1. ManagerialEpidemiology: What is the cost-effectiveness analysis and what is it used forin healthcare and public health? Provide an example study.

2.Qualitative, Quantitative(Cause-Effect): You are the Chief Operating Officer of a hospital. The HumanResources Director reports to you. Two of your valued Directors have a randomdrug screening for controlled substances with a group of hospital cohorts, andthe result comes up as positive for heroine. Your experience with epidemiologyand your understanding of cause-effect makes you skeptical of these generalscreening results. You request that the specimens be sent out to a specialtylab for confirmatory testing with gas chromatography specific for heroine. Theresults of the confirmatory testing show that both Directors are negative (0mg/dl) for all control substances, including heroine. A further investigationrevealed that both Directors attended a morning meeting the day of the randomtest and had eaten poppy seed muffins. You do research and find that poppy seedmuffins produce a byproduct in the body that mimics opiates/heroine in ascreening.

Discuss why these results occurred ,i.e., the two very different results between a screening, and the confirmatorytest in terms of a) qualitative and b) quantitative testing, c) specificity, d)reliability. 3. ResearchMethods: Why is the randomized clinical trial (RCT) research considered the goldstandard in clinical epidemiology research? What is an IRB and why is itrequirement when performing research with human beings?

4. DecisionMaking: Clinical epidemiology research should be based on empirical evident.Define empirical evidence and what it means in decision making in both privateand public health decision making in regard to interventions, i.e., theimplementation of medical testing, processes or public health programs.

5. RiskFactor Research: Why is the Framingham Heart Study a pivotal research programin healthcare today? What are some of the milestones the study has given toclinical epidemiology?

6.Case 1:Cost-Effectiveness Analysis (CEA): In Wu et al. (2006) researchers performed ananalysis to evaluate the cost-effectiveness of doing stool DNA testing inaddition to other types of traditional screenings, i.e., fecal occult bloodtesting annually, flexible sigmoidoscopy or colonoscopy, every 5 and 10 yearsfor colorectal cancer in countries where colon cancer prevalence is low. Also,evaluated was the cost/benefit of doing no screenings (Wu, 2006).

The subjects were people 50 to 75years of age in Taiwan. The researchers used the annual cost of $13,000 perlife-year saved (which is roughly the per capita GNP of) as the ceiling ratiofor assessing whether DNA testing was cost-effective (Wu, 2006).

Simulated results for screening strategies to prevent Colon Rectal Cancer (CRC)
Variable	Screening Strategy
	No Screening	DNA (3yrs)	DNA (5yrs)	DNA (10yrs)	Occult Blood	Flexible Sigmoid. (5yrs)	Colonoscopy (10 yrs)
a. Total cases of CRC, n	2,917	2,435	2,654	2,710	2,129	2,253	1,780
b. CRC deaths, n	1,729	1,345	1,467	1,574	1,059	1,328	1,077
c. Perforation deaths, n	0	3	2	1	5	3	12
e. Reduction in CRC incidence, %	0	17	9	7	27	23	39
f. Reduction in CRC mortality, %	0	22	15	9	39	23	39
g. Life expectancy, year	15.7337	15.7476	15.7434	15.74	15.7584	15.7477	15.759
h. Total costs, thousand $	22,022	35,637	31,077	26,856	19,824	24,909	21,843
i. Incremental life-year saved, year	0	1,390	970	626	2,464	1,383	2,530
j. Incremental cost, thousand $	0	13,615	9,054	4,834	-2,198	2,887	-180
k. Incremental cost ($)/life-years saved compared with no screening	0	9,794	9,335	7,717	Dominant	2,087	Dominant
* Values obtain from a cohort of 100,000 persons 50 years of age who were followed for 25 years.
The other screening strategy is more effective and less costly than stool DNA testing strategy.
The screening is more effective and less costly than No Screening.
Adapted from: Wu et al. BMC Cancer 2006 6:136 doi:10.1186/1471-2407-6-136

____________ Reference: Wu, Grace HM. Wang, Yi-Ming . Yen, Amy MF. Wong, Jau-Min Lai, Hsin-ChihWarwick, Jane and Chen, Tony HH. (2006) Cost-effectiveness analysis ofcolorectal cancer screening with stool DNA testing in intermediate-incidencecountries. BMC Cancer 2006, 6:136 doi:10.1186/1471-2407-6-136

QUESTIONS: In your own words and 1) From the research results shown in the chart above, which type of screeninghad the highest and which had the lowest reduction in colon-rectal cancermortality? 2) How do you interpret the findings (Conclusion) in regard to the A-K resultsin regard to the cost/effectives of doing DNA-testing at 3 years, 5 years, 10years, or not doing DNA tests at all?

7. Case #2 of 2: Cost/Benefitliterature review for vaginal birth after cesarean (VBAC) A client had a cesarean delivery in a hospital setting for breech presentationwith her first pregnancy. She is pregnant again and after exploring herdelivery options, has decided she wants to attempt a vaginal birth aftercesarean (VBAC). She has had an uncomplicated pregnancy this time and the fetusis not breech. The same OB-GYN will be assisting in her delivery. The OB-GYNperforms a systematic review of the literature to assess the benefits and harmsof VBAC versus repeat cesarean delivery. Part 1 of 2: Researching Empirical Evidence 1. What kinds and sources of data does the OB-GYN need to review in order tomake a rational clinical planning decision?

2. Which types of studies availableon this topic would be the most useful in clinical decision making?

3. What types of studies would youwant to exclude?

4. Why would there be a lack ofrandomized clinical trials (RCTs) available to address this clinical question?

8..NOTE: This is Part 2 of the finalessay question: The last essay question requires you to do a 2x2 table inaddition to calculations. The tables may be done by copying the table from thequestion directly into your answer and then filling the table out. Case: Calculating Odds Ratio In planning for her delivery, the client reads about birthing centers and asksthe midwife if it is safe to have a VBAC in a freestanding birthing center. Themidwife reviews the data from national studies of VBACs in birthing centerscompared to VBACs in hospital settings and obtains the following statistics toaid her in clinical decision making: N= 1913 Birthing Center based VBAC Rates 87% delivered vaginally 24% of women were transferred to the hospital prior to delivery There were 25 women who experienced a serious adverse outcome (of which 6were uterine rupture) There were 7 perinatal deaths (0.5%) There were 15 infants with low apgar scores (below 7) after 5 minutes of life(1.0%)

N= 1913 Hospital based VBAC Rates(Control) 76% delivered vaginally There were 32 women who experienced a serious adverse outcome (of which 15were uterine ruptures) There were 3 perinatal deaths There were 2 infants with low apgar scores (less than 7) after 5 minutes oflife

(Part 2 of 2): Construct thefollowing for 1 and 2 and answer question 3 1. Construct a 2 x 2 table, calculate, and interpret the odds ratio of womenwho suffered a serious adverse outcome from attempting a VBAC delivery in orderto estimate the relative risk to a mother delivering VBAC in midwifery basedfreestanding birthing centers. Cases are those with a serious outcome, controlsare those without. The exposure is treatment in a birthing center. The notexposed group is treatment in a hospital.

Exposure	Cases	Controls
Birthing Center
Hospital

2. Construct a 2 x 2 table,calculate, and interpret the odds ratio of infants who suffered a seriousadverse outcome (including death) from attempting a VBAC delivery in order toestimate the relative risk to an infant delivered VBAC in midwifery based freestanding

Cases	Controls

3. What does the midwife concluderegarding the safety to mother and baby by attempting a VBAC in midwifery basedbirthing centers? What clinically is the best decision for this client and herunborn baby?