Who benefits from Colorectal Cancer Screening? A subgroup Analysis of the Minnes

谁从结直肠癌筛查中受益？

• 批准号: 7792918
• 负责人: Aasma Shaukat
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-10-01 至 2013-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7792918
• 关键词: Adenomatous Polyps; Age; Aspirin; Attention; Body mass index; Cancer Control; Categories; Cause of Death; Characteristics; Clinical; Colon Carcinoma; Colonoscopy; Colorectal Cancer; Comorbidity; Consumption; Controlled Study; Data; Data Files; Databases; Diet; Dietary Factors; Double contrast barium enema; Effectiveness; Elderly; Fecal occult blood; Fiber; Flexible fiberoptic sigmoidoscopy; Gender; Goals; Guidelines; Healthcare Systems; Incidence; Individual; Intake; Lesion; Life Expectancy; Long-Term Effects; Malignant Neoplasms; Meta-Analysis; Methods; Minnesota; Non-Steroidal Anti-Inflammatory Agents; Nutritional; Outcome; Participant; Patients; Polypectomy; Population; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Research Personnel; Resources; Risk; Screening procedure; Specific qualifier value; Subgroup; Target Populations; Testing; Time; Update; Veterans; Vital Status; Woman; age group; colorectal cancer screening; design; experience; healthy volunteer; high risk; improved; interest; lifestyle factors; men; mortality; public health relevance

DESCRIPTION (provided by applicant): 1. To determine the effect of fecal occult blood testing (FOBT) screening on colorectal cancer mortality, non- colorectal cancer mortality and all-cause mortality in the Minnesota Colon Cancer Control Study, (MCCCS) updated to 2006 2. To determine the effect of FOBT screening on colorectal cancer mortality and non-colorectal cancer mortality by age (by 5 and 10 year age groups) and gender in the MCCCS updated to 2006 3. To determine the independent influence of baseline characteristics on colorectal cancer mortality and non-colorectal cancer mortality in the MCCCS. Significance: Most guidelines recommend starting screening for colorectal cancer at age 50 years for average risk individuals. The earliest and most tested strategy among these is FOBT, supported by four large randomized clinical trials that established the effectiveness of colorectal cancer screening. The Minnesota Colon Cancer Control Study was conducted in Minnesota, US. The trial recruited healthy volunteers between the ages of 50 to 80. The trials have not reported results stratified by age and gender. Additionally, the effects of other baseline variables, such as co-morbidities and intake of aspirin on outcomes have not been reported. A recent meta-analysis of these trials confirmed a reduction in colorectal cancer mortality (RR 0.87; 95% CI 0.8-0.95), but also reported an increase in non-colorectal cancer mortality of approximately equal absolute magnitude (RR 1.02; 95% CI 1.00-1.04) so that overall mortality was nearly identical (RR 1.002, 95% CI 0.989-1.015). Why non-CRC mortality would be increased is unclear, but one possibility is that the FOBT trials included some individuals that benefited from CRC screening, and other individuals who experienced net harm. Therefore, detailed sub-group analyses of the FOBT trial data, to separate out sub- groups that benefit from screening from those who may potentially be harmed would be important. For example, patients over age 70 or 75 might derive less benefit and more harm from screening, in which case screening this population may need to be re-considered. The goals of this research are to evaluate if effects of screening on colorectal cancer mortality seen 18 years after randomization (reported in 1999) in the Minnesota Colon Cancer Control Study persist, or are different 28-30 years after randomization (when updated to year 2006), and whether effect of screening for colorectal cancer varies in age and gender sub- groups. We also wish to evaluate the influence of baseline characteristics, such as diet, aspirin use and body mass index on these outcomes. Project Design and methods: This project involves updating the vital status and cause of death of all participants from the Minnesota Colon Cancer Control Study up to 2006 and calculating CRC, non-CRC and all-cause mortality estimates. We plan to compare colorectal cancer (CRC) mortality and non-colorectal cancer mortality rates between the screened and unscreened groups, by age categories at time of randomization of 5 year (50-54, 55-59, 60-64, 65-69, 70-74, 75-80) and 10 year (50-59, 60-69, 70-80) intervals. We will also stratify the above analyses by gender subgroups. No patient baseline data other than age and gender has been analyzed or reported from the Minnesota Colon Cancer Control Study. A 4-page, 56-item baseline questionnaire was completed by participants. We will perform a quality check on the existing data files to determine if re-entry is required for all or a subset of the questions on the baseline questionnaire. We are interested in exploring the relationship between consumption of NSAIDs, high fiber diet and BMI as effect modifiers of effectiveness of screening. PUBLIC HEALTH RELEVANCE: VA has put much effort into studying and implementing colorectal cancer screening. Colorectal cancer incidence increases with age. It is one of the most common cancers among the veteran population. Lieberman et al57 reported an incidence rate of 5.9% for colonic lesions among asymptomatic veterans undergoing screening colonoscopy. An estimated 75% of VA patients are over age 50, and 40% are over age 70. Also, women constitute 5% of veteran patients, and the number is expected is increase. A recent VA study has called attention to CRC screening in elderly veterans with serious co- morbidities who are unlikely to benefit 1. It is therefore important to clarify whether screening is beneficial in all sub-groups. A better understanding of the ideal target population to be screened would help focus efforts at resource-effective implementation.

描述（由申请人提供）： 1. 确定粪便隐血试验 (FOBT) 筛查对 2006 年更新的明尼苏达结肠癌控制研究 (MCCCS) 中结直肠癌死亡率、非结直肠癌死亡率和全因死亡率的影响 2. 确定效果MCCCS 中按年龄（按 5 岁和 10 岁年龄组）和性别分类的结直肠癌死亡率和非结直肠癌死亡率 FOBT 筛查的比例更新至 2006 年3. 确定基线特征对 MCCCS 中结直肠癌死亡率和非结直肠癌死亡率的独立影响。意义：大多数指南建议平均风险人群在 50 岁时开始筛查结直肠癌。其中最早且经过最多测试的策略是 FOBT，该策略得到了四项大型随机临床试验的支持，这些试验证实了结直肠癌筛查的有效性。明尼苏达结肠癌控制研究在美国明尼苏达州进行。该试验招募了50岁至80岁之间的健康志愿者。试验尚未报告按年龄和性别分层的结果。此外，其他基线变量（例如合并症和阿司匹林摄入量）对结果的影响尚未报告。最近对这些试验的荟萃分析证实结直肠癌死亡率降低（RR 0.87；95% CI 0.8-0.95），但也报告非结直肠癌死亡率的绝对值大致相等（RR 1.02；95% CI 0.8-0.95）增加（RR 1.02；95% CI 1.00-1.04），因此总体死亡率几乎相同（RR 1.002，95% CI 0.989-1.015）。为什么非 CRC 死亡率会增加尚不清楚，但一种可能性是 FOBT 试验包括一些受益于 CRC 筛查的个体，以及其他遭受净伤害的个体。因此，对 FOBT 试验数据进行详细的亚组分析，将受益于筛查的亚组与可能受到伤害的亚组区分开来，这一点非常重要。例如，70 岁或 75 岁以上的患者可能从筛查中获得的益处较少，而危害较大，在这种情况下，可能需要重新考虑对该人群进行筛查。本研究的目的是评估明尼苏达结肠癌控制研究中随机分组（1999 年报告）后 18 年筛查对结直肠癌死亡率的影响是否持续存在，或者随机分组后 28-30 年（更新至 2006 年时）是否有所不同），以及结直肠癌筛查的效果是否因年龄和性别亚组而异。我们还希望评估饮食、阿司匹林使用和体重指数等基线特征对这些结果的影响。项目设计和方法：该项目涉及更新截至 2006 年明尼苏达结肠癌控制研究的所有参与者的生命状况和死因，并计算 CRC、非 CRC 和全因死亡率估计值。我们计划按 5 年随机分组时的年龄类别（50-54、55-59、60-64、65-69）比较筛查组和未筛查组之间的结直肠癌 (CRC) 死亡率和非结直肠癌死亡率。 、70-74、75-80）和 10 年（50-59、60-69、70-80）间隔。我们还将按性别亚组对上述分析进行分层。明尼苏达结肠癌控制研究未分析或报告除年龄和性别以外的患者基线数据。参与者完成了一份 4 页、56 项的基线调查问卷。我们将对现有数据文件进行质量检查，以确定是否需要重新输入基线调查问卷中的全部或部分问题。我们有兴趣探索非甾体抗炎药的消费、高纤维饮食和体重指数作为筛查有效性的影响调节剂之间的关系。 公共卫生相关性： VA 投入了大量精力来研究和实施结直肠癌筛查。结直肠癌的发病率随着年龄的增长而增加。它是退伍军人中最常见的癌症之一。 Lieberman 等人57 报道，在接受结肠镜筛查的无症状退伍军人中，结肠病变的发生率为 5.9%。据估计，75% 的 VA 患者年龄在 50 岁以上，40% 的年龄在 70 岁以上。此外，女性占退伍军人患者的 5%，并且预计这一数字还会增加。 VA 最近的一项研究呼吁关注对患有严重合并症的老年退伍军人进行 CRC 筛查，这些人不太可能受益1。因此，澄清筛查是否对所有亚组都有益非常重要。更好地了解要筛查的理想目标人群将有助于集中精力以资源有效的方式实施。