Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview
Background:
There is considerable debate as to the relative merits of using randomised
controlled trial (RCT) data as opposed to observational data in systematic
reviews of adverse effects. This meta-analysis of meta-analyses aimed to
assess the level of agreement or disagreement in the estimates of harm
derived from meta-analysis of RCTs as compared to meta-analysis of
observational studies.
Methods and Findings:
Searches were carried out in ten databases in addition to reference checking,
contacting experts, citation searches, and hand-searching key journals,
conference proceedings, and Web sites. 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.
Nineteen studies, yielding 58 meta-analyses, were identified for inclusion.
The pooled ratio of odds ratios of RCTs compared to observational studies
was estimated to be 1.03 (95% confidence interval 0.93–1.15).
There was less discrepancy with larger studies. The symmetric funnel plot
suggests that there is no consistent difference between risk estimates from
meta-analysis of RCT data and those from meta-analysis of observational
studies. In almost all instances, the estimates of harm from meta-analyses
of the different study designs had 95% confidence intervals that
overlapped (54/58, 93%). In terms of statistical significance, in
nearly two-thirds (37/58, 64%), the results agreed (both studies
showing a significant increase or significant decrease or both showing no
significant difference). In only one meta-analysis about one adverse effect
was there opposing statistical significance.
Conclusions:
Empirical evidence from this overview indicates that there is no difference
on average in the risk estimate of adverse effects of an intervention
derived from meta-analyses of RCTs and meta-analyses of observational
studies. This suggests that systematic reviews of adverse effects should not
be restricted to specific study types.
:
Please see later in the article for the Editors' Summary
Vyšlo v časopise:
Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview. PLoS Med 8(5): e32767. doi:10.1371/journal.pmed.1001026
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001026
Souhrn
Background:
There is considerable debate as to the relative merits of using randomised
controlled trial (RCT) data as opposed to observational data in systematic
reviews of adverse effects. This meta-analysis of meta-analyses aimed to
assess the level of agreement or disagreement in the estimates of harm
derived from meta-analysis of RCTs as compared to meta-analysis of
observational studies.
Methods and Findings:
Searches were carried out in ten databases in addition to reference checking,
contacting experts, citation searches, and hand-searching key journals,
conference proceedings, and Web sites. 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.
Nineteen studies, yielding 58 meta-analyses, were identified for inclusion.
The pooled ratio of odds ratios of RCTs compared to observational studies
was estimated to be 1.03 (95% confidence interval 0.93–1.15).
There was less discrepancy with larger studies. The symmetric funnel plot
suggests that there is no consistent difference between risk estimates from
meta-analysis of RCT data and those from meta-analysis of observational
studies. In almost all instances, the estimates of harm from meta-analyses
of the different study designs had 95% confidence intervals that
overlapped (54/58, 93%). In terms of statistical significance, in
nearly two-thirds (37/58, 64%), the results agreed (both studies
showing a significant increase or significant decrease or both showing no
significant difference). In only one meta-analysis about one adverse effect
was there opposing statistical significance.
Conclusions:
Empirical evidence from this overview indicates that there is no difference
on average in the risk estimate of adverse effects of an intervention
derived from meta-analyses of RCTs and meta-analyses of observational
studies. This suggests that systematic reviews of adverse effects should not
be restricted to specific study types.
:
Please see later in the article for the Editors' Summary
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Štítky
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