Open AccessApproaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis
Author(s) -
S. R. Gilyarevsky
Publication year - 2021
Publication title -
racionalʹnaâ farmakoterapiâ v kardiologii
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.161
H-Index - 9
eISSN - 2225-3653
pISSN - 1819-6446
DOI - 10.20996/1819-6446-2021-08-01
Subject(s) - observational study , medicine , randomized controlled trial , confounding , psychological intervention , clinical trial , intensive care medicine , medical physics , surgery , nursing
The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed.