EXHIBIT 2 Catching a Breath Stopping Sleep Apnea Title: Author: Source: Statistical versus Clinical Significance: They Are Not the Same The Skeptical Scalpel Skeptical Scalpel, August 8, 2011, http://skepticalscalpel.blogspot.com/2011/08/ statistical-vs-clinical-significance.html In reference to an article that appeared on MedPage Today, August 5th, 2011 ("Compression Stocking Help Sleep Apnea," by Michael Smith), the Skeptical Scalpel writes: MedPage Today featured an article about the beneficial effects of daytime wearing of compression stockings on obstructive sleep apnea. The premise was that increased edema in the neck could be caused by fluid coming from the legs when patients were in the supine position at night. Twelve patients who served as their own controls wore compression stockings for a week and then no stockings for a week alternating. The stockings lowered the amount of fluid in the neck by 60%, a statistically significant difference. So far, so good. This resulted in another highly statistically significant finding, which was a 36% reduction in episodes of apnea (cessation of breathing] and hypopnea [inadequate breathing]. Sounds good, right? The problem is that the average number of episodes of apnea/hypopnea decreased from 48 per hour to 31 per hour. Patients experiencing more than 30 episodes of apnea/hypopnea per hour are classified as having severe obstructive sleep apnea. This means that the treatment only put the patients in the low range of severe obstructive sleep apnea. They still would require maximum therapy. Is a reduction in apnea/hypopnea episodes that does not move the patient out of the severe category really clinically significant? It does not seem so to me. Questions 1. Define the parameters of interest and state the null and alternative hypothesis.

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5.5

BEYOND THE NUMBERS 5.5
Practical Significance versus
Statistical Significance
Name:
To be groded, all assignments must be completed and submitted on the original book page.
EXHIBIT 1
Effect Size Matters
From Time Health
Women in the flibanserin group self-reported an average of
2.8 sexually satisfying events in the four-week baseline period.
In the final four weeks of the 24-week study period, those
women reported an average of 4.5 sexually satisfying events,
a more than 50% increase. Women in the placebo group
reported an average increase from 2.7 events to 3.7. The
difference in effect between flibanserin and the placebo-
about 0.8 sexually satisfying events-was statistically
significant, the drug company said. The side effects
from the drug, which included dizziness and fatigue,
among others, were mild to moderate and transient.
Read more: http://www.time.com/time/health/
Section Number:
article/0,8599,1939884,00.html
Questions
1. Explain where the "about 0.8 sexually satisfying events" statement comes from.
2. Read the description of the study carefully. What was the difference in effect between flibanserin
and the placebo on an average weekly basis? Was the difference impressively large? Explain.
Transcribed Image Text:BEYOND THE NUMBERS 5.5 Practical Significance versus Statistical Significance Name: To be groded, all assignments must be completed and submitted on the original book page. EXHIBIT 1 Effect Size Matters From Time Health Women in the flibanserin group self-reported an average of 2.8 sexually satisfying events in the four-week baseline period. In the final four weeks of the 24-week study period, those women reported an average of 4.5 sexually satisfying events, a more than 50% increase. Women in the placebo group reported an average increase from 2.7 events to 3.7. The difference in effect between flibanserin and the placebo- about 0.8 sexually satisfying events-was statistically significant, the drug company said. The side effects from the drug, which included dizziness and fatigue, among others, were mild to moderate and transient. Read more: http://www.time.com/time/health/ Section Number: article/0,8599,1939884,00.html Questions 1. Explain where the "about 0.8 sexually satisfying events" statement comes from. 2. Read the description of the study carefully. What was the difference in effect between flibanserin and the placebo on an average weekly basis? Was the difference impressively large? Explain.
EXHIBIT 2
Catching a Breath
Stopping Sleep Apnea
Title:
Author:
Source:
Statistical versus Clinical Significance: They Are Not the Same
The Skeptical Scalpel
Skeptical Scalpel, August 8, 2011, http://skepticalscalpel.blogspot.com/2011/08/
statistical-vs-clinical-significance.html
In reference to an article that appeared on MedPage Today, August 5th, 2011 ("Compression
Stocking Help Sleep Apnea," by Michael Smith), the Skeptical Scalpel writes:
MedPage Today featured an article about the beneficial effects of daytime wearing of compression
stockings on obstructive sleep apnea. The premise was that increased edema in the neck could be
caused by fluid coming from the legs when patients were in the supine position at night. Twelve
patients who served as their own controls wore compression stockings for a week and then no
stockings for a week alternating. The stockings lowered the amount of fluid in the neck by 60%,
a statistically significant difference. So far, so good.
This resulted in another highly statistically significant finding, which was a 36% reduction in
episodes of apnea (cessation of breathing] and hypopnea [inadequate breathing]. Sounds
good, right? The problem is that the average number of episodes of apnea/hypopnea
decreased from 48 per hour to 31 per hour. Patients experiencing more than 30
episodes of apnea/hypopnea per hour are classified as having severe obstructive
sleep apnea. This means that the treatment only put the patients in the low range
of severe obstructive sleep apnea. They still would require maximum therapy. Is
a reduction in apnea/hypopnea episodes that does not move the patient out
of the severe category really clinically significant? It does not seem so to me.
Questions
1. Define the parameters of interest and state the null and alternative hypothesis.
2. The Skeptical Scalpel is making a point about practical significance. What is that point?
Do you agree?
Transcribed Image Text:EXHIBIT 2 Catching a Breath Stopping Sleep Apnea Title: Author: Source: Statistical versus Clinical Significance: They Are Not the Same The Skeptical Scalpel Skeptical Scalpel, August 8, 2011, http://skepticalscalpel.blogspot.com/2011/08/ statistical-vs-clinical-significance.html In reference to an article that appeared on MedPage Today, August 5th, 2011 ("Compression Stocking Help Sleep Apnea," by Michael Smith), the Skeptical Scalpel writes: MedPage Today featured an article about the beneficial effects of daytime wearing of compression stockings on obstructive sleep apnea. The premise was that increased edema in the neck could be caused by fluid coming from the legs when patients were in the supine position at night. Twelve patients who served as their own controls wore compression stockings for a week and then no stockings for a week alternating. The stockings lowered the amount of fluid in the neck by 60%, a statistically significant difference. So far, so good. This resulted in another highly statistically significant finding, which was a 36% reduction in episodes of apnea (cessation of breathing] and hypopnea [inadequate breathing]. Sounds good, right? The problem is that the average number of episodes of apnea/hypopnea decreased from 48 per hour to 31 per hour. Patients experiencing more than 30 episodes of apnea/hypopnea per hour are classified as having severe obstructive sleep apnea. This means that the treatment only put the patients in the low range of severe obstructive sleep apnea. They still would require maximum therapy. Is a reduction in apnea/hypopnea episodes that does not move the patient out of the severe category really clinically significant? It does not seem so to me. Questions 1. Define the parameters of interest and state the null and alternative hypothesis. 2. The Skeptical Scalpel is making a point about practical significance. What is that point? Do you agree?
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