Politi M C, George N, Li T, Korenblat K M, Fowler K J, Ho C, Liapakis A, Roth D, Yee J
1Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis School of Medicine, 660 S. Euclid Ave., Campus Box 8100, St. Louis, MO 63110 USA.
2Department of Internal Medicine, Division of Nephrology, Washington University School of Medicine, 660 S. Euclid Ave., Campus Box 8129, St. Louis, MO 63110 USA.
Pilot Feasibility Stud. 2018 Feb 21;4:55. doi: 10.1186/s40814-018-0251-2. eCollection 2018.
Recent advances in treatment have given patients with chronic kidney disease (CKD) access to safer and more effective medications to treat comorbid hepatitis C virus (HCV) infection. Given the variety and complexity of treatment options that depend on patients' clinical characteristics and personal preferences, education and decision support are needed to prepare patients better to discuss treatment options with their clinicians.
Drawing on International Patient Decision Aids Standards guidelines, literature reviews, and guidance from a diverse expert advisory group of nephrologists, hepatologists, and patients, we will develop and test a HCV and CKD decision support tool. Named (), this tool will support patients with HCV and CKD during decisions about whether, when, and how to treat each illness. The tool will (1) explain information using plain language and graphics; (2) provide a step-by-step process for thinking about treating HCV and CKD; (3) tailor relevant information to each user by asking about the individual's stage of CKD, stage of fibrosis, prior treatment, and comorbidities; (4) assess user knowledge and values for treatment choices; and (5) help individuals use and consider information appropriate to their values and needs to discuss with a clinician. A pilot study including 70 individuals will evaluate the tool's efficacy, usability, and likelihood of using it in clinical practice. Eligibility criteria will include individuals who understand and read English, who are at least 18 years old, have a diagnosis of HCV (any genotype) and CKD (any stage), and are considering treatment options.
This study can identify particular characteristics of individuals or groups that might experience challenges initiating treatment for HCV in the CKD population. This tool could provide a resource to facilitate patient-clinician discussions regarding HCV and CKD treatment options.
治疗方面的最新进展使慢性肾脏病（CKD）患者能够获得更安全、更有效的药物来治疗合并的丙型肝炎病毒（HCV）感染。鉴于治疗方案的多样性和复杂性取决于患者的临床特征和个人偏好，需要进行教育和决策支持，以使患者更好地准备与临床医生讨论治疗方案。
借鉴国际患者决策辅助工具标准指南、文献综述以及由肾病学家、肝病学家和患者组成的多元化专家咨询小组的指导意见，我们将开发并测试一种HCV和CKD决策支持工具。该工具名为（），将在患者决定是否、何时以及如何治疗每种疾病时为HCV和CKD患者提供支持。该工具将：（1）使用通俗易懂的语言和图表解释信息；（2）提供思考治疗HCV和CKD的逐步流程；（3）通过询问个体的CKD阶段、纤维化阶段、既往治疗情况和合并症，为每个用户量身定制相关信息；（4）评估用户对治疗选择的知识和价值观；（5）帮助个体使用并考虑适合其价值观和需求的信息，以便与临床医生进行讨论。一项包括70名个体的试点研究将评估该工具的有效性、可用性以及在临床实践中使用它的可能性。入选标准将包括理解并能阅读英语且至少18岁、已诊断为HCV（任何基因型）和CKD（任何阶段）且正在考虑治疗方案的个体。
本研究可以识别在CKD人群中启动HCV治疗可能面临挑战的个体或群体的特定特征。该工具可以提供一种资源，以促进患者与临床医生就HCV和CKD治疗方案进行讨论。
