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Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures
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- James R. Roberts, Sheva K. Chervinskiy, Russell McCulloh, Jessica Snowden, Paul M. Darden, Thao-Ly T. Phan, Erin Dawley, Victoria Reynolds, Crystal S. Lim, Lee Pyles, DeAnn Hubberd, Jaime Baldner, Lora Lawrence, Ann M. Davis
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue 1 / 2022
- Published online by Cambridge University Press:
- 25 August 2022, e115
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- Article
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- Open access
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Background/Objective:
Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial.
Methods:The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation.
Results:All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources.
Conclusion:Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.
Contributors
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- By Lenard A. Adler, Pinky Agarwal, Rehan Ahmed, Jagga Rao Alluri, Fawaz Al-Mufti, Samuel Alperin, Michael Amoashiy, Michael Andary, David J. Anschel, Padmaja Aradhya, Vandana Aspen, Esther Baldinger, Jee Bang, George D. Baquis, John J. Barry, Jason J. S. Barton, Julius Bazan, Amanda R. Bedford, Marlene Behrmann, Lourdes Bello-Espinosa, Ajay Berdia, Alan R. Berger, Mark Beyer, Don C. Bienfang, Kevin M. Biglan, Thomas M. Boes, Paul W. Brazis, Jonathan L. Brisman, Jeffrey A. Brown, Scott E. Brown, Ryan R. Byrne, Rina Caprarella, Casey A. Chamberlain, Wan-Tsu W. Chang, Grace M. Charles, Jasvinder Chawla, David Clark, Todd J. Cohen, Joe Colombo, Howard Crystal, Vladimir Dadashev, Sarita B. Dave, Jean Robert Desrouleaux, Richard L. Doty, Robert Duarte, Jeffrey S. Durmer, Christyn M. Edmundson, Eric R. Eggenberger, Steven Ender, Noam Epstein, Alberto J. Espay, Alan B. Ettinger, Niloofar (Nelly) Faghani, Amtul Farheen, Edward Firouztale, Rod Foroozan, Anne L. Foundas, David Elliot Friedman, Deborah I. Friedman, Steven J. Frucht, Oded Gerber, Tal Gilboa, Martin Gizzi, Teneille G. Gofton, Louis J. Goodrich, Malcolm H. Gottesman, Varda Gross-Tsur, Deepak Grover, David A. Gudis, John J. Halperin, Maxim D. Hammer, Andrew R. Harrison, L. Anne Hayman, Galen V. Henderson, Steven Herskovitz, Caitlin Hoffman, Laryssa A. Huryn, Andres M. Kanner, Gary P. Kaplan, Bashar Katirji, Kenneth R. Kaufman, Annie Killoran, Nina Kirz, Gad E. Klein, Danielle G. Koby, Christopher P. Kogut, W. Curt LaFrance, Patrick J.M. Lavin, Susan W. Law, James L. Levenson, Richard B. Lipton, Glenn Lopate, Daniel J. Luciano, Reema Maindiratta, Robert M. Mallery, Georgios Manousakis, Alan Mazurek, Luis J. Mejico, Dragana Micic, Ali Mokhtarzadeh, Walter J. Molofsky, Heather E. Moss, Mark L. Moster, Manpreet Multani, Siddhartha Nadkarni, George C. Newman, Rolla Nuoman, Paul A. Nyquist, Gaia Donata Oggioni, Odi Oguh, Denis Ostrovskiy, Kristina Y. Pao, Juwen Park, Anastas F. Pass, Victoria S. Pelak, Jeffrey Peterson, John Pile-Spellman, Misha L. Pless, Gregory M. Pontone, Aparna M. Prabhu, Michael T. Pulley, Philip Ragone, Prajwal Rajappa, Venkat Ramani, Sindhu Ramchandren, Ritesh A. Ramdhani, Ramses Ribot, Heidi D. Riney, Diana Rojas-Soto, Michael Ronthal, Daniel M. Rosenbaum, David B. Rosenfield, Durga Roy, Michael J. Ruckenstein, Max C. Rudansky, Eva Sahay, Friedhelm Sandbrink, Jade S. Schiffman, Angela Scicutella, Maroun T. Semaan, Robert C. Sergott, Aashit K. Shah, David M. Shaw, Amit M. Shelat, Claire A. Sheldon, Anant M. Shenoy, Yelizaveta Sher, Jessica A. Shields, Tanya Simuni, Rajpaul Singh, Eric E. Smouha, David Solomon, Mehri Songhorian, Steven A. Sparr, Egilius L. H. Spierings, Eve G. Spratt, Beth Stein, S.H. Subramony, Rosa Ana Tang, Cara Tannenbaum, Hakan Tekeli, Amanda J. Thompson, Michael J. Thorpy, Matthew J. Thurtell, Pedro J. Torrico, Ira M. Turner, Scott Uretsky, Ruth H. Walker, Deborah M. Weisbrot, Michael A. Williams, Jacques Winter, Randall J. Wright, Jay Elliot Yasen, Shicong Ye, G. Bryan Young, Huiying Yu, Ryan J. Zehnder
- Edited by Alan B. Ettinger, Albert Einstein College of Medicine, New York, Deborah M. Weisbrot, State University of New York, Stony Brook
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- Book:
- Neurologic Differential Diagnosis
- Published online:
- 05 June 2014
- Print publication:
- 17 April 2014, pp xi-xx
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4 - Responses to Discrimination and Social Resilience Under Neoliberalism
- Edited by Peter A. Hall, Harvard University, Massachusetts, Michèle Lamont, Harvard University, Massachusetts
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- Book:
- Social Resilience in the Neoliberal Era
- Published online:
- 05 May 2013
- Print publication:
- 22 April 2013, pp 129-157
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Summary
Members of stigmatized groups often live with the expectation that they will be overscrutinized, overlooked, underappreciated, misunderstood, and disrespected in the course of their daily lives. How do they interpret and respond to this lived reality? What resources do they have at their disposal to do so? How are their responses shaped by neoliberalism? How can responses to stigmatization foster social resilience?
This chapter enriches our understanding of social resilience by considering whether and how stigmatized groups may be empowered by potentially contradictory contextual forces – more specifically, by cultural repertoires that enable their social inclusion. We consider repertoires to be social scripts, myths, and cultural structures and that the content of these repertoires varies to some extent across national contexts (Lamont and Thévenot 2000). We also consider that certain repertoires can foster resilience by feeding the capacity of individuals to maintain positive self-concepts; dignity; and a sense of inclusion, belonging, and recognition. We argue that societies provide individuals with different means for bolstering their identity and building resilience. This is accomplished by making available repertoires that are fed by national ideologies, neoliberalism, and narratives concerning the collective identity of their groups.
Enhancing the Tissue Donor Pool through Donation after Death in the Field
- Adam M. Shiroff, Stephen C. Gale, Mark A. Merlin, Jessica S. Crystal, Matt Linger, Anar D. Shah, Erin Beaumont, Elie Lustiger, Erica Tabakin, Vicente H. Gracias
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- Journal:
- Prehospital and Disaster Medicine / Volume 28 / Issue 2 / April 2013
- Published online by Cambridge University Press:
- 22 January 2013, pp. 187-190
- Print publication:
- April 2013
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Introduction
Tissue transplantation is an important adjunct to modern medical care and is used daily to save or improve patient lives. Tissue allografts include bone, tendon, corneas, heart valves and others. Increasing utilization may lead to tissue shortages, and tissue procurement organizations continue to explore ways to expand the cadaveric donor pool. Currently more than half of all deaths occur outside the acute care setting.
HypothesisMany who suffer prehospital deaths might be eligible for non-organ tissue donation.
MethodsA retrospective review of electronic prehospital medical records was conducted from May 1, 2008 through December 31, 2009. All prehospital deaths were included irrespective of cause. Once identified, additional medical history was obtained from prehospital, inpatient, and emergency department records. Age, medical history, and time of death were compared to exclusion criteria for four tissue procurement organizations (MTF, LifeNet, LifeCell, EyeBank). After analysis, percentages of eligible donors were calculated.
ResultsOver 50,000 prehospital records were reviewed; 432 subjects died in the field and were eligible for analysis. Ages ranged from four to 103 years of age; the average was 68.3 (SD = 20.1) years. After exclusion for age, medical conditions, and time of death, 185 unique patients (42.8%) were eligible for donation to at least one of the four tissue procurement organizations (range 11.6%-34.3%).
ConclusionsAfter prehospital death, many individuals may be eligible for tissue donation. These findings suggest that future prospective studies exploring tissue donation after prehospital death are indicated. These studies should aim to clarify eligibility criteria, create protocols and infrastructure, and explore the ethical implications of expanding tissue donation to include this population.
. ,Shiroff AM ,Gale SC ,Merlin MA ,Crystal JS ,Linger M ,Shah AD ,Beaumont E ,Lustiger E ,Tabakin E .Gracias VH Enhancing the Tissue Donor Pool through Donation after Death in the Field . Prehosp Disaster Med.2013 ;28 (2 ):1 -4
INTRODUCTION1
- Michèle Lamont, Jessica S. Welburn, Crystal M. Fleming
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- Journal:
- Du Bois Review: Social Science Research on Race / Volume 9 / Issue 1 / Spring 2012
- Published online by Cambridge University Press:
- 07 June 2012, pp. 43-49
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It is particularly fitting that Du Bois Review would publish a special feature titled “Varieties of Responses to Stigmatization: Macro, Meso, and Micro Dimensions.” In many ways, we can consider the management of stigma to be a quintessentially Du Bois topic. In his classical writings on double consciousness, this pioneering social theorist (2007) captured the complex psychological experience of managing a life where one feels divided within oneself. He focused specifically on African American identity defined by the tension of being two at once (American and Black): “The Negro ever feels his two-ness—an American, a Negro; two souls, two thoughts, two unreconciled strivings; two warring ideals in one dark body, whose dogged strength alone keeps it from being torn asunder” (p. 3).