Surgery — FIT Study (Functional Outcomes In Trauma Study)
Citation(s)
Abajas Bustillo R, Amo Setién FJ, Ortego Mate MDC, Seguí Gómez M, Durá Ros MJ, Leal Costa C Predictive capability of the injury severity score versus the new injury severity score in the categorization of the severity of trauma patients: a cross-sectional observational study. Eur J Trauma Emerg Surg. 2018 Dec 8. doi: 10.1007/s00068-018-1057-x. [Epub ahead of print]
Attenberger C, Amsler F, Gross T Clinical evaluation of the Trauma Outcome Profile (TOP) in the longer-term follow-up of polytrauma patients. Injury. 2012 Sep;43(9):1566-74. doi: 10.1016/j.injury.2011.01.002. Epub 2011 Jan 20.
Balogh ZJ, Varga E, Tomka J, Süveges G, Tóth L, Simonka JA The new injury severity score is a better predictor of extended hospitalization and intensive care unit admission than the injury severity score in patients with multiple orthopaedic injuries. J Orthop Trauma. 2003 Aug;17(7):508-12.
Boyd CR, Tolson MA, Copes WS Evaluating trauma care: the TRISS method. Trauma Score and the Injury Severity Score. J Trauma. 1987 Apr;27(4):370-8.
Palmer C Major trauma and the injury severity score--where should we set the bar? Annu Proc Assoc Adv Automot Med. 2007;51:13-29.
Spreadborough S, Radford K, das Nair R, Brooks A, Duffy M A study of outcomes of patients treated at a UK major trauma centre for moderate or severe injuries one to three years after injury. Clin Rehabil. 2018 Mar;32(3):410-418. doi: 10.1177/0269215517730862. Epub 2017 Sep 20.
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.