80% of adverse events are never published

You probably missed this study in the BMJ, as it didn’t really hit the headline news like the Yale Study findings of the INFUSE Bone Graft did.

Yet, it is one of the most important findings on the publication of adverse events in full I have seen for some time.

Based on the comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion, Rogers and colleagues looked at the reporting of industry funded study outcome data.

What did they do?

‘identified publications and conference abstracts through comprehensive literature searches. We compared outcomes provided in the individual participant data against outcomes reported in publications.’

What did they find?

far fewer total adverse events were reported across publications than were collected in the individual participant data. Around 18.5% of adverse events recorded in the individual participant data across all randomised controlled trials (published and unpublished) have been reported somewhere in the published literature

What did they conclude?  

The published literature only partially represents the total data known to have been collected on the effects of rhBMP-2. This did not lead to substantially different results for meta-analysis of effectiveness outcomes. In contrast, reporting of adverse event data in trial publications was inadequate and inconsistent to the extent that any systematic review based solely on the publicly available data would not be able to properly evaluate the safety of rhBMP-2.

 You can read my rapid response on the BMJ  which concludes: ‘…….systematic reviews methods require a rethink. If journal publications and conferences abstracts are the only data available for analysis, then an interim solution may be downgrading the quality of the evidence, until more substantive data is made available and included in the analysis.’   

 

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