In analyzing data from clinical trials, establishing the statistical significance and confidence intervals of group differences in treatment outcome is a pivotal first step. It is well known, however, that statistical significance reflects both the magnitude and variability of the treatment effect as well as the sample size. A statistically significant improvement may therefore reflect a benefit that is clinically unimportant. For this reason, determinations of statistical significance must be supplemented by consideration of the clinical importance of changes in outcome measures. Such information provides a basis for evaluating and comparing the impact of chronic pain treatments on pain and health-related quality of life. Because most measures of treatment response in chronic pain trials involve the patient's subjective experience, the patient is the most important judge of whether changes are important or meaningful. For this reason, patient evaluations of overall improvement have been considered a core outcome domain for chronic pain trials .
Responder analyses can also assist in interpreting the clinical importance of chronic pain treatment outcomes, for example, analyses of the proportions of patients whose pain decreases from baseline by >30% or by >50% , as well as graphs presenting cumulative proportion of responder analyses . Evaluating the clinical importance of the results of a clinical trial must also consider other factors besides patient assessments of pain reduction and overall improvement, including the characteristics of the disease being treated, the risks of the treatment (i.e. side effects and safety), the convenience of the treatment, and the characteristics of other treatments that are available for the same condition.
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