Verkooijen H M Lenny, Roes Kit, van Gils Carla H
Universitair Medisch Centrum Utrecht, Divisie Beeld, Utrecht, the Netherlands.
Ned Tijdschr Geneeskd. 2013;157(17):A5762.
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.
标准随机对照试验（RCT）似乎并非同时快速有效地评估针对同一病症的多种干预措施的最合适设计。群组多重随机对照试验（cmRCT）设计提供了同时对多种干预措施进行随机试验的机会，是经典RCT的一个有前景的替代方案。cmRCT的基础是患有同一病症的患者的观察性群组。患者通常会接受标准治疗。在基线时记录患者特征，并在固定时间点记录结局指标。针对每项新干预措施，在观察性群组中确定符合条件的患者，其中一些患者将被随机选择并接受新干预措施。其他符合条件的患者将不被纳入，而是接受标准治疗。对于其他干预措施，可同时重复相同的过程。其优点包括能够促进多个同时进行的随机评估、提高试验之间的可比性以及以患者为中心的知情同意程序。
