Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study

Abstract Background In nutrition research, randomised controlled trials (RCTs) and cohort studies provide complementary evidence. This meta-epidemiological study aims to evaluate the agreement of effect estimates from individual nutrition RCTs and cohort studies investigating a highly similar resear...

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Main Authors: Julia Stadelmaier, Gina Bantle, Lea Gorenflo, Eva Kiesswetter, Adriani Nikolakopoulou, Lukas Schwingshackl
Format: Article
Language:English
Published: BMC 2025-01-01
Series:BMC Medicine
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Online Access:https://doi.org/10.1186/s12916-025-03860-2
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author Julia Stadelmaier
Gina Bantle
Lea Gorenflo
Eva Kiesswetter
Adriani Nikolakopoulou
Lukas Schwingshackl
author_facet Julia Stadelmaier
Gina Bantle
Lea Gorenflo
Eva Kiesswetter
Adriani Nikolakopoulou
Lukas Schwingshackl
author_sort Julia Stadelmaier
collection DOAJ
description Abstract Background In nutrition research, randomised controlled trials (RCTs) and cohort studies provide complementary evidence. This meta-epidemiological study aims to evaluate the agreement of effect estimates from individual nutrition RCTs and cohort studies investigating a highly similar research question and to investigate determinants of disagreement. Methods MEDLINE, Epistemonikos, and the Cochrane Database of Systematic Reviews were searched from January 2010 to September 2021. We matched individual RCTs to cohort studies based on population, intervention/exposure, comparator, and outcome (PI/ECO) characteristics. Two reviewers independently extracted study characteristics and effect estimates and rated the risk of bias using RoB2 and ROBINS-E. Agreement of matched RCTs/cohort studies was analysed by pooling ratio of risk ratios (RRR) and difference of (standardised) mean differences (DSMD). Results We included 64 RCT/cohort study pairs with 4,136,837 participants. Regarding PI/ECO similarity, 20.3% pairs were “more or less identical”, 71.9% “similar but not identical” and 7.8% “broadly similar”. Most RCTs were classified as “low risk of bias” (26.6%) or with “some concerns” (65.6%); cohort studies were mostly rated with “some concerns” (46.6%) or “high risk of bias” (47.9%), driven by inadequate control of important confounding factors. Effect estimates across RCTs and cohort studies were in high agreement (RRR 1.00 (95% CI 0.91–1.10, n = 54); and DSMD − 0.26 (95% CI − 0.87–0.35, n = 7)). In meta-regression analyses exploring determinants of disagreements, risk-of-bias judgements tend to have had more influence on the effect estimate than “PI/ECO similarity” degree. Conclusions Effect estimates of nutrition RCTs and cohort studies were generally similar. Careful consideration and evaluation of PI/ECO characteristics and risk of bias is crucial for a trustworthy utilisation of evidence from RCTs and cohort studies.
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spelling doaj-art-f5731910a79b4a7ab123ab8561362d912025-01-26T12:37:14ZengBMCBMC Medicine1741-70152025-01-0123111810.1186/s12916-025-03860-2Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological studyJulia Stadelmaier0Gina Bantle1Lea Gorenflo2Eva Kiesswetter3Adriani Nikolakopoulou4Lukas Schwingshackl5Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of FreiburgInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of FreiburgInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of FreiburgInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of FreiburgInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of FreiburgInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of FreiburgAbstract Background In nutrition research, randomised controlled trials (RCTs) and cohort studies provide complementary evidence. This meta-epidemiological study aims to evaluate the agreement of effect estimates from individual nutrition RCTs and cohort studies investigating a highly similar research question and to investigate determinants of disagreement. Methods MEDLINE, Epistemonikos, and the Cochrane Database of Systematic Reviews were searched from January 2010 to September 2021. We matched individual RCTs to cohort studies based on population, intervention/exposure, comparator, and outcome (PI/ECO) characteristics. Two reviewers independently extracted study characteristics and effect estimates and rated the risk of bias using RoB2 and ROBINS-E. Agreement of matched RCTs/cohort studies was analysed by pooling ratio of risk ratios (RRR) and difference of (standardised) mean differences (DSMD). Results We included 64 RCT/cohort study pairs with 4,136,837 participants. Regarding PI/ECO similarity, 20.3% pairs were “more or less identical”, 71.9% “similar but not identical” and 7.8% “broadly similar”. Most RCTs were classified as “low risk of bias” (26.6%) or with “some concerns” (65.6%); cohort studies were mostly rated with “some concerns” (46.6%) or “high risk of bias” (47.9%), driven by inadequate control of important confounding factors. Effect estimates across RCTs and cohort studies were in high agreement (RRR 1.00 (95% CI 0.91–1.10, n = 54); and DSMD − 0.26 (95% CI − 0.87–0.35, n = 7)). In meta-regression analyses exploring determinants of disagreements, risk-of-bias judgements tend to have had more influence on the effect estimate than “PI/ECO similarity” degree. Conclusions Effect estimates of nutrition RCTs and cohort studies were generally similar. Careful consideration and evaluation of PI/ECO characteristics and risk of bias is crucial for a trustworthy utilisation of evidence from RCTs and cohort studies.https://doi.org/10.1186/s12916-025-03860-2Meta-epidemiological studyConcordanceRandomised controlled trialsCohort studies
spellingShingle Julia Stadelmaier
Gina Bantle
Lea Gorenflo
Eva Kiesswetter
Adriani Nikolakopoulou
Lukas Schwingshackl
Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
BMC Medicine
Meta-epidemiological study
Concordance
Randomised controlled trials
Cohort studies
title Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
title_full Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
title_fullStr Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
title_full_unstemmed Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
title_short Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study
title_sort evaluating agreement between individual nutrition randomised controlled trials and cohort studies a meta epidemiological study
topic Meta-epidemiological study
Concordance
Randomised controlled trials
Cohort studies
url https://doi.org/10.1186/s12916-025-03860-2
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