Adjoining section degeneration following ProDisc-C whole disc substitute (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
PURPOSE: Many investigators have reported the monetary conflicts of curiosity (COI), which may end in potential bias within the reporting of outcomes for sufferers present process whole disc substitute (TDR) somewhat than anterior cervical discectomy and fusion (ACDF). This bias could also be subconsciously launched by the investigator in a non-blinded radiographic evaluate. The aim of this research was to find out if bias was current when a gaggle of backbone specialists rated adjoining section degeneration (ASD) following cervical TDR or ACDF.
METHODS: Potential bias within the evaluation of ASD was evaluated by means of the opinions 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 evaluate, 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 had been assessed by the Kappa statistic.
RESULTS: The intra-rater reliability between opinions was substantial, indicating little to no bias in assessing ASD improvement/development. The Kappa statistics had 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 evaluate ranged from zero.316 to zero.607 (p < zero.0001) and from zero.221 to zero.644 (p < zero.0001) for the unblinded evaluate.
CONCLUSIONS: The information of the surgical process carried out didn’t bias the evaluation of ASD.
PMID: 27650387 [PubMed – indexed for MEDLINE]