Rationale for a Clinical Trial That Compares Acute Stroke Rehabilitation at Inpatient Rehabilitation Facilities to Skilled Nursing Facilities: Challenges and Opportunities

In the United States, approximately 400,000 patients with acute stroke are discharged annually to inpatient rehabilitation facilities (IRFs) or skilled nursing facilities (SNFs). Typically, IRFs provide time-intensive therapy for an average of 2-3 weeks, whereas SNFs provide more moderately intensive therapy for 4-5 weeks. The factors that influence discharge to an IRF or SNF are multifactorial and poorly understood. The complexity of these factors in combination with subjective clinical indications contributes to large variations in the use of IRFs and SNFs. This has significant financial implications for health care expenditure, given that stroke rehabilitation at IRFs costs approximately double that at SNFs. To control health care spending without compromising outcomes, the Institute of Medicine has stated that policy reforms that promote more efficient use of IRFs and SNFs are critically needed. A major barrier to the formulation of such policies is the highly variable and low-quality evidence for the comparative effectiveness of IRF- vs SNF-based stroke rehabilitation. The current evidence is limited by the inability of observational data to control for residual confounding, which contributes to substantial uncertainty around any magnitude of benefit for IRF- vs SNF-based care. Furthermore, it is unclear which specific patients would receive the most benefit from each setting. A randomized controlled trial addresses these issues, because random treatment allocation facilitates an equitable distribution of measured and unmeasured confounders. We discuss several measurement, practical, and ethical issues of a trial and provide our rationale for design suggestions that overcome some of these issues.     

Effectiveness of aromatherapy with inhaled lavender essential oil and breathing exercises on ECT-related anxiety in depressed patients

Background and aims Electroconvulsive therapy (ECT) is considered a safe, effective, and significant treatment in patients suffering from a major depressive disorder. Anxiety caused by this invasive treatment may impose several side effects on patients. The purpose of this study was to evaluate the effectiveness of aromatherapy with inhaled lavender essential oil and breathing exercises on ECT-related anxiety in depressed patients.Methods In this randomized controlled clinical trial, 90 depressed patients were selected and divided into three groups: aromatherapy, breathing exercise, and routine care using a random allocation method. Before undergoing ECT, the aromatherapy group was exposed to the inhaled lavender essential oil (n = 30), the breathing exercise group performed the breathing exercises (n = 30), and the routine care group received routine care (n = 30). Before (20 min) and after the intervention (30 min later), patients' anxiety was assessed using Beck Anxiety Inventory.Results After the intervention, the results revealed that anxiety score changes were statistically significant among the three groups (p < 0.001). In addition, it was found that the patients’ mean anxiety scores significantly decreased in the aromatherapy and breathing exercise groups compared to with the pre-intervention scores (p < 0.001).Conclusion Aromatherapy with inhaled lavender essential oil and breathing exercises can be considered by clinical nurses as simple, applicable, and effective interventions to reduce ECT-related anxiety in depressed patients.     

Post-traumatic stress disorder,suggestibility, and dissociation related to alleged alien abductions

ObjectivesThousands of people throughout the world are convinced that they have been abducted by aliens. We aimed to assess the emotional reaction to such an implausible event and propose some explanations alternative to severe psychopathology.MethodsA total of 19 individuals who reported memories of having been abducted by aliens were compared to a control group of 32 participants. We employed a battery of tests measuring post-traumatic stress disorder, suggestibility, and dissociation within all participants.ResultsThe abductee group showed higher scores in measures of post-traumatic stress disorders and dissociation, but lower in suggestibility. Nevertheless, these differences were statistically significant only in suggestibility.ConclusionsThe emotional reaction to memories of an implausible experience can be similar to an individual's response to a genuinely traumatic event. Dissociation might be involved in the clarification of some cases. Explanations alternative to psychosis for these testimonies are proposed.     

Alanine transaminase is predominantly increased in the active phase of anti-HMGCR myopathy

Autoantibodies against 3?hydroxy-3-methylglutaryl-CoA reductase (HMGCR) and the signal recognition particle (SRP) are representative antibodies causing immune-mediated necrotizing myopathies (IMNM), called as anti-HMGCR and anti-SRP myopathies, respectively. Here, we analyzed the differences in routine blood test results between 56 anti-HMGCR and 77 anti-SRP myopathy patients. A higher alanine transaminase (ALT) level and a lower aspartate transaminase (AST)/ALT ratio were observed in anti-HMGCR myopathy patients [ALT, 265.7 ± 213.3 U/L (mean ± standard deviation); AST/ALT ratio, 0.88 ± 0.32] than in anti-SRP-myopathy patients (ALT, 179.3 ± 111.2 U/L, p < 0.05; AST/ALT ratio, 1.28 ± 0.40, p < 0.01). In the active phase, anti-HMGCR myopathy often showed ALT predominance, whereas anti-SRP myopathy often showed AST predominance. In addition, there were differences in erythrocyte sedimentation rate (ESR), total cholesterol (TChol) level, and high-density lipoprotein (HDL) level between anti-HMGCR and anti-SRP myopathies (ESR: HMGCR, 24.4 ± 20.8 mm/1 h; SRP, 35.7 ± 26.7 mm/1 h, p = 0.0334; TChol: HMGCR, 226.7 ± 36.6 mg/dL; SRP, 207.6 ± 40.8 mg/dL, p = 0.0163; HDL: HMGCR, 58.4 ± 13.9 mg/dL; SRP, 46.2 ± 17.3 mg/dL, p < 0.01). Additional studies on the differences in routine blood test results may further reveal the pathomechanisms of IMNM.     

Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings

We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 μg [n = 24] and 10 μg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.