Department of Pharmacy, University of California, San Francisco, San Francisco, California.
Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California.
Clin J Am Soc Nephrol. 2024 Jan 1;19(1):76-84. doi: 10.2215/CJN.0000000000000313. Epub 2023 Oct 6.
Next-generation implantable and wearable KRTs may revolutionize the lives of patients undergoing dialysis by providing more frequent and/or prolonged therapy along with greater mobility compared with in-center hemodialysis. Medical device innovators would benefit from patient input to inform product design and development. Our objective was to determine key risk/benefit considerations for patients with kidney failure and test how these trade-offs could drive patient treatment choices.
We developed a choice-based conjoint discrete choice instrument and surveyed 498 patients with kidney failure. The choice-based conjoint instrument consisted of nine attributes of risk and benefit pertinent across KRT modalities. Attributes were derived from literature reviews, patient/clinician interviews, and pilot testing. The risk attributes were serious infection, death within 5 years, permanent device failure, surgical requirements, and follow-up requirements. The benefit attributes were fewer diet restrictions, improved mobility, pill burden, and fatigue. We created a random, full-profile, balanced overlap design with 14 choice pairs plus five fixed tasks to test validity. We used a mixed-effects regression model with attribute levels as independent predictor variables and choice decisions as dependent variables.
All variables were significantly important to patient choice preferences, except follow-up requirements. For each 1% higher risk of death within 5 years, preference utility was lower by 2.22 ( β =-2.22; 95% confidence interval [CI], -2.52 to -1.91), while for each 1% higher risk of serious infection, utility was lower by 1.38 ( β =-1.46; 95% CI, -1.77 to -1.00) according to comparisons of the β coefficients. Patients were willing to trade a 1% infection risk and 0.5% risk of death to gain complete mobility and freedom from in-center hemodialysis ( β =1.46; 95% CI, 1.27 to 1.64).
Despite an aversion to even a 1% higher risk of death within 5 years, serious infection, and permanent device rejection, patients with kidney failure suggested that they would trade these risks for the benefit of complete mobility.
与中心血液透析相比,下一代可植入和可穿戴的 KRT 可能通过提供更频繁和/或更长时间的治疗以及更大的移动性来彻底改变正在接受透析的患者的生活。医疗设备创新者将受益于患者的投入,以告知产品设计和开发。我们的目标是确定肾衰竭患者的关键风险/效益考虑因素,并测试这些权衡如何推动患者的治疗选择。
我们开发了一种基于选择的联合离散选择工具,并对 498 名肾衰竭患者进行了调查。基于选择的联合工具包括 KRT 模式相关的九个风险和效益属性。属性源自文献回顾、患者/临床医生访谈和试点测试。风险属性为严重感染、5 年内死亡、永久设备故障、手术要求和随访要求。效益属性为饮食限制减少、移动性提高、药丸负担减轻和疲劳减轻。我们创建了一个随机、全谱、平衡重叠设计,包含 14 对选择和 5 个固定任务来测试有效性。我们使用混合效应回归模型,将属性水平作为独立预测变量,将选择决策作为因变量。
除随访要求外,所有变量对患者的选择偏好都有重要意义。每增加 1%的 5 年内死亡风险,偏好效用就降低 2.22(β=-2.22;95%置信区间[CI],-2.52 至-1.91),而每增加 1%的严重感染风险,效用就降低 1.38(β=-1.46;95% CI,-1.77 至-1.00),这是根据β系数的比较得出的。与中心血液透析相比,患者愿意以 1%的感染风险和 0.5%的死亡风险换取完全的移动性和免于中心血液透析(β=1.46;95% CI,1.27 至 1.64)。
尽管患者对 5 年内死亡风险增加 1%、严重感染和永久设备排斥率的风险感到厌恶,但肾衰竭患者表示,他们愿意为完全的移动性而冒险。