Budden LM, Pierce PF, Hayes BA, Buettner PG Australian women's prediagnostic decision-making styles, relating to treatment choices for early breast cancer treatment. Res Theory Nurs Pract. 2003 Summer;17(2):117-36.
de Haes H Dilemmas in patient centeredness and shared decision making: a case for vulnerability. Patient Educ Couns. 2006 Sep;62(3):291-8. Epub 2006 Jul 21. Review.
Frongillo M, Feibelmann S, Belkora J, Lee C, Sepucha K Is there shared decision making when the provider makes a recommendation? Patient Educ Couns. 2013 Jan;90(1):69-73. doi: 10.1016/j.pec.2012.08.016. Epub 2012 Sep 20.
Hack TF, Degner LF, Watson P, Sinha L Do patients benefit from participating in medical decision making? Longitudinal follow-up of women with breast cancer. Psychooncology. 2006 Jan;15(1):9-19.
Hyphantis T, Almyroudi A, Paika V, Degner LF, Carvalho AF, Pavlidis N Anxiety, depression and defense mechanisms associated with treatment decisional preferences and quality of life in non-metastatic breast cancer: a 1-year prospective study. Psychooncology. 2013 Nov;22(11):2470-7. doi: 10.1002/pon.3308. Epub 2013 May 27.
Livaudais JC, Franco R, Fei K, Bickell NA Breast cancer treatment decision-making: are we asking too much of patients? J Gen Intern Med. 2013 May;28(5):630-6. doi: 10.1007/s11606-012-2274-3. Epub 2012 Nov 15.
Nguyen F, Moumjid N, Charles C, Gafni A, Whelan T, Carrère MO Treatment decision-making in the medical encounter: comparing the attitudes of French surgeons and their patients in breast cancer care. Patient Educ Couns. 2014 Feb;94(2):230-7. doi: 10.1016/j.pec.2013.07.011. Epub 2013 Dec 8.
O'Leary KA, Estabrooks CA, Olson K, Cumming C Information acquisition for women facing surgical treatment for breast cancer: influencing factors and selected outcomes. Patient Educ Couns. 2007 Dec;69(1-3):5-19. Epub 2007 Sep 24. Review.
Sepucha K, Mulley AG Jr A perspective on the patient's role in treatment decisions. Med Care Res Rev. 2009 Feb;66(1 Suppl):53S-74S. doi: 10.1177/1077558708325511. Epub 2008 Nov 10.
Sepucha K, Ozanne EM How to define and measure concordance between patients' preferences and medical treatments: A systematic review of approaches and recommendations for standardization. Patient Educ Couns. 2010 Jan;78(1):12-23. doi: 10.1016/j.pec.2009.05.011. Epub 2009 Jun 30. Review.
Sepucha KR, Barry MJ Making patient-centered cancer care a reality. Cancer. 2009 Dec 15;115(24):5610-1. doi: 10.1002/cncr.24824.
Sivell S, Elwyn G, Edwards A, Manstead AS; BresDex group Factors influencing the surgery intentions and choices of women with early breast cancer: the predictive utility of an extended theory of planned behaviour. BMC Med Inform Decis Mak. 2013 Aug 20;13:92. doi: 10.1186/1472-6947-13-92.
Street RL Jr, Elwyn G, Epstein RM Patient preferences and healthcare outcomes: an ecological perspective. Expert Rev Pharmacoecon Outcomes Res. 2012 Apr;12(2):167-80. doi: 10.1586/erp.12.3. Review.
Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1145-51. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25. Review.
Vogel BA, Bengel J, Helmes AW Information and decision making: patients' needs and experiences in the course of breast cancer treatment. Patient Educ Couns. 2008 Apr;71(1):79-85. doi: 10.1016/j.pec.2007.11.023. Epub 2008 Jan 8.
Vogel BA, Helmes AW, Hasenburg A Concordance between patients' desired and actual decision-making roles in breast cancer care. Psychooncology. 2008 Feb;17(2):182-9.
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.