2011
DOI: 10.1371/journal.pmed.1001026
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Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview

Abstract: Su Golder and colleagues carry out an overview of meta-analyses to assess whether estimates of the risk of harm outcomes differ between randomized trials and observational studies. They find that, on average, there is no difference in the estimates of risk between overviews of observational studies and overviews of randomized trials.

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Cited by 240 publications
(178 citation statements)
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References 118 publications
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“…These study designs, in real-world clinics and with larger samples, allow for collecting data on adverse events not found in RCTs such as rare events, longterm effects, events that occur after treatment discontinuation, as well as events incurred by malpractice [59]. In addition, safety monitoring could be prioritized in pilot and case studies of new interventions.…”
Section: Accepted M Manuscriptmentioning
confidence: 99%
“…These study designs, in real-world clinics and with larger samples, allow for collecting data on adverse events not found in RCTs such as rare events, longterm effects, events that occur after treatment discontinuation, as well as events incurred by malpractice [59]. In addition, safety monitoring could be prioritized in pilot and case studies of new interventions.…”
Section: Accepted M Manuscriptmentioning
confidence: 99%
“…Moreover, confounding is a matter of degree. For the association between a vegetarian diet and thrombosis, the confounding will be almost intractable, whereas it has been shown that side effects can reliably be assessed in observational studies, as confounding is only marginally an issue 11, 12. Importantly, standard statistical techniques (including propensity scores) cannot fully adjust for unmeasured confounding.…”
Section: Risk Of Bias Analysismentioning
confidence: 99%
“…Recently, Golder studied how individual mood varies from hour-to-hour, day-to-day, and across seasons and cultures by measuring positive and negative effect in Twitter posts, using the lexicon LIWC [10]. Studies were included where a pooled relative measure of an adverse effect (odds ratio or risk ratio) from RCTs could be directly compared, using the ratio of odds ratios, with the pooled estimate for the same adverse effect arising from observational studies.…”
Section: Related Workmentioning
confidence: 99%