Burden AR, Carr ZJ, Staman GW, Littman JJ, Torjman MC Does every code need a "reader?" improvement of rare event management with a cognitive aid "reader" during a simulated emergency: a pilot study. Simul Healthc. 2012 Feb;7(1):1-9. doi: 10.1097/SIH.0b01
Chrysochoou G, Gunn SR Demonstrating the benefit of medical emergency teams (MET) proves more difficult than anticipated. Crit Care. 2006;10(2):306. Review.
Gaba DM, Howard SK, Fish KJ, Smith BE, Sowb YA Simulation- based training in anesthesia crisis resource management (ACRM): a decade of experience. Simul Gaming 2001;32:175-93. ( via: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.454.6344&rep=rep1&type=pdf )
Johnston M, Arora S, Anderson O, King D, Behar N, Darzi A Escalation of care in surgery: a systematic risk assessment to prevent avoidable harm in hospitalized patients. Ann Surg. 2015 May;261(5):831-8. doi: 10.1097/SLA.0000000000000762.
Johnston M, Arora S, King D, Stroman L, Darzi A Escalation of care and failure to rescue: a multicenter, multiprofessional qualitative study. Surgery. 2014 Jun;155(6):989-94. doi: 10.1016/j.surg.2014.01.016. Epub 2014 Feb 7.
Koers L, Eveleens FM, Schlack WS, Preckel B [Cognitive aid for emergencies in the OR--AMC bundle helps ensure that no steps are left out]. Ned Tijdschr Geneeskd. 2015;159:A8325. Dutch.
Symons NR, Almoudaris AM, Nagpal K, Vincent CA, Moorthy K An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery. Ann Surg. 2013 Jan;257(1):1-5. doi: 10.1097/SLA.0b013e31826d
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.
