Clinical predictive value of systematic reviews with meta-analysis for future research on patients with multiple chronic conditions: a demonstration project using the case of preventive statin therapy

系统评价与荟萃分析对多种慢性病患者未来研究的临床预测价值：使用预防性他汀类药物治疗案例的示范项目

• 批准号: 9224036
• 负责人: Yuri Tertilus Jadotte
• 金额: $ 10万
• 依托单位: RBHS-SCHOOL OF NURSING
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2017-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9224036
• 关键词: Clinical; predictive; value; systematic; reviews

ABSTRACT BACKGROUND: Patients with multiple chronic conditions (MCC) are the largest consumers of healthcare in the US. Randomized controlled trials (RCT) of clinical effectiveness have not sufficiently studied these patients, while observational studies inherently produce biased estimates of clinical effectiveness. There are substantial disparities in health and healthcare for persons with MCC, particularly those with combinations of diabetes mellitus type II (DM), coronary artery disease (CAD) and chronic kidney disease (CKD). The effectiveness of statin therapy for preventing heart attacks and strokes remains unknown in populations with MCC. Furthermore, there is insufficient research done on how to best utilize existing data to study MCC in order to obtain answers that can assist these patients and their clinicians in healthcare decision-making. OBJECTIVE AND SPECIFIC AIM: The objective of this study is to help improve the utility of systematic review with meta-analysis as a method for studying the impact of MCC on clinical effectiveness. The specific aim of this project is to test the predictive value of systematic review with meta- analysis as a method for quantifying the impact of MCC on the clinical effectiveness of statin therapy for preventing heart attacks and strokes in patients with CAD, DM and CKD. METHODS: This study proposes to use systematic review with meta-analysis to identify, select and critically appraise relevant research studies, to synthesize the data from these studies in an effort to make recommendations for best practice, and to identify gaps in the literature that can lead to better-informed research for patients with MCC. A systematic review will be done to examine the impact of having MCC on the clinical effectiveness of statins for the prevention of heart attacks and strokes. AHRQ guidelines will be implemented to find, assess and synthesize the evidence from all studies, including both experimental and observational designs, which are relevant to the research question. Data from the included studies will be combined statistically to produce several meta-analyses. Meta-regression, subgroup, sensitivity and cumulative analyses will be performed to create quantitative measures of the impact of having different combinations of MCC on the effectiveness of statin therapy. PROJECTED OUTCOMES: The primary outcome of this project will be to determine how well systematic review with meta-analysis can help quantify the impact of having MCC on clinical effectiveness. A secondary outcome will be the quantification of this impact for the effectiveness of statin therapy, which represents one of the most widely prescribed treatments in the US. This study's recommendations will guide researchers on how to utilize systematic review with meta-analysis to analyze existing data on patients with other MCC. This will help reduce the need to conduct additional expensive and large experimental or observational studies, thereby rapidly improving clinical decision-making and speeding up the implementation of evidence into practice for these populations with special care needs.

摘要 背景：患有多种慢性疾病（MCC）的患者是最大的消费者， 美国的医疗保健。临床有效性的随机对照试验（RCT）尚未 充分研究了这些患者，而观察性研究固有地产生偏见， 临床有效性评估。在健康和医疗保健方面， MCC患者，特别是合并II型糖尿病（DM）的患者， 冠状动脉疾病（CAD）和慢性肾病（CKD）。他汀类药物的有效性 在MCC人群中预防心脏病发作和中风的治疗仍然未知。 此外，对于如何最好地利用现有数据进行研究， MCC，以获得答案，可以帮助这些患者及其临床医生在医疗保健 决策的 客观和具体目标：本研究的目的是帮助提高 采用荟萃分析的系统评价作为研究MCC对临床影响的方法 有效性该项目的具体目的是测试系统的预测价值， 综述Meta分析作为量化MCC对 他汀类药物治疗预防心脏病发作和中风的临床效果 CAD、DM和CKD患者。 方法：本研究拟采用系统评价和荟萃分析， 选择和批判性地评价相关的研究，综合这些数据 研究，努力提出最佳做法建议，并查明 这些文献可以为MCC患者提供更好的信息研究。的系统评价 将检查MCC对他汀类药物临床有效性的影响， 预防心脏病和中风将执行AHRQ准则， 评估和综合所有研究的证据，包括实验和 观察设计，与研究问题相关。数据来自包括 将对研究进行统计合并，以产生若干荟萃分析。元回归， 将进行亚组、敏感性和累积分析， 不同MCC组合对他汀类药物有效性影响的测量 疗法 预计成果：该项目的主要成果将是确定 荟萃分析的系统评价可以帮助量化MCC对临床的影响， 有效性次要结果将是量化这种影响 他汀类药物治疗的有效性，这是最广泛的处方治疗之一 在美国.这项研究的建议将指导研究人员如何利用系统的 使用荟萃分析进行审查，以分析其他MCC患者的现有数据。这将有助于 减少进行额外的昂贵和大型实验或观测的需要 研究，从而迅速改善临床决策，加快实施 为这些有特殊护理需求的人群提供实践证据。