Extended Reality Head-Mounted Displays Are Likely to Pose a Significant Risk in Medical Settings While Current Classification Remains as Non-Critical.

Extended reality (XR) devices, including virtual and augmented reality head-mounted displays (HMDs), are increasingly utilised within healthcare to provide clinical interventions and education. Currently, XR devices are utilised to assist in reducing pain and improving psychological outcomes for immunocompromised patients in intensive care units, palliative care environments and surgical theatres. However, there is a paucity of research on the risks of infection from such devices in healthcare settings. Identify existing literature providing insights into the infection control risk XR HMDs pose within healthcare facilities and the efficacy of current infection control and cleaning procedures. Three databases (PubMed, Embase and CINAHL) in addition to Google Scholar were systematically searched. A total of seven studies were identified for this review. Microorganisms, including pathogenic bacteria (e.g., Staphylococcus aureus and Pseudomonas aeruginosa), were found to be present on XR HMDs. Published cleaning and infection control protocols designed to disinfect XR HMDs and protect users were heterogeneous in nature. Current cleaning protocols displayed varying levels of efficacy with microbial load affected by multiple factors, including time in use, number of users and XR HMD design features. In healthcare settings, fitting XR HMDs harbouring microorganisms near biological and mucosal entry points presents an infection control risk. An urgent revision of the Spaulding classification is required to ensure flexibility that allows for these devices to be reclassified from 'Non-critical' to 'Semi-Critical' depending on the healthcare setting and patient population (surgery, immunocompromised, burns, etc.). This review identified evidence supporting the presence of microorganisms on XR HMDs. Due to the potential for HMDs to contact mucosal entry points, devices must be re-considered within the Spaulding classification as 'Semi-critical'. The existence of microbial contaminated XR HMDs in high-risk medical settings such as operating wards, intensive care units, emergency departments, labour and delivery wards and clinical areas with immunosuppressed patients requires urgent attention. Public health authorities have a duty of care to develop revised guidelines or new recommendations to ensure efficient sanitation of such devices.

Effect of a Standardized Ginger Root Powder Regimen on Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial.

BACKGROUND: There is substantial interest in the role of ginger as an adjuvant therapy for chemotherapy-induced nausea and vomiting (CINV). However, available evidence lacks robust methodology. OBJECTIVE: To assess the effect of adjuvant ginger compared with placebo on chemotherapy-induced nausea-related quality of life (QoL) and CINV-related outcomes. DESIGN: A parallel, double-blind, placebo-controlled randomized trial with 1:1 allocation was conducted. PARTICIPANTS/SETTING: One hundred three chemotherapy-naïve adults scheduled to receive moderately to highly emetogenic chemotherapy at two hospitals in Australia were enrolled and analyzed. INTERVENTION: Four standardized ginger capsules (totaling 84 mg/day active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5 days for chemotherapy cycles 1 through 3. MAIN OUTCOME MEASURES: The primary outcome was chemotherapy-induced nausea-related QoL. Secondary outcomes were vomiting- and CINV-related QoL; anticipatory, acute, and delayed nausea and vomiting; fatigue; nutritional status; depression and anxiety; health-related QoL; and adverse events. STATISTICAL ANALYSES PERFORMED: Intention-to-treat analysis was performed. Mixed analysis of variance with repeated measures determined differences between groups. The null hypothesis was no difference between groups. After applying a Bonferroni multiple testing correction, evidence against the null hypothesis was considered at P= 0.003. RESULTS: One hundred three participants (ginger: n = 52; placebo: n = 51) were enrolled and analyzed. There was clinically relevant evidence against the null hypothesis, favoring ginger, in change scores for nausea-related QoL (F[df] = 9.34[1,101]; P = 0.003; partial η2 = 0.09), overall CINV-related QoL (F[df] = 12.26[1,101]; P < 0.001; partial η2 = 0.11), delayed nausea severity (F[df] = 9.46[1,101]; P = 0.003; partial η2 = 0.09), and fatigue (F[df] = 10.11[1,101]; P = 0.002; partial η2 = 0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycle 2 (53% vs 75%; P = 0.020 and 4% vs 27%; P = 0.001, respectively) and Cycle 3 (49% vs 79%; P = 0.002 and 2% vs 23%; P = 0.001, respectively). There was a clinically meaningful lower incidence of malnutrition in the ginger group at Cycle 3 (18% vs. 41%; P = 0.032) and in change scores for Patient-Generated Subjective Global Assessment (F[df)] = 4.32[1,100]; P = 0.040; partial η2 = 0.04). Change scores between groups favored ginger for vomiting-related QoL and number of vomiting episodes; however, findings were not clinically meaningful. There was no effect of ginger on anticipatory or acute CINV, health-related QoL, anxiety, or depression. No serious adverse events were reported. CONCLUSIONS: Ginger supplementation was a safe adjuvant to antiemetic medications for CINV that enhanced QoL during chemotherapy treatment. Future trials are needed to examine dose-dependent responses to verify optimal dosing regimens.

Renal artery responses to trace amines: Multiple and differential mechanisms of action.

PURPOSE: The rise in consumption of dietary supplements containing the trace amines p-tyramine, p-synephrine and p-octopamine has been associated with cardiovascular side effects. Since renal blood flow plays an important role in blood pressure regulation, this study investigated the mechanisms of action of these trace amines on isolated porcine renal arteries. MAIN METHODS: Contractile responses to amines were investigated in noradrenaline-depleted rings of porcine main renal arteries in the absence and presence of the α1-adrenoceptor antagonist, prazosin (1 µM), ß-adrenoceptor antagonist, propranolol (1 µM), or the trace amine-associated receptor (TAAR-1) antagonist, EPPTB (RO-5212773; 100 nM or 100 µM). KEY FINDINGS: All three amines induced constrictor responses of similar magnitude and potency. However, their mechanisms of action on the renal artery appeared to differ. Depleting endogenous noradrenaline stores significantly reduced maximum responses to tyramine and synephrine, but less for octopamine. When direct responses were examined after depleting tissues of noradrenaline, responses to synephrine and octopamine, but not tyramine, were reduced in the presence of prazosin(1 µM) and potentiated in the presence of propranolol (1 µM) or L-NNA (100 µM). Generally, vasoconstrictor responses remaining after noradrenaline-depletion and α-adrenoceptor blockade were not affected by the TAAR-1 antagonist EPPTB (0.1-100 µM), although responses to low concentration of synephrine and octopamine were enhanced by this antagonist. SIGNIFICANCE: Tyramine appears to mediate constriction of the renal artery mainly via an indirect sympathomimetic mechanism, whereas synephrine and octopamine exert additional direct effects on α1-adrenoceptors and possibly contractile TAAR (not TAAR-1). The two amines also activate simultaneous inhibitory responses via ß-adrenoceptors, TAAR-1 and nitric oxide release.

Racemic synephrine found in Citrus aurantium-listing pre-workout supplements suggests a non-plant-based origin.

Multi-ingredient pre-workout supplements (MIPS) contain Citrus aurantium as a source of bioactive amines such as p-synephrine, but concerns regarding the authenticity of ingredients in some supplements as well as adverse effects from consumption have been raised. R-(-)-Synephrine is the predominant enantiomer in Citrus aurantium extracts while synthetic preparations are often racemic. The aims of this study were to develop a screening method to determine the ratio of synephrine enantiomers in pre-workout supplements listing Citrus aurantium and to assess the ingredient authenticity by directly comparing their ratios to that found in Citrus aurantium standardised reference materials (SRMs). Quantification of enantiomers in the supplements and SRMs was achieved using a validated, high-performance liquid chromatography-single quadrupole mass spectrometry (HPLC-UV-QDa) direct enantioseparation method with a cellobiohydrolase (CBH) column (100 × 4.0 mm, 5 µM) and UV detection at 225 nm. Citrus aurantium SRMs were found to have an average enantiomeric ratio of 94:6 (R:S) with total synephrine ranging from 5.7 to 90.2 mg/g. Within the pilot sample of pre-workout supplements tested, only 42% (5/12) had enantiomeric ratios consistent with the SRMs with total synephrine ranging from 0.03 to 91.2 mg/g. For the remaining supplements, four had racemic ratios of synephrine (0.14 to 5.4 mg/g), two lacked any detectable levels of synephrine, and one had solely the S-(+)-enantiomer (0.15 mg/g). These results bring the authenticity of labelling of some pre-workout supplements into question and highlight the need for more stringent labelling regulations and testing for dietary supplements.

HPLC-UV-QDa analysis of Citrus aurantium-labelled pre-workout supplements suggest only a minority contain the plant extract.

Bitter orange (Citrus aurantium) is a common ingredient in pre-workout supplements with purported weight-loss and performance-enhancing effects. Supplements listing Citrus aurantium or p-synephrine have been associated with reports of adverse cardiovascular events attributed to the active biogenic amines, p-synephrine, p-octopamine or p-tyramine. Additionally, questions have been raised as to the authenticity of the plant-derived active components listed on the supplement labels. The aim of this study was to determine the quantities of these amines in a sample of pre-workout supplements which specifically listed Citrus aurantium, and assess the authenticity of plant material by comparing the ratios of amines found to that found in Citrus aurantium standardized reference materials (SRM). The quantities of amines in the supplements and SRMs were determined using a validated high-performance liquid chromatography-single quadrupole mass spectrometry (HPLC-UV-QDa) method. In the Citrus aurantium SRMs the quantities of trace amines found ranged from 5.30 to 38.00 mg/g (synephrine) 0.14-0.35 mg/g (octopamine) and 0.15-1.90 mg/g (tyramine) with an average ratio of 100:1:5 (synephrine: octopamine: tyramine). Only 42 % (5/12) of the supplements tested had ratios consistent with that found in the SRMs. The average trace amine ratio in those supplements was 100:1:3 while the quantities of trace amines found ranged from 0.35 to 31.31 mg/g (synephrine); 0.005 - 0.10 mg/g (octopamine) and 0.01-1.51 mg/g (tyramine). For the remaining supplements, some did not contain any detectable levels of trace amines or only synephrine was detected with concentrations ranging from 0.003 - 0.95 mg/g. These results suggest a role for authenticity/quality assurance testing of pre-workout supplements and more stringent regulation of pre-workout supplements.

Differential mechanisms of action of the trace amines octopamine, synephrine and tyramine on the porcine coronary and mesenteric artery.

Trace amines such as p-tyramine, p-octopamine and p-synephrine are found in low concentrations in animals and plants. Consumption of pre-workout supplements containing these plant-derived amines has been associated with cardiovascular side effects. The aim of this study was to determine the mechanisms of action of these trace amines on porcine isolated coronary and mesenteric arteries. Noradrenaline caused contraction of mesenteric arteries and relaxation of coronary arteries. In both tissues, all three trace amines induced contractions with similar potencies and responses were unaffected by the ß-adrenoceptor antagonist propranolol (1 µM), the nitric oxide synthase inhibitor L-NNA (100 µM), or the TAAR-1 antagonist, EPPTB (100 nM). However, the contractile responses of mesenteric arteries, but not coronary arteries, were significantly reduced by depletion of endogenous noradrenaline. Mesenteric responses to all three amines were abolished in the presence of prazosin (1 µM) whereas residual contractile responses remained in the coronary artery which were inhibited by a high concentration (100 µM) of EPPTB. The results suggest complex responses of the coronary artery to the trace amines, with activity at α1-adrenoceptors and potentially TAARs other than TAAR-1. In contrast the actions of the amines on the mesenteric artery appeared to involve indirect sympathomimetic actions and direct actions on α1-adrenoceptors.

Robust tests of equivalence for k independent groups.

A common question of interest to researchers in psychology is the equivalence of two or more groups. Failure to reject the null hypothesis of traditional hypothesis tests such as the ANOVA F-test (i.e., H0 : µ(1) = ... = µ(k)) does not imply the equivalence of the population means. Researchers interested in determining the equivalence of k independent groups should apply a one-way test of equivalence (e.g., Wellek, 2003). The goals of this study were to investigate the robustness of the one-way Wellek test of equivalence to violations of homogeneity of variance assumption, and compare the Type I error rates and power of the Wellek test with a heteroscedastic version which was based on the logic of the one-way Welch (1951) F-test. The results indicate that the proposed Wellek-Welch test was insensitive to violations of the homogeneity of variance assumption, whereas the original Wellek test was not appropriate when the population variances were not equal.