Hypertension — Telemonitoring of Uncontrolled Hypertension
Citation(s)
41st World Medical Assembly Declaration of Helsinki : recommendations guiding physicians in biomedical research involving human subjects. Bull Pan Am Health Organ 1990; 24: 606-609
Burnier M Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens. 2006 Nov;19(11):1190-6. Review.
Calhoun DA, White WB Effectiveness of the selective aldosterone blocker, eplerenone, in patients with resistant hypertension. J Am Soc Hypertens. 2008 Nov-Dec;2(6):462-8. doi: 10.1016/j.jash.2008.05.005. Epub 2008 Jul 23.
Claxton AJ, Cramer J, Pierce C A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296-310.
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70.
Lowy A, Munk VC, Ong SH, Burnier M, Vrijens B, Tousset EP, Urquhart J Effects on blood pressure and cardiovascular risk of variations in patients' adherence to prescribed antihypertensive drugs: role of duration of drug action. Int J Clin Pract. 2011 Jan;65(1):41-53. doi: 10.1111/j.1742-1241.2010.02569.x. Epub 2010 Nov 22.
Pickering TG Home blood pressure monitoring: a new standard method for monitoring hypertension control in treated patients. Nat Clin Pract Cardiovasc Med. 2008 Dec;5(12):762-3. doi: 10.1038/ncpcardio1374. Epub 2008 Oct 14.
Staessen JA, Byttebier G, Buntinx F, Celis H, O'Brien ET, Fagard R Antihypertensive treatment based on conventional or ambulatory blood pressure measurement. A randomized controlled trial. Ambulatory Blood Pressure Monitoring and Treatment of Hypertension Investigators. JAMA. 1997 Oct 1;278(13):1065-72.
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.