The study recorded 368 articles for “classification of adverse events; completeness of adverse events reporting; nomenclature used to describe the events; methodological quality of the study and details of the publishing journal.” Researchers compared between pre- and post-CONsolidated Standards of Reporting Trials.
Here are seven takeaways:
1. Out of the 368 articles reviewed, researchers identified adverse events in 140 articles.
2. Researchers noted a significant spike in adverse events reporting in post-CONSORT trials.
3. The study identified two major adverse events.
4. Of the reviewed articles, 22 articles included adverse events reporting in the abstracts.
5. No differences existed among post-CONSORT articles in terms of adverse events reporting in any of the parameters.
6. Researchers concluded the level of adverse events reporting is “inadequate and unacceptable,” even though there was an increase after the release of the 2010 CONSORT guidelines.
7. They suggested all authors “adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.”
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