Fulbrook P, Anderson A Pressure injury risk assessment in intensive care: comparison of inter-rater reliability of the COMHON (Conscious level, Mobility, Haemodynamics, Oxygenation, Nutrition) Index with three scales. J Adv Nurs. 2016 Mar;72(3):680-92. doi: 10.1111/jan.12825. Epub 2015 Oct 14.
Lardenoye JW, Thiéfaine JA, Breslau PJ Assessment of incidence, cause, and consequences of pressure ulcers to evaluate quality of provided care. Dermatol Surg. 2009 Nov;35(11):1797-803. doi: 10.1111/j.1524-4725.2009.01293.x. Epub 2009 Sep 2.
Nixon J, McElvenny D, Mason S, Brown J, Bond S A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203.
Rao AD, Preston AM, Strauss R, Stamm R, Zalman DC Risk Factors Associated With Pressure Ulcer Formation in Critically Ill Cardiac Surgery Patients: A Systematic Review. J Wound Ostomy Continence Nurs. 2016 May-Jun;43(3):242-7. doi: 10.1097/WON.0000000000000224. Review.
Smit I, Harrison L, Letzkus L, Quatrara B What Factors Are Associated With the Development of Pressure Ulcers in a Medical Intensive Care Unit? Dimens Crit Care Nurs. 2016 Jan-Feb;35(1):37-41. doi: 10.1097/DCC.0000000000000153.
Sprigle S, Sonenblum S Assessing evidence supporting redistribution of pressure for pressure ulcer prevention: a review. J Rehabil Res Dev. 2011;48(3):203-13. Review.
The Effect of Support Surfaces in the Incidence of Pressure Injuries in Critically Ill Patients: a Randomized Clinical Trial
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.
