Development and feasibility testing of a lung cancer screening decision aid

摘要 拟议的项目将开发一种创新的基于网络的决策辅助(DA)，以改善对 吸烟导致肺癌高危人群的肺癌筛查(LCS)。近期 国家肺部筛查试验(NLST)数据显示， 高位肺癌患者低剂量CT筛查与胸部X线检查的比较 风险。鉴于肺癌是美国癌症死亡的主要原因，据估计 预计2012年将有160,340人死亡，新数据重新燃起了人们对LCS的兴趣。但是，LCS携带 重大风险包括高假阳性率、过度诊断、不良心理社会后果以及 辐射暴露增加。此外，目前尚不清楚LCS是否会降低人群中的肺癌死亡率 吸烟但不符合NLST资格标准的个人。因此，目前没有明确的最佳方案 选择是否应对给定的个人进行筛查。关于参与LCS的决定应 见多识广，与个人喜好保持一致。然而，我们之前的数据表明， 接受LCS治疗的人很少能透彻地了解其风险或益处。 为了应对这一迅速出现的公共卫生挑战，这项研究将1)开发一种基于网络的 决策辅助(DA)，帮助高危人群做出有关LCS的明智决策 肺癌(即吸烟者)和2)评估DA管理的可行性，并建议 进行DA有效性的未来随机临床试验(RCT)的方法。该文件的内容 DA将基于我们之前探索LCS决策的研究和其他最近的研究。 目前拟议的研究的具体目标是：目标1：制定发展援助计划以帮助个人 做出与他们的价值观和偏好一致的关于LC的明智决定。我们会 基于我们之前开发的KEV框架并在之前的研究指导下开发DA， 包括我们的LCS决策研究项目。目标2：开展发展议程的可行性试验 因大量吸烟而患肺癌的高危人群。我们将招募参与者以 评估以下项目的可行性：1)在社区环境中提供DA干预；2)进行研究 为未来的随机对照试验计划的程序和评估工具。 我们建议的工作意义重大，因为LCS的潜在风险和局限性是巨大的， 对NLST标准之外的人群进行筛查的好处是不确定的，数百万美国人将 面临关于筛查的决定。我们的工作也是高度创新的，因为LCS-DA可以从根本上 改进这些决策的制定方式。此外，将联合调查工具整合为发展议程的一部分 LCS是在这一庞大的高危人群中促进知情决策的一种新方法。

Abstract The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, our previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits. To address this rapidly emerging public health challenge, this research will 1) develop a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and 2) assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on our previous studies exploring LCS decision making and other recent research. The specific aims of the currently proposed research are: Aim 1: Develop a DA to help individuals make informed decisions about LCS that are consistent with their values and preferences. We will develop the DA based on our previously developed KEV framework and guided by previous research, including our program of LCS decision research. Aim 2: Conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. We will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT. Our proposed work is highly significant, as the potential risks and limitations of LCS are substantial, the benefits of screening for populations outside the NLST criteria are uncertain, and millions of Americans will be facing decisions about screening. Our work is also highly innovative, as a LCS-DA can fundamentally improve the way these decisions are made. In addition, integrating a conjoint survey instrument as part of a DA for LCS is a novel approach to facilitate informed decision making among this large, high-risk population.