Pre-diabetic — Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
Citation(s)
Campbell MK, Mollison J, Grimshaw JM Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001 Feb 15;20(3):391-9.
Doll R, Peto R, Boreham J, Sutherland I Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. Epub 2004 Jun 22.
Donner A, Donald A Analysis of data arising from a stratified design with the cluster as unit of randomization. Stat Med. 1987 Jan-Feb;6(1):43-52.
Reid RD, Mullen KA, Pipe AL Systematic approaches to smoking cessation in the cardiac setting. Curr Opin Cardiol. 2011 Sep;26(5):443-8. doi: 10.1097/HCO.0b013e3283497499. Review.
Reid RD, Pipe A, Dafoe WA Is telephone counselling a useful addition to physician advice and nicotine replacement therapy in helping patients to stop smoking? A randomized controlled trial. CMAJ. 1999 Jun 1;160(11):1577-81.
Reid RD, Pipe AL, Quinlan B, Oda J Interactive voice response telephony to promote smoking cessation in patients with heart disease: a pilot study. Patient Educ Couns. 2007 Jun;66(3):319-26. Epub 2007 Mar 1.
Reid RD, Pipe AL, Quinlan B Promoting smoking cessation during hospitalization for coronary artery disease. Can J Cardiol. 2006 Jul;22(9):775-80.
Reid RD, Pipe AL A telephone-based support program for over-the-counter nicotine patch users. Can J Public Health. 1999 Nov-Dec;90(6):397-8.
Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
Stamler J, Vaccaro O, Neaton JD, Wentworth D Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44.
Thompson SG, Pyke SD, Hardy RJ The design and analysis of paired cluster randomized trials: an application of meta-analysis techniques. Stat Med. 1997 Sep 30;16(18):2063-79.
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.