‘Cohort multiple randomized controlled trial’

Een oplossing voor de evaluatie van multipele interventies
Stand van zaken
H.M. (Lenny) Verkooijen, Kit Roes en Carla H. van Gils

Cohort multiple randomized controlled trial: a solution for the evaluation of multiple interventions

Conflict of interest: none declared. Financial support: none declared.

  • The standard randomized controlled trial (RCT) does not appear to be the most suitable design for the fast and efficient simultaneous evaluation of multiple interventions for the same condition.

  • The cohort multiple randomized controlled trial (cmRCT) design offers the opportunity to perform randomized trials for multiple interventions simultaneously and is a promising alternative for the classic RCT.

  • The basis of the cmRCT is an observational cohort of patients with the same condition. The patients will generally undergo standard treatment. The patient characteristics are captured at baseline and outcome measures are captured at fixed points of time.

  • Eligible patients within the observational cohort are identified for each new intervention, some of whom will be randomly selected and offered the new intervention. The other eligible patients will not be approached and will undergo the standard treatment.

  • The same process can be simultaneously repeated for other interventions.

  • Advantages include the ability to facilitate multiple simultaneous randomized evaluations, the improved comparability between trials and the patient-centered informed consent procedure.