Havas S The ACCORD Trial and control of blood glucose level in type 2 diabetes mellitus: time to challenge conventional wisdom. Arch Intern Med. 2009 Jan 26;169(2):150-4. doi: 10.1001/archinternmed.2008.518.
Kline JA, Mitchell AM, Runyon MS, Jones AE, Webb WB Electronic medical record review as a surrogate to telephone follow-up to establish outcome for diagnostic research studies in the emergency department. Acad Emerg Med. 2005 Nov;12(11):1127-33. Epub 2005 Sep 15.
Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.
Pines JM, Isserman JA, Szyld D, Dean AJ, McCusker CM, Hollander JE The effect of physician risk tolerance and the presence of an observation unit on decision making for ED patients with chest pain. Am J Emerg Med. 2010 Sep;28(7):771-9. doi: 10.1016/j.ajem.2009.03.019. Epub 2010 Feb 25.
Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. Erratum in: Med J Aust. 2006 Jun 19;184(12):616.
Venturini JM, Stake CE, Cichon ME Prehospital point-of-care testing for troponin: are the results reliable? Prehosp Emerg Care. 2013 Jan-Mar;17(1):88-91. doi: 10.3109/10903127.2012.717166. Epub 2012 Sep 6.
Can Pre-Hospital Use of the HEART Score and Abbott i-STAT® Point-of-Care Troponin Predict Major Adverse Cardiovascular Events: the PARA-HEART Pilot Implementation
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.
