CONCERT-Clinical Effectiveness Research (CONCERT-CER)

描述（由申请人提供）：慢性阻塞性肺疾病（COPD）是一种重要的健康状况。比较有效性研究（CER）尚不发达，尤其是在COPD方面。高影响力的CER研究议程的发展需要医疗保健中的各种利益相关者之间的协作基础设施，这些利益相关者产生，传播和使用新知识。基于COPD结局的临床有效性和研究转化网络（CONCERT; https：//www.kpchr.org/concert/）于2007年开发，以满足这一需求。CONCERT是一个跨学科的联盟，由美国6个医学中心的研究人员组成，他们在比较有效性研究、生物统计学、临床医院医学、肺部医学和重症监护方面具有专业知识。CONCERT研究人员为不同的COPD患者群体提供护理，包括管理和非管理护理（政府和非政府）环境中的患者。CONCERT的使命是采用CER和转化研究方法来评估和改善COPD患者的护理和结局。通过AHRQ/NHLBI提供的R13大型会议补助金的支持，CONCERT将召开共识会议，与广泛的利益相关者（包括医生和非医生专业组织（例如，ATS、ACCP、ACP）、医疗保险和医疗补助服务中心、私人健康计划、联合委员会、质量改进组织、患者倡导团体（例如，COPD基金会）和赞助商（AHRQ，NHLBI）。我们现在建议开发一个研究基础设施（CONCERT-CER），以加速多机构、跨学科研究的开发和实施，这些研究响应了这些利益相关者确定的COPD CER优先事项。我们相信，有了这一基础设施，CONCERT将有望成为美国首屈一指的CER联盟，开展开创性的、高影响力的研究，为COPD患者的医疗决策提供高质量的证据。拟议研究计划的具体目的是：（1）开发和支持一个新的国家COPD数据中心，用于管理式护理和非管理式护理环境中不同COPD患者人群的CER研究;（2）收集样本的其他详细临床信息（N= 1，200; 6个临床中心各200个）;以及（3）开发和完善4个COPD CER方案，解决利益相关者在共识会议中确定的高优先级问题。方案将由CONCERT研究者制定，包括研究人群、干预、对照组和结局指标的规范以及研究设计。 公共卫生相关性：慢性阻塞性肺疾病（COPD）是一种重要的健康状况。比较有效性研究（CER）尚不发达，特别是在COPD中，需要医疗保健中各利益相关者之间的协作基础设施。基于COPD结局的临床有效性和研究转化网络（CONCERT; https：//www.kpchr.org/concert/）建议开发一个研究基础设施，以加速多机构、多学科研究的开发和实施，以响应利益相关者的COPD CER优先事项。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is a key health condition. Comparative effectiveness research (CER) is underdeveloped, particularly in COPD. The development of a high impact CER research agenda requires a collaborative infrastructure between the various stakeholders in healthcare who generate, disseminate, and use new knowledge. The COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT; https://www.kpchr.org/concert/) was developed in 2007 to address this need. CONCERT is an interdisciplinary consortium of investigators at 6 US medical centers with expertise in comparative effectiveness research, biostatistics, clinical hospital medicine, pulmonary medicine, and critical care. CONCERT investigators provide care to diverse patient populations with COPD, including those in managed and non-managed care (government and non-government) settings. CONCERT's mission is to employ CER and translational research methodologies to evaluate and improve the care and outcomes of patients with COPD. Through support from an R13 large conference grant from AHRQ/NHLBI, CONCERT will convene consensus conferences to develop and prioritize CER agendas in Chronic COPD care (May 2009) and Acute COPD care (May 2010) in collaboration with a broad base of stakeholders, including physician and non-physician professional organizations (e.g., ATS, ACCP, ACP), the Centers for Medicare & Medicaid Services, private health plans, the Joint Commission, quality improvement organizations, patient advocacy groups (e.g., COPD Foundation), and sponsors (AHRQ, NHLBI). We now propose to develop a research infrastructure (CONCERT-CER) that will accelerate the development and conduct of multi- institutional, interdisciplinary studies that are responsive to the COPD CER priorities identified by these stakeholders. We believe that with this infrastructure CONCERT will be poised to become the premier US-based CER consortium for conducting ground-breaking, high-impact research that provides high-quality evidence to support healthcare decisions for patients with COPD. The Specific Aims of the proposed research program are: (1) to develop and support a novel national COPD Data Hub for CER studies in diverse COPD patient populations in managed care and non-managed care settings; (2) to collect additional detailed clinical information on a sample (N=1,200; 200 in each of 6 Clinical Centers) selected from the national COPD Data Hub; and (3) to develop and refine four COPD CER protocols that address high- priority questions identified in the consensus conferences by stakeholders. The protocols will be developed by the CONCERT investigators and will include specification of the study population, intervention, control group, and outcome measures, as well as the study design. PUBLIC HEALTH RELEVANCE: Chronic obstructive pulmonary disease (COPD) is a key health condition. Comparative effectiveness research (CER) is underdeveloped, particularly in COPD, and requires a collaborative infrastructure between the various stakeholders in healthcare. The COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT; https://www.kpchr.org/concert/) proposes to develop a research infrastructure that will accelerate the development and conduct of multi-institutional, multi-disciplinary studies that are responsive to the COPD CER priorities of stakeholders.