Dissemination and implementation of a corrective intervention to improve mediasti

描述(申请人提供)：在美国，每年约有60,000人接受肺癌手术。对于这些患者来说，癌症是否已经扩散到他们的淋巴结是他们预后的主要决定因素，并指导手术后的治疗决策。不幸的是，在美国进行的大多数肺癌手术不能提供足够的淋巴结样本来准确确定病理淋巴结分期。因此，死于肺癌的患者比他们手术后阶段预计的要多。对大孟菲斯大都会地区肺癌手术切除质量的检查显示，与美国国家护理质量差距非常接近。采用专门设计的淋巴结标本采集试剂盒用于肺癌切除，显著提高了病理淋巴结分期的质量，并增加了对淋巴结转移患者的检测。我们现在想测试这种独特的标本采集试剂盒在阿肯色州东部、密西西比州北部和田纳西州西部三州地区的常规使用情况，这些地区既有具有挑战性的社会经济人口统计数据，也有美国最高的肺癌死亡率。根据我们之前的工作，我们假设，成功实施这种外科淋巴结标本采集试剂盒将提高肺癌病理分期的质量，并增加在不同机构的不同外科医生手术的不同患者中的淋巴转移的检测。我们的目标是研究该试剂盒在美国人口统计多元化、肺癌高发地区常规使用的实施过程，以便在未来的传播中最大限度地发挥其影响。我们建议通过执行以下具体目标来实现这一目标：招募至少90%的符合条件的医院(那些在我们定义的集水区内每年进行5次肺切除手术的医院)和外科医生参与肺癌切除淋巴样本采集试剂盒的实施研究；使用交错实施、多基线研究设计，评估该试剂盒在不同机构中进行的手术的有效性；3)使用REACH、有效性、采用、实施和维护(RE-AIM)框架研究实施过程。我们的研究将证明，在实践环境的异质性中，显著提高外科肺癌护理的质量和结果的实际可能性。病理分期的普遍改善将为未来通过优化使用肿瘤、结节和转移(TNM)分期系统开发独立预后基因和蛋白表达谱的翻译工作奠定基础，TNM分期系统是目前我们最好的风险分层系统。这个项目的最终目标是提供临床基础设施，以支持对这种预后分子标记的未来研究，这些分子标记将补充并最终取代当前的TNM分期系统。

DESCRIPTION (provided by applicant): About 60,000 individuals undergo surgery for lung cancer in the US annually. For these patients, whether, or not, cancer has spread to their lymph nodes is the main determinant of their prognosis and guides post- operative treatment decision-making. Unfortunately, most lung cancer operations done in the US do not provide a sufficient sample of lymph nodes to make an accurate determination of pathologic lymph node stage. Therefore, a larger number of patients die of lung cancer than would have been predicted by their post- operative stage. Examination of the quality of lung cancer surgical resections in the greater Memphis Metropolitan Area reveals close approximation to the US national quality-of-care gap. Deploying a specially designed lymph node specimen collection kit for use in lung cancer resections significantly improves the quality of pathologic lymph node staging and increases the detection of patients with lymph node metastasis. We now want to test the implementation of the routine use of this unique specimen collection kit in the tri-state area of Eastern Arkansas, Northern Mississippi and Western Tennessee, which has the combination of challenging socio-economic demographics and some of the highest lung cancer mortality rates in the US. Based on our prior work, we hypothesize that successful implementation of this surgical lymph node specimen collection kit will improve the quality of pathologic staging of lung cancer and increase the detection of lymph node metastasis in a diverse mix of patients operated on by a diverse mix of surgeons in a diverse mix of institutions. Our objective is to study the implementation process of routine use of this kit in a demographically diverse, high lung cancer incidence region of the US, in order to maximize its impact in future dissemination. We propose to achieve this by performing the following Specific Aims: 1.) Recruit at least 90% of eligible hospitals (those within our defined catchment area with >5 lung resection operations annually) and surgeons to participate in an implementation study of the lymph node specimen collection kit for lung cancer resections; 2.) Evaluate the effectiveness of the kit in surgery performed in a diverse mix of institutions, using a staggered implementation, multiple baseline study design; 3.) Study the implementation process using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Our study will demonstrate the practical possibility of significantly improving the quality and outcomes of surgical lung cancer care across heterogeneity of practice settings. General improvement in pathologic staging will set the stage for future translational work on development of independently prognostic gene and protein expression profiles by optimizing the use of the Tumor, Node, and Metastasis (TNM) staging system, which is currently our best risk stratification system. The ultimate goal of this project i to provide the clinical infrastructure to support future studies of such prognostic molecular signatures that will supplement, and eventually supersede the current TNM staging system.