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）：美国心脏病学会（ACC）最近制定了冠状动脉血运重建的适当标准（AC），以支持经皮冠状动脉介入治疗（PCI）的合理和明智使用。由于使用了改良的德尔菲方法，因此没有临床证据支持大多数AC场景的适当性评级。该提案将测试在常规临床实践中应用AC的可行性，评估全国范围内适当和不适当PCI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指标相关。这些目标与NIH提高护理效率和适当性的优先事项相一致。具体目标1将研究在临床实践中应用AC的可行性。将开发采集AC所需患者临床、药物、成像和血管造影数据的数据模板，并在4中心研究中前瞻性实施。此外，将修改国家心血管数据登记研究（NCDR）Cath/PCI数据收集工具，以采集必要的AC数据元素。最后，将开发将各个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登记研究的医院之间PCI适当性的患病率和变化。该分析将提供根据AC评定为适当、不适当或不确定的PCI手术的国家流行率估计值;检查各机构适当和不适当PCI比例的变异性;并通过将医疗保险医院转诊区域内不适当和不确定的PCI的比率与PCI总体使用的可变性相关联，确定过度使用可能导致PCI使用的广泛差异的程度来自达特茅斯地图集。具体目标3将通过患者受益的客观测量来验证AC的评级。通过一项4中心前瞻性研究，将使用西雅图心绞痛问卷（SAQ）和EQ-5D工具评估6个月时心绞痛症状和生活质量的变化。然后将症状负担和生活质量变化的测量与适当性评级相关联，以确定AC是否与临床获益的客观测量相关。具体目标4将涉及简化SAQ的推导，以便于在日常实践中使用。由于患者的症状是AC评级的关键决定因素，并且由于医生对患者症状状态的分配可能是高度可变的，因此根据患者对SAQ的反应直接评估症状提供了大幅提高可靠性和保真度的机会。然而，完整的SAQ太麻烦，无法在临床实践中常规收集。使用我们机构的SAQ数据的广泛存储库，将导出并验证一个简约的SAQ，以促进其在常规实践中的使用。 项目叙述：最近，评估球囊血管成形术或心脏支架手术是否适合于患者的标准已经由心脏病学专业协会公布。然而，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能会影响未来对血管成形术和支架手术的决定，因此本研究项目将验证这些标准，并检查它们是否可行。