Authors: Tim Cook
Publish Date: 2014/05/23
Volume: 23, Issue: 7, Pages: 1579-1579
Abstract
We are writing to you to express our significant concerns about the methodology and validity of one of the articles published in your online journal on 31 December 2013 titled “A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with followup according to the SRS standardized criteria” 1 It is presented as a comparison of the treatment outcomes in users of the SpineCor brace with the users of a generic rigid brace treatmentThe SpineCor brace is a clinical tool like all other tools that requires correct application and management to avoid poor treatment outcomes SpineCor treatment itself is complex and requires a significant amount of training input to learn how to apply the brace correctly and how to manage the patient for the duration of the treatmentWe are astonished by the fact that none of the authors of this article or a previous publication in 2008 showing the initial results of the same cohort of patients 2 received any brace provider training whatsoever This must produce a strong bias to the results of their studyEvidence of the author’s lack of ability and understanding of the SpineCor brace is shown in the patient photo included in the initial publication of the same cohort of patients where the brace had clearly been fitted incorrectly 2 The photo provides proof that patients in the trial were not wearing complete braces by showing the absence of the thigh bands The thigh bands are of utmost importance for stabilising the lower ‘pelvic base’ section of the brace Without the thigh bands the pelvic base will migrate upwards and loosen which removes the effectiveness of the upper corrective part of the braceDuring the longterm treatment of a patient the replacement of brace component parts is required according to growth wear and tear and the loss of elasticity of the corrective part of the brace The historical records that we have access to show that not enough brace components were provided for the braces to be well maintained for the duration of treatmentFundamental to any clinical trial that aims to verify the efficacy of any brace treatment is the competence of the brace provider the correct use of the brace and the correct longterm management of the brace The above mentioned trial has fallen short of that and therefore the validity of the results presented within it is compromised
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