Key

The 2nd Hourly

Math 1107

Spring Semester 2010

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. Write on one side only 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 | Descriptive Statistics | 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 two numbers: the systolic blood pressure (SBP) reading, representing the maximum pressure exerted when the heart contracts and the diastolic blood pressure (DBP) reading, representing the pressure in the arteries when the heart is at rest.

Consider the systolic to diastolic blood pressure ratio R = SBP/DBP. 

A sample of FHS adult subjects yields the following ratios:

1.86        1.71        1.43        1.82        1.62        1.57        1.53        1.42        1.55        1.75        1.95        1.58

2.33        1.69        1.56        1.85        1.51        1.50        1.72        1.50        2.06        1.36        1.78        1.56

1.62        1.75        1.78        1.52        1.83        1.60        1.54        1.80        2.13        1.67        1.86        1.60

1.48        1.47        1.45        1.44        1.50        2.05        1.50        1.79        1.82        1.59        1.74        1.86

1.64        1.54        2.03        1.91        1.92        1.97        1.54        1.67        2.00        1.63        1.82        1.49

 

Compute and interpret the following statistics: sample size, p00, p25, p50, p75, p100, (p100 – p25), (p75 – p25), (p50 – p25). 

 

 

 

n=60

minimum = qo = p0 = 1.36

lower quartile = q1= p25 = 1.5375

median = q2 = p50 = 1.655

upper quartile = q3 = p75 = 1.8225

maximum = q4= p100 = 2.33

 

There are 60 Framingham Heart Study (FHS) subjects in our sample.

The FHS subject  in our sample with the lowest ratio has a ratio of 1.36 for systolic versus diastolic blood pressure.

Approximately 25% of the FHS subjects in our sample have systolic versus diastolic blood pressure ratios (DtSBPRs) of 1.5375 or less.

Approximately 50% of the FHS subjects in our sample have systolic versus diastolic blood pressure ratios of 1.655 or less.

Approximately 75% of the FHS subjects in our sample have systolic versus diastolic blood pressure ratios of 1.8225 or less.

The FHS subject  in our sample with the highest ratio has a ratio of 2.33 for systolic  versus diastolic blood pressure.

 

Range41 = Q4 – Q1 = P100 – P25 = 2.33 – 1.5375 = .7925

Approximately 75% of the FHS subjects in our sample present systolic versus diastolic BP ratios (StDBPR) between 1.5375 and 2.33. The largest possible difference in the StDBPR between any pair of FHS subjects in this upper Ύ sample is 0.7925  

 

Range31 = Q3 – Q1 = P75 – P25 = 1.8225 – 1.5375 = .285

Approximately 50% of the FHS subjects in our sample present systolic versus diastolic BP ratios (StDBPR) between 1.5375 and 1.8225. The largest possible difference in the StDBPR between any pair of FHS subjects in this middle half sample is 0.285.

 

Range21 = Q2 – Q1 = P50 – P25 = 1.655 – 1.5375 = .1175

Approximately 25% of the FHS subjects in our sample present systolic versus diastolic BP ratios (StDBPR) between 1.5375 and 1.655. The largest possible difference in the StDBPR between any pair of FHS subjects in this lower middle quarter sample is 0.1175.

 

 

 

 

 

 

Case Two | Summary Intervals | Fictitious Spotted Toad

The Fictitious Spotted Toad is a native species of Toad Island, and is noteworthy for the both the quantity and quality of its spots. Consider a random sample of toads, in which the number of spots per toad is noted:

 

9, 10, 10, 10, 11, 12, 12, 12, 12, 13, 15, 16, 17, 18, 18, 18, 18, 19, 19, 20, 20, 21, 22, 22, 23

24, 24, 25, 25, 26, 29, 29, 29, 31, 31, 33, 33, 33, 33, 33, 34, 39, 40, 40, 40, 43, 43, 45, 47, 47

50, 56, 56, 56, 60, 63, 65, 66, 67, 98

Let m denote the sample mean spot count, and sd the sample standard deviation. Compute and interpret the intervals m±2sd and m±3sd, using Tchebysheff’s Inequalities and the Empirical Rule. Be specific and complete. Show your work, and discuss completely for full credit.

 

 

 

 

lower2 = m – 2*se =  31.5 –  2*18.39998 » - 5.2999 [0]  

upper2 = m + 2*se =  31.5 +  2*18.39998 » 68.2999[68]

 

lower3 = m – 3*se =  31.5 –  3*18.39998 » -23.6999 [0]

upper3 = m + 3*se =  31.5 +  3*18.39998 » 86.6999[86]

 

At least 75% of the spotted toads in the sample have between 0 and 68 spots

At least 89% of the spotted toads in the sample have between 0 and 86 spots

 

If the Fictitious Spotted Toad spot counts cluster symmetrically around a central value, becoming rare as the distance from the center increases, then:

 

Approximately 95% of the spotted toads in the sample have between 0 and 68 spots

Approximately 100% of the spotted toads in the sample have between 0 and 86 spots

 

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.

 

3.1)   In a comparative clinical trial, treatment methods are compared in the treatment of Condition Z, which when left untreated leads to severe complications and possibly death. A standard treatment is available. Suppose we have a new candidate treatment, and further suppose that a basic clinical trial is proposed to evaluate this new candidate treatment.

 

The proposed placebo group is inappropriate – a standard treatment is available, and should be use d as the basis for comparison.

 

3.2) 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.

 

The subjects are denied informed consent – they are not aware that they are participating in a clinical trial.

If there is an available standard of care, then the placebo group is not appropriate.

 

3.3) A survey of parents and legal guardians of US high school students is used to study the sexual habits, knowledge and attitudes of US high school students. An appropriate random sample is used, and there are no problems with the wording and delivery of the survey instrument.

 

Use of proxy respondents in a survey may be misleading, especially in the study of sensitive topics. Survey the students directly, not the parents.

 

3.4) The objective of a sample survey is to study the attitudes of urban residents of the United States regarding federal programs, taxation and spending. A random sample of urban business owners is employed in this design. Assume that there are no problems with the wording and delivery of the survey instrument.

The survey excludes urban residents who do not own urban businesses, and includes urban business owners who are not urban residents. Directly survey urban residents, regardless of business ownership status.

 

Case Four | Clinical Trial Sketch | Radiation-related Retinopathy

Melanin is a natural substance that gives color to hair, skin, and the iris of the eye. It is produced by cells in the skin called melanocytes. Melanoma is cancer based on malignancy of the melanocytes. Melanoma is the rarest and most serious of the skin cancers, but melanoma can arise wherever there are melanocytes, including the eye. Choroidal melanoma is the most common primary intraocular tumor in adults. Initially appearing as a small freckle beneath the retina, choroidal melanoma can grow in height and diameter, and may eventually spread to other organs of the body, causing death. Because choroidal melanoma is intraocular (occurring inside the eye) and not usually visible to patients, patients with this disease may not recognize its presence until the tumor grows to a size that impairs vision by obstruction, retinal detachment, hemorrhage, or other complication. Periodic dilated retinal examination is the best means of early detection.

Depending on the nature of the cancer, primary treatment options include removal of the affected eye (enucleation) and radiation therapy (without enucleation). Primary radiation therapy without enucleation preserves the affected eye, however, it is common (30%-40% within five years post-treatment) for patients to experience deterioration in visual acuity due to radiation-related retinopathy (damage to the retina). The retina is the light-sensitive layer of the eye.

Case Four | Clinical Trial Sketch | Radiation-related Retinopathy

Lucentis (ranibizumab) binds to and inhibits the action of vascular endothelial growth factor  A (VEGF-A). VEGF may trigger the growth of new vessels, which may leak blood and fluid into the eye. By blocking VEGF-A in the eye, ranibizumab may prevent and reverse vision loss.

Kenalog (triamcinolone acetonide) is an anti-inflammatory medication. Post-radiation therapy related inflammation may contribute to loss or degradation of visual acuity.

 

Visual Acuity is measured by scoring the patient against the ETDRS eye chart.

 

Preservation or improvement of visual acuity can greatly affect quality of life.

 

Sketch a basic clinical trial evaluating the effect of Lucentis+Kenalog in the treatment of radiation-related retinopathy in patients treated for choroidal melanoma. Make your sketch concise and complete, following the style demonstrated in class, in the sample second hourlies and in case study summaries.

 

We recruit subjects diagnosed with choroidal melanoma who were treated with radiation therapy, but whose eyes were preserved. Those who give informed consent are enrolled in the trial.

 

Enrolled subjects are randomly assigned to either Lucentis and  Kenalog or to PlaceboLucentis and  PlaceboKenalog . Double blinding is employed, so that neither the subjects nor their clinical workers know individual treatment assignments.

 

Treated subjects are the tracked for changes in visual acuity, as assessed against the ETDRS eye chart. They are also tracked for safety and toxicity, including kidney/liver, and for changes in quality of life.

 

Work all four (4) cases.