rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2021-08-01rpcardio-2541Research ArticlePOINT OF VIEWТОЧКА ЗРЕНИЯApproaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data AnalysisПодходы к оценке качества наблюдательных исследований клинической практики, основанных на анализе «больших данных»https://orcid.org/0000-0002-8505-1848ГиляревскийС. Р.GilyarevskyS. R.

Гиляревский Сергей Руджерович

Москва

Sergey R. Gilyarevsky

Moscow

sgilarevsky@rambler.ruРоссийская медицинская академия непрерывного профессионального образованияРоссияRussian Medical Academy of Continuing Professional EducationRussian Federation202102092021174584593Copyright © Gilyarevsky S.R., 20212021Гиляревский С.Р.Gilyarevsky S.R.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/2541

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.

 

Статья посвящена обсуждению проблем оценки качества обсервационных исследований реальной клинической практики и определению их места в иерарахии доказательной информации. Рассматривается понятие «большие данные» и приемлемость использования такого термина для обозначения крупных обсервационных исследований. Приводятся данные об ограничениях административных баз данных и баз данных страховых заявок при выполнении обсервационных исследований для оценки эффектов вмешательств. Обсуждается понятие вмешивающихся факторов, влияющих на результаты обсервационных исследований. Рассматриваются современные подходы к уменьшению выраженности систематически ошибок в исследованиях реальной клинической практики. Приводятся критерии оценки качества обсервационных фармакоэпидемиологических исследований и принципиальные отличия от рандомизированных клинических исследований. Обсуждаются результаты систематических обзоров исследований реальной клинической практики для оценки эффектов применения прямых пероральных антикоагулянтов.

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The authors declare that there are no conflicts of interest present.