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Mitigating adverse event reporting bias in spine surgery.

Joshua D Auerbach¹, Kevin B McGowan, Marci Halevi

¹Department of Orthopaedics, Bronx-Lebanon Hospital Center, Albert Einstein College of Medicine, Bronx, NY 10457, USA. auerspine@gmail.com

The Journal of Bone and Joint Surgery. American Volume

|August 23, 2013

Summary

An independent Clinical Events Committee (CEC) reclassified 37% of adverse events in a spine surgery trial, often upgrading severity and relatedness. This highlights the CEC's role in mitigating investigator bias for accurate safety assessments.

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Area of Science:

Spine Surgery
Clinical Trials
Medical Device Safety

Background:

Concerns exist regarding honest adverse event reporting in industry-sponsored spine surgery studies.
Independent Clinical Events Committees (CECs) can review and reclassify adverse events to mitigate potential bias.
No prior studies have quantified investigator bias in adverse event reporting or the effect of CECs.

Purpose of the Study:

To quantify investigator bias in adverse event reporting.
To assess the effect of an independent CEC on mitigating potential bias in spine surgery trials.

Main Methods:

A prospective randomized controlled trial (coflex Investigational Device Exemption study) compared coflex stabilization to lumbar spinal fusion.
Investigators classified adverse event severity and relationship to surgery/device.

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An independent CEC of three spine surgeons reclassified all submitted adverse event reports.

Main Results:

The CEC reclassified 37.3% of 1055 adverse events.
Reclassification proportions were similar between coflex and fusion groups (37.9% vs. 36.0%).
The CEC was significantly more likely to upgrade adverse event severity (5.3x) and relatedness to surgery (7.3x) or device (11.6x). Investigator financial interest had minimal impact.

Conclusions:

A substantial proportion of adverse events were reclassified by the CEC, primarily as upgrades in severity or relatedness.
Independent CECs can identify and mitigate investigator bias, ensuring accurate safety assessments for investigational devices.
CECs should be a standard component of future clinical trials to enhance device safety evaluation.