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假设的个性化风险信息对苏格兰结直肠癌筛查结肠镜检查的知情选择和意向的影响(PERICCS)-一项随机对照试验。

The impact of hypothetical PErsonalised Risk Information on informed choice and intention to undergo Colorectal Cancer screening colonoscopy in Scotland (PERICCS)-a randomised controlled trial.

机构信息

Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, Scotland, UK.

Division of Psychology, University of Stirling, Stirling, FK9 4LA, Scotland, UK.

出版信息

BMC Med. 2020 Oct 20;18(1):285. doi: 10.1186/s12916-020-01750-3.

DOI:10.1186/s12916-020-01750-3
PMID:33076932
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7574531/
Abstract

BACKGROUND

There is currently no existing evidence on the effects of personalised risk information on uptake of colonoscopy following first line screening for colorectal cancer. This study aimed to measure the impact of providing risk information based on faecal haemoglobin concentration to allow a fully informed choice around whether or not to undergo colonoscopy.

METHODS

Two thousand seven hundred sixty-seven participants from the Scottish Bowel Screening Programme (SBoSP) database, who had not recently been invited for screening, were randomised to receive one of three types of hypothetical risk information materials: (1) numerical risk information (risk categories of one in 40, one in 1600 and one in 3500), (2) categorical risk information (highest, moderate and lowest risk), or (3) positive screening result letter (control group). The primary outcome was the impact of the risk materials on intention to undergo colonoscopy, to allow comparison with the current colonoscopy uptake of 77% for those with a positive screening result in the SBoSP. Secondary outcomes were knowledge, attitudes and emotional responses to the materials.

RESULTS

Four hundred thirty-four (15.7%) agreed to participate with 100 from the numerical risk group (69.0%), 104 from the categorical risk group (72.2%) and 104 from the control group (71.7%) returning completed materials. Intention to undergo colonoscopy was highest in the highest risk groups for the numerical and categorical study arms (96.8% and 95.3%, respectively), but even in the lowest risk groups was > 50% (58.1% and 60.7%, respectively). Adequate knowledge of colorectal screening and the risks and benefits of colonoscopy was found in ≥ 98% of participants in all three arms. All participants reported that they found the information easy-to-understand. 19.1%, 24.0% and 29.6% of those in the numerical, categorical and control group, respectively, reported that they found the information distressing (p > 0.05).

CONCLUSIONS

Applying the risk categories to existing SBoSP data shows that if all participants were offered an informed choice to have colonoscopy, over two thirds of participants would intend to have the test. Equating to an increase in the number of screening colonoscopies from approx. 14,000 to 400,000 per annum, this would place an unmanageable demand on colonoscopy services, with a very small proportion of cancers and pre-cancers detected. However, the response to the materials were very positive, suggesting that providing risk information to those in lowest and moderate risk groups along with advice that colonoscopy is not currently recommended may be an option. Future research would be required to examine actual uptake.

TRIAL REGISTRATION

Date applied 1 December 2017 ISRCTN number 14254582 .

摘要

背景

目前尚无关于个性化风险信息对结直肠癌一线筛查后接受结肠镜检查的影响的现有证据。本研究旨在测量提供基于粪便血红蛋白浓度的风险信息以允许对是否进行结肠镜检查做出完全知情选择的效果。

方法

从苏格兰结直肠筛查计划(SBoSP)数据库中随机抽取 2767 名尚未被邀请进行筛查的参与者,将他们随机分配到以下三种类型的假设风险信息材料之一:(1)数值风险信息(风险类别为 1/40、1/1600 和 1/3500),(2)分类风险信息(最高、中等和最低风险),或(3)阳性筛查结果信函(对照组)。主要结局是风险材料对接受结肠镜检查的意愿的影响,以与 SBoSP 中阳性筛查结果者 77%的当前结肠镜检查接受率进行比较。次要结局是对材料的知识、态度和情绪反应。

结果

434 人(15.7%)同意参与,其中数值风险组 100 人(69.0%)、分类风险组 104 人(72.2%)和对照组 104 人(71.7%)完成了材料。在数值和分类研究臂中,最高风险组的结肠镜检查意愿最高(分别为 96.8%和 95.3%),但即使在最低风险组中也>50%(分别为 58.1%和 60.7%)。所有组中≥98%的参与者对结直肠筛查以及结肠镜检查的风险和益处有足够的了解。所有参与者均报告称,他们发现信息易于理解。分别有 19.1%、24.0%和 29.6%的数值组、分类组和对照组的参与者表示,他们发现信息令人痛苦(p>0.05)。

结论

将风险类别应用于现有的 SBoSP 数据表明,如果向所有参与者提供进行结肠镜检查的知情选择,超过三分之二的参与者将有意接受检查。这相当于每年筛查结肠镜检查的数量从大约 14000 例增加到 400000 例,这将给结肠镜检查服务带来无法管理的需求,并且只能检测到非常小比例的癌症和癌前病变。然而,对材料的反应非常积极,这表明向最低和中等风险组提供风险信息并提供建议,即目前不建议进行结肠镜检查,可能是一种选择。未来需要进行研究以检查实际接受情况。

试验注册

2017 年 12 月 1 日申请的日期 ISRCTN 编号 14254582 。