Rationale and Design of an International Multicenter Registry of Patients With Repaired Tetralogy of Fallot to Define Risk Factors for Late Adverse Outcomes: The INDICATOR Cohort

Although early survival after tetralogy of Fallot (TOF) repair in the modern era is excellent, studies on late outcomes have shown increasing rates of mortality and morbidity. Despite multiple publications on factors associated with late complications, risk factors for major outcomes (death and sustained ventricular tachycardia [VT]) remain poorly defined. Consequently, the International Multicenter TOF Registry (INDICATOR) was established. This article describes the development, structure, and goals of this registry and characterizes the initial cohort derived from four large congenital heart centers in the United States, Canada, and Europe. A data coordinating center with a core cardiac magnetic resonance (CMR) laboratory and statistical core was established. Subjects with repaired TOF who had CMR imaging performed between 1997 and 2010 and ≥1 year follow-up were included. Clinical end points were death and sustained VT. Demographic, electrophysiologic, exercise, and outcome data were collected. A total of 873 subjects fulfilled inclusion criteria (median age at repair 2.9 years and at CMR imaging 22.8 years). Of these, 9 % had QRS duration >180 ms on electrocardiogram (ECG). On CMR imaging, 38 % had severe right-ventricular (RV) dilatation (≥160 mL/m²), and 6 % had severe RV dysfunction (ejection fraction < 35 %). Of the 551 subjects with exercise testing available, 28 % had severely decreased exercise capacity with <50 % predicted peak oxygen consumption. The INDICATOR cohort allows robust statistical analysis to evaluate major clinical outcomes in patients with repaired TOF. Continued follow-up and further expansion of the registry may provide new insights into innovative therapeutic strategies to improve late outcomes.     

Examining Insomnia and PTSD Over Time in Veterans in Residential Treatment for Substance Use Disorders and PTSD

Objective/Background: Insomnia occurs in 66–90% of individuals with posttraumatic stress disorder (PTSD) and 36–72% of individuals with substance use disorder (SUD). Individuals with both PTSD and SUD are more likely to have insomnia than individuals with only one disorder. Insomnia is associated with poorer treatment outcomes for both PTSD and SUD, increased daytime symptomology for PTSD, and increased relapse for SUDs. As such, it is important to understand how sleep affects PTSD treatment among patients dually diagnosed with SUD and how sleep changes over time in a residential unit for SUDs. Participants: Participants were 40 veterans with comorbid PTSD and SUD in a 28-day Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) PTSD track. Methods: Analyses used mixed models with Time (baseline, posttreatment, 3-month follow-up) to examine PTSD and insomnia severity over time. Results: Results of the longitudinal mixed model showed that PTSD symptoms improved over time but that insomnia symptoms did not. Although baseline insomnia did not affect follow-up PTSD symptoms, individuals with greater insomnia severity at the start of treatment had more severe baseline PTSD symptomatology. However, there was not an interaction of insomnia and PTSD severity over time such that baseline insomnia did not affect PTSD trajectories. Conclusions: These findings are consistent with the PTSD outpatient treatment findings and further adds evidence that insomnia is unremitting without direct intervention. Given the relationship insomnia has with PTSD severity, SUD, and relapse, directly targeting insomnia may further help improve both PTSD and SUD treatment outcomes.     

Cleaning frequency and the microbial load in ice-cream

This study investigates the efficacy of a 62 h cleaning frequency in the manufacturing of ice-cream. Various product and product contact surfaces were sampled progressively throughout the time period between cleaning cycles, and analyzed for microbial growth. The coliform and standard plate counts (SPC) of these samples did not vary significantly over time after 0, 24, 48, or 62 h from Cleaning in Place (CiP). Data for product contact surfaces were significant for the SPC representing sample locations. Some of the variables in cleaning practices had significant influence on microbial loads. An increase in the number of flavors manufactured caused a decrease in SPC within the 24 h interval, but by the 48 h interval the SPC increased. More washouts within the first 24 h interval were favorable, as indicated by decreased SPC. The more frequently the liquefier was sanitized within the 62 h interval, the lower the SPC. This study indicates that food safety was not compromised and safety practices were effectively implemented throughout the process.     

Profile of a leader: unearthing Ethel Johns's "buried" commitment to racial equality, 1925

In 1925, Canadian nurse leader Ethel Johns was hired by the Rockefeller Foundation to study the status of black women in nursing in the United States. Despite the acknowledged excellence of her report, the study was shelved. It remained "buried" in the basement of the Rockefeller headquarters for almost 60 years until American historian Darlene Clark Hine discovered it there in the 1980s. The aim of this article is to extend current understandings of Johns based on this and other evidence not accessible to her biographer in 1973. The discussion will illuminate her commitment to social equality by highlighting the 1925 report that perceived and articulated the racist character of relations between white institutions and black nurses in an era when few others would do so. It seems vital that this study be recognized as a focal point in Johns's outstanding nursing career, and that her success in leadership be acknowledged as inextricably linked with her passion for justice and equality.     

Non-small cell lung cancer: from cytotoxic systemic chemotherapy to molecularly targeted therapy

Surgery is the only method of cure in lung cancer. Seldom its application with radical intent is possible. Despite the efforts aimed at integrating all the therapeutic strategies, the overall outcome of the management of this disease remains disappointing. For this reason, in the last three decades, thousands of preclinical and clinical attempts have been realised in order to investigate any possible way to cure this disease and significant steps forward have been made on the basis of the increasing "molecular knowledge" in the so called "post-genomic era". Particularly the impressive step forward in the biological characterization of cancer as a result of genetic/epigenetic multistep process has brought in a multitude of variables with staggering classification potentialities. "Benchside" and "bedside" scientists have assembled in functional teams to move the common efforts "translationally" to bridge basic and clinical research for a mutual synergistic enhancement. This paper represents the effort of a lung cancer focused translational research team made up of molecular biologists, medical oncologists and thoracic surgeons to achieve a comprehensive, but simple, review of the current status of the shift from cytotoxic to molecularly targeted therapy in lung cancer treatment potentially useful in the planning of translational research trials.     

The Dlx5 homeodomain gene is essential for olfactory development and connectivity in the mouse

The distalless-related homeogene Dlx5 is expressed in the olfactory placodes and derived tissues and in the anterior-basal forebrain. We investigated the role of Dlx5 in olfactory development. In Dlx5(-/-) mice, the olfactory bulbs (OBs) lack glomeruli, exhibit disorganized cellular layers, and show reduced numbers of TH- and GAD67-positive neurons. The olfactory epithelium in Dlx5(-/-) mice is composed of olfactory receptor neurons (ORNs) that appear identical to wild-type ORNs, but their axons fail to contact the OBs. We transplanted Dlx5(-/-) OBs into a wild-type newborn mouse; wild-type ORN axons enter the mutant OB and form glomeruli, but cannot rescue the lamination defect or the expression of TH and GAD67. Thus, the absence of Dlx5 in the OB does not per se prevent ORN axon ingrowth. In conclusion, Dlx5 plays major roles in the connectivity of ORN axons and in the differentiation of OB interneurons.     

Informed consent in functional endoscopic sinus surgery

OBJECTIVES: Functional endoscopic sinus surgery (FESS) is one of the more common procedures performed by otolaryngologists. Before performing FESS, surgeons are obligated to discuss the procedure and its risks through the process of informed patient consent. The study identifies current practices in informed consent for FESS and formulates guidelines for informed consent for FESS. STUDY DESIGN: Survey. METHODS: Surveys were sent to 1000 American Academy of Otolaryngology-Head and Neck Surgery members in the United States. Surveys inquired about current informed consent practices related to FESS. RESULTS: Three hundred forty-six surveys were returned. Nearly 60% of respondents thought that 1% incidence of a complication warrants a discussion with patients. The percentage of respondents who discuss specific risks were as follows: bleeding, 96.7%; infection, 84.8%; cerebrospinal fluid leak, 99.1%; orbital injury, 96.7%; smell changes, 40.2%; cerebrovascular accident, 17.9%; myocardial infarction, 81%; and death, 28.0%. CONCLUSIONS: The study suggests that there is variability in specific informed consent practices for FESS among otolaryngologists. It also suggests that the incidence or severity of a complication does not necessarily correlate with whether or not it is mentioned during the informed consent process. The authors think that practicing otolaryngologists may be able to use this information to improve their consent practices.     

Popliteal aneurysm as a source of phantom pain: a case report

A 42-year-old man with a remote history of right transtibial amputation but no history of phantom pain developed severe phantom pain 10 years after amputation. A literature review suggested that his presentation was contrary to the natural history of phantom pain, which is usually most prominent in the early stages after amputation. Diagnostic workup revealed a popliteal artery aneurysm, which was successfully treated with coil embolization. The patient had complete resolution of his phantom pain after treatment of the aneurysm, suggesting it was the source of the pain. As a result of successful diagnosis and treatment, the amputation level did not need to be revised and the patient was able to continue his previously high level of function.