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Electronic monitoring improves brace-wearing compliance in patients with adolescent idiopathic scoliosis: a randomized clinical trial [with consumer summary]
Miller DJ, Franzone JM, Matsumoto H, Gomez JA, Avendano J, Hyman JE, Roye DP Jr, Vitale MG
Spine 2012 Apr 20;37(9):717-721
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess whether monitoring increases brace-wearing compliance in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Noncompliance is a barrier to brace treatment of AIS. Studies have demonstrated that monitoring improves medication compliance; however, this has not been investigated in spinal braces. METHODS: Twenty-one patients (mean age 12.4 +/- 2.0 years) with AIS were prescribed treatment with a custom-made Thoraco-Lumbo-Sacral-Orthosis for 18 hours a day using a standardized script. Before beginning treatment, 10 patients were randomized to be informed that their compliance was monitored, whereas 11 patients were unaware. Compliance was measured via a temperature probe embedded within the Thoraco-Lumbo-Sacral-Orthosis hidden from view. RESULTS: Patients who were notified that they had a monitor in their brace demonstrated significantly increased compliance during the first 14 weeks of treatment compared with those who were uninformed (85.7% versus 56.5%, p = 0.029), corresponding to a mean difference of 5.24 hours of daily brace wear. CONCLUSION: Electronic monitoring can improve compliance with orthoses in patients with spinal deformity during a short observation period.
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