A Risk Prediction Model for Colorectal Cancer Screening

描述（由申请人提供）：共享决策（Shared decision-making， SDM）一直被提倡作为提高结直肠癌（CRC）筛查率的策略。本研究的总体目的是评估发展晚期结直肠肿瘤风险预测模型是否是一种可行和有效的策略，以促进有效的SDM和提高结肠镜筛查的成本效益。在目标#1中，我们建议对4000名无症状的患者进行横断面调查，进行筛查结肠镜检查，目的是建立一个基于假定的可改变和不可改变的危险因素的预测模型，将患者分为不同的晚期结直肠肿瘤风险类别。受试者将被要求在检查前完成一份简短的风险评估问卷；反应将与内窥镜检查结果相关。一旦导出，我们将在不同种族/民族的患者群体（n=1200）中评估模型的性能特征。目的2是调整该模型，使其成为参与SDM的初级保健医生在与患者讨论结直肠癌筛查时的决策支持工具。我们建议使用定性和定量方法来检查影响提供者决策的因素，评估提供者的计算技能，并确定定义风险类别的阈值。一旦定义，我们将把模型转化为基于网络的风险评估工具，能够生成患者衍生的风险评估，并具有可接受的框架，优化风险沟通。将举办实施前研讨会，培训提供者使用该工具、在病历中适当记录文件以及向患者通报风险的战略。目的3是进行一项临床试验，以确定在SDM框架内风险分层是否影响与筛选试验选择相关的临床决策。符合条件的受试者（n=440）将被随机分配完成风险评估工具或不完成风险评估工具，然后再审查基于网络的决策辅助工具，该辅助工具描述了五种推荐的CRC筛查方案的优缺点。这两种干预措施都将在与提供者预先安排的办公室访问之前进行。主要结果将是筛查测试；次要结果包括测试完成率、价值一致性、患者对决策过程的满意度和提供者满意度。结果将使用计算机跟踪系统或经过验证的仪器进行评估。目的4是确定基于风险使用筛查性结肠镜检查与普遍使用筛查性结肠镜检查和其他目前推荐的筛查策略相比的成本效益。公共卫生相关性：共同决策（SDM）已被提倡作为提高结直肠癌（CRC）筛查率的策略。开发一种有效的晚期结直肠肿瘤风险预测模型将使医生在推荐首选筛查方案时将风险评估纳入决策，从而促进更有效的SDM并提高结肠镜筛查的成本效益。

DESCRIPTION (provided by applicant): Shared decision-making (SDM) has been advocated as strategy for increasing colorectal cancer (CRC) screening rates. The overall objective of this study is to assess whether the development of a risk prediction model for advanced colorectal neoplasia is a feasible and valid strategy for facilitating effective SDM and improving the cost-effectiveness of screening colonoscopy. In Aim #1, we propose to conduct a cross- sectional survey of 4000 asymptomatic patients undergoing screening colonoscopy for the purpose of developing a prediction model based on putative modifiable and non-modifiable risk factors that stratifies patients into distinct risk categories for advanced colorectal neoplasia. Subjects will be asked to complete a brief risk assessment questionnaire prior to their examination; responses will be correlated with endoscopic findings. Once derived, we will evaluate the model's performance characteristics among a racially/ethnically diverse patient population (n=1200). Aim #2 is to adapt the model for use as a decisional support tool for primary care physicians who engage in SDM when discussing CRC screening with their patients. We propose to use qualitative and quantitative methods to examine factors that influence provider decision-making, assess provider numeracy skills, and identify thresholds for defining risk categories. Once defined, we will translate the model into a web-based risk assessment tool capable of generating patient-derived risk estimates with acceptable framing that optimizes risk communication. Pre-implementation seminars will be conducted to train providers in use of the tool, appropriate documentation in the medical record and strategies for communicating risk to patients. Aim #3 is to conduct a clinical trial to determine whether risk stratification influences clinical decision-making related to screening test selection within a SDM framework. Eligible subjects (n=440) will be randomized to complete the risk assessment tool or not prior to reviewing a web-based decision aid describing the pros and cons of the five recommended CRC screening options. Both interventions will take place just before a prearranged office visit with their provider. The primary outcome will be screening test ordered; secondary outcomes will include test completion rates, value concordance, patient satisfaction with decision- making process and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments. Aim #4 is to determine the cost-effectiveness of risk-based use of screening colonoscopy compared to universal use of screening colonoscopy and other currently recommended screening strategies. PUBLIC HEALTH RELEVANCE: Shared decision-making (SDM) has been advocated as strategy for increasing colorectal cancer (CRC) screening rates. The development of a valid risk prediction model for advanced colorectal neoplasia would enable providers to incorporate risk estimates into their decision-making when recommending a preferred screening option, thus facilitating more effective SDM and improving the cost-effectiveness of screening colonoscopy.