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

Question 2. Question
:
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.

Question 3. Question
:
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?

Question 4. Question
:
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.

Question 5. Question
:
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?

Question 6. Question
:
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?

Question 7. Question
:
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?

Question 8. Question
:
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?

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