Assessing the impact of heart failure therapeutics on quality of life and functional capacity.
Assessing the impact of heart failure therapeutics on quality of life and functional capacity.
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DOI：
10.1007/s11936-013-0249-2
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发表时间：
2013-08-01
影响因子：
--
通讯作者：
Lewis, Eldrin F
中科院分区：
文献类型：
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作者：
Lewis, Eldrin F
意见声明：慢性心力衰竭（CHF）是一种日益常见的疾病，对发病率和死亡率有重大影响。治疗的目标包括提高生存率、减缓疾病进展、提高功能能力以及改善与健康相关的生活质量 (HRQL)。尽管有多种在心理测量上有效的 HRQL 工具，但人们对可靠测量 HRQL 概念的能力存在担忧。尽管如此，人们一直强调改善 HRQL，因此新疗法和临床试验已常规纳入 HRQL 评估。非药物干预对HRQL产生了更大的影响，包括使用经皮主动脉瓣置换术、左心室辅助装置和心脏再同步装置。药物治疗已导致 HRQL 适度改善，但这些改善通常对患者没有临床意义，并且持续时间不会超过 6 个月。随着针对 CHF 患者开发新疗法，研究人员必须：(a) 确定可能有意义地改善 HRQL 的机制，(b) 开发更好的工具来测量 HRQL，以及 (c) 针对幸福感严重受损的正确人群，以使干预措施发挥作用。美国食品和药物管理局最近发布的《临床试验中患者报告结果指标使用指南草案》为使用这些 HRQL 指标进行更稳健的试验设计奠定了基础。
OPINION STATEMENT: Chronic heart failure (CHF) is an increasingly common disorder with major impact on morbidity and mortality. Goals of therapy include improving survival, attenuating progression of disease, improving functional capacity, and improving health-related quality of life (HRQL). Although there are multiple HRQL instruments that are psychometrically valid, concerns exist on the ability to reliably measure HRQL concepts. Nevertheless, there has been an emphasis on improving HRQL and thus novel therapies and clinical trials have included HRQL assessment routinely. Nonpharmacologic interventions have made a greater impact on HRQL, including the use of transcutaneous aortic valve replacement, left ventricular assist devices, and cardiac resynchronization devices. Pharmacologic therapies have resulted in modest improvements in HRQL and these improvements are often not clinically meaningful to the patient and not lasting beyond 6months. As novel therapies are developed for CHF patients, researchers must: (a) identify mechanisms that may meaningfully improve HRQL, (b) develop better instruments to measure HRQL, and (c) target the right population with enough impairment in their sense of well-being to enable an intervention to work. The recent publication of the Food and Drug Administration Draft Guidance for Use of Patient-Reported Outcome measures in clinical trials has served as the foundation for more robust trial design using these HRQL measures.