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PBHE427 Epidemiology Questions Synopsis This is a randomized controlled trial to assess the effects of lifestyle modification and metformin in the prevention of diabetes in high risk individuals. The hypothesis was that lifestyle intervention or metformin would prevent or delay the development of diabetes. 3,234 persons with elevated fasting and post-load glucose concentrations were assigned to receive placebo, receive metformin, or participate in an intensive lifestyle modification program. The average follow up was 2.8 years. The study found that both metformin and lifestyle intervention did reduce the incidence of diabetes. Lifestyle intervention was significantly more effective than metformin. Challenges Of Assessing Risks And Reduction Measures Used According to Friis & Sellers (2014) there are 3 issues with controlled trials when assessing risks. The first is the diversity of the human subjects. This study boast that 68 percent are women and 45 percent were members of a minority group. The second issue is sample size. Studies that have larger sample in comparison to smaller samples have greater statistical power and reduced measurement error; of course, larger samples are more costly to collect than smaller, (Friis & Sellers, 2014, p. 403). This study has over 3,000 patients enrolled, though it is reported that there was a 10 percent rate of loss to followup per year. Which is the third issue. Noncompliance is a factor in experimental studies that can potentially nullify the effects of the intervention. The team did assess for adherence to medication compliance with pill counts and structured interviews. They also tried to mitigate adverse side effects of metformin by titrating the dose at a slower rate or decreasing the dose. Risk For Major Adverse Cardiac Events In Select Surgical Patients Hawn et al. (2013) conducted a retrospective cohort study of patients undergoing noncardiac surgery to determine risk for major adverse cardiac events (MACE) within 30 days after surgery and the relationship to time from stent to surgery with adjustment for stent type, surgical characteristics, cardiac risk factors, and comorbid conditions. The cohort consisted of patients undergoing noncardiac surgery within 24 months following coronary stent placement who had MACE compared to those did not have MACE. This study calculated odds ratios (ORs), which is a little confusing to me because Friis and Sellers (2014) describe ORs for case-control studies, not retrospective cohort studies. However, using ORs in this study makes sense because the researchers are trying to determine the odds of MACE given twelve variables. The study concluded that the top 3 variables that were most strongly associated with MACE were nonelective surgical admission, history of myocardial infarction in the 6 months preceding surgery, and a revised cardiac risk index greater than 2.   I think the challenges in assessing risk include the possibility of confounding variables. The researchers do not make any recommendations for risk reduction due to several limitations of the study. The do, however, acknowledge that the findings are hypothesis generating only and recommended randomized trials be conducted.   1a. What is the prevalence of TB in the community as of Dec 31, 2009? 60/50000, or 12 in 10000 b. What was the incidence of breast cancer in 2009? 5/50000, or 1 in 10000 c. If, of the 500 deaths in 2008, 89 were r/t Cardiovascular disease; what is the CV disease specific mortality? 89/50000, or almost 18 in 10000 d. What was the prevalence of diabetes for 2009? 2100/50000, or 42 in 10000 Calculate the % change in diabetes in Anytown for 2009. 2008 was 2000/5000 = 4%, 2009 was 2100/50000 = 4.2%. Diabetes went up by 0.2%.   What do the data mean? One could likely compare the Anytown data to national incidence/prevalence to get an idea of the towns overall health. One could also look at preceding years data to see if there are trends. The data give no information on adjusted rates, so disparities could be present.   2. What is the relative risk of being diagnosed with lung cancer in Somewhere for individuals who are smokers? 200 smokers/100 nonsmokers = 2:1 Answers Post 1: Diabetes type 2 can be countered in different ways, either the use of drugs such as metformin or changing lifestyles. The study carried out placed a large group of people into three categories: receiving a placebo, a lifestyle change program and the administration of metformin (Umpierrez et al., 2014). Use of placebo is important as a control in determining the effects of the other two approaches. Upon a follow-up, this study concludes that use of lifestyle change and taking metformin are effective in the reduction of type 2 diabetes. According to Dunkley et al., (2014), the lifestyle change program may involve high physical activity and take note of the diet composition to avoid fat accumulation as well as excess blood sugars that might damage glucose receptors and result in type 2 diabetes. Use of metformin (an antidiabetic drug) although also reduces diabetes type 2 incidences, its efficiency is low as compared to lifestyle change program. Post 2: In the retrospective study conducted to determine the major adverse effects in noncardiac surgery, statistical analysis on odds ratio was carried out. This statistical analysis was aimed at determining the relative proportion of the study population who were at risk of developing major adverse cardiac effects (Hawn et al., 2013). It is evident that confounding variables are a barrier to a successful study. The numerous limitations associated with a clinical study may make it difficult to draw meaningful recommendations. Generally, randomized trials generate more meaningful conclusions as opposed to other studies which mostly generate the hypothesis (Pearse et al., 2014). Of great importance is the follow-up period whereby it is necessary to minimize the rate of loss in follow-up. References Dunkley, A. J., Bodicoat, D. H., Greaves, C. J., Russell, C., Yates, T., Davies, M. J., & Khunti, K. (2014). Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations. Diabetes care, 37(4), 922-933. Umpierrez, G., Povedano, S. T., Manghi, F. P., Shurzinske, L., & Pechtner, V. (2014). Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes care, 37(8), 2168-2176. Hawn, M.T., Graham, L.A., Richman, J.S., Itani, K.M., Henderson, W.G., & Maddox, T.M. (2013). Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA, 310(14), 1462-1472. doi: 10.1001/jama.2013.278787. Pearse, R. M., Harrison, D. A., MacDonald, N., Gillies, M. A., Blunt, M., Ackland, G., & Hinds, C. (2014). Effect of a perioperative, cardiac output–guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: A randomized clinical trial and systematic review. Jama, 311(21), 2181-2190.

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