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

and the EQ-5D-Y, a moderation analysis across the subgroups, and attrition analysis of the characteristics of these participants and their reasons. Adoption to specific settings is expected to be assessed easily by the online delivery of this intervention. The implementation will be eval- uated by recording the number of interventions delivered perfectly, the adaptations made over the course of the study, the total budget, and the consistency of implementation across the eight weeks. Maintenance will be assessed by the measurement of all outcomes at the follow-up assessment in week eight, attrition rate, and analysis of the subgroups for each of these items. The final fully powered RCT, should it proceed based on results of this feasibility study, will assess a primary outcome of post-intervention cognitive engagement, meaning the knowledge translation for each video for weeks 1–6 and retention for all videos at Week 8. Secondary out- comes will be knowledge retention one week later for each of the six videos for weeks 2–7; affective & behavioural engagement from YouTube analytics determined by like/dislike, watch-time, number of views; health related quality of life measured by the SRS-22r and the EQ-5D-Y, anxiety measured by the STAI-Ch, and physical activity measured by the PAQ-C. Secondary outcomes will be measured at baseline and week 8. The SPIRIT schedule of enrolment, interventions, and assessments is shown in Fig 1. Statistical analysis SPSS version 27.0 for Mac (SPSS, IBM Inc., Chicago, IL) will be used to analyse study data.

Ratio and interval variables (YouTube analytics) will be analysed for differences by ANOVA. The remaining ordinal variables will have differences between groups analysed using Fried- mans. Pre- and post-test changes will be analysed using Kruskal-Wallis. Comparisons will be made using intention-to-treat principles. Generalised estimating equations (GEE) will be used to evaluate the relationship between the design characteristics and the measures of engagement. Each of the characteristics described above (Watch time / Total time (%), Retention (%)), Time spent on specific seg- ments, Mean view duration (minutes:seconds) will be included as co-variates in separate GEE models for each measure of engagement. There was an audit of previous year’s records to note that were approximately 60 eligible participants over twelve months in one of the private practice recruitment sites, and this will be in addition to social media and advocacy groups advertising (with two advocacy groups having 2542 and 579 followers in Ireland), as well as two other pending consultant clinics. Sta- tistical power of 80% for the eventual RCT has been calculated using GPower [62] to detect a minimum change of 1 out of 5 in the primary outcome, knowledge quizzes, with a one-way ANOVA to compare three groups with an alpha of 0.05 and determined that a sample size of Table 3. Protocol for adverse events. Potential event Research member responsible Action to be taken Participant distress from answering mental health questions Primary author will be available by phone or electronic means

Provide support and explain the rationale for the questions in the outcome measures and if needed, liaising with a psychologist with experience in treating an AIS population. Participant distress from receiving unexpected information about AIS Primary author will be available by phone or electronic means Answer any AIS-related questions and provide reassurance where needed. Onward referral can be made back to any scoliosis-specialised health services that the participant is already attending, or to a healthcare practitioner known to the primary author who has experience with this population https://doi.org/10.1371/journal.pone.0297394.t003 PLOS ONE Multimedia education materials for adolescent idiopathic scoliosis PLOS ONE | https://doi.org/10.1371/journal.pone.0297394 May 23, 2024 7 / 14