Extended Abstract
Introduction
pinal deformity is one of the most common reasons for referring to specialized spinal clinics [1-4]. The existence of malformation in the appearance of the spine reduces the quality of life (QOL) of individuals [5, 6]. Although wearing a spinal brace can put high psychological pressure on a person [7-16], the physicians recommend their patients to wear braces for a long time to achieve the therapeutic goals [17]. Today, the relevant information is collected with questionnaires that have been designed specifically for each deformity. These tools are an affordable, inexpensive, and standard way to demonstrate a patient’s point of view during clinical trials [18, 19].
On the other hand, variables such as QOL cannot be measured in the long run because individual, environmental, and social changes can affect the QOL [20]. The Brace questionnaire (BrQ) [21], which has already been translated into Polish [22] and Italian [23], has been designed to examine a person’s level of satisfaction in various areas of life while wearing braces. It measures QOL in eight areas of general health perception, physical functioning, emotional functioning, self-esteem and aesthetics, vitality, school activity, bodily pain, and social functioning [22]. 
In a study conducted by Rezaee et al. [26] that translated this questionnaire into Persian, 51 people with idiopathic scoliosis living in Tehran were examined. The patients were treated only with Milwaukee braces, while in the main study [21] and other localization studies, short thoracolumbosacral orthosis type was used. Rezaee et al. reported that the Milwaukee brace reduced scores on self-image and self-esteem compared with other versions, making it difficult to generalize the results [26]. The low number of samples was another disadvantage of their study. To measure the repeatability of the questionnaire, they reduced the number of samples in the second stage to 38. 
However, a low sample size can affect the results of repeatability. In the main study and other localization studies, all samples were entered from the first stage to the second stage so that the reliability of the questionnaire in all of its subscales were measured better and more effectively. According to studies, the higher sample size increases the reliability of the tool, as well as the accuracy of the measurement [27, 28]. In this regard, and considering the disadvantages of Rezaee et al. study, we decided to translate and estimate the validity and reliability of the BrQ in assessing Iranian patients with scoliosis wearing short thoracolumbosacral orthosis braces.
Materials and Methods
In this study, 50 patients with scoliosis referred to specialized spinal clinics affiliated to Isfahan University of Medical Sciences were randomly assigned as study samples. The inclusion criteria were aged 10-18, literate, and worn spinal braces for at least four months [22]. Those with a history of spinal surgery were excluded from the study. The BrQ has 34 items and eight subscales of general health perception (items 1 and 2), physical functioning (items 3-9), emotional functioning (items 10-14), self-esteem and aesthetics (items 15 and 16), vitality (items 17 and 18), school activity (items 19-21), bodily pain (items 22-27), and social functioning (items 28-34), each rated based on a Likert-type scale. The total score ranged from 20 to 100, where higher scores indicate higher QOL. 
It was translated through six stages based on Beaton et al. [29] guidelines. It included the forward translation of original version by three bilingual speakers (native in English and Persian), comparing two translated drafts by specialists and interpreters, backward translation of initial translated version by three native English speakers, sending the English version to the developer for appraisal and receiving confirmation (that it is identical to the original version). Then, the initial Persian version was sent to ten orthotics and prosthetists and ten patients with scoliosis (pilot study) to examine its face validity. The approved pre-version was considered as the final Persian version of BrQ (BrQ-P). The BrQ-P and Scoliosis Research Society questionnaire (SRS-22r) were completed by 50 participants to assess its validity. 
The validity and reliability of Persian SRS-22r have already examined by Mousavi et al. [30]. SRS-22r has five domains of function, pain, mental health, self-image, and satisfaction/dissatisfaction with treatment [20]. This questionnaire was initially designed to assess the condition of a patient with scoliosis before and after surgery [31]. To determine test-retest reliability, both questionnaires were completed by the same participants again after seven days. The collected data were analyzed in SPSS by calculating the Cronbach α for measuring reliability, Intraclass Correlation Coefficient (ICC), and the Pearson correlation coefficient for testing the relationship between BrQ-P and SRS-22r.
Results
Participants were 8 boys and 42 girls with a Mean±SD age of 15.41±1.77 years. All of them had used Boston braces to treat their spinal deformities. Their mean duration of using the brace was 20.95±1.12 months; 56% used braces only during the day, and the remaining 44% use it only at night (Table 1). The BrQ-P was completed twice with a 7-day interval. The internal consistency of BrQ-P using the Cronbach α was an acceptable level (α=0.935). To assess the repeatability of the score of each subscale, the ICC was measured and found as 0.935 (95% confidence interval) (Table 2). According to Munro’s classification, the ICC for multi-item questionnaires should be above 70% to be acceptable [32, 33]; therefore, relatively high repeatability for the BrQ-P was determined. Table 3 presents the mean and standard deviation of patients’ BrQ-P and SRS-22r scores.
The overall score of the BrQ-P was between 42.5 and 69.25, where 25% and 75% of the total score were 52.37 and 57.68, respectively. These figures indicate that the QOL of patients was at a moderate level and was not high. In other words, more than half of the participants had a QOL level of higher than 50%, but it was not favorable. As shown in Table 3, only in a few domains of the QOL, 50% of patients’ satisfaction was met, which is considerable. Their lowest scores were in the areas of general health perception, self-esteem/aesthetics, and vitality. The Pearson correlation test results (Table 4) showed a significant correlation between BrQ-P and SRS-22r (P=0.001, r=0.90). This correlation coefficient was reported 0.82 in Aulisa et al. [25], both indicating a high correlation between these two questionnaires. There was also a strong association between the domains of BrQ-P and SRS-22r. However, the pain domain of the SRS-22r was poorly correlated to the physical and school functioning domains of BrQ-P.
Discussion
One of the most fundamental issues facing scholars and experts in the study of functional outcomes at the various individual and social levels is the design and development of appropriate questionnaires for the correct evaluation of the study variables at the international level. The goal is to have tools that meet the clinical and research needs of scholars at a desirable level [34, 35]. Today, patient-centered questionnaires can play an essential role in raising the awareness of specialists about the type of treatment prescribed to the patient, especially for the patients with spinal deformities that require braces to cover a larger area of the body. The age range of people with spinal deformity is usually between 10 and 18 years. 
At this age period and during skeletal maturation, these people are socially vulnerable. A questionnaire such as the SRS-22r has been designed to assess the various dimensions, including pain, function, and mental health, but it does not specifically measure the quality of life in adults and the impact of braces on them. Therefore, the BrQ was designed to evaluate the effect of Brace on various aspects of QOL [23]. This questionnaire is currently used in different countries and different languages.
Ten experts in the field of orthosis and prosthesis, as well as 10 people with scoliosis, reviewed the Persian translation of this questionnaire. They confirmed the ease of use and comprehensibility of the questionnaire items. A strong correlation between the overall scores of the BrQ-P and SRS-22r questionnaires and their subscales were found. These correlations have also been reported in other projects that translated the BrQ into other languages. For example, its Italian version has a strong correlation with SRS-22r (P<0.001, r=0.826) [25], as well as its Polish version [22]. The Cronbach α value indicated a good internal consistency between the subscales of the BrQ-P, similar to what has been reported for other versions. Overall, the researchers hope that by using the BrQ-P, more studies be conducted on the use of different types of spinal braces and their impact on people’s QOL.
All participants in this study had used Boston braces for treatment. A point that indicates the popularity of this brace type compared with other braces such as Milwaukee. One of the limitations of this study was the small number of male samples. Also, the samples were evaluated only in Isfahan Province. By using more samples in both genders and implementing them in a wider geographical area, it is possible to make a better and more accurate judgment about the research outcome and generalize the results to the whole Persian-speaking population. To evaluate the quality of spinal braces during treatment, we recommended that individuals be evaluated by using this questionnaire to raise the awareness of the treatment team about the quantitative and qualitative process of patients’ treatment. Therefore, the design and translation of such questionnaires can be done to use in research and clinical fields.
Conclusion
The BrQ-P can be used as a valid and reliable tool to assess the QOL of people with scoliosis.
Ethical Considerations
Compliance with ethical guidelines
The Research Ethics Committee of Isfahan University of Medical Sciences approved this study (Code: IR.MUI.REC.1394.2.124). 
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Authors' contributions
Conceptualization: Ebrahim Sadeghi-Demneh; Methodology, investigation, writing – original draft, writing – review & editing, supervision: all author.
Conflicts of interest
The authors have no conflicts of interest to disclose.