Are we doing the right surgical trials?: the difficult nature of ‘true’ equipoise

[摘要] There are a number of barriers to recruitmentof patients into surgical trials, but a fundamental factor remains the ability to achievetrue equipoise.In early randomized controlled trials(RCTs), the individual physician treating apatient decided whether or not they metthe inclusion criteria for a trial. However,Freedman1 indicated that this judgementwas subject to ‘individual equipoise’ whichintroduced an element of bias, and led to theconcept of ‘clinical equipoise’. Whereas ‘individual equipoise’ pertains to the individualbeing impartial in their beliefs regarding themerits of one intervention versus another,clinical equipoise is the genuine uncertaintyin the practice community over the benefit ofa particular intervention.

[学科分类] 骨科学

[关键词] Trials;Surgery;Pragmatic;Clinicians;randomized controlled trials;clinical trials;degenerative lumbar spondylolisthesis;spinal surgeons;physician