TEAM MEMBERS

 Name: Shae Diaz Name: Kennedy Miskin Name: David Asuncion Name: Sean Smits Name: Carlos Mendez-Arias

Mean and Standard Deviation

AVG for Heart Rate Test

AVG for Temperature test

P Values

P Values for Oral Thermometer v Spree

P Values for Pulse Ox v Spree

Summary of Results (Statistical Analysis)

When looking at all the data for heart rate, we can conclude that there is a large discrepancy between the Pulse Ox (Gold Standard) and the Spree. There is an immediate red flag from the standard deviations alone; a difference of around 25 standard deviations suggests the data isn't very accurate or there were largely significant outliers. Since the p-value>0.05 for both paired and unpaired t-tests, we FAIL TO REJECT the null hypothesis that the Spree is NOT capable of giving as accurate of readings of heart rate as the gold standard. From this we can conclude that we should not believe the Spree is giving reliable readings of heart rate. The R value comparing Pulse Ox and Spree is fairly high at 0.69, and it shows how high variability data with lots of points on the scatter plot can still have a fairly significant trend. This trend suggests correlation, but doesn't necessarily prove causation. Despite this, it is another important piece of information to help understand the comparison between the Pulse Ox and the Spree.
When looking at all the data regarding temperature, we can conclude that the data is fairly similar between the Oral Thermometer (Gold Standard) and the Spree. The standard deviation is below 1, which shows a smaller spread and more concise data. Also, since the p-value<0.05 for both paired and unpaired t-tests, we REJECT the null hypothesis that the Spree is NOT capable of giving as accurate of readings of temperature as the gold standard. Therefore the data is statistically significant and we can conclude the Spree is just as reliable as the Oral Thermometer for testing temperature. Despite the proof of the t-test, the R value is relatively low at 0.19. Part of the reason this could be true is because we are dealing with humans and our anatomy and responses can be unpredictable. As mentioned before though, just because the R value seems to contradict the other data, it merely acts as another means to understanding the correlation between the Oral Thermometer and the Spree.

Design for Our Experiment

Gold Standards:

·Oral medication of Lorazepam
·IV Lorazepam
·Rectal Diazapam

Target sample size: 660, arrived at this number by calculating the current amount of people with epilepsy in the US (3 million) and the confidence level (5%)

To test how fast medication is getting into bloodstream:

1. Compare oral dosage of Lorazepam, IV injection of Lorazepam, rectal Diazepam, and our auto injector (LorazePen)
2. Obtain sample size (approximately 660 people)
• 500 people to be divided into three groups: one receiving IV, rectal, and auto injector (these people are epileptics, ranging from focal to generalized)
• 160 people will receive the oral dosage (these people are not actively seizing, rather they have been prescribed it for anxiety)
3. Set time intervals for which we will take blood samples to measure the concentration of medication inside the bloodstream
• Intervals (min): 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, 240, 360, 480
• 20 total blood draws
• Maximum amount of blood to draw per person: about 3% of their total blood volume
• On average, people have 5 liters3 of blood so the average of blood allowed to draw is .15 liters1
• It takes approximately .003 liters per blood draw to receive an accurate reading 4
• Draw blood every minute for 5 minutes, then every 5 minutes for an hour
• Draw blood once it has been 2 hours for every two hours until total time has reached 8 hours (this will show how long the drug lasts in the bloodstream)

Factors to consider: The average ambulance response time is 6 minutes and 35 seconds, which means that someone who is having a seizure has to wait 6 minutes before paramedics even arrive on the scene to start an IV or other form of treatment.2

To test how quickly seizure dissipates:

1. Compare IV Lorazepam, rectal Diazepam, and our auto injector (LorazePen)
2. Obtain sample size (660 people: all epileptics, ranging from focal to generalized)
• 220 receiving IV Lorazepam
• 220 receiving rectal Diazepam
• 220 receiving auto injector (LorazePen)
3. When someone in this experiment has a seizure, they can only receive the kind of the treatment of their group
• For IV Lorazepam (2 mg/1 mL) 5
• For rectal Diazepam (.2 mg/ 1 kg) 6
• For autoinjector (LorazePen) (2 mg/1 mL) 5
• Same dosage as IV
4. Time how long it takes for someone to stop having a seizure once the treatment has been administered

Factors to consider: The average ambulance response time is 6 minutes and 35 seconds, which means that someone who is having a seizure has to wait 6 minutes before paramedics even arrive on the scene to start an IV or other form of treatment.2

References

1. Dr. Greene, “How Much Blood is too Much Guideline”. https://www.drgreene.com/blood-guideline/
2. DC Fire and EMS Department, “Average Response Time to Emergency Scenes Improves”. https://fems.dc.gov/release
3. Elert, Glenn, “Volume of Blood in a Human”. http://www.webcitation.org/mainframe.php
4. EthnoMed, "How Much Blood is Taken?", https://ethnomed.org/patient-education/blood/how-much-blood-is-taken-spanish-english
5. Medscape, "lorazepam", http://reference.medscape.com/drug/ativan-loraz-lorazepam-342906
6. Medscape, "diazepam", http://reference.medscape.com/drug/valium-diastat-diazepam-342902