Decision Making — Organ Donation and End-of-life Decisions
Citation(s)
Bendorf A, Kerridge IH, Stewart C Intimacy or utility? Organ donation and the choice between palliation and ventilation. Crit Care. 2013 May 23;17(3):316. doi: 10.1186/cc12553. Review.
Mark NM, Rayner SG, Lee NJ, Curtis JR Global variability in withholding and withdrawal of life-sustaining treatment in the intensive care unit: a systematic review. Intensive Care Med. 2015 Sep;41(9):1572-85. doi: 10.1007/s00134-015-3810-5. Epub 2015 Apr 23. Review.
Parker M, Shemie SD Pro/con ethics debate: should mechanical ventilation be continued to allow for progression to brain death so that organs can be donated? Crit Care. 2002 Oct;6(5):399-402. Epub 2002 Aug 15.
Differences Across ICUs in Organ Donation After Brain Death: A Nationwide Study of Relationship With Variation in End-of-life Decisions
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.
