Proefschrift

1 General introduction 11 REFERENCES 1. Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 2005;365:82–93. doi:10.1016/S0140-6736(04)17670-8. 2. Antani MR, Beyth RJ, Covinsky KE, Anderson PA, Miller DG, Cebul RD, et al. Failure to prescribe warfarin to patients with nonrheumatic atrial fibrillation. J Gen Intern Med 1996;11:713–720. doi:10.1007/BF02598984. 3. Oswald N, Bateman H. Applying research evidence to individuals in primary care: a study using nonrheumatic atrial fibrillation | Family Practice | Oxford Academic. Family Practice 1999;16:414–419. doi:https://doi.org/10.1093/fampra/16.4.414. 4. Michos ED, Reddy TK, Gulati M, Brewer LC, Bond RM, Velarde GP, et al. Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement. Am J Prev Cardiol 2021;8:100250. doi:10.1016/j.ajpc.2021.100250. 5. Pinn VW. Sex and Gender Factors in Medical Studies: Implications for Health and Clinical Practice. JAMA 2003;289:397–400. doi:10.1001/jama.289.4.397. 6. Tahhan AS, Vaduganathan M, Greene SJ, Fonarow GC, Fiuzat M, Jessup M, et al. Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials: A Systematic Review. JAMA Cardiol 2018;3:1011–1019. doi:10.1001/jamacardio.2018.2559. 7. Woods B, Hawkins N, Mealing S, Sutton A, Abraham WT, Beshai JF, et al. Individual patient data network meta-analysis of mortality effects of implantable cardiac devices. Heart 2015;101:1800– 1806. doi:10.1136/heartjnl-2015-307634. 8. Zusterzeel R, Selzman KA, Sanders WE, Caños DA, O’Callaghan KM, Carpenter JL, et al. Cardiac Resynchronization Therapy in Women: US Food and Drug Administration Meta-analysis of PatientLevel Data. JAMA Internal Medicine 2014;174:1340–1348. doi:10.1001/jamainternmed.2014.2717. 9. Santema BT, Ouwerkerk W, Tromp J, Sama IE, Ravera A, Regitz-Zagrosek V, et al. Identifying optimal doses of heart failure medications in men compared with women: a prospective, observational, cohort study. Lancet 2019;394:1254–1263. doi:10.1016/S0140-6736(19)31792-1. 10. Dekkers OM, von Elm E, Algra A, Romijn JA, Vandenbroucke JP. How to assess the external validity of therapeutic trials: a conceptual approach. Int J Epidemiol 2010;39:89–94. doi:10.1093/ije/dyp174. 11. Lesko CR, Buchanan AL, Westreich D, Edwards JK, Hudgens MG, Cole SR. Generalizing Study Results: A Potential Outcomes Perspective. Epidemiology 2017;28:553–561. doi:10.1097/EDE.0000000000000664. 12. Flay BR, Biglan A, Boruch RF, Castro FG, Gottfredson D, Kellam S, et al. Standards of evidence: criteria for efficacy, effectiveness and dissemination. Prev Sci 2005;6:151–175. doi:10.1007/s11121-0055553-y. 13. Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci 2015;16:475–485. doi:10.1007/s11121-014-0513-z. 14. Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. PLoS One 2015;10:e0127242. doi:10.1371/journal.pone.0127242. 15. Innovative Medicines Initiative. BigData@Heart. IMI Innovative Medicines Initiative 2021. http://www.imi.europa.eu/projects-results/project-factsheets/bigdataheart(accessed September 7, 2021). 16. UMC Utrecht. BigData@Heart 2022. https://www.bigdata-heart.eu/ (accessed June 9, 2022).

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