Considerations in the Interpretation of Patient-Reported Outcomes in Heart Failure With Reduced and Preserved Ejection Fraction.
Considerations in the Interpretation of Patient-Reported Outcomes in Heart Failure With Reduced and Preserved Ejection Fraction.
复制标题
解释射血分数减少和保留的心力衰竭患者报告的结果时的考虑因素。
DOI：
10.1016/j.cardfail.2022.10.001
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发表时间：
2022
影响因子：
6
通讯作者：
Khazanie,Prateeti
中科院分区：
文献类型：
--
作者：
Urban,JacquelineA;Khazanie,Prateeti
Patient reported outcomes (PROs) are an important and increasingly common component of clinical research, particularly in heart failure (HF), where interest in PROs has gained ground in recent years [1]. As HF is a disease process notorious for its plethora of symptoms and vast range of available medications and therapies, PROs help focus research on patient-centered care and help balance quality of life metrics with traditional mortality reporting [2]. PROs are particularly important in HF studies that have have shown that patient preferences vary widely in terms of aggressiveness of medical treatment and time versus quality of life tradeoffs [3]. Consolidated Standards of Reporting Trials (CONSORT) PRO Extension, the methodologic framework for PRO implementation and reporting in clinical trials proposed in 2013, suggest that PROs are still in the beginning phases of implementation into the field [1, 4]. As such, there are still limitations to their uniform use and interpretation. Though the FDA broadly approved PROs as a valid outcome measure in 2007, specific PROs require validation in each study population for which they are used before full integration into a clinical trial [2]. This requirement, in addition to the fact that many different PROs exist, add to the complexity of their interpretation.In a recent systematic review of all randomized clinical trials in HF published between 2000-2020, 54% included at least 1 PRO. Of these,~ 20% used PROs as a primary or co-primary endpoint [1]. The proportion of HF trials that included PROs increased over time from 37.4%(2000-2003) to 66.7%(2016-2020)[1]. Examples of PROs include generic measures (EuroQol (ED-5D) and Short Form (SF-36)) and HF specific measures (Minnesota Living with HF Questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ)). A majority of HF trials use HF specific instruments (MLHFQ 49%, KCCQ 23%) as opposed to generic measures (dyspnea scale 13%, EQ-5D 11%).
