how does sample size affect hypothesis testing

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• Indian J Psychol Med
• v.42(1); Jan-Feb 2020

Sample Size and its Importance in Research

Chittaranjan andrade.

Clinical Psychopharmacology Unit, Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India

The sample size for a study needs to be estimated at the time the study is proposed; too large a sample is unnecessary and unethical, and too small a sample is unscientific and also unethical. The necessary sample size can be calculated, using statistical software, based on certain assumptions. If no assumptions can be made, then an arbitrary sample size is set for a pilot study. This article discusses sample size and how it relates to matters such as ethics, statistical power, the primary and secondary hypotheses in a study, and findings from larger vs. smaller samples.

Studies are conducted on samples because it is usually impossible to study the entire population. Conclusions drawn from samples are intended to be generalized to the population, and sometimes to the future as well. The sample must therefore be representative of the population. This is best ensured by the use of proper methods of sampling. The sample must also be adequate in size – in fact, no more and no less.

SAMPLE SIZE AND ETHICS

A sample that is larger than necessary will be better representative of the population and will hence provide more accurate results. However, beyond a certain point, the increase in accuracy will be small and hence not worth the effort and expense involved in recruiting the extra patients. Furthermore, an overly large sample would inconvenience more patients than might be necessary for the study objectives; this is unethical. In contrast, a sample that is smaller than necessary would have insufficient statistical power to answer the primary research question, and a statistically nonsignificant result could merely be because of inadequate sample size (Type 2 or false negative error). Thus, a small sample could result in the patients in the study being inconvenienced with no benefit to future patients or to science. This is also unethical.

In this regard, inconvenience to patients refers to the time that they spend in clinical assessments and to the psychological and physical discomfort that they experience in assessments such as interviews, blood sampling, and other procedures.

ESTIMATING SAMPLE SIZE

So how large should a sample be? In hypothesis testing studies, this is mathematically calculated, conventionally, as the sample size necessary to be 80% certain of identifying a statistically significant outcome should the hypothesis be true for the population, with P for statistical significance set at 0.05. Some investigators power their studies for 90% instead of 80%, and some set the threshold for significance at 0.01 rather than 0.05. Both choices are uncommon because the necessary sample size becomes large, and the study becomes more expensive and more difficult to conduct. Many investigators increase the sample size by 10%, or by whatever proportion they can justify, to compensate for expected dropout, incomplete records, biological specimens that do not meet laboratory requirements for testing, and other study-related problems.

Sample size calculations require assumptions about expected means and standard deviations, or event risks, in different groups; or, upon expected effect sizes. For example, a study may be powered to detect an effect size of 0.5; or a response rate of 60% with drug vs. 40% with placebo.[ 1 ] When no guesstimates or expectations are possible, pilot studies are conducted on a sample that is arbitrary in size but what might be considered reasonable for the field.

The sample size may need to be larger in multicenter studies because of statistical noise (due to variations in patient characteristics, nonspecific treatment characteristics, rating practices, environments, etc. between study centers).[ 2 ] Sample size calculations can be performed manually or using statistical software; online calculators that provide free service can easily be identified by search engines. G*Power is an example of a free, downloadable program for sample size estimation. The manual and tutorial for G*Power can also be downloaded.

PRIMARY AND SECONDARY ANALYSES

The sample size is calculated for the primary hypothesis of the study. What is the difference between the primary hypothesis, primary outcome and primary outcome measure? As an example, the primary outcome may be a reduction in the severity of depression, the primary outcome measure may be the Montgomery-Asberg Depression Rating Scale (MADRS) and the primary hypothesis may be that reduction in MADRS scores is greater with the drug than with placebo. The primary hypothesis is tested in the primary analysis.

Studies almost always have many hypotheses; for example, that the study drug will outperform placebo on measures of depression, suicidality, anxiety, disability and quality of life. The sample size necessary for adequate statistical power to test each of these hypotheses will be different. Because a study can have only one sample size, it can be powered for only one outcome, the primary outcome. Therefore, the study would be either overpowered or underpowered for the other outcomes. These outcomes are therefore called secondary outcomes, and are associated with secondary hypotheses, and are tested in secondary analyses. Secondary analyses are generally considered exploratory because when many hypotheses in a study are each tested at a P < 0.05 level for significance, some may emerge statistically significant by chance (Type 1 or false positive errors).[ 3 ]

INTERPRETING RESULTS

Here is an interesting question. A test of the primary hypothesis yielded a P value of 0.07. Might we conclude that our sample was underpowered for the study and that, had our sample been larger, we would have identified a significant result? No! The reason is that larger samples will more accurately represent the population value, whereas smaller samples could be off the mark in either direction – towards or away from the population value. In this context, readers should also note that no matter how small the P value for an estimate is, the population value of that estimate remains the same.[ 4 ]

On a parting note, it is unlikely that population values will be null. That is, for example, that the response rate to the drug will be exactly the same as that to placebo, or that the correlation between height and age at onset of schizophrenia will be zero. If the sample size is large enough, even such small differences between groups, or trivial correlations, would be detected as being statistically significant. This does not mean that the findings are clinically significant.

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8.8: Effect Size, Sample Size and Power

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• Page ID 29492

• Danielle Navarro
• University of New South Wales

In previous sections, we’ve emphasized the fact that the major design principle behind statistical hypothesis testing is that we try to control our Type I error rate. When we fix \(\alpha\)=.05 we are attempting to ensure that only 5% of true null hypotheses are incorrectly rejected. However, this doesn’t mean that we don’t care about Type II errors. In fact, from the researcher’s perspective, the error of failing to reject the null when it is actually false is an extremely annoying one. With that in mind, a secondary goal of hypothesis testing is to try to minimize \(\beta\), the Type II error rate, although we don’t usually talk in terms of minimizing Type II errors. Instead, we talk about maximizing the power of the test. Since power is defined as 1−\(\beta\), this is the same thing.

The Power Function

Let’s take a moment to think about what a Type II error actually is. A Type II error occurs when the alternative hypothesis is true, but we are nevertheless unable to reject the null hypothesis. Ideally, we’d be able to calculate a single number \(\beta\) that tells us the Type II error rate, in the same way that we can set \(\alpha\)=.05 for the Type I error rate. Unfortunately, this is a lot trickier to do. To see this, notice that in the ESP study the alternative hypothesis actually corresponds to lots of possible values of \(\theta\). In fact, the alternative hypothesis corresponds to every value of \(\theta\) except 0.5. Let’s suppose that the true probability of someone choosing the correct response is 55% (i.e., \(\theta\)=.55). If so, then the true sampling distribution for X is not the same one that the null hypothesis predicts: the most likely value for X is now 55 out of 100. Not only that, the whole sampling distribution has now shifted, as shown in Figure 8.4. The critical regions, of course, do not change: by definition, the critical regions are based on what the null hypothesis predicts. What we’re seeing in this figure is the fact that when the null hypothesis is wrong, a much larger proportion of the sampling distribution falls in the critical region. And of course, that’s what should happen: the probability of rejecting the null hypothesis is larger when the null hypothesis is actually false! However, \(\theta\)=.55 is not the only possibility consistent with the alternative hypothesis. Let’s instead suppose that the true value of \(\theta\) is actually 0.7. What happens to the sampling distribution when this occurs? The answer, shown in Figure 8.5, is that almost the entirety of the sampling distribution has now moved into the critical region. Therefore, if \(\theta\)=0.7 the probability of us correctly rejecting the null hypothesis (i.e., the power of the test) is much larger than if \(\theta\)=0.55. In short, while \(\theta\)=.55 and \(\theta\)=.70 are both part of the alternative hypothesis, the Type II error rate is different.

What all this means is that the power of a test (i.e., 1−\(\beta\)) depends on the true value of \(\theta\). To illustrate this, I’ve calculated the expected probability of rejecting the null hypothesis for all values of \(\theta\), and plotted it in Figure 8.6. This plot describes what is usually called the power function of the test. It’s a nice summary of how good the test is, because it actually tells you the power (1−\(\beta\)) for all possible values of \(\theta\). As you can see, when the true value of \(\theta\) is very close to 0.5, the power of the test drops very sharply, but when it is further away, the power is large.

Effect Size

Since all models are wrong the scientist must be alert to what is importantly wrong. It is inappropriate to be concerned with mice when there are tigers abroad – George Box 1976

The plot shown in Figure 8.6 captures a fairly basic point about hypothesis testing. If the true state of the world is very different from what the null hypothesis predicts, then your power will be very high; but if the true state of the world is similar to the null (but not identical) then the power of the test is going to be very low. Therefore, it’s useful to be able to have some way of quantifying how “similar” the true state of the world is to the null hypothesis. A statistic that does this is called a measure of effect size (e.g., Cohen 1988; Ellis 2010). Effect size is defined slightly differently in different contexts, 165 (and so this section just talks in general terms) but the qualitative idea that it tries to capture is always the same: how big is the difference between the true population parameters, and the parameter values that are assumed by the null hypothesis? In our ESP example, if we let \(\theta\) 0 =0.5 denote the value assumed by the null hypothesis, and let \(\theta\) denote the true value, then a simple measure of effect size could be something like the difference between the true value and null (i.e., \(\theta\)−\(\theta\) 0 ), or possibly just the magnitude of this difference, abs(\(\theta\)−\(\theta\) 0 ).

Why calculate effect size? Let’s assume that you’ve run your experiment, collected the data, and gotten a significant effect when you ran your hypothesis test. Isn’t it enough just to say that you’ve gotten a significant effect? Surely that’s the point of hypothesis testing? Well, sort of. Yes, the point of doing a hypothesis test is to try to demonstrate that the null hypothesis is wrong, but that’s hardly the only thing we’re interested in. If the null hypothesis claimed that \(\theta\)=.5, and we show that it’s wrong, we’ve only really told half of the story. Rejecting the null hypothesis implies that we believe that \(\theta\) ≠ .5, but there’s a big difference between \(\theta\)=.51 and \(\theta\)=.8. If we find that \(\theta\)=.8, then not only have we found that the null hypothesis is wrong, it appears to be very wrong. On the other hand, suppose we’ve successfully rejected the null hypothesis, but it looks like the true value of \(\theta\) is only .51 (this would only be possible with a large study). Sure, the null hypothesis is wrong, but it’s not at all clear that we actually care , because the effect size is so small. In the context of the ESP study we might still care, since any demonstration of real psychic powers would actually be pretty cool 166 , but in other contexts a 1% difference isn’t very interesting, even if it is a real difference. For instance, suppose we’re looking at differences in high school exam scores between males and females, and it turns out that the female scores are 1% higher on average than the males. If I’ve got data from thousands of students, then this difference will almost certainly be statistically significant , but regardless of how small the p -value is it’s just not very interesting. You’d hardly want to go around proclaiming a crisis in boys education on the basis of such a tiny difference, would you? It’s for this reason that it is becoming more standard (slowly, but surely) to report some kind of standard measure of effect size along with the results of the hypothesis test. The hypothesis test itself tells you whether you should believe that the effect you have observed is real (i.e., not just due to chance); the effect size tells you whether or not you should care.

Increasing the Power of Your Study

Not surprisingly, scientists are fairly obsessed with maximizing the power of their experiments. We want our experiments to work, and so we want to maximize the chance of rejecting the null hypothesis if it is false (and of course we usually want to believe that it is false!) As we’ve seen, one factor that influences power is the effect size. So the first thing you can do to increase your power is to increase the effect size. In practice, what this means is that you want to design your study in such a way that the effect size gets magnified. For instance, in the ESP study, we might believe that psychic powers work best in a quiet, darkened room; with fewer distractions to cloud the mind. Therefore we would try to conduct my experiments in just such an environment: if we can strengthen people’s ESP abilities somehow, then the true value of \(\theta\) will go up 167 and therefore my effect size will be larger. In short, clever experimental design is one way to boost power; because it can alter the effect size.

Unfortunately, it’s often the case that even with the best experimental designs, you may have only a small effect. Perhaps, for example, ESP really does exist, but even under the best of conditions, it’s very very weak. Under those circumstances, your best bet for increasing power is to increase the sample size. In general, the more observations that you have available, the more likely it is that you can discriminate between two hypotheses. If we ran my ESP experiment with 10 participants, and 7 of them correctly guessed the color of the hidden card, you wouldn’t be terribly impressed. But if I ran it with 10,000 participants and 7,000 of them got the answer right, you would be much more likely to think I had discovered something. In other words, power increases with the sample size. This is illustrated in Figure 8.7, which shows the power of the test for a true parameter of \(\theta\)=0.7, for all sample sizes N from 1 to 100, where I’m assuming that the null hypothesis predicts that \(\theta\) 0 =0.5.

Because power is important, whenever you’re contemplating running an experiment it would be pretty useful to know how much power you’re likely to have. It’s never possible to know for sure, since you can’t possibly know what your effect size is. However, it’s often (well, sometimes) possible to guess how big it should be. If so, you can guess what sample size you need! This idea is called power analysis , and if it’s feasible to do it, then it’s very helpful since it can tell you something about whether you have enough time or money to be able to run the experiment successfully. It’s increasingly common to see people arguing that power analysis should be a required part of experimental design, so it’s worth knowing about. I don’t discuss power analysis in this book, however. This is partly for a boring reason and partly for a substantive one. The boring reason is that I haven’t had time to write about power analysis yet. The substantive one is that I’m still a little suspicious of power analysis. Speaking as a researcher, I have very rarely found myself in a position to be able to do one – it’s either the case that (a) my experiment is a bit non-standard and I don’t know how to define effect size properly, (b) I literally have so little idea about what the effect size will be that I wouldn’t know how to interpret the answers. Not only that, after extensive conversations with someone who does stats consulting for a living (my wife, as it happens), I can’t help but notice that in practice the only time anyone ever asks her for a power analysis is when she’s helping someone write a grant application. In other words, the only time any scientist ever seems to want a power analysis in real life is when they’re being forced to do it by bureaucratic process. It’s not part of anyone’s day-to-day work. In short, I’ve always been of the view that while power is an important concept, power analysis is not as useful as people make it sound, except in the rare cases where (a) someone has figured out how to calculate power for your actual experimental design and (b) you have a pretty good idea what the effect size is likely to be. Maybe other people have had better experiences than me, but I’ve personally never been in a situation where both (a) and (b) were true. Maybe I’ll be convinced otherwise in the future, and probably a future version of this book would include a more detailed discussion of power analysis, but for now this is about as much as I’m comfortable saying about the topic.

Teach yourself statistics

Power of a Hypothesis Test

The probability of not committing a Type II error is called the power of a hypothesis test.

Effect Size

To compute the power of the test, one offers an alternative view about the "true" value of the population parameter, assuming that the null hypothesis is false. The effect size is the difference between the true value and the value specified in the null hypothesis.

Effect size = True value - Hypothesized value

For example, suppose the null hypothesis states that a population mean is equal to 100. A researcher might ask: What is the probability of rejecting the null hypothesis if the true population mean is equal to 90? In this example, the effect size would be 90 - 100, which equals -10.

Factors That Affect Power

The power of a hypothesis test is affected by three factors.

• Sample size ( n ). Other things being equal, the greater the sample size, the greater the power of the test.
• Significance level (α). The lower the significance level, the lower the power of the test. If you reduce the significance level (e.g., from 0.05 to 0.01), the region of acceptance gets bigger. As a result, you are less likely to reject the null hypothesis. This means you are less likely to reject the null hypothesis when it is false, so you are more likely to make a Type II error. In short, the power of the test is reduced when you reduce the significance level; and vice versa.
• The "true" value of the parameter being tested. The greater the difference between the "true" value of a parameter and the value specified in the null hypothesis, the greater the power of the test. That is, the greater the effect size, the greater the power of the test.

Test Your Understanding

Other things being equal, which of the following actions will reduce the power of a hypothesis test?

I. Increasing sample size. II. Changing the significance level from 0.01 to 0.05. III. Increasing beta, the probability of a Type II error.

(A) I only (B) II only (C) III only (D) All of the above (E) None of the above

The correct answer is (C). Increasing sample size makes the hypothesis test more sensitive - more likely to reject the null hypothesis when it is, in fact, false. Changing the significance level from 0.01 to 0.05 makes the region of acceptance smaller, which makes the hypothesis test more likely to reject the null hypothesis, thus increasing the power of the test. Since, by definition, power is equal to one minus beta, the power of a test will get smaller as beta gets bigger.

Suppose a researcher conducts an experiment to test a hypothesis. If she doubles her sample size, which of the following will increase?

I. The power of the hypothesis test. II. The effect size of the hypothesis test. III. The probability of making a Type II error.

The correct answer is (A). Increasing sample size makes the hypothesis test more sensitive - more likely to reject the null hypothesis when it is, in fact, false. Thus, it increases the power of the test. The effect size is not affected by sample size. And the probability of making a Type II error gets smaller, not bigger, as sample size increases.

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25.3 - calculating sample size.

Before we learn how to calculate the sample size that is necessary to achieve a hypothesis test with a certain power, it might behoove us to understand the effect that sample size has on power. Let's investigate by returning to our IQ example.

Example 25-3 Section  

Let \(X\) denote the IQ of a randomly selected adult American. Assume, a bit unrealistically again, that \(X\) is normally distributed with unknown mean \(\mu\) and (a strangely known) standard deviation of 16. This time, instead of taking a random sample of \(n=16\) students, let's increase the sample size to \(n=64\). And, while setting the probability of committing a Type I error to \(\alpha=0.05\), test the null hypothesis \(H_0:\mu=100\) against the alternative hypothesis that \(H_A:\mu>100\).

What is the power of the hypothesis test when \(\mu=108\), \(\mu=112\), and \(\mu=116\)?

Setting \(\alpha\), the probability of committing a Type I error, to 0.05, implies that we should reject the null hypothesis when the test statistic \(Z\ge 1.645\), or equivalently, when the observed sample mean is 103.29 or greater:

\( \bar{x} = \mu + z \left(\dfrac{\sigma}{\sqrt{n}} \right) = 100 +1.645\left(\dfrac{16}{\sqrt{64}} \right) = 103.29\)

Therefore, the power function \K(\mu)\), when \(\mu>100\) is the true value, is:

\( K(\mu) = P(\bar{X} \ge 103.29 | \mu) = P \left(Z \ge \dfrac{103.29 - \mu}{16 / \sqrt{64}} \right) = 1 - \Phi \left(\dfrac{103.29 - \mu}{2} \right)\)

Therefore, the probability of rejecting the null hypothesis at the \(\alpha=0.05\) level when \(\mu=108\) is 0.9907, as calculated here:

\(K(108) = 1 - \Phi \left( \dfrac{103.29-108}{2} \right) = 1- \Phi(-2.355) = 0.9907 \)

And, the probability of rejecting the null hypothesis at the \(\alpha=0.05\) level when \(\mu=112\) is greater than 0.9999, as calculated here:

\( K(112) = 1 - \Phi \left( \dfrac{103.29-112}{2} \right) = 1- \Phi(-4.355) = 0.9999\ldots \)

And, the probability of rejecting the null hypothesis at the \(\alpha=0.05\) level when \(\mu=116\) is greater than 0.999999, as calculated here:

\( K(116) = 1 - \Phi \left( \dfrac{103.29-116}{2} \right) = 1- \Phi(-6.355) = 0.999999... \)

In summary, in the various examples throughout this lesson, we have calculated the power of testing \(H_0:\mu=100\) against \(H_A:\mu>100\) for two sample sizes ( \(n=16\) and \(n=64\)) and for three possible values of the mean ( \(\mu=108\), \(\mu=112\), and \(\mu=116\)). Here's a summary of our power calculations:

As you can see, our work suggests that for a given value of the mean \(\mu\) under the alternative hypothesis, the larger the sample size \(n\), the greater the power \(K(\mu)\) . Perhaps there is no better way to see this than graphically by plotting the two power functions simultaneously, one when \(n=16\) and the other when \(n=64\):

As this plot suggests, if we are interested in increasing our chance of rejecting the null hypothesis when the alternative hypothesis is true, we can do so by increasing our sample size \(n\). This benefit is perhaps even greatest for values of the mean that are close to the value of the mean assumed under the null hypothesis. Let's take a look at two examples that illustrate the kind of sample size calculation we can make to ensure our hypothesis test has sufficient power.

Example 25-4 Section  

Let \(X\) denote the crop yield of corn measured in the number of bushels per acre. Assume (unrealistically) that \(X\) is normally distributed with unknown mean \(\mu\) and standard deviation \(\sigma=6\). An agricultural researcher is working to increase the current average yield from 40 bushels per acre. Therefore, he is interested in testing, at the \(\alpha=0.05\) level, the null hypothesis \(H_0:\mu=40\) against the alternative hypothesis that \(H_A:\mu>40\). Find the sample size \(n\) that is necessary to achieve 0.90 power at the alternative \(\mu=45\).

As is always the case, we need to start by finding a threshold value \(c\), such that if the sample mean is larger than \(c\), we'll reject the null hypothesis:

That is, in order for our hypothesis test to be conducted at the \(\alpha=0.05\) level, the following statement must hold (using our typical \(Z\) transformation):

\(c = 40 + 1.645 \left( \dfrac{6}{\sqrt{n}} \right) \) (**)

But, that's not the only condition that \(c\) must meet, because \(c\) also needs to be defined to ensure that our power is 0.90 or, alternatively, that the probability of a Type II error is 0.10. That would happen if there was a 10% chance that our test statistic fell short of \(c\) when \(\mu=45\), as the following drawing illustrates in blue:

This illustration suggests that in order for our hypothesis test to have 0.90 power, the following statement must hold (using our usual \(Z\) transformation):

\(c = 45 - 1.28 \left( \dfrac{6}{\sqrt{n}} \right) \) (**)

Aha! We have two (asterisked (**)) equations and two unknowns! All we need to do is equate the equations, and solve for \(n\). Doing so, we get:

\(40+1.645\left(\frac{6}{\sqrt{n}}\right)=45-1.28\left(\frac{6}{\sqrt{n}}\right)\) \(\Rightarrow 5=(1.645+1.28)\left(\frac{6}{\sqrt{n}}\right), \qquad \Rightarrow 5=\frac{17.55}{\sqrt{n}}, \qquad n=(3.51)^2=12.3201\approx 13\)

Now that we know we will set \(n=13\), we can solve for our threshold value c :

\( c = 40 + 1.645 \left( \dfrac{6}{\sqrt{13}} \right)=42.737 \)

So, in summary, if the agricultural researcher collects data on \(n=13\) corn plots, and rejects his null hypothesis \(H_0:\mu=40\) if the average crop yield of the 13 plots is greater than 42.737 bushels per acre, he will have a 5% chance of committing a Type I error and a 10% chance of committing a Type II error if the population mean \(\mu\) were actually 45 bushels per acre.

Example 25-5 Section  

Consider \(p\), the true proportion of voters who favor a particular political candidate. A pollster is interested in testing at the \(\alpha=0.01\) level, the null hypothesis \(H_0:9=0.5\) against the alternative hypothesis that \(H_A:p>0.5\). Find the sample size \(n\) that is necessary to achieve 0.80 power at the alternative \(p=0.55\).

In this case, because we are interested in performing a hypothesis test about a population proportion \(p\), we use the \(Z\)-statistic:

\(Z = \dfrac{\hat{p}-p_0}{\sqrt{\frac{p_0(1-p_0)}{n}}} \)

Again, we start by finding a threshold value \(c\), such that if the observed sample proportion is larger than \(c\), we'll reject the null hypothesis:

That is, in order for our hypothesis test to be conducted at the \(\alpha=0.01\) level, the following statement must hold:

\(c = 0.5 + 2.326 \sqrt{ \dfrac{(0.5)(0.5)}{n}} \) (**)

But, again, that's not the only condition that c must meet, because \(c\) also needs to be defined to ensure that our power is 0.80 or, alternatively, that the probability of a Type II error is 0.20. That would happen if there was a 20% chance that our test statistic fell short of \(c\) when \(p=0.55\), as the following drawing illustrates in blue:

This illustration suggests that in order for our hypothesis test to have 0.80 power, the following statement must hold:

\(c = 0.55 - 0.842 \sqrt{ \dfrac{(0.55)(0.45)}{n}} \) (**)

Again, we have two (asterisked (**)) equations and two unknowns! All we need to do is equate the equations, and solve for \(n\). Doing so, we get:

\(0.5+2.326\sqrt{\dfrac{0.5(0.5)}{n}}=0.55-0.842\sqrt{\dfrac{0.55(0.45)}{n}} \\ 2.326\dfrac{\sqrt{0.25}}{\sqrt{n}}+0.842\dfrac{\sqrt{0.2475}}{\sqrt{n}}=0.55-0.5 \\ \dfrac{1}{\sqrt{n}}(1.5818897)=0.05 \qquad \Rightarrow n\approx \left(\dfrac{1.5818897}{0.05}\right)^2 = 1000.95 \approx 1001 \)

Now that we know we will set \(n=1001\), we can solve for our threshold value \(c\):

\(c = 0.5 + 2.326 \sqrt{\dfrac{(0.5)(0.5)}{1001}}= 0.5367 \)

So, in summary, if the pollster collects data on \(n=1001\) voters, and rejects his null hypothesis \(H_0:p=0.5\) if the proportion of sampled voters who favor the political candidate is greater than 0.5367, he will have a 1% chance of committing a Type I error and a 20% chance of committing a Type II error if the population proportion \(p\) were actually 0.55.

Incidentally, we can always check our work! Conducting the survey and subsequent hypothesis test as described above, the probability of committing a Type I error is:

\(\alpha= P(\hat{p} >0.5367 \text { if } p = 0.50) = P(Z > 2.3257) = 0.01 \)

and the probability of committing a Type II error is:

\(\beta = P(\hat{p} <0.5367 \text { if } p = 0.55) = P(Z < -0.846) = 0.199 \)

just as the pollster had desired.

We've illustrated several sample size calculations. Now, let's summarize the information that goes into a sample size calculation. In order to determine a sample size for a given hypothesis test, you need to specify:

The desired \(\alpha\) level, that is, your willingness to commit a Type I error.

The desired power or, equivalently, the desired \(\beta\) level, that is, your willingness to commit a Type II error.

A meaningful difference from the value of the parameter that is specified in the null hypothesis.

The standard deviation of the sample statistic or, at least, an estimate of the standard deviation (the "standard error") of the sample statistic.

Power and Sample Size Determination

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Issues in Estimating Sample Size for Hypothesis Testing

Ensuring that a test has high power.

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In the module on hypothesis testing for means and proportions, we introduced techniques for means, proportions, differences in means, and differences in proportions. While each test involved details that were specific to the outcome of interest (e.g., continuous or dichotomous) and to the number of comparison groups (one, two, more than two), there were common elements to each test. For example, in each test of hypothesis, there are two errors that can be committed. The first is called a Type I error and refers to the situation where we incorrectly reject H 0 when in fact it is true.   In the first step of any test of hypothesis, we select a level of significance, α , and α = P(Type I error) = P(Reject H 0 | H 0 is true). Because we purposely select a small value for α , we control the probability of committing a Type I error. The second type of error is called a Type II error and it is defined as the probability we do not reject H 0 when it is false. The probability of a Type II error is denoted β , and β =P(Type II error) = P(Do not Reject H 0 | H 0 is false). In hypothesis testing, we usually focus on power, which is defined as the probability that we reject H 0 when it is false, i.e., power = 1- β = P(Reject H 0 | H 0 is false). Power is the probability that a test correctly rejects a false null hypothesis. A good test is one with low probability of committing a Type I error (i.e., small α ) and high power (i.e., small β, high power).  

Here we present formulas to determine the sample size required to ensure that a test has high power. The sample size computations depend on the level of significance, aα, the desired power of the test (equivalent to 1-β), the variability of the outcome, and the effect size. The effect size is the difference in the parameter of interest that represents a clinically meaningful difference. Similar to the margin of error in confidence interval applications, the effect size is determined based on clinical or practical criteria and not statistical criteria.  

The concept of statistical power can be difficult to grasp. Before presenting the formulas to determine the sample sizes required to ensure high power in a test, we will first discuss power from a conceptual point of view.  

Suppose we want to test the following hypotheses at aα=0.05:  H 0 : μ = 90 versus H 1 : μ ≠ 90. To test the hypotheses, suppose we select a sample of size n=100. For this example, assume that the standard deviation of the outcome is σ=20. We compute the sample mean and then must decide whether the sample mean provides evidence to support the alternative hypothesis or not. This is done by computing a test statistic and comparing the test statistic to an appropriate critical value. If the null hypothesis is true (μ=90), then we are likely to select a sample whose mean is close in value to 90. However, it is also possible to select a sample whose mean is much larger or much smaller than 90. Recall from the Central Limit Theorem (see page 11 in the module on Probability ), that for large n (here n=100 is sufficiently large), the distribution of the sample means is approximately normal with a mean of

If the null hypothesis is true, it is possible to observe any sample mean shown in the figure below; all are possible under H 0 : μ = 90.  

Rejection Region for Test H 0 : μ = 90 versus H 1 : μ ≠ 90 at α =0.05

The areas in the two tails of the curve represent the probability of a Type I Error, α= 0.05. This concept was discussed in the module on Hypothesis Testing .  

Now, suppose that the alternative hypothesis, H 1 , is true (i.e., μ ≠ 90) and that the true mean is actually 94. The figure below shows the distributions of the sample mean under the null and alternative hypotheses.The values of the sample mean are shown along the horizontal axis.  

If the true mean is 94, then the alternative hypothesis is true. In our test, we selected α = 0.05 and reject H 0 if the observed sample mean exceeds 93.92 (focusing on the upper tail of the rejection region for now). The critical value (93.92) is indicated by the vertical line. The probability of a Type II error is denoted β, and β = P(Do not Reject H 0 | H 0 is false), i.e., the probability of not rejecting the null hypothesis if the null hypothesis were true. β is shown in the figure above as the area under the rightmost curve (H 1 ) to the left of the vertical line (where we do not reject H 0 ). Power is defined as 1- β = P(Reject H 0 | H 0 is false) and is shown in the figure as the area under the rightmost curve (H 1 ) to the right of the vertical line (where we reject H 0 ).  

Note that β and power are related to α, the variability of the outcome and the effect size. From the figure above we can see what happens to β and power if we increase α. Suppose, for example, we increase α to α=0.10.The upper critical value would be 92.56 instead of 93.92. The vertical line would shift to the left, increasing α, decreasing β and increasing power. While a better test is one with higher power, it is not advisable to increase α as a means to increase power. Nonetheless, there is a direct relationship between α and power (as α increases, so does power).

β and power are also related to the variability of the outcome and to the effect size. The effect size is the difference in the parameter of interest (e.g., μ) that represents a clinically meaningful difference. The figure above graphically displays α, β, and power when the difference in the mean under the null as compared to the alternative hypothesis is 4 units (i.e., 90 versus 94). The figure below shows the same components for the situation where the mean under the alternative hypothesis is 98.

Notice that there is much higher power when there is a larger difference between the mean under H 0 as compared to H 1 (i.e., 90 versus 98). A statistical test is much more likely to reject the null hypothesis in favor of the alternative if the true mean is 98 than if the true mean is 94. Notice also in this case that there is little overlap in the distributions under the null and alternative hypotheses. If a sample mean of 97 or higher is observed it is very unlikely that it came from a distribution whose mean is 90. In the previous figure for H 0 : μ = 90 and H 1 : μ = 94, if we observed a sample mean of 93, for example, it would not be as clear as to whether it came from a distribution whose mean is 90 or one whose mean is 94.

In designing studies most people consider power of 80% or 90% (just as we generally use 95% as the confidence level for confidence interval estimates). The inputs for the sample size formulas include the desired power, the level of significance and the effect size. The effect size is selected to represent a clinically meaningful or practically important difference in the parameter of interest, as we will illustrate.  

The formulas we present below produce the minimum sample size to ensure that the test of hypothesis will have a specified probability of rejecting the null hypothesis when it is false (i.e., a specified power). In planning studies, investigators again must account for attrition or loss to follow-up. The formulas shown below produce the number of participants needed with complete data, and we will illustrate how attrition is addressed in planning studies.

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Content ©2020. All Rights Reserved. Date last modified: March 13, 2020. Wayne W. LaMorte, MD, PhD, MPH