Feldstein AC, Smith DH, Robertson NR, Kovach CA, Soumerai SB, Simon SR, Sittig DF, Laferriere DS, Kalter M Decision Support System Design and Implementation for Outpatient Prescribing: The Safety in Prescribing Study. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Freeborn DK PC Promise and performance in managed care. Greenlick M, Freeborn D, Pope C, editors. 1994. Baltimore, MD, Johns Hopkins University Press.
Kaushal R, Shojania KG, Bates DW Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Arch Intern Med. 2003 Jun 23;163(12):1409-16. Review.
Krishna S, Balas EA, Boren SA, Maglaveras N Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods Inf Med. 2002;41(5):360-9. Review.
Linkins RW, Dini EF, Watson G, Patriarca PA A randomized trial of the effectiveness of computer-generated telephone messages in increasing immunization visits among preschool children. Arch Pediatr Adolesc Med. 1994 Sep;148(9):908-14.
Piette JD, Mah CA The feasibility of automated voice messaging as an adjunct to diabetes outpatient care. Diabetes Care. 1997 Jan;20(1):15-21.
Selby JV, Ettinger B, Swain BE, Brown JB First 20 months' experience with use of metformin for type 2 diabetes in a large health maintenance organization. Diabetes Care. 1999 Jan;22(1):38-44.
Shea S, DuMouchel W, Bahamonde L A meta-analysis of 16 randomized controlled trials to evaluate computer-based clinical reminder systems for preventive care in the ambulatory setting. J Am Med Inform Assoc. 1996 Nov-Dec;3(6):399-409.
Skipwith DH Telephone counseling interventions with caregivers of elders. J Psychosoc Nurs Ment Health Serv. 1994 Mar;32(3):7-12.
Smith CC, Bernstein LI, Davis RB, Rind DM, Shmerling RH Screening for statin-related toxicity: the yield of transaminase and creatine kinase measurements in a primary care setting. Arch Intern Med. 2003 Mar 24;163(6):688-92.
Tanke ED, Leirer VO Automated telephone reminders in tuberculosis care. Med Care. 1994 Apr;32(4):380-9.
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.
