Adverse events recording and reporting in clinical trials of cervical total disk replacement.
Adverse events reporting in pivotal trials of new technologies, such as cervical total disk replacement, are essential to determine safety. Important questions concerning the adequacy of reporting about such new technologies in peer-reviewed publications have prompted this analysis to assess the safety of cervical disk replacement compared with fusion as presented in peer-reviewed publications and FDA summary reports. Identifying differences among these reports highlight the poor quality of adverse event reporting in the peer-reviewed literature. Nine peer-reviewed studies and five FDA summary reports documented excellent safety for both cervical fusion and disk arthroplasty. No differences in rates of adverse events were found to exist between the two treatments. The methods of recording and the actual reporting of adverse events were poor in peer-reviewed manuscripts, whereas they were comprehensive but difficult to clinically apply in the FDA summaries. Recommendations to improve documentation and reporting of adverse events are presented.
Professor, Department of Orthopedic Surgery and Rehabilitation, University of Wisconsin, Madison, Wisconsin.
Paul A
PA
Anderson
Robert A
RA
Hart
D000328:Adult; D002574:Cervical Vertebrae / Q000601:surgery*; D017586:Diskectomy / Q000009:adverse effects; D006801:Humans; D017063:Outcome Assessment, Health Care; D011843:Radiculopathy / Q000209:etiology / Q000473:pathology / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic; D012086:Reoperation / Q000009:adverse effects; D012107:Research Design; D058028:Research Report; D013118:Spinal Cord Diseases / Q000209:etiology / Q000473:pathology / Q000601:surgery*; D013123:Spinal Fusion / Q000009:adverse effects*; D059145:Total Disc Replacement / Q000009:adverse effects*