Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Trials. 2011 Dec 13;12:258. doi: 10.1186/1745-6215-12-258.
Randomised controlled trials are being increasingly used to evaluate new surgical interventions. There are a number of problematic methodological issues specific to surgical trials, the most important being identifying whether patients are eligible for recruitment into the trial. This is in part due to the diversity in practice patterns across institutions and the enormous range of available interventions that often leads to a low level of agreement between clinicians about both the value and the appropriate choice of intervention. We argue that a clinician should offer patients the option of recruitment into a trial, even if the clinician is not individually in a position of equipoise, if there is collective (clinical) equipoise amongst the wider clinical community about the effectiveness of a proposed intervention (the clinical equipoise principle). We show how this process can work using data collected from an ongoing trial of a surgical intervention.
We describe a statistical framework for the assessment of uncertainty prior to patient recruitment to a clinical trial using a panel of expert clinical assessors and techniques for eliciting, pooling and modelling of expert opinions. The methodology is illustrated using example data from the UK Heel Fracture Trial. The statistical modelling provided results that were clear and simple to present to clinicians and showed how decisions regarding recruitment were influenced by both the collective opinion of the expert panel and the type of decision rule selected.
The statistical framework presented has potential to identify eligible patients and assist in the simplification of eligibility criteria which might encourage greater participation in clinical trials evaluating surgical interventions.
随机对照试验越来越多地被用于评估新的手术干预措施。有许多特定于手术试验的有问题的方法学问题，最重要的是确定患者是否有资格参加试验。这在一定程度上是由于机构间实践模式的多样性和可用干预措施的广泛范围，这常常导致临床医生之间对干预措施的价值和适当选择的共识程度较低。我们认为，如果在更广泛的临床社区中对拟议干预措施的有效性存在集体（临床）均衡（即临床均衡原则），即使临床医生个人没有处于均衡状态，临床医生也应该向患者提供参加试验的选择。我们展示了如何使用正在进行的手术干预试验中收集的数据来实现这一过程。
我们描述了一种使用专家组临床评估员和征求、汇总和建模专家意见的技术，在对患者进行临床试验招募之前评估不确定性的统计框架。使用来自英国足跟骨折试验的示例数据说明了该方法。该统计建模提供了清晰且易于向临床医生呈现的结果，并展示了招募决策如何受到专家组集体意见和所选决策规则类型的影响。
所提出的统计框架有可能确定合格的患者，并有助于简化可能鼓励更多人参与评估手术干预的临床试验的资格标准。
