Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
Value Health. 2013 Jul-Aug;16(5):789-96. doi: 10.1016/j.jval.2013.04.015. Epub 2013 Jun 19.
There is a need for a brief symptom index for advanced kidney cancer that includes perspectives of both patients and clinicians and is consistent with the Food and Drug Administration's guidance for patient-reported outcome measures. This study developed and examined the preliminary reliability and validity of the new National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19.
Fifty patients with advanced kidney cancer provided open-ended and survey responses ranking their most important symptoms. Responses were reconciled with published clinician reports of the most important symptoms. Ten experienced oncologists rated symptoms as disease- or treatment-related. Patients completed quality-of-life and performance status measures.
A 19-item index was produced from symptoms that were rated as most important by patients or clinicians. It includes three subscales: disease-related symptoms (DRS), treatment side effects (TSE), and general function and well-being (FWB). Internal consistency was good for the full instrument (α = 0.83), the DRS subscale (α = 0.76), and the FWB subscale (α = 0.78) but lower for the TSE subscale (α = 0.59). Convergent validity was demonstrated through correlations with the FACT-General. Patients with differing performance status were distinguished by the total score (F2,47 = 17.37; P < .0001), the DRS subscale (F2,47 = 14.22; P < .0001), and the FWB subscale (F2,47 = 13.40; P < .0001) but not the TSE subscale (F2,47 =1.48; P = 0.2380).
The National Comprehensive Cancer Network/FACT-Kidney Symptom Index 19 combines symptoms deemed most important by patients and clinicians. Preliminary evidence suggests that the total score and DRS and FWB subscales are reliable and valid as summary indexes. The TSE subscale may be least relevant given the advent of newer therapies.
需要有一种简短的晚期肾癌症状指数，该指数应同时包含患者和临床医生的观点，并符合食品和药物管理局（FDA）对患者报告的结果测量指标的指导原则。本研究开发并检验了新的国家综合癌症网络/癌症治疗功能评估（FACT）-肾脏症状指数 19 的初步可靠性和有效性。
50 名晚期肾癌患者提供了开放式和调查回复，对他们最重要的症状进行了排名。回复与已发表的临床医生报告的最重要症状进行了协调。10 名经验丰富的肿瘤学家对症状进行了疾病相关或治疗相关的评估。患者完成了生活质量和表现状态的测量。
从患者或临床医生认为最重要的症状中产生了一个 19 项的指数。它包括三个子量表：疾病相关症状（DRS）、治疗副作用（TSE）和一般功能和幸福感（FWB）。整个工具（α=0.83）、DRS 子量表（α=0.76）和 FWB 子量表（α=0.78）的内部一致性良好，但 TSE 子量表（α=0.59）的一致性较低。与 FACT-General 的相关性证明了其收敛效度。不同表现状态的患者在总分（F2,47=17.37；P<.0001）、DRS 子量表（F2,47=14.22；P<.0001）和 FWB 子量表（F2,47=13.40；P<.0001）上有区别，但 TSE 子量表（F2,47=1.48；P=0.2380）上没有区别。
国家综合癌症网络/FACT-肾脏症状指数 19 结合了患者和临床医生认为最重要的症状。初步证据表明，总分和 DRS 和 FWB 子量表作为综合指标具有可靠性和有效性。考虑到新疗法的出现，TSE 子量表可能相关性最小。
