Adverse Event Reporting in a Federally Funded Randomized Clinical Trial

Background: Randomized controlled trials are a significant contributor to inform the public about efficacy and safety of treatment interventions. To appropriately inform the public about safety, methodology of adverse event data collection needs to be uniformly reported. Spinal manipulation (SM) is a common intervention for spinal pain, but there is a need to uniformly report on SM safety.

Methods: An Adverse Event (AE) is defined as: any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it is considered to be related to study treatment. A serious adverse event is defined as any adverse event occurring during the study or within 30 days of conclusion resulting in any one of the following outcomes: death, life threatening, persistent or significant disability/incapacity, hospitalization.

Results: 114 patient's data revealed 6 serious adverse events. None of the serious adverse events were considered study related. We also will report adverse events which, for the purpose of the study are broken into “post treatment soreness” and “other”. In the “other” category 53 events are reported, 5 of which are considered study related. Each of the adverse events is coded to the World Health Organization Adverse Event Term (WHOART).

Conclusion: Adverse event reporting is an integral part of performing randomized controlled trials. We will present our methodology including data collection and coding. We hope that this will lead to a standardized methodology for adverse event reporting for randomized controlled trials investigating spinal manipulation in the future.