Use of outcome measures in pulmonary hypertension clinical trials.
作者： Kishan S Parikh , Sudarshan Rajagopal , Kristine Arges , Tariq Ahmad , Joseph Sivak
DOI: 10.1016/J.AHJ.2015.06.010
关键词:
摘要: Objectives To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to practice. Background Studies arterial (PAH) employ a variety addition events because small patient population, participant burden, costs. The these PH drug is poorly defined. Methods We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH treatment from 1985 2013. Extracted data included intervention, trial duration, study design, characteristics, primary secondary outcome measures. compare with practice, we assessed sample patients on medications at Duke University Medical Center between 2003 2014. Results Between 2013, 126 were identified analyzed. Surrogate served as endpoints 119 (94.0%). Inclusion invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P trend=.02), while functional testing (7.1%, 60.0%, 81.5%; trend = .04), but did not continue 2005-2013 (25.0%). In comparison, among 450 therapies our institution assessments regularly incorporated serial echocardiography 6-minute walk distance tests (92% 95% patients, respectively) repeat measurement (46% patients). Conclusions majority have utilized endpoints. has evolved significantly increasing patient-centered decreasing stable imaging contrast, are commonly used contemporary Further research needed validate standardize currently
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