Clinical Significance

Definition - What does Clinical Significance mean?

Clinical significance is a term used to describe how much a treatment or a diagnostic test is useful in the management of a patient. It shows the magnitude of the practical importance a medical intervention has on the patients. If a clinical trial concludes that the effect of a certain fertility medication is clinically significant, it means that the medicine has markedly increased the fertility in the treatment group. Clinical significance is used by clinicians in treatment planning when they want to discuss with patients the efficacy of available drugs/tests.

FertilitySmarts explains Clinical Significance

Broadly speaking, clinical significance gives the answers to the common questions that come with any test or treatment; Is it effective? How effective?

For example, one study on sperm function tests found "A positive finding of >50% of motile sperm with attached beads is considered to be clinically significant." What this means is that if the sperm analysis reveals more than 50% of the sperm are normal in shape and function, it is like to have a noticeable impact on fertility.

Clinical significance should not be confused with the term 'statistical significance,' which also is used to describe results in scientific studies. Statistical significance indicates how likely the observed results are to be due to chance. It does not describe if this difference is big enough to make an impact on patients. The effect of a medicine that has a statistical significance may not be clinically significant.

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