Module 3.4 Clinical Importance
Now that you know the results are valid and well-reported, are they clinically important?
A very large clinical trial may be able to show small differences between interventions that have little clinical significance. Statistical significance does not always equate to clinical significance.
| Statistical significance | Clinical significance |
|---|---|
| Is a treatment effect (therapy) or improvement in sensitivity/specificity (diagnosis), clinically relevant? | A small therapeutic benefit or improvement in sensitivity may be important for a highly fatal disease but may not be enough to justify a new intervention in a disease with a good prognosis. |
| What level of uncertainty surrounds any results? | Are CIs given? A CI shows the range of results within which the ‘true’ result is likely to fall. If a 95% CI is given, this means that if a study was repeated many times with in the same population, the ‘true’ value should fall within these limits 95% of the time. If CIs are given, do they encompass values that would not be clinically relevant? A larger clinical trial should give a smaller CI, and a more precise estimate of the likely treatment effect. |
| Do the risks of a treatment or diagnostic procedure outweigh the potential benefits? | What are the toxicities and side effects of an intervention? How do these compare with the comparator arm? Is there potential morbidity in performing a test that outweighs the benefits of making a diagnosis? |
