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The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.
O'Brien, Emily C; Sugarman, Jeremy; Weinfurt, Kevin P; Larson, Eric B; Heagerty, Patrick J; Hernandez, Adrian F; Curtis, Lesley H.
Afiliación
  • O'Brien EC; Department of Population Health Sciences, School of Medicine, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. emily.obrien@duke.edu.
  • Sugarman J; Duke Clinical Research Institute, School of Medicine, Duke University, Durham, NC, USA. emily.obrien@duke.edu.
  • Weinfurt KP; Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
  • Larson EB; Department of Population Health Sciences, School of Medicine, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
  • Heagerty PJ; Duke Clinical Research Institute, School of Medicine, Duke University, Durham, NC, USA.
  • Hernandez AF; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
  • Curtis LH; Department of Biostatistics, University of Washington, Seattle, WA, USA.
Trials ; 23(1): 424, 2022 May 21.
Article en En | MEDLINE | ID: mdl-35597988
BACKGROUND: The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research. METHODS: We collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. A COVID-19 impact questionnaire was administered electronically to principal investigators in June 2020. Text responses were analyzed thematically, and qualitative summaries were subsequently reviewed by five independent reviewers, who made iterative revisions. Additional COVID-19-related impacts were identified during virtual meetings with trial teams during April-July 2020 and combined with questionnaire responses for analysis. RESULTS: Impacts of the pandemic were broadly classified into two main types: healthcare operations and social distancing. In some instances, trial delays created statistical challenges, particularly with trials using stepped-wedge designs, and necessitated changing data collection strategies or modifying interventions. The majority of projects used existing stakeholder-driven approaches to adapt interventions. Several benefits of these adaptions were identified, including expanded outreach capabilities and ability to study virtual intervention delivery. All trial teams were able to adapt to pandemic-related modifications. CONCLUSION: In a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Pragmáticos como Asunto / COVID-19 Tipo de estudio: Clinical_trials / Qualitative_research Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Pragmáticos como Asunto / COVID-19 Tipo de estudio: Clinical_trials / Qualitative_research Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido