Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study

Abstract Background To assess the completeness of reporting, research transparency practices, and risk of selection and immortal bias in observational studies using routinely collected data for comparative effectiveness research. Method We performed a meta-research study by searching PubMed for comp...

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Autores principales:	Van Thu Nguyen, Mishelle Engleton, Mauricia Davison, Philippe Ravaud, Raphael Porcher, Isabelle Boutron
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Observational studies Routinely collected data Emulated trial Meta-research Risk of bias Medicine R
Acceso en línea:	https://doaj.org/article/08650bd1bde741d09d44cafcb60922e9
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spelling	oai:doaj.org-article:08650bd1bde741d09d44cafcb60922e92021-11-28T12:15:19ZRisk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study10.1186/s12916-021-02151-w1741-7015https://doaj.org/article/08650bd1bde741d09d44cafcb60922e92021-11-01T00:00:00Zhttps://doi.org/10.1186/s12916-021-02151-whttps://doaj.org/toc/1741-7015Abstract Background To assess the completeness of reporting, research transparency practices, and risk of selection and immortal bias in observational studies using routinely collected data for comparative effectiveness research. Method We performed a meta-research study by searching PubMed for comparative effectiveness observational studies evaluating therapeutic interventions using routinely collected data published in high impact factor journals from 01/06/2018 to 30/06/2020. We assessed the reporting of the study design (i.e., eligibility, treatment assignment, and the start of follow-up). The risk of selection bias and immortal time bias was determined by assessing if the time of eligibility, the treatment assignment, and the start of follow-up were synchronized to mimic the randomization following the target trial emulation framework. Result Seventy-seven articles were identified. Most studies evaluated pharmacological treatments (69%) with a median sample size of 24,000 individuals. In total, 20% of articles inadequately reported essential information of the study design. One-third of the articles (n = 25, 33%) raised some concerns because of unclear reporting (n = 6, 8%) or were at high risk of selection bias and/or immortal time bias (n = 19, 25%). Only five articles (25%) described a solution to mitigate these biases. Six articles (31%) discussed these biases in the limitations section. Conclusion Reporting of essential information of study design in observational studies remained suboptimal. Selection bias and immortal time bias were common methodological issues that researchers and physicians should be aware of when interpreting the results of observational studies using routinely collected data.Van Thu NguyenMishelle EngletonMauricia DavisonPhilippe RavaudRaphael PorcherIsabelle BoutronBMCarticleObservational studiesRoutinely collected dataEmulated trialMeta-researchRisk of biasMedicineRENBMC Medicine, Vol 19, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Observational studies Routinely collected data Emulated trial Meta-research Risk of bias Medicine R
spellingShingle	Observational studies Routinely collected data Emulated trial Meta-research Risk of bias Medicine R Van Thu Nguyen Mishelle Engleton Mauricia Davison Philippe Ravaud Raphael Porcher Isabelle Boutron Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
description	Abstract Background To assess the completeness of reporting, research transparency practices, and risk of selection and immortal bias in observational studies using routinely collected data for comparative effectiveness research. Method We performed a meta-research study by searching PubMed for comparative effectiveness observational studies evaluating therapeutic interventions using routinely collected data published in high impact factor journals from 01/06/2018 to 30/06/2020. We assessed the reporting of the study design (i.e., eligibility, treatment assignment, and the start of follow-up). The risk of selection bias and immortal time bias was determined by assessing if the time of eligibility, the treatment assignment, and the start of follow-up were synchronized to mimic the randomization following the target trial emulation framework. Result Seventy-seven articles were identified. Most studies evaluated pharmacological treatments (69%) with a median sample size of 24,000 individuals. In total, 20% of articles inadequately reported essential information of the study design. One-third of the articles (n = 25, 33%) raised some concerns because of unclear reporting (n = 6, 8%) or were at high risk of selection bias and/or immortal time bias (n = 19, 25%). Only five articles (25%) described a solution to mitigate these biases. Six articles (31%) discussed these biases in the limitations section. Conclusion Reporting of essential information of study design in observational studies remained suboptimal. Selection bias and immortal time bias were common methodological issues that researchers and physicians should be aware of when interpreting the results of observational studies using routinely collected data.
format	article
author	Van Thu Nguyen Mishelle Engleton Mauricia Davison Philippe Ravaud Raphael Porcher Isabelle Boutron
author_facet	Van Thu Nguyen Mishelle Engleton Mauricia Davison Philippe Ravaud Raphael Porcher Isabelle Boutron
author_sort	Van Thu Nguyen
title	Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
title_short	Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
title_full	Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
title_fullStr	Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
title_full_unstemmed	Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
title_sort	risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study
publisher	BMC
publishDate	2021
url	https://doaj.org/article/08650bd1bde741d09d44cafcb60922e9
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Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study

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