Improve the Meaning of Patient Reported Outcomes to Evaluate Effectiveness for Cardiac Care" (IMPROVE-Cardiac Care)

项目摘要 心脏疾病是全球发病率和死亡率的主要原因。超过4亿人生活在 每年有1800万人死于心脏病在美国，冠心病影响18.2 心脏衰竭影响超过650万人，其中超过30%的人因急性心脏病住院治疗。 每年加重。患者报告的结局为医疗保健专业人员和患者提供了见解 患者在疾病轨迹上的位置，无论是在常规管理期间还是在从 重大临床事件。改善患者报告结局的意义以评估 心脏护理的有效性”（IMPROVE：心脏护理）研究旨在确定人群和个体 最小临床重要差异（MCIDS），这是有意义的最小改善， 心脏病患者。在目标1中，研究者将在患者报告的结局中建立MCID 适用于冠状动脉搭桥手术后恢复期的冠心病患者或心力衰竭患者 正在从住院治疗中恢复。在目标2中，研究者将在患者报告的结局中建立MCID 对于在门诊接受疾病管理的射血分数保留的心力衰竭患者， 设置.对于目标1和2，我们将使用三种统计方法，包括：1）基于锚点的方法 （PRO和临床指标的相关变化、平均变化、受试者操作特征），以及2） 基于条件锚点的方法（使用多变量逻辑回归）。在目标3中，研究人员将确定 心脏病患者报告的结果如何为临床决策提供信息。指导 通过意义建构的数据框架理论，我们将评估60名患者和医疗保健专业人员的配对 使用患者报告的结果健康信息做出临床决策：1）视频民族志， 测量沟通行为; 2）基于视频临床接触的反思性访谈， 描述如何将患者报告的结果纳入意义构建过程。总的来说，改进： 心脏护理研究将确定可用于识别患者的最低临床重要差异 从心脏事件中恢复得不理想的患者，并使用MCID进行早期干预。的 研究人员还将开发一种新的框架，用于如何有意义地评估患者报告的结果。 纳入临床实践。

PROJECT SUMMARY Cardiac conditions are the leading cause of morbidity and mortality globally. Over 400 million people are living with cardiac conditions, and 18 million people die annually. In the U.S., coronary heart disease affects 18.2 million adults and heart failure affects over 6.5 million people, of whom over 30% are hospitalized for acute exacerbations annually. Patient-reported outcomes provide healthcare professionals and patients with insight into where patients are on the disease trajectory, both during routine management and during recovery from a major clinical event. The overall goal of the Improve the Meaning of Patient-Reported Outcomes to eValuate Effectiveness for Cardiac Care” (IMPROVE: Cardiac Care) study is to establish population and individual minimally clinically important differences (MCIDS), which are the smallest improvement that is meaningful to patients with cardiac conditions. In Aim 1, the investigators will establish MCIDs in patient-reported outcomes for patients with coronary heart disease recovering from coronary artery bypass surgery, or with heart failure recovering from a hospitalization. In Aim 2, the investigators will establish MCIDs in patient-reported outcomes for patients with heart failure with preserved ejection fraction undergoing disease management in the ambulatory setting. For both Aims 1 and 2, we will use three statistical approaches including: 1) anchor-based methods (associated changes in PROs and clinical indicators, mean changes, receiver operating characteristics), and 2) conditional anchor-based methods (using multivariate logistic regression). In Aim 3, investigators will determine how patient-reported outcomes from patients with cardiac condition can inform clinical decision-making. Guided by the Data-Frame Theory of Sensemaking, we will evaluate 60 patient and healthcare professional dyads making clinical decisions using patient-reported outcome health information with: 1) video ethnography to measure communication behaviors; and 2) reflexive interviewing based on videoed clinical encounters to describe how patient-reported outcomes are incorporated into the sensemaking process. Overall, the IMPROVE: Cardiac Care study will establish minimally clinically important differences that can be used to identify patients who are not optimally recovering from a cardiac event, and use the MCIDs to target early interventions. The investigators will also develop a novel framework for how patient-reported outcomes can be meaningfully incorporated into clinical practice.