Achieving appropriate, safe, and patient-centered lung cancer screening

实现适当、安全和以患者为中心的肺癌筛查

• 批准号: 10296365
• 负责人: Renda Soylemez Wiener
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10296365
• 关键词: Address; Advisory Committees; Affect; Belief; Cancer Etiology; Caring; Cause of Death; Cessation of life; Characteristics; Clinical; Complement; Data; Decision Making; Demographic Factors; Development; Disadvantaged; Distress; Ensure; Equilibrium; Future; Goals; Guidelines; Health; Health Priorities; Health Promotion; Health Status; Healthcare; Homelessness; Intervention; Interview; Knowledge; Lead; Learning; Life; Life Expectancy; Logistic Regressions; Lung; Lung CAT Scan; Lung nodule; Malignant neoplasm of lung; Methods; Minority; Modeling; Operative Surgical Procedures; Outcome; Participant; Patient Selection; Patients; Persons; Positioning Attribute; Predictive Factor; Preventive service; Primary Health Care; Procedures; Process; Pulmonology; Qualitative Research; Recommendation; Research; Resources; Risk; Rural; Savings; Scientific Advances and Accomplishments; Screening Result; Site; Smoker; Survival Analysis; Testing; Translating; Uncertainty; Variant; Veterans; Vulnerable Populations; Work; aged; base; cohort; computed tomography screening; design; disorder prevention; effectiveness implementation study; experience; improved; lung cancer screening; patient oriented; personalized decision; point of care; predictive modeling; preference; programs; safe patient; screening; shared decision making; support tools; tool; wasting; willingness

Background: Lung cancer screening (LCS) reduces lung cancer death, but can also cause harm, especially when applied to patients with co-existing serious health problems. Recognizing these trade-offs, guidelines recommend that persons with “a health problem that substantially limits life expectancy or ability to have curative lung surgery” should not be screened, and that all patients considering LCS should undergo a shared decision-making (SDM) process to review LCS benefits and harms with their clinicians. Yet these recommendations are difficult to achieve, as there is little evidence to guide clinicians on which health problems or other patient factors tip the balance of LCS from net benefit to net harm, and little is known about Veteran and clinician approaches to and needs for LCS decision-making when anticipated benefit is marginal. Objectives: We propose a sequential explanatory mixed methods study with the following 3 specific aims: 1. Identify factors that predict little LCS benefit due to limited life expectancy or increased LCS harms; 2. Identify clinical patient factors associated with real-world clinician and Veteran LCS decisions; and 3. Characterize approaches to and needs for decision-making when predicted LCS benefit is marginal. Methods: Aim 1a. To determine when competing (non-lung cancer) causes of death limit LCS benefit, we will conduct a survival analysis among LCS-eligible but unscreened Veterans, building a competing risks model and applying recursive partitioning to identify clinically meaningful risk groups. Aim 1b. We will build a model to identify combinations of patient factors that predict complications of invasive procedures for LCS-detected findings. Aim 2: We will compare how well factors associated with actual LCS decisions align with factors that predict little LCS benefit (Aim 1 models), using data from 10 VA sites that tracked rates at which LCS-eligible Veterans were deemed “too sick” for LCS, were offered LCS, and accepted LCS. We will build mixed effects logistic regression models to complete these subaims: 2a-Identify patient factors associated with clinicians deeming Veterans “not appropriate” for LCS, characterizing variation across sites in offering LCS, and whether vulnerable groups (minorities, rural, homeless) are disproportionately deemed “not appropriate” for LCS. 2b- Identify clinical and demographic factors associated with Veteran decisions to decline vs accept LCS. Aim 3: We will interview up to 30 clinicians and 30 Veterans (15 who accepted, 15 who declined LCS) for whom predicted LCS benefit is marginal based on our Aim 1 models. For clinicians, we will explore beliefs about, expected outcomes of, and site-level influences on LCS decision-making, presenting vignettes to learn how providing predicted LCS benefit (Aim 1 models) affects LCS decision-making. For patients, we will explore experiences with LCS discussions, health priorities relative to LCS, and other influences on decision-making. For all participants, we will assess informational needs and preferences to support SDM at the point of care. Anticipated Impacts on Veteran's Healthcare: To maximize the life-saving potential of LCS without creating additional harms and wasting VA resources, LCS must be applied appropriately. This proposal will lay the groundwork to inform future development, testing, and implementation of a personalized decision tool to optimize patient selection for LCS and facilitate SDM between Veterans and VA clinicians at the point of care. This work is essential to achieve safe, appropriate, and Veteran-centered care as lung cancer screening is implemented across VA – a priority for our partners in the National Center for Health Promotion & Disease Prevention, the Office of Primary Care, and the National Program Office for Pulmonary Medicine. This work addresses Secretary Shulkin’s priority to focus resources efficiently on high-impact problems for Veterans.

背景：肺癌筛查(LCS)可降低肺癌死亡率，但也会造成危害，尤其是 适用于同时存在严重健康问题的患者。认识到这些权衡，指导方针 建议有“健康问题，大大限制预期寿命或能力”的人 根治性肺手术“不应进行筛查，所有考虑LCS的患者都应接受共享的 与临床医生一起审查LCS的益处和危害的决策(SDM)过程。然而，这些 建议很难实现，因为几乎没有证据来指导临床医生 问题或其他患者因素使LCS的天平从净收益转向净危害，人们对此知之甚少 当预期收益微乎其微时，资深医生和临床医生对LCS决策的方法和需求。 目的：我们提出了一项序贯解释性混合方法研究，具体目标如下： 1.找出由于预期寿命有限或LCS危害增加而导致LCS获益不大的因素； 2.确定与真实世界的临床医生和资深LCS决策相关的临床患者因素；以及 3.描述当预测的LCS收益为边际时的决策方法和需求。 方法：目标1a。为了确定何时竞争(非肺癌)死因限制LCS受益，我们将 在符合LCS资格但未进行筛查的退伍军人中进行生存分析，构建竞争风险模型 以及应用递归分区来识别具有临床意义的风险组。目标1b。我们将建立一个模型来 确定患者因素的组合，预测LCS检测到的侵入性手术的并发症 调查结果。目标2：我们将比较与实际LCS决策相关的因素与以下因素的一致性程度 使用来自10个退伍军人管理局站点的数据，跟踪符合LCS条件的比率，预测LCS几乎没有好处(Aim 1模型) 退伍军人被认为“病得太重”，不能接受LCS，他们被提供LCS，并接受LCS。我们将构建混合效果 完成这些子目标的Logistic回归模型：2A-确定与临床医生相关的患者因素 认为退伍军人不适合LCS，在提供LCS时描述不同地点的差异，以及 弱势群体(少数族裔、农村、无家可归者)被认为是不适当的，不适合于最不发达国家。2B- 确定与退伍军人决定拒绝与接受LCS相关的临床和人口统计学因素。目标3： 我们将采访多达30名临床医生和30名退伍军人(15名接受LCS，15名拒绝LCS) 根据我们的目标1模型，预测的LCS收益微乎其微。对于临床医生，我们将探索关于， LCS决策的预期结果和现场影响，提供小插曲以了解如何 提供预测的LCS收益(目标1模型)会影响LCS决策。对于患者，我们将探索 LCS讨论的经验，相对于LCS的健康优先事项，以及对决策的其他影响。 对于所有参与者，我们将评估信息需求和偏好，以便在护理时支持SDM。 对退伍军人医疗的预期影响：在不创建的情况下最大限度地发挥LCS的救生潜力 对于额外的危害和浪费VA资源，必须适当地应用LCS。这项建议将为 为个性化决策工具的未来开发、测试和实施提供信息的基础工作 优化LCS患者选择，促进退伍军人和退伍军人临床医生在护理点进行SDM。 这项工作对于实现安全、适当和以退伍军人为中心的护理至关重要，就像肺癌筛查一样 在退伍军人事务部实施--我们在国家健康促进和疾病中心的合作伙伴优先考虑 预防、初级保健办公室和国家肺部医学项目办公室。这部作品 解决部长舒尔金的优先事项，高效地将资源集中在对退伍军人具有重大影响的问题上。