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Adjoining phase degeneration following ProDisc-C whole disc alternative (TDR) and anterior cervical discectomy and fusion (ACDF): does surgeon bias impact radiographic interpretation?
Eur Backbone J. 2017 Apr;26(four):1199-1204
Authors: Laxer EB, Brigham CD, Darden BV, Bradley Segebarth P, Alden Milam R, Rhyne AL, Odum SM, Spector LR
Summary
PURPOSE: Many investigators have reported the monetary conflicts of curiosity (COI), which might lead to potential bias within the reporting of outcomes for sufferers present process whole disc alternative (TDR) somewhat than anterior cervical discectomy and fusion (ACDF). This bias could also be subconsciously launched by the investigator in a non-blinded radiographic overview. The aim of this research was to find out if bias was current when a gaggle of backbone specialists rated adjoining phase degeneration (ASD) following cervical TDR or ACDF.
METHODS: Potential bias within the evaluation of ASD was evaluated via the evaluations of cervical radiographs (pre- and 6 years post-operative) from sufferers collaborating within the ProDisc-C FDA trial (ProDisc-C IDE #G030059). The index degree was blinded on all radiographs throughout the first overview, however unblinded within the second. 5 reviewers (a radiologist, two non-TDR surgeons, and two TDR surgeons), two of whom had a COI with the ProDisc-C trial sponsor, assessed ASD on a 3 level scale: sure, no, or unable to evaluate. Intra- and inter-rater reliabilities between all raters have been assessed by the Kappa statistic.
RESULTS: The intra-rater reliability between evaluations was substantial, indicating little to no bias in assessing ASD growth/development. The Kappa statistics have been zero.580 and zero.644 for the TDR surgeons (p < zero.0001), zero.718 and zero.572 for the non-TDR surgeons (p < zero.0001), and zero.642 for the radiologist (p < zero.0001). Inter-rater reliability for the blinded overview ranged from zero.316 to zero.607 (p < zero.0001) and from zero.221 to zero.644 (p < zero.0001) for the unblinded overview.
CONCLUSIONS: The information of the surgical process carried out didn’t bias the evaluation of ASD.
PMID: 27650387 [PubMed – indexed for MEDLINE]