1.Managerial Epidemiology:
What is the cost-effectiveness analysis and what is it used for in healthcare
and public health? Provide an example study. (Points : 10)

Question
2.2.Qualitative, Quantitative (Cause-Effect): You are the
Chief Operating Officer of a hospital. The Human Resources Director
reports to you. Two of your valued Directors have a random drug
screening for controlled substances with a group of hospital cohorts, and the
result comes up as positive for heroine. Your experience with
epidemiology and your understanding of cause-effect makes you skeptical of
these general screening results. You request that the specimens be sent
out to a specialty lab for confirmatory testing with gas chromatography
specific for heroine. The results of the confirmatory testing show that
both Directors are negative (0 mg/dl) for all control substances, including
heroine. A further investigation revealed that both Directors attended
a morning meeting the day of the random test and had eaten poppy seed
muffins. You do research and find that poppy seed muffins produce a
byproduct in the body that mimics opiates/heroine in a screening.
Homework help – Discuss
why these results occurred , i.e., the two very different results
between a screening, and the confirmatory test in terms of a) qualitative and
b) quantitative testing, c) specificity, d) reliability.
(Points : 10)

Question 3.3.Research
Methods: Why is the randomized clinical trial (RCT) research considered
the “gold standard” in clinical epidemiology research? What is an IRB
and why is it requirement when performing research with human beings? (Points
: 10)

Question 4.4.Decision
Making: Clinical epidemiology research should be based on empirical
evident. Define empirical evidence and what it means in decision making
in both private and public health decision making in regard to interventions,
i.e., the implementation of medical testing, processes or public health
programs. (Points : 10)

Question 5.5.Risk
Factor Research: Why is the Framingham Heart Study a pivotal research
program in healthcare today? What are some of the milestones the study
has given to clinical epidemiology? (Points : 10)

Question
6.6.Case 1 of 2 (50 Pts): Cost-Effectiveness Analysis
(CEA): In Wu et al. (2006) researchers performed an analysis to
evaluate the cost-effectiveness of doing stool DNA testing in addition to
other types of traditional screenings, i.e., fecal occult blood testing
annually, flexible sigmoidoscopy or colonoscopy, every 5 and 10 years for
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 75 years of age in Taiwan. The researchers
used the annual cost of $13,000 per life-year saved (which is roughly the per
capita GNP of) as the ceiling ratio for 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-Chih Warwick, Jane and Chen, Tony HH. (2006) Cost-effectiveness
analysis of colorectal cancer screening with stool DNA testing in
intermediate-incidence countries. 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
screening had the highest and which had the lowest reduction in colon-rectal
cancer mortality?

2) How do you interpret the findings (Conclusion) in regard to the A-K
results in regard to the cost/effectives of doing DNA-testing at 3 years, 5
years, 10 years, or not doing DNA tests at all?

(Points : 50)

Question
7.7.NOTE: Essay Question is in 2 parts. This is Part
1 to be completed and then go , to Part 2 and complete
it.

Case #2 of 2: (50 pts) Cost/Benefit literature review for vaginal birth
after cesarean (VBAC)

A client had a cesarean delivery in a hospital setting for breech
presentation with her first pregnancy. She is pregnant again and after
exploring her delivery options, has decided she wants to attempt a vaginal
birth after cesarean (VBAC). She has had an uncomplicated pregnancy this time
and the fetus is not breech. The same OB-GYN will be assisting in her
delivery. The OB-GYN performs a systematic review of the literature to assess
the benefits and harms of 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 to make a rational clinical planning decision?
2.
Which types of studies available on this topic would be the most useful
in clinical decision making?
3.
What types of studies would you want to exclude?
4.
Why would there be a lack of randomized clinical trials (RCT’s)
available to address this clinical question?

(Points : 20)

Question 8.8.NOTE:
This is Part 2 of the final essay question: The last essay
question requires you to do a 2×2 table in addition
to calculations. The tables may be done by copying the table
from the question 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
asks the midwife if it is safe to have a VBAC in a freestanding birthing
center. The midwife reviews the data from national studies of VBACs in
birthing centers compared to VBACs in hospital settings and obtains the
following statistics to aid 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 6
were 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 15
were uterine ruptures)
• There were 3 perinatal deaths
• There were 2 infants with low apgar scores (less than 7) after 5 minutes of
life
(Part 2
of 2): Construct the following for 1 and 2 and answer question 3

1. Construct a 2 x 2 table, calculate, and interpret the odds ratio of
women who suffered a serious adverse outcome from attempting a VBAC delivery
in order to estimate the relative risk to a mother delivering VBAC in
midwifery based freestanding birthing centers. Cases are those with a serious
outcome, controls are those without. The exposure is treatment in a birthing
center. The not exposed 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 serious adverse outcome (including death) from attempting a VBAC
delivery in order to estimate the relative risk to an infant delivered VBAC
in midwifery based freestanding

Cases

Controls

3. What
does the midwife conclude regarding the safety to mother and baby by
attempting a VBAC in midwifery based birthing centers? What clinically is the
best decision for this client and her unborn baby?

(Points : 30)

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