Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Trans-Pacific tele-ultrasound image transmission of fetal central nervous system structures

Objective: To assess the quality of images and video clips of fetal central nervous (CNS) structures obtained by ultrasound and transmitted via tele-ultrasound from Brazil to Australia.

Methods: In this cross-sectional study, 15 normal singleton pregnant women between 20 and 26 weeks were selected. Fetal CNS structures were obtained by images and video clips. The exams were transmitted in real-time using a broadband internet and an inexpensive video streaming device. Four blinded examiners evaluated the quality of the exams using the Likert scale. We calculated the mean, standard deviation, mean difference, and p values were obtained from paired t tests.

Results: The quality of the original video clips was slightly better than that observed by the transmitted video clips; mean difference considering all observers = 0.23 points. In 47/60 comparisons (78.3%; 95% CI?=?66.4–86.9%) the quality of the video clips were judged to be the same. In 182/240 still images (75.8%; 95% CI?=?70.0–80.8%) the scores of transmitted image were considered the same as the original.

Conclusion: We demonstrated that long distance tele-ultrasound transmission of fetal CNS structures using an inexpensive video streaming device provided images of subjective good quality.     

Patient Involvement: A New Source of Stress in Health Care Work?

Patients have become increasingly well informed with higher expectations to be involved in decision-making processes regarding their care and treatment. However, few studies have examined the impact of patient involvement on health care providers’ partnership-building communication. The aim of this study was to measure and explore the self-reported effects of patient involvement on the work of physicians and nurses. A questionnaire survey was distributed among cardiology staff in 12 Swedish hospitals (N = 488, response rate 67%). The sample was comprised of registered nurses (RNs, n = 303), licensed practical nurses (LPNs, n = 132), and physicians (MDs, n = 53). Confirmatory factor analysis was used to examine seven questionnaire statements concerning implications of patient involvement for one’s clinical work. Regression analyses were used to examine factors associated with staff’s partnership-building communication. Analysis confirmed two distinct factors accounting for 57% of the total variance, representing both negative—“Hassles”—and positive—“Uplifts”—aspects of patient involvement. Regression analyses revealed that only positive aspects (i.e., uplifts) of patient involvement predicted staff behavior aimed at involving patients. Working with actively involved patients may be a source of stress, both negative and positive, for health care professionals. By developing work routines for involving patients in their care, health care workplaces may help health care professionals to buffer the negative effects, and enhance the positive effects, of that stress.     

Ebola Virus RNA Stability in Human Blood and Urine in West Africa’s Environmental Conditions

We evaluated RNA stability of Ebola virus in EDTA blood and urine samples collected from infected patients and stored in West Africa’s environmental conditions. In blood, RNA was stable for at least 18 days when initial cycle threshold values were <30, but in urine, RNA degradation occurred more quickly.     

MRI T2-Hyperintense Signal Structures in the Cervical Spinal Cord: Anterior Median Fissure versus Central Canal in Chiari and Control—An Exploratory Pilot Analysis

BACKGROUND AND PURPOSE:Cervical spine axial MRI T2-hyperintense fluid signal of the anterior median fissure and round hyperintense foci resembling either the central canal or base of the anterior median fissure are associated with a craniocaudad sagittal line, also simulating the central canal. On the basis of empiric observation, we hypothesized that hyperintense foci, the anterior median fissure, and the sagittal line are seen more frequently in patients with Chiari malformation type I, and the sagittal line may be the base of the anterior median fissure in some patients.MATERIALS AND METHODS:Saggital line incidence and the incidence/frequency of hyperintense foci and anterior median fissure in 25 patients with Chiari I malformation and 25 contemporaneous age-matched controls were recorded in this prospective exploratory study as either combined (hyperintense foci+anterior median fissure in the same patient), connected (anterior median fissure extending to and appearing to be connected with hyperintense foci), or alone as hyperintense foci or an anterior median fissure. Hyperintense foci and anterior median fissure/patient, hyperintense foci/anterior median fissure ratios, and anterior median fissure extending to and appearing to be connected with hyperintense foci were compared in all, in hyperintense foci+anterior median fissure in the same patient, and in anterior median fissure extending to and appearing to be connected with hyperintense foci in patients with Chiari I malformation and controls.RESULTS:Increased sagittal line incidence (56%), hyperintense foci (8.5/patient), and anterior median fissure (4.0/patient) frequency were identified in patients with Chiari I malformation versus controls (28%, 3.9/patient, and 2.7/patient, respectively). Increased anterior median fissure/patient, decreasing hyperintense foci/anterior median fissure ratio, and increasing anterior median fissure extending to and appearing to be connected with hyperintense foci/patient were identified in Chiari subgroups. A 21%–58% increase in observed anterior median fissure extending to and appearing connected to hyperintense foci in the entire cohort and multiple sagittal line subgroups compared with predicted occurred.CONCLUSIONS:In addition to the anticipated increased incidence/frequency of sagittal line and hyperintense foci in patients with Chiari I malformation, an increased incidence and frequency of anterior median fissure and anterior median fissure extending to and appearing to be connected with hyperintense foci/patient were identified. We believe an anterior median fissure may contribute to a saggital line appearance in some patients with Chiari I malformation. While thin saggital line channels are usually ascribed to the central canal, we believe some may be due to the base of the anterior median fissure, created by pulsatile CSF hydrodynamics.

Axial MR imaging of the cervical spine frequently demonstrates hyperintense, linear, anatomically, sagittally-oriented T2 fluid signal of the anterior median fissure (AMF) and hyperintense foci (HIF) resembling the central canal or the base of the AMF.^1-3 These axial T2 findings may be associated with a channel-like T2-hyperintense craniocaudad line on images parallel to the sagittal plane (a sagittal line [SL]), simulating the central canal (Fig 1).^4,5 A previous analysis of HIF, AMF, and a thin SL in a population without Chiari I malformation provided not only a baseline for their identification but also a confirmation of a relationship between not only the AMF and HIF but also their relationship to the SL.¹ It found the following:

1. HIF were greater in number than AMFs, but AMFs increase in the presence of increasing HIF, suggesting an anatomic relationship.
2. SLs were associated with greater numbers of both HIF and AMF/patient (pt.) versus no SL, 6.7 versus 2.7/pt. and 3.3 versus 2.0/pt., respectively. SL presence correlated more closely to HIF than to AMF presence within the entire 358-patient group.
3. When HIF and AMF were classified as combined (concurrent HIF and AMF, with ≥1 of each both present in the same patient [HIF+AMF]) or continuous (AMF appearing to extend to and join an HIF [AMF>HIF]), HIF and AMF/pt. each differed numerically and patients with an SL had more combined HIF+AMF and continuous AMF>HIF than patients without an SL.
4. In patients with both SL and combined HIF+AMF (a circumstance allowing the possibility of a relationship of all 3 structures), HIF become proportionally fewer compared with AMFs. In patients with an SL actually exhibiting continuous AMF>HIF, the HIF/AMF ratio decreased further.

Open in a separate windowFIG 1.A patient with Chiari I with 19 HIF up to 3 mm in diameter, 1 AMF, no AMF>HIF, and an SL of various hyperintensity and diameter from C4 through T1, consistent with hydromyelia.While it is expected that manifestations of the central canal as an SL and HIF are more frequent in patients with Chiari syndrome type I,⁶ past experience leads us to hypothesize that AMFs are also seen more frequently in patients with Chiari I malformation and that the SL or channel may represent the base of a wide AMF, rather than the central canal, in some patients (Figs 1 and ​and2).2). Therefore, we performed an exploratory prospective analysis of HIF, AMF, and SL in patients with Chiari I malformation to examine their relationships.Open in a separate windowFIG 2.Postdecompressive craniectomy patient with Chiari I with 9 HIF, 4 AMFs, 1 AMF>HIF, and sharp and hyperintense SLs at C6–C7 and less hyperintense, sharp, and defined SLs at C2–C6.