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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 ...
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 ...
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.
Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6) Clinician A health professional who takes care of patients. (NCI)
The positive predictive value (PPV), or precision, is defined as = + = where a "true positive" is the event that the test makes a positive prediction, and the subject has a positive result under the gold standard, and a "false positive" is the event that the test makes a positive prediction, and the subject has a negative result under the gold standard.
In 2016, the American Statistical Association (ASA) published a statement on p-values, saying that "the widespread use of 'statistical significance' (generally interpreted as 'p ≤ 0.05') as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process". [57]
A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, [1] or examines their medical records for exposure and outcome.
The investigators then obtain a standard set of clinical observations on each patient and a test or clinical follow-up to define the true state of the patient. They then use statistical methods to identify the best clinical predictors of the patient's true state. The probability of disease will depend on the patient's key clinical predictors.