A Risk Prediction Model for Colorectal Cancer Screening

结直肠癌筛查的风险预测模型

基本信息

批准号：
7892994
负责人：
PAUL C SCHROY
金额：
$ 57.88万
依托单位：
BOSTON MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-15 至 2013-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7892994
关键词：
Advocate Agreement Benefits and Risks Cancer Etiology Categories Cessation of life Characteristics Client satisfaction Clinical Data Clinical Trials Colonoscopy Colorectal Cancer Colorectal Neoplasms Communication Cross-Sectional Studies Decision Aid Decision Making Development Documentation Incidence Individual Intervention Intervention Trial Medical Records Methods Modeling Office Visits Online Systems Outcome Patient Preferences Patients Performance Primary Care Physician Primary Health Care Process Provider Questionnaires Randomized Risk Risk Assessment Risk Estimate Risk Factors Screening procedure Stratification System Testing Training Translating United States base clinical decision-making colorectal cancer screening computerized cost cost effective cost effectiveness high risk improved instrument modifiable risk mortality patient oriented patient population primary outcome public health relevance response satisfaction secondary outcome shared decision making skills tool

项目摘要

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.

描述（由申请人提供）：共同决策（SDM）已被提倡作为提高结直肠癌（CRC）筛查率的策略。本研究的总体目标是评估晚期结直肠肿瘤风险预测模型的开发是否是促进有效 SDM 和提高筛查结肠镜检查成本效益的可行且有效的策略。在目标#1中，我们建议对 4000 名接受筛查结肠镜检查的无症状患者进行横断面调查，目的是开发一个基于假定的可修改和不可修改风险因素的预测模型，将患者分为不同的晚期结直肠肿瘤风险类别。受试者在检查前将被要求填写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，我们将评估模型在种族/民族多样化的患者群体 (n=1200) 中的表现特征。目标 2 是调整该模型，使其成为初级保健医生在与患者讨论 CRC 筛查时参与 SDM 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，评估提供者的计算能力，并确定定义风险类别的阈值。一旦定义完毕，我们将把模型转化为基于网络的风险评估工具，能够生成来自患者的风险估计，并采用可接受的框架来优化风险沟通。将举办实施前研讨会，培训提供者使用该工具、病历中的适当文件以及向患者传达风险的策略。目标#3 是进行临床试验，以确定风险分层是否影响与 SDM 框架内筛选测试选择相关的临床决策。符合条件的受试者 (n=440) 将被随机分配是否完成风险评估工具，然后再查看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 筛查选项的优缺点。这两种干预措施都将在预先安排的与服务提供者进行办公室访问之前进行。主要结果将是进行筛选测试；次要结果将包括测试完成率、价值一致性、患者对决策过程的满意度和提供者的满意度。将使用计算机跟踪系统或经过验证的仪器来评估结果。目标#4是确定基于风险的结肠镜筛查与普遍使用结肠镜筛查和其他当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。开发晚期结直肠肿瘤的有效风险预测模型将使提供者能够在推荐首选筛查方案时将风险评估纳入决策中，从而促进更有效的 SDM 并提高筛查结肠镜检查的成本效益。