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Updated: Sep 26, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Pooling of cohort studies and RCTs affects GRADE certainty of evidence in nutrition research
Lukas Schwingshackl1, Blin Nagavci1, Julia Stadelmaier1
1Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Background:
There is a little empirical evidence of the impact of pooling randomized controlled trials (RCTs) and cohort studies (CSs) on the certainty-of-evidence. To evaluate the hypothetical-scenario of pooling bodies-of-evidence from RCTs with matched bodies-of-evidence from CSs on the certainty-of-evidence.
Methods:
We extracted GRADE ratings of bodies-of-evidence from RCTs in Cochrane reviews, and rated the certainty-of-evidence from matched bodies-of-evidence from CSs. We then evaluated the impact of pooling both bodies-of-evidence on the overall certainty-of-evidence, and on individual GRADE domains.
Results:
Fourty-two pooled bodies-of-evidence were rated, ranging from very-low (bodies-of-evidenceRCTs: 9.5%; bodies-of-evidenceCSs: 40.5%; pooled-bodies-of-evidence: 0%) to low (bodies-of-evidenceRCTs: 38.1%; bodies-of-evidenceCSs: 45.2%; pooled-bodies-of-evidence: 19.1%), moderate (bodies-of-evidenceRCTs: 33.4%; bodies-of-evidenceCSs: 14.3%; pooled-bodies-of-evidence: 57.1%), and high (bodies-of-evidenceRCTs: 19%; bodies-of-evidenceCSs: 0%; pooled-bodies-of-evidence: 23.8%). Certainty-of-evidence was downgraded mostly for imprecision and risk of bias for bodies-of-evidence from RCTs, and for risk of bias and inconsistency for bodies-of-evidence from CSs. Pooling both bodies-of-evidence mitigates rating down for imprecision compared to bodies-of-evidence from RCTs and inconsistency compared to bodies-of-evidence from CSs.
Conclusion:
Our hypothetical study suggests that pooling both bodies-of-evidence would reduce the amount of very-low and low certainty-of-evidence ratings, but how to integrate RCTs and CSs and whether or not to pool these bodies-of-evidence requires proper guidance before systematic review authors or guideline developers should consider this approach.
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