Compliance With Lung Cancer Screening

描述(由申请人提供)：随机癌症筛查试验被认为是评估新的癌症筛查技术的最佳方法。不幸的是，如果研究参与者未能遵守筛查、诊断确认或治疗，这些试验可能会低估新筛查技术的有效性。在这项研究中，我们建议在一项大型的多中心肺癌筛查试验中检查与癌症筛查不依从性相关的因素。这项研究将使用作为国家肺部筛查试验(NLST)美国放射学会(ACRIN)分支机构的一部分收集的现有数据进行。ACRIN负责在全美23个地点筛选18,843名参与者。目前正在对这些参与者进行跟踪调查，以确定使用低剂量螺旋计算机体层摄影(CT)或胸部X光(CXR)筛查是否可以降低肺癌死亡率。我们将重点关注那些在基线筛查检查中被诊断为肺癌阴性或假阳性的参与者(这意味着筛查检查是阳性的，但进一步的测试表明筛查异常是良性的)。我们在这项试验中的第一个目标是确定在基线筛查检查中被诊断为肺癌假阳性的参与者是否比接受肺癌筛查结果为阴性的参与者在下一次预定的筛查检查中返回进行筛查的可能性较小。我们在这项试验中的第二个目标是确定那些在基线筛查检查之前测量的参与者特征，这些特征与下一次预定的筛查检查中的不遵守有关。在这一阶段的研究中，我们计划考察人口因素的影响，包括性别、年龄、种族、教育水平、收入、所在国家的地区，以及健康史、肺癌家族史、吸烟状况和病史、与健康相关的生活质量指数和肺癌的感知风险。获得与不依从性相关的特征信息是有用的，原因有两个：1)与不依从性相关的特征信息可用于更好地进行靶向干预，并在未来的临床试验和临床实践中减少不依从性；2)临床试验分析的标准方法是意向治疗(ITT)分析，即在两个随机化组之间比较感兴趣的结果，而不考虑参与者的不依从性。然而，使用ITT分析时，假设试验中观察到的不合规率将与实施干预的社区中的不合规率相同。情况往往并非如此。在筛查试验中，参与者很多，预期的癌症病例很少，即使是一小部分参与者不遵守筛查、随访或治疗的规定，也可能导致对筛查检查效果的不准确估计。本研究的重点是筛查阶段的不依从行为。未来的工作将检查诊断跟踪和治疗的不依从情况，并使用不符合情况的信息来开发评估不同条件下、不同目标人群中肺癌筛查潜在有效性的模型。这项研究建议检查与癌症筛查不依从性相关的因素。关于不依从性的原因的信息可用于开发量身定制的干预措施，旨在未来的临床试验和临床实践中提高依从性。这些信息还可以用来开发模型，评估在不同条件下和在不同目标人群中进行肺癌筛查的潜在有效性。

DESCRIPTION (provided by applicant): Randomized cancer screening trials are considered the best approach for evaluating new cancer screening technologies. Unfortunately, these trials may underestimate the efficacy of a new screening technique if study participants fail to comply with screening, diagnostic confirmation, or treatment. In this study, we propose to examine the factors associated with cancer screening nonadherence in a large, multi-center lung cancer screening trial. This study will be conducted using existing data collected as part of the American College of Radiology (ACRIN) arm of the National Lung Screening Trial (NLST). ACRIN is responsible for screening 18,843 participants at 23 sites across the United States. These participants are currently being followed to determine whether screening with low-dose spiral computed tomography (CT) or chest X-ray (CXR) reduces lung cancer mortality. We will focus on participants who receive a diagnosis at the baseline screening exam that is negative or false positive for lung cancer (meaning that the screening exam is positive, but further testing indicates that the screening abnormality is benign). Our first aim in this trial is to determine whether participants who receive a diagnosis that is false positive for lung cancer at the baseline screening exam are less likely to return for screening at their next scheduled screening exam than are participants who receive a screening result negative for lung cancer. Our second aim in this trial is to identify those participant characteristics, measured before the baseline screening exam, that are associated with nonadherence at the next scheduled screening exam. In this phase of the study, we plan to examine the influence of demographic factors, including sex, age, race, education level, income, area of the country, as well as health history, family history of lung cancer, smoking status and history, health related quality of life indices, and perceived risk of lung cancer. Obtaining information on characteristics associated with noncompliance is useful for two reasons: 1) Information on characteristics associated with noncompliance can be used to better target interventions and reduce nonadherence in future clinical trials and clinical practice, and 2) The standard approach to analyzing clinical trials is the intent to treat (ITT) analysis, in which the outcome of interest is compared between the two randomization groups regardless of participant noncompliance. Using an ITT analysis, however, assumes that the noncompliance rate observed in the trial will be equal to that in the communities in which the intervention will be implemented. This is often not the case. In screening trials, with many participants and few anticipated cancer cases, noncompliance by even a small proportion of participants with screening, follow-up, or treatment, may lead to inaccurate estimates of the efficacy of the screening exam. This study focuses on noncompliance at the screening stage. Future work will examine noncompliance with diagnostic follow-up and treatment and use the information on noncompliance to developed models that estimate the potential effectiveness of lung cancer screening under different conditions and in different target populations. This study proposes to examine factors that are associated with cancer screening nonadherence. Information on the reasons for nonadherence may be used to develop tailored interventions designed to improve adherence in future clinical trials and in clinical practice. This information may also be used to develop models that estimate the potential effectiveness of lung cancer screening under different conditions and in different target populations.