Evidence Based Medicine

Define evidence-based medicine, its key principles and how it is applied in medical practice.

Describe the science of epidemiology and its use in evidence and product development. Describe how to calculate incidence, prevalence, and number needed-to-treat. Define the terms statistical significance, P-value, and confidence interval. Describe how analyses of a study methodology can provide an assessment of the clinical evidence validity.

Identify the key elements of a clinical/scientific literature search and critically evaluate it from both an individual as well as a group perspective. Differentiate between meta-analysis, non-randomized, randomized and placebo–controlled trials. Demonstrate ability to access PubMed and perform a key word search.

Describe the role of evidence in regulatory submissions and market clearance.

Identify how payors determine coverage using principles of evidence based medicine.

Develop operational knowledge of Clinical Evidence Reports (CERs) including systematic literature reviews, screening articles against inclusion/exclusion criteria, extracting data from included studies, interpretation of study results and synthesis of statistical results.

Describe the elements and process of a publication strategy, including assessment of clinical evidence gaps, identification of clinical messaging, development of a clinical data dissemination plan, and identification of authorship per ICMJE (International Committee of Medical Journal Editors) guidelines.

Identify the elements of a publication and apply a systematic method for critically analyzing the scientific research methods and results. Grade scientific publications according to level of evidence.