Mackey K, Parchman ML, Leykum LK, Lanham HJ, Noël PH, Zeber JE Impact of the Chronic Care Model on medication adherence when patients perceive cost as a barrier. Prim Care Diabetes. 2012 Jul;6(2):137-42. doi: 10.1016/j.pcd.2011.12.004. Epub 2012 Jan 20.
Noël PH, Lanham HJ, Palmer RF, Leykum LK, Parchman ML The importance of relational coordination and reciprocal learning for chronic illness care within primary care teams. Health Care Manage Rev. 2013 Jan-Mar;38(1):20-8. doi: 10.1097/HMR.0b013e3182497262.
Parchman ML, Pugh JA, Culler SD, Noel PH, Arar NH, Romero RL, Palmer RF A group randomized trial of a complexity-based organizational intervention to improve risk factors for diabetes complications in primary care settings: study protocol. Implement Sci. 2008 Mar 5;3:15. doi: 10.1186/1748-5908-3-15.
Improving Risk Factors for Diabetes Complications in Primary Care
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.
