META ANALYTIC TECHNIQUES FOR ASSESSING VALVE SURGERY

这项建议的广泛和长期目标是改善 心脏瓣膜病患者的转归及扩大应用 超越随机对照试验(RCT)领域的荟萃分析。 瓣膜手术中人工瓣膜的选择是一个常见且困难的问题。 临床决策对患者的预后也有很大影响 作为护理费用。瓣膜置换术后患者预后的Meta分析 使用不同假体的手术将为 考虑假体选择的患者和医生。一具大身躯 然而，与这个问题有关的数据不在RCT的范围内 并涉及纵向(时间相关)数据。统计技术 需要超越Meta分析中常用的方法。我们 建议通过开发新的方法来填补这一方法空白 纵向和非RCT数据，并使用这些方法完成元数据。 分析一个重要的临床问题。我们的具体目标是： 1)对瓣膜置换术患者的预后进行荟萃分析 做手术。值得关注的结果包括围手术期死亡、长期死亡 生存、并发症、再手术、功能状态和假体 阀门失灵。元分析的数据来源包括少量 随机对照试验中，一些非随机对照试验和大量的 外科病例系列。我们将使用成熟的元分析方法 对符合条件的文献进行整理、分级和提炼。 2)开发和应用新的统计方法进行荟萃分析 对于非RCT和纵向数据。我们计划解决描述性的 以及对单点时间和纵向时间的比较分析 措施。来自非受控病例系列报告的数据和 纵向结果报告(例如，生存曲线)具有特殊性 因为它们在瓣膜手术文献中很常见 因为分析方法还没有被描述。 这一临床问题的可用数据类似于 可用于许多其他医疗技术：几项随机对照试验，但许多 观察性报告。因此，我们预计这些新方法 将在瓣膜手术之外有广泛的应用，并将 可广泛推广到卫生保健中的其他研究问题。在… 完成后，我们希望对患者有可靠的概要估计 瓣膜置换术后的预后和新的统计方法 到将在许多其他应用中有用的荟萃分析。

The broad, long-term objectives of this proposal are to improve the outcome of patients with valvular heart disease and to expand the use of meta-analysis beyond the realm of randomized controlled trials (RCTs). The choice of prosthesis in valve surgery is a common and difficult clinical decision with large implications for patient outcomes as well as the cost of care. A meta-analysis of patient outcomes after valve surgery with different prostheses would provide valuable information for patients and physicians considering choice of prosthesis. A large body of data pertaining to this problem, however, is outside the realm of RCTs and involve longitudinal (time-dependent) data. Statistical techniques that go beyond those commonly used in meta-analysis are required. We propose to fill this gap in methodology by developing new approaches to longitudinal and non-RCT data and using these methods to complete a meta- analysis of an important clinical problem. Our specific aims are: 1) Perform a meta-analysis of patient outcomes after valve replacement surgery. Outcomes of interest include perioperative death, long-term survival, complications, reoperation, functional status and prosthetic valve failure. Data sources for the meta-analysis include a small number of RCTs, some nonrandomized comparative trials and a large number of surgical case series. We will use well-established meta-analytic methods to assemble, grade and abstract the eligible literature. 2) Develop and apply new statistical methods to perform meta-analysis for non-RCT and longitudinal data. We plan to address both descriptive and comparative analyses of both single-point-in-time and longitudinal measures. Data from non-controlled case series reports and data with longitudinal outcome reports (e.g., survival curves) are of special interest because they are very common in the valve surgery literature and because analytic approaches have not yet been described. The data available for this clinical problem are similar to those available for many other medical technologies: few RCTs but many observational reports. Therefore, we anticipate that these new methods will have wide application beyond the issue of valve surgery and will be broadly generalizable to other research questions in health care. At completion, we expect to have reliable summary estimates of the patient outcomes after valve replacement surgery and new statistical approaches to meta-analysis that will be useful in many other applications.