**2. Study 1: qualitative investigation of patients' experiences of living with scoliosis and using a soft brace.**

### **2.1 Method**

### *2.1.1 Participants*

For participants to be eligible for this part of the overall study, they were required to wear the brace for 6 months. This time period was selected as clinicians felt it would be where the most noticeable changes in the patients' health and pain scores would be observed. Furthermore, 6 months gave enough time for any initial teething problems with wearing the brace to be identified and resolved, as well as allowing the patients to reflect on their experiences of wearing the brace over a reasonable period of time. In total, eight participants, 1 male and 7 female, aged 55 and over were eligible for the semi-structured interviews.

### *2.1.2 Ethical approval*

Ethical approval was granted by the NHS and the university research ethics committee of the first author. All participants were provided with a participant information sheet which provided a detailed explanation of the purpose of the study. A consent form asked participants to confirm that they had read the information sheet and fully understood what was being asked and whether they were happy to take part, if they met the inclusion criteria and did not match any of the exclusion criteria. Potential participants were also informed that the interview would be audio-recorded and that they had the right to withdraw their data up to 2 weeks after participating, after which time the data would be anonymised.

### **2.2 Interview schedule and procedure**

### *2.2.1 Interviews*

In this study, participants were asked about their experiences of living with scoliosis before they received the brace and once they had received the brace. From the overall larger themes that were generated from the participants' answers, subthemes were then extracted [17]. Braun and Clarke [17] recommend that thematic analysis should be seen as the foundation method for all qualitative analysis. They describe thematic analysis as a method for identifying, analysing and reporting patterns and themes within data. No specific interview schedule was used when carrying out the interviews; however, a list of overall questions was used to ensure consistency throughout all the interviews.

Semi-structured interviews are a common technique used in qualitative research as the method allows flexibility for both the researcher and the participant in regard to the fluidity and structure of the questions [18]. For this study, the semi-structured interview transcripts were analysed using thematic analysis [17]. Thematic analysis was adopted as it allows flexibility with regard to how the participants'

answers are organised, analysed and grouped [17]. Furthermore, the aim of thematic analysis is to obtain and extract themes from the written transcripts generated from the interviews.

An interview schedule was prepared at the beginning of the study. However, as the interviews were semi-structured, the schedule was only a guide, and based on the responses from the participants, further questions were also asked. The main areas covered by the interview schedule are related to the participants' lives before they received the brace and whether the brace had changed the individuals' quality of life. The questions were focused on gaining an insight into any changes to the participants' scoliosis that they thought were due to wearing the brace. The third set of questions focused on gaining an insight and understanding into the patients' feelings towards the brace. These questions asked the participants if they would change any aspect of the brace's design, and what if any problems they encountered (if any) whilst wearing the brace.

Participants who dropped out of the study were also interviewed, but with a slightly different interview schedule. Instead of the final set of questions focusing on satisfaction, the questions focused on the reasons why the participants dropped out and what could be improved in the future to stop this from occurring. Participants 1–6 continued with the trial, whilst participants 7 and 8 dropped out of the trial shortly after the interviews took place.

### **2.3 Results**

### *2.3.1 Themes and sub-themes*

From the interview transcripts, four major themes emerged as follows: the persistence of pain, the impact of the brace on pain and daily living, problems with the device and trial satisfaction.
