Qualitative methods in a learning healthcare system: Balancing rigour and the need for rapid analysis and dissemination

Qualitative methods are used to capture stakeholder perspectives within learning healthcare systems (LHS), but there is a need to specify methods that balance rigour and pragmatic approaches to inform quality improvement (QI). Utilizing examples from two QI projects within the OTNY LHS, we illustrate methods and strategies that build team capacity and flexibility to respond to an evolving LHS. Method(s): Qualitative methods were tailored to fit each project's timelines and goals, to inform both practice and research. Tools to facilitate rapid cycle feedback included interview/focus group summary templates, aggregate summaries that synthesize findings by stakeholder group, case matrix templates for rapid extraction and systematic categorization of data along topic areas, and dissemination materials adapted for stakeholder audience and project phases. Strategies to maintain rigour included processes for data reduction and interpretation, a multi-disciplinary approach for analysis, frequent consensus-based meetings, data triangulation, and member checks. Result(s): Rapid cycle approaches yielded interim results that reshaped research questions or identified critical gaps. Case summary analysis exploring the impact of COVID-19 revealed limited information on telehealth challenges amongst OTNY participants, necessitating a shift in recruitment and interview focus. For another project, analytic methods were sequenced to rapidly inventory suggestions from interview summaries on how to enhance OTNY practice to better address racism, while subsequent thematic analysis of transcripts captured participants' experiences of racism for context. Challenges included concurrent alignment of data collection and analysis, tailoring summary templates to maximize utility for rapid analysis, and maintaining flexibility to respond to evolving findings and LHS stakeholder input. Conclusion(s): The diverse methods and strategies illustrated by these projects offer guidance for balancing.

Pandemic related mental health

OnTrackNY is a nationally recognized Coordinated Specialty Care model disseminated across New York state for young people experiencing early non-affective psychosis. OnTrackNY is a network of 22 teams located in licensed outpatient clinics, serving over 2500 individuals. OnTrackNY offers medication management, case management, individual and group cognitive behaviourally oriented therapy, family support and psychoeducation, supported employment and education, and peer support services. Teams receive training for implementation through an intermediary organization called OnTrack Central. OnTrackNY was selected as a regional hub of the National Institute of Mental Health Early Psychosis Intervention Network (EPINET), a national learning healthcare system (LHS) for young adults with early psychosis. This symposium will present the different ways in which EPINET OnTrackNY implemented systematic communitybased participatory processes to ensure robust stakeholder involvement to improve the quality of OnTrackNY care. Florence will present results of an assessment of stakeholder feedback experiences used to develop strategies for assertive outreach and engagement of program participants, families and providers. Bello will present on mechanisms for integrating of co-creation principles to design, develop and execute quality improvement projects in EPINET OnTrackNY. Stefancic will present on quality improvement projects that used rapid cycle qualitative methods, tools, and strategies to build team capacity and flexibility to respond to an LHS. Montague will present adaptations to OnTrackNY services during the COVID-19 pandemic using an implementation science framework. Finally, Patel will lead a discussion on the implications of involving individuals with lived experiences in all phases of the process to maximize learning in an LHS.

The integration of principles of co-creation for promoting quality improvement within a learning healthcare system providing coordinated specialty care for people with FEP

Co-creation places key stakeholders at the centre of development processes for quality improvement projects to reduce gaps between research and practice. We describe an Amplify OnTrackNY project that used principles of community-based participatory research to meaningfully partner with individuals with lived experience and describe lessons learned. Method(s): Two individuals with lived experience were hired and coled decision-making about project selection and design. The project examined OnTrackNY provider, participant, and family perspectives on the impact of COVID-19 on service delivery. To enhance the lived experience perspective, we hired two OnTrackNY graduates and a family member, and created mechanisms for team building and integration, and co-planning sessions. All team members contributed to the development of research questions, co-facilitated interviews/ focus groups, and participated in data analysis and dissemination. Result(s): Team members conducted focus groups and semi-structured interviews with 13 participants and five family members, presented results to various stakeholder groups, and are contributing to scientific publications. To ensure participation, our flexible working structure focused on promoting equity and building trust. Dedicated time ensured opportunities for meetings focused on mutual support, sharing, capacity building, and training in qualitative methods. Individuals with lived experience were in decision-making roles, created content, and led project activities embodying principles of power-sharing, reciprocity, and mutual learning. Orienting new team members to the office culture required extra effort. Conclusion(s): Provided sufficient time and infrastructure, it is feasible to meaningfully involve individuals with lived experience in quality improvement projects. Co-creation ensures that important perspectives are incorporated from the outset and procedures improve the relevance and uptake of research findings in the real world.

Shared longitudinal health records for clinical and population health

The ability of a health information exchange (HIE) to consolidate information, collected from multiple, disparate information systems, into a single, person-centric health record can provide a comprehensive and longitudinal representation of an individual's medical history. Shared, longitudinal health records can be leveraged to enhance the delivery of individual clinical care and provide opportunities to improve health outcomes at the population level. This chapter describes the clinical benefits imparted by the shared health record (SHR) component an HIE infrastructure. It also characterizes the potential public health benefits of the aggregate level, population health indicators calculated, stored, and distributed by a health management information system (HMIS) component. Tools for visualizing health indicators from the HMIS, including disease surveillance systems developed during the COVID-19 pandemic, are also described. Postpandemic components such as the SHR and HMIS will likely play critical roles in strengthening health information infrastructures in states and nations. © 2023 Elsevier Inc. All rights reserved.

Stakeholder-engaged co-design and implementation of web-based tools to enhance the dissemination and implementation of AHRQ EPC reports.

Introduction: A mission-critical aspect of learning health systems (LHSs) is the provision of evidence-based practice. One source of such evidence is provided by the Agency for Healthcare Research and Quality (AHRQ) through rigorous systematic reviews, termed evidence reports that synthesize available evidence on nominated topics of interest. However, the AHRQ Evidence-based Practice Center (EPC) program recognizes that the production of high-quality evidence reviews does not guarantee or promote their use and usability in practice. Methods: To make these reports more relevant to LHSs and promote evidence dissemination, AHRQ awarded a contract to the American Institutes for Research (AIR) and its Kaiser Permanente ACTION (KPNW ACTION) partner to design and implement web-based tools to meet the gap in dissemination and implementation of EPC reports in LHSs. We used a co-production approach to accomplish this work across three phases of activity: planning, co-design, and implementation between 2018 and 2021. We describe the methods and results and discuss implications for future efforts. Results: Web-based information tools that provide clinically relevant summaries with clear visual representations from the AHRQ EPC systematic evidence reports may be used by LHSs to increase awareness and accessibility of EPC reports, formalize and enhance LHSs' evidence review infrastructure, develop system-specific protocols and care pathways, improve practice at the point of care, and train and educate. Conclusions: The co-design of these tools and facilitated implementation generated an approach to making EPC reports more accessible and allows for more widespread application of systematic review results in supporting evidence-based practices in LHSs.

Short- and long-term strategies for navigating research-ambivalent organizational cultures besetting embedded researchers.

Many health systems may host embedded researchers (ERs) and provide fiscal resources to encourage health service research. However, ERs may remain challenged to initiate research in these settings. This discussion examines how health system culture may impede research initiation, thereby exposing a paradox for embedded researchers immersed in research-ambivalent health systems. The discussion ultimately describes potential short-term and long-term strategies embedded researchers may employ to initiate scholarly inquiry in research-ambivalent health systems.

Planning, Prioritizing, and Conducting Clinical Research in the Va Learning Healthcare System during the Covid-19 Pandemic

The Veterans Affairs (VA) Cooperative Studies Program (CSP) and Clinical Science Research and Development (CSRD) are both divisions of the VA Office of Research and Development (ORD) that is responsible for the planning and conduct of clinical trials and epidemiological studies within the VA's learning healthcare system. Since the outbreak of the COVID-19 pandemic in the United States, the VA has been facing some new and evolving challenges in clinical research, especially in planning, prioritizing, and conducting new clinical research projects aimed at preventing and/or treating SARS CoV-2 infection/ COVID-19 disease. In considering clinical research projects, different stakeholders of the VA research enterprise assess needs using numerous parameters: (1) CSP and CSRD leadership: VAMC network infrastructure, financial support, available funding, and enterprise-wide impact. (2) Clinical researchers: clinical perspectives and needs, as they relate to study design and operations, in the context of an ever-evolving epidemiological picture and disease knowledgebase. (3) VA research Coordinating Center(s): the challenges that reside in aspects of trial design and planning, in an effort to account for frequent changes in the COVID-19 epidemiology, and its impact on project feasibility/participant recruitment, choice of study endpoints, safety of healthcare providers, research personnel, and study participants. Notwithstanding these evolving challenges, the VA ORD stood up the VA CoronavirUs Research and Efficacy Studies (VA CURES) network in a coordinated effort to develop a master protocol framework that could efficiently utilize the VA's clinical research infrastructure to address the COVID-19 pandemic. The VA CURES framework has been serving as the umbrella structure encompassing numerous COVID-19 clinical research activities. Both CSP and CSRD have an established clinical research infrastructure, including Coordinating Centers, a Network Of Enrollment Dedicated Sites (NODES) and over 150 VA Medical Centers across the United States, with a clear and streamlined process of submission and review of research proposals (Letters of Intent;LOI), subsequent trial planning leading up to scientific review and, once approved, conduct of research projects. In this session, we will present the VA clinical research infrastructure and share its mobilization in this pandemic. Furthermore, we will share lessons learned in conducting research in emergency situations and how the research infrastructure pivoted and adapted to fulfill its mission of providing the best healthcare to Veterans. The following four areas will be the focus of this session: the VA ORD leadership perspective: Infrastructure/support/funding/priorities;clinical research perspectives: Study design in the face of evolving epidemiological picture;trial design and planning: Protocol drafting/timelines/shifting priorities/feasibility/ VAMC networks;organizing and operationalizing the VA CURES umbrella/platform: CURES-1, and CURES-2.

Exploring Patient Journey Mapping and the Learning Health System: Scoping Review.

BACKGROUND: Journey maps are visualization tools that can facilitate the diagrammatical representation of stakeholder groups by interest or function for comparative visual analysis. Therefore, journey maps can illustrate intersections and relationships between organizations and consumers using products or services. We propose that some synergies may exist between journey maps and the concept of a learning health system (LHS). The overarching goal of an LHS is to use health care data to inform clinical practice and improve service delivery processes and patient outcomes. OBJECTIVE: The purpose of this review was to assess the literature and establish a relationship between journey mapping techniques and LHSs. Specifically, in this study, we explored the current state of the literature to answer the following research questions: (1) Is there a relationship between journey mapping techniques and an LHS in the literature? (2) Is there a way to integrate the data from journey mapping activities into an LHS? (3) How can the data gleaned from journey map activities be used to inform an LHS? METHODS: A scoping review was conducted by querying the following electronic databases: Cochrane Database of Systematic Reviews (Ovid), IEEE Xplore, PubMed, Web of Science, Academic Search Complete (EBSCOhost), APA PsycInfo (EBSCOhost), CINAHL (EBSCOhost), and MEDLINE (EBSCOhost). Two researchers applied the inclusion criteria and assessed all articles by title and abstract in the first screen, using Covidence. Following this, a full-text review of included articles was done, with relevant data extracted, tabulated, and assessed thematically. RESULTS: The initial search yielded 694 studies. Of those, 179 duplicates were removed. Following this, 515 articles were assessed during the first screening phase, and 412 were excluded, as they did not meet the inclusion criteria. Next, 103 articles were read in full, and 95 were excluded, resulting in a final sample of 8 articles that satisfied the inclusion criteria. The article sample can be subsumed into 2 overarching themes: (1) the need to evolve service delivery models in health care, and (2) the potential value of using patient journey data in an LHS. CONCLUSIONS: This scoping review demonstrated the gap in knowledge regarding integrating the data from journey mapping activities into an LHS. Our findings highlighted the importance of using the data from patient experiences to enrich an LHS and provide holistic care. To satisfy this gap, the authors intend to continue this investigation to establish the relationship between journey mapping and the concept of LHSs. This scoping review will serve as phase 1 of an investigative series. Phase 2 will entail the creation of a holistic framework to guide and streamline data integration from journey mapping activities into an LHS. Lastly, phase 3 will provide a proof of concept to demonstrate how patient journey mapping activities could be integrated into an LHS.

Creating a provincial post COVID-19 interdisciplinary clinical care network as a learning health system during the pandemic: Integrating clinical care and research.

Introduction: Coronavirus Disease-2019 (COVID-19) affects multiple organ systems in the acute phase and also has long-term sequelae. Research on the long-term impacts of COVID-19 is limited. The Post COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN), conceived in July 2020, is a provincially funded resource that is modelled as a Learning Health System (LHS), focused on those people with persistent symptoms post COVID-19 infection. Methods: The PC-ICCN emerged through collaboration among over 60 clinical specialists, researchers, patients, and health administrators. At the core of the network are the post COVID-19 Recovery Clinics (PCRCs), which provide direct patient care that includes standardized testing and education at regular follow-up intervals for a minimum of 12 months post enrolment. The PC-ICCN patient registry captures data on all COVID-19 patients with confirmed infection, by laboratory testing or epi-linkage, who have been referred to one of five post COVID-19 Recovery Clinics at the time of referral, with data stored in a fully encrypted Oracle-based provincial database. The PC-ICCN has centralized administrative and operational oversight, multi-stakeholder governance, purpose built data collection supported through clinical operations geographically dispersed across the province, and research operations including data analytics. Results: To date, 5364 patients have been referred, with an increasing number and capacity of these clinics, and 2354 people have had at least one clinic visit. Since inception, the PC-ICCN has received over 30 research proposal requests. This is aligned with the goal of creating infrastructure to support a wide variety of research to improve care and outcomes for patients experiencing long-term symptoms following COVID-19 infection. Conclusions: The PC-ICCN is a first-in-kind initiative in British Columbia to enhance knowledge and understanding of the sequelae of COVID-19 infection over time. This provincial initiative serves as a model for other national and international endeavors to enable care as research and research as care.

Competitive intelligence: A precursor to a learning health system.

Unlike other developed countries, the US healthcare system is largely privatized and highly competitive. This dynamic stifles effective information sharing, while the need for prompt and accurate evidence-based decision making has become crucial. Crises, like the COVID-19 pandemic, elevate the importance of quality decision making and exacerbate issues associated with the lack of a cohesive system to share information. Competitive intelligence (CI) is a discipline that encourages gathering, analyzing, and sharing information throughout a firm in order to develop and sustain competitive advantage. CI could be considered a precursor in establishing a learning organization (LO). Although CI research has focused on its process and value, little is found in the literature on how to integrate CI into an organization; this is particularly true in healthcare. A conceptual model is proposed to build and integrate a CI function and culture within a healthcare organization to encourage effective information sharing and knowledge development. In turn, this can provide a mechanism to create a learning health system (LHS). Although the model was developed specifically for US healthcare, it offers application to healthcare in other countries as well as most any industry.

Reducing hospital acquired pressure injury in a learning health center: Making the case for quality

Introduction: The purpose of this descriptive study is to examine a learning health system (LHS) continuous improvement and learning approach as a case for increased quality, standardized processes, redesigned workflows, and better resource utilization. Hospital acquired pressure injuries (HAPI) commonly occur in the hospitalized patient and are costly and preventable. This study examines the effect of a LHS approach to reducing HAPI within a large academic medical center. Methods: Our learning health center implemented a 6-year series of iterative improvements that included both process and technology changes, with robust data and analytical reforms. In this descriptive, observational study, we retrospectively examined longitudinal data from April 1, 2018 to March 31, 2022, examining the variables of total number of all-stage HAPI counts and average length of stay (ALOS). We also analyzed patient characteristics observed/expected mortality ratios, as well as total patient days, and the case-mix index to determine whether these factors varied over the study period. We used the Agency for Healthcare Research and Quality cost estimates to identify the estimated financial benefit of HAPI reductions on an annualized basis. Results: HAPI per 1000 patient days for FY 20 (October 1-September 30) and FY 21, decreased from 2.30 to 1.30 and annualized event AHRQ cost estimates for HAPI decreased by $4 786 980 from FY 20 to FY 21. A strong, statistically significant, negative and seemingly counterintuitive correlation was found (r = -.524, P = .003) between HAPI and ALOS. Conclusions: The LHS efforts directed toward HAPI reduction led to sustained improvements during the study period. These results demonstrate the benefits of a holistic approach to quality improvement offered by the LHS model. The LHS model goes beyond a problem-based approach to process improvement. Rather than targeting a specific problem to solve, the LHS system creates structures that yield process improvement benefits over a continued time period.

Research in Mental Health During the Pandemic

All healthcare had to rapidly adjust to covid-19;remote options were implemented at pace and unnecessary face to face contact minimised, with infection prevention and control taking primacy. Many research projects were suspended and some clinical researchers moved to frontline care. For psychiatric academic trainees, covid-19 affected recruitment, and risked delaying work on research degrees such as PhDs, potentially beyond the timeframe of a grant, leading to funding uncertainties. Those valuable casual conversations with senior colleagues in the cafe stopped and with many schools closed, parents had extra pressures on their time at home. In the UK the government prioritised "Urgent Public Health" (UPH) studies and took a co-ordinated approach to research approvals and recruitment strategies, contributing to the success of covid-19 platform trials such as RECOVERY. While initially only a minority of UPH studies were open to people with serious mental illnesses, now the effect of the pandemic on mental health has become a research priority. In parallel, service planners recognised the value of emergent research in informing decision-making creating de facto learning health systems. While covid-19 interrupted research as we knew it, it necessitated new ways of working, some of which will persist. These included an increase in remote data collection, allowing greater access to research opportunities for potential participants, along with more efficient research approval and evidence dissemination pathways.

Multi-center cohort study exploring the impact of the first U.K. COVID-19 lockdown on nebulizer use in adults with cystic fibrosis in the CFHealthHub learning health system

Background: Promoting adherence to preventative inhaled therapy in cystic fibrosis (CF) is challenging despite a clear association with better outcomes. Motivation to maintain adherence is one aspect of the complex process required for sustained behavior change. Fear is recognized as an acute motivator, and the COVID-19 pandemic created a significant fear stimulus, especially in people with underlying respiratory disease. The objective of this study was to explore changes in nebulizer use in response to the COVID-19 pandemic. Method(s): This 16-center cohort study involved more than 60% of adult CF centers in England through the CFHealthHub learning health system. CFHealthHub was established in 2015 to help promote adherence to nebulized therapy. It provides people with CF and their clinicians objective usage information through nebulizers with real-time electronic data capture capability. We explored the association between the first U.K. national lockdown (March 23, 2020, to May 28, 2020) and nebulizer use, using the mixed-effect multilevel model adjusted for potential confounders including age (fitted as a nonlinear term), sex, and deprivation index. Result(s): We included 581 adults with CF participating in CFHealthHub between September 1, 2019, and August 21, 2020. Mean age was 34;49% participants were female. The range of mean weekly nebulizations per patient increased from 9 to 12 to 12 to 14 in the week after the first U.K. national lockdown before decreasing to 11 to 12 throughout the rest of the study period (Figure 1). The association between lockdown and nebulizer Figure 1: Mean weekly nebulizations in 581 adults with cystic fibrosis at 16 U.K. centers between September 2019 and August 2020.(Figure Presented) use was attenuated after adjusting for age, sex, and deprivation index (adjusted odds ratio = 0.96, 95% CI, 0.89-1.07). Conclusion(s): We did not find a sustained change in nebulizer use in response to the firstU.K. national lockdown. This may support the assertion that behavior change with respect to sustained increased nebulizer use may not be achieved when focusing on motivational aspects, especially fear, alone Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Developing a highly-reliable learning health system.

Multiple independent frameworks to support continuous improvement have been proposed to guide healthcare organizations. Two of the most visible are High-reliability Health care, (Chassin et al., 2013) which is emphasized by The Joint Commission, and Learning Health Systems, (Institute of Medicine, 2011) highlighted by the National Academy of Medicine. We propose that organizations consider tightly linking these two models, creating a "Highly-reliable Learning Health System." We describe several efforts at our organization that has resulted from this combined model and have helped our organization weather the COVID-19 pandemic. The organizational changes created using this framework will enable our health system to support a culture of quality across our teams and better fulfill our tripartite mission of high-quality care, effective education of trainees, and dissemination of important innovations.

Developing a highly-reliable learning health system.

Multiple independent frameworks to support continuous improvement have been proposed to guide healthcare organizations. Two of the most visible are High-reliability Health care, (Chassin et al., 2013) which is emphasized by The Joint Commission, and Learning Health Systems, (Institute of Medicine, 2011) highlighted by the National Academy of Medicine. We propose that organizations consider tightly linking these two models, creating a "Highly-reliable Learning Health System." We describe several efforts at our organization that has resulted from this combined model and have helped our organization weather the COVID-19 pandemic. The organizational changes created using this framework will enable our health system to support a culture of quality across our teams and better fulfill our tripartite mission of high-quality care, effective education of trainees, and dissemination of important innovations.

Evaluating a learning health system initiative: Lessons learned during COVID-19 in Saskatchewan, Canada.

Introduction: Evaluating a learning health system (LHS) encourages continuous system improvement and collaboration within the healthcare system. Although LHS is a widely accepted concept, there is little knowledge about evaluating an LHS. To explore the outputs and outcomes of an LHS model, we evaluated the COVID-19 Evidence Support Team (CEST) in Saskatchewan, Canada, an initiative to rapidly review scientific evidence about COVID-19 for decision-making. By evaluating this program during its formation, we explored how and to what extent the CEST initiative was used by stakeholders. An additional study aim was to understand how CEST could be applied as a functional LHS and the value of similar knowledge-to-action cycles. Methods: Using a formative evaluation design, we conducted qualitative interviews with key informants (KIs) who were involved with COVID-19 response strategies in Saskatchewan. Transcripts were analyzed using reflexive thematic analysis to identify key themes. A program logic model was created to represent the inputs, activities, outputs, and outcomes of the CEST initiative. Results: Interview data from 11 KIs were collated under three overarching categories: (1) outputs, (2) short-term outcomes, and (3) long-term outcomes from the CEST initiative. Overall, participants found the CEST initiative improved speed and access to reliable information, supported and influenced decision-making and public health strategies, leveraged partnerships, increased confidence and reassurance, and challenged misinformation. Themes relating to the long-term outcomes of the initiative included improving coordination, awareness, and using good judgment and planning to integrate CEST sustainably into the health system. Conclusion: This formative evaluation demonstrated that CEST was a valued program and a promising LHS model for Saskatchewan. The future direction involves addressing program recommendations to implement this model as a functional LHS in Saskatchewan.

COMPARING OUTCOMES IN COVID-19 PATIENTS WHO RECEIVED STANDARD, INTERMEDIATE, OR TREATMENT DOSE ENOXAPARIN AND UNDERWENT INTENSIVE CARE: A LEARNING HEALTH SYSTEM SCIENCE INITIATIVE

BACKGROUND: Effectiveness of anticoagulation dosing strategies on outcomes in hospitalized COVID-19 patients was examined by REMAPCAP (standard vs. treatment-dosing and the Inspiration trial (standard vs. “Intermediate” dosing). Intermediate dosing was defined as < 1mg/kg daily but > 30-40mg QD). To our knowledge there has not been a study which compared the three regimens in COVID-19 patients who underwent intensive care. METHODS: Data were ed under IRB exemption from electronic medical records of consecutively discharged or expired patients who received at least one dose of enoxaparin and underwent intensive care. Patients were stratified by primary anticoagulation regimen received during their hospitalization defined as regimen received for 24h consecutively and 51% of their anticoagulation course. Patients receiving oral anticoagulation for other reasons were excluded. Continuous data were summarized with median [IQR] compared using Kruskal-Wallis Test. Discrete data were summarized as proportions compared with chi-squared test. Mortality confounders statistically balanced included age, sex, race, comorbidities, and local 4-surges of pandemic with multiple contrast. p <0.017 was significant. RESULTS: Descriptive statistics for patient characteristics, clinical course and outcomes are presented in attached table. Significantly different age strata were 18-39 and 70-79 years. There were no significant differences in comorbidities, time to anticoagulation, acute physiology score, ventilator days, or ICU and hospital LOS. CONCLUSIONS: No significant difference was observed between standard and intermediate groups with respect to VTE, ventilator days, vasopressor use, ICU or hospital LOS, death, or DC. Mortality and DC to hospice were significantly higher in the treatment dose group vs. the standard and intermediate groups.

Subcutaneous Sarilumab for the Treatment of Hospitalized patients with Moderate to Severe COVID19 Disease: A Pragmatic, Embedded, Multi-Center Randomized Clinical Trial

Background. The aim of this pragmatic, embedded adaptive trial was to measure the effectiveness of subcutaneous sarilumab in addition to an evolving standard of care for clinical management of inpatients with moderate to severe COVID-19 disease (NCT04359901). The study is also a real-world demonstration of the realization of a prospective learning healthcare system. Methods. Two-arm, randomized, open-label controlled 5-center trial comparing standard care alone to standard care (SOC), which evolved over time, with addition of subcutaneous sarilumab (200 mg or 400 mg anti-IL6R) among hospitalized patients with moderate to severe COVID-19 not requiring mechanical ventilation. The primary outcome was 14-day incidence of intubation or death. The trial used a randomized play-the-winner design and was fully embedded within the EHR system, including the adaptive randomization process. Results. Among 417 patients screened, 162 were eligible based on chart review, 53 consented, and 50 were evaluated for the primary endpoint of intubation or death ( >30% of eligible patients enrolled) (Figure 1). After the second interim review, the unblinded Data Monitoring Committee recommended that the study be stopped due to concern for safety: a high probability that rates of intubation or death were higher with addition of sarilumab to SOC (92.6%), and a very low probability (3.4%) that sarilumab would be found to be superior. Conclusion. This randomized trial of patients hospitalized with COVID-19 and requiring supplemental oxygen but not mechanical ventilation found no evidence of benefit from subcutaneous sarilumab in addition to an evolving standard-of-care. The numbers of patients and events were too low to allow independent conclusions to be drawn, but this study contributes valuable information about the role of subcutaneous IL-6 inhibition in the treatment of patients hospitalized with COVID-19. The major innovation of this trial was the advancement of embedded, point-of-care clinical trials for FDA-approved drugs;this represents a realization of the learning healthcare system. Methods developed and piloted during the conduct of this trial can be used in future investigations to speed the advancement of clinical science.

Prevalence of anxiety and depression during COVID-19 pandemic among healthcare students in Jordan and its effect on their learning process: A national survey

Rational: During pandemics, including the most recent COVID-19 pandemic, the mental health of university healthcare students' is expected to be affected negatively, impacting the students' learning process. Objectives: The aim of this study was to assess the level of anxiety and depression of healthcare students living in Jordan, and the effect on their learning process during the COVID-19 pandemic. Methods: This descriptive cross-sectional study was conducted via an online survey completed by students studying a healthcare-oriented degree in a university in Jordan. Participants were recruited through social media (Facebook and WhatsApp). The validated previously published Hospital Anxiety and Depression Scale (HADS) questionnaire was used as a part of the online survey to assess students' anxiety/depression scores. Students' responses regarding their learning process during the COVID-19 was also assessed. Results: The mean age of participants was 21.62 (SD = 4.90), with the majority being females (67.1%). The HADs' assessment revealed that 43.8% and 40.0% of participants had normal anxiety and depression scores, while 22.4% showed borderline abnormal anxiety/depression scores (33.8%). Many students (33.8%) were classified to have abnormal anxiety scores, while a smaller proportion (26.2%) was classified to have abnormal depression scores. Smoking (p = 0.022), lower family income (p = 0.039), and use of medications (p = 0.032) were positively associated with higher (worse) anxiety scores. Ranking the learning process during COVID-19 showed that 45.8% of the participants believed it was a 'good/ very good/excellent' process. Conclusions: Anxiety and depression levels amongst university healthcare students in Jordan were found to be high when assessed during the COVID-19 pandemic. In addition, the learning process during the pandemic was not accepted by more than half of the students. Implementing psychological interventions for healthcare students during pandemics is strongly recommended in order to optimize students' mental health and their learning process alike. (PsycInfo Database Record (c) 2022 APA, all rights reserved)