Abstract:
Consideration of how applicable the results of surgical trials are to clinical practice is important to inform decision-making. Randomized controlled trials comparing at least two surgical interventions (of gastric bypass, gastric band, and sleeve gastrectomy) for severe and complex obesity were examined using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, to consider how applicable the trial results are to clinical practice, and the Risk of Bias 2 tool, to examine validity. MEDLINE, Embase, and CENTRAL databases were searched for studies published between November 2013 and June 2021, and 15 were identified. Using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, three were classified as pragmatic, with good applicability to clinical practice. Ten had more explanatory domains but did include some pragmatic characteristics, and two were predominantly explanatory. This was due to some trial design features that would not be considered applicable to the wider clinical setting, including being single-centered, having prescribed intervention delivery methods, and intensive follow-up regimens. Only two trials had low risk of bias, of which one was considered pragmatic. Three had high risk of bias. Overall, few trials in bariatric surgery are pragmatic with low risk of bias. Well-designed pragmatic trials are needed to inform practice and reduce research waste.
摘要:
考虑手术试验的结果如何适用于临床实践对于告知决策很重要。随机对照试验比较了至少两种手术干预措施(胃旁路术,胃束带,和袖状胃切除术)使用PRagmatic解释性连续指标摘要2工具检查了严重和复杂的肥胖,考虑试验结果对临床实践的适用性,和偏向2工具的风险,检查有效性。MEDLINE,Embase,我们在CENTRAL数据库中搜索了2013年11月至2021年6月期间发表的研究,并确定了15项.使用PRagmatic解释性连续体指标摘要-2工具,三个被归类为务实,具有良好的临床实践适用性。十个有更多的解释域,但确实包括一些语用特征,两个主要是解释性的。这是由于某些试验设计特征不被认为适用于更广泛的临床环境。包括以单一为中心,有规定的干预交付方法,和密集的后续方案。只有两项试验有低偏倚风险,其中一个被认为是务实的。三人有较高的偏倚风险。总的来说,很少有减重手术试验是实用的,偏倚风险低.需要精心设计的务实试验来指导实践并减少研究浪费。