BIOE 301: Bioengineering and World Health Name:______________________Exam 3: April 19, 2007 Signature:___________________The exam consists of 8 questions and 2 extra credits on 10 pages. Show all work toreceive credit. Clearly organize your work and draw a box around your final answers forcalculations. NEATNESS COUNTS! Good Luck!Problem 1 (14): Problem 2 (12): Problem 3 (15): Problem 4 (13): Problem 5 (10): Problem 6 (10): Problem 7 (12): Problem 8 (14): Extra Credit (2): Total (100):1. Heart disease (14 pts)a. What are four major treatments for ischemic heart disease? (6pts)Drugs to dilate coronary arteriesClot busters to dissolve clots (TPA)Open heart surgery (CABG)Balloon angioplasty (PTCA)Stentsb. Describe the sequence of events and how it gives rise to a heart attack. (8 pts)The coronary artery supplies blood to the heart muscle. The surface of the coronary artery can be damaged (due to high blood pressure, high cholesterol, and smoking). Lipid can build up under the surface of the blood vessel. This begins to narrow the lumenof the blood vessel. If the surface lining the blood vessel breaks open, the substance beneath the surface causes a blood clot to form. The blood clot suddenly blocks off the artery, and no blood flows to the heart muscle. The heart muscle begins to die and a heartattack results.2. Cardiovascular diseases claimed 871,500 of the 2,428,033 American lives in 2004. 147,000 Americans died by CVD are under age 65. 2004 death rates from CVDwere 335.7 for white males and 448.9 for black males; for white females 239.3 and forblack females 331.6. (Death rates are per 100,000 population) From 1994 to 2004, death rates from CVD declined 25 percent. These declines in death from heart diseasehave been attributed percent to smoking cessation, weight loss, or blood-pressure control. (12 pts)a. What percent of all deaths was due to cardiovascular diseases? (2 pts)35.9%b. What is the percentage of Americans who died by CVD are over the age of 65? (2 pts)29.8% (total is 2,428,033)83.1% (total is 871,500)c. What were the death rates for white males, black males, white females and black females in 1994? (4 pts)White males: 447.5Black males: 598.5White females: 319.1Black females: 442.1b. How can smoking cessation, weight loss, or blood-pressure control lead to lowering of death rates? (4 pts)It improves serum cholesterol levels and reduces risk of cardiovascular diseases3. Consider the Acute Respiratory Distress Syndrome Network trial of low versus traditional tidal volume ventilation in patients with acute lung injury and acute respiratorydistress syndrome published in 1996. Mortality rates in the low and traditional volume groups were 31% and 40%, respectively, corresponding to a reduction of 9% in the low volume group. (15 pts)What sample size would be required to detect this difference with 90% power using a cutoff for statistical significance of 0.05? Show calculations for standardized difference and show the line plot on the graph.In this case the standardized difference is given by the following equation:Standardized difference = (p1-p2) / Sqrt[ (1- )],where p1 and p2 are the mortality rates in the two groups and = (p1 + p2)/2 is the mean ofthe two values.Standardized difference = (0.40-0.31) / Sqrt[0.355(1-0.355)] =0.188So, the required sample size, estimated using the nomogram to be approximately 1200 in total (i.e. 600 in each arm). See the following plot.Scale is 14 points. Standardized difference is worth 5 points. Drawing the line correctly based on the standardized difference is worth 6 points. Final answer based on the interaction is worth 4 points.4. Cardiological disease is the number one killer in United States. It's true that U.S. heart disease deaths overall are down. From 1993 to 2003, cardiovascular disease death rates dropped 22.1 percent. But more than 910,000 Americans still die of heart disease annually, according to the American Heart Association. And more than 70 million Americans live every day with some form of heart disease, which can include high blood pressure, cardiovascular disease, stroke, angina (chest pain), heart attack and congenital heart defects. (13 pts)a. Could you draw a schematic plot to illustrate the progression of heart failure? (7 pts)The schematic plot is worth 7 points (5 elements are worth 1 point each. Connections areworth 2 points)b. What are the major treatments of heart failure? (6 pts). The three treatments are worth 6 points. Heart transplant LVAD Artificial heart5. Diffusion of Technology (10 pts)a. What are some considerations that should be made in preventing cultural diffusionlags and making sure that technology is “morally” appropriate? (5 pts) High Blood PressureHigh Cholesterol LevelsAtherosclerosisIschemiaHeart AttackHeart FailureNew technologies should reflect values and goals prior to the development of new technologies and preserve current diversity. In addition, community leaders’ knowledge of technology is critical to diffusion. b. What might be problematic about technology assistance programs created by advanced technological societies in order to "assist" lesser developed societies? (5 pts)Not all countries have equal resources (human and material) andpoorer countries need technologies that create human jobs, not replace human jobs6. Dietary Supplements (10 pts)a. In your own words, describe the current regulatory framework for dietary supplements? (5 pts)A company is responsible for determining that the dietary supplementsit manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. Dietary supplements do notneed approval from FDA before they are marketed. In addition, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label. b. What claims can dietary supplement manufacturers make about their products? What claims are not allowed? (5 pts)They cannot make claims about curing or treating disease, but they can make claims that supplement can affect structure or function of the body.7. Consider a new implantable device that does not have any reasonably similar products already in the market: (12 pts)a. What class of device would the FDA
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