Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations

Abstract Randomized controlled trials (RCTs) are regarded as the most reputable source of evidence. In some studies, factors beyond the intervention itself may contribute to the measured effect, an occurrence known as heterogeneity of treatment effect (HTE). If the RCT population differs from the re...

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Autores principales:	Amelia J. Averitt, Chunhua Weng, Patrick Ryan, Adler Perotte
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/f2941ae407db4ad197e6d29fe2663bf3
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spelling	oai:doaj.org-article:f2941ae407db4ad197e6d29fe2663bf32021-12-02T15:36:31ZTranslating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations10.1038/s41746-020-0277-82398-6352https://doaj.org/article/f2941ae407db4ad197e6d29fe2663bf32020-05-01T00:00:00Zhttps://doi.org/10.1038/s41746-020-0277-8https://doaj.org/toc/2398-6352Abstract Randomized controlled trials (RCTs) are regarded as the most reputable source of evidence. In some studies, factors beyond the intervention itself may contribute to the measured effect, an occurrence known as heterogeneity of treatment effect (HTE). If the RCT population differs from the real-world population on factors that induce HTE, the trials effect will not replicate. The RCTs eligibility criteria should identify the sub-population in which its evidence will replicate. However, the extent to which the eligibility criteria identify the appropriate population is unknown, which raises concerns for generalizability. We compared reported data from RCTs with real-world data from the electronic health records of a large, academic medical center that was curated according to RCT eligibility criteria. Our results show fundamental differences between the RCT population and our observational cohorts, which suggests that eligibility criteria may be insufficient for identifying the applicable real-world population in which RCT evidence will replicate.Amelia J. AverittChunhua WengPatrick RyanAdler PerotteNature PortfolioarticleComputer applications to medicine. Medical informaticsR858-859.7ENnpj Digital Medicine, Vol 3, Iss 1, Pp 1-10 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Computer applications to medicine. Medical informatics R858-859.7 Amelia J. Averitt Chunhua Weng Patrick Ryan Adler Perotte Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
description	Abstract Randomized controlled trials (RCTs) are regarded as the most reputable source of evidence. In some studies, factors beyond the intervention itself may contribute to the measured effect, an occurrence known as heterogeneity of treatment effect (HTE). If the RCT population differs from the real-world population on factors that induce HTE, the trials effect will not replicate. The RCTs eligibility criteria should identify the sub-population in which its evidence will replicate. However, the extent to which the eligibility criteria identify the appropriate population is unknown, which raises concerns for generalizability. We compared reported data from RCTs with real-world data from the electronic health records of a large, academic medical center that was curated according to RCT eligibility criteria. Our results show fundamental differences between the RCT population and our observational cohorts, which suggests that eligibility criteria may be insufficient for identifying the applicable real-world population in which RCT evidence will replicate.
format	article
author	Amelia J. Averitt Chunhua Weng Patrick Ryan Adler Perotte
author_facet	Amelia J. Averitt Chunhua Weng Patrick Ryan Adler Perotte
author_sort	Amelia J. Averitt
title	Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
title_short	Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
title_full	Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
title_fullStr	Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
title_full_unstemmed	Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
title_sort	translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/f2941ae407db4ad197e6d29fe2663bf3
work_keys_str_mv	AT ameliajaveritt translatingevidenceintopracticeeligibilitycriteriafailtoeliminateclinicallysignificantdifferencesbetweenrealworldandstudypopulations AT chunhuaweng translatingevidenceintopracticeeligibilitycriteriafailtoeliminateclinicallysignificantdifferencesbetweenrealworldandstudypopulations AT patrickryan translatingevidenceintopracticeeligibilitycriteriafailtoeliminateclinicallysignificantdifferencesbetweenrealworldandstudypopulations AT adlerperotte translatingevidenceintopracticeeligibilitycriteriafailtoeliminateclinicallysignificantdifferencesbetweenrealworldandstudypopulations
_version_	1718386327437705216

Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations

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