between SRH and inflammation in apparently healthy individuals.

Methods: Our analysis included 13,773 apparently healthy individuals attending the Tel Aviv Sourasky Medical Center for periodic health examinations. Estimated marginal means of the inflammation-sensitive biomarkers [i.e., highly sensitive C-reactive protein (hs-CRP) and fibrinogen] for the different SRH groups were calculated and adjusted for multiple potential confounders including risk factors, health behavior, socioeconomic status, and coexistent depression.

Results: The group with the lowest SRH had a significantly higher atherothrombotic profile and significantly higher concentrations of all inflammation-sensitive biomarkers in both genders. Hs-CRP was found to differ significantly between SRH groups in both genders even after gradual adjustments for all potential confounders. Fibrinogen differs significantly according to SRH in males only, with low absolute value differences.

Conclusions: A valid association exists for apparently healthy individuals of both genders between inflammation-sensitive biomarker levels and SRH categories, especially when comparing levels of hs-CRP. Our findings underscore the importance of assessing SRH and treating it like other markers of poor health.

Objectives: To estimate the effect of implementation of a safety checklist in an orthopedic surgical department.

Methods: We conducted a single-center cross-sectional study to compare the incidence of complications prior to and following implementation of the Guidelines for Safe Surgery checklist. The medical records of all consecutive adult patients admitted to the orthopedics department at Wolfson Medical Center during the period 1 July 2008 to 1 January 2009 (control group) and from 1 January 2009 to 1 July 2009 (study group) were reviewed. The occurrences of all complications were compared between the two groups.

Results: The records of 760 patients (380 in each group) hospitalized during this 12 month period were analyzed. Postoperative fever occurred in 5.3% vs. 10.6% of patients with and without the checklist respectively (P = 0.008). Significantly more patients received only postoperative prophylactic antibiotics rather than both pre-and postoperative antibiotic treatment prior to implementation of the checklist (3.2% vs. 0%, P = 0.004). In addition, a statistically non-significant 34% decrease in the rate of surgical wound infection was also detected in the checklist group. In a logistic regression model of postoperative fever, the checklist emerged as a significant independent predictor of this outcome: odds ratio 0.53, 95% confidence interval 0.29–0.96, P = 0.037.

Conclusion: A significant reduction in postoperative fever after the implementation of the surgical safety checklist was found. It is possible that the improved usage of preoperative prophylactic antibiotics may explain the reduction in postoperative fever.

Objectives: To describe the phenotypic and genotypic features in five Bulgarian Jewish patients, from different families, with autosomal dominant OPMD.

Methods: We performed clinical follow-up, electrodiagnostic tests and mutation detection. Blood samples were obtained after informed consent and DNA was extracted; measurement of GCG repeats in both PABPN1 alleles and sequencing of OPMD mutations were performed according to standard techniques.

Results: We identified five patients (four females), aged 58 to 71 years, with bilateral ptosis, dysphagia, dysphonia (n=3) and myopathic motor units by electromyography. In all patients we noticed proximal weakness of the upper limbs with winging scapulae in three of them. All cases shared the (GCG)13-(GCG)10 PABPN1 genotype.

Conclusions: OPMD among Bulgarian Jews is produced by a (GCG)13 expansion, identical to the mutation in Uzbek Jews and French Canadians. In addition to the classical neurological and neuro-ophthalmological features, early shoulder girdle weakness is common in Bulgarian Jewish patients; this is an unusual feature during the early stages of OPMD produced by the same mutation in other populations. We suggest that besides the disease-producing GCG expansion, additional ethnicity-related genetic factors may influence the OPMD phenotype. OPMD is a rare disease, and the identification of five affected families in the rather small Bulgarian Jewish community in Israel probably represents a new cluster; future haplotype studies may elucidate whether a founder effect occurred. 

Methods: In this retrospective multicenter open-label study we examined the efficacy and tolerability of VNS in patients in five adult and pediatric epilepsy centers in Israel. All patients had drug-resistant epilepsy and after VNS implantation in 2006–2007 were followed for a minimum of 18 months. Patients were divided into two age groups: < 21 and > 21 years old.

Results: Fifty-six adults and children had a stimulator implanted in 2006–2007. At 18 months post-VNS implantation, none of the patients was seizure-free, 24.3% reported a reduction in seizures of ≥ 75%, 19% reported a 50–75% reduction, and 10.8% a 25–50% reduction. The best response rate occurred in patients with complex partial seizures. Among these patients, 7 reported a ≥ 75% reduction, 5 patients a 50–75% reduction, 3 patients a 25–50% reduction, and 8 patients a < 25% reduction. A comparison of the two age groups showed a higher reduction in seizure rate in the older group (< 21 years old) than the younger group.

Conclusions: VNS is a relatively effective and safe palliative method for treating refractory epilepsy in both adults and children. It is an alternative treatment for patients with drug-resistant epilepsy, even after a relatively longed disease duration, who are not candidates for localized epilepsy surgery.

Objectives: To review our use of ECMO over a 10 year period.

Methods: All children supported with ECMO from 2000 to 2010 were reviewed. Most of these children suffered from cardiac anomalies. The patients were analyzed by age, weight, procedure, RACHS-1 when appropriate, length of support, and outcome.

Results: Sixty-two children were supported with ECMO; their median age was 3 months (range 0–216 months) and median weight 4.3 kg (range 1.9–51 kg). Thirty-four patients (52.3%) needed additional hemofiltration or dialysis due to renal failure. The children requiring ECMO support represented a wide spectrum of cardiac lesions; the most common procedure was arterial switch operation 27.4% (n=17). ECMO was required mainly for failure to separate from the heart-lung machine (n=55). The median duration of ECMO support was 4 days (range 1–14 days); 29 (46.7%) patients were weaned successfully from ECMO during this time period, and 5 of them died during hospitalization, yielding an overall hospital survival rate of 38.7%.

Conclusions: ECMO support has significant survival benefit for patients with post-cardiotomy heart failure. Its early deployment should be considered in cardiopulmonary resuscitation.

Background: Microvolt T-wave alternans (MTWA) measures subtle beat-to-beat fluctuations in the T-wave amplitude. It was found to be associated with cardiac electrical instability in patients with ischemic and dilated cardiomyopathy.

Objectives: To investigate the reproducibility of the MTWA test results in patients with ischemic heart disease.

Methods: The study group comprised patients with ischemic heart disease who participated in a rehabilitation program at the Assaf Harofeh Medical Center. MTWA was measured during a bicycle exercise test at the first encounter and repeated after one week.

Results: Of the 40 study patients with coronary artery disease, 4 had an indeterminate result and were excluded from the data analysis; 5 had a positive MTWA in the first and second study (14%), 27 had a negative MTWA in the first and second study (75%), and 4 had a negative MTWA in the first study and a positive MTWA in the second study (11%). Overall, there was a correlation between the results of the first and the second study in 89% of the patients (kappa = 0.652, P = 0.0001).

Conclusions: MTWA measurements are reproducible in the short term in patients with coronary artery disease.