- 2017;20;E1081-E1090Analysis of Reporting Bias in Vertebral Augmentation
Douglas P. Beall, MD, Sean M. Tutton, MD, Kieran Murphy, MD, Wayne Olan, MD, Christopher Warner, MD, and Jack B. Test, BS.
Osteoporotic vertebral compression fractures (OVCFs) are a significant cause of morbidity and mortality in the United States and worldwide, with estimates of 750,000 to 1.5 million occurring annually. As the elderly population continues to increase, the incidence of OVCFs will continue to rise, as will the morbidity and mortality associated with this condition. Vertebral augmentation (VA) was almost universally accepted as the appropriate treatment modality prior to 2 sham trials published in 2009 by the New England Journal of Medicine (NEJM). Subsequently, there is now significant controversy regarding the optimal treatment of OVCFs. Since 2009 there have been 6 prospective randomized controlled studies (PRCTs) and 2 meta-analyses on VA for the treatment of OVCFs. Five of the PRCTs and both of the meta-analyses have shown superior results with VA as compared with nonsurgical management (NSM).
However, a recent health technology assessment and review article continue to over-emphasize the 2 NEJM sham trials, despite the most current literature. These are examples of inconsistent or biased data reporting with overemphasis on certain trial types and exclusion of other types of data, resulting in the reporting of conclusions that are partially representative or not representative of the complete data. As clinical investigators, we have a responsibility to limit bias and ensure that the appropriate treatment modalities are made available to vulnerable populations.
The aim of this perspective analysis is to examine sources of bias in reporting and some of the publications that contain it, along with comparing the publications to the current body of published literature relevant to this topic.
KEY WORDS: Vertebral augmentation, vertebroplasty, kyphoplasty, bias, osteoporosis, compression fracture