Petersen Mette K, Andersen Karen V, Andersen Niels T, Søballe Kjeld
Department of Orthopaedics, Aarhus Sygehus, Aarhus University Hospital, Aarhus C, Denmark.
Acta Orthop. 2007 Feb;78(1):12-8. doi: 10.1080/17453670610013367.
Although the randomized controlled trial (RCT) is regarded as the gold standard for evaluation of the effect of an intervention, its external validity has been questioned. RCTs cannot be expected to produce results that are directly relevant to all patients and all settings, but they should at least allow patients and clinicians to judge to whom trial results can reasonably be applied. We assessed the external validity of an RCT investigating the efficacy of a fast-track program after total hip replacement.
130 patients were identified as potential participants.18 patients were excluded, 33 enrolled patients declined to participate, and 79 patients were enrolled and randomized. We studied the distribution of preoperative characteristics and postoperative clinical variables in these 3 groups.
A significant difference was found in both preoperative characteristics and clinical outcome variables. The non-consenters were older, less healthy, and needed more help from the home care system. Furthermore, they were hospitalized longer and were more often transferred to a rehabilitation ward.
Our findings demonstrate the importance of patient inclusion criteria in RCTs. Moreover, they may account for the lack of reproducibility of RCT results in clinical practice dealing with fast-track programs.
尽管随机对照试验（RCT）被视为评估干预效果的金标准，但其外部效度一直受到质疑。不能期望随机对照试验产生与所有患者和所有环境都直接相关的结果，但它们至少应让患者和临床医生能够判断试验结果合理适用于哪些人。我们评估了一项关于全髋关节置换术后快速康复计划疗效的随机对照试验的外部效度。
确定130名患者为潜在参与者。18名患者被排除，33名已登记患者拒绝参与，79名患者被纳入并随机分组。我们研究了这三组患者术前特征和术后临床变量的分布情况。
术前特征和临床结局变量均存在显著差异。拒绝参与者年龄更大，健康状况更差，需要家庭护理系统提供更多帮助。此外，他们住院时间更长，更常被转到康复病房。
我们的研究结果证明了随机对照试验中患者纳入标准的重要性。此外，这可能解释了在涉及快速康复计划的临床实践中随机对照试验结果缺乏可重复性的原因。
