Badia X, Arribas F, Ormaetxe JM, Peinado R, de Los Terreros MS Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrillation (AF-QoL). Health Qual Life Outcomes. 2007 Jul 4;5:37. doi: 10.1186/1477-7525-5-37.
Bae JM Value-based medicine: concepts and application. Epidemiol Health. 2015 Mar 4;37:e2015014. doi: 10.4178/epih/e2015014. eCollection 2015.
Barra S, Fynn S Untreated atrial fibrillation in the United Kingdom: Understanding the barriers and treatment options. J Saudi Heart Assoc. 2015 Jan;27(1):31-43. doi: 10.1016/j.jsha.2014.08.002. Epub 2014 Sep 3.
Buchholz I, Janssen MF, Kohlmann T, Feng YS A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D. Pharmacoeconomics. 2018 Jun;36(6):645-661. doi: 10.1007/s40273-018-0642-5.
Dar T, Yarlagadda B, Vacek J, Dawn B, Lakkireddy D Management of Stroke risk in atrial fibrillation patients with bleeding on Oral Anticoagulation Therapy-Role of Left Atrial Appendage Closure, Octreotide and more. J Atr Fibrillation. 2017 Dec 31;10(4):1729. doi: 10.4022/jafib.1729. eCollection 2017 Dec.
Darby-Stewart A, Dachs R, Graber MA Rivaroxaban vs. warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Am Fam Physician. 2012 Mar 15;85(6):577-86.
Gorman EW, Perkel D, Dennis D, Yates J, Heidel RE, Wortham D Validation Of The HAS-BLED Tool In Atrial Fibrillation Patients Receiving Rivaroxaban. J Atr Fibrillation. 2016 Aug 31;9(2):1461. doi: 10.4022/jafib.1461. eCollection 2016 Aug-Sep.
Kannel WB, Wolf PA, Benjamin EJ, Levy D Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.
Lancaster GA, Dodd S, Williamson PR Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
Lane DA, Skjoth F, Lip GYH, Larsen TB, Kotecha D Temporal Trends in Incidence, Prevalence, and Mortality of Atrial Fibrillation in Primary Care. J Am Heart Assoc. 2017 Apr 28;6(5):e005155. doi: 10.1161/JAHA.116.005155.
Li X, Tse VC, Au-Doung LW, Wong ICK, Chan EW The impact of ischaemic stroke on atrial fibrillation-related healthcare cost: a systematic review. Europace. 2017 Jun 1;19(6):937-947. doi: 10.1093/europace/euw093.
Liu GJ, Wang YF, Chen PY, Chang W, Tu ML, Chang LY, Cheng P, Luo J The efficacy and safety of novel oral anticoagulants for the preventive treatment in atrial fibrillation patients: a systematic review and meta-analysis. Drug Deliv. 2014 Sep;21(6):436-52. doi: 10.3109/10717544.2013.873500. Epub 2014 Jan 8.
Montbleau KE, King D, Henault L, Magnani JW Health literacy, health-related quality of life, and atrial fbrillation. Cogent Med. 2017;4:1412121. doi: 10.1080/2331205X.2017.1412121. Epub 2017 Dec 11.
Patel NJ, Atti V, Mitrani RD, Viles-Gonzalez JF, Goldberger JJ Global rising trends of atrial fibrillation: a major public health concern. Heart. 2018 Dec;104(24):1989-1990. doi: 10.1136/heartjnl-2018-313350. Epub 2018 Jun 15. No abstract available.
Res LCS, Lubberts B, Shah SH, DiGiovanni CW Health-related quality of life after adverse bleeding events associated with antithrombotic drug therapy - A systematic review. Hellenic J Cardiol. 2019 Jan-Feb;60(1):3-10. doi: 10.1016/j.hjc.2018.06.012. Epub 2018 Jul 24.
Riva S, Pravettoni G Value-Based Model: A New Perspective in Medical Decision-making. Front Public Health. 2016 Jun 13;4:118. doi: 10.3389/fpubh.2016.00118. eCollection 2016. No abstract available.
Thrall G, Lane D, Carroll D, Lip GY Quality of life in patients with atrial fibrillation: a systematic review. Am J Med. 2006 May;119(5):448.e1-19. doi: 10.1016/j.amjmed.2005.10.057.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.