Amputation — A Client-Based Outcome System for Individuals With Lower Limb Amputation
Citation(s)
Amtmann D, Morgan SJ, Kim J, Hafner BJ Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
Gaunaurd I, Spaulding SE, Amtmann D, Salem R, Gailey R, Morgan SJ, Hafner BJ Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. Prosthet Orthot Int. 2015 Aug;39(4):314-21. doi: 10.1177/0309364614532865. Epub 2014 May 14.
Hafner BJ, Morgan SJ, Abrahamson DC, Amtmann D Characterizing mobility from the prosthetic limb user's perspective: Use of focus groups to guide development of the Prosthetic Limb Users Survey of Mobility. Prosthet Orthot Int. 2015 May 5. pii: 0309364615579315. [Epub ahead of print]
Morgan SJ, Kelly VE, Amtmann D, Salem R, Hafner BJ Self-Reported Cognitive Concerns in People With Lower Limb Loss. Arch Phys Med Rehabil. 2016 Feb 1. pii: S0003-9993(16)00045-9. doi: 10.1016/j.apmr.2016.01.010. [Epub ahead of print]
A Client-Based Outcome System for Individuals With Lower Limb Amputation
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.
