13 Research methods, statistics, critical review and evidence-based practice13.9 Differential and analytic statistics
13.9.1 Hypothesis testing
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Written by Resident Doctor Committee · Published
Null and alternative hypotheses
The null hypothesis (H0) states that there is no difference or association, such as a mean difference of zero or a risk ratio of one. It is what the test tries to reject.
The alternative hypothesis (H1), also called the research hypothesis, states that a real effect, difference or association exists. It is what the study seeks to support.
Alternative | What it predicts | When justified |
|---|---|---|
Two-tailed (non-directional) | A change in either direction | Differences either way matter; the usual default |
One-tailed (directional) | The direction of the effect | Direction fixed in advance, and an effect the other way is implausible or of no consequence |
The p value
The p value is the probability of a result at least as extreme as the one observed, calculated from the data on the assumption that the null hypothesis is true.
A smaller p value means the data are less compatible with the null, which is stronger evidence against it.
A p value depends on both effect size and sample size, so it does not measure how large the effect is. Equal p values from trials of different size do not mean equal effects.
The p value is not the probability that the alternative hypothesis is true, it is not power, and it is not a measure of clinical importance.
The p value is not | Why |
|---|---|
The probability that the null is true | The calculation assumes the null is true |
The probability that the result happened by chance | It already assumes chance is the only explanation |
One minus the probability that the alternative is true | The alternative never enters the calculation |
Significance level, errors and power
The alpha (significance) level is the Type I error threshold, commonly 0.05, fixed in advance. If the p value falls below alpha, the null is rejected.
Significance is decided by comparing the p value with alpha, not by the size of the observed effect.
Alpha caps the long-run rate of rejecting a true null hypothesis.
A p value just above 0.05 is a non-significant trend: it is not a significant result and not proof of no effect.
Decision | Null true | Null false |
|---|---|---|
Reject null | Type I error (false positive), probability alpha | Correct |
Retain null | Correct | Type II error (false negative), probability beta |
Power is the probability of detecting a true effect, equal to 1 minus beta. It rises with sample size and with effect size.
Running many tests raises the chance of at least one false positive, and the Bonferroni correction divides alpha by the number of tests.
Statistical against clinical significance
Statistical and clinical significance are separate. Clinical importance is judged by reading the confidence interval (CI) against the minimal clinically important difference.
Failing to reject the null does not show that there is no effect or that treatments are equivalent.
Study | Result | Reading |
|---|---|---|
Blood pressure, 50,000 per arm | 0.4 mmHg difference, p = 0.001 | Significant, but patient benefit is not shown |
Weight, small study | 3 kg difference, 95% CI -2 to +8 kg | Not significant, yet compatible with no difference and with an important effect |