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In null-hypothesis significance testing, the p-value [note 1] is the probability of obtaining test results at least as extreme as the result actually observed, under the assumption that the null hypothesis is correct. [2] [3] A very small p-value means that such an extreme observed outcome would be very unlikely under the null hypothesis.
Although this p-value objectified research outcome, using it as a rigid cut off point can have potentially serious consequences: (i) clinically important differences observed in studies might be statistically non-significant (a type II error, or false negative result) and therefore be unfairly ignored; this often is a result of having a small ...
To gauge the research significance of their result, researchers are encouraged to always report an effect size along with p-values. An effect size measure quantifies the strength of an effect, such as the distance between two means in units of standard deviation (cf. Cohen's d ), the correlation coefficient between two variables or its square ...
Another disadvantage is that investigators and readers frequently do not understand how the p-values are reported: for example, if there are five interim analyses planned, but the trial is stopped after the third interim analysis because the p-value was 0.01, then the overall p-value for the trial is still reported as <0.05 and not as 0.01. [4]
In broad usage, the "practical clinical significance" answers the question, how effective is the intervention or treatment, or how much change does the treatment cause. In terms of testing clinical treatments, practical significance optimally yields quantified information about the importance of a finding, using metrics such as effect size, number needed to treat (NNT), and preventive fraction ...
The rule is useful in the interpretation of clinical trials generally, particularly in phase II and phase III where often there are limitations in duration or statistical power. The rule of three applies well beyond medical research, to any trial done n times. If 300 parachutes are randomly tested and all open successfully, then it is concluded ...
[11] [12] Falling for the temptation to use the statistical analysis of the collected data to estimate the power will result in uninformative and misleading values. In particular, it has been shown that post-hoc "observed power" is a one-to-one function of the p-value attained. [11]
Note that a p-value of 0.01 suggests that 1% of the time a result at least that extreme would be obtained by chance; if hundreds or thousands of hypotheses (with mutually relatively uncorrelated independent variables) are tested, then one is likely to obtain a p-value less than 0.01 for many null hypotheses.