IMPROVING PATIENT SAFETY THROUGH THE ESTABLISHMENT OF A PHARMACIST-LED BLOOD MONITORING CLINIC FOR JAK INHIBITORS IN RHEUMATOLOGY

BackgroundJanus kinase inhibitors drugs (JAKi) are novel small molecule medications known to cause abnormalities such as elevations in hepatic transaminases, decreases in neutrophil and lymphocyte counts and elevations in cholesterol and creatinine kinase. Blood monitoring is recommended and dose adjustments are advised if abnormalities arise. Recent warnings by the EMA and MHRA have highlighted the importance of monitoring these medications.Timely review and management of patients on JAKi drugs is difficult to maintain with increasing workload amongst the rheumatology team. A baseline audit (2020) demonstrated that hospital blood monitoring guidelines for JAKi drugs were not being followed. The rheumatology multidisciplinary team met and utilised Quality Improvement methodology including fish and driver diagrams to address this. This led to the creation of a pharmacist-led JAKi blood monitoring clinic.ObjectivesTo establish a pharmacist-led rheumatology blood monitoring clinic for the JAKi drug class in order to: increase patient safety with increased compliance to blood monitoring, save consultant/nurse time, improve communication with primary care on the frequency of blood testing required, increase patient understanding of the importance of blood monitoring with JAKi drugs, reinforce counselling advice such as risk of infections, shingles and thrombosis and promote medication adherence.MethodsThe clinic was established in March 2021. Patients commencing JAKi drugs are referred to the pharmacist-led clinic by the medical team. The pharmacist contacts the patient by phone following delivery of their medication. The patient is counselled on their new medication and dates for blood checks are agreed. A letter is sent to the patient and their GP providing this information. The patient is booked into virtual telephone appointments and bloods are monitored every month for the first 3 months and every 3 months thereafter. Any change or abnormality in blood results are flagged early in the patient's treatment and if necessary, discussed with the consultant. Adjustments are made to the patient's dose if appropriate.ResultsIn order to evaluate the benefit of the pharmacist clinic a re-audit of compliance with blood monitoring (March 2021- September 2022) was carried out alongside a patient satisfaction postal survey (August 2022).A total of 58 patients were sampled in the re-audit. The re-audit found an increase in compliance in blood monitoring since the introduction of the pharmacist clinic. 98% of patients had their full blood count performed at 3 months compared to 56% in audit 1 and 95% of patients had their lipid profile completed at 3 months compared to 15% in audit 1 (Table 1).A patient satisfaction survey (N=62, response rate 48%) found that 28 (93%) patients either agreed or strongly agreed that they were more aware of the importance of attending for regular blood monitoring when prescribed JAKi therapy as a result of the clinic.The pharmacy team made several significant interventions (self-graded Eadon grade 4 and 5). For example by improving medication adherence, detecting haematological abnormalities that required JAKi dose reduction, identifying patients suffering from infection requiring intervention including shingles and Covid-19.Table 1.Comparison of audit results pre (Audit 1) and post (Audit 2) clinic establishmentAudit 1 (N=48)Audit 2 (N=58)Number of patients with full blood count completed at weeks 4, 8 & 1227 (56%)57 (98%)Number of patients with lipid profile completed at week 127 (15%)55 (95%)Number of patients LFTs completed at weeks 4, 8 & 1226 (54%)54 (93%)ConclusionIntroduction of the pharmacist-led clinic has increased patient safety by ensuring compliance with blood monitoring as per hospital guidelines. The clinic has paved the way for improved communication with primary care teams and has provided patients with extra support during their first months on treatment with their JAKi. It has also expanded the role of the rheumatology pharmacy team and saved nursing and medical time.Acknowled ementsI wish to thank the SHSCT Rheumatology team for all their help, support and guidance with this project.Disclosure of InterestsNone Declared.

Defence context for the UK's Defence Engagement (Health).

Defence Engagement (DE) has been a core UK Defence task since 2015. DE (Health) is the use of military medical capabilities to achieve DE effects within the health sector to achieve security and defence objectives. DE (Health) practitioners must understand the underlying defence context that shapes these objectives. The strategic context is becoming more uncertain with the return of great power competition layered on enduring threats from non-state actors and transnational challenges. The UK response has been to develop the Integrated Review, outlining four national security and international policy objectives. UK Defence has responded by developing the integrated operating concept, differentiating military activity between operating and warfighting. Engage is one of the three functions of operate activity, which is complementary to the other operate functions of protect and constrain. DE (Health) can play a unique role in engagement, given its ability to develop new partnerships through health-related activity. DE (Health) may be an enabler for other engagements or to enable the protect and constrain functions. This will be dependent on delivering improvement in health outcomes. Therefore, the DE (Health) practitioner must be conversant with both the contemporary defence and global health contexts to deliver effective DE (Health) activities. This is an article commissioned for the DE special issue of BMJ Military Health.

Accounting for partisanship and politicization: Employing Benford's Law to examine misreporting of COVID-19 infection cases and deaths in the United States

The unprecedented contagion of the SARS-CoV-2 virus, causative of COVID-19, has spawned watershed economic, social, ethical, and political upheaval—catalyzing severe polarization among the global populace. Ostensibly, to demonstrate the most appropriate path towards responding to the virus outbreak, public officials in the United States ("U.S.”), representing both Democratic and Republican parties, stand accused of unduly influencing COVID-19 records in their respective jurisdictions. This study investigates the role political partisanship may have played in decreasing the accuracy of publicly reported COVID-19 data in the U.S. Leveraging social identity theory, we contend that public officials may have manipulated the reporting records in accounting for COVID-19 infection cases and deaths to validate the effectiveness of political party objectives. We employ Benford's Law to assess misreporting and evaluate the integrity of county-level COVID-19 reporting data through the construction of four distinct political party classifications. Specifically, we cross the county voting majority for the 2016 presidential candidate for each U.S. state (Democratic and Republican) with the 2020 gubernatorial political party (Democratic and Republican) in which each county resides. For the sample period of January 21, 2020 through November 3, 2020 (Election Day), the study's results suggest that the reported COVID-19 infection cases and deaths in the U.S. violate Benford's Law in a manner consistent with underreporting. Our analysis reveals that Democratic counties demonstrate the smallest departures from Benford's Law while Republican counties demonstrate the greatest departures. © 2023 Elsevier Ltd

Older Chinese and Korean migrants' experiences of the first COVID-19 lockdown in Aotearoa New Zealand: A qualitative study

Later-life migrants, as older people living away from their home nations, occupy multiply-precarious positions in relation to national COVID-19 pandemic responses. Concern has particularly centred on this group's increased risk of social and linguistic exclusion. We explore the perspectives of later-life older Chinese and Koreans living in New Zealand during the nation's COVID-19 lockdown of 2020. This paper presents a sub-analysis of culturally-matched interviews conducted with 3 Korean and 5 Chinese later-life migrants. These participants are a sub-sample of a larger qualitative interview study comprising 44 interviews. A social capital approach has been used to aid conceptualisation of participants' experiences and a reflexive thematic approach guided analysis. Despite their underrepresentation in national response efforts, Chinese and Korean later-life migrants resourcefully participated in ethnically-specific pandemic initiatives. Three themes identified were: (1) taking it seriously (2) already digitally literate (3) challenges and difficulties. Older Asian migrants engaged in a range of creative strategies to stay connected during COVID-19 lockdowns which drew heavily on pre-existing social capital. Future pandemic responses should seek to improve connectedness between the national government COVID-19 response and older Korean and Chinese later-life migrants. © 2022 The Authors. Asia Pacific Viewpoint published by Victoria University of Wellington and John Wiley & Sons Australia, Ltd.

Using diverse community feedback to inform inclusive community action: Insights from the Louisiana Community Engagement Alliance

Purpose of Study: Clinical trial participation remains low among US minority groups, who account for <1/10 of trial participants.1,2 Diverse, equitable and inclusive participation is needed to lessen disparities in health status and clinical outcomes.3 Community-based participatory research (CBPR) strategies identify salient community issues, and may be useful for understanding and addressing participation barriers among minority groups.4,5 The Louisiana Community Engagement Alliance Against COVID-19 Disparities (LA-CEAL) - a partnership of universities, community pharmacies, faith-based organizations (FBOs), and federally qualified health centers (FQHCs) - aims to strengthen and leverage community relationships to address barriers to uptake of preventive/therapeutic strategies in underserved populations. This study examines the utility of LA-CEAL's CBPR approach in facilitating inclusive participation in clinical trials. Methods Used: Listening forums were held with a diverse group of LA community stakeholders, including healthcare providers, community pharmacists, FBO leaders and other trusted community members, to gather views on the need for and challenges to inclusive trial participation. Ongoing discussions between community representatives and leaders, academics and program staff facilitated outreach and guided development of informational strategies targeting minority groups. Summary of Results: Listening forums (N = 4;20 participants) revealed limited awareness, mistrust and fear stemming from historical and present injustices, and difficulty accessing opportunities as key themes underlying barriers to participation. To address identified barriers, 8 video testimonials featuring participants, investigators, and health advocates (62.5% Black;12.5% Hispanic;50% female) were developed to educate on expectations and experiences, motivations to participate, human subject protections, and the importance of diversity. Two animated videos featuring trusted community leaders and cultural ambassadors (e. g., New Orleans cultural icon, Irma Thomas) were created to explain trial processes, discuss participation benefits, and address the history of racism in medicine. Finally, connections between the Tulane Clinical Translational Unit and rural FQHCs enabled clinical trial study buses to visit and recruit in diverse LA communities. Conclusion(s): Via LA community stakeholder discussions, targeted strategies to address barriers to minority participation in clinical trials were developed and applied. Use of CBPR strategies was critical to developing intentional action reflective of LA community needs. Copyright © 2023 Southern Society for Clinical Investigation.

Geauxhealth.org - A technological approach to addressing social determinants of health in New Orleans

Purpose of Study: GeauxHealth! is a multi-institutional, multi-disciplinary collaboration designed to create an easy-to-use guide for community health resources based on significant need in the Greater New Orleans area. The 2019 New Orleans Community Health Assessment found that New Orleanians identified mental health, substance use, women's health and chronic medical diagnosis management as areas of concern. Health barriers identified include crime and violence, infrastructure, environmental factors, healthy food, housing and income Additionally, the COVID-19 pandemic has further highlighted health inequity in communities across the United States. In an effort to address these findings and to promote awareness of social determinants of health among providers, Geauxhealth.org was created with a vision to be an updated, user-friendly website created by medical trainees for medical trainees and patients. Methods Used: 139 residents and fellows across multiple specialties within Tulane School of Medicine and LSUHSC School of Medicine were surveyed before and after the introduction of Geauxhealth.org. Summary of Results: When asked about confidence in referring patients to community resources when needed, 27% of trainees answered "Definitely not confident" and 31% answered "Somewhat confident." Nearly all respondents noted that barriers to referring patients to resources included: "Lack of Time" and "Lack of Knowledge." 96% of trainees noted they would use a website or app if available for referring patients to community resources. Post-intervention results are currently being analyzed. Conclusion(s): Awareness of social determinants of health is the first step in addressing health inequity experienced by the patients we serve. GeauxHealth! is designed to bridge the gap between awareness and action. Over time, the hope is for GeauxHealth! to serve as education for [Table presented] incoming residents, to be a utilized tool by providers, hospital employees and patients and to create a framework for the development of health resource guides in other cities. Copyright © 2023 Southern Society for Clinical Investigation.

The NSW Telestroke Service: A cross-agency collaboration to implement and sustain a virtual care hyperacute stroke service at 23 regional and rural hospitals

Background: The $21.7 million NSW Telestroke Service was a 2019 NSW Government election commitment. Implementation of the service is a collaboration between South Eastern Sydney Local Health District, the NSW Agency for Clinical Innovation, eHealth NSW and the NSW Ministry of Health. Between March 2020 and June 2022, the telestroke service launched at 23 sites across regional and rural NSW, providing access to specialist stroke physicians for rapid assessment, diagnosis and treatment through virtual care. The service has treated over 2200 patients with a reperfusion rate for acute ischaemic stroke patients of 34%. Aim(s): To understand the factors driving the successful implementation of a major project led by multiple health organisations in a complex environment. Interrogating and documenting the success factors will help NSW Health agencies implement similar large-scale, complex projects. Method(s): The implementation team adopted a reflective approach to draw out key lessons during the implementation at each site. Lessons learnt discussions were held at a local and program-wide level, focusing on areas including resourcing, leadership, education and training, and sustainability. Result(s): Key elements of successful implementation highlighted by the reflective lessons learnt approach include: * Division of responsibility that reflected the strengths of each partner agency * Clear implementation roadmap including comprehensive implementation and training packages * Flexibility to adapt the implementation approach based on contextual factors and intervening events * Strong executive support at each partner agency * Upfront focus on sustainability to identify and mitigate issues early on The telestroke service was implemented by the target schedule, despite the significant impacts caused by the COVID-19 pandemic and natural disasters. The service was a finalist in the 2021 NSW Premier's Awards. Conclusion(s): The implementation of telestroke can offer insights for partner agencies into the key factors driving success of transformative projects to improve access to healthcare.

Preparation of Female and Minority PhD and Post-Docs for Careers in Engineering Academia (Experience)

Improving undergraduate STEM teaching for diverse students is dependent to some extent on increasing the representation of Black, Indigenous and People of Color (BIPOC) and women in the ranks of faculty in engineering departments. However, new faculty members, whether they had postdoctoral training or not, report that they were not adequately prepared for academia. To address this need, a professional development program was developed for underrepresented doctoral and postdoctoral students, which focused on various strategies to be successful in teaching, research and service aspects of academic positions. The program included an intensive two-week summer session, with follow-up mentoring during the academic year, and was conducted from 2017 to 2020 with three cohorts of fellows recruited from across the country. To evaluate the impact of the program on the participants' perceptions of their preparation for academic careers, a follow up survey was sent in May 2021 to the three former cohorts of participants (n=61), and responses were received from 37 of them. The survey asked participants to reflect on areas that they felt most prepared for in their academic positions, and areas that they felt least prepared for. The survey also asked participants to discuss additional supports they would have liked to have been provided with to better prepare them given their current positions (academic, industry, etc.). Results from the survey indicated that 92% of participants found the professional development program prepared them for the responsibilities and expectations to succeed in academic positions. Over 90% agreed that the program prepared them for the application process for a tenure track search, and 89% agreed the program prepared them for the primary components of the startup package. In addition, participants reported that the program increased their preparation in developing teaching philosophy (100%), developing learning outcomes (97%), and using active learning strategies during teaching (91%). The majority agreed that the program helped prepare them to teach students with various cultural backgrounds, and to develop and use assessment strategies. Participants were also asked to discuss the impact of the Covid 19 pandemic on their career trajectory, and most of them reported being somewhat impacted (65%) to extremely impacted (29%). Participants reported few or no job openings, cancelations of interviews, delays in research which impacted the rate of completing degrees, and publications, which affected the participants' application competitiveness. Furthermore, working from home and balancing family and academic responsibilities affected their productivity. Based on the survey results, funds were secured to provide an additional day of professional training to cover any items not addressed during summer training, as well as any issues, challenges, or concerns they might have encountered while fulfilling their academic position. Thirty-three ACADEME fellows have indicated that they will participate in the new professional development, held in May 2022. Results from this analysis, and preliminary topics and outcomes of the supplemental activities are discussed. The findings contribute to the literature by increasing knowledge of specific challenges that new faculty encounter and can inform future efforts to support minorities and women in engineering doctoral programs. © American Society for Engineering Education, 2022.

SETTING PRIORITIES FOR CONNECTIONS AND ACTIVITIES DURING A PANDEMIC

This paper will describe and analyze restrictions on connection and interaction (i.e., social distancing) during the first pandemic in a century. During a pandemic, decision makers are required to make difficult decisions with incomplete information, under high levels of uncertainty, public scrutiny and urgency. Many critical and far-reaching priority setting decisions have occurred outside the health sector, for instance the closing of schools or restrictions on businesses or transportation. These decisions, like decisions about allocating vaccine or hospital care, involve the allocation of some budgetary and human resources. However, more so than in healthcare, they also explicitly involve the allocation of burdens or costs, from both limits on movement and, for instance for service workers, greater exposure to infection. These decisions, like those about allocating healthcare resources, have critical consequences for health. Households suffer job losses and reduced income;children miss school;many, especially those residing in institutions, suffer social isolation- outcomes which have been associated with declines in physical and mental health. These burdens of restrictions on movement and connection and consequent health outcomes may be unevenly distributed and exacerbate existing health inequities. Fair decision making about priorities for connection and interaction is as crucial as fair decision making about allocating intensive care and vaccine. The application of priority setting methods and principles, however, has focused on healthcare and not on other policy actions that can profoundly influence health. This paper presents an analysis of restrictive measures introduced during the COVID-19 pandemic, what we have learned, so far, about the consequences of those restrictions, and makes recommendations for the development and application of priority setting frameworks in this arena to inform future research and practice.

How has the COVID-19 pandemic influenced patient-centred care? Analysis of a qualitative collective case study by high-performing practice teams

Background and objective The COVID-19 pandemic has significantly affected primary healthcare systems throughout the world. The aim of this article is to present the analysis of the perspectives and experiences of patientcentred care (PCC) during the pandemic by high-functioning general practice teams in Australia. Methods A qualitative descriptive approach and collective case study method was employed. Participants, who undertook a semi-structured interview, were representatives of high-functioning general practice teams. Reflective thematic analysis was applied to all interview data (meta-synthesis) using a constant comparison approach. Results Five clinic representatives were interviewed. Six themes developed, highlighting that despite the pandemic creating new challenges to delivering PCC, general practice teams maintained a focus on PCC. General practice teams adapted to deliver PCC through strategies not used prior to the pandemic. Discussion This study identified new approaches to PCC that can guide other general practices and progress the health system towards policy-based PCC objectives.

Hand Washing Observations in Fast-Food and Full-Service Restaurants: Results from the 2014 U.S. Food and Drug Administration Retail Food Risk Factors Study.

ABSTRACT: Properly executed hand washing by food service employees can greatly minimize the risk of transmitting foodborne pathogens to food and food contact surfaces in restaurants. However, food service employee hand washing is often not done correctly or does not occur as often as it should. The purpose of this study was to assess the relative impact of (i) the convenience and accessibility of hand washing facilities; (ii) the maintenance of hand washing supplies, (iii) multiunit status, (iv) having a certified food protection manager, and (v) having a food safety management system for compliance with proper hand washing. Results revealed marked differences in hand washing behaviors between fast-food and full-service restaurants; 45% of 425 fast-food restaurants and 57% of 396 full-service restaurants were out of compliance for washing hands correctly, and 57% of fast-food restaurants and 78% of full-service restaurants were out of compliance for employee hands being washed when required. Logistic regression results indicated the benefits of accessibility and maintenance of the hand washing sink and of a food safety management system for increasing the likelihood of employees washing hands when they are supposed to and washing them correctly when they do.

Predicting death from COVID-19 using pre-existing conditions: implications for vaccination triage.

INTRODUCTION: Global shortages in the supply of SARS-CoV-2 vaccines have resulted in campaigns to first inoculate individuals at highest risk for death from COVID-19. Here, we develop a predictive model of COVID-19-related death using longitudinal clinical data from patients in metropolitan Detroit. METHODS: All individuals included in the analysis had a laboratory-confirmed SARS-CoV-2 infection. Thirty-six pre-existing conditions with a false discovery rate p<0.05 were combined with other demographic variables to develop a parsimonious prediction model using least absolute shrinkage and selection operator regression. The model was then prospectively validated in a separate set of individuals with confirmed COVID-19. RESULTS: The study population consisted of 15 502 individuals with laboratory-confirmed SARS-CoV-2. The main prediction model was developed using data from 11 635 individuals with 709 reported deaths (case fatality ratio 6.1%). The final prediction model consisted of 14 variables with 11 comorbidities. This model was then prospectively assessed among the remaining 3867 individuals (185 deaths; case fatality ratio 4.8%). When compared with using an age threshold of 65 years, the 14-variable model detected 6% more of the individuals who would die from COVID-19. However, below age 45 years and its risk equivalent, there was no benefit to using the prediction model over age alone. DISCUSSION: Using a prediction model, such as the one described here, may help identify individuals who would most benefit from COVID-19 inoculation, and thereby may produce more dramatic initial drops in deaths through targeted vaccination.

Pediatric gastroenterology tool kit for telemedicine during the COVID-19 pandemic

Background/Significance: Telehealth (TH) services rapidly expanded during the COVID-19 pandemic. This rapid deployment precluded the opportunity for initial planning of implementation strategies. Purpose and Goals: To understand the needs of nurse practitioners and examine TH procedures and interventions designed to promote high quality, equitable health care for pediatric patients with gastrointestinal concerns. Methods: The Plan, Do, Study, Act model was used. Survey data from providers and families were collected and analyzed. They were further illuminated through iterative dialog across the research team to determine the quality and efficiency of TH. Findings: A toolkit of strategies for promoting the quality and efficiency of TH was created according to the three domains of health equity: availability, accessibility, and acceptability. We reached the following conclusions: No specific telehealth training and competencies have been established for NPs. Interpreters are needed for patients who have language barriers and hearing impairment. Scheduling flexibility and revenue needs should account for increased time needed for complex patients. Technology needs to be current for NPs and patients to prevent audiovisual failures. Reading level of introductory TH emails need to be at a 5th grade literacy level and should be available in different languages. Ideally families should have access to a scale at home since accurate weights are an integral part of the GI visit. Patient's location should be matched with location of clinic when scheduling appointments so that follow up care can be provided easily when visits are in person. Physical examination is limited and laboratory orders and stool/urine collections require a prescheduled appointment. Implications/Next Steps: Development and implementation of comprehensive education to address the above findings. Ongoing collaboration with virtual visit team and AAs to find systems to proactively arrange for interpreters and flexibility with allotted time for visits. Provide alternate methods to support families with audio/visual difficulties;IT/help desk telephone number and option of in-person visits. Introductory email that meets literacy standards now includes specific expectations, including: all patient visits need to be done in a private setting, presence of patient for the entire visit, and weight to be obtained before visit. Development and provision of alternative communication when audio connectivity fails, ie: flashcards to alert family and suggest solutions (signing in/out of appointment) to preserve full audio/visual visit capabilities. Develop algorithm to prioritize in person visits, based on acuity of presenting illness and complexity of patient.

Implementation of a novel patientreported outcomes measure for patients with cancer and COVID-19 infection

Background: The long-term symptoms from COVID-19 (C19) infection in pts with cancer is not fully known. To monitor the evolution of this symptom burden over time, we designed and implemented a C19-specific patient-reported outcome (PRO) measure that integrated with a known measure of cancer symptom burden. Methods: Within the institutional initiative on C19 and cancer named Data-Driven Determinants for C19 Oncology Discovery Effort (D3CODE), pts with cancer & PCR-pos C19 are invited to participate in this longitudinal study. Pts complete the EQ-5D-5L, the 13 symptom severity & 6 interference items of the core MD Anderson Symptom Inventory (MDASI)+14 COVID-specific items, all scored on a 0-10 scale, 0 = none, 10 = worst imaginable. Pts complete the survey daily x 14 days from positive test date, then weekly x 3months, then monthly x 2yrs. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: Between 5/15/20-02/14/21, 2154 pts w PCR-confirmed C19 were invited to participate in the longitudinal study. 1282 (60%) pts provided consent and began the longitudinal completion of PRO surveys. Pts were 54.5% Female and 45.5% Male, median age 59 years (range 15-92). 1021 (80%) are White/Caucasian, 206 (16%) Hispanic, 113 (9%) African American, and 39 (3%) Asian. The validation analysis of MDASI-COVID instrument included the 1 600 pts where the mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). showed internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation =-0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between pts who required hospitalization (symptom M 2.32, SD 2.09;interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85;interference M 2.20, SD 2.64) (symptom P 0.007;interference P 0.004). Conclusions: We successfully deployed a PRObased long-term symptom monitoring platform for pts with C19 and cancer. The validation analysis of this novel C19 specific PRO, the MDASI-COVID, AIDS in the quantification of the global symptom burden in pts with both cancer and COVID-19 infection. Deployment of this measure in the ongoing longitudinal observational cohort allows for in-depth understanding of the long-term symptoms related to C19 and cancer.

Disenfranchised: How Lower Income Mothers Navigated the Social Safety Net during the COVID-19 Pandemic

Government programs and other forms of assistance act as critical safety nets in times of crisis. The federal government’s initial response to coronavirus disease 2019 represented a significant increase in the welfare state, but the provisions enacted were not permanent and did not reach all families. Drawing on interviews with 54 lower-income mothers and grandmothers, we analyze how families navigated the safety net to access food during the pandemic. Pandemic aid served as a critical support for many families, but participants also described gaps and barriers. Following the argument that food is a basic human right, we identify how mothers encountered three forms of disenfranchisement: being denied or experiencing delayed public benefits, being afraid to access assistance, and receiving paltry or inedible emergency food. We conclude by arguing for an expanded social safety net that broadens access to necessary food resources before, during, and after crises such as the coronavirus disease 2019 pandemic. © The Author(s) 2021.

Real-world patient-reported and clinical outcomes of BNT162b2 mRNA COVID-19 vaccine in patients with cancer

Background: Most COVID-19 (C19) vaccine trials excluded patients with active cancer. Here, we report our real-world patient-reported and clinical outcomes of BNT162b2 mRNA C19 vaccine in patients with cancer. Methods: Our institutional Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE) follows a longitudinal observational cohort of pts w cancer getting C19 vaccine. Pts complete a validated PRO tool, MD Anderson Symptom Inventory (MDASI, 13 core, 6 interference plus 17 items of symptoms from prior vaccine trials) pre-dose 1, then daily x 6d, then weekly, then on day of dose 2, then daily x 6d, then weekly x 3w. Demographics, cancer variables, prior immune checkpoint inhibitors (ICI), C19 status pre- & post-vaccine are aggregated via Syntropy platform: Palantir Foundry. Primary outcome is incidence of PRO symptoms bw dose 1 & 2 across AYA 15-39y, mid-age 40-64y & senior 65y+ cohorts. Secondary outcomes include PRO symptom incidence post-dose 2, post-vaccine change in cancer symptoms, post-vaccine symptom severity based on prior ICI, and confirmed C19 > 7 days post-dose 2. First planned 8-wk interim analysis is reported here. Results: 6388 pts w cancer (4973 w mets) received a BNT162b2 vaccine dose (4811 both doses, 1577 received one & await dose 2). Overall, median age 64y (range 16-95y);382 AYAs, 2927 mid-age, 3079 seniors (65-70y n = 1158, 70-79y n = 1521, 80-89y n = 378, 90y+ n = 22). 4099 (64%) are White, 823 (13%) AA, 791 (12%) Hispanic, 441 (7%) Asians. Primary cancers: breast (1397), GU (821), heme (775), thoracic/HN (745), and CRC (385). Prior to dose 1, 1862 had no prior systemic tx while 4526 pts did including 3243 who had only non-IO tx (chemo, targeted tx), 1,283 had immunotherapy including 857 who had ICIs prior to dose 1. Patient-reported symptoms after C19 Vaccine: Of 6388 pts, 4714 (74% response rate, median age 67y, range 16-95y) completed 16485 PRO surveys. After 2 doses, seniors reported lower mean scores vs mid-age or AYAs on 22 of 36 symptoms including injection site pain, palpitations, itch, rash, malaise, fevers/chills, arthralgia, myalgia, headache, pain, fatigue, nausea, disturbed sleep, distress (p < 0.05). Pts w prior ICIs had higher severity of itch, rash (p < 0.05) from baseline after both dose 1 & 2 vs pts without systemic tx. Post dose 1, pts with prior ICI had higher increase in fatigue, malaise, itch, rash, myalgia, anorexia from their baseline vs pts without systemic tx (p < 0.05). C19 Outcomes: Of 6388 pts, 616 had a C19 test at any time post-dose 1: 23 (0.36%) tested positive of whom 20 (0.3%) were between dose 1 & 2;two (0.031%) were within 7 days post-dose 2, and one patient (0.016%) tested positive 16 days after dose 2, requiring admission. Conclusions: This real-world observational cohort demonstrates post-vaccine symptom burden and outcomes in patients with cancer. Second interim analysis is planned at 16 weeks.

Development and validation of a novel patient-reported outcomes (PRO) measure for symptom burden in patients with cancer and COVID-19 infection

Background: The symptom burden experienced by patients with cancer who contract the COVID-19 (C19) infection remains to be fully understood. To accurately assess this symptom burden, we developed a valid, reliable patient-reported outcome (PRO) measure of C19 symptoms combined with a known measure of cancer symptom burden. Methods: Within the institutional initiative on COVID-19 and cancer named Data- Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE), patients with cancer and PCR-positive C19 tests were invited to participate in this longitudinal study after providing consent. Pts completed the EQ-5D-5L and the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 14 COVID-specific symptom items generated from literature and expert review. Items were measured on a 0-10 scale, 0 = none to 10 = worst imaginable symptom or interference. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: 600 pts enrolled, mean age 56.5y (range 20 to 91y). 59% female, 80% white. 78% solid tumors, 19% heme cancers. 12.5% required hospitalization for C19. Median number of days between positive C19 test and PRO completion was 17 days. Mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). Internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between patients who required C19 hospitalization (symptom M 2.32, SD 2.09;interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85;interference M 2.20, SD 2.64) (symptom P 0.007;interference P 0.004). Conclusions: We have validated a novel PRO, the MDASI-COVID, to quantify the combined symptom burden in patients with cancer and COVID-19. This measure allows longitudinal evaluation of COVID-19 on cancer symptom burden and provide clinicians with an accurate tool for ongoing symptom assessment and management. Longitudinal analysis on long-term symptoms related to COVID-19 and cancer are ongoing.

Association of a predatory mite with galls of rosette bud mite (Acari: Phytoptidae)

The occurrence of a phytoseiid mite Typhlodromalus peregrinus (Muma) (Acari: Phytoseiidae), over-wintering in rosette bud mite Tricetacus fraseri Amrine (Acari: Phytoptidae) galls is documented with parameters, including aperture size and morphological features, influencing the occupation of rosette bud mite galls by this predator during the winter months. Observations are made on utilization of T. fraseri as a winter food source for T. peregrinus. This paper also reports on the over wintering stage of T. fraseri. Studies were conducted in a single commercial Fraser fir tree plantation in Ashe County, N.C. during the winter of 2006-7. Twenty-nine phytoseiid mites were found in 14 galls (10.6%). There was an average of 2 phytoseiid mites per gall and the highest number of phytoseiid mites in any one gall was 4. Gall heights, width, cavity depth, and aperture size (n = 121) averaged 7.4 mm, 7.4 mm, 2.1 mm, and 2.0 mm, respectively. The height, width, depth, and aperture size of galls containing T. peregrinus (n = 14) averaged 7.2 mm, 7.5 mm, 2.9 mm, and 1.6 mm, respectively. Typhlodromalus peregrinus was observed feeding on all stages of the rosette bud mite.

Factors associated with COVID-19 infection and severity in a large insured patient population in metropolitan detroit

Introduction: The novel coronavirus disease 2019 (COVID-19) pandemic is a public health emergency that disparately affects older individuals and individuals with chronic health conditions. However, the relative importance of these factors in contributing to infection-related hospitalization or death is not known. Such information could help in identify groups most in need of sheltering or early vaccination. Methods: We investigated the relationship between pre-existing medical conditions and treatments with COVID-19 diagnosis, hospitalization, intensive care unit (ICU) admission, and death. We identified 48,370 individuals aged ≥20 years with detailed longitudinal clinical and pharmaceutical records by virtue of their receiving care from a single, integrated provider serving southeast Michigan and the Detroit metropolitan area. Within this group, there were 1,196 laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections between March 12, 2020 and October 27, 2020. Logistic regression was used to assess the relationship between each of the individual characteristics, pre-existing diagnostic categories and the COVID-19 related outcomes. Results: Age (adjusted odds ratio [aOR] 1.27 per decade;P=2.03x10-6), African American and Asian race-ethnicity (aOR 3.00;P=2.53x10-9 and aOR 2.79;P=0.006, respectively vs. non-Hispanic white), body mass index (aOR 1.04 per unit increase;P=2.44x10-4), renal function (aOR 1.37 per mg/dL increase in serum creatinine;P=8.96x10-8), healthcare occupation (aOR 2.24, P=0.016), and household income (aOR 0.94 per $10,000 increase, P=0.032) were significantly associated with the combined outcome of COVID-19 related hospitalization or death. Many preexisting conditions were associated with COVID-19 hospitalization or death;however, any diabetes (aOR=1.98;P=1.76x10-6) and type-2 diabetes (aOR 1.95;P=3.52x10-6) were the most significant. Other notable associations included pain (aOR 1.71;P=1.07x10-4), history of supplemental oxygen or ventilation (aOR 7.41;P=4.07x10-4), living assistance (aOR 4.46;P=4.07x10-4), prior pulmonary embolism or DVT (aOR 2.61;P=0.001), and opioid use (aOR 3.99;P=0.002). Relationships between COVID-19 severity and both thrombosis and pain were additionally supported by analyzing pharmacy records of anticoagulant and opioid use. Conclusion: This large patient population study supports many of the risk factors previously associated with COVID-19 diagnosis and complications, including age, non-white race-ethnicity, and healthcare occupation. Higher body mass index, poorer renal function, and diabetes appear to be leading independent risk factors. The heightened risk observed for opioid users is novel and requires further investigation.