Does Patient Blinding Influence Clinical Outcomes After Annular Closure Device Implantation? A Propensity Score-Matched Analysis
Received 24 May 2019
Accepted for publication 25 October 2019
Published 8 November 2019 Volume 2019:11 Pages 177—182
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor Clark Hung
Gerrit J Bouma,1 Wimar van den Brink,2 Larry E Miller,3 Jasper FC Wolfs,4 Mark P Arts5
1Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, Amsterdam, The Netherlands; 2Neurochirurgisch Centrum Zwolle, Zwolle, The Netherlands; 3Miller Scientific Consulting, Asheville, NC, USA; 4Haaglanden Medical Center Westeinde Antoniushove, Leidschendam, The Netherlands; 5Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, The Netherlands
Correspondence: Gerrit J Bouma
Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, P.O. Box 22700, Amsterdam 1100 DD, The Netherlands
Background: Awareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation.
Methods: This was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device- or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded.
Results: There were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device- or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients.
Conclusion: In patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment.
Keywords: annulus fibrosus, blinding, disc, discectomy, elderly, herniation, lumbar, sciatica
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