Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial.

INTRODUCTION: The successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and treatment support based on behavioural science theory may improve treatment adherence and completion. METHODS AND ANALYSIS: A pragmatic multicentre, open-label, randomised controlled trial assessing the effect of novel short-course rifapentine-based regimens for TB prevention and additional theory-based treatment support on treatment adherence against standard-of-care. Participants aged between 16 and 65 who are eligible to start TB preventive therapy will be recruited in England. 920 participants will be randomised to one of six arms with allocation ratio of 5:5:6:6:6:6: daily isoniazid +rifampicin for 3 months (3HR), routine treatment support (control); 3HR, additional treatment support; weekly isoniazid +rifapentine for 3 months (3HP), routine treatment support; weekly 3HP, additional treatment support ; daily isoniazid +rifapentine for 1 month (1HP), routine treatment support; daily 1HP, additional treatment support. Additional treatment support comprises reminders using an electronic pillbox, a short animation, and leaflets based on the perceptions and practicalities approach. The primary outcome is adequate treatment adherence, defined as taking ≥90% of allocated doses within the pre-specified treatment period, measured by electronic pillboxes. Secondary outcomes include safety and TB incidence within 12 months. We will conduct process evaluation of the trial interventions and assess intervention acceptability and fidelity and mechanisms for effect and estimate the cost-effectiveness of novel regimens. The protocol was developed with patient and public involvement, which will continue throughout the trial. ETHICS AND DISSEMINATION: Ethics approval has been obtained from The National Health Service Health Research Authority (20/LO/1097). All participants will be required to provide written informed consent. We will share the results in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2020-004444-29.

Validation of a multiplex flow immunoassay for detection of IgG antibodies against SARS-CoV-2 in dried blood spots.

BACKGROUND: Dried blood spots (DBS) are an established specimen type for clinical testing given their low cost, ease of collection and storage, and convenient shipping capabilities through the postal system. These attributes are complementary to the expansion of SARS-CoV-2 serologic testing, which may be used to inform community seroprevalence rates. METHODS: The Luminex xMAP SARS-CoV-2 Multi-Antigen assay utilizes magnetic beads labeled with three viral antigens (nucleocapsid [NC], receptor binding domain [RBD], spike S1 subunit) to detect anti-viral IgG-class antibodies, and has Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in serum and plasma. This assay was modified for use with DBS and validated against paired sera tested by one of two reference assays: the Roche Diagnostics Elecsys anti-SARS-CoV-2 ECLIA or the Euroimmun anti-SARS-CoV-2 IgG ELISA. RESULTS: 159 paired DBS and serum specimens analyzed using the modified Luminex xMAP assay on DBS and the reference methods on serum showed an overall concordance of 96.9% (154/159). Use of multivariate pattern recognition software (CLIR) for post-analytical interpretation of the Luminex xMAP DBS assay results, instead of manufacturer provided interpretive thresholds, increased overall qualitative result concordance to 99.4% (158/159) between the modified Luminex xMAP DBS and reference results. CONCLUSIONS: Use of DBS for detection of antibodies against SARS-CoV-2 provides comparable results to those obtained using serum. DBS concordance was improved with multivariate pattern recognition software (CLIR). We demonstrate that DBS are a reliable specimen type for SARS-CoV-2 antibody detection using the modified Luminex xMAP assay.

Detection of SARS-CoV-2 IgG antibodies in dried blood spots.

The COVID-19 pandemic led to development of numerous serologic tests. To obviate the need for phlebotomy services, we validated dried blood spots (DBS) for anti-SARS-CoV-2 serologic testing. Immunoglobulins were extracted from 3 mm DBS punches and the extracts were analyzed using the Euroimmun anti-SARS-CoV-2 IgG ELISA. Various pre-analytical factors were studied. Results were favorable for DBS stored for at least 67 days at or below 37°C. Comparison between paired serum and DBS specimens tested by the Euroimmun ELISA showed 96.8% and 81.3% positive and negative agreement, respectively, indicating that confirmatory testing of positive Euroimmun results on DBS extracts is necessary to achieve clinical accuracy. Our findings suggest that any SARS-CoV-2 antibody assay that requires pre-dilution of serum is amenable to DBS as an alternate specimen type that is relatively low cost, self-collectable, stable, can be shipped by standard mail and could be used to establish the seroprevalence of large populations.

Prevalence of SARS-CoV-2 Antibodies in a Multistate Academic Medical Center.

OBJECTIVE: To estimate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in health care personnel. METHODS: The Mayo Clinic Serology Screening Program was created to provide a voluntary, two-stage testing program for SARS-CoV-2 antibodies to health care personnel. The first stage used a dried blood spot screening test initiated on June 15, 2020. Those participants identified as reactive were advised to have confirmatory testing via a venipuncture. Venipuncture results through August 8, 2020, were considered. Consent and authorization for testing was required to participate in the screening program. This report, which was conducted under an institutional review board-approved protocol, only includes employees who have further authorized their records for use in research. RESULTS: A total of 81,113 health care personnel were eligible for the program, and of these 29,606 participated in the screening program. A total of 4284 (14.5%) of the dried blood spot test results were "reactive" and warranted confirmatory testing. Confirmatory testing was completed on 4094 (95.6%) of the screen reactive with an overall seroprevalence rate of 0.60% (95% CI, 0.52% to 0.69%). Significant variation in seroprevalence was observed by region of the country and age group. CONCLUSION: The seroprevalence for SARS-CoV-2 antibodies through August 8, 2020, was found to be lower than previously reported in other health care organizations. There was an observation that seroprevalence may be associated with community disease burden.

15 Deathbed etiquette-support for being at the bedside of the person you love

BackgroundPeople in the UK are often uncomfortable with supporting the dying. As the population ages we are less likely to have supported a loved one who has died.MethodsThe Centre for the Art of Dying Well, with palliative care experts and experts by experience, created a resource to support someone at the deathbed of a loved one. This was updated for the COVID-19 pandemic. This abstract describes the wider public engagement with this resource, using content analysis to evaluate public sentiment and understanding of it.ResultsRelease of the original Guide coincided with a report assessing preparedness for supporting someone who is dying, a podcast and a press release. It was widely quoted in the news media with reports in The Times;local and national news (Radio Oxfordshire, Talk Radio, Channel 5 News). Google Analytics demonstrated 7,341 unique visitors to the Guide spending, on average, 2 minutes 2 seconds reading it. The version updated for COVID-19 was widely cited in the Financial Times, the Daily Mail, the Sun and Vatican News and an interview on 5 Live Radio. Based on an analysis of article comments, public sentiment and understanding were shown to be varied including very positive and very negative reactions. There was widespread individual engagement online and offline and also endorsement by organisations such as Marie Curie and Health Improvement Scotland. The Guide for COVID-19 had 2,545 unique page reviews with users spending on average 2 minutes 50 seconds on the page. Analysis of Twitter data demonstrated a wide level of engagement with the content of both guides, and discussions occurring across a diverse range of individuals.ConclusionsThere has been widespread uptake. Public reception, as evaluated in the content analysis, will guide future research to explore the Guide’s impact.

British government communication during the 2020 COVID-19 pandemic: learning from high reliability organizations

This article examines British government communication during the COVID-19 pandemic, assessing how it aligns to the communicational characteristics of high reliability organizations (HROs). The central proposition of the study is that HROs’ organizational culture enables and cultivates effective, ethical communication that, in turn, enhances the trust and engagement of stakeholders and citizens. A thematic content analysis of the UK prime minister’s public communication about the new coronavirus outbreak, examining televised statements, news briefings and prime minister’s questions from January to June 2020, shows that the British prime minister’s initial approach to communication about the virus was complacent about the country’s preparedness and capacity to control the disease’s spread. No errors were admitted in any of the government’s subsequent handling of the pandemic nor were mistakes acknowledged in the actions of those in or advising government. These approaches to communication are at odds with those adopted by HROs. The study suggests that lessons can be learnt from HRO practices for communication in high risk environments. They are also applicable to organizations that have experienced historical difficulties both in admitting errors and in fostering a transparent, responsive communicational culture.

Broadening Our Bandwidth: A Multiple Case Report of Expanded Use of Telehealth Technology to Perform Wound Consultations During the COVID-19 Pandemic.

BACKGROUND: Managing patients during the coronavirus disease-2019 (COVID-19) pandemic, and the associated severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) in particular, required the nimble responsiveness for which WOC nurses are known. Problem-solving skills were needed to continue the level of WOC nursing services expected by patients, families, and professional colleagues, while reducing the hours we were physically present at our clinical facility. In order to respond to these demands, our team realized it must create an innovative approach to provide efficient, cost-effective consultations during this global crisis. This Challenges in Practice article summarizes our experience with use of telemedicine technologies to perform remote consultations within the acute care setting. CASES: Case 1 was a 52-year-old woman with a history of paraplegia. She had several pressure injuries but had not received topical care for these wounds prior to admission. A consultation for the WOC nurse was requested and performed via telehealth services on a day our team was working off-site. This case illustrates the process our team used to perform a virtual consultation and demonstrates how the use of images placed in the electronic medical record aided in developing an effective plan of care. Case 2 was a 48-year-old man who tested positive for COVID-19. He developed bilateral unstageable pressure injuries on his cheeks after being placed in the prone position for a prolonged period while critically ill. This case describes multiple technologic platforms used for telemedicine consults in a patient with COVID-19 requiring isolation. CONCLUSIONS: Remote consultation by WOC nurses was possible in our healthcare system because of previous experience using telemedicine technology and well-established collaborative relationships with providers and bedside nurses. By expanding our use of telemedicine technology, we were able to provide ongoing care to a patient without COVID-19 who had WOC consultation needs, and a patient with strict isolation demands due to COVID-19.