Chinese validation of the quality of life profile for spinal deformities (QLPSD).

We aimed to translate and validate the Quality of Life Profile for Spine Deformities (QLPSD), an age-specific tool assessing the individuals' health-related quality of life (HRQoL), into a Chinese version for adolescent individuals with adolescent idiopathic scoliosis (AIS). The Chinese version was translated from the original Spanish QLPSD following widely accepted guidelines and evaluated by both individuals with AIS and experts. 172 Chinese-speaking individuals between 9 and 18 years of age with Cobb angles between 20° and 40° were included. Internal consistency, test-retest reliability, and floor and ceiling effects were all analyzed. Convergent validity was evaluated by correlating the measures in the Chinese QLPSD with those in the 22-item Scoliosis Research Society Questionnaire (SRS-22). Known-groups construct validity was assessed by comparing the QLPSD scores of two groups of individuals divided by their Cobb angles. The internal consistency (total Cronbach's alpha = 0.917) and the test-retest reliability (total intra-class correlation coefficient = 0.896) were both satisfactory. The Chinese QLPSD correlated well with the SRS-22 in the total score and in relevant subscales (r = -0.572, p < 0.01). The questionnaire was able to differentiate between individuals with different Cobb angles. No floor or ceiling effects were shown in the total score, neither were there ceiling effects in the subscales, but floor effects were observed in four of the five subscales, between 20.0% and 45.7%. The Chinese version of the QLPSD shows adequate transcultural adaptation, reliability, and validity, and is useful as a clinical evaluation tool for the HRQoL of adolescent Chinese-speaking individuals with AIS.

Reliability and validity of simplified Chinese version of the Italian spine youth quality of life questionnaire in adolescents with idiopathic scoliosis.

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.

Translation and validation of the Chinese version of Brace Questionnaire (BrQ).

BACKGROUND: The Brace Questionnaire (BrQ) is a tool developed to assess the health-related quality of life (HRQoL) among patients with adolescent idiopathic scoliosis (AIS) who receiving bracing as the primary treatment. It was initially developed and validated in Greek. The current study aimed to culturally adapt and psychometrically validate the BrQ in contemporary Chinese used in mainland China. METHODS: Translation of the BrQ from the original Greek into Chinese was performed. This study involved 70 Chinese adolescents between 10 and 18 years of age with a diagnosis of AIS and a Cobb angle measuring between 20 and 40 degrees. All patients received the same kind of brace for more than 4 months. Statistical analyses included internal consistency and the floor and ceiling effects of the BrQ. Subsequently, convergent validity was evaluated by correlating the measures in the BrQ with those in the Scoliosis Research Society-22 Questionnaire (SRS-22). RESULTS: There were no floor and ceiling effects observed with the Chinese version of BrQ. The intra-class correlation coefficient (ICC) was 0.967. Internal consistency as measured by Cronbach's alpha was 0.923. The global BrQ score correlated strongly with the SRS-22 total score (r=0.743, P<0.001). Most domain-level sub-scores from the BrQ correlated with the respective domain scores of SRS-22. CONCLUSIONS: Cross-cultural translation and validation demonstrated excellent reliability, high internal consistency and satisfactory concurrent validity of the Chinese version of BrQ.

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.

INTRODUCTION: Adolescent 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 ANALYSIS: Patients 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 DISSEMINATION: This 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 NUMBER: ChiCTR1900027379, pre-results.