A comparative evaluation of risk communication formats in cancer prevention

说明(由申请人提供)：自知情同意原则通过以来，关于医疗干预对患者可能的风险和好处的有效沟通一直是医疗保健的一个组成部分。近年来，由于公认的医患关系模式发生了变化，促使患者更积极地参与有关其护理的决策，循证医学实践的兴起，以及对旨在减少未来健康风险的预防措施的日益重视，这一点变得越来越重要。关于医疗干预可能结果的有效沟通也是改进将生物医学研究成果转化为实践的方法的重要组成部分。尽管它很重要，但在如何有效地向患者和从业者传达有关不确定未来事件的信息方面，我们的知识存在很大差距。本研究的具体目的是：1)提供对目前推荐的数字和图形格式之间在向患者传达有关具有代表性的一系列临床重要可能性和结果的不同可能结果的能力方面的差异的初步估计；2)提供对风险沟通格式的有效性和患者特征之间相互作用的初步估计，包括：数字、识字、教育水平、社会经济地位、年龄和种族/民族背景；以及3)开发一个分析框架和收集有关关键参数的数据，以用于规划和进行将彻底解决这些问题的R01级后续研究。患者群体将包括360名年龄至少18岁的患者的人口统计学分层样本，他们是纽约罗切斯特三家门诊部的患者。将使用两个五水平受试者内因素的不完全析因设计。其中一个因素是目前推荐的五种风险沟通格式：垂直条形图、分组图标显示、风险等级、频率图和数字频率信息。另一个因素是疾病筛查计划的五个结果：疾病风险、死于疾病的风险、严重筛查副作用的风险、筛查副作用死亡的风险和筛查测试结果假阳性的风险。每个受试者将被随机分配以25种可能的组合中的5种对风险信息做出反应，以便以某种组合向他们呈现每种风险结果和每种风险形式。为了促进未来R01级综合研究的设计，这项研究的数据将被用来获得关于五种风险呈现格式之间关于以下结果的差异的风险形式和受试者变量的初步估计：a)理解，b)决策有用性，c)风险-响应一致性，d)一致性，e)患者评估，f)沟通错误的方向。我们还将确定这些结果是否与风险的性质或患者的个体特征之间存在关联，这些特征包括人口统计学、教育、识字和算术。公共卫生相关性：就医疗干预的可能风险和好处进行有效沟通，对于确保提供始终如一的高质量卫生保健至关重要。尽管它很重要，但在如何有效地向患者和从业者传达有关卫生保健决策未来不确定结果的信息方面，我们的知识存在很大差距。该项目将开始解决这些差距：a)比较当前推荐的五种风险沟通格式在一系列临床重要概率和结果中向患者传达风险信息的情况，以及b)确定患者特征(如人口统计、计算能力和识字能力)是否影响健康风险沟通的有效性。

DESCRIPTION (provided by applicant): Effective communication about possible risks and benefits of medical interventions to patients has been an integral part of medical care since the doctrine of informed consent was adopted. In recent years, it has become increasingly more important due to changes in the accepted model of the doctor-patient relationship that promote more active involvement of patients in decisions about their care, the rise of evidence-based medical practice, and the increasing emphasis placed on preventive measures that are intended to reduce future health risks. Effective communication about the possible outcomes of medical interventions is also an essential component of methods for improving the translation of biomedical research findings into practice. Despite its importance, there are large gaps in our knowledge of how to effectively convey information about uncertain future events to patients and practitioners. The specific aims of this study are: 1) To provide initial estimates differences among currently recommended numeric and graphic formats in their ability to convey information to patients about possible outcomes that vary across a representative range of clinically important likelihoods and consequences; 2) To provide initial estimates of interactions between the effectiveness of the risk communication formats and patient characteristics including: numeracy, literacy, educational level, socio- economic status, age, and racial/ethnic background; and 3) To develop an analytic framework and to gather data about key parameters for use in planning and conducting a follow-up R01-level study that will thoroughly address these issues. The patient population will consist of demographically-stratified sample of 360 patients at least 18 years of age who are patients at three outpatient practices in Rochester New York. An incomplete factorial design with two five-level within-subject factors will be used. One factor will be five currently recommended risk communication formats: vertical bar charts, grouped icon displays, risk scales, frequency diagrams, and numeric frequency information. The other factor will be five outcomes of a disease screening program: risk of disease, risk of dying from disease, risk of a serious screening side effect, risk of dying from a screening side effect, and risk of a false positive screening test result. Each subject will be randomly assigned to respond to risk information in five of the possible 25 combinations such that they are presented with each risk outcome and each risk format in some combination. To facilitate the design of a future comprehensive R01-level study, data from this study will be used to gain initial estimates of risk format and subject variables on the differences among the five risk presentation formats on the following outcomes: a) comprehension, b) usefulness for decision making, c) hazard-response consistency, d) uniformity, e) patient evaluation, and f) direction of communication errors. We will also determine if there are associations between these outcomes and either the nature of the risk or individual patient characteristics including demographics, education, literacy, and numeracy. PUBLIC HEALTH RELEVANCE: Effective communication about possible risks and benefits of medical interventions is essential for ensuring the delivery of consistently high quality health care. Despite its importance, there are large gaps in our knowledge of how to effectively convey information about uncertain future outcomes of health care decisions to patients and practitioners. This project will begin to address these gaps by: a) comparing how well five currently recommended risk communication formats convey risk information to patients across a range of clinically important probabilities and outcomes, and b) determining whether patient characteristics such as demographics, numeracy, and literacy affect the effectiveness of health risk communications.