Designing multimedia patient education materials for adolescent idiopathic scoliosis: A protocol for a feasibility randomized controlled trial of patient education videos

consideration of the CONSORT guidelines for feasibility studies and the TIDieR [49] and RoB-2 [50] appraisal tools. The RE-AIM framework [45] will be used to ensure proper consid- eration of sustainable adoption and implementation. While it is not expected or intended, any changes to the trial protocol will be reported along with reasons for such changes. The trial is approved by University College Dublin Human Research Ethics Committee (LS-23- 15-VanOirschot-Doherty, 3 May 2023). Participants The inclusion criteria will be as follows: aged 10–18 years, parent/guardian consent for those under 18 years of age, AIS confirmed during adolescence by Cobb angle �10deg on plain film radiographs, able to watch and listen to online educational materials as well as read and com- plete online surveys. The age and 10-degree cut-off criteria were selected to ensure consistency with previous AIS literature [11,51] and international research bodies [52]. Non-AIS scoliosis including but not limited to neurological conditions will be excluded. Patient and public involvement Two individuals over age 18 who have been through the adolescent care pathway for AIS were consulted when designing the study protocol for feedback on the design and educational con- tent to be used in the interventions. Information was also sought from a physiotherapist who treats scoliosis on a daily basis and collaborates with scoliosis orthopaedic surgeons in Ireland. Their opinion will also be sought about disseminating the results, which parts of the results should be shared, and in which digital/or print format.

Recruitment Participants will be recruited via three private healthcare clinics serving an AIS population and three scoliosis advocacy groups based in Ireland using verbal, digital and poster advertising within these organizations alongside social media and word of mouth. The primary author, a PhD student and physiotherapist of 18 years’ experience with a post-graduate musculoskeletal and sports masters degree, will conduct the preliminary screening and provide the participant information package to those who express interest. All participants will be screened by phone or by video call prior to inclusion, and all participants not meeting eligibility will have their exclusion reasons recorded but without any identifying information. Advertising and recruit- ment opened on 28 November 2023, with the study due to commence in early 2024. Consent process Informed consent will be sought from all potential participants meeting the inclusion criteria. The primary author will discuss the trial methodology and answer any questions or concerns about the trial before taking consent / assent electronically. Those aged 18 will be able to con- sent for themselves, while potential participants under the age of 18 will require parent/guard- ian consent before granting assent themselves. All participant rights will remain protected. Fidelity Treatment fidelity for the two video intervention groups will be monitored through YouTube analytics, which will show the lack of views for each participant with their video or with sec- tions of video that are skipped over. PLOS ONE

Multimedia education materials for adolescent idiopathic scoliosis PLOS ONE | https://doi.org/10.1371/journal.pone.0297394 May 23, 2024 3 / 14