Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes

2021 ◽  
pp. OP.21.00169
Author(s):  
David E. Gerber ◽  
Valerie L. Clark ◽  
Thomas Y. Sheffield ◽  
M. Shaalan Beg ◽  
Yang Xie ◽  
...  
Keyword(s):  
Clinical Research ◽  
Personal Experience ◽  
Research Personnel ◽  
Global Pandemic ◽  
Perceived Impact ◽  
Office Personnel ◽  
Research Professionals ◽  
Study Monitoring ◽  
Research Office

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

scholarly journals Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments

2021 ◽  
Vol 19 (5) ◽  
pp. 505-512
Author(s):  
David E. Gerber ◽  
Thomas Y. Sheffield ◽  
M. Shaalan Beg ◽  
Erin L. Williams ◽  
Valerie L. Clark ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Personal Experience ◽  
Positive Impact ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Professional Experience ◽  
Fisher Exact Test ◽  
Detailed Knowledge ◽  
Research Professionals

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.

Listening to the Voices of Individuals with Disabilities

1998 ◽  
Vol 79 (2) ◽  
pp. 188-196 ◽  
Author(s):  
Stephen French Gilson ◽  
John C. Bricout ◽  
Frank R. Baskind
Keyword(s):  
Social Work ◽  
Exploratory Study ◽  
Personal Experience ◽  
Work Practice ◽  
Social Work Practice ◽  
Fundamental Rights ◽  
Individuals With Disabilities ◽  
Research And Practice ◽  
The Social

Social work literature, research, and practice on disabilities has lagged behind other topical areas dealing with oppressed groups. The social work literature remains “expert focused” and generally fragmented into discussions of specific disabilities or subpopulations. A viable general model that deals with the personal experience of disability is not available. This exploratory study presents a social work literature search and analysis as well as interviews with six individuals with disabilities about their experiences with social workers. Individuals with disabilities assert that they were treated as though they had categorically fewer aspirations, abilities, and perhaps even fundamental rights than did nondisabled people. This study provides a base for follow-up research on models of consumer-focused social work practice in the area of disability.

scholarly journals A Case Study Supporting Lack of SARS-CoV-2 Spread to a 3-Month Old Infant Through Exclusive Breastfeeding

2021 ◽  
pp. 089033442199107 ◽  
Author(s):  
Wei Liu ◽  
Yujie Liu ◽  
Zhenjun Liu ◽  
Changxin Hong ◽  
Jian Liu ◽  
...  
Keyword(s):  
Male Infant ◽  
Computed Tomography Imaging ◽  
Full Data ◽  
Laboratory Findings ◽  
Global Pandemic ◽  
Breast Pump ◽  
Acid Test ◽  
Maternal And Newborn

Introduction During the Coronavirus Disease 2019 global pandemic, maternal and newborn wellbeing has received much attention. Detailed reports of infected women breastfeeding their infants are uncommon. Due to incomplete information available, full data about those infants’ outcomes are lacking, and evidence of infectivity through breastfeeding has not been documented. Main Issue Here, we report about a mother who breastfed her infant until she was confirmed with the SARS-Cov-2 infection. After follow-up, we have confirmed that the infant, who was breastfed by the infected mother, was not infected. Methods A 33-year-old woman gave birth to a full-term male infant on November 8, 2019. Since birth, she had been exclusively breastfeeding the baby until she was confirmed with the SARS-Cov-2 infection on February 8, 2020. She was hospitalized, isolated from her baby, and stopped breastfeeding. Even though she remained asymptomatic, her milk was expressed using a breast pump and discarded. The mother’s milk sample was collected on February 9, 2020, and the result of the nucleic acid test for COVID-19 was negative. Her infant was asymptomatic and remained virus negative. Her laboratory findings and chest Computed Tomography imaging was normal. She was treated according to the national protocol with aerosolized interferon α2β, lopinavir/ritonavir and ribavirin. Her serum SARS-CoV-2 specific antibodies(IgG and IgM) tested positive when discharged. She returned to breastfeeding after discharge. Conclusion Our findings suggest that breastfeeding may be less of a risk than anticipated. Additional research is needed to explore this possibility.

scholarly journals Acute care research competencies for clinical research professionals

2020 ◽  
Vol 4 (6) ◽  
pp. 485-492
Author(s):  
Stephanie Schuckman ◽  
Lynn Babcock ◽  
Cristina Spinner ◽  
Opeolu Adeoye ◽  
Dina Gomaa ◽  
...  
Keyword(s):  
Clinical Research ◽  
Acute Care ◽  
Performance Metrics ◽  
Task Force ◽  
Continuing Professional Development ◽  
Personal Characteristics ◽  
Care Research ◽  
Trial Competency ◽  
Conducting Research ◽  
Research Professionals

AbstractIntroduction:Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings.Methods:Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom’s Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics.Results:There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success.Conclusion:The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.

scholarly journals Teaching Mathematics during the COVID-19 Lockdown in a Context of Historical Disadvantage

2021 ◽  
Vol 11 (4) ◽  
pp. 177
Author(s):  
Brantina Chirinda ◽  
Mdutshekelwa Ndlovu ◽  
Erica Spangenberg
Keyword(s):  
South Africa ◽  
South African ◽  
Mathematics Teachers ◽  
Education System ◽  
Teaching And Learning ◽  
Face To Face ◽  
Global Pandemic ◽  
Education Community ◽  
South African Education

The COVID-19 global pandemic widely affected education across the world and engendered unprecedented scenarios that required expeditious responses. In South Africa, the pandemic came on top of pre-existing inequalities in the education system. Using a qualitative research method of exploratory and descriptive nature, this study engaged a social justice framework to explore the teaching and learning of mathematics during the COVID-19 lockdown in a context of historical disadvantage. A sample of twenty-three Grade 12 mathematics teachers at various public secondary schools in Gauteng, South Africa was used in the study. The teachers were selected through purposive sampling. A Google-generated open-ended questionnaire and follow-up telephonic interviews were used to collect data. Data were analysed thematically in five steps. The findings revealed that the WhatsApp platform is a valuable tool that can support the teaching and learning of mathematics beyond the classroom in the contexts of historical disadvantage. The findings also provided insights into how mathematics teachers became learners themselves during emergency remote teaching (ERT) as they had to adapt to digital teaching, find solutions to unfamiliar problems and acquire knowledge from a larger mathematics education community around the globe. The article discusses these findings and teachers’ challenges of transitioning from traditional face-to-face classrooms to ERT and how they were addressed. At the time of publishing the article, most learners in South Africa had started going to school on a rotational basis. Nonetheless, the study reported in this article is of importance as ERT in the context of historical disadvantage has foregrounded issues of inequality in the South African education system that must be dealt with urgently.

scholarly journals The Ways of Knowing the Pandemic With the Help of Prompted Autoethnography

2020 ◽  
pp. 107780042096013
Author(s):  
Pille Pruulmann-Vengerfeldt
Keyword(s):  
Personal Experience ◽  
Self Care ◽  
Ways Of Knowing ◽  
Qualitative Inquiry ◽  
Global Pandemic ◽  
Different Types ◽  
And Performance

This article discusses how different forms of autoethnographic production prompted by diverse forms of academic self-expression can lead to different types of knowing. Utilizing five examples from the Massive_Microscopic project, where participants responded to 21 different prompts inviting autoethnographic reflections about COVID-19 global pandemic, the article explores the responses from the perspective of alternative ways of knowing, reflecting on questions of motherhood, self-care, and performance in academia. Whether visual, rhythmic, or text produced from the perspective of things, the different modalities of the prompts allowed unexpected knowledge to emerge and supported deeper and more colorful reflections. Exploring the personal experience with the pandemic is expanded by the qualitative inquiry supported by different (self-)expression formats.

scholarly journals The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: Nephrolithotomy in 189 Patients with Solitary Kidneys

2012 ◽  
Vol 26 (4) ◽  
pp. 336-341 ◽  
Author(s):  
Viorel Bucuras ◽  
Ganesh Gopalakrishnam ◽  
J. Stuart Wolf ◽  
Yinghao Sun ◽  
Giampaolo Bianchi ◽  
...  
Keyword(s):  
Clinical Research ◽  
Percutaneous Nephrolithotomy ◽  
Global Study ◽  
Research Office

What we have achieved in the design of 3D printed metal implants for application in orthopedics? Personal experience and review

2018 ◽  
Vol 24 (8) ◽  
pp. 1365-1379 ◽  
Author(s):  
Zuhao Li ◽  
Chenyu Wang ◽  
Chen Li ◽  
Zhonghan Wang ◽  
Fan Yang ◽  
...  
Keyword(s):  
Personal Experience ◽  
Three Dimensional ◽  
High Patient Satisfaction ◽  
Functional Rehabilitation ◽  
Content Type ◽  
Metal Implants ◽  
Potential Development ◽  
3D Printed ◽  
Future Potential

PurposeThis paper aims to review the latest applications in terms of three-dimensional printed (3DP) metal implants in orthopedics, and, importantly, the design of 3DP metal implants through a series of cases operated at The Second Hospital of Jilin University were presented.Design/methodology/approachThis paper is available to practitioners who are use 3DP implants in orthopedics. This review began with the deficiency of traditional prostheses and basic concepts of 3DP implants. Then, representative 3DP clinical cases were summarized and compared, and the experiences using customized prostheses and directions for future potential development are also shown.FindingsThe results obtained from the follow-up of clinical applications of 3DP implants show that the 3D designed and printed metal implants could exhibit good bone defect matching, quick and safe joint functional rehabilitation as well as saving time in surgery, which achieved high patient satisfaction collectively.Originality/valueSingle center experiences of 3DP metal implants design were shared and the detailed technical points between various regions were compared and analyzed. In conclusion, the 3DP technology is infusive and will present huge potential to reform future orthopedic practice.

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