Aim 1

A user-centered design is presently being conducted at SHC-Canada, a bilingual (French and English), university-affiliated orthopedic hospital, inviting input on a global scale. Adoption of a user-centric design and a “user experience of websites” conceptual framework [46,47] will guide the collaborative and participatory design and development of Teens OI, addressing prior limitations including developing eHealth interventions without explicit theoretical frameworks, using single measures with limited end user input, and neglecting environmental factors [48]. By partnering with the end users (ie, youths with all OI Types and their parents) from study onset [49], we will lay the foundations for an effective eHealth program and ensure the content and format of the program are relevant, acceptable, and culturally sensitive [16,35,39,40,50]. Aligned with Shriners’ Mission and FOCUSED philosophy of care [51,52], we are seeking to close the transitional care gap encountered by youths with OI and their families, improve the quality of health care services, and help youths and their families better manage OI. Our analysis of all education material for patients with OI at SHC-Canada revealed the dearth of resources available, targeting solely the parents of patients with OI [53]. Hence, our team has partnered with the end users from the study onset with the goal of introducing a series of eHealth programs to complement our existing health care services and enhance the global reach of Shriners [12,54].

A “Website Design and Development Council” (ie, Council) has been convened. Membership comprises patients, parents, health professionals, and decision makers (n=8-12) from the study site and the greater OI community. Maximum variation sampling techniques were used to recruit 20 youth-parent dyads from SHC-Canada over 5-10 cycles. The inclusion criteria consisted of (1) youths between 12 and 21 years of age; (2) youths receiving OI care at the study site; and (3) both youths and parents able to speak and read English or French. The exclusion criteria excluded youths if they had major cognitive impairments or comorbid medical or psychiatric illnesses that may impact their ability to understand and use the program. The power of the maximum variation sampling technique used lies in selecting information-rich cases for in-depth study, which maximizes variation and diversity. The variability affords a more comprehensive understanding of the many diverse experiences that will enhance the design and development of Teens OI and the transferability of the proposed eHealth platform. While a sample size of 20 youths and parent dyads was proposed, the sample size was tentative and may change based on achieving data saturation and the desire for a diverse sample (eg, cultural, linguistic, OI type, and severity of disability) [55,56]. About 150 eligible patients with OI were followed at the study site. Our experiences suggest there is substantial interest in study participation, with over >90% of participation rated as experienced at the study site [22]. Our youths and their parents remain concerned about their impending transition and welcome the proposed support [12,14,16].

A multipronged approach was used to announce the study and commence recruitment (Multimedia Appendix 1). To protect the families’ privacy, the health care team assisted by identifying, screening, and approaching the families to determine if they were interested in hearing more about the study. If the patients express interest in hearing more about the study, their names and contact information are provided to the clinical research coordinator, who approaches the patients, provides a verbal and written explanation of the study, and, if agreeable, obtains written informed consent for study participation and audio-taping. Parents consent for their child to participate, and they consent for themselves to participate. Youths aged 12-13 years, provide assent and youths aged 14-21 years provide consent (Multimedia Appendix 2). Each study participant receives a copy of the consent. The health care professionals consider patients’ health status and interest in participating in the study during regularly scheduled clinic appointments and in-patient visits. The recruitment method will be supplemented, if needed, by sending a study postal information letter, signed by their medical doctor and principal investigator, inviting them to participate at home.

The Council will oversee the design and development of Teens OI using Garrett’s Theory of User Experience [47]. Garrett proposed the following 5 different planes of a website that affect the user experience: surface, skeleton, structure, scope, and strategy, which have been used for understanding and improving youths’ exposure to internet-delivered interventions [46,47]. The Council will receive training in patient engagement and partnerships, which includes topics of cultural competency [57], mutual respect, and inclusivity [58]. Conceptboard, a centralized hub for content and ideas for visual projects, will be used to facilitate the web-based, real-time, collaborative design and development of Teens OI with the global OI community and eliminate social distancing barriers due to COVID-19 [44]. Varying data will be collected in English and French by conducting youths’ and their parents’ interviews and focus groups; hosting 2 symposiums at SHC-Canada; presenting ongoing work; soliciting input from OI experts; and surveying the OI community using Qualtrics. Presently, we foresee 12 interactive, multicomponent modules adapted from Teens JIA [28] being designed for our diverse English- and French-speaking populations. Although draft modules have been created, we will inquire about topics and create, modify, or eliminate draft modules as needed. Other features such as multimedia (eg, video and audio) and other interactive, technological features (eg, discussion boards, animations, quizzes, stories of hope, and video clips) will be designed and developed with input from the end users.

Guided by Garrett’s 5 planes contributing to users’ experiences of websites [47], interview guides (Multimedia Appendix 3) outlining the procedures, questions, and probes have been created to guide discussions of website development and design, user experiences, and tools to solve related problems (1-2 cycles per plane). While each plane will be addressed individually, the discussion will naturally combine all planes. Field notes and feedback from the first cycle of interviews and focus groups will inform the discussion for subsequent cycles of data collection. With 117 user experience instruments available, the Council will decide on the quantitative metrics of the design and development of Teens OI [59]. One sociodemographic survey will be used to collect demographic, health, and internet-use characteristics [12,16].

All survey data are being descriptively analyzed using SAS (version 9.4; SAS Institute Cary). Observations, field notes, and transcribed data will be imported into NVivo (version 12; QSR International Pty Ltd) for data management and analysis. The qualitative data are analyzed using content analysis techniques involving an iterative process of data reduction, data display, conclusion drawing, and verification [60]. All data will be analyzed and triangulated in each of the 5 planes, fostering the process of “building from the bottom to the top” and “moving from abstract to concrete,” allowing for refinement of Teens OI between each cycle within each of the 5 planes [47]. Individual and aggregate comparisons and contrasts of subgroups (eg, parent or youth [22,61,62]; English or French; OI Types and disability severity) are lending insight into how to synergize results and establish consensus with participants and the Council to maximize the inclusivity of Teens OI. An audit trail, composed primarily of methodological and analytical documentation, will be kept to permit the transferability of this innovative process [63]. Unanimous support from the Council to proceed to Aim 2 will be sought.