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In broad usage, the "practical clinical significance" answers the question, how effective is the intervention or treatment, or how much change does the treatment cause. In terms of testing clinical treatments, practical significance optimally yields quantified information about the importance of a finding, using metrics such as effect size, number needed to treat (NNT), and preventive fraction ...
Such a small difference could be irrelevant (i.e., of no clinical importance) to patients or clinicians. Thus, statistical significance does not necessarily imply clinical importance. Over the years clinicians and researchers have moved away from physical and radiological endpoints towards patient-reported outcomes.
The term significance does not imply importance here, and the term statistical significance is not the same as research significance, theoretical significance, or practical significance. [1] [2] [18] [19] For example, the term clinical significance refers to the practical importance of a treatment effect. [20]
Medical statistics (also health statistics) deals with applications of statistics to medicine and the health sciences, including epidemiology, public health, forensic medicine, and clinical research. [1] Medical statistics has been a recognized branch of statistics in the United Kingdom for more than 40 years, but the term has not come into ...
For example, a pain-relief drug is tested on 1500 human subjects, and no adverse event is recorded. From the rule of three, it can be concluded with 95% confidence that fewer than 1 person in 500 (or 3/1500) will experience an adverse event. By symmetry, for only successes, the 95% confidence interval is [1−3/ n,1].
Clinical trials are medical research studies conducted on human subjects. [1] The human subjects are assigned to one or more interventions, and the investigators evaluate the effects of those interventions. [1] [2] The progress and results of clinical trials are analyzed statistically. [3] [4]
However, statistical significance is often not enough to define success. To address this issue, the power concept can be extended to the concept of predictive probability of success (PPOS). The success criterion for PPOS is not restricted to statistical significance and is commonly used in clinical trial designs.
If a clinical endpoint is devastating enough (e.g. death, heart attack), drugs with a high NNT may still be indicated in particular situations. If the endpoint is minor, health insurers may decline to reimburse drugs with a high NNT. NNT is significant to consider when comparing possible side effects of a medication against its benefits.