Improving Clinical Decisions Via Remote Blood Sampling

3 An important component for the provision of patient-centric healthcare is the ability to collect blood samples remotely in a manner that delivers samples of a quality comparable to that of current standard phlebotomy collection, enabling routine clinical testing, monitoring disease progression and testing drug concentrations.2-4-г, This blood sampling could be performed at the patient's home, at a nearby pharmacy, or at a local clinic, rather than a centralized facility. Examples of commercially available devices include the Neoteryx Mitra,13 Tasso-M20, SST and Tasso+,14 SeventhSense TAP and TAP II,15 Trajan hemaPEN,16 Labcorp Pixel,17 Capitainer qDBS,1" HemaXis DB10 and DX,19 and Drawbridge OneDraw.20 These devices are capable of collecting from as little as 20 microliters (approximately half a drop) to several hundred microliters of blood and have been widely used to determine clinical parameters,21 drug concentrations,5'22 therapeutic drug monitoring,23 and, more recently, COVID antibody levels.24,25 Some of these devices enable the collection of a fixed volume of blood, collected as dried blood, which can then be shipped and handled at room temperatures-avoiding the need for freezers and dry ice for storing and shipping samples-enabling its adoption even in remote areas with limited infrastructure. Patient-centric blood sampling techniques have been gaining popularity for use in pharmaceutical drug development;however, to date they have not been broadly accessible to the general public.26 This can be partially attributed to the "cliniccentric" healthcare model, where reimbursement is dependent on in-person visits and sample collection. [...]the status quo remains and anyone who needs a blood test is required to go to the doctor's office or clinic. [...]studies have demonstrated that the overall cost to society will be lower, by improving health outcomes and allowing broader access and patient convenience.27 The availability and adoption of patient-centric approaches can provide access and treatment options to clinical trial participants not geographically co-located with the investigative sites and improving access in rural or lesser developed communities, globally, potentially improving the health of the general population.

Impact of COVID-19 on electroconvulsive therapy practice across Canadian provinces during the first wave of the pandemic.

BACKGROUND: Electroconvulsive therapy (ECT) is a procedural treatment that is potentially life-saving for some patients with severe psychiatric illness. At the start of the global coronavirus disease 2019 (COVID-19) pandemic, ECT practice was remarkably disrupted, putting vulnerable individuals at increased risk of symptom exacerbation and death by suicide. This study aimed to capture the self-reported experiences of psychiatrists based at healthcare facilities across Canadian provinces who were delivering ECT treatments during the first phase of the COVID-19 pandemic (i.e., from mid-March 2020 to mid-May 2020). METHODS: A multidisciplinary team of experts developed a survey focusing on five domains: ECT unit operations, decision-making, hospital resources, ECT procedure, and mitigating patient impact. Responses were collected from psychiatrists providing ECT at 67 ECT centres in Canada, grouped by four geographical regions (Ontario, Quebec, Atlantic Canada, and Western Canada). RESULTS: Clinical operations of ECT programs were disrupted across all four regions - however, centres in Atlantic Canada were able to best preserve outpatient and maintenance care, while centres in Western Canada were able to best preserve inpatient and acute care. Similarly, Atlantic and Western Canada demonstrated the best decision-making practices of involving the ECT team and clinical ethicists in the development of pandemic-related guidelines. Across all four regions, ECT practice was affected by the redeployment of professionals, the shortage of personal protective equipment, and the need to enforce social distancing. Attempts to introduce modifications to the ECT delivery room and minimize bag-valve-mask ventilation were consistently reported. All four regions developed a new patient prioritization framework, and Western Canada, notably, aimed to provide ECT to only the most severe cases. CONCLUSIONS: The results suggest that ECT provision was disproportionately affected across different parts of Canada. Possible factors that could explain these interregional differences include population, distribution of urban vs. rural areas, pre-pandemic barriers in access to ECT, number of cases, ability to control the spread of infection, and the general reduction in physicians' activities across different areas of health care. Studying these factors in the future will inform how medical centres should respond to public health emergencies and pandemic-related circumstances in the context of procedural treatments.

Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality.

Advances in the technologies to enable patient-centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self-collection or with the help of a caregiver in their home. Typically, blood samples to assess pharmacokinetics and pharmacodynamics of a drug during clinical development are collected at a clinical site via venous blood draw. In this position paper by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the potential value PCS can bring to patients, to the clinical datasets generated, and to clinical trial sponsors is discussed, along with considerations for program decision making, bioanalytical feasibility, operations, and regulatory implications. With an understanding of the value of PCS and considerations when implementing during clinical drug development, we can bring the promise of PCS closer to reality and enable decentralized clinical trials.

CHLA 2022 CONFERENCE ABSTRACTS / RÉSUMÉS DU CONGRÈS ABSC/CHLA 2022

This workshop will provide health science librarians and information professionals at any level/context with an overview of the best practices in finding and identifying the best scientific evidence during novel public health emergencies. Attendees will be presented with an overview of a best practices statement developed by the Librarian Reserve Corps. Attendees will then apply the recommendations from the best practices statement in designing a plan to respond to real-life case study/information request during a public health emergency. A discussion period will follow on how to apply the best practices in other contexts, environments, and cultures. Attendees will also be invited to share their own experiences and best practices during the discussion session. Through hands-on learning and discussion, librarians and information professionals at any level/context will develop strategies to find and critically appraise the best evidence in any novel public health emergency situation. Introduction: To inform the design of a consumer health strategy for a provincial health library system, the library sought to understand patient challenges and barriers in accessing quality sources of health information. Description: Over a period of three months in the winter of 2020-2021, the library engaged in semi-structured interviews with relevant clinical and corporate stakeholders. Program leads were asked about their role in consumer health information provision and support, and where they saw gaps and opportunities within the organization. Answers were themed and analyzed, and an internal report was produced to guide next steps in developing a consumer health strategy. Outcomes: The environmental scan showed that there are clear challenges and barriers for patients in accessing quality health information. Barriers include the duration of interaction with a healthcare practitioner;the specificity of patient information needs;and the organizational emphasis on a single enterprise-wide patient information resource. More significant challenges include language;lack of health information literacy skills;and low digital literacy among certain populations. Discussion: The environmental scan results provided strong rationale for developing a cohesive consumer health strategy for the library. They highlighted valuable but disjointed resources and programs throughout the organization. A Consumer Health Framework was drafted to guide the library in setting achievable goals and leveraging existing supports. Due to the Covid-19 pandemic it was not possible to engage directly with patients for the initial scan, however consultation with patient advisory groups is now being planned to check and validate the library’s direction.

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States.

Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results. We received 73 survey responses, with 51 from community members, 12 from biomedical HIV cure researchers and 10 from HIV care providers. Of those, 51 (70%) were cisgender men and 50 (68%) reported living with HIV. Most (>80% overall) indicated that the device would be helpful during ATI trials and they would feel comfortable using it themselves or recommending it to their patients/participants. Of the 50 PWH, 42 (84%) indicated they would use the device if they were participating in an ATI trial and 27 (54%) also expressed a willingness to use the device outside of HIV cure studies. Increasing sensitivity of viral load tests and pluri-potency of the device (CD4 count, chemistries) would augment acceptability. Survey findings provide evidence that viral load home testing would be an important adjunct to ongoing HIV cure-directed trials involving ATIs. Survey findings may help inform successful implementation and uptake of the device in the context of personalized HIV care.

Electroconvulsive Therapy in Canada During the First Wave of COVID-19: Results of the "What Happened" National Survey.

OBJECTIVES: The COVID-19 pandemic has disrupted the provision of essential and potentially life-saving procedural treatments such as electroconvulsive therapy (ECT). We surveyed ECT providers across Canada to understand how the first wave of the pandemic affected ECT delivery between mid-March 2020 and mid-May 2020. METHODS: The survey was administered to ECT team members and decision makers at 107 Canadian health care centers with a focus on 5 domains: operations, decision-making, hospital resources, ECT procedure, and patient impact. Responses were obtained from 72 institutions, and collected answers were used to derive representative responses reflecting the situation at each ECT center. For specific domains, responses were split into 2 databases representing the perspective of psychiatrists (n = 67 centers) and anesthesiologists (n = 24 centers). RESULTS: Provision of ECT decreased in 64% centers and was completely suspended in 27% of centers after the onset of the pandemic. Outpatient and maintenance ECT were more affected than inpatient and acute ECT. Programs reported a high level of collaboration between psychiatry and hospital leadership (59%) but a limited input from clinical ethicists (18%). Decisions were mostly made ad hoc leading to variability across institutions in adopted resource allocation, physical location of ECT delivery, and triaging frameworks. The majority of centers considered ECT to be aerosol-generating and incorporated changes to airway management. CONCLUSIONS: Electroconvulsive therapy services in Canada were markedly disrupted by the COVID-19 pandemic. The variability in decision-making across centers warrants the development of a rational approach toward offering ECT in pandemic contexts.

How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis.

Thousands of clinical trials all over the world were stopped, disrupted or delayed while countries grappled to contain the pandemic and research resources were redeployed. The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly. This disruption is opening doors for rethinking traditional approaches to clinical trial conduct - including decentralizing site visits, introducing new methods of sample collection, rethinking matrix selection, reducing sample volumes and collaborating on device development. These approaches reduce participant burden while improving critical trial data.

Rapid Knowledge Mobilization and Continuing Professional Development: Educational Responses to COVID-19.

INTRODUCTION: The field of Continuing Professional Development (CPD) has a role to play in supporting health care professionals as they respond to the COVID-19 pandemic. However, the evolving science of COVID-19, the need for quick action, and the disruption of conventional knowledge networks pose challenges to existing CPD practices. To meet these emergent and rapidly evolving needs, what is required is an approach to CPD that draws insights from the domain of knowledge mobilization (KMb). METHODS: This short report describes a research protocol for exploring rapid KMb responses to COVID-19 at one Canadian academic teaching hospital. The proposed research will proceed as a case study using a mixed methods design collecting quantitative (surveys and Web site use metrics) and qualitative data (interviews) from individuals involved in developing, using, and supporting the KMb resources. Analysis will proceed in two phases: descriptive analysis of data to share insights and integrative analysis of data to build theory. RESULTS: Results from this study will inform the immediate KMb and CPD contribution to the COVID-19 response. DISCUSSION: Findings from this study will also make a broader contribution to the field of CPD, theoretically informing intersections between KMb and CPD and therefore contributing to an integrated science of CPD.

Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.

The microsampling workshop generated recommendations pertaining to blood sampling site (venous blood versus capillary blood), when to conduct a bridging study, statistical approaches to establish correlation/concordance and deciding on sample size, opportunities and challenges with patient-centric sampling, and how microsampling technology can enrich clinical drug development. Overall, the goal was to provide clarity and recommendations and enable the broader adoption of microsampling supporting patients' needs, convenience, and the transformation from clinic-centric to patient-centric drug development. The need and adoption of away-from-clinic sampling techniques has become critical to maintain patient safety during the current COVID-19 pandemic.