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Background/Purpose: Receiving a cancer diagnosis during adolescence and young adulthood (AYA;15-39) coincides with a period of pivotal developmental milestones. Coping with the stress of cancer diagnosis exacerbates risk for distress and feelings of isolation among AYAs. Mind-body resiliency programs may offer a compassionate approach for tackling these negative post-treatment psychosocial experiences. The present mixed methods study explores the acceptability of an 8-week, synchronous, virtual group Relaxation Response Resiliency Program (3RP) adapted to address the unique challenges facing AYAs (3RP-AYA). Method(s): Recruitment occurred at an academic hospital in Boston, MA from 03/2019 to 09/2020. Participants (N = 72, Mage = 23.8, female = 73.6%, non-Hispanic White = 59.7%, Hispanic/Latino = 20.8%, 1.6 years post-treatment) were randomized to receive 3RP-AYA immediately (intervention group;n = 35) or after 3 months (waitlist control;n = 37) via Zoom. Electronic surveys were collected before and after participants completed treatment;we report post-treatment survey data measuring acceptability across five domains (enjoyability, helpfulness, convenience, future use, and satisfaction) using 4-point Likert scales (1 = not at all to 4 = very). Qualitative post-treatment interviews further queried program acceptability. Result(s): Program acceptability responses indicated program satisfaction: enjoyability (M = 3.62, SD = 0.69), helpfulness (M = 3.45, SD = 0.75), and convenience (M = 3.67, SD = 0.71). More specifically, 76.7% of participants found the virtual delivery to be very convenient, and 71.7% rated the sessions as very enjoyable. 91.7% of participants reported they were likely/very likely to use learned skills in the future and 91.7% reported the intervention as helpful/very helpful. Additionally, 96.6% reported satisfaction with the overall content. Exit interviews highlighted session intergroup connectivity as a particular strength. Conclusions and Implications: Across multiple domains, the 3RPAYA was deemed acceptable by AYAs. Participants valued the opportunity to learn mind-body skills and connect with other young survivors. The synchronous virtual study platform showed promise for being a convenient and helpful tool to deliver mind-body programs to AYA survivors during the Covid-19 pandemic.
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Ongoing trends towards more flexible work arrangements (FWA) have been accelerated by the Covid-19 crisis. Whilst research has shown the overall benefits FWA can have, limited research has explored whether use and benefits of FWA are equal across differentiated organisational contexts and genders. We suggest that individuals working in their family's business face less organizational constraints that typically hinder employees from taking advantage of FWA. It could be suggested that these workers may make higher use of FWA than individuals in regular employment because of their entrepreneurial status and nepotistic privileges. Consequently, the aim of this paper is to explore if family members working in their family's business, work under favourable boundary conditions which enable them to more freely make use of and benefit from FWAs. Utilising representative data from the German Family Panel (pairfam), our comparative analysis based on propensity score matching, suggests that family members working in their family's business (N = 337) do make greater use of FWA than those in regular employment. Counter to common assumptions, the findings reveal that FWA leads to higher workloads for owner-managers but not for family employees. Furthermore, families working in their business show no differences in how they divide household tasks compared to regular employed families–yet they perceive that division to be fairer. This study extends knowledge by introducing family ownership and kinship ties as important boundary conditions to existing theories on FWA, such as life-course theory. It also provides new insights into the commonly assumed consequences of FWA use. © 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
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Background. We characterize the incidence and risk factors of SARS-CoV-2 breakthrough infections in the NC-CCRP. Cumulative Incidence of Breakthrough infections after Self-reported Symptomatic SARS-CoV-2 Test Cumulative incidence curves (1 minus the unadjusted Kaplan-Meier risk), number at risk at each time point for the first self-reported symptomatic positive SARS-CoV-2 test, starting from full vaccination among participants who reported full vaccination. Methods. The NC-CCRP is an observational cohort study assessing COVID-19 symptoms, test results, vaccination status, and risk behavior via daily email or text surveys. Cox models were used to estimate hazard rates. Fixed covariates were age at enrollment, race/ethnicity, sex, county of residence classification, vaccine product, and healthcare worker status. Time varying covariates were vaccination rate in county of residence, mask usage in the week prior, the Delta time frame, the Omicron time frame, and receipt of a vaccine booster. Results. Among 15,808 eligible adult participants, 638 (4.0%) reported a positive SARS-CoV-2 test after vaccination from 01/15/2021 to 01/03/2022. The breakthrough rate increased with time from vaccination (Figure), with a cumulative incidence of 6.95% over 45 weeks of follow-up. Factors associated with a lower risk of breakthrough infection (p< 0.05) included older age (HR 0.7 for participants 45-64 years and 0.41 for those > 65 years compared to those 18-44 years), prior SARS-CoV-2 infection (HR 0.58), higher rates of mask use (HR 0.66), and receipt of a booster vaccination (HR 0.33). Higher rates of breakthrough infection were reported by participants vaccinated with BNT162b2 (HR 1.35) or Ad26.COV2.S (1.74) compared to mRNA-1273, those residing in suburban (HR 1.33) or rural (1.24) counties compared to urban counties, and during circulation of the Delta (3.54) and Omicron (16.68) variants compared to earlier time periods. There was no association of breakthrough infection with sex, race/ethnicity, healthcare worker status, or vaccination rate in the county of residence. Conclusion. In this real-world analysis, risk of breakthrough infections increased with time since vaccination, with some variability among the specific vaccine products. Risk increased dramatically during the Omicron surge. Higher rates among younger individuals may reflect more frequent, or higher risk exposures, including those related to childcare. Significantly lower rates of breakthrough associated with mask wearing and receipt of a booster highlight specific measures that individuals can take to minimize the risk for COVID-19.
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Background. The COVID-19 Community Research Partnership (CCRP) is a large multicenter healthcare system-based study of the COVID-19 pandemic, including factors impacting risk of infection and hospitalization. The CCRP includes a subset of immunocompromised (IC) participants with varying vaccination status over time. Methods. We conducted an observational cohort study of 2,515 IC and 41,941 non-IC CCRP participants who contributed electronic health record data and daily electronic surveys to self-report COVID-19 symptoms, test results, and vaccinations from April 2020 to March 2022. The IC population included those with stem cell transplant, HIV, cancer, autoimmune disease, or solid organ transplant. The latter 3 must have also had an active systemic therapy to meet the IC condition (e.g. chemotherapy, immune modulator, steroid). Logistic regression was used to investigate risk of COVID-19 and hospitalization among IC participants and according to vaccine status within viral variant time periods (pre-delta, delta, omicron). Results. IC conditions included cancer (51%), autoimmune (41%), solid organ/ stem cell transplant (9%), and HIV (7%). The IC group was older and had more comorbidities. 95% of vaccine recipients received an mRNA vaccine. More vaccine breakthrough infections occurred in the IC group than non-IC group (36.1% vs 29.5%, p< 0.001). IC participants were less likely to remain COVID-19 free over time if vaccinated but not boosted (Fig 1A). However, after receiving a booster there was no difference in COVID-19 cases between the groups (Fig 1B). IC participants were more likely to be hospitalized with COVID-19 (OR 2.85;95% CI 1.69-4.76), but vaccination reduced risk for hospitalization (OR 0.26;95% CI 0.08-0.8). Receipt of a booster dose reduced risk of COVID-19 among IC participants during the delta wave (IRR 0.52;95% CI 0.28-0.94) but not during omicron. However, during omicron risk of hospitalization in the IC group was reduced by a booster dose (OR 0.13;95% CI 0.02-0.72). Conclusion. IC individuals were at increased risk for COVID-19 hospitalizations and breakthrough infections. After receiving a booster, IC participants were conferred the same level of protection from infection as their non-IC counterparts, highlighting the importance of boosters for these individuals. (Figure Presented).
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Background: The ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST), which opened in 2017, is a randomized trial designed to assess whether Tomosynthesis Mammography (TM) should replace Digital Mammography (DM) for breast cancer screening. It is hypothesized that women assigned to TM for 3-5 screening rounds will have fewer advanced breast cancers than the women assigned to DM. Advanced cancers are those that have distant metastases or positive nodes, are invasive tumors greater than or equal to 2.0 cm in size, or are invasive tumors greater than 1.0 cm in size that are triple negative or HER 2+. The initially planned enrollment of 164,946 women was due to be completed by the end of 2020, with follow-up concluded by 2025. There were substantial challenges in meeting this timeline, including the organizational and funding structure of the NCI National Clinical Trials Network which is dependent upon sites using their existing staffing resources (not always readily available at the time of study activation). This led to longer than anticipated start of enrollment for most interested sites and lower than anticipated annual enrollment per participating site based ultimately on the staffing support that could be allocated to manage TMIST. In addition, research staffing shortages and periodic research operations closures due to COVID-19 have also impacted enrolling TMIST sites, though unevenly, since the start of the pandemic. Enrollment plateaued at approximately 2,100 subjects per month by the end of 2020. With that accrual rate expected, the trial design was modified to reduce the sample size so that the study could be completed by 2027. Methods: With the approval of the NCI CIRB, we changed how the primary endpoint measure for TMIST is assessed from the number of advanced cancers that occur by 4.5 years after randomization to the time from randomization to occurrence of advanced cancers. All advanced cancers occurring within 7 years of randomization are now included and all participants followed for at least three years. In addition, the power of the study of the study was modified from 0.9 to 0.85, while the originally assumed effect size at 4.5 years was retained These changes allowed a reduction of sample size to 128,905, with subject recruitment projected to end in 2024. As of February 14, 2022, there are 125 sites open, 114 in the U.S. and 11 in other countries, with an additional 31 sites planning to open. As of February 14, 2022, a total of 63,845 women have been enrolled in the trial worldwide at 115 sites, with 20% of US participants self-identifying as belonging to minority racial and ethnic groups and 70% consenting to optional blood and/or buccal cell collection.
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Background: In the thick of the ongoing global crises of the COVID-19 pandemic, uprisings against anti-Black racism and police brutality, and anti-Asian racism and violence, Black, indigenous, and people of color (BIPOC) adolescent and young adult (AYA) cancer patients may be particularly vulnerable and exploited. Whilst embroiled in sociopolitical complexity, BIPOC AYAs are increasingly called upon to contribute as patient advocates in AYA oncology research and advocacy. Researchers, clinicians, and advocates in AYA oncology must dismantle long-standing racism and create meaningful structural change. The purpose of this study is to derive vital best practices for implementing antiracist patient engagement in AYA oncology research and advocacy that are co-developed by BIPOC AYA cancer patients and oncology professionals. Methods: We utilized a modified Delphi technique with a panel of BIPOC AYA cancer patients (n = 32) to build consensus opinions on professional recommendations from a prior study (Cheung et al., 2021), and to generate antiracist best practices in patient engagement. The Delphi study was comprised of three consecutive and iterative survey rounds over the course of 8 months in 2021;participants were BIPOC AYAs diagnosed with cancer between ages 15-36 years. Results: Results detail best practices for the implementation of antiracist patient engagement across all research activities within the Patient-Centered Outcomes Research Institute's (PCORI) Framework for Patient Engagement. For example, BIPOC AYAs agreed with oncology professionals' high priority recommendation for including BIPOC AYAs at the highest levels of decision making in research topic selection. As such, a best practice is for researchers to ensure that such representatives not only hold BIPOC AYA identity, but also hold direct experience with the particular oncology diagnosis, issue, or other outcome of interest. Additionally, BIPOC AYAs concurred with oncology professionals' high priority for “transparency, honesty, and trust” as a core principle for best practices in patient engagement. They further explained that trustworthy relationships are especially important when collaborating with teens and young adults, who are developmentally just coming into their own. When describing successful experiences of inclusion, participants ranked “build collaborative relationships with BIPOC AYA communities and listen to patients not usually heard” and “recruit a diverse range of BIPOC patients and let them give actual input into the study” as the highest priority best practices. Conclusions: Findings from this study are instructional for AYA oncology researchers, clinicians, and advocates to prevent harmful tokenism and implement genuine antiracist inclusion to advance health equity. Future research should investigate best practices within unique clinical settings.
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Background: The coronavirus disease 2019 (COVID-19) pandemic resulted in delayed medical care that may have led to increased death rates in 2020 among people with medical conditions such as cancer. This study examined changes in cancer-related mortality between 2019 and 2020. Methods: We used the US 2019-2020 Multiple Cause of Death database from the CDC WONDER to identify cancer-related deaths, defined as decedents with invasive or noninvasive cancer as a contributing cause of death (ICD-10 codes: C00-C97 and D00-D09). We compared age-standardized cancer-related annual and monthly mortality rates (per 100,000 person-years and person-months, respectively) in January-December 2020 (pandemic) versus January-December 2019 (pre-pandemic) overall and stratified by rurality and place of death. We calculated the 2020 excess death by comparing the numbers of observed death with the projected death based on age-specific cancer-related death rate from 2015 to 2019. Results: The number of cancer-related deaths was 686 054 in 2020, up from 664 888 in 2019, with an annual increase of 3.2%. Compared to the number of projected deaths for 2020 (666 286), the number of cancer-related excess deaths was 19 768 in 2020. Annual age-standardized cancer-related mortality rate (per 100,000 person-years) continuously decreased from 173.7 in 2015 to 162.1 in 2019, while it increased to 164.1 in 2020 (2020 vs 2019 rate ratio (RR): 1.013, 95% confidence interval (CI): 1.009 - 1.016). The cancer-related monthly mortality rate was higher in April 2020 (RR: 1.032, 95% CI: 1.020 - 1.044) when healthcare capacity was most challenged by the pandemic, subsequently declined in May and June 2020, and higher mortality rates were again observed each month from July to December 2020 compared to 2019. In large metropolitan areas, the largest increase in cancer-related mortality was observed in April 2020, while in non-metropolitan areas, the largest increases occurred from July to December 2020, coinciding with the time-spatial pattern of COVID-19 incidence in the country. Compared to 2019, cancer-related mortality rates were lower from March to December 2020 in medical facilities, hospice facilities, and nursing homes or long-term care settings but higher in decedent's homes. Conclusions: The COVID-19 pandemic led to significant increases in cancer-related deaths in 2020 versus 2019. Ongoing evaluation of the spatialtemporal effects of the pandemic on cancer care and outcomes is warranted, especially in relation to patterns in vaccine uptake and COVID-19 hospitalization rates.
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It is well established that exposure to Adverse Childhood Experiences (ACEs) can have a profound negative impact on physical and mental health and other health-related processes (e.g. decision making;Chang et al. 2019). Research has also indicated that individual differences in coping styles represent one pathway through which exposure to ACEs can confer risk for negative health outcomes (Sheffler et al. 2019). It is less clear however, whether the negative effects of exposure to ACEs extend also to one's self-efficacy for preventing and overcoming COVID-19. The current study aimed to examine the relationship between ACEs, measured as the total number of adverse childhood experiences endorsed on the Adverse Childhood Experiences Scale, and self-efficacy for preventing and overcoming COVID-19, measured using a modified version of the Self-Efficacy for Middle East Respiratory Syndrome. In addition, we examined whether the use of avoidant coping strategies (denial, venting, and behavioral disengagement) derived from a principal components analysis of the Brief Coping Questionnaire, statistically mediated the association between ACE scores and COVID-19 self-efficacy. Young adults (N = 86, Mage = 23.6;69% female;34% Asian, 33% white, 23% Latinx, 8% Mixed Race, 2% Black or African American) completed measures as part of a larger study. A series of linear regression analyses indicated that both exposure to a greater number of ACEs (β = -.23, p = .033) and greater use of avoidant coping strategies (β = -.36, p < .001) were associated with lower COVID-19 self-efficacy. On the other hand, ACE scores did not significantly predict the use of avoidant coping strategies (β = .09, p = .41) and when entered into a model simultaneously, both ACEs (β = -.20, p = .049) and coping (β = -.34, p = .001) remained significant predictors of COVID-19 self-efficacy. These results indicate that ACE scores and the use of avoidant coping strategies independently affect COVID-19 self-efficacy, and confirm that the negative health effects of ACEs extend also to perceptions of ability to prevent and overcome COVID-19.
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Individual differences in experiences of stress are considered a primary pathway through which health disparities are thought to arise. Because COVID-19-related outcomes differ across demographic characteristics, it is important to examine factors associated with increased stress among diverse participants during the COVID-19 pandemic. Higher discrimination based on demographic characteristics has been associated with heightened stress prior to the pandemic, and lower self-efficacy for preventing and overcoming COVID-19 might disproportionately lead to stress among demographic groups where individuals are more likely to hold “essential worker” positions. Therefore, the current study examined whether experiences of discrimination and COVID-19 self-efficacy associate with stress assessed during the COVID-19 pandemic. A sample of N=75 participants (Mage= 24;35% Asian, 30% White, 23% Hispanic/Latino, 11% multi-racial, and 3% Black;72% Female;65% Straight/Heterosexual) completed an online questionnaire packet assessing their COVID-19 self-efficacy (assessed using a revised version of the Middle Eastern Respiratory Syndrome Self-Efficacy Scale), perceived daily discrimination (Daily Discrimination Scale), and perceived stress (Stress Overload Scale - Short Form). Results from a sequential linear regression indicated that neither demographic characteristics (race, gender identity, sexual orientation, and age) nor COVID-19 self-efficacy predicted stress during the COVID-19 pandemic. On the other hand, perceived discrimination predicted stress above and beyond demographic and COVID-19 self-efficacy differences, β = 0.43, p < 0.01, ΔR2 = 0.17. Though in the direction we might expect, there were no significant demographic differences in perceived discrimination, indicating that differences in perceived daily discrimination in our sample might be associated with factors not presently studied (e.g., socioeconomic status) or may arise through an intersection of group membership. These results demonstrate that perceived daily discrimination is an important predictor of stress during the COVID-19 pandemic and highlight the importance of addressing daily discrimination as a potential avenue for mitigating stress-related COVID-19 outcomes.
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Rationale: LAU-7b is developed as a broadly effective oral COVID-19 therapeutic targeting membrane lipids to exert dual antiviral and inflammation-controlling activity. SARS-CoV-2 reprograms host cellular lipid metabolism to favor entry and replication, a mechanism shared by all lipid-enveloped viruses. LAU-7b decreases host cell membrane lipids fluidity, inhibits de-novo cell lipogenesis, and modulates phospholipid signaling promoting resolution of inflammation. Due to its host-directed mutation-agnostic mechanism, LAU-7b utility could span across future variants, as demonstrated in-vitro against multiple SARS-CoV-2 strains and MERS-CoV. RESOLUTION, a large Phase 2/3 study evaluating LAU-7b in hospitalized COVID-19 patients, is ongoing in the US and Canada, and preliminary Phase 2 results are presented. Methods: RESOLUTION is a placebocontrolled study of oral LAU-7b, once-a-day for 14 days on top of standard of care, in hospitalized COVID-19 patients at risk of developing pulmonary complications. The Phase 2 portion of the study randomized 148 patients with moderate-to-severe COVID-19 and 84 patients in critical condition, but not on invasive ventilation. Key endpoints included proportion of patients alive and free of respiratory failure at Day 29, rates of progression to mechanical ventilation and all-causes death by Day 60, time to recovery and length of hospitalization. Results: Both study arms were highly comparable in terms of mean age, number of comorbidities and concomitant medications. LAU-7b demonstrated a 100% reduction in the risk of progressing to mechanical ventilation or death by Day 60 in moderate-to-severe COVID-19 patients. None of the 76 patients on LAU-7b required mechanical ventilation and none died, while 5 out of 72 patients on placebo progressed to mechanical ventilation (6.9% difference, p=0.025), and 4 patients died (5.6% difference, p=0.053). LAU-7b group also showed an increase of 6.9% (p=0.055) in the proportion of patients alive and free of respiratory failure at Day 29, versus placebo. Patients on LAU-7b tended to recover more rapidly and leave hospital faster. LAU-7b was well-tolerated, with safety comparable to placebo. Critically ill patients treated with LAU-7b did not show improvement over placebo, suggesting that COVID-19 patients in respiratory failure at baseline are too severely affected to benefit. Conclusion: LAU-7b showed positive results in the trial's Phase 2 portion on both survival and avoidance of mechanical ventilation in moderate-to-severe COVID-19. The confirmatory Phase 3 portion was triggered and received approval from the FDA and Health Canada, focusing on moderate-to-severe COVID-19 and using the “Proportion of patients requiring mechanical ventilation and/or death by Day 60” as primary efficacy endpoint.
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Objective: characterize the subjective dimension of the work processes at the first level of care in the context of a pandemic, through the description and analysis of the speeches of the workers produced within the framework of the Health Team Support device implemented in a municipality in the metropolitan area of Buenos Aires. Methodology: qualitative, exploratory and descriptive research. Single case study focused on participant observation in 10 meetings in health centers of the Municipality of Tigre, during the months of April and May 2020. The systematization of the material was carried out following techniques of content analysis and category generation. Results: the analysis identified five emerging categories: a) changes in work settings, b) emotions and attitudes towards the task, c) ties within teams, d) ties with authorities, and e) ties with the community. Discussion: the subjective dimension contained in the experiences reported are characterized by feelings of uncertainty, fears, tensions in the relationship between colleagues, with hierarchical instances and with the assisted population, but also by active searches for alternatives, support among colleagues, participation, motivation in the sense of work, mutual care and approach to the community. In this way, aspects that pre-existed the pandemic situation and aspects that the context introduce are made visible. Finally, we come up with some reflections on the implications of the inclusion of this device in the work process of health teams during the pandemic.
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AIMS: Adjuvant radiotherapy is recommended for most patients with early breast cancer (EBC) receiving breast-conserving surgery and those at moderate/high risk of recurrence treated by mastectomy. During the first wave of COVID-19 in England and Wales, there was rapid dissemination of randomised controlled trial-based evidence showing non-inferiority for five-fraction ultra-hypofractionated radiotherapy (HFRT) regimens compared with standard moderate-HFRT, with guidance recommending the use of five-fraction HFRT for eligible patients. We evaluated the uptake of this recommendation in clinical practice as part of the National Audit of Breast Cancer in Older Patients (NABCOP). MATERIALS AND METHODS: Women aged ≥50 years who underwent surgery for EBC from January 2019 to July 2020 were identified from the Rapid Cancer Registration Dataset for England and from Wales Cancer Network data. Radiotherapy details were from linked national Radiotherapy Datasets. Multivariate mixed-effects logistic regression models were used to assess characteristics influential in the use of ultra-HFRT. RESULTS: Among 35 561 women having surgery for EBC, 71% received postoperative radiotherapy. Receipt of 26 Gy in five fractions (26Gy5F) increased from <1% in February 2020 to 70% in April 2020. Regional variation in the use of 26Gy5F during April to July 2020 was similar by age, ranging from 49 to 87% among women aged ≥70 years. Use of 26Gy5F was characterised by no known nodal involvement, no comorbidities and initial breast-conserving surgery. Of those patients receiving radiotherapy to the breast/chest wall, 85% had 26Gy5F; 23% had 26Gy5F if radiotherapy included regional nodes. Among 5139 women receiving postoperative radiotherapy from April to July 2020, nodal involvement, overall stage, type of surgery, time from diagnosis to start of radiotherapy were independently associated with fractionation choice. CONCLUSIONS: There was a striking increase in the use of 26Gy5F dose fractionation regimens for EBC, among women aged ≥50 years, within a month of guidance published at the start of the COVID-19 pandemic in England and Wales.
Subject(s)
Breast Neoplasms , COVID-19 , Aged , Breast Neoplasms/epidemiology , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , COVID-19/epidemiology , Cohort Studies , Female , Humans , Mastectomy , Mastectomy, Segmental , Pandemics , Radiotherapy, Adjuvant/adverse effects , Wales/epidemiologyABSTRACT
Purpose: Osteoarthritis (OA) is a chronic and disabling condition affecting morbidity and mortality. Despite its high prevalence and the availability of international management guidelines, nearly half of patients do not receive recommended treatments. OA Management Programs (OAMPs) are an alternative care model to reduce barriers and enhance the receipt of evidence-based care. This study was designed to evaluate the fidelity and feasibility of an OAMP in a United States academic medical center and understand its patients' baseline characteristics. Methods: The OAMP, which opened on July 1, 2017, is focused on knee and hip osteoarthritis. A multi-disciplinary group, including patients with OA, designed the clinic model and operations based on international OAMP implementation recommendations considering local factors. The intended treatment dose was 1-6 appointments over 4-12 months with no more than two months between visits. At each appointment, patients had the opportunity to meet with a care team comprised of a medical provider (physician or advanced practice provider), registered dietitian, physical therapist, and mental health counselor. All providers had completed OA clinical competency training. Telemedicine video visits were also available after June 2020 due to the COVID-19 pandemic. Patients are asked to complete the patient questionnaires before their visit through a patient portal in the electronic health record. They are also provided with a tablet computer to complete the VR-12 and the HOOS and/or KOOS while in the clinic waiting room. For this study, a database was created for all adult patients who had at least one clinic visit from July 1, 2017, to January 15, 2021. Data was collected by an electronic health record data pull and a manual audit of visit notes. Primary outcomes related to clinic feasibility and fidelity included clinic operations and expansion, treatment duration, and number and type of appointments attended. Secondary outcomes included patients' baseline characteristics. Results: The 938 eligible patients attended an average of 2.7 visits over a mean of 114.4 days (±5.9). Patients utilized the OAMP differently: 371 (39.5%) of patients attended 1 visit, 348 (37.1%) attended 2-3, and 232 (24.7%) attended 4 or more. A total of 175 (18.66%) completed at least one telemedicine visit. Patient referrals came predominantly from primary care (61%%) and orthopedics (20.3%);8.6% were self-referred. The average time between seeking care and the first appointment is just over six weeks. Due to patient demand, the program has expanded from seeing six patients per week to seeing more than 40 patients per week. The expansion has required hiring and training an increased number of clinicians, starting with four clinicians in different specialties to 11 clinicians. The average patient was 62.2 years (±10.2), and most were female (72%). Nearly all were Caucasian (91.3%). Medicare (51.4%) was the most common type of insurance, followed by commercial insurance (38.3%). Half of the patients were employed (49%), while 32% were retired. At the initial visit, the average BMI was 40.9 (±10). The average Charlson Comorbidity Index score (CCI) was 2.1 (±1.3), indicating moderate severity of comorbid conditions. The baseline pain rating was moderate at 4.44 (±2.37) on a 1-10 pain scale. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) pain scores were 47.9 (±18) and 44.9 (±23.6), respectively showing moderate baseline levels of pain. Veterans-Rand 12 scores were low at the initial visit. The VR-12 physical and mental subscales were 25.66 (±7.35) and 48.15 (±10.76) lower than expected for an adult population. The average number of repetitions obtained from the 30-second chair rise test was 10.65 (±3.49), which is lower than age and gender norms. The completion rate of self-administered patient questionnaires was low, with less than half of patients completing all questionnaires at the initial visit. Conclusions: Baseline data reveals patie ts with high levels of pain, low function, and multiple comorbid conditions who are willing to attend multiple visits. The program has continued to expand to meet increased patient demand. Patient utilization of the clinic varied, with some patients attending only one appointment and others returning numerous times. Despite being invited back within two months, a subset of patients returned for a second appointment more than six months after their initial appointment. Completion rates of the self-questionnaires (HOOS/KOOS, VR-12) were low despite having options of how to complete these. The low completion rate indicates that instruments should be selected judiciously with careful consideration for which should be administered at every clinic visit. Clinic operations and growth are feasible with variable fidelity. The next steps will be an evaluation of patient utilization of the clinic and its impact on patients outcomes.
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Purpose: Osteoarthritis (OA) is a chronic and disabling disease, affecting both morbidity and mortality. Prevalence is rising as the age and weight of the general population increase. Despite its high prevalence, nearly half of patients do not receive recommended treatments. Multiple barriers to receipt of evidence-based care have been identified and OA Management Programs (OAMPs) have been posited as an alternative care model to facilitate treatment. This mixed-methods study was designed to examine and evaluate patients’ perceptions of the acceptability and effectiveness of an OAMP at a U.S. academic medical center. Methods: Eligible patients included adults with knee or hip OA who completed at least one visit in the OAMP from July 1, 2017, to January 15, 2021 (n=938). These patients were divided into three groups based on the number of completed visits: 1 visit, 2-3 visits, or 4+ visits. Seventy patients from each group were randomly selected to receive a mailing that included: 1) the Osteoarthritis Quality Indicator (OA-QI) which queried receipt of guideline-recommended care;2) an invitation to participate in an interview regarding their OAMP care experience;3) the study’s informed consent document;and 4) an addressed, stamped envelope to return the completed OA-QI and consent form to investigators. Interviews of consenting patients were conducted in person or over the phone by a trained medical student who followed a semi-structured interview script. Interviews were recorded, transcribed, and analyzed using NVivo QSR 12, supplemented by a manual analysis to confirm themes. Results: Fifty-six patients (26.67%) completed the OA-QI and reported receiving an average of 13.24 (±2.85) of the 17 quality indicators. Thirty-four participants (60.7%) reported receiving at least 80% of the included quality indicators, 11 reported receiving 60-80%, and 11 (17.2%) reported receiving less than 60%. There was no statistical difference in OA-QI scores based on the number of OAMP appointments attended. Less than 60% of respondents reported being seen by a specialist for weight management. Every patient who returned the OA-QI had met with a registered dietitian for weight management as part of OAMP care. Seventeen patients (30%) reported not being referred to a joint specialist to evaluate for surgery for their severe symptoms. A total of 17 patient interviews were conducted, at which time data saturation was reached. Seventy-seven percent affirmed having had enough time to discuss their joint disease and treatment recommendations, 64.7% reported positive changes in their knowledge or beliefs about OA, and 64.7% had made at least some progress toward achieving their goals. Thirty percent cited a lack of proactiveness, motivation, or proper time management as barriers to starting or maintaining their treatment goals. Fifteen of the 17 participants responded to a query regarding confidence in self-managing their OA: 40% reported increased confidence, 40% reported no change, and one person reported a decrease. Two interviewees reported no change in confidence, but felt affirmed that they were “doing the right thing”. Rapport with providers was highly endorsed (88.2%), and telemedicine visits were mentioned as a mechanism for support and encouragement. Forty-one percent of interviewees had attended a group medical visit;non-attendance was attributed to distance to the clinic and group visit unavailability when COVID-19 arose. Fifty-nine percent of the interviewees endorsed a belief that OA could be managed without surgery;however, only 47% knew anyone who had successfully done so. Conclusions: Patients reported receiving a very high number of OA quality indicators, higher than reported in the literature for general populations. Interviewees were very satisfied with OAMP providers and nearly two-thirds affirmed positive changes in knowledge or beliefs regarding OA and progress toward meeting goals. Many patients did not recognize that the OAMP offers specialized care. They reported not receiving care from a specialist f r weight management despite having met with a registered dietitian. Others reported not being referred to a joint specialist to discuss surgery for their severe symptoms, although this discussion is a routine part of the OAMP’s services. These gaps in perception could potentially influence satisfaction and adherence. They suggest that improved communication regarding the OAMP’s specialized, evidence-based care may need to be provided. Additionally, many patients still believed that surgical intervention is an inevitable part of having OA, which may impede buy-in to minimally invasive OA management.
ABSTRACT
Background. While splashes to the eyes, nose and mouth can often be prevented through appropriate personal protective equipment (PPE) use, they continue to occur frequently when PPE is not used consistently. Due to the COVID-19 pandemic, we implemented universal masking and eye protection for all healthcare personnel (HCP) performing direct patient care and observed a subsequent decline in bloodborne pathogen (BBP) splash exposures. Methods. Our healthcare system, employing >12,000 healthcare personnel (HCP), implemented universal masking in April 2020 and eye protection in June 2020. We required HCP to mask at all times, and use a face shield, safety glasses or goggles when providing direct patient care. Occupational Safety tracked all BBP exposures due to splashes to the eyes, nose, mouth and/or face, and compared exposures during 2020 to those in 2019. We estimated costs, including patient and HCP testing, related to splash exposures, as well as the additional cost of PPE incurred. Results. In 2019, HCP reported 90 splashes, of which 57 (63%) were to the eyes. In 2020, splashes decreased by 54% to 47 (36 [77%] to eyes). In both years, nurses were the most commonly affected HCP type (62% and 72%, respectively, of all exposures). Physicians (including residents) had the greatest decrease in 2020 (10 vs. 1 splash exposures [90%]), while nurses had a 39% decrease (56 vs. 34 exposures). Nearly all of the most common scenarios leading to splash exposures declined in 2020 (Table). We estimated the cost of each BBP exposure as $2,940;this equates to a savings of $123,228. During 2020, we purchased 65,650 face shields, safety glasses and goggles (compared to 5303 similar items in 2019), for an additional cost of $238,440. Specific activities identified as leading to bloodborne pathogen splash exposures, 2019 vs. 2020. Conclusion. We observed a significant decline in splash-related BBP exposures after implementing universal masking and eye protection for the COVID-19 pandemic. While cost savings were not observed, we were unable to incorporate the avoided pain and emotional trauma for the patient, exposed HCP, and coworkers. This unintended but positive consequence of the COVID-19 pandemic exemplifies the need for broader use of PPE, particularly masks and eyewear, for all patient care scenarios where splashes may occur.
ABSTRACT
COVID-19 has resulted in global lockdowns, social distancing and demand fluctuations. Existing crisis management research often provides a retrospective account of strategy making after a crisis. Limited studies have explored the factors which aid policy responses during an ongoing crisis. This research helps fill this gap by exploring the influence Covid-19 had on job vulnerability during the first wave of the COVID-19 crisis (spring and summer of 2020). We explore Northern Ireland (NI) which historically has experienced disadvantages. We utilise point-in-time modelling which considers contextual variations. The findings reveal that a reduction in social distancing reduces the vulnerability of over 30,000 jobs, however, ongoing uncertainties regarding demand will have a more significant longer-term impact on job vulnerabilities. We identify how COVID-19 may impact sectors, groups and geographies differently. We provide policy recommendations on how to alleviate the impact COVID-19 has for job vulnerability across the NI economy.
ABSTRACT
In this study, we explore whether Zoom is a viable method for collecting data for sociophonetic research, focusing on vocalic analysis. We investigate whether recordings collected through Zoom yield different acoustic measurements than recordings collected through in-person recording equipment, for the exact same speech. We analyze vowel formant data from 18 speakers who recorded Zoom conversations at the same time as they recorded themselves with portable recording equipment. We find that, overall, Zoom recordings yield lower raw F1 values and higher F2 values than recording equipment. We also tested whether normalization affects discrepancies between recording methods and found that while discrepancies still appear after normalizing with the Watt and Fabricius modified method, Lobanov normalization largely minimizes discrepancies between recording methods. Discrepancies are also mitigated with a Zoom recording setup that involves the speaker wearing headphones and recording with an external microphone.
ABSTRACT
Background: Survivors of colorectal cancer (CRC) are at risk for late effects of therapy and recurrence of cancer. With recurrence rates ranging between 30-40% (Siegal et al., 2020), consistent, survivor-focused follow-up care is needed for early detection of late effects and recurrence (Jeffery et al., 2019). CRC-related care delivery has been significantly disrupted by the SARS-CoV-2 pandemic, with decreases of 40% in CRC services in the United States between April 2020 and 2019 (Jammu, 2020). Consequentially, survivors may be left with fewer options for care, potentially causing increases in emergency room (ER) utilization. Methods: This cross-sectional study examined the patterns of ER utilization during the SARS-CoV-2 pandemic among young adult CRC survivors and assessed the relationship between self-reported care satisfaction and ER use. Eligible participants were diagnosed with colon or rectal cancer between 18-39 years, between 6-36 months from diagnosis/relapse, English speaking, and based in the United States. Questions on care satisfaction were Consumer Assessment of Healthcare Providers and Systems (CAHPS) questions. A multivariable logistic regression was conducted to assess the association between patient satisfaction and ER utilization, adjusting for factors related to the pandemic. Covariates for this analysis were chosen based on a significance of p < 0.1 at the univariate level, as well as general clinical significance. Results: The overall sample was N = 196, mean age (SD) was 32.1 years (4.5), and 116 survivors (59%) were male. Tumor location was colon or rectal in 42% and 57%, respectively, and the majority (56%) were diagnosed with stage 2 disease;42.6% reported relapsed disease, and 20% had an ostomy. The majority of survivors (72.5%) had between 1-4 visits to an emergency room in the last 12 months and were categorized as normal users. Approximately 24.7% of the sample had greater than 4 visits to the ER in the last 12 months and were categorized as super-utilizers (Johnson et al., 2015). Colorectal cancer survivors that reported a delay in their follow-up cancer care as a result of the pandemic were two times (OR: 2.05, 95% CI 0.99, 4.24) more likely to be super-utilizers of the ER. Higher self-reported satisfaction with overall care was associated with a 13.7% (OR: 0.86, 95%CI: -0.68, 1.09) lower likelihood of being a super-utilizer. Conclusions: This study found strong associations between delays in care, self-reported care satisfaction, and being a super-utilizer of the ER during the pandemic among young adult CRC survivors off treatment. Increasing patient satisfaction and minimizing care interruptions amongst this vulnerable population may aid in mitigating over-utilization in the ER during an ongoing pandemic.
ABSTRACT
Background: The coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a pandemic that has taken millions of lives around the globe. Treatment of patients with moderate and severe COVID-19 disease has included dexamethasone, tocilizumab, Remdesivir, convalescent plasma, and targeted antibodies, however, currently, there are no FDA approved targeted cellular therapies in the treatment of mild or moderate SARS-CoV-2 disease. Virus-specific cytotoxic T cell lymphocytes (vCTLs) have shown therapeutic efficacy in immunocompromised patients with viral infections. We developed a multicenter and multidisciplinary Viral Cytotoxic T-Cell Consortium (VIRCTLC) to investigate the use of vCTLs manufactured by direct enrichment using the Cytokine Capture System (CCS) on the CliniMACS® Prodigy device. SARS-CoV-2 specific PepTivator Peptides consist of overlapping peptides that span the entire sequence of the protein (Protein N and M), or the length of its immunodominant domain (Protein S). The peptides can bind to either MHC class I or MHC class II molecules and are therefore able to target both CD4 and CD8 T cells. Objective: To screen, manufacture, and characterize SARS-CoV-2 vCTLs generated from convalescent COVID-19 donors using the CliniMACS® Cytokine Capture System on the CliniMACS® Prodigy device. Methods: Donor screening was done utilizing PBMNCs from 15 convalescent COVID-19 donors after informed consent. PBMNCs were stimulated with a mix of PepTivator peptides (Miltenyi Biotech®) contained in the S, M and N proteins. IFN-γ levels were examined in CD3, CD4, and CD8 T cells by flow cytometry analysis. After informed consent, PBMNCs from three convalescent COVID-19 donors who screened positively to the PepTivator® peptide pools of SARS-CoV-2 Proteins M, N and S were collected by apheresis using the SPECTRA Optia® apheresis instrument. PBMNCs were incubated with the PepTivator® peptide pools for 4 hours. After incubation, the SARS-CoV-2 vCTLs were enriched using the CliniMACS Cytokine Capture System as we have previously described (Flower/Cairo, et al, ASTCT, 2020). Samples were taken from the enriched vCTLs and tested in gram stains, sterility cultures, cell counts, viability and IFN-γ cytokine staining (CD3/CD4/CD8/IFN-γ marker panel) by flow cytometry. Amplification and sequencing of TCRβ CDR3 regions of pre-stimulated PBMNC, stimulated PBMNCs samples taken from the QC bag (QC samples) and the enriched SARS-CoV-2 vCTLs were performed on the ImmunoSEQ platform using ImmunoSEQ® TCRB Assay kit (Adaptive Biotechnologies, Seattle, WA, USA). Characterization of immune subsets was done by mass cytometry analysis with 41 Immunophenotypic markers. Transcriptome of the immune landscape of QC samples, and enriched vCTLs was compared with the pre samples using the human nCounter PanCancer Immune Profiling Panel on the nCounter system. Results: We demonstrate that 93.3% of convalescent donor blood samples passed the screening criteria for clinical manufacture. Three validation runs resulted in enriched T cells that consisted of 79% + 21% (mean + SEM) IFNγ + T cells (Fig.1). TCRβ sequencing showed that convalescent COVID-19 donors have a highly diverse TCR repertoire and we identified TCRβ CDR3 clones that are known to be associated with SARS-CoV-2 T cell responses. Immunophenotyping analysis demonstrated more CD4 T cells than CD8 T cells in the SARS CoV-2 vCTLs, an increase in memory CD8 and CD4 cells, especially CD8 T EM, CD4 T cm and CD4 T EMRA cells (Fig.2) and an increase DC cells in the SARS CoV-2 vCTL products as compared to pre-stimulated PBMNCs. Expression of the exhaustion markers was not enhanced in the SARS CoV-2 vCTLs as compared to pre-stimulated PBMNCs. Transcriptome analysis showed increased gene expression in T-cell function, interleukin, pathogen defense, and TNF superfamily pathway genes in the SARS CoV-2 vCTLs as compared to pre-stimulated PBMNCs. Conclusion: Our study demonstrates that highly functional SARS-CoV-2 vCTLs can be rapidly generat d by direct cytokine enrichment from convalescent donor peripheral blood mononuclear cells. These data serve as pre-clinical validation for an ongoing clinical trial utilizing related HLA-matched and haplo-identical SARS CoV-2 vCTLs for the treatment of patients with mild and moderate SARS-CoV-2 disease (IND #27260, NCT# 04896606). [Formula presented] Disclosures: Lee: Kiadis Pharma: Divested equity in a private or publicly-traded company in the past 24 months, Honoraria, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding;Courier Therapeutics: Current holder of individual stocks in a privately-held company. Johnson: Miltenyi Biotec: Research Funding. Cairo: Jazz Pharmaceutical: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Amgen: Speakers Bureau;Sanofi: Speakers Bureau;Servier: Speakers Bureau;Sobi: Speakers Bureau;Omeros: Membership on an entity's Board of Directors or advisory committees;Nektar: Membership on an entity's Board of Directors or advisory committees.