Statistical Significance versus Clinical Significance in Clinical Trials

The clinical significance of statistical significance.

Modern clinical trials provide the evidence for most therapeutic advances, and that evidence, expressed in a statistical format, is used to draw inferences about a population from the study's results. Clinician judgment translates these inferences for best individual patient care, but many clinicians struggle with the statistical interpretation of trial results. This review provides a clinical ...

Defining therapeutic success in rheumatoid arthritis clinical trials: from statistical significance to clinical significance.

The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials

BACKGROUND Thresholds for statistical significance are insufficiently demonstrated by 95% confidence intervals or P-values when assessing results from randomised clinical trials. First, a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the null hypothes...

A sample size planning approach that considers both statistical significance and clinical significance

BACKGROUND The CONSORT statement requires clinical trials to report confidence intervals, which help to assess the precision and clinical importance of the treatment effect. Conventional sample size calculations for clinical trials, however, only consider issues of statistical significance (that is, significance level and power). METHOD A more consistent approach is proposed whereby sample si...

Reporting statistics in clinical trials published in Indian journals: a survey.

OBJECTIVES Clinical trials are having very important place in the hierarchy of evidence based medicine. It has been observed that current methods of use and reporting of statistics of clinical trials are responsible for errors in the interpretation of results. So we decided to evaluate clinical trials published in three Indian journals of 2007 and 2008 to analyse statistical issues which may af...