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Artery Disease. An article in the New England Journal of Medicine describes a randomized controlled trial that compared the effects of using a balloon with a special coating in angioplasty (the repair of blood vessels) compared with a standard balloon. According to the article, the study was designed to have power \(90 \%\), with a two-sided Type I error of \(0.05\), to detect a clinically important difference of approximately 17 percentage points in the presence of certain lesions 12 months after surgery. 14 a. What fixed significance level was used in calculating the power? b. Explain to someone who knows no statistics why power \(90 \%\) means that the experiment would probably have been significant if there had been a difference between the use of the balloon with a special coating and the use of the standard balloon.

Short Answer

Expert verified
a. 0.05; b. A 90% power means a high probability of detecting a true difference, suggesting significance is probable if a real difference exists.

Step by step solution

01

Understanding Significance Level

The significance level of a test, often denoted by \( \alpha \), is the probability of rejecting the null hypothesis when it is actually true. In this exercise, it's given directly in the problem: a two-sided Type I error of 0.05. This means \( \alpha = 0.05 \), which is the fixed significance level.
02

Explain Power Concept

Statistical power is the probability that a test will correctly reject a false null hypothesis. A power of 90% means that if there is a true effect or significant difference, there is a 90% chance that the test will detect it.
03

Relating Power to Experiment Outcome

The high power of 90% in the experiment implies that if there truly is a difference between the use of the balloon with a special coating and the standard balloon, the experiment is very likely to detect this difference. This doesn't guarantee significance, but it gives high confidence that the experiment is well-designed to find significant results if they exist.

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Key Concepts

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

Significance Level
In statistical tests, the significance level, often denoted by the Greek letter \( \alpha \), is a crucial concept. It represents the threshold at which we decide whether to reject the null hypothesis. In simple terms, it's the probability of making a "Type I error," which is rejecting the truth when it shouldn't be rejected. In the context of the angioplasty study, the significance level is set at 0.05, or 5%. This implies there is a 5% risk of concluding that the use of the balloon with special coating is different when it actually isn't.

The significance level is important because it sets the standard for how sure we need to be before declaring a result "statistically significant." This level is chosen based on how much risk the researchers are willing to accept of making a misstep in claiming a difference that’s not truly there.
Type I Error
A Type I error occurs when the null hypothesis is incorrectly rejected. Imagine you think there's a difference when, in fact, there isn’t one—this is a Type I error. In medical studies, this can mean concluding a treatment is effective when it’s not.

In the angioplasty study, there’s a Type I error probability of 0.05. This means there is a 5% chance of wrongly claiming that the special balloon is better than the standard balloon when it really isn't. Avoiding this error is crucial, as false positives can lead to wrong conclusions, unnecessary treatments, and wasted resources.

Researchers carefully choose the Type I error rate to balance the risk of false findings with the ability to detect true differences effectively in their studies.
Randomized Controlled Trial
A Randomized Controlled Trial (RCT) is a gold standard method in clinical research. It involves randomly assigning participants into different groups to compare treatment effects. In the case of the angioplasty study, participants were divided into groups where one received the balloon with special coating and the other received a standard balloon.

The heart of an RCT is randomization, which ensures each participant has an equal chance of being allocated to any of the groups. This minimizes bias and confounding factors, ensuring that the differences observed between groups are likely due to the intervention itself rather than external influences.

RCTs are known for their ability to demonstrate causality in medical research, providing strong evidence on the effectiveness and safety of treatments. They help ensure that any effect attributed to an intervention is indeed due to that intervention, rather than chance or external factors.
Angioplasty Study
The angioplasty study involved the comparison of two types of balloons used in procedures for repairing blood vessels that are affected by artery disease. The study aimed to assess whether a balloon with a special coating was more effective than a standard balloon.

Such studies are vital in the world of medical research as they help improve treatment methods and patient outcomes. Considering its significance level and statistical power, the study was carefully designed to identify any meaningful differences between the interventions. It considered variables affecting artery disease repair, ensuring robust and reliable conclusions could be drawn.

This specific research had a statistical power of 90%, meaning if a difference truly exists between the two types of balloons, the study had a 90% chance of detecting it. This high power level speaks to the study's design robustness, aiming to uncover any substantial differences to guide future medical practice.

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Most popular questions from this chapter

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What Is Power? The Trial Urban District Assessment (TUDA) measures educational progress within participating large urban districts. TUDA gives a reading test scored from 0 to 500 . A score of 208 is a "basic" reading level for fourthgraders. I Suppose scores on the TUDA reading test for fourthgraders in your district follow a Normal distribution with standard deviation \(\sigma=40\). In 2019 the mean score for fourthgraders in your district was 219 . You plan to give the reading test to a random sample of 25 fourth-graders in your district this year to test whether the mean score \(\mu\) for all fourthgraders in your district is still above the basic level. You will therefore test $$ \begin{aligned} &H_{0}: \mu=208 \\ &H_{a}: \mu>208 \end{aligned} $$ If the true mean score is again 219, on average, students are performing above the basic level. You learn that the power of your test at the \(5 \%\) significance level against the alternative \(\mu=219\) is \(0.394 .\) a. Explain in simple language what "power \(=0.394\) " means. b. Explain why the test you plan will not adequately protect you against incorrectly deciding that average reading scores in your district are not above basic level.

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