Key|The
Second Hourly | Math 1107 | Spring 2009 | CJ Alverson
Protocol
You
will use only the following resources: Your individual calculator; individual
tool-sheet (one (1) 8.5 by 11 inch sheet), writing utensils, blank paper (provided by me) and this copy of the
hourly. Do not share these resources with anyone else. Show complete detail and work for full credit. Follow case study solutions and sample hourly keys in
presenting your solutions. Work all four cases. Using only one side of
the blank sheets provided, present your work. Do not write on both sides of the
sheets provided, and present your work only on these sheets. Do not share
information with any other students during this hourly. When you are finished:
Prepare a Cover Sheet: Print your name on an otherwise blank sheet of paper.
Then stack your stuff as follows: Cover Sheet (Top), Your Work
Sheets, The Test Papers, Your Toolsheet.
Then hand all of this in to me.
Sign and Acknowledge:
I agree to follow this protocol.
________________________________________________________________________
Name
(PRINTED)
Signature
Date
Case One |
Clinical Trial Sketch | Atomoxetine Augmentation
Therapy in Patients With Alzheimer's
Disease
(http://clinicaltrials.gov/ct2/show/NCT00191009?term=alzheimers&rank=2)
Atomoxetine (Strattera) is a norepinephrine
reuptake inhibitors (NRIs),
also known as noradrenaline reuptake inhibitors (NARIs). NARIs are
compounds that elevate the extracellular level of the neurotransmitter norepinephrine in the central nervous system. Norepinephrine acts as a neurotransmitter, affecting
cognitive awareness. Alzheimer’s disease is a form of progressive dementia.Symptoms
include memory loss and other cognitive deficits, advancing to major
personality changes and eventual loss of control over bodily functions. The
hallmark of Alzheimer’s disease is the abnormally rapid and progressive loss of
cognitive function, including memory, language and cognitive awareness. Patients with Alzheimer’s disease are
assessed using the Alzheimer's Disease
Assessment Scale, Clinician's Interview-Based Impression of Change,
Neuropsychiatric Inventory (NPI) and Alzheimer's
Disease Cooperative Study Inventory. Primary
Outcome Measures: To see if Alzheimer's patients receiving a stable dose of
an Alzheimer's drug randomly assigned to atomoxetine
will have cognitive performance improved as measured by the Alzheimer's Disease Assessment Scale – Cognitive. Secondary Outcome Measures: To see if patients taking an
Alzheimer's medication plus atomoxetine will be
superior to an Alzheimer's medication alone as assessed by the Clinician's
Interview-Based Impression of Change (CIBIC+) score. To see if patients taking
an Alzheimer's medication plus atomoxetine will
display less comorbid psychological symptoms, such as
depression, as assessed by the Neuropsychiatric Inventory (NPI). To see if
current Alzheimer's medications plus atomoxetine
compared to Alzheimer's medications plus placebo is better at preserving or
slowing cognitive decline as measured by the Alzheimer's Disease
Cooperative Study Inventory – Activities.To show that
current Alzheimer's drugs can be taken with atomoxetine
without significant side effects.
Sketch a basic
clinical trial for the use of atomoxetine when used in
addition to standard Alzheimer’s disease therapies in treating the progressive
loss of cognitive functions. Make your sketch concise and complete, following
the style demonstrated in class, in the second hourly and in case study
summaries.
We
recruit patients diagnosed with Alzheimer’s disease (AD). Those who are
eligible for the study and who give informed consent (or whose caregivers give
informed consent by proxy) are enrolled in the study.
Enrolled
subjects are randomly assigned to either atomoxetine
+ standard care or to placeboatomoxetine + standard
care. Double blinding is employed, so that neither the patients(nor
their caregivers) nor the clinical
workers know the individual treatment assignments.
Treated
patients are tracked for changes in cognitive performance as assessed by the Alzheimer's
Disease Assessment Scale – Cognitive, and as assessed by the Clinician's
Interview-Based Impression of Change (CIBIC+) score. Treated patients are
tracked for comorbid symptoms, including depression,
as assessed by the Neuropsychiatric Inventory (NPI). Treated patients are
tracked for cognitive decline as measured by the Alzheimer's Disease
Cooperative Study Inventory – Activities. Treated patients are tracked for side
effects and drug toxicity.
Case Two | Descriptive
Statistics | Duchenne Muscular Dystrophy Survival
Time
Duchenne
muscular dystrophy (DMD) is an inherited disorder characterized
by rapidly progressive muscle weakness which starts in the legs and pelvis and
later affects the whole body. Suppose that we follow individuals diagnosed with
DMD from diagnosis until death, noting age at death in months. Consider a random
sample of individuals who were diagnosed with, and died with DMD. Age at
death in months follows below:
34, 50,
75, 80, 85, 97, 100, 112, 120, 123, 127, 143, 150, 156, 161, 169,
173, 177, 179, 184, 185, 186, 189, 190 190, 193, 194,
196, 196, 197, 199, 200, 203, 204, 207, 210, 213, 215, 227, 228 230, 231, 233,
234, 235, 237, 265
Compute
and interpret the following statistics: sample size, p00, p25, p50, p75, p100, (p75 – p25),
(p100 – p25), (p50-p25). Show
complete detail and work for full credit. Follow case study solutions and
sample hourly keys in presenting your solutions.
Numbers
n p00 p25
p50 p75 p100
range41 range31 range21
47 34
143 190 210
265 122 67 47
range41
= p100 – p25 = 265 – 143 = 122
range31
= p75 – p25 = 210 – 143 = 67
range21
= p50– p25 = 190 – 143 = 47
Interpretation
There are 47 patients with Duchenne muscular dystrophy (DMD) in the sample.
The
shortest-lived DMD patient in the sample was aged 34 months at death.
Approximately
25% of the DMD patients in the sample were aged 143 months or less at death.
Approximately
50% of the DMD patients in the sample were aged 190 months or less at death.
Approximately
75% of the DMD patients in the sample were aged 210 months or less at death.
The
longest-lived DMD patient in the sample was aged 265 months at death.
Approximately
75% of the DMD patients in the sample were aged between 143 and 265 months at
death. The largest difference in age at death between any pair of DMD patients
in the upper three-quarter sample is 122 months.
Approximately
50% of the DMD patients in the sample were aged between 143 and 210 months at
death. The largest difference in age at death between any pair of DMD patients
in the middle half sample is 67 months.
Approximately
25% of the DMD patients in the sample were aged between 143 and 190 months at
death. The largest difference in age at death between any pair of DMD patients
in the lower middle quarter sample is 47 months.
Case Three | Design Fault Spot: In each of the following a brief description of a design is presented. Briefly identify faults present in the design. Use the information provided. Be brief and complete.
1. A sample of
college students is needed for a sample survey. The people running the study
decide on the following: they divide the population of colleges and
universities into groups based upon enrollment size and whether the college or
university is private or public; next, they used judgment to select one school
from each group. Then, a random sample of students was selected from each
selected school.
The schools should be
randomly sampled.
2. A sample survey design employs a
random sample of the United Kingdom (England, Wales, Scotland, and Northern
Ireland) adult subjects (18 years or older, non-institutionalized). The
research objective of the survey is to determine attitudes of Irish* subjects
regarding Birth Control. Assume that the Survey Instrument is written properly
and delivered in an unbiased way. * Ireland is split into two
countries: Northern Ireland and Ireland
Respondents from Northern
Ireland are excluded, and non-Irish respondents from the United Kingdom are
included.
3. In a
comparative clinical trial, treatment methods are compared in the treatment of
Condition X, which when left untreated leads to severe complications and
possibly death. A new surgical method is compared to a standard surgical
method. Study physicians classify subjects by the severity of their disease,
and assign only the "moderate" subjects to the new surgical method.
Only the "severe" subjects are assigned to the standard surgical
method. A placebo group is also employed for the “mild” cases.
Treatments must be randomly
assigned.
4.
A clinical trial of a new Hepatitis C treatment is designed as
follows: subjects are screened for Hepatitis C infection. Those who test
positive for Hepatitis C infection are then told of their status, and are
offered treatment for Hepatitis C at no cost, and are given no further
information. Those who accept the free treatment offer are then randomly
assigned to either a Placebo, or to the New Treatment Plan.
Abuse of informed consent;
inappropriate use of placebo, denial of treatment
Case
Four | Summary Intervals | The Framingham
Heart Study
The
objective of the Framingham Heart Study was to identify the common factors or
characteristics that contribute to Cardiovascular disease (CVD) by following
its development over a long period of time (since 1948) in a large group of participants who had not
yet developed overt symptoms of CVD or suffered a heart attack or stroke. Blood
pressure is a measurement of the force applied to the walls of the arteries as
the heart pumps blood through the body. Blood pressure readings are measured
in millimeters of mercury (mm Hg) and usually given as 2 numbers. The top
number is the systolic blood pressure reading. It represents the maximum
pressure exerted when the heart contracts. The bottom
number is the diastolic blood pressure reading. It represents the pressure in
the arteries when the heart is at rest. A
sample of FHS adult subjects yields the following readings: (top/bottom)
124/88, 130/70, 175/75, 136/84, 124/84,
154/90, 160/92, 210/120, 110/75, 166/108, 100/70, 172/110, 160/90, 145/75,
122/84, 162/80, 156/84, 120/65, 130/90, 210/110, 110/68, 160/106, 140/90,
200/100, 165/105, 132/88, 134/84, 120/75, 138/85, 118/86, 152/74, 138/70,
124/74, 122/80, 155/90, 160/100, 294/144, 140/82, 132/86, 120/80, 200/130,
135/75, 140/78, 142/85, 146/94, 185/90, 166/78, 140/80, 120/80, 150/95, 124/75,
150/110, 140/84, 130/82, 130/80, 230/124, 128/72, 220/118, 130/80, 165/95,
208/114, 126/80, 140/90, 166/104, 130/70, 130/80, 120/90
Let m denote the
sample mean, and sd the
sample standard deviation. Compute and interpret the intervals
m ± 2sd and m ±
3sd for diastolic blood pressure (DBP), using Tchebysheff’s Inequalities and the Empirical Rule. Be
specific and complete. Show complete detail and work
for full credit. Follow case study solutions and sample hourly keys in
presenting your solutions.
Numbers
If
you analyze systolic blood pressure(SBP), you’ll get:
n m sd lower2
upper2 lower3 upper3
67 149.4
33.35 82.7 216.1 49.4
249.5
But we
want diastolic blood pressure(DBP):
n m sd lower2
upper2 lower3 upper3
67 88.7
15.96 56.8 120.6 40.8
136.6
Lower2 = m – 2*sd » 88.7 – 2*15.96 » 56.8
Upper2 = m + 2*sd » 88.7 + 2*15.96 » 120.6
Lower3 = m – 3*sd » 88.7 – 3*15.96 » 40.8
Upper3 = m - 3*sd » 88.7 + 3*15.96 » 136.6
There
are 67 Framingham Heart Study (FHS) subjects in the sample.
At
least 75% of the FHS subjects in the sample present diastolic blood pressure(DBP) between 56.8 and 120.6 mmHg.
At
least 89% of the FHS subjects in the sample present diastolic blood pressure(DBP) between 40.8 and 136.6 mmHg.
If
the FHS subjects’ diastolic blood pressures cluster symmetrically around a
central value, becoming rare as the distance from the center increases, then:
approximately 95% of the FHS subjects in
the sample present diastolic blood pressure(DBP) between 56.8 and 120.6 mmHg
and
approximately100%
of the FHS subjects in the sample present diastolic blood pressure(DBP)
between 40.8 and 136.6 mmHg.
Work
all four (4) cases.