Decentralized Clinical Trials as a New Paradigm of Trial Delivery to Improve Equity of Access.

Importance: The need to maintain clinical trial recruitment during the COVID-19 pandemic has precipitated the rapid uptake of digital health for the conduct of clinical trials. Different terms are used in different jurisdictions and clinical contexts, including digital trials, networked trials, teletrials (TT), and decentralized clinical trials (DCT) with a need to agree to terms. Observations: This clinical care review summarized publications and gray literature, including government policies for the safe conduct of clinical trials using digital health. It compares 2 frequently used methodologies, DCT and TT, first developed before the COVID-19 pandemic by trialists and stakeholders in Australia to improve access to cancer clinical trials for geographically dispersed populations. TT uses a networked approach to implement clinical trials to share care between facilities and uses an agreement between sites or a supervision plan to improve governance and safety. Government regulators have adapted existing regulations and invested in the rollout of the TT model. The term DCT emerged in the northern hemisphere and has been the subject of guidance from regulatory agencies. DCT uses digital health to deliver care in nontraditional sites, such as participants' homes, but does not mandate a networked approach between health facilities or require a supervision plan to be in place. Conclusions and Relevance: TT can be considered as a specific type of DCT with several potential advantages, including upskilling across a network. DCT is a new paradigm for the use of digital health in the safe conduct of clinical trials and is a transformative issue in cancer care, addressing disparities in access to clinical trials and improving clinical outcomes.

A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas.

Background: Participation in clinical trials is linked to improved patient outcomes. Despite this, most trial participants either reside in, or are treated in metropolitan areas. TrialHub developed hub-and-spoke models to support and grow clinical trial units in outer metropolitan and regional/rural centres in order to boost clinical trial engagement and reduce demands of trial participation on patients from outer metropolitan and regional/rural areas. The aim of this project was to establish a capability framework for clinical trial unit growth and development. Methods: An integrative methods study design was used to inform the co-design and development of the capability framework based on data collected in Victoria during 2020-21. This included reviews of the literature and of existing local resources, infrastructure, and staffing; as well as education, mentoring and support, and a needs assessment through multidisciplinary working groups. Results: We developed a capability framework based on the level of support required for outer metropolitan and regional/rural centres with diverse existing capabilities across Victoria. The framework applies a maturity model to assess resources, processes and practices which impact the capacity and capability of centres to conduct trials safely and sustainably. Each level of the model uses a consistent set of factors to describe the core elements required for safe clinical trial delivery. This benchmarking allows targeted investment to ensure safe and high-quality delivery of trials at newly establishing trial units. Conclusion: The capability framework developed by TrialHub provides a basis for staged, planned and successful trial unit development and trial implementation. Further validation of the framework is required.

Teletrials, the new norm? Expert recommendations for teletrials into the future: Findings from the Clinical Oncology Society of Australia Clinical Trial Research Professionals Group Workshop.

INTRODUCTION: The Australasian Teletrial Model was piloted in co-funded sites across Australia. The purpose was to extend the reach of clinical trials using telemedicine to improve equity and access to this treatment pathway for oncology patients. Experts across Australia gathered to share the learnings of implementation so that future directions can be effective and sustainable. METHODS: The 1-day workshop was attended in person and virtually. Attendees were invited to analyze and disseminate the results. Recordings from the presentations were coded independently by three researchers and synthesized. The results were sent to the authorship team for further review to build consensus on the findings in three drafts. RESULTS: Four key themes were identified: "Being on the Same Page," "Building Foundations," "Key Roles in Teletrials," and "Incentives." Although there were many successes that were accelerated by the COVID-19 pandemic, there is work still to be done. CONCLUSION: The Australasian Teletrial Model has been identified as acceptable and feasible. Future directions need to continue to work on streamlining regulatory processes, implementation and monitoring, and build knowledge to further build networks across Australia.

Reducing the risk of unplanned perioperative hypothermia.

Maintaining normothermia is important for patient safety, positive surgical outcomes, and increased patient satisfaction. Causes of unplanned hypothermia in the OR include cold room temperatures, the effects of anesthesia, cold IV and irrigation fluids, skin and wound exposure, and patient risk factors. Nurses at Riddle Memorial Hospital in Media, Pennsylvania, performed a quality improvement project to evaluate the effectiveness of using warm blankets, warm irrigation fluids, or forced-air warming on perioperative patients to maintain their core temperature during the perioperative experience. Results of the project showed that 75% of patients who received forced-air warming perioperatively had temperatures that reached or were maintained at 36° C (96.8° F) or higher within 15 minutes after leaving the OR.

Recycled dehydrated lithosphere observed in plume-influenced mid-ocean-ridge basalt.

A substantial uncertainty in the Earth's global geochemical water cycle is the amount of water that enters the deep mantle through the subduction and recycling of hydrated oceanic lithosphere. Here we address the question of recycling of water into the deep mantle by characterizing the volatile contents of different mantle components as sampled by ocean island basalts and mid-ocean-ridge basalts. Although all mantle plume (ocean island) basalts seem to contain more water than mid-ocean-ridge basalts, we demonstrate that basalts associated with mantle plume components containing subducted lithosphere--'enriched-mantle' or 'EM-type' basalts--contain less water than those associated with a common mantle source. We interpret this depletion as indicating that water is extracted from the lithosphere during the subduction process, with greater than 92 per cent efficiency.