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Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants.
Coleman, Brian C; Purcell, Natalie; Geda, Mary; Luther, Stephen L; Peduzzi, Peter; Kerns, Robert D; Seal, Karen H; Burgess, Diana J; Rosen, Marc I; Sellinger, John; Salsbury, Stacie A; Gelman, Hannah; Brandt, Cynthia A; Edwards, Robert R.
  • Coleman BC; Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America. Electronic address: Brian.Colem
  • Purcell N; San Francisco VA Health Care System, San Francisco, CA, United States of America; Department of Social and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States of America.
  • Geda M; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, United States of America.
  • Luther SL; Research and Development Service, James A. Haley Veterans Hospital, Tampa, FL, United States of America; College of Public Health, University of South Florida, Tampa, FL, United States of America.
  • Peduzzi P; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Biostatistics, Yale School of Public Health, New Haven, CT, United States of America.
  • Kerns RD; Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Psychiatry, Yale
  • Seal KH; San Francisco VA Health Care System, San Francisco, CA, United States of America; Departments of Medicine and Psychiatry, University of California, San Francisco, San Francisco, CA, United States of America.
  • Burgess DJ; Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN, United States of America; Department of Medicine, University of Minnesota School of Medicine, Minneapolis, MN, United States of America.
  • Rosen MI; Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
  • Sellinger J; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
  • Salsbury SA; Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, United States of America.
  • Gelman H; Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.
  • Brandt CA; Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Emergency Medicin
  • Edwards RR; Department of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America.
Contemp Clin Trials ; 111: 106619, 2021 12.
Article in English | MEDLINE | ID: covidwho-1574060
ABSTRACT
Characterizing the impacts of disruption attributable to the COVID-19 pandemic on clinical research is important, especially in pain research where psychological, social, and economic stressors attributable to the COVID-19 pandemic may greatly impact treatment effects. The National Institutes of Health - Department of Defense - Department of Veterans Affairs Pain Management Collaboratory (PMC) is a collective effort supporting 11 pragmatic clinical trials studying nonpharmacological approaches and innovative integrated care models for pain management in veteran and military health systems. The PMC rapidly developed a brief pandemic impacts measure for use across its pragmatic trials studying pain while remaining broadly applicable to other areas of clinical research. Through open discussion and consensus building by the PMC's Phenotypes and Outcomes Work Group, the PMC Coronavirus Pandemic (COVID-19) Measure was iteratively developed. The measure assesses the following domains (one item/domain) access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization. The measure uses structured responses with a three-point scale for COVID-19 infection status and four-point ordinal rank response for all other domains. We recommend individualized adaptation as appropriate by clinical research teams using this measure to survey the effects of the COVID-19 pandemic on study participants. This can also help maintain utility of the measure beyond the COVID-19 pandemic to characterize impacts during future public health emergencies that may require mitigation strategies such as periods of quarantine and isolation.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pragmatic Clinical Trials as Topic / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pragmatic Clinical Trials as Topic / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article