Pregnancy — Effect of a Patient-Centered Decision App on TOLAC
Citation(s)
Bernstein SN, Matalon-Grazi S, Rosenn BM Trial of labor versus repeat cesarean: are patients making an informed decision? Am J Obstet Gynecol. 2012 Sep;207(3):204.e1-6. doi: 10.1016/j.ajog.2012.06.057. Epub 2012 Jul 4.
Farnworth A, Robson SC, Thomson RG, Watson DB, Murtagh MJ Decision support for women choosing mode of delivery after a previous caesarean section: a developmental study. Patient Educ Couns. 2008 Apr;71(1):116-24. doi: 10.1016/j.pec.2007.11.020. Epub 2008 Feb 6.
Guise J-M, Eden K, Emeis C, Denman MA, Marshall N, Fu R, Janik R, Nygren P, Walker M, McDonagh M Vaginal birth after cesarean: New insights. Evidence report/Technology assessment no.191. (prepared by the Oregon Health & Science University Evidence-based Practice Center under contract no. 290-2007-10057-I). AHRQ publication no. 10-E003. Rockville, MD: Agency for Healthcare Research and Quality. March 2010.
Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter M The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
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.
