Beam DM, Kahler ZP, Kline JA Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis. Acad Emerg Med. 2015 Jul;22(7):788-95. doi: 10.1111/acem.12711. Epub 2015 Jun 25.
Kline JA, Kahler ZP, Beam DM Outpatient treatment of low risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance. Patient.Prefer.Adherence. IN PRESS.
Liu Z, Doan QV, Blumenthal P, Dubois RW A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding. Value Health. 2007 May-Jun;10(3):183-94. Review.
Matteson KA, Boardman LA, Munro MG, Clark MA Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16. Review.
Myers B, Webster A Heavy menstrual bleeding on Rivaroxaban - Comparison with Apixaban. Br J Haematol. 2016 Mar 11. doi: 10.1111/bjh.14003. [Epub ahead of print]
PIOPED Investigators Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). JAMA. 1990 May 23-30;263(20):2753-9.
Sesti F, Ruggeri V, Pietropolli A, Piancatelli R, Piccione E Thermal balloon ablation versus laparoscopic supracervical hysterectomy for the surgical treatment of heavy menstrual bleeding: a randomized study. J Obstet Gynaecol Res. 2011 Nov;37(11):1650-7. doi: 10.1111/j.1447-0756.2011.01596.x. Epub 2011 Jul 25.
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.
