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The article "Spray Flu Vaccine May Work Better than Injections for Tots" (San Luis Obispo Tribune, May 2, 2006) described a study that compared flu vaccine administered by injection and flu vaccine administered as a nasal spray. Each of the 8000 children under the age of 5 who participated in the study received both a nasal spray and an injection, but only one was the real vaccine and the other was salt water. At the end of the flu season, it was determined that of the 4000 children receiving the real vaccine by nasal spray, \(3.9 \%\) got the flu. Of the 4000 children receiving the real vaccine by injection, \(8.6 \%\) got the flu. a. Why would the researchers give every child both a nasal spray and an injection? b. Use a \(99 \%\) confidence interval to estimate the difference in the proportion of children who get the flu after being vaccinated with an injection and the proportion of children who get the flu after being vaccinated with the nasal spray. Based on the confidence interval, would you conclude that the proportion of children who get the flu is different for the two vaccination methods? (Hint: See Example \(11.7 .\) )

Short Answer

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The researchers gave every child both a nasal spray and an injection to avoid placebo effect and reduce potential biases. After calculating the proportions, their difference, standard error, and the 99% confidence interval for the difference in proportions, we analyze if the interval contains 0 or not. If it does not contain 0, it means that there is a significant difference between the two vaccination methods at a 99% confidence level. If the confidence interval includes 0, we cannot conclude that there is a difference between the two vaccination methods at a 99% confidence level.

Step by step solution

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a. Understanding the research methodology

The researchers gave every child both a nasal spray and an injection to avoid any placebo effect and make sure that the children (and potentially their parents) would not know which type of vaccination they received. This double-blind procedure helps reduce potential biases in the study results, making the comparison between the two vaccination methods more reliable.
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b.1. Calculating the proportions and their differences

To calculate the difference in the proportion of children who get the flu after being vaccinated with an injection (P1) and the proportion of children who get the flu after being vaccinated with the nasal spray (P2), we first find P1 and P2. For the injection group: Total children = 4000 Children who got flu = \(8.6 \%\) of 4000 = 344 P1 = 344/4000 For the nasal spray group: Total children = 4000 Children who got flu = \(3.9 \%\) of 4000 = 156 P2 = 156/4000 Difference in proportions (P1 - P2): d = P1 - P2
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b.2. Calculating the standard error and confidence interval

We now calculate the standard error (SE) for the difference in proportions using the formula: SE = \(\sqrt{\frac{P1(1 - P1)}{n1} + \frac{P2(1 - P2)}{n2}}\) Where n1 and n2 are the number of children in the injection and nasal spray groups, respectively. Since we have a 99% confidence interval, our critical value (z) will be 2.576. Confidence interval (CI) for the difference in proportions is given by: CI = (d - z * SE, d + z * SE)
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b.3. Analyzing the confidence interval

After calculating the confidence interval for the difference in proportions, we need to analyze if the interval contains 0 or not. If it does not contain 0, it means that there is a significant difference between the two vaccination methods at a 99% confidence level. If the confidence interval includes 0, we cannot conclude that there is a difference between the two vaccination methods at a 99% confidence level.

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Confidence Interval
Confidence intervals are used to estimate a range of values within which we can be reasonably sure that the true parameter of a population lies. In the context of this study, researchers are interested in the difference between two proportions: those who got the flu after receiving the nasal spray versus those who received it after a traditional injection.
The confidence interval provides a way to claim, with a certain level of confidence (in this case 99%), that the actual difference in proportions isn't random, but possibly influenced by the mode of vaccination.
To calculate the confidence interval, we need to know the difference in sample proportions, the standard error, and the critical value matching our desired confidence level. Here, a critical value of 2.576 is used which is standard for a 99% confidence level. The confidence interval is calculated like this:
- Estimate the sample proportions (P1 and P2) - Compute the difference between these proportions - Use the formula: SE = \(\sqrt{\frac{P1(1 - P1)}{n1} + \frac{P2(1 - P2)}{n2}}\) - Finally, the confidence interval is d ± z * SE.
This interval helps assess if there is a statistically significant difference in the effectiveness of the two vaccination methods at reducing flu cases.
Difference in Proportions
Understanding the difference in proportions can shine a light on which flu vaccine method might be more effective for children under five. The basic idea here is to compare how many children got the flu despite being vaccinated with each method.
- For the nasal spray group, only 3.9% of children developed the flu. - However, in the injection group, 8.6% of children caught the flu.
This comparison uses basic probabilities assuming each child has an equal chance of getting the flu, given the vaccination. By calculating the actual difference of these proportions (P1 for injection minus P2 for nasal spray), we can evaluate which method works better.
In this scenario, calculate P1 = 0.086 and P2 = 0.039. Then, the difference is P1 - P2, indicating how much one method might differ from the other in terms of effectiveness. This exploration is foundational in determining which method can be statistically claimed as better.
Research Methodology
Research methodology defines the structured way that research is conducted. In this study, the researchers wanted to ensure unbiased results in comparing the nasal and injection methods of delivering flu vaccines. That's where the careful planning of a double-blind study comes into play:
- **Double-Blind Design:** Each child received both an injection and a nasal spray; however, only one was an actual vaccine, while the other was a placebo of saltwater. Neither the children, nor the parents or researchers, knew which was the real vaccine.
This kind of methodology prevents the placebo effect—where just thinking one has received medication might cause perceived improvements—and keeps everyone's expectations from influencing the results.
By structuring the study in this way, researchers ensured that any differences observed were genuinely due to the type of vaccination given, and not other confounding factors.
Placebo Effect
The placebo effect occurs when individuals experience perceived improvement in symptoms simply because they believe they have received treatment, even if it's inactive. In the study on flu vaccines, understanding and countering the placebo effect was crucial to obtaining valid results.
- **Controlling the Placebo Effect:** By giving every participant both a nasal spray and an injection, and making sure only one was the actual vaccine, researchers controlled for this effect. Participants can't base any expectations on which method they received, leading to unbiased outcomes.
The concept is vital because treatment beliefs can alter behavior and perceptions, inadvertently skewing study results. By using a placebo-controlled design, scientists can ensure that the outcomes accurately reflect the vaccine's efficacy rather than the participants' minds playing tricks.

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Most popular questions from this chapter

Women diagnosed with breast cancer whose tumors have not spread may be faced with a decision between two surgical treatments-mastectomy (removal of the breast) or lumpectomy (only the tumor is removed). In a long-term study of the effectiveness of these two treatments, 701 women with breast cancer were randomly assigned to one of two treatment groups. One group received mastectomies, and the other group received lumpectomies and radiation. Both groups were followed for 20 years after surgery. It was reported that there was no statistically significant difference in the proportion surviving for 20 years for the two treatments (Associated Press, October 17,2002 ). Suppose that this conclusion was based on a \(90 \%\) confidence interval for the difference in treatment proportions. Which of the following three statements is correct? Explain why you chose this statement. Statement 1: Both endpoints of the confidence interval were negative. Statement 2: The confidence interval included \(0 .\) Statement 3: Both endpoints of the confidence interval were positive.

Researchers carried out an experiment to evaluate the effectiveness of using acupuncture to treat heel pain. The experiment is described in the paper "Effectiveness of Trigger Point Dry Needling for Plantar Heel Pain: A Randomized Controlled Trial" (Physical Therapy [2014]: \(1083-1094\) ) and a follow-up response to a letter to the editor of the journal (Physical Therapy [2014]: \(1354-1355)\). In this experiment, 84 patients experiencing heel pain were randomly assigned to one of two groups. One group received acupuncture and the other group received a sham treatment that consisted of using a blunt needle that did not penetrate the skin. Of the 43 patients in the sham treatment group, 17 reported pain reduction of more than 13 points on a foot pain scale (this was considered a meaningful reduction in pain). Of the 41 patients in the acupuncture group, 28 reported pain reduction of more than 13 points on the foot pain scale. a. Use a \(95 \%\) confidence interval to estimate the difference in the proportion who experience a meaningful pain reduction for the acupuncture treatment and for the sham treatment. b. What does the interval in Part (b) suggest about the effectiveness of acupuncture in reducing heel pain?

The Insurance Institute for Highway Safety issued a news release titled "Teen Drivers Often Ignoring Bans on Using Cell Phones" (June 9,2008 ). The following quote is from the news release: Just \(1-2\) months prior to the ban's Dec. \(1,2006,\) start, \(11 \%\) of teen drivers were observed using cell phones as they left school in the afternoon. About 5 months after the ban took effect, \(12 \%\) of teen drivers were observed using cell phones. Suppose that the two samples of teen drivers (before the ban, after the ban) are representative of these populations of teen drivers. Suppose also that 200 teen drivers were observed before the ban (so \(n_{1}=200\) and \(\hat{p}_{1}=0.11\) ) and that 150 teen drivers were observed after the ban. a. Construct and interpret a \(95 \%\) large-sample confidence interval for the difference in the proportion using a cell phone while driving before the ban and the proportion after the ban. b. Is 0 included in the confidence interval of Part (a)? What does this imply about the difference in the population proportions?

The Bureau of Labor Statistics report referenced in the previous exercise also reported that \(7.3 \%\) of high school graduates were unemployed in October 2013 and \(5.7 \%\) of high school graduates were unemployed in October \(2014 .\) Suppose that the reported percentages were based on independently selected representative samples of 400 high school graduates in each of these 2 years. a. Construct and interpret a 99\% large-sample confidence interval for the difference in the proportions of high school graduates who were unemployed in these 2 years. b. Is the confidence interval from Part (a) wider or narrower than the confidence interval calculated in the previous exercise? Give two reasons why it is wider or narrower.

A hotel chain is interested in evaluating reservation processes. Guests can reserve a room by using either a telephone system or an online system that is accessed through the hotel's web site. Independent random samples of 80 guests who reserved a room by phone and 60 guests who reserved a room online were selected. Of those who reserved by phone, 57 reported that they were satisfied with the reservation process. Of those who reserved online, 50 reported that they were satisfied. Based on these data, is it reasonable to conclude that the proportion who are satisfied is greater for those who reserve a room online? Test the appropriate hypotheses using a significance level of \(0.05 .\) (Hint: See Example \(11.4 .)\)

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