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Slobogean GP, Soswa L, Rotunno G, et al. Digital blinding of radiographs to mask allocation in a randomized control trial. World J Orthop. 2017;8(10):785-789doi: 10.5312/wjo.v8.i10.785.
Slobogean, G. P., Soswa, L., Rotunno, G., O'Brien, P. J., & Lefaivre, K. A. (2017). Digital blinding of radiographs to mask allocation in a randomized control trial. World journal of orthopedics, 8(10), 785-789. https://doi.org/10.5312/wjo.v8.i10.785
Slobogean, Gerard P, et al. "Digital blinding of radiographs to mask allocation in a randomized control trial." World journal of orthopedics vol. 8,10 (2017): 785-789. doi: https://doi.org/10.5312/wjo.v8.i10.785
Slobogean GP, Soswa L, Rotunno G, O'Brien PJ, Lefaivre KA. Digital blinding of radiographs to mask allocation in a randomized control trial. World J Orthop. 2017 Oct 18;8(10):785-789. doi: 10.5312/wjo.v8.i10.785. eCollection 2017 Oct 18. PMID: 29094009; PMCID: PMC5656494.
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World J Orthop. 2017 Oct 18;8(10):785-789. doi: 10.5312/wjo.v8.i10.785. eCollection 2017 Oct 18.

Digital blinding of radiographs to mask allocation in a randomized control trial.

World journal of orthopedics

Gerard P Slobogean, Lukasz Soswa, Giuliana Rotunno, Peter J O'Brien, Kelly A Lefaivre

Affiliations

  1. Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD 21201, United States. [email protected].
  2. Department of Orthopaedics, University of British Columbia, Vancouver V5Z 1M9, Canada.
  3. University of Maryland School of Medicine, Baltimore, MD 21201, United States.

PMID: 29094009 PMCID: PMC5656494 DOI: 10.5312/wjo.v8.i10.785

Abstract

AIM: To demonstrate the effectiveness of a digital radiographic altering technique in concealing treatment allocation to blind outcome assessment of distal femur fracture fixation.

METHODS: Digital postoperative anteroposterior and lateral radiographs from a sample of 33 randomly-selected patients with extra-articular distal femur fractures treated by surgical fixation at a Level 1 trauma center were included. Using commercially available digital altering software, we devised a technique to blind the radiographs by overlaying black boxes over the implant hardware while preserving an exposed fracture site for assessment of fracture healing. Three fellowship-trained surgeons evaluated a set of blinded radiographs twice and a control set of unblinded radiographs once. Each set of radiographs were reviewed independently and in a randomly-assigned order. The degrees of agreement and disagreement among evaluators in identifying implant type while reviewing both blinded and unblinded radiographs were assessed using the Bang Blinding Index and James Blinding Index. The degree of agreement in fracture union was assessed using kappa statistics.

RESULTS: The assessment of blinded radiographs with both the Bang Blinding Index (BBI) and James Blinding Index (JBI) demonstrated a low degree of evaluator success at identifying implant type (Mean BBI, far cortical locking: -0.03, SD: 0.04; Mean BBI, standard screw: 0, SD: 0; JBI: 0.98, SD: 0), suggesting near perfect blinding. The assessment of unblinded radiographs with both blinding indices demonstrated a high degree of evaluator success at identifying implant type (Mean BBI, far cortical locking: 0.89, SD: 0.19; Mean BBI, standard screw: 0.87, SD: 0.04; JBI: 0.26, SD: 0.12), as expected. There was moderate agreement with regard to assessment of fracture union among the evaluators in both the blinded (Kappa: 0.38, 95%CI: 0.25-0.52) and unblinded (Kappa: 0.35, 95%CI: 0.25-0.45) arms of the study. There was no statistically significant difference in fracture union agreement between the blinded and unblinded groups.

CONCLUSION: The digital blinding technique successfully masked the surgeons to the type of implant used for surgical treatment of distal femur fractures but did not interfere with the surgeons' ability to reliably evaluate radiographic healing at the fracture site.

Keywords: Femoral fractures; Fracture healing; Methods; Patient outcome assessment; Randomized controlled trials

Conflict of interest statement

Conflict-of-interest statement: The authors certify that they, or a member of their immediate families, have no funding or commercial associations.

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