3.1 Sex differences in generalizability of HFrEF trials 103 17. U.S. Department of Health and Human Services, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. Silver Spring, MD: Center for Drug Evaluation and Research; 2020. 18. Lim YMF, Molnar M, Vaartjes I, Savarese G, Eijkemans MJC, Uijl A, et al. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction. European Heart Journal - Quality of Care and Clinical Outcomes 2022;8:761–769. doi:10.1093/ehjqcco/qcab070. 19. Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. The Lancet 2010;376:875– 885. doi:10.1016/S0140-6736(10)61198-1. 20. Fox K, Ferrari R, Tendera M, Steg PG, Ford I, BEAUTIFUL Steering Committee. Rationale and design of a randomized, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction: the morBidity-mortality EvAlUaTion of the I(f) inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction (BEAUTIFUL) study. Am Heart J 2006;152:860–866. doi:10.1016/j.ahj.2006.01.013. 21. Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency†. Eur Heart J 2015;36:657–668. doi:10.1093/eurheartj/ehu385. 22. Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, et al. Rationale and design of Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail 2009;11:1084–1091. doi:10.1093/eurjhf/hfp140. 23. Voors AA, Shah SJ, Bax JJ, Butler J, Gheorghiade M, Hernandez AF, et al. Rationale and design of the phase 2b clinical trials to study the effects of the partial adenosine A1-receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced (PANTHEON) and preserved (PANACHE) ejection fraction. European Journal of Heart Failure 2018;20:1601–1610. doi:10.1002/ejhf.1295. 24. Savarese G, Vasko P, Jonsson Å, Edner M, Dahlström U, Lund LH. The Swedish Heart Failure Registry: a living, ongoing quality assurance and research in heart failure. Ups J Med Sci 2019;124:65–69. doi:10.1080/03009734.2018.1490831. 25. Brugts JJ, Linssen GCM, Hoes AW, Brunner-La Rocca HP, CHECK-HF investigators. Real-world heart failure management in 10,910 patients with chronic heart failure in the Netherlands : Design and rationale of the Chronic Heart failure ESC guideline-based Cardiology practice Quality project (CHECK-HF) registry. Neth Heart J 2018;26:272–279. doi:10.1007/s12471-018-1103-7. 26. Taylor P. Standardized mortality ratios. Int J Epidemiol 2013;42:1882–1890. doi:10.1093/ije/dyt209. 27. Roessler M, Schmitt J, Schoffer O. Can we trust the standardized mortality ratio? A formal analysis and evaluation based on axiomatic requirements. PLoS One 2021;16:e0257003. doi:10.1371/journal.pone.0257003. 28. Vishram-Nielsen JKK, Foroutan F, Ross HJ, Gustafsson F, Alba AC. Performance of Prognostic Risk Scores in Heart Failure Patients: Do Sex Differences Exist? Can J Cardiol 2020;36:45–53. doi:10.1016/j.cjca.2019.08.021. 29. Sartipy U, Dahlström U, Edner M, Lund LH. Predicting survival in heart failure: validation of the MAGGIC heart failure risk score in 51,043 patients from the Swedish heart failure registry. Eur J Heart Fail 2014;16:173–179. doi:10.1111/ejhf.32. 30. Khanam SS, Choi E, Son J-W, Lee J-W, Youn YJ, Yoon J, et al. Validation of the MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) heart failure risk score and the effect of adding natriuretic peptide for predicting mortality after discharge in hospitalized patients with heart failure. PLoS One 2018;13:e0206380. doi:10.1371/journal.pone.0206380. 31. Breslow NE, Day NE. Statistical methods in cancer research. Volume II--The design and analysis of cohort studies. IARC Sci Publ 1987:1–406.
RkJQdWJsaXNoZXIy MjY0ODMw