The Appropriateness Criteria for Coronary Revascularization: Feasibility of Measu

描述（由申请人提供）：美国心脏病学会（ACC）最近制定了冠状动脉血运重建术的适当性标准（AC），以支持合理和明智地使用经皮冠状动脉介入治疗（PCI）。由于采用了改进的德尔菲法，因此缺乏临床证据来支持大多数交流方案的适当性评级。本提案将测试在常规临床实践中应用AC的可行性，评估全国PCI适当和不适当使用率的变化，并检查AC是否与以患者为中心的获益的客观测量相关。这些目标与美国国立卫生研究院提高护理效率和适当性的优先事项一致。具体目标1将检查在临床实践中应用AC的可行性。数据模板捕获必要的患者临床，药物，成像和血管造影数据的AC将开发和前瞻性地实施在一个4中心的研究。此外，国家心血管数据登记（NCDR） Cath/PCI数据收集工具将被修改，以捕获必要的AC数据元素。最后，将开发将单个PCI程序映射到AC的链接算法。具体目标2将描述参与NCDR Cath/PCI登记的医院中PCI适宜性的流行程度和变化。该分析将提供国家PCI手术的患病率估计，这些手术根据AC被评为适当、不适当或不确定；检查各机构中适当和不适当的个人信息安全指数比例的差异；并通过将医疗保险医院转诊区域内不适当和不确定PCI的比率与达特茅斯地图集中PCI总体使用的可变性相关联，确定过度使用在多大程度上可能导致PCI使用的广泛变化。特异性目标3将通过客观测量患者获益来验证AC的评级。通过一项4个中心的前瞻性研究，使用西雅图心绞痛问卷（SAQ）和EQ-5D仪器评估6个月心绞痛症状和生活质量的变化。测量症状负担和生活质量的变化将与适当性评分相关联，以确定AC是否与临床获益的客观测量相关联。具体目标4将涉及推导一个缩短的SAQ，以方便其在日常实践中的使用。由于患者的症状是AC评分的关键决定因素，并且由于医生对患者症状状态的分配可能是高度可变的，因此从患者对SAQ的反应中直接评估症状提供了大大提高可靠性和保真度的机会。然而，在临床实践中常规收集完整的SAQ过于繁琐。利用我们机构广泛的SAQ数据存储库，我们将推导和验证一个简约的SAQ，以促进其在日常实践中的使用。

DESCRIPTION (provided by applicant): The American College of Cardiology (ACC) has recently developed Appropriateness Criteria (AC) for coronary revascularization to support the rational and judicious use of percutaneous coronary intervention (PCI). Because a modified Delphi approach was used, there is an absence of clinical evidence to support the appropriateness ratings for most of the AC scenarios. This proposal will test the feasibility of applying the AC in routine clinical practice, assess variations in rates of appropriate and inappropriate PCI use nationally, and examine whether the AC are associated with objective measures of patient-centered benefit. These aims are aligned with the NIH's priorities of improving the efficiency and appropriateness of care. Specific Aim 1 will examine the feasibility of applying the AC in clinical practice. Data templates that capture the requisite patients' clinical, medication, imaging, and angiographic data for the AC will be developed and prospectively implemented in a 4-center study. In addition, the National Cardiovascular Data Registry (NCDR) Cath/PCI data collection tool will be modified to capture the necessary AC data elements. Finally, linking algorithms to map individual PCI procedures to the AC will be developed. Specific Aim 2 will describe the prevalence of and variations in PCI appropriateness across hospitals participating in the NCDR Cath/PCI registry. This analysis will provide national prevalence estimates of PCI procedures that are rated appropriate, inappropriate, or uncertain, per the AC; examine the variability in the proportion of appropriate and inappropriate PCIs across institutions; and determine the degree to which overuse may account for wide variations in PCI use by correlating rates of inappropriate and uncertain PCIs within Medicare Hospital Referral Regions with variability in overall PCI use from the Dartmouth Atlas. Specific Aim 3 will validate the ratings of the AC with objective measurements of patient benefit. Through a 4-center prospective study, 6-month changes in angina symptoms and quality of life will be assessed with the Seattle Angina Questionnaire (SAQ) and the EQ-5D instruments. Measurements of change in symptom burden and quality of life will then be correlated with ratings of appropriateness to determine if the AC are associated with objective measures of clinical benefit. Specific Aim 4 will involve derivation of a shortened SAQ to facilitate its use in routine practice. As patients' symptoms are a critical determinant of the AC ratings, and as assignment of patients' symptom status by physicians can be highly variable, direct assessment of symptoms from patients' responses to the SAQ offers the opportunity for substantially greater reliability and fidelity. However, the full SAQ is too cumbersome to routinely collect in clinical practice. Using the extensive repository of SAQ data at our institution, a parsimonious SAQ will be derived and validated to facilitate its use in routine practice. PROJECT NARRATIVE: Recently, criteria which assess whether a balloon angioplasty or heart stent procedure is appropriate for a patient have been published by cardiology professional societies. These criteria, however, are primarily based on expert opinion rather than scientific evidence. Because these appropriateness criteria may be used to influence future decisions on angioplasty and stent procedures, this research project will validate these criteria and examine whether they are feasible to implement.