Respiratory Distress Syndrome, Adult — Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome
Citation(s)
Ciesla N, Barbe C, Patel N, Mendez-Tellez PA, Dennison CR, Needham DM Physical therapy for the intensive care unit: implications based on evaluation of critical care management of 150 acute lung injury/acute respiratory distress syndrome patients. Cardiopulmonary Physical Therapy Journal 17(4): 142, 2006.
Dowdy DW, Needham DM, Mendez-Tellez PA, Herridge MS, Pronovost PJ Studying outcomes of intensive care unit survivors: the role of the cohort study. Intensive Care Med. 2005 Jul;31(7):914-21. Epub 2005 May 21. Review. Erratum in: Intensive Care Med. 2005 Sep;31(9):1299.
Fan E, Khatri P, Mendez-Tellez PA, Shanholtz C, Needham DM Review of a large clinical series: sedation and analgesia usage with airway pressure release and assist-control ventilation for acute lung injury. J Intensive Care Med. 2008 Nov-Dec;23(6):376-83. doi: 10.1177/0885066608324293. Epub 2008 Sep 19.
Fan E, Needham DM, Stewart TE Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. Review.
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.
