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Do multiple outcome measures require p-value adjustment?
Background
Readers may question the interpretation of findings in clinical trials when multiple outcome measures are used without adjustment of the p-value. This question arises because of the increased risk of Type I errors (findings of false "significance") when multiple simultaneous hypotheses are tested at set p-values. The primary aim of this study was to estimate the need to make appropriate p-value adjustments in clinical trials to compensate for a possible increased risk in committing Type I errors when multiple outcome measures are used.
Discussion
The classicists believe that the chance of finding at least one test statistically significant due to chance and incorrectly declaring a difference increases as the number of comparisons increases. The rationalists have the following objections to that theory: 1) P-value adjustments are calculated based on how many tests are to be considered, and that number has been defined arbitrarily and variably; 2) P-value adjustments reduce the chance of making type I errors, but they increase the chance of making type II errors or needing to increase the sample size.
Summary
Readers should balance a study's statistical significance with the magnitude of effect, the quality of the study and with findings from other studies. Researchers facing multiple outcome measures might want to either select a primary outcome measure or use a global assessment measure, rather than adjusting the p-value.
Complete Metadata
| bureauCode |
[ "009:25" ] |
|---|---|
| identifier | https://healthdata.gov/api/views/vkg6-kajc |
| issued | 2025-07-14 |
| landingPage | https://healthdata.gov/d/vkg6-kajc |
| programCode |
[ "009:032" ] |
| theme |
[ "NIH" ] |