Berridge E, Roudsari A, Taylor S, Carey S Computer-aided learning for the education of patients and family practice professionals in the personal care of diabetes. Comput Methods Programs Biomed. 2000 Jul;62(3):191-204.
Brown SA Studies of educational interventions and outcomes in diabetic adults: a meta-analysis revisited. Patient Educ Couns. 1990 Dec;16(3):189-215.
Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2003 Jan;41(1):1-12.
KDOQI KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154.
Khosla N, Bakris G Lessons learned from recent hypertension trials about kidney disease. Clin J Am Soc Nephrol. 2006 Mar;1(2):229-35. Epub 2005 Nov 30. Review.
Kshirsagar AV, Joy MS, Hogan SL, Falk RJ, Colindres RE Effect of ACE inhibitors in diabetic and nondiabetic chronic renal disease: a systematic overview of randomized placebo-controlled trials. Am J Kidney Dis. 2000 Apr;35(4):695-707.
Lynn ML Determination and quantification of content validity. Nursing Research 35:362-5, 1996.
National Kidney Foundation [NKF] Kidney disease outcomes quality initiative (K/DOQI): Clinical Practice Guideline 2-evaluation and treatment 2002: Accessed March 21, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g2.htm.
National Kidney Foundation [NKF] Kidney disease outcomes quality initiative (K/DOQI): Clinical practice Guideline 4-Estimation of GFR Part 5 evaluation of laboratory measures for clinical assessment of kidney disease. 2002: Accessed March 27, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p5_lab_g4.htm.
National Kidney Foundation [NKF] Kidney Disease Outcomes Quality Initiative (K/DOQI): Clinical Practice Guideline 9-assoc of level of GFR with nutritional status and Guideline 24-dietary protein intake for nondialyzed patients, 2002.
Prochaska JO, DiClemente CC Stages of change in the modification of problem behaviors. In: Hersen M, Eisler R, eds. Progress in behavior modification. Newbury Park, CA: Sage Publications; 1992.
Rollnick S, Mason P, Butler C Health behavior change: A guide for practitioners. Edinburgh, Scotland: Churchill Livingstone Elsevier; 1999.
Rollnick S, Miller WR, Butler CC Motivational interviewing in health care: Helping patients change behavior. New York: Guilford Press; 2007.
Sakraida TJ, Robinson MV Health literacy self-management by patients with type 2 diabetes and stage 3 chronic kidney disease. West J Nurs Res. 2009 Aug;31(5):627-47. doi: 10.1177/0193945909334096. Epub 2009 Apr 23.
Sheiner LB, Rubin DB Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995 Jan;57(1):6-15. Review.
Toobert DJ, Hampson SE, Glasgow RE The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50.
Ware J, Snow K, Kosinski M, Gandek B SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Centre;1993.
Ware JE Jr, Sherbourne CD The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
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.