Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a “Pure” Patient Phenotype and the Generalizability of Trial Findings.

Title : Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a Pure Patient Phenotype and the Generalizability of Trial Findings

Source : PubMed
ID : 28434933
Authors : Patel, Hitesh C.; Hayward, Carl; Dungu, Jason N.; Papadopoulou, Sofia; Saidmeerasah, Abdel; Ray, Robin; Di Mario, Carlo; Shanmugam, Nesan; Cowie, Martin R.; Anderson, Lisa J
Year : 2017
Disease Category : Cardiovascular diseases
Focused Population : Not Specified
Priori/Posteriori : Posteriori
Single-study Generalibility? : Multiple
Score/Non-Score : Non-score
Tutorial/Method : NHANES_T2D
Compared general demographic and patient characteristics : Yes
Compared disease-specific clinical characteristics : Yes
Compared adverse events : No
Compared outcomes/treatment effect (including survival) : No
Trial participants vs. eligible patients (by applying eligibility criteria on the patient data) : Yes
Real-world data sources : HFpEF population (n = 557) seen in modern European cardiological practice / At a hospital in South London between January 2005 and November 2012
Target Population Data Type Levels : Hospital

Welcome to the College of Communication & Information

Schools and Colleges

Centers of Distinction

CTGATE: Clinical Trial Generalizability Assessment Toolbox

Clinical Trial Generalizability Assessment Informatics Toolbox

Title : Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a Pure Patient Phenotype and the Generalizability of Trial Findings