The Appropriateness Criteria for Coronary Revascularization: Feasibility of Measu

冠状动脉血运重建的适当性标准：测量的可行性

• 批准号: 8079691
• 负责人: Paul Sheung-Yan Chan
• 金额: $ 12.69万
• 依托单位: SAINT LUKE'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8079691
• 关键词: Accounting; Adopted; Adoption; Algorithms; American; American Heart Association; Angioplasty; Atlases; Balloon Angioplasty; Bypass; Cardiac; Cardiology; Cardiovascular system; Caring; Case Report Form; Clinical; Clinical Trials; Coronary; Coronary Arteriosclerosis; Data; Data Collection; Data Element; Decision Aid; Derivation procedure; Development; Documentation; Enrollment; Expert Opinion; Foundations; Frequencies; Funding; Future; Gender; Goals; Grant; Health; Health Status; Healthcare; Heart; Hospital Referrals; Hospitals; Image; Incentives; Individual; Institution; Judgment; Link; Maps; Measurement; Measures; Medicare; Methods; Multicenter Studies; Myocardial; Operative Surgical Procedures; Outcome; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Policy Maker; Prevalence; Procedures; Prospective Studies; Publishing; Quality of life; Questionnaires; Recommendation; Registries; Relative (related person); Research; Research Personnel; Research Project Grants; Rest; Series; Site; Societies; Specialist; Stents; Surgeon; Symptoms; System; Techniques; Testing; Update; Validation; Variant; Weight; Work; adjudicate; base; beneficiary; clinical care; clinical practice; college; data registry; design; follow-up; improved; insight; instrument; member; men; patient oriented; percutaneous coronary intervention; repository; response; routine practice; sound; tool

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.

描述（由申请人提供）：美国心脏病学院（ACC）最近开发了适当的标准（AC），用于冠状动脉血运重建，以支持对经皮冠状动脉干预（PCI）的合理和明智地使用。由于使用了修改后的Delphi方法，因此缺乏临床证据来支持大多数AC场景的适当评级。该提案将测试将AC应用于常规临床实践，评估全国范围内适当和不适当的PCI使用率的变化，并检查AC是否与以患者为中心的利益相关的AC是否相关的可行性。这些目标与NIH提高护理效率和适当性的优先事项保持一致。具体目标1将检查在临床实践中应用AC的可行性。在一项四点研究中，将开发并前瞻性地实施了AC的临床，药物，影像学和血管造影数据的数据模板。此外，将修改CATH/PCI数据收集工具的国家心血管数据注册表（NCDR）以捕获必要的AC数据元素。最后，将开发将算法链接到将单个PCI程序映射到AC的过程。具体目标2将描述参与NCDR CATH/PCI注册中心的医院PCI适当性的流行和变化。该分析将提供对AC的适当，不适当或不确定的PCI程序的全国患病率估计；检查机构中适当和不适当的PCI的比例的变异性；并确定过度使用可能在多大变化的程度上，通过将Medicare医院转诊区域内不适当和不确定的PCI的速率与Dartmouth Atlas的总体PCI使用差异相关联。特定的目标3将通过对患者福利的客观测量来验证AC的评分。通过一项四点前瞻性研究，将评估西雅图心绞痛问卷（SAQ）和EQ-5D仪器的6个月改变心绞痛症状和生活质量。症状负担和生活质量变化的测量将与适当性的评级相关，以确定AC是否与临床益处的客观测量有关。特定的目标4将涉及缩短的SAQ的推导，以促进其在常规实践中的使用。由于患者的症状是AC评级的关键决定因素，并且作为患者症状状况的分配可能是高度可变的，因此直接评估患者对SAQ的症状的直接评估为基本上的可靠性和保真度提供了机会。但是，完整的SAQ太麻烦了，无法在临床实践中定期收集。使用我们机构中SAQ数据的广泛存储库，将得出和验证的简约SAQ，以促进其在常规实践中的使用。 项目叙述：最近，评估气球血管成形术或心脏支架程序是否适合患者的标准已由心脏病学专业社会发表。但是，这些标准主要基于专家意见而不是科学证据。由于这些适当性标准可用于影响对血管成形术和支架程序的未来决策，因此该研究项目将验证这些标准并检查它们是否可行实施。