This study was approved by the Ethics Committee of Baoding Second Central Hospital. A retrospective investigation was conducted on AIS patients who received brace treatment in Baoding Second Central Hospital from January 2019 to December 2021. This study was approved by the Medical Ethics Committee of Baoding Second Central Hospital (No.202141). All patients gave informed consent and signed an informed consent form.
Inclusion criteria: Age > 10 years old when brace treatment was started, Risser Sign ≤ 2, initial Cobb angle 20°-45°, and no other treatment.
Exclusion criteria: Patients with congenital spinal deformities, neuromuscular scoliosis, or other musculoskeletal disorders.
Questionnaire Assessment Before Brace Wearing
The content of the questionnaire evaluation included the Eysenck personality questionnaire, the family environment scale, and the school environment. The data entry was performed using the EPIDATA data entry program uniformly prepared by the project team. A special person is responsible for entering the original data in the form of double entry. Since the completion of the questionnaire requires an education level above elementary school, some patients who have not graduated from primary school are assisted by their parents to fill it out.
The Eysenck Personality Questionnaire (EPQ)[8] is used to evaluate the personality tendency of adolescent patients, including four subscales: E(extroversion or introversion), N(emotional stability), P(psychoticism), and L(maskability). Among them, E, N, and P test the three personality dimensions respectively, and L is the validity scale to measure lying and concealment.
The third edition of the Family Environment Scale compiled by MOSS[9] is used to evaluate the family environment. The scale has 90 items in total, each with a score of 0.1. It is summarized into 10 dimensions and evaluates 10 different family environment characteristics: Intimacy; emotional expression; ambivalence; independence; success; culture; entertainment; morality and religion; organization; control. Among them, intimacy, ambivalence, culture and organization have high reliability and validity in the Chinese population. Since the research mainly focuses on factors related to adolescent psychology, this study only includes three dimensions of intimacy, ambivalence, and culturality for investigation.
Assessment of the school environment: The Visual Analogue Scale (VAS) was used to assess the relationship between teachers and students and classmates in the school. A score of 1 to 5 is considered poor, and a score greater than 5 is considered good.
Standardized Brace Manufacturing Process
According to the principle of Chêneau-Brace production, the initial degree of correction is adjusted according to the stiffness of spine, and the later adjustment is made according to the comfort of the patient after wearing it (Figure. 1). All braces are made by the same orthopedist, and the production material is poly Vinyl planks. The traditional plaster molding process is used to make the brace. Brace production requirements: the front opening of the orthosis is about 6 cm; the side edge of the orthosis must not press the greater trochanter; the lowest point of the lower edge of the back of the orthosis is kept at a distance of 2 to 3cm from the stool surface; the lowest point of the front lower edge of the orthosis is 2cm above the pubic symphysis; The edge of the groin at the lower front of the orthosis is 3 to 5 cm below the anterior superior iliac spine. After the brace is made, the patient will try it on initially, and evaluate the following conditions: the patient's feeling of the back, chest and waist pressure pads; whether the position of the open area meets the requirements and comfort; the contact between the edge of the window and the body must not Squeeze the skin and soft tissue; whether the pressure and edge cutting of the upper edge of the back of the brace meet the requirements; the attachment of the brace to the body to improve the concealment performance of the brace after wearing. Re-modifications were made when necessary to improve patient comfort and reduce the impact of the brace on the patient's daily life.
Compliance Evaluation
Follow-up was conducted at 1, 3, 6, and 12 months after wearing the brace, and the patients were instructed to wear the brace for 22 hours a day.
The patient records the amount of time the brace is worn each day on a diary sheet. The compliance log form includes: 1. How long the brace was worn at night? 2. How long was the brace worn at school? 3. How long the brace was worn at other times? Calculate the time sum of these three parts. Studies have shown that in order to control the progression of scoliosis, braces need to be worn for more than 20 hours[10]. According to the brace wearing time of patients, patients who wear braces for 20 hours or more per day will enter the compliance group, and patients who wear braces for less than 20 hours per day will enter the control group .
The reliability of the adherence log was assessed during each visit, including examination of brace wear, patient skill in putting on and removing the brace, and skin discoloration caused by the brace in areas of pressure on the patient.
Statistical Methods
SPSS 25.0 was used for statistical analysis of retrospective survey design. The t-test was used to compare the environmental psychological parameters of the patient sample with the Chinese norm to determine the representativeness of the patient sample. The relationship between each independent variable and compliance was preliminarily evaluated by Pearson χ2 test or independent sample t test, and the selected variables with P < 0.05 were subjected to multivariate Logistic regression analysis to determine the relevant factors of compliance.