Background The Italian Spine Youth Quality of Life (ISYQOL) questionnaire is used to evaluate health-related quality of life in adolescents with Idiopathic Scoliosis. The study aimed to undertake the process of cultural adaptation of the ISYQOL questionnaire into Simplified Chinese. Methods Translate from Italian into Simplified Chinese. It involved 138 adolescents whose Cobb angle ranged between 20 and 40 degrees, 50 wearing the brace and 88 not wearing the brace. Statistical analysis calculated the reliability, floor effects, and ceiling effects of the ISYQOL. After that, construct validity was measured by analyzing the ISYQOL relationship Scoliosis Research Society-22 patient Questionnaire (SRS-22). Results There were no floor or ceiling effects in the ISYQOL questionnaire. Cronbach’s alpha coefficient evaluated for Internal consistency was 0.75 in the no-treated group and 0.88 in the brace-treated group. Intraclass correlation coefficients assessed with the use of the test-retest method were 0.72 in the no-treated group and 0.80 in the brace-treated group. A strong relationship exists between the ISYQOL measure and SRS-22 scores (rho = 0.62; p < 0.01), reflecting the high validity of the questionnaires. Both ISYQOL and SRS-22 scores showed no statistical difference between groups wearing and not wearing the brace (p > 0.05). Conclusions Trans-cultural validation in Chinses language showed the reliability and validity of the ISYQOL.
IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.
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