Validity and Usefulness of a Single-Item Measure of Patient-Reported Bother From Side Effects of Cancer Therapy
Validity and Usefulness of a Single-Item Measure of Patient-Reported Bother From Side Effects of Cancer Therapy
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DOI：
10.1002/cncr.31133
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发表时间：
2018-03-01
期刊：
影响因子：
6.2
通讯作者：
Cella, David
中科院分区：
文献类型：
--
作者：
Pearman, Timothy P.;Beaumont, Jennifer L.;Cella, David
背景技术背景：癌症治疗功效的提高导致治疗相关症状的增加以及对正在接受其疾病的积极治疗的个体施加的相关负担。通常，临床试验比较具有不同类型和严重程度的不良反应的疗法。无论是由临床医生还是患者本人进行评估，都很难知道哪种副作用对患者更具破坏性或更令人困扰。一个简单的困扰总结指数可以帮助判断相互比较的治疗之间不良反应的变异性。方法：在4项研究中，共有5765例患者入组了合作组研究和行业申办的临床试验，这些患者是本研究的受试者。患者被诊断患有一系列原发性癌症部位，包括膀胱、脑、乳腺、结肠/直肠、头/颈、肝胆、肾、肺、卵巢、胰腺和前列腺以及白血病和淋巴瘤。所有患者均接受了癌症治疗功能评估-通用版（FACT-G）。在5分Likert量表上评定的单项“我对治疗的副作用感到困扰”（GP 5）是FACT-G的一部分。为了从患者的角度确定其作为有用的总结性测量的有效性，将其与个体和汇总的临床医生评定的不良事件以及患者报告的其享受生活的一般能力相关。研究结果：对药物试验的分析表明，平均GP 5评分（“我被治疗的副作用所困扰”）与最大不良事件等级有显著差异（P
BACKGROUND: The improving efficacy of cancer treatment has resulted in an increasing array of treatment-related symptoms and associated burdens imposed on individuals undergoing aggressive treatment of their disease. Often, clinical trials compare therapies that have different types, and severities, of adverse effects. Whether rated by clinicians or patients themselves, it can be difficult to know which side effect profile is more disruptive or bothersome to patients. A simple summary index of bother can help to adjudicate the variability in adverse effects across treatments being compared with each other. METHODS: Across 4 studies, a total of 5765 patients enrolled in cooperative group studies and industry-sponsored clinical trials were the subjects of the current study. Patients were diagnosed with a range of primary cancer sites, including bladder, brain, breast, colon/rectum, head/neck, hepatobiliary, kidney, lung, ovary, pancreas, and prostate as well as leukemia and lymphoma. All patients were administered the Functional Assessment of Cancer Therapy-General version (FACT-G). The single item "I am bothered by side effects of treatment" (GP5), rated on a 5-point Likert scale, is part of the FACT-G. To determine its validity as a useful summary measure from the patient perspective, it was correlated with individual and aggregated clinician-rated adverse events and patient reports of their general ability to enjoy life. RESULTS: Analyses of pharmaceutical trials demonstrated that mean GP5 scores ("I am bothered by side effects of treatment") significantly differed by maximum adverse event grade (P