A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points
A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points
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DOI：
10.1016/j.ijcard.2015.05.109
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发表时间：
2015-09-15
影响因子：
3.5
通讯作者：
Sen, Sayan
中科院分区：
文献类型：
--
作者：
Ahmad, Yousif;Nijjer, Sukhjinder;Sen, Sayan
背景：现代随机对照试验通常使用复合终点。这仅在每个终点对患者同等重要时有效，但很少有试验记录患者偏好并寻求组合终点组分的相对重要性。如果患者权衡终点差异，我们对试验数据的解释需要refined.Methods和结果：我们得出一个定量的，结构化的工具，以确定每个终点对患者的相对重要性。然后，我们将此工具应用于血管成形术与药物洗脱支架和旁路手术的比较数据。这项调查是对接受心脏导管插入术的患者进行的。然后使用（a）标准MACE和（B）以患者为中心的MACE进行比较冠状动脉旁路移植术（CABG）和经皮冠状动脉介入治疗（PCI）的荟萃分析。（中风102.3 +/-19.6%，p < 0.01），MI和重复血运重建的严重程度低于死亡（分别为61.9 +/- 26.8%和41.9 +/- 25.4%，p < 0.01）。7项RCT（5251例患者）合格。荟萃分析表明，PCI的标准MACE发生率高于手术（OR 1.44; 95% CI 1.10 - 1.87; p = 0.007）。以患者为中心的MACE再分析发现PCI和CABG之间无显著差异（OR 1.22，95%CI 0.97至1.53; p = 0.10）。结论：患者不认为MACE的组成终点相等。我们推导出一种新的以患者为中心的指标，该指标识别并量化了归因于每个终点的差异。当患者偏好数据应用于当代试验结果时，PCI和CABG之间没有显著差异。来自临床个体患者的响应可用于为个体患者提供真正个性化的建议。(C)2015爱思唯尔爱尔兰有限公司版权所有。
Background: Modern randomised controlled trials typically use composite endpoints. This is only valid if each endpoint is equally important to patients but few trials document patient preference and seek the relative importance of components of combined endpoints. If patients weigh endpoints differentially, our interpretation of trial data needs to be refined.Methods and results: We derive a quantitative, structured tool to determine the relative importance of each endpoint to patients. We then apply this tool to data comparing angioplasty with drug-eluting stents to bypass surgery. The survey was administered to patients undergoing cardiac catheterisation. A meta-analysis comparing coronary artery bypass grafting (CABG) to percutaneous coronary interventuin (PCI) was then performed using (a) standard MACE and (b) patient-centred MACE.Patients considered stroke worse than death (stroke 102.3 +/- 19.6%, p < 0.01), and MI and repeat revascularisation less severe than death (61.9 +/- 26.8% and 41.9 +/- 25.4% respectively p < 0.01 for both). 7 RCTs (5251 patients) were eligible. Meta-analysis demonstrated that standard MACE occurs more frequently with PCI than surgery (OR 1.44; 95% CI 1.10 to 1.87; p = 0.007). Re-analysis using patient-centred MACE found no significant difference between PCI and CABG (OR 1.22, 95% CI 0.97 to 1.53; p = 0.10).Conclusions: Patients do not consider the constituent endpoints of MACE equal. We derive a novel patient-centred metric that recognises and quantifies the differences attributed to each endpoint. When patient preference data are applied to contemporary trial results, there is no significant difference between PCI and CABG. Responses from individual patients in clinic could be used to give individual patients a recommendation that is truly personalised. (C) 2015 Elsevier Ireland Ltd. All rights reserved.