Combined Use of ECMO, Prone Positioning, and APRV in the Management of Severe COVID-19 Patients.

Background: Severe COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) may warrant extracorporeal membrane oxygenation (ECMO). We evaluated the safety and physiologic changes in oxygenation and hemodynamic profile during ECMO, prone positioning, and the two modalities combined in patients receiving veno-venous (VV) ECMO. Methods: Cohort study of consecutive adult patients with COVID-19-associated ARDS requiring VV-ECMO, classified into three groups: ECMO support only; Prone positioning only; and Prone positioning during ECMO. We collected hemodynamic, respiratory and ventilation variables as follows: pre-treatment, 1, 6, and 24 h post-treatment, and documented treatment-related complications. On-treatment variables were compared with pre-treatment using one-sample paired t-test with Bonferroni correction. Results: Fourteen patients (mean age 48.1 [SD 9.3] years, male [100%]) received VV-ECMO. Of those, 10 patients had data during prone positioning alone and seven had data while proned on ECMO. While on ECMO, patients had improvement in oxygen saturation, PaO2/FiO2 ratio, and minute ventilation up to 24 h post-treatment. Vasopressor requirements increased with ECMO at 1 h and 24 h post-treatment. Prone positioning was not associated with clinically significant hemodynamic or respiratory changes, either alone or during ECMO support. All patients sustained deep tissue injuries, but only those on the face or chest were related to prone positioning. Three patients required cannula replacement. In-hospital mortality was 43%. Conclusions: VV-ECMO and prone positioning in patients with COVID-19 ARDS was overall well-tolerated; however, physiologic improvements were marginal, and patients sustained deep tissue injuries. Although this was a selected population with high mortality, our data call into question the benefits of these management modalities in this severe COVID-19 population.

Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward.

PURPOSE: Asia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance, digital platform, accepting electronic document and process integration. Dialogues and strong partnership witnessed reforms and efficiencies amidst the pandemic. In tracking the progress of regulatory agility, APAC identifies areas for improvement and recommends prioritizing these areas for change. METHODS: As one voice, 13 main industry associations under the umbrella of APAC sent joint letters to our National Regulatory Authorities (NRAs) with a call to maintain regulatory agility and consider new ways of working. Consequently, APAC surveyed its member associations to measure regulatory agilities implemented by the NRAs during 2020 and 2021 in view of the pandemic. RESULTS: This paper reports progress in implementing regulatory agility, e.g. the number of economies that can accept electronic Certificate of Pharmaceutical Products (eCPP) has reached 100% for the economies that require CPP and more than 90% can waive onsite inspection in the presence of Good Manufacturing Practice (GMP) certificate and/or inspection report. The paper also features the progress made in Malaysia, the Philippines, and the ASEAN (Association of South East Asian Nations) regional reliance initiative to reduce inefficiencies and duplications. CONCLUSIONS: We have demonstrated the power of working together to enable regulatory agilities and efficiencies. APAC will continue to track the progress of all economies including India within the areas for improvement prioritized and discussed in this paper. APAC is also committed to working with key stakeholders including our NRAs in Asia to sustain and enable a new era of innovation ushered in by COVID-19 to benefit patients.

Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.

INTRODUCTION: Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE-vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self-care materials, and health-related quality of life. METHODS AND ANALYSIS: Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes. ETHICS AND DISSEMINATION: The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care. TRIAL REGISTRATION NUMBER: NCT04966104.