Consideration Regarding the Analysis of Randomized Controlled Trials in the Era of Evidence-based Medicine. Issue 5 (May 2022)

• Record Type: Journal Article
• Authors: Ennezat, Pierre V.; Alavi, Zarrin; Le Jemtel, Thierry H.; Hansen, Morten R.
• Is Part Of: Journal of cardiovascular pharmacology. Volume 79:Issue 5(2022)
• Page Start: 605
• Page End: 619
• Publication Date: 2022-05
• Subjects: randomized controlled trials -- cardiovascular disease -- fragility index -- number need to treat -- gain postponement; Cardiovascular Diseases -- drug therapy -- Periodicals; Cardiovascular System -- drug effects -- Periodicals; Cardiovascular pharmacology -- Periodicals; Cardiovascular agents -- Periodicals; Cardiovascular agents; Cardiovascular pharmacology; Periodicals; 615.7105
• DOI: 10.1097/FJC.0000000000001215
• Languages: English
• ISSNs: 0160-2446

Abstract

Abstract: Analysis of randomized controlled trials (RCTs) is the cornerstone of evidence-based medicine, therapeutic guidelines and ultimately daily practice. However, 2 issues contribute to cloud the analysis of RCTs. Industry-sponsored RCTs aim at capturing as large indications as possible and clinicians rely excessively on P value statistical significance for the evaluation of the findings. To be most valuable to practitioners, analysis of RCTs needs to provide absolute risk reduction, number of patients needed to treat, fragility index along with the estimation of lost to follow-up patients, and outcome postponement (gain in survival time). We analyzed few major cardiovascular RCTs and assessed the robustness of their findings. Our suggested analytic parameters may be further used in future systematic reviews and meta-analyses.