Brief Report: Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design

Danny A Young-Afat1, Helena A M Verkooijen, Carla H van Gils

  • 1From the aDepartment of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; bDepartment of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands; cImaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; dDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; and eSchool of Health and Related Research (Public Health section), University of Sheffield, Sheffield, United Kingdom.

Summary

A staged-informed consent procedure can avoid prerandomization in cohort multiple randomized controlled trials (cmRCTs). This approach ethically integrates multiple trials within a cohort, enhancing pragmatic research.

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