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Multistudy Research Operations in the ICU: An Interprofessional Pandemic-Informed Approach.
Cook, Deborah J; Duan, Erick H; Clarke, France J; Matic, Karlo; Culgin, Sarah; Kelly, Laurel; Nelson, Katlynne S; Wallace, Christine V; Soth, Mark D; Lewis, Kimberley A; Rudkowski, Jill C; Perri, Dan; Ligori, Tania L; Jaeschke, Roman Z; Chagla, Zain; Chaudhuri, Dipayan; Wright, Angela E; Fu, Zoe Y; Reeve, Brenda K; Lee, Hilary M; Overington, Jeffrey D; Rozenberg, Anna; Bloomfield, Kimberly A; Love, Katryn; Gain, Jennifer L; Zytaruk, Nicole L; Cheung, Jason H; Thabane, Lehana; Kho, Michelle E.
Afiliación
  • Cook DJ; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Duan EH; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Clarke FJ; Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Matic K; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Culgin S; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Kelly L; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Nelson KS; Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Wallace CV; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Soth MD; Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Lewis KA; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Rudkowski JC; Department of Respiratory Therapy, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Perri D; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Ligori TL; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Jaeschke RZ; Department of Physiotherapy, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Chagla Z; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Chaudhuri D; Department of Pharmacy, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Wright AE; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Fu ZY; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Reeve BK; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Lee HM; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Overington JD; Research Institute of St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Rozenberg A; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Bloomfield KA; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Love K; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Gain JL; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Zytaruk NL; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Cheung JH; Department of Anesthesia, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Thabane L; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Kho ME; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Crit Care Explor ; 4(12): e0808, 2022 Dec.
Article en En | MEDLINE | ID: mdl-36506834
Proliferation of COVID-19 research underscored the need for improved awareness among investigators, research staff and bedside clinicians of the operational details of clinical studies. The objective was to describe the genesis, goals, participation, procedures, and outcomes of two research operations committees in an academic ICU during the COVID-19 pandemic. DESIGN: Two-phase, single-center multistudy cohort. SETTING: University-affiliated ICU in Hamilton, ON, Canada. PATIENTS: Adult patients in the ICU, medical stepdown unit, or COVID-19 ward. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: An interprofessional COVID Collaborative was convened at the pandemic onset within our department, to proactively coordinate studies, help navigate multiple authentic consent encounters by different research staff, and determine which studies would be suitable for coenrollment. From March 2020 to May 2021, five non-COVID trials continued, two were paused then restarted, and five were launched. Over 15 months, 161 patients were involved in 215 trial enrollments, 110 (51.1%) of which were into a COVID treatment trial. The overall informed consent rate (proportion agreed of those eligible and approached including a priori and deferred consent models) was 83% (215/259). The informed consent rate was lower for COVID-19 trials (110/142, 77.5%) than other trials (105/117, 89.7%; p = 0.01). Patients with COVID-19 were significantly more likely to be coenrolled in two or more studies (29/77, 37.7%) compared with other patients (13/84, 15.5%; p = 0.002). Review items for each new study were collated, refined, and evolved into a modifiable checklist template to set up each study for success. The COVID Collaborative expanded to a more formal Department of Critical Care Research Operations Committee in June 2021, supporting sustainable research operations during and beyond the pandemic. CONCLUSIONS: Structured coordination and increased communication about research operations among diverse research stakeholders cultivated a sense of shared purpose and enhanced the integrity of clinical research operations.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Crit Care Explor Año: 2022 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Crit Care Explor Año: 2022 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos