Design
We conducted a mixed-method pilot and feasibility study in a single French tertiary care centre (Departement of Physical and Rehabilitation Medicine, Cochin Hospital, Paris), that falls under the conceptual framework of feasibility as defined by Eldridge and colleagues [12]. Our study is reported in accordance with the STROBE checklist (Appendix 1) and COREQ guidelines [13, 14] (Appendix 2). Our internet survey is reported in accordance with the CHERRIES checklist (Appendix 3). All eligible patients who had a wearing brace referral between July 2019 and January 2020 were interviewed between July and September 2020. The mean time elapsed between referral and a follow-up interview for assessments was 9.8 (2.0) months.
Participants
Patients who had a multidisciplinary custom-made bracing consultation from July 2019 to January 2020 were consecutively screened. Those who fulfilled inclusion criteria were invited to participate in the study. Inclusion criteria were: 1/ age ≥ 40 years old, 2/ painful adult degenerative scoliosis (idiopathic or de novo), and 3/ having had a prescription for a rigid custom-made lumbar-sacral orthosis. Exclusion criteria were: 1/ spinal deformity secondary to a specific cause, 2/ insufficient proficiency in French, 3/ cognitive disorders, 4/ refusal to participate in the study, and 5/ patients under guardianship or curatorship. Individuals who were already using a brace were eligible, so as those for whom it was a new and first-time wearing brace referral.
Intervention
Multidisciplinary custom-made bracing consultation is designed to discuss prescription of custom-made brace in adults with spinal disorders and to implement measures to enhance adherence, as appropriate. It involves senior physicians in physical and rehabilitation medicine (EC,VN, CD, CN) with experience in prescribing custom-made bracing (prescription of ≥5 custom-made braces a month) and senior orthotists (SM, SG), in presence of the patients and their families. Firstly, indication of custom-made bracing is considered and discussed between health care providers and patients based on the assessments of impairments and activities and participation and the risk of progression of the deformity, as well as the willingness of patients to be treated with bracing. Secondly, if indication to bracing is retained, specific oral and written advice and follow-up are offered at the time of the brace prescription to enhance adherence to bracing and to monitor efficacy and safety. Patients are also instructed to contact the orthotist and/or the physicians as needed to adapt the brace.
Qualitative assessments
A provisional questionnaire was elaborated by a senior general practitioner (MOC) and a senior physician in physical and rehabilitation medicine (CN) in order to collect barriers and facilitators to bracing, as experienced by patients. The provisional questionnaire was reviewed by senior physicians (EC, MMLC, VN, FR, CD), physiotherapists (AR) and orthotists (SM, SG). After consensus, five categories were included in the final version of the questionnaire (Appendix 4): 1/ material fabrication, 2/ acceptability of bracing, 3/ side effects and self-reported solutions, 4/ barriers to bracing and self-reported solutions, and 5/ facilitators to bracing.
A single investigator, a female general practitioner (MOC), contacted consecutively all eligible patients by phone from July to September 2020 to invite them to participate in the study. If a patient did not respond after two phone calls on two different days or refused to participate, he was considered as having declined participation. At the beginning of each phone contact, the investigator introduced herself and explained the purpose of the study, then started the interview following the prespecified interview guide (Appendix 4). The mean duration for each interview was 45 min. Each interview was audiorecorded then transcribed. When a participant was not able to answer an open question, answering a checklist was offered. Verbatims were analyzed for thematic analysis by two female investigators (MOC, FD), who received a specific training in qualitative research before the study. The two investigators manually and independently extracted key themes from the verbatims [13, 14]. The individual interview guide was not refined during the study.
Quantitative assessments
On the same day as the phone contact, the investigator sent an email with a link to the online self-administered questionnaires, as well as an anonymization number. If the self-administered questionnaires were not completed within 2 weeks, a reminding e-mail was sent to patients. If a participant could not complete the self-administered questionnaires online, he/she could complete it by phone with the investigator. If a participant did not complete the questionnaires online or by phone, after at least one reminder, he/she was considered as non-respondent to the quantitative assessments. Five outcomes were assessed post-intervention: 1/ lumbar pain using a numeric rating scale (0, no pain to 10, maximal pain), 2/ radicular pain scale using a numeric rating scale (0, no pain to 10, maximal pain) [15], 3/ spine-specific activity limitations using the Oswestry disability index (ODI, 10 items, each one rated from 0, no limitations, to 5, maximal limitations; a minimal disability corresponds to a score between 0 and 20, a moderate disability between 21 and 40 and a severe disability between 41 and 60) [16, 17]; 4/ symptoms of depression using the patient health questionnaire-2 (PHQ-2, 2 questions, each one rated from 0, no symptoms to 3, symptoms almost every day; if the score is ≥3, major depressive disorder is likely) [18, 19], and 5/ satisfaction with bracing using the Quebec user evaluation of satisfaction with assistive technology (QUEST) questionnaire (12 questions, each one rated from 0, not satisfied at all to 5, very satisfied) [20]. The QUEST questionnaire evaluates the satisfaction of the patient with its assistive technology. We chose this questionnaire because evidence suggests good psychometric properties [21]. Minimum clinically important difference for low back pain intensity, leg pain intensity and Oswestry Disability Index has been previously reported [22], but is not available for PHQ-2 and QUEST questionnaires, yet.
Statistical analysis
Discrete variables were expressed as absolute frequencies (n/N [%]). Continuous variables were expressed as mean (SD). All analyses were performed using the Excel software.
Ethical consideration and funding statement
Our study was not funded. It was approved by our institutional review board (CERAPHP, IRB registration #00011928). All participants were informed and gave consent to participate.