Dissemination and implementation of a corrective intervention to improve mediasti

描述（申请人提供）：美国每年约有60，000人接受肺癌手术。对于这些患者，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，并指导术后治疗决策。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，死于肺癌的患者数量比根据其术后分期预测的要多。对大孟菲斯都市区肺癌手术切除质量的检查显示，与美国全国护理质量差距非常接近。部署用于肺癌切除术的专门设计的淋巴结标本采集试剂盒显著提高了病理淋巴结分期的质量，并增加了淋巴结转移患者的检测。我们现在想测试在东阿肯色州、北方密西西比和西田纳西三州地区常规使用这种独特的标本采集套件的实施情况，该地区具有挑战性的社会经济人口统计学和美国最高的肺癌死亡率。基于我们先前的工作，我们假设，成功地实施这种手术淋巴结标本采集试剂盒将提高肺癌病理分期的质量，并增加淋巴结转移的检测，在不同的混合手术的不同组合的外科医生在不同的混合机构的患者。我们的目标是研究在美国人口统计学多样化的肺癌高发地区常规使用该试剂盒的实施过程，以最大限度地提高其在未来传播中的影响。我们建议通过执行以下具体目标来实现这一目标：1。招募至少90%符合条件的医院（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结标本采集包的实施研究; 2.）使用交错实施、多基线研究设计，评估工具包在不同机构中进行手术的有效性; 3.）研究实施过程中使用的范围，有效性，采用，实施和维护（RE-AIM）框架。我们的研究将证明在实践环境的异质性中显着提高外科肺癌护理的质量和结果的实际可能性。病理分期的总体改善将为未来的翻译工作奠定基础，通过优化使用肿瘤、淋巴结和转移（TNM）分期系统（目前我们最好的风险分层系统），开发独立预后的基因和蛋白质表达谱。该项目的最终目标是提供临床基础设施，以支持未来对这些预后分子标记的研究，这些预后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.