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For some time there has been debate about whether regular large doses of vitamin \(\mathrm{C}\) reduce the chance of getting a common cold. a. Explain how you could design an experiment to test this. Describe all parts of the experiment, including (i) what the treatments are, (ii) how you assign subjects to the treatments, and (iii) how you could make the study double-blind. b. An observational study indicates that people who take vitamin C regularly get fewer colds, on the average. Explain why these results could be misleading.

Short Answer

Expert verified
Conduct a double-blind controlled experiment with vitamin C and placebo groups. Observational studies might be misleading due to confounding variables.

Step by step solution

01

Defining the Treatments

The treatments in this experiment involve two groups. Group A will receive regular large doses of vitamin C, while Group B will receive a placebo. This distinction allows us to assess the potential effects of vitamin C on the incidence of the common cold.
02

Assigning Subjects to Treatments

Subjects should be randomly assigned to either Group A or Group B to eliminate bias. A random number generator could be used to ensure each participant has an equal chance of being placed in either the vitamin C group or the placebo group.
03

Ensuring a Double-Blind Experiment

To make the study double-blind, neither the participants nor the researchers administering the treatments should know who belongs to which group. This can be achieved by using identical-looking pills for both vitamin C and placebo treatments and by coding the treatments with identifiers unknown to both the subjects and the administering researchers.
04

Collection of Data

Throughout the experiment, systematically collect data on the number of colds each participant reports. This data will provide a basis for comparing the cold incidences between the two groups.
05

Analyzing Experimental Results

After collecting the data, perform statistical analyses, such as chi-square or t-tests, to determine if there is a significant difference in cold incidence between the vitamin C and placebo groups.
06

Understanding Observational Study Pitfalls

Observational studies can be misleading because they do not conclusively show causation. Correlation might arise from confounding variables, such as individuals who take vitamin C may also lead healthier lifestyles or have better health awareness, which could reduce cold incidence independently of vitamin C intake.

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Key Concepts

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

Double-Blind Study
A double-blind study is a powerful experimental design method used in clinical trials to eliminate bias. In a double-blind setup, neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo. This helps ensure that the results are due to the treatment itself and not influenced by participants' or administrators’ expectations.

To achieve a double-blind study, both treatment and placebo must be indistinguishable. For instance, in a vitamin C study, identical-looking pills should be given to both groups, coded in a way that neither participants nor researchers can identify which one is vitamin C. By doing so, it eliminates the potential for bias that could arise if participants or researchers behaved differently knowing who is receiving which treatment.

Double-blind studies are crucial in validating the effectiveness of a treatment as they reduce placebo effects and conscious or unconscious biases, thereby providing more reliable and scientifically sound results.
Random Assignment
Random assignment is a key component in experimental design that contributes to the overall validity of a study’s findings. In random assignment, each participant has an equal chance of being placed into the treatment or placebo group. This randomness helps ensure that any differences observed between groups are a result of the treatment itself rather than pre-existing differences between participants.

In our scenario, suppose we have two groups: one receiving vitamin C and the other receiving a placebo. By using a random number generator to assign participants to these groups, we mitigate the risk of selection bias and confounding variables.

Random assignment ensures that other factors likely to affect the outcome are distributed evenly across the groups. This results in higher confidence that any observed effects on the common cold incidence are due to the vitamin C treatment, thereby strengthening the arguments for or against its efficacy.
Observational Study Challenges
While observational studies can provide valuable insights, they have inherent limitations, especially in proving causation. In our scenario, an observational study might suggest a link between regular vitamin C intake and reduced instances of the common cold. However, these results can be misleading due to the presence of confounding variables.

Confounding variables are external factors that influence the variables being studied. For example, individuals who take vitamin C regularly might also engage in other health-promoting behaviors, such as eating healthily or exercising regularly, which can independently reduce cold incidence. These lifestyle factors could confound the results, creating the illusion that vitamin C alone is responsible for the reduced cold incidence when, in reality, it could be a combination of various health behaviors.

To accurately establish causation, it is essential to conduct well-designed experiments like double-blind, randomized controlled trials. These address the confounding variables by controlling circumstances and treatments, largely absent in observational studies, leading to more accurate and reliable conclusions.

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Most popular questions from this chapter

Multiple choice: Be skeptical of medical studies? An analysis of published medical studies about heart attacks (Crossen, \(1994,\) p. 168 ) noted that in the studies having randomization and strong controls for bias, the new therapy provided improved treatment \(9 \%\) of the time. In studies without randomization or other controls for bias, the new therapy provided improved treatment \(58 \%\) of the time. a. This result suggests it is better not to use randomization in medical studies because it is harder to show that new ideas are beneficial. b. Some newspaper articles that suggest a particular food, drug, or environmental agent is harmful or beneficial should be viewed skeptically unless we learn more about the statistical design and analysis for the study. c. This result shows the value of case-control studies over randomized studies. d. The randomized studies were poorly conducted, or they would have found the new treatment to be better much more than \(9 \%\) of the time.

There have been anecdotal reports of the ability of duct tape to remove warts. In an experiment conducted at the Madigan Army Medical Center in the state of Washington (Archives of Pediatric and Adolescent Medicine \(2002 ; 156: 971-974)\), 51 patients between the ages of 3 and 22 were randomly assigned to receive either duct-tape therapy (covering the wart with a piece of duct tape) or cryotherapy (freezing a wart by applying a quick, narrow blast of liquid nitrogen). After two months, the percentage successfully treated was \(85 \%\) in the duct tape group and \(60 \%\) in the cryotherapy group. a. Identify the response variable, the explanatory variable, the experimental units, and the treatments. b. Describe the steps of how you could randomize in assigning the 51 patients to the treatment groups.

The journal Energy Policy ( 2014,\(65: 57-67)\) presents a survey of opinions about fracking. Hydraulic fracturing, or fracking, is the process of drilling through rock and injecting a pressurized mixture of sand, water, and chemicals that fractures the rock and releases oil and gas. There has been much debate in the media about its impact on the environment, on land owners, and on the economy. The survey involved contacting a nationally representative sample of 1960 adults in 2012 . Of the 1960 people contacted, 1061 adults responded to the survey. The study reported that those more familiar with fracking, women, and those holding egalitarian worldviews were more likely to oppose fracking. a. Describe the population of interest for this study. b. Explain why a census is not practical for this study. What advantages does sampling offer? c. Explain how nonresponse bias might be an issue in this study.

A study published in 2010 in the New England Journal of Medicine discusses a breast-cancer screening program that began in Norway in 1996 and was expanded geographically through \(2005 .\) Women in the study were offered mammography screening every two years. The goal of the study was to compare incidence- based rates of death from breast cancer across four groups: 1\. Women who from 1996 through 2005 were living in countries with screening. 2\. Women who from 1996 through 2005 were living in countries without screening. 3\. A historical-comparison group who lived in screening countries from 1986 through 1995 . 4\. A historical-comparison group who lived in nonscreening countries from 1986 through \(1995 .\) Data were analyzed for 40,075 women. Rates of death were reduced in the screening group as compared to the historical screening group and in the nonscreening group as compared to the historical nonscreening group. a. Is this an observational or experimental study? b. Identify the explanatory and response variable(s). c. Does the study prove that being offered mammography screening causes a reduction in death rates associated with breast cancer? Why or why not?

Multiple choice: Effect of response categories \(\quad\) A study (N. Schwarz et al., Public Opinion Quarterly, vol. \(49,1985,\) p. 388 ) asked German adults how many hours a day they spend watching TV on a typical day. When the possible responses were the six categories (up to \(\frac{1}{2}\) hour, \(\frac{1}{2}\) to 1 hour, 1 to \(1 \frac{1}{2}\) hours, \(\ldots,\) more than \(2 \frac{1}{2}\) hours \(), 16 \%\) of respondents said they watched more than \(2 \frac{1}{2}\) hours per day. When the six categories were (up to \(2 \frac{1}{2}\) hours, \(2 \frac{1}{2}\) to 3 hours, ..., more than 4 hours \(), 38 \%\) said they watched more than \(2 \frac{1}{2}\) hours per day. a. The samples could not have been random, or this would not have happened. b. This shows the importance of question design, especially when people may be uncertain what the answer to the question really is. c. This study was an experiment, not an observational study.

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