In the Eye of the Beholder: Commentary on an article by Joshua D. Auerbach, MD, et al.: “Mitigating Adverse Event Reporting Bias in Spine Surgery”

第一作者：Jeffery L. Stambough

2013-11-19 点击量：581 　　我要说

Auerbach et al. should be congratulated on the publication of their paper on mitigating bias in the reporting of adverse events in spine surgery. Equal praise is deserved by Paradigm Spine, the corporate sponsor of the Level-I, prospective, randomized multicenter study of the coflex interlaminar stabilization device, for incorporating a Clinical Events Committee (CEC) for the readjudication of the study’s adverse events and device-related complications end point.

It has been said that “the data is the data.” The rub is often in the interpretation and presentation of those data, which are complicated by a wide variety of biases—both perceived and real. This process is even more likely exposed to biases when subjective rather than objective ratings are involved. The primary issue addressed by Auerbach et al. is the fact that adverse events and complications tend to be underreported by the principal investigator or those intimately involved in the study, who may or may not have additional financial or other conflicts of interests. Certainly, there seems to be a human tendency to minimize the bad and maximize the good. This does not imply malice or dishonesty. Regardless, this tendency is a source of observational bias¹.

In this study, the CEC members, three independent blinded spine surgeons, were commissioned to recategorize adverse events into one of three severity categories (mild, moderate, severe) and also to reassess the relationship of reported complications to the device or surgery in one of five categories (unrelated, unlikely, possibly, probably, or definitely). These are subjective rankings, although numerical values could be applied. Furthermore, these independent spine surgeons were knowledgeable, were trained, and had no financial interest in or relationship to the study sponsor or investigators. These physicians reviewed the complications in one day and repeated the process about two years later, demonstrating that their subjective ratings were consistent and reliable over that period of time.

Thirty-seven percent of the reported adverse events and complications were reclassified by the CEC. The vast majority of these, 89%, were upgraded. Of those upgraded in relatedness, about 10% to 20% moved from the lower three rankings (unrelated, likely, possibly) to a probable or definite ranking. It is important not to extrapolate or infer any significance of this fact. It simply means that these independent evaluators were stricter on average in their rankings. It does not mean that the data were different, nor does it imply clinical significance, much less a good or bad interpretation. Interestingly, potential financial conflicts of interest were not demonstrated to be a factor in the reassignment or readjudication of adverse events and related complications in this study.

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