Significant increase in reporting of adverse events post-CONSORT statement of 2010
TUESDAY, Sept. 27, 2016 (HealthDay News) — Many randomized clinical trials (RCTs) involving spinal manipulative therapy (SMT) do not report adverse events, although there has been an increase in such reporting since publication of the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement, according to a review published in the September issue of The Spine Journal.
Lindsay M. Gorrell, B.Chiro.Sc., M.Chiroprac., from Macquarie University in Sydney, and colleagues conducted a systematic literature review to describe the extent of adverse event reporting in published RCTs involving SMT. A total of 368 articles were eligible for inclusion in the review. The differences in the proportions between pre- and post-CONSORT trials were calculated.
The researchers found that there were reports of adverse events in 38.0 percent of the articles. Post-CONSORT, there was a significant increase in the reporting of adverse events (P = 0.001). Only two major adverse events were reported (0.3 percent). Adverse events were reported in the abstract in 22 articles (15.7 percent). For the chosen parameters, there were no differences in reporting of adverse events post-CONSORT.
“Although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable,” the authors write. “We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.”
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