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1.
European journal of public health ; 32(Suppl 3), 2022.
Article in English | EuropePMC | ID: covidwho-2102816

ABSTRACT

Preprints occupied the spotlight early in the pandemic, as scientists, the media and the public sought information on the evolving pandemic. While some in the scientific community embraced this shift, others were concerned about the quality of these papers, which had not yet undergone peer review. Furthermore, the flood of COVID-19 preprints quickly overwhelmed the scientific community's ability to monitor and assess new preprints. Automated screening tools that detect beneficial practices, or common problems, in preprints are one potential solution to this problem. These tools could potentially provide individualized feedback, allowing authors to improve their manuscripts prior to publication in a peer-reviewed journal. We have combined many tools into a single pipeline, called ScreenIT. ScreenIT assess factors such as open data and open code, blinding, randomization, power calculations, limitations sections, and data visualization problems. Since June 2020, we have used ScreenIT to screen and post daily reports on more than 23,000 new COVID-19 preprints deposited on bioRxiv and medRxiv. Results show that practices such as sharing data and code are relatively uncommon. Sample size calculations, blinding and randomization are rarely reported and most papers do not report the sex of participants, animals or samples. This work demonstrates the feasibility of using automated tools to rapidly screen many preprints in real time, and provide authors and readers with rapid feedback. However, this approach has important limitations. Automated screening tools can make mistakes. Tools can't always determine whether an item is relevant to a particular manuscript. Further studies are needed to determine whether feedback from automated tools is effective in encouraging authors to improve reporting.

2.
European journal of public health ; 32(Suppl 3), 2022.
Article in English | EuropePMC | ID: covidwho-2102299

ABSTRACT

Background COVID-19 vaccine hesitancy is a major problem worldwide that impedes vaccine uptake. We explored factors associated with vaccine hesitancy in Kazakhstan. Methods We conducted a cross-sectional face-to-face survey of 991 adults in Kazakhstan in July 2021, using quota sampling of respondents over 18 years old reflecting the distribution of gender, age, residence type, and geographical regions of Kazakhstan, according to the 2020 census. Results Over two third (68.4%) of the sample was vaccine hesitant;22.11% - received a vaccine (18.6%-Sputnik V, 2%-Hayat-Vax, 0.9%-QazCovid and 0.6%- CoronaVac). We used logistic regression to explore factors that were associated with vaccine hesitancy, adjusting age, education, employment, type of residence, self-reported COVID-19. The odds of not being vaccine hesitant were higher among those who had a higher perception that the COVID-19 vaccine was important for health OR = 2.66 (95%CI:2.24,3.17), higher belief in vaccine safety/effectiveness OR = 3.16 (95%CI:2.57,3.89), higher trust in government/health providers OR = 3.32 (95%CI:2.72,4.05), higher trust in official sources of information OR = 1.16 (95%CI:1.12,1.21), higher adherence to preventive measures OR = 1.05 (95%CI:1.03,1.08), knew someone diagnosed with COVID-19 OR = 1.36 (95%CI:1.01,1.82), or who died of COVID-19 OR = 1.47 (95%CI:1.04,2.08), had been ever tested for COVID-19 OR = 1.75 (95%CI:1.30,2.35), had ever received flu vaccine OR = 2.16 (95%CI:1.62,2.88), among health professionals OR = 2.76 (95%CI:1.38,5.51), and who had lower vaccine conspiracy beliefs OR = 0.48 (95% CI:0.40,0.58). Conclusions Vaccine accepting individuals held positive beliefs about the COVID-19 vaccine, had greater trust in government/official sources of information/health care workers, had greater exposure to COVID-19. Interventions aimed at reducing vaccine hesitancy need to address sources people find credible and may need to target individuals who have had limited exposure to the risks of COVID-19. Key messages • Strategies to increase trust in government/ health care workers and official sources of information can be an effective approach to reduce COVID-19 vaccination hesitancy. • Interventions to reduce COVID-19 vaccination hesitancy should target individuals who have had limited exposure to the risks of COVID-19.

3.
Journal of Library and Information Services in Distance Learning ; 2022.
Article in English | Scopus | ID: covidwho-2077311

ABSTRACT

Reading resources are essential for teaching and learning. Today’s students and instructors are used to the Learning Management System (LMS) for teaching and learning. Within the general LMS trend, a variety of electronic course reserves tools have emerged. One particular tool is Leganto which has been increasingly widely deployed, particularly in the wake of COVID-19. This article adopts the Educause reporting model of teaching and learning technologies best practices of “7 things You Should Know About.” The article also presents the authors’ institutional case of adoption, implementation, and data analytics results at Purdue University. © 2022 The Author(s). Published with license by Taylor & Francis Group, LLC.

4.
Chest ; 162(4):A686, 2022.
Article in English | EMBASE | ID: covidwho-2060668

ABSTRACT

SESSION TITLE: ECMO and ARDS in COVID-19 Infections SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/17/2022 12:15 pm - 1:15 pm PURPOSE: Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is an important salvage therapy for patients with severe COVID-19 associated acute respiratory distress syndrome (ARDS). Whether gas exchange after initiation of ECMO predicts survival remains unknown. The present study aims to investigate if gas exchange parameters are associated with survival during ECMO support of COVID-19 associated ARDS. METHODS: We retrospectively evaluated all ARDS patients initiated on VV-ECMO according to ELSO guidelines between 2018 and 2021 at a tertiary academic medical center. ECMO sweep and ventilator fraction of inspire oxygen (FiO2) were catalogued every eight hours for all patients and compared between COVID-19 survivors and non-survivors at Days 0, 7, 14, 21, and 28 of ECMO using the Mann-Whitney U test. Cohort characteristics were compared between patients with and without COVID-19 using the chi-squared test for categorical comparisons and the Mann-Whitney U test for comparison of non-parametric continuous variables. Statistical significance was considered as p<0.05 for all tests. RESULTS: Forty-two ARDS patients were initiated on VV-ECMO during the study period, including 30 patients with COVID-19. Mortality was similar between patients with and without COVID-19 (43.3% vs 41.7%, p=0.92). ECMO duration (31 [33.5] vs 9.5 [7.0] days, p=0.002), median sweep (7.0 [4.5] vs 4.3 [4.0], p< 0.001), and median ventilator FiO2 (0.55 [0.50] vs 0.45 [25], p < 0.001) were significantly increased in patients with COVID-19 compared to those without. Among COVID-19 patients, median sweep did not differ between survivors and non-survivors at Day 0 (3.5 [1.0] vs 4.0 [1.0], p=0.20), Day 7 (6.0 [3.0] vs 7.5 [2.3], p=0.38), Day 14 (6.0 [2.5] vs 8.0 [3.3], p=0.14), Day 21 (8.0 [3.5] vs 9.0 [3.0], p= 0.97), or Day 28 (7.5 [3.5] vs 8.0 [3.0], p=0.74). Median ventilator FiO2 was significantly lower in COVID-19 survivors compared to non-survivors at Day 28 (0.50 [0.16] vs 0.81 [0.40], p=0.03), but not at Day 0 (0.75 [0.52] vs 0.60 [0.25], p= 0.98), Day 7 (0.90 [0.50] vs 1 [0.45], p = 0.54), Day 14 (0.90 [0.50] vs 1 [0.08], p=0.08), or Day 21 (0.80 [0.10] vs 0.90 [0.40], p=0.62). CONCLUSIONS: Survival was similar between ARDS patients with and without COVID-19 despite significantly increased ECMO duration and gas exchange support in patients with COVID-19. Early gas exchange parameters after initiation of ECMO were not associated with survival in patients with COVID-19. At Day 28 of ECMO, COVID-19 survivors had significantly lower ventilator FiO2 requirements compared to non-survivors. CLINICAL IMPLICATIONS: Gas exchange parameters did not discriminate survivors from non-survivors until day 28 of ECMO in patients with COVID-19 associated ARDS. Given the need for increased gas exchange support and duration of ECMO therapy in this population, gas exchange parameters prior day 28 of ECMO may not be suitable markers for prognostication. DISCLOSURES: No relevant relationships by Andrew Davis No relevant relationships by Malcolm DeCamp No relevant relationships by Hilary Faust No relevant relationships by James Maloney No relevant relationships by Daniel McCarthy No relevant relationships by Michael Peliska

5.
Pediatrics ; 149, 2022.
Article in English | EMBASE | ID: covidwho-2002981

ABSTRACT

Background: Exclusive breastfeeding is recognized as the ideal feeding method for infants. Newborns receiving formula inhospital are at higher risk for early breastfeeding cessation. Among infants born in 2017, CDC Breastfeeding Report Card, 2020, reported the rate of breastfed infants receiving formula before two days of age as 15% in West Virginia (WV). We aimed to determine factors associated with in-hospital formula supplementation of breastfed newborns at a large community hospital in Southern WV. We hypothesized that disparities exist in supporting women to exclusively breastfeed. Methods: We retrospectively reviewed 500 randomly selected charts of infants born 09/01/2019-09/1/2020. Full-term infants with a recorded maternal decision to exclusively breastfeed were included. Exclusion criteria were prematurity, NICU admission, maternal diabetes, and infant hypoglycemia. Factors associated with formula supplementation were compared between mothers exclusively breastfeeding and those who were not at the time of discharge. Results: Of the reviewed charts, 70% of birth mothers desired to exclusively breastfeed. 211 infants met all inclusion criteria. 70% were delivered via vaginal delivery;52% were induced. Of the included newborns, 41% were supplemented with formula. 32% of mothers met with lactation consultants prior to formula supplementation. Top reasons for formula supplementation were mother request (45%) and newborn difficulty latching (22%). Median time of first supplementation was 20.0 hours (range:0.5-54). 12% of the supplementation occurred within 6 hours and 96.5% within 2 days of age. Rates of formula supplementation did not increase during the nurses' night shift or at nurses' shift change. Exclusive breastfeeding at discharge was associated with higher education level (p=0.002), tobacco abstinence (p=0.03), prior births (p=0.04), and increased maternal age (p=0.02);with every 1 year increase in maternal age, there was 7% decrease in supplementation. No statistically significant associations were present between exclusive breastfeeding at discharge meeting with a hospital lactation consultant, maternal race, marital status, induction need, or neonatal characteristics (p>0.05). When controlling for confounders of maternal age, marital status, tobacco use, and lactation consultation, Cesarean delivery (odd ratio: 2.0,1.03-4.2, 95% confidence interval), primiparity (2.6, 1.4-4.8), and not completing high school (12.5, 1.6-96.5) predicted formula supplementation. Exclusive breastfeeding discharge rates remained relatively steady over the 12 month study period, including during the COVID-19 pandemic. Conclusion: At our center, formula supplementation rate of 41% in the first two days of age appears higher than the state's rate using the CDC report card. Mother request and newborn difficulty latching are the top reasons for formula supplementation. Median age of supplementation was 20 hours. Lactation consultations were not universal and disparities existed for breastfeeding mothers supplementing with formula. Addressing maternal disparities is essential to enhance newborn health equity. Our study's findings will be used to develop prenatal and postnatal interventions to maximize hospital breastfeeding support and minimize formula supplementation.

6.
Journal of General Internal Medicine ; 37:S441, 2022.
Article in English | EMBASE | ID: covidwho-1995634

ABSTRACT

CASE: A 44 year old female with history of depression and recent suicide attempt presents with one week of cognitive and functional decline. One month prior to presentation, patient attempted suicide with opioids requiring intubation for respiratory depression and stroke sequelae. She was discharged from this stay after 12 days having returned to mental and functional baseline. Two weeks later, she demonstrated decreased focus and concentration, progressing to decreased mobility and akinesis, eventually presenting to our hospital. Admission metabolic and toxic workup was negative. CT head redemonstrated findings of previously known stroke. MRI demonstrated new increased T2 Flair of the parietal lobes and the cerebral white matter. LP was without evidence of infection or inflammation. Encephalitis panel and autoimmune workup were negative. Neurology consult suggested delayed post-hypoxic leukoencephalopathy as a possible diagnosis, given clinical course of improvement and subsequent decline, along with akinetic mutism and deep cortical white matter flair abnormalities. After failed trial of lorazepam, she was started on amantadine and her cognitive and functional status improved slowly. IMPACT/DISCUSSION: Delayed post-hypoxic leukoencephalopathy (DPHL) is a rare syndrome characterized by biphasic time course with initial recovery and subsequent cognitive and functional decline. DPHL can follow any event of prolonged cerebral hypoxia most frequently CO poisoning. It can occur with more common causes of hypoxia including overdose, cardiac arrest, and seizures;recent case reports have reported DPHL following severe covid infection. The clinical course involves a hypoxic event followed by a return to functional baseline typically lasting 7-21 days, after which progressive physical and mental decline occur. Signs include neuropsychiatric symptoms like amnesia and disorientation, as well as parkinsonism or akinetic mutism (1). The mechanism of DPHL is unclear. One possible mechanisms involves diffuse demyelination. The half life of myelin basic proteins is approximately 20 days, the length of the lucid interval. Hypoxia may abruptly halt the myelination process but symptoms may not emerge until a critical threshold of loss was achieved. Evaluation of DPHL involves considering other causes of encephalopathy, such as infection, substance use, stroke, catatonia, and toxins. In the absence of other causes, diagnosis of DPHL is based on characteristic time course following hypoxic event, symptoms, and MRI findings of diffuse T2 hyperintensity of cerebral white matter are pathognomonic (1). Treatment of DPHL is generally supportive. Limited evidence suggests amantadine may be of benefit. CONCLUSION: Physicians should consider DPHL in patients who have experienced cerebral hypoxia and present with the characteristic time course and imaging findings.

7.
Internet Journal of Allied Health Sciences and Practice ; 20(3):24, 2022.
Article in English | Web of Science | ID: covidwho-1976035

ABSTRACT

Background: Clinical education placements for students enrolled in healthcare programs were abruptly upended in March 2020 due to COVID-19. Programs were faced with decisions of how to mitigate substantive challenges due to an unforeseen pandemic within timeframes that would align with curricular sequences and graduation dates. Schools quickly modified curriculum formats, implemented alternative teaching and learning instruction and developed safety protocols to protect students, clinical faculty, and patients. Purpose: The aim of this study explored the strategies employed by one physical therapy school's clinical education team, which resulted in successful completion of clinical course requirements and on-time graduation. Method: Data was collected on a single cohort of eighty (n=80) students who experienced changes in the timing, location, and/or progression of their clinical experiences due to COVID-19 related complications. The use of innovative clinically-oriented teaching strategies including web-based patient case simulation, virtual grand rounds, and other creative learning activities effectively supported student engagement both in and outside of clinical settings. Alternative learning strategies provided students the opportunity to progress through the clinical education curriculum, meet educational objectives, and satisfy the standard requirements by the Commission on Accreditation in Physical Therapy Education (CAPTE). Performance on the Clinical Performance Instrument (CPI) for the cohort of students affected by COVID-19 was compared to a cohort from 2019 who were not affected by COVID-19 related issues. Results: Analysis using Mann Whitney U statistics showed there were no significant differences in performance on the CPI between the groups (p=0.874). Conclusion: Looking forward, there is an opportunity for schools to build on what was learned during the pandemic and apply those strategies to other non-pandemic related situations with successful outcomes. Innovative teaching and learning strategies can help to bridge the gap of time out of clinic for any student who may experience an interruption in clinical education due to injury, illness, or other situation, and can provide a way for students to progress successfully through their physical therapy education.

8.
Infect Dis Ther ; 11(4): 1327-1341, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1906576

ABSTRACT

Tuberculous meningitis (TBM) is the most severe and disabling form of tuberculosis (TB), with at least 100,000 cases per year and a mortality rate of up to 50% in individuals co-infected with human immunodeficiency virus type 1 (HIV-1). To evaluate the efficacy and safety of an intensified anti-tubercular regimen and an anti-inflammatory treatment, the INTENSE-TBM project includes a phase III randomised clinical trial (TBM-RCT) in four countries in sub-Saharan Africa (SSA). Within this framework, we designed a comprehensive capacity-building work package ensuring all centres had, or would acquire, the ability to conduct the TBM-RCT and developing a network of skilled researchers, clinical centres and microbiology laboratories. Here, we describe these activities, identify strengths/challenges and share tools adaptable to other projects, particularly in low- and lower-middle income countries with heterogeneous settings and during the coronavirus disease 2019 (COVID-19) pandemic. Despite major challenges, TBM-RCT initiation was achieved in all sites, promoting enhanced local healthcare systems and encouraging further clinical research in SSA. In terms of certified trainings, the achievement levels were 95% (124/131) for good clinical practice, 91% (39/43) for good clinical laboratory practice and 91% (48/53) for infection prevention and control. Platform-based research, developed as part of capacity-building activities for specific projects, may be a valuable tool in fighting future infectious diseases and in developing high-level research in Africa.


The INTENSE-TBM project aimed to design a comprehensive work-package on capacity building, ensuring all centres would acquire the ability to conduct a phase III randomised clinical trial on TBM in sub-Saharan Africa, to reduce tuberculous meningitis mortality and morbidity in patients with/without HIV-1 co-infection. Therefore, the INTENSE-TBM project is an example of how an international clinical research consortium can provide opportunities to enhance local capacity building and promote centres without previous experience in clinical research. This article provides practical approaches for implementing effective capacity-building programmes. We highlight how to overcome limitations imposed by the COVID-19 pandemic to successfully complete clinics, laboratory set-ups and personnel training, so as to optimise resources and empower African institutions on a local level. At the same time, our experience shows how capacity-building programmes can deliver long-lasting impact that extends beyond the original aims of the project (e.g. HIV and TB), and support local health systems in fighting other infectious disease (e.g. COVID-19). Research projects in low- and lower-middle income countries with heterogeneous settings could stand to benefit the most.

10.
American Journal of Respiratory and Critical Care Medicine ; 205:1, 2022.
Article in English | English Web of Science | ID: covidwho-1880140
11.
Pediatric Blood & Cancer ; 69:1, 2022.
Article in English | Web of Science | ID: covidwho-1848655
12.
Open Forum Infectious Diseases ; 8(SUPPL 1):S167-S168, 2021.
Article in English | EMBASE | ID: covidwho-1746741

ABSTRACT

Background. The COVID-19 pandemic placed a strain on inpatient clinical and hospital programs due to increased patient volume and rapidly evolving data on best COVID-19 management strategies. However, the impact of the pandemic on ASPs has not been well described. Methods. We performed a cross-sectional electronic survey of stewardship pharmacy and physician leaders in 37 hospitals within the Duke Antimicrobial Stewardship Outreach Network (DASON) (community) and Duke/UNC Health systems (academic) in April-May 2021. The survey included 60 questions related to staffing changes, use of COVID-targeted therapies, related restrictions, and medication shortages. Results. Twenty-seven facilities responded (response rate of 73%). Pharmacy personnel was reduced in 17 (63%) facilities by an average of 16%. Impacted pharmacy personnel included the stewardship lead in 15/17 (88.2%) hospitals. Converting to remote work was rare and only reported in academic institutions (n=2, 7.4%). ASP personnel were reassigned to non-stewardship duties in 12 (44%) hospitals with only half returning to routine ASP work as of May 2021. Respondents estimated that 62% of routine ASP activities were diverted during the time of the pandemic. Non-traditional, pandemic-related ASP activities included managing multiple drug shortages, of which ventilator support medications (91%) were most common affecting patient care at 52% of facilities. Steroid and hydroxychloroquine shortages were less frequent (44% and 22%, respectively). Despite staff reductions, pharmacists often served as primary contact for remdesivir approvals either using a criteria-based checklist at dispensing or as part of a dedicated phone approval team (Figure). Most (77%) hospitals used a criteria-based pharmacist review strategy after remdesivir FDA approval. Restriction processes for other COVID-19 therapies such as tocilizumab, hydroxychloroquine, and ivermectin were reported in 64% of hospitals. Proportion of facilities implementing specific remdesivir allocation strategies from the time of the first US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) through FDA approval Conclusion. Pandemic response diverted routine ASP work and has not yet returned to baseline. Despite the reduction in pharmacy personnel due to the pandemic, the ASP pharmacy lead took on a novel and critical stewardship role throughout the pandemic exemplified by their involvement in novel treatment allocation for COVID patients.

13.
Journal of Investigative Medicine ; 70(2):528-529, 2022.
Article in English | EMBASE | ID: covidwho-1707464

ABSTRACT

Purpose of Study The objective of this study was to identify generational differences in COVID-19 vaccine hesitancy among college students. Methods Used An online survey was conducted between September and October 2021 to the student body at Louisiana State University Shreveport to compare COVID-19 vaccine hesitancy among the following generations: Baby Boomers (1955-1964), Generation X (1965-1980), Millennials (1981- 1996), and Generation Z (1997-2000). Summary of Results Among the 339 participants, 66.8% were female, 28.5% male, 2.4% non-binary, and 2.4% other. Regarding their race, 64% were White, 16% African American, 9.8% selected two or more races or other, 6% Middle Eastern or North African, 5% Hispanic/Latinx, 2.7% Asian, and 1.2% Native American or Alaska Native. Among the generations who participated in the study, 43.2% were from Generation Z (GZ), 31.8% Millennials (M), 21.9% Generation X (GX), and 3% Baby Boomer (BB). Of the participants who selected that they had not received the COVID-19 vaccine, Generation Z (53.8%) reported the highest number, followed by Millennials (26.1%). In addition, when asked if participants planned to receive the COVID-19 vaccine, over half of Generation Z reported that they did not plan to get the vaccine compared to 19.7% of Generation X and 1.7% of Baby Boomers. Interestingly, when asked if FDA approval made them feel more confident in the vaccine's safety, the data suggests no statistical significance between groups. The leading causes for vaccine hesitancy among Generation Z were not trusting the COVID-19 vaccine (56.7%), and concerns about unknown long-term side effects of the vaccine (68.3%). Conclusions Of the generational groups, Generation Z college students report low rates of COVID-19 vaccination and intention of receiving the vaccine. This fact may have implications for herd immunity for college campuses across the nation.

14.
Journal of Investigative Medicine ; 70(2):538, 2022.
Article in English | EMBASE | ID: covidwho-1701808

ABSTRACT

Purpose of Study Prior to the COVID-19 pandemic, we initiated a randomized clinical trial for childhood obesity. The trial consented 131 and randomized 104;6-12 year old patients who reside in rural regions in 4 member states (DE, NE, SC, and WV) of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) Approximately 6 weeks into the 10-week recruitment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment and study methods to using virtual procedures. This descriptive paper outlines ways to recruit and manage clinical trial participants using technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods Used We reviewed multiple data sources to describe the transition to virtual study procedures. These include research electronic data capture (REDCap) surveys conducted both during the pause and at the completion of the study to identify readiness for each site to conduct virtual recruitment and other study procedures as well as at the end of the study to identify issues that each site encountered during the virtual phase of the project. We also reviewed meeting notes and study enrollment figures. Summary of Results The IRB approved study changes allowed for variability between clinical sites in terms of virtual communication platforms and methods for participant consent and height/weight assessment. Identified advantages of the study included ability to conduct visits during all times of the day or evening, and reduced travel requirements. Challenges included poor Internet reliability in some rural areas;additional participant contacts for consent and eligibility screening;shipping delays of materials;reliance on family to perform height and weight measures;increased costs for materials and shipping. Despite the added challenges, all sites were able to meet the study enrollment objectives. Flexibility was key in implementation of virtual procedures given the variations in site resources. Conclusions While each study site had certain challenges unique to their location during the pandemic, we also identified several common issues with the transition to remote procedures. Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with a difficult to reach rural and underserved populations or during challenging events like the pandemic.

15.
Cancer Epidemiology Biomarkers and Prevention ; 31(1 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1677437

ABSTRACT

Development of medicines and vaccines for COVID-19 amplified the need for all US communities to participate in research. This recognition spurred interest in adopting inclusive and equitable research practices across industry and the clinical research ecosystem in general. Between 2018-2021, regulatory bodies, professional organizations, and working groups issued policy and/or recommendations outlining measures that support the conduct of inclusive and equitable clinical trials. We applied previously published multi-themed strategies, multi-stakeholder recommendations, and calls to action by surveying industry to document baseline practices towards equitable clinical trial representation in the US. Research Question: What strategies are industry leaders deploying to increase diversity in clinical trials? Methods: Using a 4-staged approach, we first identified 48 success factors sourced from 12 documents. This analysis included previously documented measures that are both inclusive of diverse populations as well as practices that facilitate insights from diverse communities. Second, a survey tool was developed that organized the individual success factors into 6 categories with one open-ended question on ecosystem changes;survey measures and 4 choices for each factor were “Actively implementing,” “Recommended to be implemented,” “No plans to implement,” and “No answer.” Third, the survey was administered between April 10-30, 2021, to 12 pharmaceutical companies all having a proven external commitment to health equity in oncology and all are represented on the 2021 1Q Biopharma top 25 by Market Cap report. Fourth, responses were anonymized and aggregated;results were provided to respondents. Results: The response rate was 67% (8/12). Responders indicated success factors across two major implementation categories as follows: “actively implemented” (51%);“recommended/planned for implementation” (44%). No responders added any additional success factors via free text. Being “actively implemented” was highest for the 3 categories “site selection” (78%), “general capabilities” (72%), “leadership” (53%). “Recommended/planned for implementation” was highest for the 3 categories “participant focused” (50%), “other factors” (50%), “racial and ethnic minority group data (REMG)” (48%). Conclusions: Pharmaceutical companies reported active implementation of success factors sourced from public documents across all categories. As an example, stakeholders have generally considered thoughtful site selection an important measure to enroll diverse representation in clinical trials as it may mitigate access barriers to participation. In the site selection category, the survey reported 7/8 companies were actively implementing three measures and 5/8 were actively implementing two measures. An approach and analysis should be considered for expansion to more biotech companies and include a process devised for annual fielding and transparently reporting results.

16.
Obesity ; 29(SUPPL 2):76, 2021.
Article in English | EMBASE | ID: covidwho-1616049

ABSTRACT

Background: Pediatric obesity interventions of 26 or more contact hours may be more effective than those with fewer contact hours, but research is inconclusive. Disagreement may be due to the lack of uniformity in reporting dose. To remedy this issue experts recommend reporting dose intended, dose delivered, and dose received. Also, very little is known about the accumulation of dose in rural populations, and no information has been published regarding the accumulation of dose in the time of COVID 19. The purpose of the current is to describe the accumulation of dose in a four-state pediatric obesity intervention trial that was conducted in the IDeA States Pediatric Clinical Trials Network. Methods: Rural medical clinics located in four states participated. Each clinic targeted recruitment of 28 children from rural areas who were 6-11 years of age with a BMI%ile≥85th and their primary caregivers who (after consent/assent) were randomly assigned to a monthly newsletter only condition or to the iAmHealthy mHealth intervention, which was composed of 12 weekly and 3 monthly one hour group sessions and 11 hours of individual family health coaching. The 6-month intervention period began on August 24, 2020 and completed on February 7, 2021 when the impact of the COVID 19 pandemic was high in participating sites. Results: 52 of the 104 randomized participants were assigned to iAmHealthy;87% (n = 45) of these participants were retained through the final measurement. Dose intended was 26 contact hours (15 hours of group sessions and 11 hours of health coaching sessions), with a goal for families to receive 80% of these hours (20.8 hours). Dose delivered by the intervention team included 15 hours of group sessions and up to 17 hours for health coaching sessions. Dose received varied widely for both group (0.73-16.78;X = 10.65) and health coaching sessions (0.45-16.85;X = 8.21). Therefore, total accumulated contact hours varied as well (2.45-31.13;X = 18.86). Two thirds of the retained participants met the a priori dose goal of 20.8 contact hours. Conclusions: Dose intended and dose received were highly concordant, but dose received varied widely by participant. Future research should continue to explore these measures of dose, especially in underserved populations, and whether these factors are related to health behavior outcomes and body mass changes.

17.
Paediatrics and Child Health (Canada) ; 26(SUPPL 1):e21-e23, 2021.
Article in English | EMBASE | ID: covidwho-1584151

ABSTRACT

BACKGROUND: Visits to pediatric emergency departments have decreased up to 75% during the pandemic, with corresponding increases in high acuity visits, inpatient admissions, and intensive care unit admissions compared to historical cohorts. OBJECTIVES: To determine if caregivers of children presenting to pediatric emergency departments (EDs) during the COVID-19 pandemic are delaying presenting to care for fear of contracting COVID-19. Secondary objectives were to: a) evaluate potential predictors of delay;b) describe the proportion of children whose symptoms worsened during time to presentation. DESIGN/METHODS: A multicentre cross-sectional survey study of caregivers accompanying their children aged 0-19 years old to 16 pediatric EDs in 6 countries, from May-June 2020. An anonymous online survey, completed by caregivers via RedCAP, included caregiver and child demographics, presenting complaints, if they delayed presentation and whether symptoms worsened during this interval, as well as caregiver concerns about the child or caregiver having COVID-19 at the time of ED visit. RESULTS: Of 1543 caregivers completing the survey, 287 (18.6%) reported a delay in seeking ED care due to concerns of contracting COVID-19 in the hospital. Of those, 124 (43.2%) stated their child's symptoms worsened during the waiting interval. Caregiver relationship to child [mother] (OR 1.85, 95% CI 1.27-2.76), presence of chronic illness in child (OR 1.78. 95% CI 1.14-2.79), younger age of caregiver (OR 0.965, 95% CI 0.943-0.986), and caregiver concerns about lost work during the pandemic (OR 1.08, 95% CI 1.04-1.12), were independently associated with a COVID-19-related delayed presentation in multivariate regression analysis. CONCLUSION: Almost one in five caregivers reported delaying ED presentation for their ill or injured child, specifically due to fear of contracting COVID-19 while in hospital. Mothers, younger caregivers, caregivers of children with chronic illness, and those concerned about lost work were at highest risk for delay.

19.
Journal of Clinical Oncology ; 39(15):3, 2021.
Article in English | Web of Science | ID: covidwho-1538138
20.
Journal of Pediatric Gastroenterology and Nutrition ; 73(1 SUPPL 1):S7-S8, 2021.
Article in English | EMBASE | ID: covidwho-1529263

ABSTRACT

Prospective multicenter center studies are needed to develop inter-institutional clinical pathways and improve health care practices. Multicenter studies are encouraged by the National Institutes of Health and desired by investigators. However, investigator-initiated, randomized, controlled, multi-site trials face many challenges1, one of which is the timeline involved in contracting, regulatory and human subjects' requirements. These steps must be finalized prior to each site's activation to engage in any study-related activities. Research indicates these timelines can be especially challenging for pediatric trials, and trials involving medically complex patients.2,3 Given the typical investigator-initiated funding cycle of five years or less, understanding the timeline necessary to achieve multi-site activation is key to the conduct of multi-site trials, especially trials that are complex. Therefore, the purpose of the current analysis is to present the timeline for site activation across nine sites in the United States participating in the iKanEat trial (NCT03815019;NIH R01 HD093933) from October 2018 thru present. iKanEat is a prospective randomized controlled trial conducted across 10 sites in the United States focused on the use of megesterol as part of a pediatric tube weaning program. Data were collected from the regulatory system at the primary site regarding the variables of: expressing interest, IRB approval, contract approval, site activation, and first subject recruited. Data indicate that time from expressing interest in the study to full IRB approval averaged 230 days (range = 70-396) and time to full contract approval averaged 190 days (range = 88-190). The time for clearing all administrative hurdles and moving to full site activation for subject recruitment averaged 288 days (range = 253-350) and the time from site activation to consenting a first patient to the study averaged 463 days (range = 314-669). Reasons for delays collected from each site included coordination with the investigational pharmacy, site accounting set up, and scheduling site trainings with the investigative team at the primary site. It is also likely that the outbreak of SARS COV-2, and subsequent pauses in site activities, impacted these timelines, especially from March 2020-March 2021. These longer than anticipated timelines have put subject recruitment goals at risk and also increased cost for the current study. These findings indicate that at least one year should be built into study timelines prior to subject recruitment. This information should be helpful to other investigators planning multi-site investigator-initiated pediatric trials. Future research should examine specific methods for decreasing these timelines, with an emphasis on those trials that involve medically complex children.

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