Stroke — The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.
Citation(s)
Gawande AA, Thomas EJ, Zinner MJ, Brennan TA The incidence and nature of surgical adverse events in Colorado and Utah in 1992. Surgery. 1999 Jul;126(1):66-75. doi: 10.1067/msy.1999.98664.
Hachenberg T, Schneemilch C Anesthesia in neurologic and psychiatric diseases: is there a 'best anesthesia' for certain diseases? Curr Opin Anaesthesiol. 2014 Aug;27(4):394-402. doi: 10.1097/ACO.0000000000000098.
Kable AK, Gibberd RW, Spigelman AD Adverse events in surgical patients in Australia. Int J Qual Health Care. 2002 Aug;14(4):269-76. doi: 10.1093/intqhc/14.4.269.
Malik OS, Brovman EY, Urman RD The Use of Regional or Local Anesthesia for Carotid Endarterectomies May Reduce Blood Loss and Pulmonary Complications. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):935-942. doi: 10.1053/j.jvca.2018.08.195. Epub 2018 Aug 23.
van Diepen S, Bakal JA, McAlister FA, Ezekowitz JA Mortality and readmission of patients with heart failure, atrial fibrillation, or coronary artery disease undergoing noncardiac surgery: an analysis of 38 047 patients. Circulation. 2011 Jul 19;124(3):289-96. doi: 10.1161/CIRCULATIONAHA.110.011130. Epub 2011 Jun 27.
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.