Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia.

BACKGROUND: Coronavirus disease 2019 (Covid-19) pneumonia is often associated with hyperinflammation. Despite the disproportionate incidence of Covid-19 among underserved and racial and ethnic minority populations, the safety and efficacy of the anti-interleukin-6 receptor antibody tocilizumab in patients from these populations who are hospitalized with Covid-19 pneumonia are unclear. METHODS: We randomly assigned (in a 2:1 ratio) patients hospitalized with Covid-19 pneumonia who were not receiving mechanical ventilation to receive standard care plus one or two doses of either tocilizumab (8 mg per kilogram of body weight intravenously) or placebo. Site selection was focused on the inclusion of sites enrolling high-risk and minority populations. The primary outcome was mechanical ventilation or death by day 28. RESULTS: A total of 389 patients underwent randomization, and the modified intention-to-treat population included 249 patients in the tocilizumab group and 128 patients in the placebo group; 56.0% were Hispanic or Latino, 14.9% were Black, 12.7% were American Indian or Alaska Native, 12.7% were non-Hispanic White, and 3.7% were of other or unknown race or ethnic group. The cumulative percentage of patients who had received mechanical ventilation or who had died by day 28 was 12.0% (95% confidence interval [CI], 8.5 to 16.9) in the tocilizumab group and 19.3% (95% CI, 13.3 to 27.4) in the placebo group (hazard ratio for mechanical ventilation or death, 0.56; 95% CI, 0.33 to 0.97; P = 0.04 by the log-rank test). Clinical failure as assessed in a time-to-event analysis favored tocilizumab over placebo (hazard ratio, 0.55; 95% CI, 0.33 to 0.93). Death from any cause by day 28 occurred in 10.4% of the patients in the tocilizumab group and 8.6% of those in the placebo group (weighted difference, 2.0 percentage points; 95% CI, -5.2 to 7.8). In the safety population, serious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group. CONCLUSIONS: In hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival. No new safety signals were identified. (Funded by Genentech; EMPACTA ClinicalTrials.gov number, NCT04372186.).

Incidence of Norovirus and Other Viral Pathogens That Cause Acute Gastroenteritis (AGE) among Kaiser Permanente Member Populations in the United States, 2012-2013.

Noroviruses and other viral pathogens are increasingly recognized as frequent causes of acute gastroenteritis (AGE). However, few laboratory-based data are available on the incidence of AGE caused by viral pathogens in the U.S. This study examined stool specimens submitted for routine clinical diagnostics from patients enrolled in Kaiser Permanente (KP) health plans in metro Portland, OR, and the Maryland, District of Columbia, and northern Virginia geographic areas to estimate the incidence of viral enteropathogens in these populations. Over a one-year study period, participating laboratories randomly selected stools submitted for routine clinical diagnostics for inclusion in the study along with accompanying demographic and clinical data. Selected stools were tested for norovirus, rotavirus, sapovirus, and astrovirus using standardized real-time RT-PCR protocols. Each KP site provided administrative data which were used in conjunction with previously published data on healthcare utilization to extrapolate pathogen detection rates into population-based incidence rates. A total of 1,099 specimens collected during August 2012 to September 2013 were included. Mean age of patients providing stool specimens was 46 years (range: 0-98 years). Noroviruses were the most common viral pathogen identified among patients with AGE (n = 63 specimens, 6% of specimens tested). In addition, 22 (2%) of specimens were positive for rotavirus; 19 (2%) were positive for sapovirus; and 7 (1%) were positive for astrovirus. Incidence of norovirus-associated outpatient visits was 5.6 per 1,000 person-years; incidence of norovirus disease in the community was estimated to be 69.5 per 1,000 person-years. Norovirus incidence was highest among children <5 years of age (outpatient incidence = 25.6 per 1,000 person-years; community incidence = 152.2 per 1,000 person-years), followed by older adults aged >65 years (outpatient incidence = 7.8 per 1,000 person-years; community incidence = 75.8 per 1,000 person-years). Outpatient incidence rates of rotavirus, sapovirus, and astrovirus were 2.0, 1.6, 0.6 per 1,000 person-years, respectively; community incidence rates for these viruses were 23.4, 22.5, and 8.5 per 1,000 person-years, respectively. This study provides the first age-group specific laboratory-based community and outpatient incidence rates for norovirus AGE in the U.S. Norovirus was the most frequently detected viral enteropathogen across the age spectrum with the highest rates of norovirus disease observed among young children and, to a lesser extent, the elderly. These data provide a better understanding of the norovirus disease burden in the United States, including variations within different age groups, which can help inform the development, targeting, and future impacts of interventions, including vaccines.

Remote supervision of medical training via videoconference in northern Australia: a qualitative study of the perspectives of supervisors and trainees.

OBJECTIVES: Telemedicine has revolutionised the ability to provide care to patients, relieve professional isolation and provide guidance and supervision to junior medical officers in rural areas. This study evaluated the Townsville teleoncology supervision model for the training of junior medical officers in rural areas of North Queensland, Australia. Specifically, the perspectives of junior and senior medical officers were explored to identify recommendations for future implementation. DESIGN: A qualitative approach incorporating observation and semistructured interviews was used to collect data. Interviews were uploaded into NVivo 10 data management software. Template analysis enabled themes to be tested and developed through consensus between researchers. SETTING: One tertiary level and four secondary level healthcare centres in rural and regional Queensland, Australia. PARTICIPANTS: 10 junior medical officers (Interns, Registrars) and 10 senior medical officers (Senior Medical Officers, Consultants) who participated in the Townsville teleoncology model of remote supervision via videoconference (TTMRS) were included in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: Perspectives on the telemedicine experience, technology, engagement, professional support, satisfaction and limitations were examined. Perspectives on topics raised by participants were also examined as the interviews progressed. RESULTS: Four major themes with several subthemes emerged from the data: learning environment, beginning the learning relationship, stimulus for learning and practicalities of remote supervision via videoconference. While some themes were consistent with the current literature, new themes like increased professional edge, recognising non-verbal cues and physical examination challenges were identified. CONCLUSIONS: Remote supervision via videoconference provides readily available guidance to trainees supporting their delivery of appropriate care to patients. However, resources required for upskilling, training in the use of supervision via videoconference, administration issues and nursing support, as well as physical barriers to examinations, must be addressed to enable more efficient implementation.

Physicians' perceptions of clinical supervision and educational support via videoconference: a systematic review.

We conducted a systematic review of the perceptions of physicians about clinical supervision and educational support via videoconferencing. A search of literature databases, reference lists and specific journals was performed for relevant articles published between 1990 and 2013. A total of 1288 studies were identified, of which 13 fulfilled the inclusion criteria for review. Six studies concerned education, six concerned clinical practice and one concerned supervision. The studies employed a wide variety of methodologies, including quantitative and qualitative techniques, so a meta-analysis was not practicable. Overall satisfaction and acceptance rates were reported in nine studies, mainly using Likert scales. Several positive aspects of videoconferencing were reported, including increased education and clinical practice support, and autonomy for rural areas. The main negative aspects related to the technology itself, poorer interaction and decreased rapport building when using videoconferencing. There is a paucity of literature regarding the perceptions of videoconferencing-based supervision of junior doctors in rural areas. No studies have considered measures of cost effectiveness. More rigorous study design in future research is recommended.

Tibetan medicine and integrative health: validity testing and refinement of the constitutional self-assessment tool and lifestyle guidelines tool.

CONTEXT: Tibetan medicine offers an ancient, timely model for the promotion of health and treatment of disease by teaching individuals to make healthy lifestyle choices. This holistic model consists of analyzing one's unique constitution and recommending supportive lifestyle modifications. An experienced Tibetan medicine practitioner is the gold standard for constitutional assessment. Because few Tibetans practice Tibetan medicine in the United States, research-based tools with content and criterion validity are needed for self-assessment. OBJECTIVE: To test the validity of and refine the Constitutional Self-Assessment Tool (CSAT) and Lifestyle Guidelines Tool (LGT). DESIGN: Mixed methods pilot study conducted in three phases. SETTING: Tibetan Medical Institute (TMI) of His Holiness the Dalai Lama, Dharamsala, India and the University of Minnesota, a U.S. research University. PARTICIPANTS: Six TMI senior faculty; 88 students at the university. METHODS: Phase 1: TMI faculty evaluated the tools' content validity. Phase 2: 59 students completed the CSAT, had a Tibetan medicine consultation, completed the LGT, and answered qualitative questions. Phase 3: 29 students studying Tibetan medicine followed a modified phase 2 method. Quantitative and phenomenological analyses were performed to investigate the CSAT's criterion validity (agreement of CSAT results and consultations) and refine the tools. RESULTS: The tools were shown to have high content validity. Phase 2 CSAT had 51% agreement and 0.24 kappa statistic, suggesting fair criterion validity. Phase 3-refined CSAT had 76% agreement and 0.50 kappa statistic, suggesting moderate criterion validity. CONCLUSION: The refined CSAT and LGT in Appendix A and B demonstrate the potential for additional research and use in integrated care.

Korean nursing students' ethical problems and ethical decision making.

This Korean study replicated a previously published American study. The conceptual framework and method combined ethical enquiry and phenomenology. The research questions were: (1) What is nursing students' experience of ethical problems involving nursing practice? and, (2) What is nursing students' experience of using an ethical decision-making model? The participants were 97 senior baccalaureate nursing students, each of whom described one ethical problem and chose to use one of five ethical decision-making models. From 97 ethical problems, five content categories emerged, the largest being health professionals (69%). The basic nature of the ethical problems was the students' experience of conflict, resolution and rationale. Using an ethical decision-making model helped 94% of the students. A comparison of the Korean and American results yields important implications for nursing ethics education, practice and research.

Older persons' ethical problems involving their health.

Although older persons (aged 65 years and older) experience stressful ethical problems involving their health, research is lacking about this phenomenon. The purpose of this study was to describe and examine the content and basic nature of older persons' ethical problems concerning their health. The conceptual framework and method combined ethical enquiry and phenomenology. The participants were 18 older persons and 12 of their children or grandchildren (for contextual understanding). The 19 women and 11 men, 73% of whom were Caucasian, described 184 ethical problems, from which emerged 10 content categories. The basic nature of the ethical problems consisted of conflict, resolution and rationale. The results could assist health professionals to promote older persons' ethical decision making, quality of life, and good death.