VA Medical Center, White River Junction, Vermont.
Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.
JAMA Netw Open. 2023 Jul 3;6(7):e2321730. doi: 10.1001/jamanetworkopen.2023.21730.
The Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy.
To (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference's association with geographic and temporal factors.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022.
Case report forms were used to capture enrolled participant data and reasons for declining participation among otherwise eligible individuals.
Descriptive statistics were used to characterize the cohort overall and by intervention. Among individuals declining participation, logistic regression was used to compare preference for FOBT/FIT or colonoscopy by recruitment region and year.
A total of 50 126 participants were recruited (mean [SD] age, 59.1 [6.9] years; 46 618 [93.0%] male and 3508 [7.0%] female). The cohort was racially and ethnically diverse, with 748 (1.5%) identifying as Asian, 12 021 (24.0%) as Black, 415 (0.8%) as Native American or Alaska Native, 34 629 (69.1%) as White, and 1877 (3.7%) as other race, including multiracial; and 5734 (11.4%) as having Hispanic ethnicity. Of the 11 109 eligible individuals who declined participation (18.0%), 4824 (43.4%) declined due to a stated preference for a specific screening test, with FOBT/FIT being the most preferred method (2820 [58.5%]) vs colonoscopy (1958 [40.6%]; P < .001) or other screening tests (46 [1.0%] P < .001). Preference for FOBT/FIT was strongest in the West (963 of 1472 [65.4%]) and modest elsewhere, ranging from 199 of 371 (53.6%) in the Northeast to 884 of 1543 (57.3%) in the Midwest (P = .001). Adjusting for region, the preference for FOBT/FIT increased by 19% per recruitment year (odds ratio, 1.19; 95% CI, 1.14-1.25).
In this cross-sectional analysis of veterans choosing nonenrollment in the CONFIRM study, those who declined participation more often preferred FOBT or FIT over colonoscopy. This preference increased over time and was strongest in the western US and may provide insight into trends in CRC screening preferences.
重要性:结肠镜检查与粪便免疫化学试验在降低结直肠癌死亡率(CONFIRM)的随机临床试验中,旨在招募 50000 名成年人参与研究,比较随机分组后接受结直肠癌(CRC)死亡率的结果,分别为每年进行粪便免疫化学试验(FIT)或结肠镜检查。
目的:(1)描述研究参与者的特征,(2)检查由于偏好结肠镜检查或粪便检测(即粪便潜血试验[FOBT]/FIT)而拒绝参与的人数,并评估这种偏好与地理和时间因素的关系。
设计、地点和参与者:这是 CONFIRM 中的一项横断面研究,该研究于 2012 年 5 月 22 日至 2017 年 12 月 1 日在 46 个退伍军人事务部医疗中心完成了招募,计划随访至 2028 年,参与者为年龄在 50 至 75 岁之间、平均结直肠癌风险且需要筛查的退伍军人。数据于 2022 年 3 月 7 日至 12 月 5 日进行分析。
暴露:病例报告表用于捕获登记参与者的数据和其他合格人员拒绝参与的原因。
主要结果和措施:描述性统计用于描述总体队列和干预组的特征。在拒绝参与的个体中,使用逻辑回归比较 FOBT/FIT 或结肠镜检查的偏好与招募区域和年份的关系。
结果:共招募了 50126 名参与者(平均[标准差]年龄,59.1[6.9]岁;46618[93.0%]为男性,3508[7.0%]为女性)。该队列在种族和民族上多样化,其中 748(1.5%)为亚洲人,12021(24.0%)为黑人,415(0.8%)为美国原住民或阿拉斯加原住民,34629(69.1%)为白人,1877(3.7%)为其他种族,包括多种族;11091(22.1%)为西班牙裔。在 11109 名符合条件但拒绝参与的人中(18.0%),有 4824 人(43.4%)因表示偏好特定的筛查试验而拒绝参与,FOBT/FIT 是最受欢迎的方法(2820 人[58.5%]),而结肠镜检查(1958 人[40.6%];P<.001)或其他筛查试验(46 人[1.0%];P<.001)。FOBT/FIT 的偏好最强的是西部地区(1472 人中有 963 人[65.4%]),其他地区则适度,从东北部的 371 人中有 199 人(53.6%)到中西部的 1543 人中有 884 人(57.3%)不等(P=.001)。调整地区因素后,FOBT/FIT 的偏好每年增加 19%(优势比,1.19;95%置信区间,1.14-1.25)。
结论和相关性:在这项对选择不参加 CONFIRM 研究的退伍军人的横断面分析中,那些拒绝参与的人更倾向于选择 FOBT 或 FIT 而不是结肠镜检查。这种偏好随着时间的推移而增加,在西部地区最为强烈,这可能为结直肠癌筛查偏好的趋势提供了一些见解。